atrs-10q_20200930.htm
10-Q false Q3 0001016169 --12-31 P3Y P6Y9M18D P5Y7M6D 0.10 0.10 0.10 0.10 0.10 0.10 0001016169 2020-01-01 2020-09-30 xbrli:shares 0001016169 2020-11-02 iso4217:USD 0001016169 2020-09-30 0001016169 2019-12-31 iso4217:USD xbrli:shares 0001016169 us-gaap:ProductMember 2020-07-01 2020-09-30 0001016169 us-gaap:ProductMember 2019-07-01 2019-09-30 0001016169 us-gaap:ProductMember 2020-01-01 2020-09-30 0001016169 us-gaap:ProductMember 2019-01-01 2019-09-30 0001016169 atrs:LicensingAndDevelopmentRevenueMember 2020-07-01 2020-09-30 0001016169 atrs:LicensingAndDevelopmentRevenueMember 2019-07-01 2019-09-30 0001016169 atrs:LicensingAndDevelopmentRevenueMember 2020-01-01 2020-09-30 0001016169 atrs:LicensingAndDevelopmentRevenueMember 2019-01-01 2019-09-30 0001016169 us-gaap:RoyaltyMember 2020-07-01 2020-09-30 0001016169 us-gaap:RoyaltyMember 2019-07-01 2019-09-30 0001016169 us-gaap:RoyaltyMember 2020-01-01 2020-09-30 0001016169 us-gaap:RoyaltyMember 2019-01-01 2019-09-30 0001016169 2020-07-01 2020-09-30 0001016169 2019-07-01 2019-09-30 0001016169 2019-01-01 2019-09-30 0001016169 atrs:CostOfDevelopmentRevenueMember 2020-07-01 2020-09-30 0001016169 atrs:CostOfDevelopmentRevenueMember 2019-07-01 2019-09-30 0001016169 atrs:CostOfDevelopmentRevenueMember 2020-01-01 2020-09-30 0001016169 atrs:CostOfDevelopmentRevenueMember 2019-01-01 2019-09-30 0001016169 us-gaap:CommonStockMember 2020-06-30 0001016169 us-gaap:AdditionalPaidInCapitalMember 2020-06-30 0001016169 us-gaap:RetainedEarningsMember 2020-06-30 0001016169 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-06-30 0001016169 2020-06-30 0001016169 us-gaap:CommonStockMember 2020-07-01 2020-09-30 0001016169 us-gaap:AdditionalPaidInCapitalMember 2020-07-01 2020-09-30 0001016169 us-gaap:RetainedEarningsMember 2020-07-01 2020-09-30 0001016169 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-07-01 2020-09-30 0001016169 us-gaap:CommonStockMember 2020-09-30 0001016169 us-gaap:AdditionalPaidInCapitalMember 2020-09-30 0001016169 us-gaap:RetainedEarningsMember 2020-09-30 0001016169 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-09-30 0001016169 us-gaap:CommonStockMember 2019-12-31 0001016169 us-gaap:AdditionalPaidInCapitalMember 2019-12-31 0001016169 us-gaap:RetainedEarningsMember 2019-12-31 0001016169 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-12-31 0001016169 us-gaap:CommonStockMember 2020-01-01 2020-09-30 0001016169 us-gaap:AdditionalPaidInCapitalMember 2020-01-01 2020-09-30 0001016169 us-gaap:RetainedEarningsMember 2020-01-01 2020-09-30 0001016169 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-01-01 2020-09-30 0001016169 us-gaap:CommonStockMember 2019-06-30 0001016169 us-gaap:AdditionalPaidInCapitalMember 2019-06-30 0001016169 us-gaap:RetainedEarningsMember 2019-06-30 0001016169 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-06-30 0001016169 2019-06-30 0001016169 us-gaap:CommonStockMember 2019-07-01 2019-09-30 0001016169 us-gaap:AdditionalPaidInCapitalMember 2019-07-01 2019-09-30 0001016169 us-gaap:RetainedEarningsMember 2019-07-01 2019-09-30 0001016169 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-07-01 2019-09-30 0001016169 us-gaap:CommonStockMember 2019-09-30 0001016169 us-gaap:AdditionalPaidInCapitalMember 2019-09-30 0001016169 us-gaap:RetainedEarningsMember 2019-09-30 0001016169 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-09-30 0001016169 2019-09-30 0001016169 us-gaap:CommonStockMember 2018-12-31 0001016169 us-gaap:AdditionalPaidInCapitalMember 2018-12-31 0001016169 us-gaap:RetainedEarningsMember 2018-12-31 0001016169 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2018-12-31 0001016169 2018-12-31 0001016169 us-gaap:CommonStockMember 2019-01-01 2019-09-30 0001016169 us-gaap:AdditionalPaidInCapitalMember 2019-01-01 2019-09-30 0001016169 us-gaap:RetainedEarningsMember srt:CumulativeEffectPeriodOfAdoptionAdjustmentMember 2019-09-30 0001016169 srt:CumulativeEffectPeriodOfAdoptionAdjustmentMember 2019-09-30 0001016169 us-gaap:RetainedEarningsMember 2019-01-01 2019-09-30 0001016169 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-01-01 2019-09-30 atrs:ProprietaryProduct 0001016169 us-gaap:FairValueInputsLevel1Member 2020-09-30 0001016169 us-gaap:FairValueInputsLevel1Member 2019-12-31 0001016169 srt:MinimumMember atrs:ComputerEquipmentAndSoftwareMember 2020-01-01 2020-09-30 0001016169 atrs:ComputerEquipmentAndSoftwareMember srt:MaximumMember 2020-01-01 2020-09-30 0001016169 srt:MinimumMember atrs:FurnitureFixturesAndOfficeEquipmentMember 2020-01-01 2020-09-30 0001016169 atrs:FurnitureFixturesAndOfficeEquipmentMember srt:MaximumMember 2020-01-01 2020-09-30 0001016169 srt:MinimumMember atrs:ProductionMoldsToolingAndEquipmentMember 2020-01-01 2020-09-30 0001016169 atrs:ProductionMoldsToolingAndEquipmentMember srt:MaximumMember 2020-01-01 2020-09-30 0001016169 us-gaap:LeaseholdImprovementsMember 2020-01-01 2020-09-30 xbrli:pure 0001016169 atrs:TevaMember 2020-01-01 2020-09-30 0001016169 srt:MinimumMember 2020-01-01 2020-09-30 0001016169 srt:MaximumMember 2020-01-01 2020-09-30 0001016169 atrs:TermLoanMember atrs:HerculesCapitalIncMember 2017-06-01 2017-06-30 0001016169 atrs:TermLoanTrancheTwoMember atrs:HerculesCapitalIncMember 2019-05-27 2019-06-26 0001016169 atrs:TermLoanTrancheThreeMember atrs:HerculesCapitalIncMember srt:MinimumMember atrs:SecondAmendmentMember 2020-09-15 0001016169 atrs:TermLoanTrancheThreeMember atrs:HerculesCapitalIncMember srt:MaximumMember atrs:SecondAmendmentMember 2020-09-15 0001016169 us-gaap:PrimeRateMember atrs:HerculesCapitalIncMember atrs:TermLoanMember 2020-01-01 2020-09-30 0001016169 atrs:HerculesCapitalIncMember atrs:TermLoanMember 2020-09-30 0001016169 atrs:HerculesCapitalIncMember atrs:TermLoanMember 2019-12-31 0001016169 atrs:HerculesCapitalIncMember atrs:TermLoanMember 2020-01-01 2020-09-30 0001016169 atrs:HerculesCapitalIncMember atrs:TermLoanMember atrs:FirstAmendmentMember 2020-01-01 2020-09-30 0001016169 us-gaap:PerformanceSharesMember 2019-12-31 0001016169 us-gaap:RestrictedStockUnitsRSUMember 2019-12-31 0001016169 us-gaap:PerformanceSharesMember 2020-01-01 2020-09-30 0001016169 us-gaap:RestrictedStockUnitsRSUMember 2020-01-01 2020-09-30 0001016169 us-gaap:PerformanceSharesMember 2020-09-30 0001016169 us-gaap:RestrictedStockUnitsRSUMember 2020-09-30 0001016169 us-gaap:PerformanceSharesMember atrs:LongTermIncentiveProgramMember 2020-01-01 2020-09-30 0001016169 us-gaap:PerformanceSharesMember atrs:LongTermIncentiveProgramMember srt:MinimumMember 2020-01-01 2020-09-30 0001016169 us-gaap:PerformanceSharesMember atrs:LongTermIncentiveProgramMember srt:MaximumMember 2020-01-01 2020-09-30 0001016169 atrs:EmployeesTaxObligationsMember 2020-01-01 2020-09-30 0001016169 atrs:EmployeesTaxObligationsMember 2019-01-01 2019-09-30 0001016169 atrs:LongTermIncentiveProgramMember us-gaap:EmployeeStockOptionMember 2020-07-01 2020-09-30 0001016169 atrs:LongTermIncentiveProgramMember us-gaap:EmployeeStockOptionMember 2019-07-01 2019-09-30 0001016169 atrs:LongTermIncentiveProgramMember us-gaap:EmployeeStockOptionMember 2020-01-01 2020-09-30 0001016169 atrs:LongTermIncentiveProgramMember us-gaap:EmployeeStockOptionMember 2019-01-01 2019-09-30 0001016169 atrs:LongTermIncentiveProgramMember us-gaap:RestrictedStockUnitsRSUMember 2020-07-01 2020-09-30 0001016169 atrs:LongTermIncentiveProgramMember us-gaap:RestrictedStockUnitsRSUMember 2019-07-01 2019-09-30 0001016169 atrs:LongTermIncentiveProgramMember us-gaap:RestrictedStockUnitsRSUMember 2020-01-01 2020-09-30 0001016169 atrs:LongTermIncentiveProgramMember us-gaap:RestrictedStockUnitsRSUMember 2019-01-01 2019-09-30 0001016169 atrs:LongTermIncentiveProgramMember us-gaap:PerformanceSharesMember 2020-07-01 2020-09-30 0001016169 atrs:LongTermIncentiveProgramMember us-gaap:PerformanceSharesMember 2019-07-01 2019-09-30 0001016169 atrs:LongTermIncentiveProgramMember us-gaap:PerformanceSharesMember 2019-01-01 2019-09-30 0001016169 atrs:LongTermIncentiveProgramMember 2020-07-01 2020-09-30 0001016169 atrs:LongTermIncentiveProgramMember 2019-07-01 2019-09-30 0001016169 atrs:LongTermIncentiveProgramMember 2020-01-01 2020-09-30 0001016169 atrs:LongTermIncentiveProgramMember 2019-01-01 2019-09-30 0001016169 atrs:ProprietaryProductMember us-gaap:SalesMember 2020-07-01 2020-09-30 0001016169 atrs:ProprietaryProductMember us-gaap:SalesMember 2019-07-01 2019-09-30 0001016169 atrs:ProprietaryProductMember us-gaap:SalesMember 2020-01-01 2020-09-30 0001016169 atrs:ProprietaryProductMember us-gaap:SalesMember 2019-01-01 2019-09-30 0001016169 atrs:PartneredProductMember us-gaap:SalesMember 2020-07-01 2020-09-30 0001016169 atrs:PartneredProductMember us-gaap:SalesMember 2019-07-01 2019-09-30 0001016169 atrs:PartneredProductMember us-gaap:SalesMember 2020-01-01 2020-09-30 0001016169 atrs:PartneredProductMember us-gaap:SalesMember 2019-01-01 2019-09-30 0001016169 us-gaap:SalesMember 2020-07-01 2020-09-30 0001016169 us-gaap:SalesMember 2019-07-01 2019-09-30 0001016169 us-gaap:SalesMember 2020-01-01 2020-09-30 0001016169 us-gaap:SalesMember 2019-01-01 2019-09-30 0001016169 atrs:LicensingAndDevelopmentRevenueMember 2020-07-01 2020-09-30 0001016169 atrs:LicensingAndDevelopmentRevenueMember 2019-07-01 2019-09-30 0001016169 atrs:LicensingAndDevelopmentRevenueMember 2020-01-01 2020-09-30 0001016169 atrs:LicensingAndDevelopmentRevenueMember 2019-01-01 2019-09-30 0001016169 atrs:RoyaltiesRevenueMember 2020-07-01 2020-09-30 0001016169 atrs:RoyaltiesRevenueMember 2019-07-01 2019-09-30 0001016169 atrs:RoyaltiesRevenueMember 2020-01-01 2020-09-30 0001016169 atrs:RoyaltiesRevenueMember 2019-01-01 2019-09-30 0001016169 country:US 2020-07-01 2020-09-30 0001016169 country:US 2019-07-01 2019-09-30 0001016169 country:US 2020-01-01 2020-09-30 0001016169 country:US 2019-01-01 2019-09-30 0001016169 srt:EuropeMember 2020-07-01 2020-09-30 0001016169 srt:EuropeMember 2019-07-01 2019-09-30 0001016169 srt:EuropeMember 2020-01-01 2020-09-30 0001016169 srt:EuropeMember 2019-01-01 2019-09-30 0001016169 atrs:OtherGeographicalAreaMember 2019-07-01 2019-09-30 0001016169 atrs:OtherGeographicalAreaMember 2019-01-01 2019-09-30 0001016169 atrs:TevaMember us-gaap:CustomerConcentrationRiskMember 2020-07-01 2020-09-30 0001016169 atrs:TevaMember us-gaap:CustomerConcentrationRiskMember 2019-07-01 2019-09-30 0001016169 atrs:TevaMember us-gaap:CustomerConcentrationRiskMember 2020-01-01 2020-09-30 0001016169 atrs:TevaMember us-gaap:CustomerConcentrationRiskMember 2019-01-01 2019-09-30 0001016169 atrs:AMAGPharmaceuticalsIncMember srt:MaximumMember us-gaap:CustomerConcentrationRiskMember 2020-07-01 2020-09-30 0001016169 atrs:AMAGPharmaceuticalsIncMember us-gaap:CustomerConcentrationRiskMember 2019-07-01 2019-09-30 0001016169 atrs:AMAGPharmaceuticalsIncMember us-gaap:CustomerConcentrationRiskMember 2020-01-01 2020-09-30 0001016169 atrs:AMAGPharmaceuticalsIncMember us-gaap:CustomerConcentrationRiskMember 2019-01-01 2019-09-30 0001016169 atrs:McKessonCorporationMember us-gaap:CustomerConcentrationRiskMember 2020-07-01 2020-09-30 0001016169 atrs:McKessonCorporationMember srt:MaximumMember us-gaap:CustomerConcentrationRiskMember 2019-07-01 2019-09-30 0001016169 atrs:McKessonCorporationMember us-gaap:CustomerConcentrationRiskMember 2020-01-01 2020-09-30 0001016169 atrs:McKessonCorporationMember srt:MaximumMember us-gaap:CustomerConcentrationRiskMember 2019-01-01 2019-09-30 0001016169 atrs:AmerisourceBergenCorporationMember us-gaap:CustomerConcentrationRiskMember 2020-07-01 2020-09-30 0001016169 atrs:AmerisourceBergenCorporationMember us-gaap:CustomerConcentrationRiskMember 2019-07-01 2019-09-30 0001016169 atrs:AmerisourceBergenCorporationMember us-gaap:CustomerConcentrationRiskMember 2020-01-01 2020-09-30 0001016169 atrs:AmerisourceBergenCorporationMember srt:MaximumMember us-gaap:CustomerConcentrationRiskMember 2019-01-01 2019-09-30 0001016169 atrs:CardinalHealthMember us-gaap:CustomerConcentrationRiskMember 2020-07-01 2020-09-30 0001016169 atrs:CardinalHealthMember srt:MaximumMember us-gaap:CustomerConcentrationRiskMember 2019-07-01 2019-09-30 0001016169 atrs:CardinalHealthMember us-gaap:CustomerConcentrationRiskMember 2020-01-01 2020-09-30 0001016169 atrs:CardinalHealthMember srt:MaximumMember us-gaap:CustomerConcentrationRiskMember 2019-01-01 2019-09-30 0001016169 atrs:FerringInternationalCenterSAAndItsAffiliatesMember atrs:LicenseAgreementMember us-gaap:SubsequentEventMember 2020-10-01 2020-10-01 0001016169 atrs:FerringInternationalCenterSAAndItsAffiliatesMember atrs:LicenseAgreementMember us-gaap:SubsequentEventMember srt:MaximumMember 2020-10-01 2020-10-01

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

 

    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2020

    TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period ________ to ________

Commission File Number 1-32302

 

ANTARES PHARMA, INC.

 

 

A Delaware Corporation

(State or Other Jurisdiction of Incorporation)

 

41-1350192

(I.R.S. Employer Identification No.)

 

100 Princeton South, Suite 300, Ewing, NJ

 

08628

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (609) 359-3020

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.01 per share

 

ATRS

 

NASDAQ

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes      No  

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

 

  

Accelerated filer

 

 

 

 

 

 

 

 

Non–accelerated filer

 

☐  

  

Smaller reporting company

 

 

 

 

 

 

 

 

Emerging growth company

 

  

 

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.          

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes      No  

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.     Yes      No  

As of November 2, 2020, the registrant had 166,672,429 shares of common stock, $0.01 par value per share, outstanding.

 

 

 


 

ANTARES PHARMA, INC.

INDEX

 

 

 

 

 

 

 

PAGE

 

 

 

 

 

 

 

PART I.

 

 

 

FINANCIAL INFORMATION

 

3

 

 

 

 

 

 

 

 

 

Item 1.

 

Financial Statements

 

3

 

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets as of September 30, 2020 and December 31, 2019 (Unaudited)

 

3

 

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2020 and 2019 (Unaudited)

 

4

 

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Comprehensive Income (Loss) for the three and nine months ended September 30, 2020 and 2019 (Unaudited)

 

5

 

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three and nine months ended September 30, 2020 and 2019 (Unaudited)

 

6

 

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2020 and 2019 (Unaudited)

 

8

 

 

 

 

 

 

 

 

 

 

 

Notes to Condensed Consolidated Financial Statements (Unaudited)

 

9

 

 

 

 

 

 

 

 

 

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

18

 

 

 

 

 

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

26

 

 

 

 

 

 

 

 

 

Item 4.

 

Controls and Procedures

 

26

 

 

 

 

 

 

 

PART II.

 

 

 

OTHER INFORMATION

 

27

 

 

 

 

 

 

 

 

 

Item 1.

 

Legal Proceedings

 

27

 

 

 

 

 

 

 

 

 

Item 1A.

 

Risk Factors

 

27

 

 

 

 

 

 

 

 

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

29

 

 

 

 

 

 

 

 

 

Item 3.

 

Default Upon Senior Securities

 

29

 

 

 

 

 

 

 

 

 

Item 4.

 

Mine Safety Disclosures

 

29

 

 

 

 

 

 

 

 

 

Item 5.

 

Other Information

 

29

 

 

 

 

 

 

 

 

 

Item 6.

 

Exhibits

 

30

 

 

 

 

 

 

 

 

 

 

 

SIGNATURES

 

31

 

 

 

2


 

PART I – FINANCIAL INFORMATION

Item 1.

FINANCIAL STATEMENTS

ANTARES PHARMA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except per share amounts)

(UNAUDITED)

 

 

 

September 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Assets

 

 

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

50,172

 

 

$

23,201

 

Short-term investments

 

 

1,997

 

 

 

22,520

 

Accounts receivable

 

 

42,507

 

 

 

35,074

 

Inventories

 

 

19,809

 

 

 

16,000

 

Contract assets

 

 

8,784

 

 

 

8,235

 

Prepaid expenses and other current assets

 

 

1,851

 

 

 

3,416

 

Total current assets

 

 

125,120

 

 

 

108,446

 

Property and equipment, net

 

 

22,547

 

 

 

15,961

 

Operating lease right-of-use assets

 

 

4,881

 

 

 

5,463

 

Other assets

 

 

3,026

 

 

 

2,881

 

Total Assets

 

$

155,574

 

 

$

132,751

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

18,016

 

 

$

12,905

 

Accrued expenses and other liabilities

 

 

22,846

 

 

 

17,772

 

Long-term debt, current portion

 

 

6,415

 

 

 

 

Deferred revenue

 

 

3,277

 

 

 

1,738

 

Total current liabilities

 

 

50,554

 

 

 

32,415

 

Long-term debt

 

 

34,358

 

 

 

40,395

 

Operating lease liabilities, long-term

 

 

4,940

 

 

 

5,441

 

Other long-term liabilities

 

 

481

 

 

 

 

Total liabilities

 

 

90,333

 

 

 

78,251

 

Stockholders’ Equity:

 

 

 

 

 

 

 

 

Preferred Stock: $0.01 par; 3,000 shares authorized, none outstanding

 

 

 

 

 

 

Common Stock: $0.01 par; 300,000 shares authorized; 166,672 and

    165,221 issued and outstanding at September 30, 2020 and

   December 31, 2019, respectively

 

 

1,667

 

 

 

1,652

 

Additional paid-in capital

 

 

338,277

 

 

 

332,377

 

Accumulated deficit

 

 

(274,012

)

 

 

(278,827

)

Accumulated other comprehensive loss

 

 

(691

)

 

 

(702

)

 

 

 

65,241

 

 

 

54,500

 

Total Liabilities and Stockholders’ Equity

 

$

155,574

 

 

$

132,751

 

 

See accompanying notes to condensed consolidated financial statements.

3


 

ANTARES PHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(UNAUDITED)

 

 

 

For the Three Months Ended

 

 

For the Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

$

28,947

 

 

$

24,687

 

 

$

80,709

 

 

$

63,607

 

Licensing and development revenue

 

 

4,321

 

 

 

1,211

 

 

 

8,763

 

 

 

4,365

 

Royalties

 

 

6,735

 

 

 

8,408

 

 

 

15,994

 

 

 

18,053

 

Total revenue

 

 

40,003

 

 

 

34,306

 

 

 

105,466

 

 

 

86,025

 

Cost of revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales

 

 

13,615

 

 

 

12,510

 

 

 

38,556

 

 

 

33,791

 

Cost of development revenue

 

 

2,902

 

 

 

552

 

 

 

5,485

 

 

 

2,658

 

Total cost of revenue

 

 

16,517

 

 

 

13,062

 

 

 

44,041

 

 

 

36,449

 

Gross profit

 

 

23,486

 

 

 

21,244

 

 

 

61,425

 

 

 

49,576

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

2,405

 

 

 

2,863

 

 

 

7,803

 

 

 

7,744

 

Selling, general and administrative

 

 

15,231

 

 

 

16,385

 

 

 

46,101

 

 

 

46,407

 

Total operating expenses

 

 

17,636

 

 

 

19,248

 

 

 

53,904

 

 

 

54,151

 

Operating income (loss)

 

 

5,850

 

 

 

1,996

 

 

 

7,521

 

 

 

(4,575

)

Interest expense

 

 

(782

)

 

 

(1,097

)

 

 

(2,810

)

 

 

(2,470

)

Other income (expense)

 

 

(72

)

 

 

144

 

 

 

104

 

 

 

323

 

Net income (loss)

 

$

4,996

 

 

$

1,043

 

 

$

4,815

 

 

$

(6,722

)

Net income (loss) per common share, basic and diluted

 

$

0.03

 

 

$

0.01

 

 

$

0.03

 

 

$

(0.04

)

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

166,375

 

 

 

163,119

 

 

 

165,838

 

 

 

162,109

 

Diluted

 

 

169,655

 

 

 

168,503

 

 

 

169,759

 

 

 

162,109

 

 

See accompanying notes to condensed consolidated financial statements.

4


 

ANTARES PHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(in thousands)

(UNAUDITED)

 

 

 

For the Three Months Ended

 

 

For the Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net income (loss)

 

$

4,996

 

 

$

1,043

 

 

$

4,815

 

 

$

(6,722

)

Foreign currency translation adjustment

 

 

5

 

 

 

(2

)

 

 

11

 

 

 

(3

)

Comprehensive income (loss)

 

$

5,001

 

 

$

1,041

 

 

$

4,826

 

 

$

(6,725

)

 

See accompanying notes to condensed consolidated financial statements.

5


 

ANTARES PHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(in thousands)

(UNAUDITED)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional

Paid-In

Capital

 

 

Accumulated

Deficit

 

 

Other

Comprehensive

Loss

 

 

Total

Stockholders’

Equity

 

June 30, 2020

 

 

166,085

 

 

$

1,661

 

 

$

335,372

 

 

$

(279,008

)

 

$

(696

)

 

$

57,329

 

Common stock issued under equity

   compensation plan, net of

   shares withheld for taxes

 

 

7

 

 

 

 

 

 

(16

)

 

 

 

 

 

 

 

 

 

 

(16

)

Exercise of options

 

 

580

 

 

 

6

 

 

 

1,117

 

 

 

 

 

 

 

 

 

1,123

 

Share-based compensation

 

 

 

 

 

 

 

 

1,804

 

 

 

 

 

 

 

 

 

1,804

 

Net income

 

 

 

 

 

 

 

 

 

 

 

4,996

 

 

 

 

 

 

4,996

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5

 

 

 

5

 

September 30, 2020

 

 

166,672

 

 

$

1,667

 

 

$

338,277

 

 

$

(274,012

)

 

$

(691

)

 

$

65,241

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional

Paid-In

Capital

 

 

Accumulated

Deficit

 

 

Other

Comprehensive

Loss

 

 

Total

Stockholders’

Equity

 

December 31, 2019

 

 

165,221

 

 

$

1,652

 

 

$

332,377

 

 

$

(278,827

)

 

$

(702

)

 

$

54,500

 

Common stock issued under equity

   compensation plan, net of

   shares withheld for taxes

 

 

676

 

 

 

7

 

 

 

(1,373

)

 

 

 

 

 

 

 

 

(1,366

)

Exercise of options

 

 

775

 

 

 

8

 

 

 

1,504

 

 

 

 

 

 

 

 

 

1,512

 

Share-based compensation

 

 

 

 

 

 

 

 

5,769

 

 

 

 

 

 

 

 

 

5,769

 

Net income

 

 

 

 

 

 

 

 

 

 

 

4,815

 

 

 

 

 

 

4,815

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11

 

 

 

11

 

September 30, 2020

 

 

166,672

 

 

$

1,667

 

 

$

338,277

 

 

$

(274,012

)

 

$

(691

)

 

$

65,241

 

 

See accompanying notes to condensed consolidated financial statements.

6


 

ANTARES PHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (Cont.)

(in thousands)

(UNAUDITED)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional

Paid-In

Capital

 

 

Accumulated

Deficit

 

 

Other

Comprehensive

Loss

 

 

Total

Stockholders’

Equity

 

June 30, 2019

 

 

163,053

 

 

$

1,630

 

 

$

325,075

 

 

$

(284,449

)

 

$

(704

)

 

$

41,552

 

Common stock issued under equity

   compensation plan, net of

   shares withheld for taxes

 

 

9

 

 

 

1

 

 

 

(14

)

 

 

 

 

 

 

 

 

(13

)

Exercise of options

 

 

142

 

 

 

1

 

 

 

189

 

 

 

 

 

 

 

 

 

190

 

Share-based compensation

 

 

 

 

 

 

 

 

1,645

 

 

 

 

 

 

 

 

 

1,645

 

Net income

 

 

 

 

 

 

 

 

 

 

 

1,043

 

 

 

 

 

 

1,043

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2

)

 

 

(2

)

September 30, 2019

 

 

163,204

 

 

$

1,632

 

 

$

326,895

 

 

$

(283,406

)

 

$

(706

)

 

$

44,415

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional

Paid-In

Capital

 

 

Accumulated

Deficit

 

 

Other

Comprehensive

Loss

 

 

Total

Stockholders’

Equity

 

December 31, 2018

 

 

159,721

 

 

$

1,597

 

 

$

314,907

 

 

$

(276,800

)

 

$

(703

)

 

$

39,001

 

Issuance of common stock

 

 

2,307

 

 

 

23

 

 

 

7,758

 

 

 

 

 

 

 

 

 

7,781

 

Common stock issued under equity

   compensation plan, net of

   shares withheld for taxes

 

 

664

 

 

 

7

 

 

 

(1,084

)

 

 

 

 

 

 

 

 

(1,077

)

Exercise of options

 

 

512

 

 

 

5

 

 

 

669

 

 

 

 

 

 

 

 

 

674

 

Share-based compensation

 

 

 

 

 

 

 

 

4,645

 

 

 

 

 

 

 

 

 

4,645

 

Cumulative effect of change in

   accounting principle

 

 

 

 

 

 

 

 

 

 

 

116

 

 

 

 

 

 

116

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(6,722

)

 

 

 

 

 

(6,722

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3

)

 

 

(3

)

September 30, 2019

 

 

163,204

 

 

$

1,632

 

 

$

326,895

 

 

$

(283,406

)

 

$

(706

)

 

$

44,415

 

 

See accompanying notes to condensed consolidated financial statements.

 

 

 

 

 

 

 

7


 

ANTARES PHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(UNAUDITED)

 

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2020

 

 

2019

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net income (loss)

 

$

4,815

 

 

$

(6,722

)

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

5,769

 

 

 

4,645

 

Depreciation and amortization

 

 

1,730

 

 

 

1,916

 

Other

 

 

662

 

 

 

279

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(7,422

)

 

 

(14,957

)

Inventories

 

 

(3,809

)

 

 

(5,153

)

Contract assets

 

 

(549

)

 

 

1,743

 

Prepaid expenses and other assets

 

 

1,345

 

 

 

847

 

Accounts payable

 

 

5,171

 

 

 

4,669

 

Accrued expenses and other liabilities

 

 

4,967

 

 

 

2,854

 

Deferred revenue

 

 

1,538

 

 

 

394

 

Net cash provided by (used in) operating activities

 

 

14,217

 

 

 

(9,485

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(7,893

)

 

 

(1,274

)

Proceeds from sale of assets

 

 

 

 

 

2,500

 

Proceeds from maturities of investment securities

 

 

20,500

 

 

 

 

Net cash provided by investing activities

 

 

12,607

 

 

 

1,226

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of long-term debt

 

 

 

 

 

15,000

 

Payment of debt issuance costs

 

 

 

 

 

(136

)

Proceeds from issuance of common stock, net

 

 

 

 

 

7,781

 

Proceeds from exercise of stock options

 

 

1,512

 

 

 

674

 

Taxes paid related to net share settlement of equity awards

 

 

(1,366

)

 

 

(1,077

)

Net cash provided by financing activities

 

 

146

 

 

 

22,242

 

Effect of exchange rate changes on cash

 

 

1

 

 

 

(1

)

Net increase in cash and cash equivalents

 

 

26,971

 

 

 

13,982

 

Cash and cash equivalents:

 

 

 

 

 

 

 

 

Beginning of period

 

 

23,201

 

 

 

27,892

 

End of period

 

$

50,172

 

 

$

41,874

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

Cash paid for interest

 

$

2,679

 

 

$

2,073

 

Supplemental disclosure of non-cash investing activities:

 

 

 

 

 

 

 

 

Purchases of property and equipment recorded in accounts payable

   and accrued expenses

 

$

1,577

 

 

$

881

 

 

See accompanying notes to condensed consolidated financial statements.

 

 

8


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

 

 

1.

Description of Business

Antares Pharma, Inc. (“Antares,” “we,” “our,” “us” or the “Company”) is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products and technologies.  We develop, manufacture and commercialize, for ourselves or with partners, novel therapeutic products using advanced drug delivery technology to enhance existing drug compounds and delivery methods. Our injection technology platforms include the VIBEX® and VIBEX® QuickShot® pressure-assisted auto injector systems suitable for branded and generic injectable drugs in unit dose containers and disposable multi-dose pen injectors. We have a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. We have formed several significant strategic alliances with partners including Teva Pharmaceutical Industries, Ltd. (“Teva”), AMAG Pharmaceuticals, Inc. (“AMAG”), Pfizer Inc. (“Pfizer”) and Idorsia Pharmaceuticals Ltd (“Idorsia”).

The Company directly markets and sells two proprietary products in the United States, XYOSTED® (testosterone enanthate) injection and OTREXUP® (methotrexate) injection. XYOSTED® (testosterone enanthate) injection is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, and OTREXUP® (methotrexate) injection is indicated for adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis.   

Through our commercialization partner Teva, we sell Sumatriptan Injection USP, indicated in the U.S. for the acute treatment of migraine and cluster headache in adults.  

In collaboration with AMAG, we developed a subcutaneous auto injector and are the exclusive supplier of devices and the final assembled and packaged commercial product of AMAG’s Makena® (hydroxyprogesterone caproate injection) subcutaneous auto injector, which is a ready-to-administer treatment indicated to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered at least one preterm baby in the past.

Through a license, development and supply agreement with Teva, Antares developed and is the exclusive supplier of the device for Teva’s Epinephrine Injection USP, which is indicated for emergency treatment of severe allergic reactions in adults and certain pediatric patients. The Company also developed and is the exclusive supplier of devices for Teva’s generic equivalent of Forsteo® (Teriparatide Injection) which is approved and sold in various countries in Europe, Canada and Israel.

The Company is also developing two multi-dose pen injector products in collaboration with Teva, a combination drug device rescue pen in collaboration with Pfizer, a combination drug device product with Idorsia, and has other ongoing internal and partnered research and development programs.

 

 

2.

Basis of Presentation and Significant Accounting Policies

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles (“GAAP”) in the U.S. for interim financial information and with the instructions to Form 10-Q and Article 10 of the Securities and Exchange Commission's Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the U.S. for complete financial statements.  In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included.  The accompanying condensed consolidated financial statements and notes thereto should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2019.  Operating results for the three and nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2020.

Accounting Pronouncements Recently Adopted

The Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) No. 2018-15 Customers’ Accounting for Implementation Costs Incurred in Cloud Computing Arrangement that is a Service Contract, effective January 1, 2020. This ASU provides new guidance on a customer's accounting for implementation, set-up, and other upfront costs incurred in a cloud computing arrangement that is hosted by the vendor (i.e., a service contract). Under the new guidance, entities apply the same criteria for capitalizing implementation costs as they would for an arrangement that has a software license. The Company’s adoption of this standard did not have a material impact on its consolidated financial statements.

9


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

The Company adopted ASU No. 2018-18 Clarifying the Interaction Between Topic 808 and 606, effective January 1, 2020. The guidance clarifies that certain transactions between collaborative arrangement participants should be accounted for under the revenue guidance, adds unit of account guidance to the collaborative arrangement guidance to align with the revenue standard, and clarifies presentation guidance for transactions with a collaborative arrangement participant that is not accounted for under the revenue standard. The Company’s adoption of this standard did not have a material impact on its consolidated financial statements.

Recent Accounting Pronouncements Not Yet Adopted

In 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This standard replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses on instruments within its scope, including trade receivables, and requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. The original effective date for ASU 2016-13 was for annual and interim periods beginning after December 15, 2019.

However, in October 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses, Derivatives and Hedging, and Leases: Effective Dates, which deferred the effective date of ASU 2016-13 for certain entities, including those that are eligible to be smaller reporting companies. A company’s determination about whether it is eligible for the deferral is a one-time assessment as of November 15, 2019 based on its most recent determination of its small reporting company eligibility as of the last business day of the most recently completed second quarter. Based on this determination, the Company qualified as a smaller reporting entity and is therefore eligible for the deferral of adoption of ASU 2016-13, resulting in a new effective date of January 1, 2023. The Company has historically had minimal credit losses on financial instruments and is currently evaluating the impact the adoption of ASU 2016-13 will have on its consolidated financial statements.

Cash and Cash Equivalents

Cash and cash equivalents consist of demand deposits at commercial banks and highly liquid investments with an original maturity of three months or less. Cash equivalents, consisting of investments in money market funds, are remeasured and reported at fair value each reporting period, in accordance with ASC Topic 820, Fair Value Measurements (“ASC 820”) based on quoted market prices, which is a Level 1 input within the three-level valuation hierarchy for disclosure of fair value measurements, and totaled $32,104 and $11,153 as of September 30, 2020 and December 31, 2019, respectively.

Investments

From time to time, the Company invests in U.S. Treasury bills and government agency notes that are classified as held-to-maturity because of the Company’s intent and ability to hold the securities to maturity. Investments with maturities of one year or less are classified as short-term.  The securities are carried at their amortized cost and the fair value is determined by quoted market prices.  The Company’s short-term investments had a carrying value of $1,997 and $22,520 as of September 30, 2020 and December 31, 2019, respectively, which approximated fair value.

 

Fair Value Measurements

The Company applies the provisions of ASC 820 for financial assets and liabilities that are required to be measured and reported at fair value each reporting period. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value:

Level 1: Quoted prices in active markets for identical assets or liabilities.

Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

10


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

The Company’s financial assets and liabilities that are not measured at fair value on a recurring basis under ASC 820 include its held-to-maturity investments and long-term debt, the carrying values of which approximate fair value. The estimated fair value of debt is based on Level 2 inputs, including management’s understanding of current market rates it could obtain for similar loans. The fair value of the Company’s cash, short-term investments, accounts receivable and accounts payable approximate fair value due to their short-term nature.

Inventories

Inventories are stated at the lower of cost or net realizable value. Cost is determined on a first-in, first-out basis. Certain components of the Company’s products are provided by a limited number of vendors, and the Company’s production, assembly, warehousing and distribution operations are outsourced to third-parties where substantially all of the Company’s inventory is located.  Disruption of supply from key vendors or third-party suppliers may have a material adverse impact on the Company’s operations. The Company provides a reserve for potentially excess, dated or obsolete inventories based on an analysis of inventory on hand compared to forecasts of future sales, which was $282 and $464 at September 30, 2020 and December 31, 2019, respectively.  Inventories consist of the following:

 

 

 

September 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Inventories:

 

 

 

 

 

 

 

 

Raw material

 

$

325

 

 

$

325

 

Work in process

 

 

9,088

 

 

 

8,390

 

Finished goods

 

 

10,396

 

 

 

7,285

 

 

 

$

19,809

 

 

$

16,000

 

Property and Equipment

Property and equipment are stated at cost and depreciated using the straight-line method over their estimated useful lives as follows:

 

 

Useful Life

Computer equipment and software

 

3-5 Years

Furniture, fixtures and office equipment

 

5-7 years

Production molds, tooling and equipment

 

3-10 years

Leasehold improvements

 

Lesser of useful life or lease term

Expenditures, including interest costs, for assets under construction that are not yet ready for their intended use are capitalized and will be depreciated based on the above guidelines when placed in service. The Company capitalized $212 of interest costs associated with construction in process during the nine months ended September 30, 2020. Costs associated with repairs and maintenance activities are expensed as incurred. As of September 30, 2020 and December 31, 2019, the Company’s property and equipment totaled $22,547 and $15,961, respectively, which is presented net of accumulated depreciation of $10,809 and $9,769 as of September 30, 2020 and December 31, 2019, respectively.

Revenue Recognition

The Company generates revenue from proprietary and partnered product sales, license and development activities and royalty arrangements.  Revenue is recognized when or as the Company transfers control of the promised goods or services to its customers at the transaction price, which is the amount that reflects the consideration to which it expects to be entitled to in exchange for those goods or services.

At inception of each contract, the Company identifies the goods and services that have been promised to the customer and each of those that represent a distinct performance obligation, determines the transaction price including any variable consideration, allocates the transaction price to the distinct performance obligations and determines whether control transfers to the customer at a point in time or over time. Variable consideration is included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company reassesses its reserves for variable consideration at each

11


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

reporting date and makes adjustments, if necessary, which may affect revenue and earnings in periods in which any such changes become known.

The Company has elected to recognize the cost for freight and shipping activities as fulfilment cost. Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of underlying goods are transferred to the customer. The related shipping and freight charges incurred by the Company are included in cost of revenue.

Proprietary Product Sales

The Company sells its proprietary products XYOSTED® and OTREXUP® primarily to wholesale and specialty distributors. Revenue is recognized when control has transferred to the customer, which is typically upon delivery, at the net selling price, which reflects the variable consideration for which reserves and sales allowances are established for estimated returns, wholesale distribution fees, prompt payment discounts, government rebates and chargebacks, insurance plan rebate arrangements and patient discount and support programs.

The determination of certain of these reserves and sales allowances require management to make a number of judgements and estimates to reflect the Company’s best estimate of the transaction price and the amount of consideration to which it believes it is ultimately entitled to receive. The expected value is determined based on unit sales data, contractual terms with customers and third-party payers, historical and expected utilization rates, any new or anticipated changes in programs or regulations that would impact the amount of the actual rebates, customer purchasing patterns, product expiration dates and levels of inventory in the distribution channel. Reserves for prompt payment discounts are recorded as a reduction in accounts receivable. Reserves for returns, rebates and chargebacks, distributor fees and customer co-pay support programs are included within current liabilities in the consolidated balance sheets.

Partnered Product Sales

The Company is party to several license, development, supply and distribution arrangements with pharmaceutical partners, under which the Company produces and is the exclusive supplier of certain products, devices and/or components. Revenue is recognized when or as control of the goods transfers to the customer based on the terms of the contract as described below.

The Company is the exclusive supplier of the Makena® subcutaneous auto injector product to AMAG. Because the product is custom manufactured for AMAG with no alternative use and the Company has a contractual right to payment for performance completed to date, control is continuously transferred to the customer as product is produced pursuant to firm purchase orders. Revenue is recognized over time using the output method based on the contractual selling price and number of units produced.  The amount of revenue recognized in excess of the amount shipped/billed to the customer, if any, is recorded as contract assets due to the short-term nature in which the amount is ultimately expected to be billed and collected from the customer.

All other partnered product sales are recognized at the point in time in which control is transferred to the customer, which is typically upon shipment. Sales terms and pricing are governed by the respective supply and distribution agreements, and there is generally no price protection or right of return. Revenue is recognized at the transaction price, which includes the contractual per unit selling price and estimated variable consideration, if any.  For example, the Company sells Sumatriptan Injection USP to Teva at cost and is entitled to receive 50 percent of the net profits from commercial sales made by Teva, payable to the Company within 45 days after the end of the quarter in which the commercial sales are made. The Company recognizes revenue, including the estimated variable consideration it expects to receive for contract margin on future commercial sales, upon shipment of the goods to Teva.  The estimated variable consideration is recognized at an amount the Company believes is not subject to significant reversal based on historical experience, and is adjusted at each reporting period if the most likely amount of expected consideration changes or becomes fixed.

Licensing and Development Revenue

The Company has entered into several license, development and supply arrangements with pharmaceutical partners under which the Company grants a license to its device technology and know-how and provides research and development services that often involve multiple performance obligations and highly customized deliverables. For such arrangements, the Company identifies each of the promised goods and services within the contract and the distinct performance obligations at inception, and allocates

12


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

consideration to each performance obligation based on relative standalone selling price, which is generally determined based on the expected cost plus margin.

If the contract includes an enforceable right to payment for performance completed to date and performance obligations are satisfied over time, the Company recognizes revenue over the development period using either the input or output method depending on which is most appropriate given the nature of the distinct deliverable. For other contracts that do not contain an enforceable right to payment for performance completed to date, revenue is recognized when control is transferred to the customer. Factors that may indicate that the transfer of control has occurred include the transfer of legal title, transfer of physical possession, the customer has obtained the significant risks and rewards of ownership of the assets and the Company has a present right to payment.

The Company’s typical payment terms for development contracts may include an upfront payment equal to a percentage of the total contract value with the remaining portion to be billed upon completion and transfer of the individual deliverables or satisfaction of the individual performance obligations. The Company records a contract liability for cash received in advance of performance, which is presented within deferred revenue on the consolidated balance sheet and recognized as revenue when the associated performance obligations have been satisfied. The Company recognized $780 in licensing and development revenue in connection with contract liabilities that were outstanding as of December 31, 2019 and satisfied during the nine months ended September 30, 2020.

License fees and milestones received in exchange for the grant of a license to the Company’s functional intellectual property such as patented technology and know-how in connection with a partnered development arrangement are generally recognized at inception of the arrangement, or over the development period depending on the facts and circumstances, as the license is not generally distinct from the non-licensed goods or services to be provided under the contract. Milestone payments that are contingent upon the occurrence of future events are evaluated and recorded at the most likely amount, and to the extent that it is probable that a significant reversal will not occur when the associated uncertainty is resolved.

Royalties

The Company earns royalties in connection with licenses granted under license and development arrangements with partners. Royalties are based upon a percentage of commercial sales of partnered products with rates ranging from mid-single digit to low double digit and are tiered based on levels of net sales. These sales-based royalties, for which the license was deemed the predominant element to which the royalties relate, are estimated and recognized in the period in which the partners’ commercial sales occur.  The royalties are generally reported and payable to the Company within 45 to 60 days of the end of the period in which the commercial sales are made.  The Company bases its estimates of royalties earned on actual sales information from its partners when available or estimated prescription sales from external sources and estimated net selling price. If actual royalties received are different than amounts estimated, the Company would adjust the royalty revenue in the period in which the adjustment becomes known.

Remaining Performance Obligations

Remaining performance obligations represents the allocation of transaction price of firm orders and development contract deliverables for which work has not been completed or orders fulfilled, and excludes potential purchase orders under ordering-type supply contracts with indefinite delivery or quantity.  As of September 30, 2020, the aggregate value of remaining performance obligations, excluding contracts with an original expected length of one year or less, was $20,967. The Company expects to recognize revenue on the remaining performance obligations over the next four years.

 

3.

Long-Term Debt

On September 15, 2020, the Company entered into a second amendment (the “Second Amendment”) to its loan and security agreement dated June 6, 2017 (the “Loan Agreement”), as amended by the First Amendment to Loan and Security Agreement dated June 26, 2019 (the “First Amendment”), with Hercules Capital, Inc., as a lender and agent for the several banks and other financial institutions or entities from time to time party thereto.

13


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

The Company initially borrowed $25.0 million upon execution of the original Loan Agreement in June 2017, and an additional $15.0 million (the “Tranche II Loan”) was funded in June 2019 upon the signing of the First Amendment. The Company may, but is not obligated to, request one or more additional advances of at least $5.0 million, not to exceed $10.0 million in the aggregate (the “Tranche III Loan”), during the period between January 1, 2020 and September 15, 2020. The sole change under the Second Amendment was to extend the period during which the Company may request advances under the Tranche III Loan to October 31, 2020.

Payments under the amortizing loan are interest only until the first principal payment is due on August 1, 2021. The interest only period may be extended to August 1, 2022 if the Company achieves a certain loan extension milestone, requests such extension, and pays an extension fee equal to one half of one percent of the principal amount outstanding. Interest accrues at a calculated prime-based variable rate with a maximum interest rate of 9.50%. The interest rate in effect as of September 30, 2020 and December 31, 2019 was 8.50% and 9.25%, respectively. The loan matures on July 1, 2022, but may be extended to July 1, 2024 contingent upon satisfaction of a certain loan extension milestone.

4.

Share-Based Compensation

The Company has an Equity Compensation Plan (the “Plan”), which allows for grants in the form of incentive stock options, nonqualified stock options, stock units, stock awards, stock appreciation rights, and other stock-based awards. The Company also has a long-term incentive program (“LTIP”), pursuant to which the Company’s senior executives have been awarded stock options, restricted stock units (“RSUs”) and performance stock units (“PSUs”).

The following is a summary of stock option activity under the Plan as of and for the nine months ended September 30, 2020:   

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

Average

 

 

 

 

 

 

 

 

 

 

 

Average

 

 

Remaining

 

 

Aggregate

 

 

 

Number of

 

 

Exercise

 

 

Contractual

 

 

Intrinsic

 

 

 

Shares

 

 

Price

 

 

Term (Years)

 

 

Value

 

Outstanding at December 31, 2019

 

 

13,861

 

 

$

2.41

 

 

 

 

 

 

 

 

 

Granted

 

 

3,328

 

 

 

2.73

 

 

 

 

 

 

 

 

 

Exercised

 

 

775

 

 

 

1.95

 

 

 

 

 

 

 

 

 

Cancelled/Forfeited

 

 

728

 

 

 

2.83

 

 

 

 

 

 

 

 

 

Outstanding at September 30, 2020

 

 

15,686

 

 

 

2.48

 

 

 

6.8

 

 

$

5,106

 

Exercisable at September 30, 2020

 

 

10,826

 

 

$

2.33

 

 

 

5.6

 

 

$

5,105

 

 

The following is a summary of PSU and RSU award activity under the Plan as of and for the nine months ended September 30, 2020:   

 

 

 

Performance Stock Units

 

 

Restricted Stock Units

 

 

 

Number of

Shares

 

 

Weighted

Average Grant

Date Fair

Value

 

 

Number of

Shares

 

 

Weighted

Average Grant

Date Fair

Value

 

Outstanding at December 31, 2019

 

 

1,841

 

 

$

3.00

 

 

 

1,401

 

 

$

2.82

 

Granted

 

 

605

 

 

 

2.00

 

 

 

1,078

 

 

 

2.73

 

Incremental shares earned

 

 

77

 

 

 

 

 

 

 

 

 

 

Vested/settled

 

 

(388

)

 

 

3.11

 

 

 

(785

)

 

 

2.80

 

Forfeited/expired

 

 

(494

)

 

 

3.02

 

 

 

(128

)

 

 

2.83

 

Outstanding at September 30, 2020

 

 

1,641

 

 

$

2.61

 

 

 

1,566

 

 

$

2.77

 

 

The PSUs granted to senior executives under the LTIP are expressed as a target number of shares in the table above and may be earned based upon the Company’s achievement of certain corporate development goals, net revenue goals and total shareholder return (“TSR”) relative to the Nasdaq Biotechnology Index over the performance period, which is generally a three-year period. Depending on the outcome of the performance goals, a recipient may ultimately earn a number of shares greater or less than the target number of shares granted, ranging from 0% to 150%. The fair value of the TSR PSUs are expensed over the performance

14


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

period and determined using a Monte Carlo simulation. The grant date fair value of PSUs that are not tied to market-based performance are expensed over the remaining performance period when it becomes probable that the related goal will be achieved.

 

The LTIP awards that vested during the nine months ended September 30, 2020 and 2019 were net-share settled such that the Company withheld shares with a value equivalent to the employees’ tax obligations for applicable income and other employment taxes, and remitted cash to the appropriate taxing authorities. The Company withheld 425 and 365 shares during the nine months ended September 30, 2020 and 2019, respectively, to satisfy tax obligations, which was determined based on the fair value of the shares on their vesting date equal to the Company’s closing stock price on such date. The Company paid $1,366 and $1,077 during the nine months ended September 30, 2020 and 2019, respectively, to taxing authorities for the employees’ tax obligations, which is reflected as a cash outflow from financing activities within the consolidated statements of cash flows. Net-share settlements have the effect of share repurchases by the Company as they reduce the number of shares that would have otherwise been issued as a result of the vesting.

 

In connection with Plan awards, the Company recognized share-based compensation expense for the three and nine months ended September 30, 2020 and 2019 as follows:

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Stock options

 

$

1,045

 

 

$

888

 

 

$

2,801

 

 

$

2,555

 

Restricted stock units

 

 

579

 

 

 

565

 

 

 

1,661

 

 

 

1,267

 

Performance stock units

 

 

180

 

 

 

192

 

 

 

1,307

 

 

 

823

 

Total share-based compensation expense

 

$

1,804

 

 

$

1,645

 

 

$

5,769

 

 

$

4,645

 

 

 

5.

Revenues, Significant Customers and Concentrations of Risk

The following table presents the Company’s revenue on a disaggregated basis by types of goods and services and major product lines:

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Proprietary product sales

 

$

15,765

 

 

$

11,458

 

 

$

43,177

 

 

$

25,213

 

Partnered product sales

 

 

13,182

 

 

 

13,229

 

 

 

37,532

 

 

 

38,394

 

Total product revenue

 

 

28,947

 

 

 

24,687

 

 

 

80,709

 

 

 

63,607

 

Licensing and development revenue

 

 

4,321

 

 

 

1,211

 

 

 

8,763

 

 

 

4,365

 

Royalties

 

 

6,735

 

 

 

8,408

 

 

 

15,994

 

 

 

18,053

 

Total revenue

 

$

40,003

 

 

$

34,306

 

 

$

105,466

 

 

$

86,025

 

 

Revenues disaggregated by customer location are as follows: 

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

United States of America

 

$

39,371

 

 

$

33,684

 

 

$

103,638

 

 

$

82,411

 

Europe

 

 

632

 

 

 

566

 

 

 

1,828

 

 

 

3,444

 

Other

 

 

 

 

 

56

 

 

 

 

 

 

170

 

 

 

$

40,003

 

 

$

34,306

 

 

$

105,466

 

 

$

86,025

 

 

15


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

The following table identifies customers from which the Company derived 10% or more of its total revenue in any of the periods presented:

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Teva

 

45%

 

 

41%

 

 

42%

 

 

43%

 

AMAG

 

<10%

 

 

20%

 

 

10%

 

 

19%

 

McKesson Corporation

 

12%

 

 

<10%

 

 

12%

 

 

<10%

 

AmerisourceBergen Corporation

 

11%

 

 

10%

 

 

12%

 

 

<10%

 

Cardinal Health

 

11%

 

 

<10%

 

 

11%

 

 

<10%

 

 

6.

Earnings per Share

Basic earnings or loss per common share is computed by dividing the net income or loss applicable to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted earnings per common share is computed in a similar manner, except that the weighted average number of shares outstanding is increased to reflect the potential dilution from the exercise or conversion of securities into common stock. Diluted earnings per share contemplate a complete conversion to common shares of all convertible instruments only if such instruments are dilutive in nature with respect to earnings per share. The following table sets forth the computation for basic and diluted net earnings (loss) per share for the three and nine months ended September 30, 2020 and 2019:

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Numerator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Numerator for basic and diluted earnings (loss) per share

 

$

4,996

 

 

$

1,043

 

 

$

4,815

 

 

$

(6,722

)

Denominator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic weighted average common shares outstanding

 

 

166,375

 

 

 

163,119

 

 

 

165,838

 

 

 

162,109

 

Dilutive effects of stock options and share-based awards

     issuable under equity compensation plans

 

 

3,280

 

 

 

5,384

 

 

 

3,921

 

 

 

 

Diluted weighted average common shares outstanding

 

 

169,655

 

 

 

168,503

 

 

 

169,759

 

 

 

162,109

 

Computation of:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic net earnings (loss) per share

 

$

0.03

 

 

$

0.01

 

 

$

0.03

 

 

$

(0.04

)

Diluted net earnings (loss) per share

 

$

0.03

 

 

$

0.01

 

 

$

0.03

 

 

$

(0.04

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Anti-dilutive common stock equivalents (1)

 

 

8,596

 

 

 

5,000

 

 

 

6,719

 

 

 

19,080

 

 

 

(1)

These common stock equivalents were outstanding for the period but were not included in the computation of diluted EPS for those periods as their inclusion would have had an anti-dilutive effect.

 

 

7.

Commitments and Contingencies

Pending Litigation

From time to time, the Company may be involved in various legal matters generally incidental to its business. Although the results of litigation and claims cannot be predicted with certainty, after discussion with legal counsel, management is not aware of any matters for which the likelihood of a loss is probable and reasonably estimable and which could have a material impact on its consolidated financial condition, liquidity, or results of operations.

On October 23, 2017, Randy Smith filed a complaint in the District of New Jersey, captioned Randy Smith, Individually and on Behalf of All Others Similarly Situated v. Antares Pharma, Inc., Robert F. Apple and Fred M. Powell (“Smith”), Case No. 3:17-cv-08945-MAS-DEA, on behalf of a putative class of persons who purchased or otherwise acquired Antares securities between December 21, 2016 and October 12, 2017, inclusive, asserting claims for purported violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, against Antares, Robert F. Apple and Fred M. Powell.  The Smith complaint

16


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

contends that defendants made false and/or misleading statements and/or failed to disclose that: (i) Antares had provided insufficient data to the FDA in connection with the NDA for XYOSTED®; and (ii) accordingly, Antares had overstated the approval prospects for XYOSTED®.  On July 27, 2018, the court entered an order appointing Serghei Lungu as lead plaintiff, Pomerantz LLP as lead counsel, and Lite DePalma Greenberg, LLC as liaison counsel for plaintiff.  On August 3, 2018, the parties submitted a stipulation and proposed order, setting forth an agreed-upon schedule for responding to the complaint, which the court granted. Pursuant to that order, plaintiff filed a Consolidated Amended Class Action Complaint on October 9, 2018. On November 26, 2018, defendants filed a motion to dismiss. Plaintiff filed an opposition to the motion on January 10, 2019 and defendants filed a reply in support of their motion on February 25, 2019. On July 2, 2019, the court dismissed the complaint in its entirety without prejudice. On July 29, 2019, plaintiff filed a Consolidated Second Amended Class Action Complaint against the same parties alleging substantially similar claims. On September 12, 2019, defendants filed a motion to dismiss the Consolidated Second Amended Class Action Complaint. Plaintiffs’ opposition was filed on October 28, 2019 and defendants’ reply in support of their motion was filed on November 27, 2019. On April 28, 2020, the court dismissed the Consolidated Second Amended Class Action Complaint in its entirety. The court further ordered that plaintiff may file an amended complaint by May 29, 2020 and provide the court with a form of the amended complaint that indicates in what respect(s) it differs from the complaint which it proposes to amend. On May 29, 2020, plaintiff filed a Consolidated Third Amended Class Action Complaint and defendants filed a motion to dismiss on July 10, 2020. Briefing on defendants’ motion was complete on August 25, 2020. The Company believes that the claims in the Smith action lack merit and intends to defend them vigorously.

On January 12, 2018, a stockholder of the Company filed a derivative civil action, captioned Chiru Mackert, derivatively on behalf of Antares Pharma, Inc., v. Robert F. Apple, et al., in the Superior Court of New Jersey Chancery Division, Mercer County (Case No. C-000011-18).  On January 17, 2018, another stockholder filed a derivative action in the same court, captioned Vikram Rao, Derivatively on Behalf of Antares Pharma, Inc. v. Robert F. Apple, et al. (Case No. C-000004-18). Both complaints name Robert F. Apple, Fred M. Powell, Thomas J. Garrity, Jacques Gonella, Anton Gueth, Leonard S. Jacob, Marvin Samson and Robert P. Roche, Jr. as defendants, and the Company as nominal defendant, and they assert claims for breach of fiduciary duties, unjust enrichment, abuse of control, gross mismanagement, and waste of corporate assets arising from the same facts underlying the Smith securities class action.  The plaintiffs seek damages, corporate governance and internal procedure reforms and improvements, restitution, reasonable attorneys’ fees, experts’ fees, costs, and expenses. The parties have filed a stipulation and order consolidating the two actions and staying the proceedings pending the court’s decision on defendants’ motion to dismiss the Smith action. On August 17, 2020, the court terminated the case pending a lifting of the stay as set forth in the stipulation and order.

On January 17, 2018, a stockholder of the Company filed a derivative civil action, captioned Robert Clark, Derivatively on Behalf of Antares Pharma, Inc. v. Robert F. Apple, et al. (“Clark”) (Case No. 3:18-cv-00703-MAS-DEA), against Robert F. Apple, Thomas J. Garrity, Jacques Gonella, Leonard S. Jacob, Marvin Samson, Anton G. Gueth and Robert P. Roche, Jr. as defendants, and Company as a nominal defendant.  The action was filed in the U.S. District Court for the District of New Jersey and asserts claims for breach of fiduciary duties, unjust enrichment, abuse of control, waste of corporate assets, and a violation of Section 14(a) of the Securities Exchange Act of 1934. This complaint relates to the same facts underlying the Smith securities class action and the other derivative actions.  The plaintiff in Clark seeks damages, corporate governance and internal procedure reforms and improvements, reasonable attorneys’ fees, accountants’ and experts’ fees, costs, and expenses. The parties have filed a stipulation and order staying the action pending the court’s decision on defendants’ motion to dismiss the Smith action. On August 17, 2020, the court terminated the case pending a lifting of the stay as set forth in the stipulation and order.

 

 

 8.

Subsequent Event

On October 1, 2020, the Company entered into an exclusive license agreement (the “License Agreement”) with Ferring International Center S.A. and its affiliates (“Ferring”) for the marketed product NOCDURNA® (desmopressin acetate) in the United States, which is indicated for the treatment of nocturia due to nocturnal polyuria (NP) in adults who awaken at least two times per night to urinate. Under the terms of the License Agreement, the Company paid Ferring an upfront payment of $5.0 million upon execution and will pay an additional $2.5 million at one year from execution. Ferring is eligible for tiered royalties and additional commercial milestone payments potentially totaling up to $17.5 million based on the Company’s net sales of NOCDURNA® in the United States.

 

 

17


 

Item 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward-Looking Statements

Certain statements in this report, including statements in the management’s discussion and analysis section set forth below, may be considered “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties.  Forward-looking statements can be identified by the words “expect,” “estimate,” “plan”, “project,” “anticipate,” “should,” “intend,” “may,” “will,” “believe,” “continue” or other words and terms of similar meaning in connection with any discussion of, among other things, future operating or financial performance, strategic initiatives and business strategies, regulatory or competitive environments, our intellectual property and product development. In particular, these forward-looking statements include, among others, statements about:

 

our expectations about the COVID-19 pandemic (the “Pandemic”) and any potential disruption or impact to our operations, financial position or cash flows;

 

our expectations regarding the continued successful commercialization of XYOSTED® (testosterone enanthate) injection for testosterone replacement therapy, including the continued success of our marketing and reimbursement strategies, the continued growth in prescriptions and sales, and continued growth in revenues related thereto;

 

our expectations regarding continued sales of OTREXUP® (methotrexate) injection;

 

our expectations regarding the recent licensing agreement with Ferring International Center S.A. and its affiliates, (“Ferring”) for the marketed product NOCDURNA® (desmopressin acetate) and future sales and revenue therefrom;

 

our expectations regarding continued sales of Sumatriptan Injection USP to our partner, Teva Pharmaceutical Industries, Ltd. (“Teva”), and Teva’s ability to successfully distribute and sell Sumatriptan Injection USP;

 

our expectations regarding the ability of AMAG Pharmaceuticals, Inc. (“AMAG”) to continue to successfully commercialize Makena® (hydroxyprogesterone caproate injection), and our continued future sales to AMAG and royalty revenue from the same, in light of the U.S Food and Drug Administration’s (“FDA”) recent proposal to withdraw approval of Makena® (hydroxyprogesterone caproate injection), AMAG’s request for a hearing to maintain its approval of Makena® (hydroxyprogesterone caproate injection), and the timing and outcome of any hearings and future regulatory actions by the FDA;

 

our expectations regarding the ability of our partner Teva to continue to successfully commercialize the generic equivalent version of Mylan’s EpiPen® (“generic epinephrine injection”), and any future revenue related thereto;

 

our expectations regarding the exclusive distribution agreement with Lunatus Global Medical Supplies (“Lunatus”) to distribute and promote the sale of XYOSTED® in Saudi Arabia and United Arab Emirates, Lunatus’ ability to obtain regulatory approval and commercialize the product in the territories, and the amount of future revenues from the same;

 

our expectations regarding continued product development with Teva of the teriparatide disposable pen injector and exenatide disposable pen injector, Teva’s ability to obtain FDA approval and AB-rating for each of those products, and Teva’s ability to successfully commercialize the teriparatide disposable pen injector product in Europe;

 

our expectations about the development of a rescue pen for an undisclosed drug and our intention to enter into a separate supply agreement with Pfizer, Inc. (“Pfizer”) for the same;

 

our expectations about our development activities with Idorsia Pharmaceuticals Ltd (“Idorsia”), including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel, a new chemical entity (“NCE”) being developed for the treatment of a suspected acute myocardial infarction (“AMI”) in adult patients with a history of AMI, and the potential future FDA and global regulatory approval of the same;

 

our expectations about our research and development projects, including but not limited to ATRS-1901 and ATRS-1902, the timing and results of clinical trials, and our anticipated continued reliance on third parties in conducting studies, trials and other research and development activities;

 

our expectations about the timing and outcome of pending or potential claims and litigation, including without limitation, the pending securities class action and derivative actions;

 

our anticipated continued reliance on contract manufacturers to manufacture our products;

 

our anticipated continued reliance on third parties to provide certain services for our products including logistics, warehousing, distribution, invoicing, contract administration and chargeback processing;

 

our sales and marketing plans;

18


 

 

our expectation about our future revenues, including the 2020 revenue guidance, our cash flows and our ability to support our operations and achieve or maintain profitability;

 

our estimates and expectations regarding the sufficiency of our cash resources, anticipated capital requirements and our need for and ability to obtain additional financing;

 

our expectations and estimates with regards to current accounting practices and the potential impact of new accounting pronouncements and tax legislation; and

 

other statements regarding matters that are not historical facts or statements of current condition.

These forward-looking statements are based on assumptions that we have made in light of our industry experience as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. As you read and consider this report, you should understand that these statements are not guarantees of performance results. Forward-looking statements involve known and unknown risks, uncertainties and assumptions, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements.  While we believe that we have a reasonable basis for each forward-looking statement contained in this report, we caution you that these statements are based on a combination of facts and factors currently known by us and projections of the future about which we cannot be certain.  Many factors may affect our ability to achieve our objectives, including:

 

potential business interruptions and/or any financial or operational impact as a result of the COVID-19 Pandemic;

 

delays in product introduction or unsuccessful marketing and commercialization efforts by us or our partners;

 

interruptions in supply or an inability to adequately manage third party contract manufacturers to meet customer supply requirements;

 

our inability to obtain or maintain adequate third-party payer coverage of marketed products;

 

the timing and results of our or our partners’ research projects or clinical trials of product candidates in development including projects with Teva, Pfizer and Idorsia;

 

actions by the FDA or other regulatory agencies with respect to our products or product candidates of our partners;

 

our inability to generate or sustain continued growth in product sales and royalties;

 

the lack of market acceptance of our and our partners’ products and future revenues from these products;

 

a decrease in business from our major customers and partners;

 

our inability to compete successfully against new and existing competitors or to leverage our research and development capabilities or our marketing capabilities;

 

our inability to establish and maintain our sales and marketing capability, our inability to effectively market our services or obtain and maintain arrangements with our customers, payors, partners and manufacturers;

 

changes or delays in the regulatory review and approval process;

 

our inability to effectively protect our intellectual property;

 

costs associated with litigation and the outcome of such litigation;

 

our inability to attract and retain key personnel;

 

our inability to obtain additional financing, reduce expenses or generate funds when necessary; and

 

adverse economic and political conditions.

In addition, you should refer to the “Risk Factors” sections of this report and in our other filings with the Securities and Exchange Commission for a discussion of other factors that may cause our actual results to differ materially from those described by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements contained in this report will prove to be accurate and, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material.

We encourage readers of this report to understand forward-looking statements to be strategic objectives rather than absolute targets of future performance. Forward-looking statements speak only as of the date they are made. We do not intend to update publicly any forward-looking statements to reflect circumstances or events that occur after the date the forward-looking statements are

19


 

made or to reflect the occurrence of unanticipated events except as required by law. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, if at all.

The following discussion and analysis, the purpose of which is to provide investors and others with information that we believe to be necessary for an understanding of our financial condition, changes in financial condition and results of operations, should be read in conjunction with the financial statements, notes thereto and other information contained in this report.

Company Overview

Antares Pharma, Inc. (“Antares,” “we,” “our,” “us” or the “Company”) is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products and technologies.  Our strategy is to identify new or existing approved drug formulations and apply our patented drug delivery technology to enhance the drug delivery methods.  We develop, manufacture and commercialize, for ourselves or with partners, novel therapeutic products using our advanced drug delivery systems that are designed to provide commercial or functional advantages, such as improved safety and efficacy, reduced side effects, and enhanced patient comfort and adherence. Our injection technology platforms include the VIBEX® and VIBEX® QuickShot® pressure-assisted auto injector systems suitable for branded and generic injectable drugs in unit dose containers as well as disposable multi-dose pen injectors. We have a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. We have formed several significant strategic alliances and partnership arrangements with industry leading pharmaceutical companies including Teva, AMAG, Pfizer and Idorsia.  

We market and sell, in the U.S., our proprietary product XYOSTED® (testosterone enanthate) injection, indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. XYOSTED® is the only FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration. XYOSTED® was approved by the FDA on September 28, 2018 and launched for commercial sale in late 2018. In August 2020, we entered into an exclusive distribution agreement with Lunatus to distribute and promote the sale of XYOSTED® in Saudi Arabia and the United Arab Emirates. Lunatus is responsible for obtaining regulatory approval and, assuming approval, for the promotion and commercialization of the product in the territories.

We also market and sell our proprietary product OTREXUP® (methotrexate) injection, which is a subcutaneous methotrexate injection for once weekly self-administration with an easy-to-use, single dose, disposable auto injector, indicated for adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis.

In October 2020, we entered into an exclusive license agreement (the “License Agreement”) with Ferring for the marketed product NOCDURNA® (desmopressin acetate) in the United States, which is indicated for the treatment of nocturia due to nocturnal polyuria (NP) in adults who awaken at least two times per night to urinate. Under the terms of the License Agreement, the Company paid Ferring an upfront payment of $5.0 million upon execution and will pay an additional $2.5 million at one year from execution. Ferring is eligible for tiered royalties and additional commercial milestone payments potentially totaling up to $17.5 million based on the Company’s net sales of NOCDURNA® in the United States. We are preparing to launch the product and begin detailing later in the fourth quarter of 2020.

Through our commercialization partner Teva, we sell Sumatriptan Injection USP indicated in the U.S. for the acute treatment of migraine and cluster headache in adults.

Under an exclusive license and development agreement with AMAG, we developed, manufacture and supply a variation of our VIBEX® QuickShot® subcutaneous auto injector for use with AMAG’s progestin hormone drug Makena® (hydroxyprogesterone caproate injection), indicated to help reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in the past. The Makena® (hydroxyprogesterone caproate injection) subcutaneous auto injector was approved by the FDA and commercialized in February 2018. We are the exclusive supplier of the devices and the final assembled and packaged commercial product and receive royalties on AMAG’s net sales of the product. In October 2019, AMAG announced that the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee met to better understand and interpret the PROLONG (Progestin’s Role in Optimizing Neonatal Gestation) confirmatory clinical trial for Makena® (hydroxyprogesterone caproate) injection. Nine advisory committee members voted to recommend that the FDA pursue withdrawal of approval for Makena® and seven committee members voted to leave the product on the market under accelerated approval and require a new confirmatory trial. In October 2020, AMAG received notice that the FDA is proposing to withdraw approval of Makena® (hydroxyprogesterone caproate injection). AMAG has formally requested a public hearing in response to the FDA’s proposal to withdraw its approval and has stated that it remains committed to working with the FDA to maintain patient access to Makena® as a treatment option to reduce pre-term birth.

20


 

In collaboration with Teva, we developed a version of our VIBEX® auto injector for use in a generic epinephrine auto injector product that was approved by the FDA in August 2018 and launched in late fourth quarter of 2018.  Teva’s Epinephrine Injection USP is indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and certain pediatric patients and was approved as a generic drug product with an AB rating, meaning that it is therapeutically equivalent to Mylan, Inc.’s branded products EpiPen® and EpiPen Jr® and therefore, subject to state law, substitutable at the pharmacy. We are the exclusive supplier of the device and Teva is responsible for commercialization and distribution of the finished product, for which we also receive royalties on Teva’s net sales.

We are also collaborating with Teva on a multi-dose pen for a generic form of BYETTA® (exenatide injection) for the treatment of type 2 diabetes, and another multi-dose pen for a generic form of Forteo® (teriparatide [rDNA origin] injection) for the treatment of osteoporosis. Teva continues to work through the U.S. regulatory process with the FDA for exenatide and teriparatide using the ANDA pathway. Teva recently launched Teriparatide Injection (“teriparatide”), the generic version of Eli Lilly’s branded product Forsteo® featuring the Antares multi-dose pen platform in Austria, Croatia, Denmark, Hungary, Ireland, The Netherlands, Portugal, Sweden, Switzerland, and The United Kingdom, as well as Canada and Israel, and is expected to launch in other European countries later this year. Antares is responsible for the manufacturing and supply of the multi-dose pen utilized in Teva’s generic teriparatide product under an exclusive development, license and supply agreement with Teva, the scope of which is worldwide.

In August 2018, we entered into a collaboration agreement with Pfizer to develop a combination drug device rescue pen. This rescue pen will utilize the Antares QuickShot® auto injector and an undisclosed Pfizer drug. We will develop the product and Pfizer will be responsible for obtaining FDA approval of the combination product. We intend to enter into a separate supply agreement with Pfizer pursuant to which we will provide fully packaged commercial ready finished product to Pfizer and Pfizer will then be responsible for commercializing the product in the U.S., pending FDA approval, for which the Company will receive royalties on net sales.

In November 2019, we entered into a new global agreement with Idorsia to develop a novel, drug-device product containing selatogrel. Selatogrel, a new chemical entity, is being developed for the treatment of a suspected acute myocardial infarction (AMI) in adult patients with a history of AMI. Idorsia will pay for the development of the combination product and will be responsible for applying for and obtaining global regulatory approvals for the product. The parties intend to enter into a separate commercial license and supply agreement pursuant to which Antares will provide fully assembled and labelled product to Idorsia at cost plus margin. Idorsia will then be responsible for global commercialization of the product, pending FDA or foreign approval. Antares will be entitled to receive royalties on net sales of the commercial product.

We are committed to advancing our internal research and development programs and continue to invest in the development of our proprietary product pipeline. Our research and development efforts are focused primarily on leveraging our existing product and technology platforms by broadening their applications for use in other drug device combination products, as well as exploring new pharmaceutical products, technologies and drug delivery methods.

We previously manufactured and sold reusable, needle-free injection devices, marketed primarily through Ferring and JCR Pharmaceuticals CO., Ltd. for use with human growth hormone. In October 2017, we entered into an asset purchase agreement with Ferring to sell the worldwide rights, including certain assets related to the needle-free auto injector device product line for $14.5 million to be paid to us in installments and completed over a two-year period. The transaction was completed in October 2019, and with the completion of this transaction, Antares no longer manufactures or sells needle-free devices or components.

COVID-19

In December 2019, a novel strain of coronavirus (COVID-19) emerged in China, and has since spread worldwide, including every state in the United States. On March 11, 2020, the World Health Organization declared the outbreak a Pandemic and on March 13, 2020, the United States declared a national emergency with respect to the coronavirus outbreak. This outbreak has severely impacted global economic activity, and many countries and states in the U.S. have responded to the outbreak by instituting various quarantine, shelter-in-place or stay-at-home orders, mandating school and business closures for non-essential services and restricting travel and public gatherings. As some of these initial restriction have been lifted and phased re-openings have begun to occur, the spread of the virus and number of cases continue to rise and there is speculation and uncertainty about a second wave of the Pandemic as we approach seasonal cold and flu season.

As of the date of this report, we have not experienced any significant disruptions in our sales, operations or supply chain and continue to monitor the situation and potential effects on our business, suppliers, partners and workforce. We have also taken several measures to help minimize the impact of the Pandemic on our business. We have implemented safety measures and protocols to

21


 

protect the health and safety of our employees and comply with governmental mandates and restrictions while working to ensure the sustainability of our business operations.

Many of our corporate and administrative functions continue to work remotely and we have limited the number of staff in our facilities to those necessary for essential functions such as research, development, manufacturing and supply. While our sales force has been subject to varying limitations on their ability to physically visit physicians, we have strategically shifted to virtual detailing and sales meetings, and are leveraging our social media presence to connect with our existing and potential customers and healthcare professionals. We believe we are well-positioned with these virtual capabilities to continue to reach healthcare professionals and patients as the ongoing Pandemic and related restrictions continue to evolve. Our sales force has resumed in-person office visits in some areas and continues to work virtually in other territories based on the varying restrictions and phased re-openings. However, the restrictions and closures during the Pandemic have limited or reduced patient access to physicians for non-essential services, and we have experienced, and may continue to experience, a decrease in the rate of new prescriptions for our proprietary products. Our partners may also experience a decrease or fluctuation in demand for our partnered products due to the COVID-19 Pandemic or the related restrictions.

While we have taken measures to help minimize the potential impact of the Pandemic and various government orders, and believe any potential or significant disruption, when and if experienced, could be temporary, there is uncertainty around the timing and duration of a potential disruption, and the magnitude of any potential impact. As a result, we are unable to estimate the potential impact on our operations or cash flows as of the date of this filing. For more information on these risks, see “Part II — Item 1A. Risk Factors — We face uncertainty and risks related to the outbreak of the novel coronavirus disease, COVID-19, which could significantly disrupt our operations and may materially and adversely impact our business and financial conditions.”

Results of Operations

We reported net income of $5.0 million and $4.8 million for the three and nine months ended September 30, 2020, respectively, as compared to net income of $1.0 million and a net loss of $6.7 million for the three and nine months ended September 30, 2019, respectively. Our earnings per share was $0.03 for the three and nine months ended September 30, 2020 as compared to earnings per share of $0.01 and a net loss per share of $0.04 for the three and nine months ended September 30, 2019, respectively. Operating results for the three and nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2020.  The following is an analysis and discussion of our operations for the three and nine months ended September 30, 2020 as compared to the same periods in 2019.

Revenues

We generate revenue from proprietary and partnered product sales, license and development activities and royalty arrangements.  Total revenue for the three months ended September 30, 2020 and 2019 was $40.0 million and $34.3 million, respectively, representing an increase in total revenue of 17% on a comparative basis. Total revenue for the nine months ended September 30, 2020 and 2019 was $105.5 million and $86.0 million, respectively, representing an increase of 23%. These overall increases were primarily driven by the continued growth in our proprietary product sales. The following table provides details about the components and drivers of our overall revenue growth (in thousands):

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Proprietary product sales

 

$

15,765

 

 

$

11,458

 

 

$

43,177

 

 

$

25,213

 

Partnered product sales

 

 

13,182

 

 

 

13,229

 

 

 

37,532

 

 

 

38,394

 

Total product revenue

 

 

28,947

 

 

 

24,687

 

 

 

80,709

 

 

 

63,607

 

Licensing and development revenue

 

 

4,321

 

 

 

1,211

 

 

 

8,763

 

 

 

4,365

 

Royalties

 

 

6,735

 

 

 

8,408

 

 

 

15,994

 

 

 

18,053

 

Total revenue

 

$

40,003

 

 

$

34,306

 

 

$

105,466

 

 

$

86,025

 

22


 

Product Revenue

Revenue from product sales was $28.9 million and $24.7 million for the three months ended September 30, 2020 and 2019, respectively, an increase of 17% on a period over period basis. For the nine months ended September 30, 2020 and 2019 we generated revenue from product sales of $80.7 million and $63.6 million, respectively, representing an increase of 27%. The increases in product revenue were driven primarily by sales of recently approved products, both proprietary and partnered, as discussed below.

Sales of our proprietary products XYOSTED® and OTREXUP®, which are presented net of estimated product returns and sales allowances, generated revenue of $15.8 million and $43.2 million for the three and nine months ended September 30, 2020, respectively, as compared to $11.5 million and $25.2 million for the three and nine months ended September 30, 2019, respectively, representing increases of 38% and 71% for the comparable three month and nine month periods, respectively. The increase in proprietary product sales for the three and nine months ended September 30, 2020 as compared to the three and nine months ended September 30, 2019 were principally attributable to continued growth in prescriptions and sales of XYOSTED®, which was launched for commercial sale in late 2018.

We manufacture and sell devices, components and fully assembled and packaged product to our partners Teva, AMAG and formerly Ferring. Partnered product sales were $13.2 million in both of the three-month periods ended September 30, 2020 and 2019, and were $37.5 million and $38.4 million for the nine months ended September 30, 2020 and 2019, respectively. Partnered product sales for the three months ended September 30, 2020 as compared to the three months ended September 30, 2019 were relatively consistent as a result of an increase in sales of auto injector devices to Teva for use with their generic Epinephrine Injection USP and an increase in sales of Sumatriptan Injection USP, offset by a decrease in sales of the Makena® auto-injectors to AMAG and other partnered device products. The net decrease in revenue from sales of partnered products for the nine months ended September 30, 2020 as compared to the same period in 2019 is primarily attributable to the decreases in sales of needle-free devices to Ferring, a decrease in sales of Makena® auto-injectors to AMAG, a decrease in sales of Sumatriptan Injection USP and a reduction in pre-launch quantities of teriparatide pen devices sold to Teva in previous periods in anticipation of a potential launch. These year-to-date decreases were offset by a 66% increase in sales of auto injector devices to Teva for use with their generic Epinephrine Injection USP for the nine months ended September 30, 2020 as compared to 2019.  

Licensing and development revenue

Licensing and development revenues include license fees received from partners for the right to use our intellectual property and amounts earned in joint development arrangements with partners under which we perform joint development activities or develop new products on their behalf. Licensing and development revenue was $4.3 million and $1.2 million for the three months ended September 30, 2020 and 2019, respectively, and $8.8 million and $4.4 million for the nine months ended September 30, 2020 and 2019, respectively. The increase in licensing and development revenue recognized for the three and nine months ended September 30, 2020 as compared to the same period 2019 was primarily a result of an increase in development activities from the ongoing development project with Pfizer, the new development project with Idorsia that was announced in the fourth quarter of 2019 and other recent partnered development projects, offset by a reduction in revenue from the development of the Teva teriparatide pen.

Royalties

Royalty revenue was $6.7 million and $8.4 million for the three months ended September 30, 2020 and 2019, respectively and $16.0 million and $18.1 million for the nine months ended September 30, 2020 and 2019, respectively. The net decrease in royalty revenue was a result of a decrease in royalties from AMAG on their net sales of the Makena® subcutaneous auto injector offset by an increase in royalties from Teva on their net sales of Epinephrine Injection USP.

Cost of Revenue and Gross Profit

The following table summarizes our total revenue, cost of revenue and gross profit (in thousands):

 

 

 

Three Months Ended September 30,

 

 

Nine months ended September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Total revenue

 

$

40,003

 

 

$

34,306

 

 

$

105,466

 

 

$

86,025

 

Total cost of revenue

 

 

16,517

 

 

 

13,062

 

 

 

44,041

 

 

 

36,449

 

Gross profit

 

$

23,486

 

 

$

21,244

 

 

$

61,425

 

 

$

49,576

 

Gross profit percentage

 

 

59

%

 

 

62

%

 

 

58

%

 

 

58

%

 

23


 

Fluctuations in our gross profit and gross profit percentage are driven by our overall revenue mix. Our gross profit was $23.5 million and $21.2 million for the three months ended September 30, 2020 and 2019, respectively, and $61.4 million and $49.6 million for the nine months ended September 30, 2020 and 2019, respectively. The overall increase in our gross profits is attributable to the relative increase in our proprietary product sales, which carry a higher gross margin. The slight decrease in our gross profit percentage for the three months ended September 30, 2020 as compared to the three months ended September 30, 2019 was primarily due to the relative decrease in royalty revenues, which have no associated costs. Other variations in cost of revenue and gross profit were attributable to partnered development activities, which fluctuate depending on the mix of development projects in progress and stages of completion in each period.

Research and Development Expenses

Research and development expenses consist of external costs for clinical studies and analysis activities, design work and prototype development, FDA application fees, personnel costs and other general operating expenses associated with our research and development activities.  Research and development expenses were $2.4 million and $2.9 million for the three months ended September 30, 2020 and 2019, respectively, and $7.8 million and $7.7 million for the nine months ended September 30, 2020 and 2019 respectively. Research and development costs were attributable to our ongoing internal development programs including, but not limited to, ATRS-1901 and ATRS-1902, and fluctuate based on the respective phases of development.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $15.2 million and $16.4 million for three months ended September 30, 2020 and 2019, respectively, and $46.1 million and $46.4 million for the nine months ended September 30, 2020 and 2019 respectively. The decrease in selling, general and administrative expenses for the three and nine months ended September 30, 2020 compared to 2019 was principally due to a reduction in sales and marketing costs incurred as a result of the various stay at home orders and travel restrictions related to COVID-19.  

Liquidity and Capital Resources

At September 30, 2020, we had cash and cash equivalents of $50.2 million and short-term investments of $2.0 million. Our principal liquidity needs are to fund our product manufacturing costs, research and development activities, capital expenditures, sales and marketing activities and other operating expenses. We have not historically generated enough revenue or operating cash flow to support or grow our operations and our primary sources of liquidity and capital have been proceeds from equity offerings and debt issuance. However, we believe that the combination of our current cash and cash equivalents, investments, projected product sales, development revenue and royalties will provide us with sufficient funds to meet our obligations and support operations through at least the next twelve months from the date of this report.

Long-term Debt Financing

The Company is party to a loan and security agreement, as amended, with Hercules Capital, Inc., for a term loan of up to $50.0 million (the “Term Loan”), under which the Company has borrowed $40.0 million. The amortizing Term Loan is secured by substantially all of the Company’s assets, excluding intellectual property, accrues interest at a prime-based variable rate with a maximum of 9.5%, which was 8.5% at September 30, 2020, provides for payments of interest-only until August 1, 2021 and matures on July 1, 2022, which may be extended to July 1, 2024 contingent upon satisfaction of a certain loan extension milestone.

The Company had the option, but was not obligated to, request one or more additional advances of at least $5.0 million, not to exceed $10.0 million in the aggregate through October 31, 2020, which was not utilized.  The interest-only payment period of the Term Loan may also be extended to August 1, 2022 if the Company achieves a certain loan extension milestone, requests such extension, and pays an extension fee equal to one half of one percent of the principal amount outstanding. The Company is required to pay an end of term fee equal to 4.25% of the first $25.0 million and 3.95% of all other borrowings under the loan, payable upon the earlier of July 1, 2022 or repayment of the loan.

24


 

Net Cash Flows from Operating Activities

Operating cash inflows are generated primarily from product sales, license and development fees and royalties. Operating cash outflows consist principally of expenditures for manufacturing costs, personnel costs, general and administrative expenses, research and development activities, and sales and marketing costs. Fluctuations in cash from operating activities are primarily a result of the timing of cash receipts and disbursements. Net cash provided by operating activities was $14.2 million for the nine months ended September 30, 2020 as compared to net cash used in operating activities of $9.5 million for the nine months ended September 30, 2019.  The change in the net cash from operating activities was primarily a result of our net income of $4.8 million in 2020 as compared to a net loss of $6.7 million in 2019 and other changes in operating assets and liabilities due to timing of cash receipts and cash payments.  

Net Cash Flows from Investing Activities

Net cash provided by investing activities was $12.6 million for the nine months ended September 30, 2020 as compared to $1.2 million for the nine months ended September 30, 2019.  The net cash provided by investing activities for the nine months ended September 30, 2020 was attributable to $20.5 million in maturities of short-term investments offset by capital expenditures of $7.9 million. Cash provided by investing activities for the nine months ended September 30, 2019 were comprised of $2.5 million of proceeds from the sale of assets to Ferring, offset by capital expenditures of $1.3 million.

Net Cash Flows from Financing Activities

The net cash flow from financing activities was $0.1 million for the nine months ended September 30, 2020, and consisted of $1.5 million in proceeds from the exercise of stock options offset by $1.4 million paid to taxing authorities in connection with net-share settled stock-based awards for which we withheld shares equivalent to the value of the employees’ tax obligation for the applicable income and other employment taxes. Net cash provided by financing activities for the nine months ended September 30, 2019 was $22.2 million, which included $15.0 million in additional loan proceeds, $7.8 million in net cash proceeds received from sales of our common stock through an at-the-market selling agreement and $0.7 million in proceeds from the exercise of stock options offset by $1.1 million paid to taxing authorities in connection with net-share settled stock-based awards.  

Contractual Obligations

There have been no significant changes to our contractual obligations and arrangements reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019.

Critical Accounting Policies and Use of Estimates

The preceding discussion and analysis of our results of operations and financial condition is based upon our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these consolidated financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, revenues and expenses. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances.  Actual results could differ from our estimates, and significant variances could materially impact our financial condition and results of operations.

The accounting policies we believe to be most critical to understanding our results of operations and financial condition related to revenue recognition and inventory valuation, which are fully described in our Annual Report on Form 10-K for the year ended December 31, 2019.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements, including any arrangements with any structured finance, special purpose or variable interest entities.

25


 

Item 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are exposed to foreign exchange rate fluctuations of the Swiss Franc to the U.S. dollar as the financial position and operating results of our subsidiaries in Switzerland are translated into U.S. dollars for consolidation. In addition, we have exposure to exchange rate fluctuations between the Euro and the U.S. dollar for some of our transactions. We do not currently use derivative financial instruments to hedge against exchange rate risk.  The effect of foreign exchange rate fluctuations on our financial results for the period ended September 30, 2020 was not material.

We may also be exposed to interest rate risk and interest rate fluctuations as a result of our long-term debt financing. Our loan, with a current outstanding principal balance of $40.0 million accrues interest at a calculated prime-based variable rate, which was 8.5% as of September 30, 2020, with a maximum interest rate of 9.50%. A hypothetical increase or decrease in the interest rate of 1.0% would result in additional or lower annual interest expense of $400,000.

Item 4.

CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

The Company’s management, under the supervision and with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this report.  The evaluation was performed to determine whether the Company’s disclosure controls and procedures have been designed and are functioning effectively to provide reasonable assurance that the information required to be disclosed by the Company in reports filed under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and is accumulated and communicated to management, including the Company’s principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.  Based on such evaluation, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures as of the end of the period covered by this report were effective.

Internal Control over Financial Reporting

There have not been any material changes in the Company’s internal control over financial reporting during the fiscal quarter to which this report relates that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting. We have not experienced any material impact to our internal controls over financial reporting despite the fact that most of our corporate and administrative employees are working remotely due to the Pandemic. The Company is continually monitoring and assessing the COVID-19 situation and any potential impact on the design and operating effectiveness of internal control over financial reporting.

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected.  The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, control may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

 

26


 

PART II - OTHER INFORMATION

Item 1.

On October 23, 2017, Randy Smith filed a complaint in the District of New Jersey, captioned Randy Smith, Individually and on Behalf of All Others Similarly Situated v. Antares Pharma, Inc., Robert F. Apple and Fred M. Powell (“Smith”), Case No. 3:17-cv-08945-MAS-DEA, on behalf of a putative class of persons who purchased or otherwise acquired Antares securities between December 21, 2016 and October 12, 2017, inclusive, asserting claims for purported violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 against Antares, Robert F. Apple and Fred M. Powell.  The Smith complaint contends that defendants made false and/or misleading statements and/or failed to disclose that: (i) Antares had provided insufficient data to the FDA in connection with the NDA for XYOSTED®; and (ii) accordingly, Antares had overstated the approval prospects for XYOSTED®. On July 27, 2018, the court entered an order appointing Serghei Lungu as lead plaintiff, Pomerantz LLP as lead counsel, and Lite DePalma Greenberg, LLC as liaison counsel for plaintiff.  On August 3, 2018, the parties submitted a stipulation and proposed order, setting forth an agreed-upon schedule for responding to the complaint, which the court granted. Pursuant to that order, plaintiff filed a Consolidated Amended Class Action Complaint on October 9, 2018. On November 26, 2018, defendants filed a motion to dismiss. Plaintiff filed an opposition to the motion on January 10, 2019 and defendants filed a reply in support of their motion on February 25, 2019. On July 2, 2019, the court dismissed the complaint in its entirety without prejudice. On July 29, 2019, plaintiff filed a Consolidated Second Amended Class Action Complaint against the same parties alleging substantially similar claims. On September 12, 2019, defendants filed a motion to dismiss the Consolidated Second Amended Class Action Complaint. Plaintiffs’ opposition was filed on October 28, 2019 and defendants’ reply in support of their motion was filed on November 27, 2019. On April 28, 2020, the court dismissed the Consolidated Second Amended Class Action Complaint in its entirety. The court further ordered that plaintiff may file an amended complaint by May 29, 2020 and provide the court with a form of the amended complaint that indicates in what respect(s) it differs from the complaint which it proposes to amend. On May 29, 2020, plaintiff filed a Consolidated Third Amended Class Action Complaint and defendants filed a motion to dismiss on July 10, 2020.  Briefing on defendants’ motion was complete on August 25, 2020. The Company believes that the claims in the Smith action lack merit and intends to defend them vigorously.

On January 12, 2018, a stockholder of our Company filed a derivative civil action, captioned Chiru Mackert, derivatively on behalf of Antares Pharma, Inc., v. Robert F. Apple, et al., in the Superior Court of New Jersey Chancery Division, Mercer County (Case No. C-000011-18).  On January 17, 2018, another stockholder filed a derivative action in the same court, captioned Vikram Rao, Derivatively on Behalf of Antares Pharma, Inc. v. Robert F. Apple, et al. (Case No. C-000004-18). Both complaints name Robert F. Apple, Fred M. Powell, Thomas J. Garrity, Jacques Gonella, Anton Gueth, Leonard S. Jacob, Marvin Samson and Robert P. Roche, Jr. as defendants, and the Company as nominal defendant, and they assert claims for breach of fiduciary duties, unjust enrichment, abuse of control, gross mismanagement, and waste of corporate assets arising from the same facts underlying the Smith securities class action.  The plaintiffs seek damages, corporate governance and internal procedure reforms and improvements, restitution, reasonable attorneys’ fees, experts’ fees, costs, and expenses. The parties have filed a stipulation and order consolidating the two actions and staying the proceedings pending the court’s decision on defendants’ motion to dismiss the Smith action.  On August 17, 2020, the court terminated the case pending a lifting of the stay as set forth in the stipulation and order.

On January 17, 2018, a stockholder of our Company filed a derivative civil action, captioned Robert Clark, Derivatively on Behalf of Antares Pharma, Inc. v. Robert F. Apple, et al. (“Clark”) (Case No. 3:18-cv-00703-MAS-DEA), against Robert F. Apple, Thomas J. Garrity, Jacques Gonella, Leonard S. Jacob, Marvin Samson, Anton G. Gueth and Robert P. Roche, Jr. as defendants, and Company as a nominal defendant.  The action was filed in the U.S. District Court for the District of New Jersey and asserts claims for breach of fiduciary duties, unjust enrichment, abuse of control, waste of corporate assets, and a violation of Section 14(a) of the Securities Exchange Act of 1934.  This complaint relates to the same facts underlying the Smith securities class action and the other derivative actions. The plaintiff in Clark seeks damages, corporate governance and internal procedure reforms and improvements, reasonable attorneys’ fees, accountants’ and experts’ fees, costs, and expenses. The parties have filed a stipulation and order staying the action pending the court’s decision on defendants’ motion to dismiss the Smith action. On August 17, 2020, the court terminated the case pending a lifting of the stay as set forth in the stipulation and order.

Item 1A.

RISK FACTORS

We face uncertainty and risks related to the outbreak of the novel coronavirus disease, COVID-19, which could significantly disrupt our operations and may materially and adversely impact our business and financial conditions.

The COVID-19 Pandemic continues to evolve rapidly and the related risks and uncertainty could materially and adversely affect our business and financial conditions. The United States and many other countries have declared a national emergency with respect to the COVID-19 outbreak. The outbreak and government measures taken in response to the Pandemic have severely impacted global economic activity. Many countries and almost all states in the United States have reacted to the outbreak by implementing stay-at-home or quarantine orders, mandating certain business and school closures, enacting social distancing requirements, and restricting large gatherings and travel.

In response to the Pandemic, we have taken steps to protect the health and safety of our employees and comply with governmental mandates and restrictions while working to ensure the sustainability of our business operations. For example, many of our corporate and administrative functions are working remotely and we have limited the number of staff in our facilities to those

27


 

necessary for essential functions such as research, development, manufacturing and supply.  We have also implemented various safety measures and protocols and continuously monitor and evaluate the impact COVID-19 may have on our ability to effectively conduct our business operations as planned; however, there can be no assurances that we will be able to avoid any or all impact from the Pandemic.

Our sales force has been subject to limitations on their ability to visit physicians and we are utilizing virtual meeting platforms and other forms of social media to connect with our existing and potential customers and healthcare professionals. Our sales force has resumed in-person office visits in some areas and continues to work virtually in other territories based on the varying stay-at-home orders, restrictions and phased openings during the ongoing Pandemic. These restrictions and closures have also limited patient access to physicians, and we have experienced, and may continue to experience, a decrease in new prescriptions for our proprietary products. Our partners may also experience a decrease in demand for our partnered products due to the Pandemic or the related restrictions. While we have taken measures to help minimize the potential impact of the various government orders, the effects of these restrictions may negatively impact productivity and demand for our products, disrupt our business and delay development programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. These restrictions and others in the future, as well as the continued uncertainty on the duration, scope and severity of the outbreak, could negatively impact our business, operating results and financial condition.

We currently rely on many third parties to source API and drug product, manufacture and assemble our devices, distribute finished products and provide various logistics activities for our business.  If any of these third parties are adversely impacted by the Pandemic or the restrictions resulting from the outbreak, for example, one of our third party manufacturer’s facility had a temporary shutdown as a result of a positive COVID-19 diagnosis by an employee, we may experience delays or disruptions in our product supply chain which could have a material and adverse impact on our business. The ongoing spread of COVID-19 in the United States and the mitigation measures imposed may limit healthcare professional interaction, curtail patient visits to physicians and reduce the demand for our products in the future which could have a material adverse impact on our business. Moreover, to the extent that we or our partners are conducting clinical trials, the Pandemic could cause delays or disruptions in these or future development programs. The Pandemic could potentially impact the FDA or other regulatory authorities which could cause delays in meetings or review of pending applications or submissions and impact our business.

While the full economic impact and duration of the Pandemic and the mitigation measures may be difficult to assess or predict at this time, global economic conditions have already been adversely affected by the COVID-19 crisis and these conditions could have an adverse effect on our business including demand for our product, future revenue and operating results. The Pandemic has also had an adverse impact on the financial markets including our current stock price and continued and further disruption of the global financial markets could further negatively impact the price of our common stock and reduce our ability to access capital in the future, if required.              

The global Pandemic continues to evolve rapidly and the ultimate impact is highly uncertain and subject to change. The full extent to which the Pandemic may impact our business or the economy as a whole is unknown and will depend on future developments, which are highly uncertain and cannot be predicted, such as the ultimate spread and rate of infection, the duration of the Pandemic, travel restrictions and social distancing requirements, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease and to address its impact, including on financial markets or otherwise.  In the United States, as some of these initial restriction have been lifted and phased re-openings have begun to occur, the spread of the virus and number of cases continue to rise and there is speculation and uncertainty about a second wave of the Pandemic as we approach seasonal cold and flu season.  As a result, Federal, State or local governments may re-impose or implement new restrictions or mitigation measures or halt or reverse previously implemented phased re-openings. These effects could have a material and adverse impact on our business and operations.                              

To the extent the Pandemic adversely affects our business and financial results, it may also have the effect of heightening many of the other risks described in this section and in the “Risk Factor” section in our other filings with the Securities and Exchange Commission. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results.

We depend on AMAG to manufacture and supply the drug, distribute and commercialize a variation of our VIBEX® QuickShot® subcutaneous auto injector for use with AMAG’s progestin hormone drug Makena®, and to maintain regulatory approval of the product.

We have entered into a license, development and supply agreement with AMAG to distribute a variation of our VIBEX® QuickShot® subcutaneous auto injector for use with AMAG’s progestin hormone drug Makena®, the Makena® Auto Injector.

28


 

Makena® was first approved by FDA via the accelerated approval pathway in 2011.  In 2018, FDA approved a supplemental application for the use of Makena® with our VIBEX® QuickShot® subcutaneous auto injector.

There is no guarantee that our partnership with AMAG will be successful, that AMAG will be able to maintain approval for Makena® or that AMAG will be able to successfully manufacture, supply, commercialize, and distribute the drug product. By example, in October 2019, AMAG announced that the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee met to better understand and interpret the PROLONG (Progestin’s Role in Optimizing Neonatal Gestation) confirmatory clinical trial for Makena® (hydroxyprogesterone caproate) injection. The PROLONG trial was conducted as a post-market study requirement under the 2011 Makena® accelerated approval.  Nine advisory committee members voted to recommend that the FDA pursue withdrawal of approval for Makena® and seven committee members voted to leave the product on the market under accelerated approval and require a new confirmatory trial. The advisory committee's recommendation, while not binding, will be considered by the FDA in making its decision. In October 2020, AMAG received notice that the FDA is proposing to withdraw approval of Makena® (hydroxyprogesterone caproate injection). AMAG has formally requested a public hearing in response to the FDA’s proposal to withdraw its approval and has stated that it remains committed to working with the FDA to maintain patient access to Makena®. However, we do not yet know what FDA’s decision will be, and if the FDA decides to withdraw Makena® from the market, our business may be materially harmed.  Moreover, even if FDA determines that Makena® may remain on the market, Makena® sales may decrease or AMAG may decrease the resources that it dedicates to the manufacture, supply, commercialization, and distribution of Makena®.  Finally, if the FDA requires that AMAG conduct a new confirmatory study, AMAG may not be able to successfully conduct such study, which could ultimately result in FDA withdrawal of the Makena® approval.  

Additionally, AMAG controls the manufacture and supply of the drug, hydroxyprogesterone caproate, and has complete control over the launch and continuous commercialization and marketing of Makena® Auto Injector worldwide. If, at any time, AMAG ceases to manufacture and supply us with hydroxyprogesterone caproate or fails to produce sufficient supplies of the drug, we will be unable to produce a finished product or sell our auto injectors for this product to AMAG. In addition, if AMAG is unable to produce sufficient supplies of the drug in accordance with cGMPs or otherwise fails to comply with the applicable regulatory requirements, we also will be unable to produce a finished product and/or we and/or AMAG may be subject to regulatory enforcement action, which would impact the ability to produce, market, commercialize, sell, and distribute the finished drug product, and in turn, our revenue. We rely on AMAG to commercialize and distribute the product worldwide and if AMAG is unsuccessful in commercializing the product, the resulting revenue may be lower than expected. Additionally, we may disagree with AMAG on certain business strategies or its manufacturing and distribution decisions. Such decisions by AMAG may be beyond our control and may impact the success of the Makena® Auto Injector and we may receive less revenue than desired or expected.

Item 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

Item 3.

DEFAULT UPON SENIOR SECURITIES

None.

Item 4.

MINE SAFETY DISCLOSURES

Not applicable.

Item 5.

OTHER INFORMATION

None.

 

29


 

Item 6.

EXHIBITS

(a)

Exhibit Index

 

Exhibit No.

 

Description

  10.1

 

Second Amendment to Loan and Security Agreement, dated September 15, 2020, by and among Antares Pharma, Inc., Hercules Capital, Inc., and the several banks and other financial institutions or entities from time to time party to the Loan Agreement (Filed as exhibit 10.1 to Form 8-K on September 21, 2020 and incorporated herein by reference).

 

 

 

  31.1#

 

Certificate of the Chief Executive Officer of Antares Pharma, Inc. required by Rule 13a-14(a) under the Securities Exchange Act of 1934, as amended, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

  31.2#  

 

Certificate of the Chief Financial Officer of Antares Pharma, Inc. required by Rule 13a-14(a) under the Securities Exchange Act of 1934, as amended, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

  32.1## 

 

Certificate of the Chief Executive Officer of Antares Pharma, Inc. required by Rule 13a-14(b) under the Securities Exchange Act of 1934, as amended, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

  32.2## 

 

Certificate of the Chief Financial Officer of Antares Pharma, Inc. required by Rule 13a-14(b) under the Securities Exchange Act of 1934, as amended, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

101.INS#

 

XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.)

 

 

 

101.SCH#

 

Inline XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL#

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

101.LAB#

 

Inline XBRL Taxonomy Extension Label Linkbase Document

 

 

 

101.PRE#

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document

 

 

 

101.DEF#

 

Inline XBRL Taxonomy Extension Definition Document

 

 

 

104#

 

Cover Page Interactive Data File (the cover page interactive data does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)

 

#  

Filed herewith.

##

Furnished herewith.

 

30


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

ANTARES PHARMA, INC.

 

 

 

November 5, 2020

 

/s/ Robert F. Apple

 

 

Robert F. Apple

 

 

President and Chief Executive Officer

 

 

(Principal Executive Officer)

 

 

 

November 5, 2020

 

/s/ Fred M. Powell

 

 

Fred M. Powell

 

 

Executive Vice President and Chief Financial Officer

 

 

(Principal Financial and Accounting Officer)

 

 

31

atrs-ex311_8.htm

 

Exhibit 31.1

CERTIFICATIONS

I, Robert F. Apple, certify that:

1.

I have reviewed this report on Form 10-Q for the fiscal quarter ended September 30, 2020 of Antares Pharma, Inc.;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15(d)-15(f)) for the registrant and have:

 

a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 5, 2020

 

/s/ Robert F. Apple

Robert F. Apple

President and Chief Executive Officer

 

 

atrs-ex312_9.htm

 

Exhibit 31.2

CERTIFICATIONS

I, Fred M. Powell, certify that:

1.

I have reviewed this report on Form 10-Q for the fiscal quarter ended September 30, 2020 of Antares Pharma, Inc.;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15(d)-15(f)) for the registrant and have:

 

a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 5, 2020

 

/s/ Fred M. Powell

Fred M. Powell

Executive Vice President and Chief Financial Officer

 

 

atrs-ex321_7.htm

 

Exhibit 32.1

ANTARES PHARMA, INC.

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 (18 U.S.C. 1350)

The undersigned, Robert F. Apple, the Chief Executive Officer of Antares Pharma, Inc. (the “Company”), has executed this Certification in connection with the filing with the Securities and Exchange Commission of the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2020 (the “Report”).

The undersigned hereby certifies that:

 

1.

The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

 

2.

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

IN WITNESS WHEREOF, the undersigned has executed this Certification as of the 5th day of November, 2020.

 

/s/ Robert F. Apple

Robert F. Apple

President and Chief Executive Officer

 

 

atrs-ex322_6.htm

 

Exhibit 32.2

ANTARES PHARMA, INC.

CERTIFICATION OF CHIEF FINANCIAL OFFICER

PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 (18 U.S.C. 1350)

The undersigned, Fred M. Powell, the Chief Financial Officer of Antares Pharma, Inc. (the “Company”), has executed this Certification in connection with the filing with the Securities and Exchange Commission of the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2020 (the “Report”).

The undersigned hereby certifies that:

 

1.

The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

 

2.

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

IN WITNESS WHEREOF, the undersigned has executed this Certification as of the 5th day of November, 2020.

 

/s/ Fred M. Powell

Fred M. Powell

Executive Vice President and Chief Financial Officer

 

 

v3.20.2
Document and Entity Information - shares
9 Months Ended
Sep. 30, 2020
Nov. 02, 2020
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Sep. 30, 2020  
Document Fiscal Year Focus 2020  
Document Fiscal Period Focus Q3  
Trading Symbol ATRS  
Security Exchange Name NASDAQ  
Entity Registrant Name ANTARES PHARMA, INC.  
Entity Central Index Key 0001016169  
Current Fiscal Year End Date --12-31  
Entity Filer Category Accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Title of 12(b) Security Common Stock, par value $0.01 per share  
Entity Common Stock, Shares Outstanding   166,672,429
Entity Shell Company false  
Entity Current Reporting Status Yes  
Entity File Number 1-32302  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 41-1350192  
Entity Address, Address Line One 100 Princeton South  
Entity Address, Address Line Two Suite 300  
Entity Address, City or Town Ewing  
Entity Address, State or Province NJ  
Entity Address, Postal Zip Code 08628  
City Area Code 609  
Local Phone Number 359-3020  
Entity Interactive Data Current Yes  
Document Quarterly Report true  
Document Transition Report false  
v3.20.2
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
$ in Thousands
Sep. 30, 2020
Dec. 31, 2019
Current Assets:    
Cash and cash equivalents $ 50,172 $ 23,201
Short-term investments 1,997 22,520
Accounts receivable 42,507 35,074
Inventories 19,809 16,000
Contract assets 8,784 8,235
Prepaid expenses and other current assets 1,851 3,416
Total current assets 125,120 108,446
Property and equipment, net 22,547 15,961
Operating lease right-of-use assets 4,881 5,463
Other assets 3,026 2,881
Total Assets 155,574 132,751
Current Liabilities:    
Accounts payable 18,016 12,905
Accrued expenses and other liabilities 22,846 17,772
Long-term debt, current portion 6,415  
Deferred revenue 3,277 1,738
Total current liabilities 50,554 32,415
Long-term debt 34,358 40,395
Operating lease liabilities, long-term 4,940 5,441
Other long-term liabilities 481  
Total liabilities 90,333 78,251
Stockholders’ Equity:    
Preferred Stock: $0.01 par; 3,000 shares authorized, none outstanding
Common Stock: $0.01 par; 300,000 shares authorized; 166,672 and 165,221 issued and outstanding at September 30, 2020 and December 31, 2019, respectively 1,667 1,652
Additional paid-in capital 338,277 332,377
Accumulated deficit (274,012) (278,827)
Accumulated other comprehensive loss (691) (702)
Total Stockholders' Equity 65,241 54,500
Total Liabilities and Stockholders’ Equity $ 155,574 $ 132,751
v3.20.2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
Sep. 30, 2020
Dec. 31, 2019
Statement Of Financial Position [Abstract]    
Preferred Stock, par value $ 0.01 $ 0.01
Preferred Stock, shares authorized 3,000,000 3,000,000
Preferred Stock, shares outstanding 0 0
Common Stock, par value $ 0.01 $ 0.01
Common Stock, shares authorized 300,000,000 300,000,000
Common Stock, shares issued 166,672,000 165,221,000
Common Stock, shares outstanding 166,672,000 165,221,000
v3.20.2
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
shares in Thousands, $ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2020
Sep. 30, 2019
Revenue:        
Total revenue $ 40,003 $ 34,306 $ 105,466 $ 86,025
Cost of revenue:        
Total cost of revenue 16,517 13,062 44,041 36,449
Gross profit 23,486 21,244 61,425 49,576
Operating expenses:        
Research and development 2,405 2,863 7,803 7,744
Selling, general and administrative 15,231 16,385 46,101 46,407
Total operating expenses 17,636 19,248 53,904 54,151
Operating income (loss) 5,850 1,996 7,521 (4,575)
Interest expense (782) (1,097) (2,810) (2,470)
Other income (expense) (72) 144 104 323
Net income (loss) $ 4,996 $ 1,043 $ 4,815 $ (6,722)
Net income (loss) per common share, basic and diluted $ 0.03 $ 0.01 $ 0.03 $ (0.04)
Weighted average common shares outstanding:        
Basic 166,375 163,119 165,838 162,109
Diluted 169,655 168,503 169,759 162,109
Product sales [Member]        
Revenue:        
Total revenue $ 28,947 $ 24,687 $ 80,709 $ 63,607
Cost of revenue:        
Total cost of revenue 13,615 12,510 38,556 33,791
Licensing and Development Revenue [Member]        
Revenue:        
Total revenue 4,321 1,211 8,763 4,365
Royalties [Member]        
Revenue:        
Total revenue 6,735 8,408 15,994 18,053
Cost of development revenue [Member]        
Cost of revenue:        
Total cost of revenue $ 2,902 $ 552 $ 5,485 $ 2,658
v3.20.2
Condensed Consolidated Statements of Comprehensive Income (Loss) (Unaudited) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2020
Sep. 30, 2019
Statement Of Income And Comprehensive Income [Abstract]        
Net income (loss) $ 4,996 $ 1,043 $ 4,815 $ (6,722)
Foreign currency translation adjustment 5 (2) 11 (3)
Comprehensive income (loss) $ 5,001 $ 1,041 $ 4,826 $ (6,725)
v3.20.2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)
$ in Thousands
Total
Cumulative Effect of Change in Accounting Principle [Member]
Common Stock [Member]
Additional Paid-in Capital [Member]
Accumulated Deficit [Member]
Accumulated Deficit [Member]
Cumulative Effect of Change in Accounting Principle [Member]
Accumulated Other Comprehensive Loss [Member]
Balance at Dec. 31, 2018 $ 39,001   $ 1,597 $ 314,907 $ (276,800)   $ (703)
Balance, shares at Dec. 31, 2018     159,721,000        
Issuance of common stock 7,781   $ 23 7,758      
Issuance of common stock, shares     2,307,000        
Common stock issued under equity compensation plan, net of shares withheld for taxes (1,077)   $ 7 (1,084)      
Common stock issued under equity compensation plan, net of shares withheld for taxes, shares     664,000        
Exercise of options 674   $ 5 669      
Exercise of options, shares     512,000        
Share-based compensation 4,645     4,645      
Net income (loss) (6,722)       (6,722)    
Other comprehensive income (loss) (3)           (3)
Balance at Sep. 30, 2019 44,415 $ 116 $ 1,632 326,895 (283,406) $ 116 (706)
Balance, shares at Sep. 30, 2019     163,204,000        
Balance at Jun. 30, 2019 41,552   $ 1,630 325,075 (284,449)   (704)
Balance, shares at Jun. 30, 2019     163,053,000        
Common stock issued under equity compensation plan, net of shares withheld for taxes (13)   $ 1 (14)      
Common stock issued under equity compensation plan, net of shares withheld for taxes, shares     9,000        
Exercise of options 190   $ 1 189      
Exercise of options, shares     142,000        
Share-based compensation 1,645     1,645      
Net income (loss) 1,043       1,043    
Other comprehensive income (loss) (2)           (2)
Balance at Sep. 30, 2019 44,415 $ 116 $ 1,632 326,895 (283,406) $ 116 (706)
Balance, shares at Sep. 30, 2019     163,204,000        
Balance at Dec. 31, 2019 54,500   $ 1,652 332,377 (278,827)   (702)
Balance, shares at Dec. 31, 2019     165,221,000        
Common stock issued under equity compensation plan, net of shares withheld for taxes (1,366)   $ 7 (1,373)      
Common stock issued under equity compensation plan, net of shares withheld for taxes, shares     676,000        
Exercise of options 1,512   $ 8 1,504      
Exercise of options, shares     775,000        
Share-based compensation 5,769     5,769      
Net income (loss) 4,815       4,815    
Other comprehensive income (loss) 11           11
Balance at Sep. 30, 2020 65,241   $ 1,667 338,277 (274,012)   (691)
Balance, shares at Sep. 30, 2020     166,672,000        
Balance at Jun. 30, 2020 57,329   $ 1,661 335,372 (279,008)   (696)
Balance, shares at Jun. 30, 2020     166,085,000        
Common stock issued under equity compensation plan, net of shares withheld for taxes (16)     (16)      
Common stock issued under equity compensation plan, net of shares withheld for taxes, shares     7,000        
Exercise of options 1,123   $ 6 1,117      
Exercise of options, shares     580,000        
Share-based compensation 1,804     1,804      
Net income (loss) 4,996       4,996    
Other comprehensive income (loss) 5           5
Balance at Sep. 30, 2020 $ 65,241   $ 1,667 $ 338,277 $ (274,012)   $ (691)
Balance, shares at Sep. 30, 2020     166,672,000        
v3.20.2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Cash flows from operating activities:    
Net income (loss) $ 4,815 $ (6,722)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:    
Stock-based compensation expense 5,769 4,645
Depreciation and amortization 1,730 1,916
Other 662 279
Changes in operating assets and liabilities:    
Accounts receivable (7,422) (14,957)
Inventories (3,809) (5,153)
Contract assets (549) 1,743
Prepaid expenses and other assets 1,345 847
Accounts payable 5,171 4,669
Accrued expenses and other liabilities 4,967 2,854
Deferred revenue 1,538 394
Net cash provided by (used in) operating activities 14,217 (9,485)
Cash flows from investing activities:    
Purchases of property and equipment (7,893) (1,274)
Proceeds from sale of assets   2,500
Proceeds from maturities of investment securities 20,500  
Net cash provided by investing activities 12,607 1,226
Cash flows from financing activities:    
Proceeds from issuance of long-term debt   15,000
Payment of debt issuance costs   (136)
Proceeds from issuance of common stock, net   7,781
Proceeds from exercise of stock options 1,512 674
Taxes paid related to net share settlement of equity awards (1,366) (1,077)
Net cash provided by financing activities 146 22,242
Effect of exchange rate changes on cash 1 (1)
Net increase in cash and cash equivalents 26,971 13,982
Cash and cash equivalents:    
Beginning of period 23,201 27,892
End of period 50,172 41,874
Supplemental disclosure of cash flow information:    
Cash paid for interest 2,679 2,073
Supplemental disclosure of non-cash investing activities:    
Purchases of property and equipment recorded in accounts payable and accrued expenses $ 1,577 $ 881
v3.20.2
Description of Business
9 Months Ended
Sep. 30, 2020
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Description of Business

1.

Description of Business

Antares Pharma, Inc. (“Antares,” “we,” “our,” “us” or the “Company”) is a pharmaceutical technology company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products and technologies.  We develop, manufacture and commercialize, for ourselves or with partners, novel therapeutic products using advanced drug delivery technology to enhance existing drug compounds and delivery methods. Our injection technology platforms include the VIBEX® and VIBEX® QuickShot® pressure-assisted auto injector systems suitable for branded and generic injectable drugs in unit dose containers and disposable multi-dose pen injectors. We have a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. We have formed several significant strategic alliances with partners including Teva Pharmaceutical Industries, Ltd. (“Teva”), AMAG Pharmaceuticals, Inc. (“AMAG”), Pfizer Inc. (“Pfizer”) and Idorsia Pharmaceuticals Ltd (“Idorsia”).

The Company directly markets and sells two proprietary products in the United States, XYOSTED® (testosterone enanthate) injection and OTREXUP® (methotrexate) injection. XYOSTED® (testosterone enanthate) injection is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, and OTREXUP® (methotrexate) injection is indicated for adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis.   

Through our commercialization partner Teva, we sell Sumatriptan Injection USP, indicated in the U.S. for the acute treatment of migraine and cluster headache in adults.  

In collaboration with AMAG, we developed a subcutaneous auto injector and are the exclusive supplier of devices and the final assembled and packaged commercial product of AMAG’s Makena® (hydroxyprogesterone caproate injection) subcutaneous auto injector, which is a ready-to-administer treatment indicated to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered at least one preterm baby in the past.

Through a license, development and supply agreement with Teva, Antares developed and is the exclusive supplier of the device for Teva’s Epinephrine Injection USP, which is indicated for emergency treatment of severe allergic reactions in adults and certain pediatric patients. The Company also developed and is the exclusive supplier of devices for Teva’s generic equivalent of Forsteo® (Teriparatide Injection) which is approved and sold in various countries in Europe, Canada and Israel.

The Company is also developing two multi-dose pen injector products in collaboration with Teva, a combination drug device rescue pen in collaboration with Pfizer, a combination drug device product with Idorsia, and has other ongoing internal and partnered research and development programs.

v3.20.2
Basis of Presentation and Significant Accounting Policies
9 Months Ended
Sep. 30, 2020
Accounting Policies [Abstract]  
Basis of Presentation and Significant Accounting Policies

2.

Basis of Presentation and Significant Accounting Policies

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles (“GAAP”) in the U.S. for interim financial information and with the instructions to Form 10-Q and Article 10 of the Securities and Exchange Commission's Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the U.S. for complete financial statements.  In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included.  The accompanying condensed consolidated financial statements and notes thereto should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2019.  Operating results for the three and nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2020.

Accounting Pronouncements Recently Adopted

The Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) No. 2018-15 Customers’ Accounting for Implementation Costs Incurred in Cloud Computing Arrangement that is a Service Contract, effective January 1, 2020. This ASU provides new guidance on a customer's accounting for implementation, set-up, and other upfront costs incurred in a cloud computing arrangement that is hosted by the vendor (i.e., a service contract). Under the new guidance, entities apply the same criteria for capitalizing implementation costs as they would for an arrangement that has a software license. The Company’s adoption of this standard did not have a material impact on its consolidated financial statements.

The Company adopted ASU No. 2018-18 Clarifying the Interaction Between Topic 808 and 606, effective January 1, 2020. The guidance clarifies that certain transactions between collaborative arrangement participants should be accounted for under the revenue guidance, adds unit of account guidance to the collaborative arrangement guidance to align with the revenue standard, and clarifies presentation guidance for transactions with a collaborative arrangement participant that is not accounted for under the revenue standard. The Company’s adoption of this standard did not have a material impact on its consolidated financial statements.

Recent Accounting Pronouncements Not Yet Adopted

In 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This standard replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses on instruments within its scope, including trade receivables, and requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. The original effective date for ASU 2016-13 was for annual and interim periods beginning after December 15, 2019.

However, in October 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses, Derivatives and Hedging, and Leases: Effective Dates, which deferred the effective date of ASU 2016-13 for certain entities, including those that are eligible to be smaller reporting companies. A company’s determination about whether it is eligible for the deferral is a one-time assessment as of November 15, 2019 based on its most recent determination of its small reporting company eligibility as of the last business day of the most recently completed second quarter. Based on this determination, the Company qualified as a smaller reporting entity and is therefore eligible for the deferral of adoption of ASU 2016-13, resulting in a new effective date of January 1, 2023. The Company has historically had minimal credit losses on financial instruments and is currently evaluating the impact the adoption of ASU 2016-13 will have on its consolidated financial statements.

Cash and Cash Equivalents

Cash and cash equivalents consist of demand deposits at commercial banks and highly liquid investments with an original maturity of three months or less. Cash equivalents, consisting of investments in money market funds, are remeasured and reported at fair value each reporting period, in accordance with ASC Topic 820, Fair Value Measurements (“ASC 820”) based on quoted market prices, which is a Level 1 input within the three-level valuation hierarchy for disclosure of fair value measurements, and totaled $32,104 and $11,153 as of September 30, 2020 and December 31, 2019, respectively.

Investments

From time to time, the Company invests in U.S. Treasury bills and government agency notes that are classified as held-to-maturity because of the Company’s intent and ability to hold the securities to maturity. Investments with maturities of one year or less are classified as short-term.  The securities are carried at their amortized cost and the fair value is determined by quoted market prices.  The Company’s short-term investments had a carrying value of $1,997 and $22,520 as of September 30, 2020 and December 31, 2019, respectively, which approximated fair value.

 

Fair Value Measurements

The Company applies the provisions of ASC 820 for financial assets and liabilities that are required to be measured and reported at fair value each reporting period. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value:

Level 1: Quoted prices in active markets for identical assets or liabilities.

Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

The Company’s financial assets and liabilities that are not measured at fair value on a recurring basis under ASC 820 include its held-to-maturity investments and long-term debt, the carrying values of which approximate fair value. The estimated fair value of debt is based on Level 2 inputs, including management’s understanding of current market rates it could obtain for similar loans. The fair value of the Company’s cash, short-term investments, accounts receivable and accounts payable approximate fair value due to their short-term nature.

Inventories

Inventories are stated at the lower of cost or net realizable value. Cost is determined on a first-in, first-out basis. Certain components of the Company’s products are provided by a limited number of vendors, and the Company’s production, assembly, warehousing and distribution operations are outsourced to third-parties where substantially all of the Company’s inventory is located.  Disruption of supply from key vendors or third-party suppliers may have a material adverse impact on the Company’s operations. The Company provides a reserve for potentially excess, dated or obsolete inventories based on an analysis of inventory on hand compared to forecasts of future sales, which was $282 and $464 at September 30, 2020 and December 31, 2019, respectively.  Inventories consist of the following:

 

 

 

September 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Inventories:

 

 

 

 

 

 

 

 

Raw material

 

$

325

 

 

$

325

 

Work in process

 

 

9,088

 

 

 

8,390

 

Finished goods

 

 

10,396

 

 

 

7,285

 

 

 

$

19,809

 

 

$

16,000

 

Property and Equipment

Property and equipment are stated at cost and depreciated using the straight-line method over their estimated useful lives as follows:

 

 

Useful Life

Computer equipment and software

 

3-5 Years

Furniture, fixtures and office equipment

 

5-7 years

Production molds, tooling and equipment

 

3-10 years

Leasehold improvements

 

Lesser of useful life or lease term

Expenditures, including interest costs, for assets under construction that are not yet ready for their intended use are capitalized and will be depreciated based on the above guidelines when placed in service. The Company capitalized $212 of interest costs associated with construction in process during the nine months ended September 30, 2020. Costs associated with repairs and maintenance activities are expensed as incurred. As of September 30, 2020 and December 31, 2019, the Company’s property and equipment totaled $22,547 and $15,961, respectively, which is presented net of accumulated depreciation of $10,809 and $9,769 as of September 30, 2020 and December 31, 2019, respectively.

Revenue Recognition

The Company generates revenue from proprietary and partnered product sales, license and development activities and royalty arrangements.  Revenue is recognized when or as the Company transfers control of the promised goods or services to its customers at the transaction price, which is the amount that reflects the consideration to which it expects to be entitled to in exchange for those goods or services.

At inception of each contract, the Company identifies the goods and services that have been promised to the customer and each of those that represent a distinct performance obligation, determines the transaction price including any variable consideration, allocates the transaction price to the distinct performance obligations and determines whether control transfers to the customer at a point in time or over time. Variable consideration is included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company reassesses its reserves for variable consideration at each

reporting date and makes adjustments, if necessary, which may affect revenue and earnings in periods in which any such changes become known.

The Company has elected to recognize the cost for freight and shipping activities as fulfilment cost. Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of underlying goods are transferred to the customer. The related shipping and freight charges incurred by the Company are included in cost of revenue.

Proprietary Product Sales

The Company sells its proprietary products XYOSTED® and OTREXUP® primarily to wholesale and specialty distributors. Revenue is recognized when control has transferred to the customer, which is typically upon delivery, at the net selling price, which reflects the variable consideration for which reserves and sales allowances are established for estimated returns, wholesale distribution fees, prompt payment discounts, government rebates and chargebacks, insurance plan rebate arrangements and patient discount and support programs.

The determination of certain of these reserves and sales allowances require management to make a number of judgements and estimates to reflect the Company’s best estimate of the transaction price and the amount of consideration to which it believes it is ultimately entitled to receive. The expected value is determined based on unit sales data, contractual terms with customers and third-party payers, historical and expected utilization rates, any new or anticipated changes in programs or regulations that would impact the amount of the actual rebates, customer purchasing patterns, product expiration dates and levels of inventory in the distribution channel. Reserves for prompt payment discounts are recorded as a reduction in accounts receivable. Reserves for returns, rebates and chargebacks, distributor fees and customer co-pay support programs are included within current liabilities in the consolidated balance sheets.

Partnered Product Sales

The Company is party to several license, development, supply and distribution arrangements with pharmaceutical partners, under which the Company produces and is the exclusive supplier of certain products, devices and/or components. Revenue is recognized when or as control of the goods transfers to the customer based on the terms of the contract as described below.

The Company is the exclusive supplier of the Makena® subcutaneous auto injector product to AMAG. Because the product is custom manufactured for AMAG with no alternative use and the Company has a contractual right to payment for performance completed to date, control is continuously transferred to the customer as product is produced pursuant to firm purchase orders. Revenue is recognized over time using the output method based on the contractual selling price and number of units produced.  The amount of revenue recognized in excess of the amount shipped/billed to the customer, if any, is recorded as contract assets due to the short-term nature in which the amount is ultimately expected to be billed and collected from the customer.

All other partnered product sales are recognized at the point in time in which control is transferred to the customer, which is typically upon shipment. Sales terms and pricing are governed by the respective supply and distribution agreements, and there is generally no price protection or right of return. Revenue is recognized at the transaction price, which includes the contractual per unit selling price and estimated variable consideration, if any.  For example, the Company sells Sumatriptan Injection USP to Teva at cost and is entitled to receive 50 percent of the net profits from commercial sales made by Teva, payable to the Company within 45 days after the end of the quarter in which the commercial sales are made. The Company recognizes revenue, including the estimated variable consideration it expects to receive for contract margin on future commercial sales, upon shipment of the goods to Teva.  The estimated variable consideration is recognized at an amount the Company believes is not subject to significant reversal based on historical experience, and is adjusted at each reporting period if the most likely amount of expected consideration changes or becomes fixed.

Licensing and Development Revenue

The Company has entered into several license, development and supply arrangements with pharmaceutical partners under which the Company grants a license to its device technology and know-how and provides research and development services that often involve multiple performance obligations and highly customized deliverables. For such arrangements, the Company identifies each of the promised goods and services within the contract and the distinct performance obligations at inception, and allocates

consideration to each performance obligation based on relative standalone selling price, which is generally determined based on the expected cost plus margin.

If the contract includes an enforceable right to payment for performance completed to date and performance obligations are satisfied over time, the Company recognizes revenue over the development period using either the input or output method depending on which is most appropriate given the nature of the distinct deliverable. For other contracts that do not contain an enforceable right to payment for performance completed to date, revenue is recognized when control is transferred to the customer. Factors that may indicate that the transfer of control has occurred include the transfer of legal title, transfer of physical possession, the customer has obtained the significant risks and rewards of ownership of the assets and the Company has a present right to payment.

The Company’s typical payment terms for development contracts may include an upfront payment equal to a percentage of the total contract value with the remaining portion to be billed upon completion and transfer of the individual deliverables or satisfaction of the individual performance obligations. The Company records a contract liability for cash received in advance of performance, which is presented within deferred revenue on the consolidated balance sheet and recognized as revenue when the associated performance obligations have been satisfied. The Company recognized $780 in licensing and development revenue in connection with contract liabilities that were outstanding as of December 31, 2019 and satisfied during the nine months ended September 30, 2020.

License fees and milestones received in exchange for the grant of a license to the Company’s functional intellectual property such as patented technology and know-how in connection with a partnered development arrangement are generally recognized at inception of the arrangement, or over the development period depending on the facts and circumstances, as the license is not generally distinct from the non-licensed goods or services to be provided under the contract. Milestone payments that are contingent upon the occurrence of future events are evaluated and recorded at the most likely amount, and to the extent that it is probable that a significant reversal will not occur when the associated uncertainty is resolved.

Royalties

The Company earns royalties in connection with licenses granted under license and development arrangements with partners. Royalties are based upon a percentage of commercial sales of partnered products with rates ranging from mid-single digit to low double digit and are tiered based on levels of net sales. These sales-based royalties, for which the license was deemed the predominant element to which the royalties relate, are estimated and recognized in the period in which the partners’ commercial sales occur.  The royalties are generally reported and payable to the Company within 45 to 60 days of the end of the period in which the commercial sales are made.  The Company bases its estimates of royalties earned on actual sales information from its partners when available or estimated prescription sales from external sources and estimated net selling price. If actual royalties received are different than amounts estimated, the Company would adjust the royalty revenue in the period in which the adjustment becomes known.

Remaining Performance Obligations

Remaining performance obligations represents the allocation of transaction price of firm orders and development contract deliverables for which work has not been completed or orders fulfilled, and excludes potential purchase orders under ordering-type supply contracts with indefinite delivery or quantity.  As of September 30, 2020, the aggregate value of remaining performance obligations, excluding contracts with an original expected length of one year or less, was $20,967. The Company expects to recognize revenue on the remaining performance obligations over the next four years.

 

v3.20.2
Long-Term Debt
9 Months Ended
Sep. 30, 2020
Debt Disclosure [Abstract]  
Long-Term Debt

3.

Long-Term Debt

On September 15, 2020, the Company entered into a second amendment (the “Second Amendment”) to its loan and security agreement dated June 6, 2017 (the “Loan Agreement”), as amended by the First Amendment to Loan and Security Agreement dated June 26, 2019 (the “First Amendment”), with Hercules Capital, Inc., as a lender and agent for the several banks and other financial institutions or entities from time to time party thereto.

The Company initially borrowed $25.0 million upon execution of the original Loan Agreement in June 2017, and an additional $15.0 million (the “Tranche II Loan”) was funded in June 2019 upon the signing of the First Amendment. The Company may, but is not obligated to, request one or more additional advances of at least $5.0 million, not to exceed $10.0 million in the aggregate (the “Tranche III Loan”), during the period between January 1, 2020 and September 15, 2020. The sole change under the Second Amendment was to extend the period during which the Company may request advances under the Tranche III Loan to October 31, 2020.

Payments under the amortizing loan are interest only until the first principal payment is due on August 1, 2021. The interest only period may be extended to August 1, 2022 if the Company achieves a certain loan extension milestone, requests such extension, and pays an extension fee equal to one half of one percent of the principal amount outstanding. Interest accrues at a calculated prime-based variable rate with a maximum interest rate of 9.50%. The interest rate in effect as of September 30, 2020 and December 31, 2019 was 8.50% and 9.25%, respectively. The loan matures on July 1, 2022, but may be extended to July 1, 2024 contingent upon satisfaction of a certain loan extension milestone.

v3.20.2
Share Based Compensation
9 Months Ended
Sep. 30, 2020
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]  
Share Based Compensation

4.

Share-Based Compensation

The Company has an Equity Compensation Plan (the “Plan”), which allows for grants in the form of incentive stock options, nonqualified stock options, stock units, stock awards, stock appreciation rights, and other stock-based awards. The Company also has a long-term incentive program (“LTIP”), pursuant to which the Company’s senior executives have been awarded stock options, restricted stock units (“RSUs”) and performance stock units (“PSUs”).

The following is a summary of stock option activity under the Plan as of and for the nine months ended September 30, 2020:   

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

Average

 

 

 

 

 

 

 

 

 

 

 

Average

 

 

Remaining

 

 

Aggregate

 

 

 

Number of

 

 

Exercise

 

 

Contractual

 

 

Intrinsic

 

 

 

Shares

 

 

Price

 

 

Term (Years)

 

 

Value

 

Outstanding at December 31, 2019

 

 

13,861

 

 

$

2.41

 

 

 

 

 

 

 

 

 

Granted

 

 

3,328

 

 

 

2.73

 

 

 

 

 

 

 

 

 

Exercised

 

 

775

 

 

 

1.95

 

 

 

 

 

 

 

 

 

Cancelled/Forfeited

 

 

728

 

 

 

2.83

 

 

 

 

 

 

 

 

 

Outstanding at September 30, 2020

 

 

15,686

 

 

 

2.48

 

 

 

6.8

 

 

$

5,106

 

Exercisable at September 30, 2020

 

 

10,826

 

 

$

2.33

 

 

 

5.6

 

 

$

5,105

 

 

The following is a summary of PSU and RSU award activity under the Plan as of and for the nine months ended September 30, 2020:   

 

 

 

Performance Stock Units

 

 

Restricted Stock Units

 

 

 

Number of

Shares

 

 

Weighted

Average Grant

Date Fair

Value

 

 

Number of

Shares

 

 

Weighted

Average Grant

Date Fair

Value

 

Outstanding at December 31, 2019

 

 

1,841

 

 

$

3.00

 

 

 

1,401

 

 

$

2.82

 

Granted

 

 

605

 

 

 

2.00

 

 

 

1,078

 

 

 

2.73

 

Incremental shares earned

 

 

77

 

 

 

 

 

 

 

 

 

 

Vested/settled

 

 

(388

)

 

 

3.11

 

 

 

(785

)

 

 

2.80

 

Forfeited/expired

 

 

(494

)

 

 

3.02

 

 

 

(128

)

 

 

2.83

 

Outstanding at September 30, 2020

 

 

1,641

 

 

$

2.61

 

 

 

1,566

 

 

$

2.77

 

 

The PSUs granted to senior executives under the LTIP are expressed as a target number of shares in the table above and may be earned based upon the Company’s achievement of certain corporate development goals, net revenue goals and total shareholder return (“TSR”) relative to the Nasdaq Biotechnology Index over the performance period, which is generally a three-year period. Depending on the outcome of the performance goals, a recipient may ultimately earn a number of shares greater or less than the target number of shares granted, ranging from 0% to 150%. The fair value of the TSR PSUs are expensed over the performance

period and determined using a Monte Carlo simulation. The grant date fair value of PSUs that are not tied to market-based performance are expensed over the remaining performance period when it becomes probable that the related goal will be achieved.

 

The LTIP awards that vested during the nine months ended September 30, 2020 and 2019 were net-share settled such that the Company withheld shares with a value equivalent to the employees’ tax obligations for applicable income and other employment taxes, and remitted cash to the appropriate taxing authorities. The Company withheld 425 and 365 shares during the nine months ended September 30, 2020 and 2019, respectively, to satisfy tax obligations, which was determined based on the fair value of the shares on their vesting date equal to the Company’s closing stock price on such date. The Company paid $1,366 and $1,077 during the nine months ended September 30, 2020 and 2019, respectively, to taxing authorities for the employees’ tax obligations, which is reflected as a cash outflow from financing activities within the consolidated statements of cash flows. Net-share settlements have the effect of share repurchases by the Company as they reduce the number of shares that would have otherwise been issued as a result of the vesting.

 

In connection with Plan awards, the Company recognized share-based compensation expense for the three and nine months ended September 30, 2020 and 2019 as follows:

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Stock options

 

$

1,045

 

 

$

888

 

 

$

2,801

 

 

$

2,555

 

Restricted stock units

 

 

579

 

 

 

565

 

 

 

1,661

 

 

 

1,267

 

Performance stock units

 

 

180

 

 

 

192

 

 

 

1,307

 

 

 

823

 

Total share-based compensation expense

 

$

1,804

 

 

$

1,645

 

 

$

5,769

 

 

$

4,645

 

 

v3.20.2
Revenues, Significant Customers and Concentrations of Risk
9 Months Ended
Sep. 30, 2020
Revenue From Contract With Customer [Abstract]  
Revenues, Significant Customers and Concentrations of Risk

5.

Revenues, Significant Customers and Concentrations of Risk

The following table presents the Company’s revenue on a disaggregated basis by types of goods and services and major product lines:

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Proprietary product sales

 

$

15,765

 

 

$

11,458

 

 

$

43,177

 

 

$

25,213

 

Partnered product sales

 

 

13,182

 

 

 

13,229

 

 

 

37,532

 

 

 

38,394

 

Total product revenue

 

 

28,947

 

 

 

24,687

 

 

 

80,709

 

 

 

63,607

 

Licensing and development revenue

 

 

4,321

 

 

 

1,211

 

 

 

8,763

 

 

 

4,365

 

Royalties

 

 

6,735

 

 

 

8,408

 

 

 

15,994

 

 

 

18,053

 

Total revenue

 

$

40,003

 

 

$

34,306

 

 

$

105,466

 

 

$

86,025

 

 

Revenues disaggregated by customer location are as follows: 

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

United States of America

 

$

39,371

 

 

$

33,684

 

 

$

103,638

 

 

$

82,411

 

Europe

 

 

632

 

 

 

566

 

 

 

1,828

 

 

 

3,444

 

Other

 

 

 

 

 

56

 

 

 

 

 

 

170

 

 

 

$

40,003

 

 

$

34,306

 

 

$

105,466

 

 

$

86,025

 

 

The following table identifies customers from which the Company derived 10% or more of its total revenue in any of the periods presented:

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Teva

 

45%

 

 

41%

 

 

42%

 

 

43%

 

AMAG

 

<10%

 

 

20%

 

 

10%

 

 

19%

 

McKesson Corporation

 

12%

 

 

<10%

 

 

12%

 

 

<10%

 

AmerisourceBergen Corporation

 

11%

 

 

10%

 

 

12%

 

 

<10%

 

Cardinal Health

 

11%

 

 

<10%

 

 

11%

 

 

<10%

 

 

v3.20.2
Earnings per Share
9 Months Ended
Sep. 30, 2020
Earnings Per Share [Abstract]  
Earnings per Share

6.

Earnings per Share

Basic earnings or loss per common share is computed by dividing the net income or loss applicable to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted earnings per common share is computed in a similar manner, except that the weighted average number of shares outstanding is increased to reflect the potential dilution from the exercise or conversion of securities into common stock. Diluted earnings per share contemplate a complete conversion to common shares of all convertible instruments only if such instruments are dilutive in nature with respect to earnings per share. The following table sets forth the computation for basic and diluted net earnings (loss) per share for the three and nine months ended September 30, 2020 and 2019:

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Numerator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Numerator for basic and diluted earnings (loss) per share

 

$

4,996

 

 

$

1,043

 

 

$

4,815

 

 

$

(6,722

)

Denominator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic weighted average common shares outstanding

 

 

166,375

 

 

 

163,119

 

 

 

165,838

 

 

 

162,109

 

Dilutive effects of stock options and share-based awards

     issuable under equity compensation plans

 

 

3,280

 

 

 

5,384

 

 

 

3,921

 

 

 

 

Diluted weighted average common shares outstanding

 

 

169,655

 

 

 

168,503

 

 

 

169,759

 

 

 

162,109

 

Computation of:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic net earnings (loss) per share

 

$

0.03

 

 

$

0.01

 

 

$

0.03

 

 

$

(0.04

)

Diluted net earnings (loss) per share

 

$

0.03

 

 

$

0.01

 

 

$

0.03

 

 

$

(0.04

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Anti-dilutive common stock equivalents (1)

 

 

8,596

 

 

 

5,000

 

 

 

6,719

 

 

 

19,080

 

 

 

(1)

These common stock equivalents were outstanding for the period but were not included in the computation of diluted EPS for those periods as their inclusion would have had an anti-dilutive effect.

v3.20.2
Commitments and Contingencies
9 Months Ended
Sep. 30, 2020
Commitments And Contingencies Disclosure [Abstract]  
Commitments and Contingencies

7.

Commitments and Contingencies

Pending Litigation

From time to time, the Company may be involved in various legal matters generally incidental to its business. Although the results of litigation and claims cannot be predicted with certainty, after discussion with legal counsel, management is not aware of any matters for which the likelihood of a loss is probable and reasonably estimable and which could have a material impact on its consolidated financial condition, liquidity, or results of operations.

On October 23, 2017, Randy Smith filed a complaint in the District of New Jersey, captioned Randy Smith, Individually and on Behalf of All Others Similarly Situated v. Antares Pharma, Inc., Robert F. Apple and Fred M. Powell (“Smith”), Case No. 3:17-cv-08945-MAS-DEA, on behalf of a putative class of persons who purchased or otherwise acquired Antares securities between December 21, 2016 and October 12, 2017, inclusive, asserting claims for purported violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, against Antares, Robert F. Apple and Fred M. Powell.  The Smith complaint

contends that defendants made false and/or misleading statements and/or failed to disclose that: (i) Antares had provided insufficient data to the FDA in connection with the NDA for XYOSTED®; and (ii) accordingly, Antares had overstated the approval prospects for XYOSTED®.  On July 27, 2018, the court entered an order appointing Serghei Lungu as lead plaintiff, Pomerantz LLP as lead counsel, and Lite DePalma Greenberg, LLC as liaison counsel for plaintiff.  On August 3, 2018, the parties submitted a stipulation and proposed order, setting forth an agreed-upon schedule for responding to the complaint, which the court granted. Pursuant to that order, plaintiff filed a Consolidated Amended Class Action Complaint on October 9, 2018. On November 26, 2018, defendants filed a motion to dismiss. Plaintiff filed an opposition to the motion on January 10, 2019 and defendants filed a reply in support of their motion on February 25, 2019. On July 2, 2019, the court dismissed the complaint in its entirety without prejudice. On July 29, 2019, plaintiff filed a Consolidated Second Amended Class Action Complaint against the same parties alleging substantially similar claims. On September 12, 2019, defendants filed a motion to dismiss the Consolidated Second Amended Class Action Complaint. Plaintiffs’ opposition was filed on October 28, 2019 and defendants’ reply in support of their motion was filed on November 27, 2019. On April 28, 2020, the court dismissed the Consolidated Second Amended Class Action Complaint in its entirety. The court further ordered that plaintiff may file an amended complaint by May 29, 2020 and provide the court with a form of the amended complaint that indicates in what respect(s) it differs from the complaint which it proposes to amend. On May 29, 2020, plaintiff filed a Consolidated Third Amended Class Action Complaint and defendants filed a motion to dismiss on July 10, 2020. Briefing on defendants’ motion was complete on August 25, 2020. The Company believes that the claims in the Smith action lack merit and intends to defend them vigorously.

On January 12, 2018, a stockholder of the Company filed a derivative civil action, captioned Chiru Mackert, derivatively on behalf of Antares Pharma, Inc., v. Robert F. Apple, et al., in the Superior Court of New Jersey Chancery Division, Mercer County (Case No. C-000011-18).  On January 17, 2018, another stockholder filed a derivative action in the same court, captioned Vikram Rao, Derivatively on Behalf of Antares Pharma, Inc. v. Robert F. Apple, et al. (Case No. C-000004-18). Both complaints name Robert F. Apple, Fred M. Powell, Thomas J. Garrity, Jacques Gonella, Anton Gueth, Leonard S. Jacob, Marvin Samson and Robert P. Roche, Jr. as defendants, and the Company as nominal defendant, and they assert claims for breach of fiduciary duties, unjust enrichment, abuse of control, gross mismanagement, and waste of corporate assets arising from the same facts underlying the Smith securities class action.  The plaintiffs seek damages, corporate governance and internal procedure reforms and improvements, restitution, reasonable attorneys’ fees, experts’ fees, costs, and expenses. The parties have filed a stipulation and order consolidating the two actions and staying the proceedings pending the court’s decision on defendants’ motion to dismiss the Smith action. On August 17, 2020, the court terminated the case pending a lifting of the stay as set forth in the stipulation and order.

On January 17, 2018, a stockholder of the Company filed a derivative civil action, captioned Robert Clark, Derivatively on Behalf of Antares Pharma, Inc. v. Robert F. Apple, et al. (“Clark”) (Case No. 3:18-cv-00703-MAS-DEA), against Robert F. Apple, Thomas J. Garrity, Jacques Gonella, Leonard S. Jacob, Marvin Samson, Anton G. Gueth and Robert P. Roche, Jr. as defendants, and Company as a nominal defendant.  The action was filed in the U.S. District Court for the District of New Jersey and asserts claims for breach of fiduciary duties, unjust enrichment, abuse of control, waste of corporate assets, and a violation of Section 14(a) of the Securities Exchange Act of 1934. This complaint relates to the same facts underlying the Smith securities class action and the other derivative actions.  The plaintiff in Clark seeks damages, corporate governance and internal procedure reforms and improvements, reasonable attorneys’ fees, accountants’ and experts’ fees, costs, and expenses. The parties have filed a stipulation and order staying the action pending the court’s decision on defendants’ motion to dismiss the Smith action. On August 17, 2020, the court terminated the case pending a lifting of the stay as set forth in the stipulation and order.

v3.20.2
Subsequent Event
9 Months Ended
Sep. 30, 2020
Subsequent Events [Abstract]  
Subsequent Event

 8.

Subsequent Event

On October 1, 2020, the Company entered into an exclusive license agreement (the “License Agreement”) with Ferring International Center S.A. and its affiliates (“Ferring”) for the marketed product NOCDURNA® (desmopressin acetate) in the United States, which is indicated for the treatment of nocturia due to nocturnal polyuria (NP) in adults who awaken at least two times per night to urinate. Under the terms of the License Agreement, the Company paid Ferring an upfront payment of $5.0 million upon execution and will pay an additional $2.5 million at one year from execution. Ferring is eligible for tiered royalties and additional commercial milestone payments potentially totaling up to $17.5 million based on the Company’s net sales of NOCDURNA® in the United States.

 

v3.20.2
Basis of Presentation and Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2020
Accounting Policies [Abstract]  
Recent Accounting Pronouncements

Accounting Pronouncements Recently Adopted

The Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) No. 2018-15 Customers’ Accounting for Implementation Costs Incurred in Cloud Computing Arrangement that is a Service Contract, effective January 1, 2020. This ASU provides new guidance on a customer's accounting for implementation, set-up, and other upfront costs incurred in a cloud computing arrangement that is hosted by the vendor (i.e., a service contract). Under the new guidance, entities apply the same criteria for capitalizing implementation costs as they would for an arrangement that has a software license. The Company’s adoption of this standard did not have a material impact on its consolidated financial statements.

The Company adopted ASU No. 2018-18 Clarifying the Interaction Between Topic 808 and 606, effective January 1, 2020. The guidance clarifies that certain transactions between collaborative arrangement participants should be accounted for under the revenue guidance, adds unit of account guidance to the collaborative arrangement guidance to align with the revenue standard, and clarifies presentation guidance for transactions with a collaborative arrangement participant that is not accounted for under the revenue standard. The Company’s adoption of this standard did not have a material impact on its consolidated financial statements.

Recent Accounting Pronouncements Not Yet Adopted

In 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This standard replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses on instruments within its scope, including trade receivables, and requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. The original effective date for ASU 2016-13 was for annual and interim periods beginning after December 15, 2019.

However, in October 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses, Derivatives and Hedging, and Leases: Effective Dates, which deferred the effective date of ASU 2016-13 for certain entities, including those that are eligible to be smaller reporting companies. A company’s determination about whether it is eligible for the deferral is a one-time assessment as of November 15, 2019 based on its most recent determination of its small reporting company eligibility as of the last business day of the most recently completed second quarter. Based on this determination, the Company qualified as a smaller reporting entity and is therefore eligible for the deferral of adoption of ASU 2016-13, resulting in a new effective date of January 1, 2023. The Company has historically had minimal credit losses on financial instruments and is currently evaluating the impact the adoption of ASU 2016-13 will have on its consolidated financial statements.

Cash and Cash Equivalents

Cash and Cash Equivalents

Cash and cash equivalents consist of demand deposits at commercial banks and highly liquid investments with an original maturity of three months or less. Cash equivalents, consisting of investments in money market funds, are remeasured and reported at fair value each reporting period, in accordance with ASC Topic 820, Fair Value Measurements (“ASC 820”) based on quoted market prices, which is a Level 1 input within the three-level valuation hierarchy for disclosure of fair value measurements, and totaled $32,104 and $11,153 as of September 30, 2020 and December 31, 2019, respectively.

Investments

Investments

From time to time, the Company invests in U.S. Treasury bills and government agency notes that are classified as held-to-maturity because of the Company’s intent and ability to hold the securities to maturity. Investments with maturities of one year or less are classified as short-term.  The securities are carried at their amortized cost and the fair value is determined by quoted market prices.  The Company’s short-term investments had a carrying value of $1,997 and $22,520 as of September 30, 2020 and December 31, 2019, respectively, which approximated fair value.

Fair Value Measurements

Fair Value Measurements

The Company applies the provisions of ASC 820 for financial assets and liabilities that are required to be measured and reported at fair value each reporting period. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value:

Level 1: Quoted prices in active markets for identical assets or liabilities.

Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

The Company’s financial assets and liabilities that are not measured at fair value on a recurring basis under ASC 820 include its held-to-maturity investments and long-term debt, the carrying values of which approximate fair value. The estimated fair value of debt is based on Level 2 inputs, including management’s understanding of current market rates it could obtain for similar loans. The fair value of the Company’s cash, short-term investments, accounts receivable and accounts payable approximate fair value due to their short-term nature.

Revenue Recognition

Revenue Recognition

The Company generates revenue from proprietary and partnered product sales, license and development activities and royalty arrangements.  Revenue is recognized when or as the Company transfers control of the promised goods or services to its customers at the transaction price, which is the amount that reflects the consideration to which it expects to be entitled to in exchange for those goods or services.

At inception of each contract, the Company identifies the goods and services that have been promised to the customer and each of those that represent a distinct performance obligation, determines the transaction price including any variable consideration, allocates the transaction price to the distinct performance obligations and determines whether control transfers to the customer at a point in time or over time. Variable consideration is included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company reassesses its reserves for variable consideration at each

reporting date and makes adjustments, if necessary, which may affect revenue and earnings in periods in which any such changes become known.

The Company has elected to recognize the cost for freight and shipping activities as fulfilment cost. Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of underlying goods are transferred to the customer. The related shipping and freight charges incurred by the Company are included in cost of revenue.

Proprietary Product Sales

The Company sells its proprietary products XYOSTED® and OTREXUP® primarily to wholesale and specialty distributors. Revenue is recognized when control has transferred to the customer, which is typically upon delivery, at the net selling price, which reflects the variable consideration for which reserves and sales allowances are established for estimated returns, wholesale distribution fees, prompt payment discounts, government rebates and chargebacks, insurance plan rebate arrangements and patient discount and support programs.

The determination of certain of these reserves and sales allowances require management to make a number of judgements and estimates to reflect the Company’s best estimate of the transaction price and the amount of consideration to which it believes it is ultimately entitled to receive. The expected value is determined based on unit sales data, contractual terms with customers and third-party payers, historical and expected utilization rates, any new or anticipated changes in programs or regulations that would impact the amount of the actual rebates, customer purchasing patterns, product expiration dates and levels of inventory in the distribution channel. Reserves for prompt payment discounts are recorded as a reduction in accounts receivable. Reserves for returns, rebates and chargebacks, distributor fees and customer co-pay support programs are included within current liabilities in the consolidated balance sheets.

Partnered Product Sales

The Company is party to several license, development, supply and distribution arrangements with pharmaceutical partners, under which the Company produces and is the exclusive supplier of certain products, devices and/or components. Revenue is recognized when or as control of the goods transfers to the customer based on the terms of the contract as described below.

The Company is the exclusive supplier of the Makena® subcutaneous auto injector product to AMAG. Because the product is custom manufactured for AMAG with no alternative use and the Company has a contractual right to payment for performance completed to date, control is continuously transferred to the customer as product is produced pursuant to firm purchase orders. Revenue is recognized over time using the output method based on the contractual selling price and number of units produced.  The amount of revenue recognized in excess of the amount shipped/billed to the customer, if any, is recorded as contract assets due to the short-term nature in which the amount is ultimately expected to be billed and collected from the customer.

All other partnered product sales are recognized at the point in time in which control is transferred to the customer, which is typically upon shipment. Sales terms and pricing are governed by the respective supply and distribution agreements, and there is generally no price protection or right of return. Revenue is recognized at the transaction price, which includes the contractual per unit selling price and estimated variable consideration, if any.  For example, the Company sells Sumatriptan Injection USP to Teva at cost and is entitled to receive 50 percent of the net profits from commercial sales made by Teva, payable to the Company within 45 days after the end of the quarter in which the commercial sales are made. The Company recognizes revenue, including the estimated variable consideration it expects to receive for contract margin on future commercial sales, upon shipment of the goods to Teva.  The estimated variable consideration is recognized at an amount the Company believes is not subject to significant reversal based on historical experience, and is adjusted at each reporting period if the most likely amount of expected consideration changes or becomes fixed.

Licensing and Development Revenue

The Company has entered into several license, development and supply arrangements with pharmaceutical partners under which the Company grants a license to its device technology and know-how and provides research and development services that often involve multiple performance obligations and highly customized deliverables. For such arrangements, the Company identifies each of the promised goods and services within the contract and the distinct performance obligations at inception, and allocates

consideration to each performance obligation based on relative standalone selling price, which is generally determined based on the expected cost plus margin.

If the contract includes an enforceable right to payment for performance completed to date and performance obligations are satisfied over time, the Company recognizes revenue over the development period using either the input or output method depending on which is most appropriate given the nature of the distinct deliverable. For other contracts that do not contain an enforceable right to payment for performance completed to date, revenue is recognized when control is transferred to the customer. Factors that may indicate that the transfer of control has occurred include the transfer of legal title, transfer of physical possession, the customer has obtained the significant risks and rewards of ownership of the assets and the Company has a present right to payment.

The Company’s typical payment terms for development contracts may include an upfront payment equal to a percentage of the total contract value with the remaining portion to be billed upon completion and transfer of the individual deliverables or satisfaction of the individual performance obligations. The Company records a contract liability for cash received in advance of performance, which is presented within deferred revenue on the consolidated balance sheet and recognized as revenue when the associated performance obligations have been satisfied. The Company recognized $780 in licensing and development revenue in connection with contract liabilities that were outstanding as of December 31, 2019 and satisfied during the nine months ended September 30, 2020.

License fees and milestones received in exchange for the grant of a license to the Company’s functional intellectual property such as patented technology and know-how in connection with a partnered development arrangement are generally recognized at inception of the arrangement, or over the development period depending on the facts and circumstances, as the license is not generally distinct from the non-licensed goods or services to be provided under the contract. Milestone payments that are contingent upon the occurrence of future events are evaluated and recorded at the most likely amount, and to the extent that it is probable that a significant reversal will not occur when the associated uncertainty is resolved.

Royalties

The Company earns royalties in connection with licenses granted under license and development arrangements with partners. Royalties are based upon a percentage of commercial sales of partnered products with rates ranging from mid-single digit to low double digit and are tiered based on levels of net sales. These sales-based royalties, for which the license was deemed the predominant element to which the royalties relate, are estimated and recognized in the period in which the partners’ commercial sales occur.  The royalties are generally reported and payable to the Company within 45 to 60 days of the end of the period in which the commercial sales are made.  The Company bases its estimates of royalties earned on actual sales information from its partners when available or estimated prescription sales from external sources and estimated net selling price. If actual royalties received are different than amounts estimated, the Company would adjust the royalty revenue in the period in which the adjustment becomes known.

Remaining Performance Obligations

Remaining performance obligations represents the allocation of transaction price of firm orders and development contract deliverables for which work has not been completed or orders fulfilled, and excludes potential purchase orders under ordering-type supply contracts with indefinite delivery or quantity.  As of September 30, 2020, the aggregate value of remaining performance obligations, excluding contracts with an original expected length of one year or less, was $20,967. The Company expects to recognize revenue on the remaining performance obligations over the next four years.

v3.20.2
Basis of Presentation and Significant Accounting Policies (Tables)
9 Months Ended
Sep. 30, 2020
Accounting Policies [Abstract]  
Inventories Inventories consist of the following:

 

 

 

September 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Inventories:

 

 

 

 

 

 

 

 

Raw material

 

$

325

 

 

$

325

 

Work in process

 

 

9,088

 

 

 

8,390

 

Finished goods

 

 

10,396

 

 

 

7,285

 

 

 

$

19,809

 

 

$

16,000

 

Summary of Estimated Useful Lives of Property and Equipment

Property and equipment are stated at cost and depreciated using the straight-line method over their estimated useful lives as follows:

 

 

Useful Life

Computer equipment and software

 

3-5 Years

Furniture, fixtures and office equipment

 

5-7 years

Production molds, tooling and equipment

 

3-10 years

Leasehold improvements

 

Lesser of useful life or lease term

v3.20.2
Share Based Compensation (Tables)
9 Months Ended
Sep. 30, 2020
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]  
Summary of Stock Option Activity

The following is a summary of stock option activity under the Plan as of and for the nine months ended September 30, 2020:   

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

Average

 

 

 

 

 

 

 

 

 

 

 

Average

 

 

Remaining

 

 

Aggregate

 

 

 

Number of

 

 

Exercise

 

 

Contractual

 

 

Intrinsic

 

 

 

Shares

 

 

Price

 

 

Term (Years)

 

 

Value

 

Outstanding at December 31, 2019

 

 

13,861

 

 

$

2.41

 

 

 

 

 

 

 

 

 

Granted

 

 

3,328

 

 

 

2.73

 

 

 

 

 

 

 

 

 

Exercised

 

 

775

 

 

 

1.95

 

 

 

 

 

 

 

 

 

Cancelled/Forfeited

 

 

728

 

 

 

2.83

 

 

 

 

 

 

 

 

 

Outstanding at September 30, 2020

 

 

15,686

 

 

 

2.48

 

 

 

6.8

 

 

$

5,106

 

Exercisable at September 30, 2020

 

 

10,826

 

 

$

2.33

 

 

 

5.6

 

 

$

5,105

 

Summary of PSU and RSU Award Activity Under Plan

 

The following is a summary of PSU and RSU award activity under the Plan as of and for the nine months ended September 30, 2020:   

 

 

 

Performance Stock Units

 

 

Restricted Stock Units

 

 

 

Number of

Shares

 

 

Weighted

Average Grant

Date Fair

Value

 

 

Number of

Shares

 

 

Weighted

Average Grant

Date Fair

Value

 

Outstanding at December 31, 2019

 

 

1,841

 

 

$

3.00

 

 

 

1,401

 

 

$

2.82

 

Granted

 

 

605

 

 

 

2.00

 

 

 

1,078

 

 

 

2.73

 

Incremental shares earned

 

 

77

 

 

 

 

 

 

 

 

 

 

Vested/settled

 

 

(388

)

 

 

3.11

 

 

 

(785

)

 

 

2.80

 

Forfeited/expired

 

 

(494

)

 

 

3.02

 

 

 

(128

)

 

 

2.83

 

Outstanding at September 30, 2020

 

 

1,641

 

 

$

2.61

 

 

 

1,566

 

 

$

2.77

 

Summary of Share Based Compensation Allocation Expense

In connection with Plan awards, the Company recognized share-based compensation expense for the three and nine months ended September 30, 2020 and 2019 as follows:

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Stock options

 

$

1,045

 

 

$

888

 

 

$

2,801

 

 

$

2,555

 

Restricted stock units

 

 

579

 

 

 

565

 

 

 

1,661

 

 

 

1,267

 

Performance stock units

 

 

180

 

 

 

192

 

 

 

1,307

 

 

 

823

 

Total share-based compensation expense

 

$

1,804

 

 

$

1,645

 

 

$

5,769

 

 

$

4,645

 

v3.20.2
Revenues, Significant Customers and Concentrations of Risk (Tables)
9 Months Ended
Sep. 30, 2020
Revenue From Contract With Customer [Abstract]  
Summary of Revenues Disaggregated by Types of Goods and Services and Major Product and Customer Location

The following table presents the Company’s revenue on a disaggregated basis by types of goods and services and major product lines:

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Proprietary product sales

 

$

15,765

 

 

$

11,458

 

 

$

43,177

 

 

$

25,213

 

Partnered product sales

 

 

13,182

 

 

 

13,229

 

 

 

37,532

 

 

 

38,394

 

Total product revenue

 

 

28,947

 

 

 

24,687

 

 

 

80,709

 

 

 

63,607

 

Licensing and development revenue

 

 

4,321

 

 

 

1,211

 

 

 

8,763

 

 

 

4,365

 

Royalties

 

 

6,735

 

 

 

8,408

 

 

 

15,994

 

 

 

18,053

 

Total revenue

 

$

40,003

 

 

$

34,306

 

 

$

105,466

 

 

$

86,025

 

 

Revenues disaggregated by customer location are as follows: 

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

United States of America

 

$

39,371

 

 

$

33,684

 

 

$

103,638

 

 

$

82,411

 

Europe

 

 

632

 

 

 

566

 

 

 

1,828

 

 

 

3,444

 

Other

 

 

 

 

 

56

 

 

 

 

 

 

170

 

 

 

$

40,003

 

 

$

34,306

 

 

$

105,466

 

 

$

86,025

 

Summary of Significant Customers from which the Company Derived 10% or More of Total Revenue

The following table identifies customers from which the Company derived 10% or more of its total revenue in any of the periods presented:

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Teva

 

45%

 

 

41%

 

 

42%

 

 

43%

 

AMAG

 

<10%

 

 

20%

 

 

10%

 

 

19%

 

McKesson Corporation

 

12%

 

 

<10%

 

 

12%

 

 

<10%

 

AmerisourceBergen Corporation

 

11%

 

 

10%

 

 

12%

 

 

<10%

 

Cardinal Health

 

11%

 

 

<10%

 

 

11%

 

 

<10%

 

 

v3.20.2
Earnings per Share (Tables)
9 Months Ended
Sep. 30, 2020
Earnings Per Share [Abstract]  
Summary of Computation for Basic and Diluted Net Earnings (Loss) per Share The following table sets forth the computation for basic and diluted net earnings (loss) per share for the three and nine months ended September 30, 2020 and 2019:

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Numerator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Numerator for basic and diluted earnings (loss) per share

 

$

4,996

 

 

$

1,043

 

 

$

4,815

 

 

$

(6,722

)

Denominator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic weighted average common shares outstanding

 

 

166,375

 

 

 

163,119

 

 

 

165,838

 

 

 

162,109

 

Dilutive effects of stock options and share-based awards

     issuable under equity compensation plans

 

 

3,280

 

 

 

5,384

 

 

 

3,921

 

 

 

 

Diluted weighted average common shares outstanding

 

 

169,655

 

 

 

168,503

 

 

 

169,759

 

 

 

162,109

 

Computation of:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic net earnings (loss) per share

 

$

0.03

 

 

$

0.01

 

 

$

0.03

 

 

$

(0.04

)

Diluted net earnings (loss) per share

 

$

0.03

 

 

$

0.01

 

 

$

0.03

 

 

$

(0.04

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Anti-dilutive common stock equivalents (1)

 

 

8,596

 

 

 

5,000

 

 

 

6,719

 

 

 

19,080

 

 

 

(1)

These common stock equivalents were outstanding for the period but were not included in the computation of diluted EPS for those periods as their inclusion would have had an anti-dilutive effect.

v3.20.2
Description of Business - Additional Information (Detail)
Sep. 30, 2020
ProprietaryProduct
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Number of proprietary products directly marketed and sold 2
v3.20.2
Basis of Presentation and Significant Accounting Policies - Additional Information (Detail) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2020
Dec. 31, 2019
Summary Of Significant Accounting Policies [Line Items]    
Carrying value of short-term investments $ 1,997 $ 22,520
Inventory reserve 282 464
Interest costs capitalized 212  
Property and equipment, net 22,547 15,961
Accumulated depreciation 10,809 9,769
Remaining performance obligations $ 20,967  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Explanation The Company expects to recognize revenue on the remaining performance obligations over the next four years.  
Licensing and Development Revenue [Member]    
Summary Of Significant Accounting Policies [Line Items]    
Revenue recognized $ 780  
Teva [Member]    
Summary Of Significant Accounting Policies [Line Items]    
Future net profits from commercial sales percent 50.00%  
Minimum [Member]    
Summary Of Significant Accounting Policies [Line Items]    
Royalty payment period 45 days  
Maximum [Member]    
Summary Of Significant Accounting Policies [Line Items]    
Royalty payment period 60 days  
Level 1 Input [Member]    
Summary Of Significant Accounting Policies [Line Items]    
Cash and cash equivalents, remeasured and reported at fair value $ 32,104 $ 11,153
v3.20.2
Basis of Presentation and Significant Accounting Policies - Inventories (Detail) - USD ($)
$ in Thousands
Sep. 30, 2020
Dec. 31, 2019
Inventory Disclosure [Abstract]    
Raw material $ 325 $ 325
Work in process 9,088 8,390
Finished goods 10,396 7,285
Inventory, Total $ 19,809 $ 16,000
v3.20.2
Basis of Presentation and Significant Accounting Policies - Summary of Estimated Useful Lives of Property and Equipment (Details)
9 Months Ended
Sep. 30, 2020
Leasehold Improvements [Member]  
Property Plant And Equipment [Line Items]  
Property, plant and equipment, estimated useful lives Lesser of useful life or lease term
Minimum [Member] | Computer Equipment and Software [Member]  
Property Plant And Equipment [Line Items]  
Property, plant and equipment, useful life 3 years
Minimum [Member] | Furniture, Fixtures and Office Equipment [Member]  
Property Plant And Equipment [Line Items]  
Property, plant and equipment, useful life 5 years
Minimum [Member] | Production Molds, Tooling and Equipment [Member]  
Property Plant And Equipment [Line Items]  
Property, plant and equipment, useful life 3 years
Maximum [Member] | Computer Equipment and Software [Member]  
Property Plant And Equipment [Line Items]  
Property, plant and equipment, useful life 5 years
Maximum [Member] | Furniture, Fixtures and Office Equipment [Member]  
Property Plant And Equipment [Line Items]  
Property, plant and equipment, useful life 7 years
Maximum [Member] | Production Molds, Tooling and Equipment [Member]  
Property Plant And Equipment [Line Items]  
Property, plant and equipment, useful life 10 years
v3.20.2
Long-Term Debt - Additional Information (Detail) - USD ($)
1 Months Ended 9 Months Ended
Jun. 26, 2019
Jun. 30, 2017
Sep. 30, 2020
Sep. 30, 2019
Sep. 15, 2020
Dec. 31, 2019
Debt Instrument [Line Items]            
Proceeds from issuance of long-term debt       $ 15,000,000    
Hercules Capital, Inc [Member] | Term Loan [Member]            
Debt Instrument [Line Items]            
Proceeds from issuance of long-term debt   $ 25,000,000.0        
Debt instrument, effective interest rate     8.50%     9.25%
Debt instrument, first principal payment due date     Aug. 01, 2021      
Debt instrument, payment terms     Payments under the amortizing loan are interest only until the first principal payment is due on August 1, 2021. The interest only period may be extended to August 1, 2022 if the Company achieves a certain loan extension milestone, requests such extension, and pays an extension fee equal to one half of one percent of the principal amount outstanding.      
Debt instrument, maturity date     Jul. 01, 2022      
Debt instrument, extended maturity date     Jul. 01, 2024      
Hercules Capital, Inc [Member] | Term Loan [Member] | Prime Based Variable Rate [Member]            
Debt Instrument [Line Items]            
Debt Instrument, variable interest rate     9.50%      
Hercules Capital, Inc [Member] | Term Loan [Member] | First Amendment [Member]            
Debt Instrument [Line Items]            
Debt instrument, payment terms     The loan matures on July 1, 2022, but may be extended to July 1, 2024 contingent upon satisfaction of a certain loan extension milestone.      
Hercules Capital, Inc [Member] | Tranche II [Member]            
Debt Instrument [Line Items]            
Long-term debt, increase in face amount $ 15,000,000.0          
Hercules Capital, Inc [Member] | Minimum [Member] | Tranche III [Member] | Second Amendment [Member]            
Debt Instrument [Line Items]            
Debt instrument, available option to request additional advance amount         $ 5,000,000.0  
Hercules Capital, Inc [Member] | Maximum [Member] | Tranche III [Member] | Second Amendment [Member]            
Debt Instrument [Line Items]            
Debt instrument, available option to request additional advance amount         $ 10,000,000.0  
v3.20.2
Share Based Compensation - Summary of Stock Option Activity (Detail)
$ / shares in Units, $ in Thousands
9 Months Ended
Sep. 30, 2020
USD ($)
$ / shares
shares
Stockholders Equity Note [Abstract]  
Number of Shares Outstanding, Beginning Balance | shares 13,861,000
Number of Shares Granted | shares 3,328,000
Number of Shares Exercised | shares 775,000
Number of Shares Cancelled/Forfeited | shares 728,000
Number of Shares Outstanding, Ending Balance | shares 15,686,000
Number of Shares Exercisable, Ending Balance | shares 10,826,000
Weighted Average Exercise Price Outstanding, Beginning Balance | $ / shares $ 2.41
Weighted Average Exercise Price Granted | $ / shares 2.73
Weighted Average Exercise Price Exercised | $ / shares 1.95
Weighted Average Exercise Price Cancelled/Forfeited | $ / shares 2.83
Weighted Average Exercise Price Outstanding, Ending Balance | $ / shares 2.48
Weighted Average Exercise Price Exercisable, Ending Balance | $ / shares $ 2.33
Weighted Average Remaining Contractual Term (Years) Outstanding, Ending Balance 6 years 9 months 18 days
Weighted Average Remaining Contractual Term (Years) Exercisable, Ending Balance 5 years 7 months 6 days
Aggregate Intrinsic Value Outstanding, Ending Balance | $ $ 5,106
Aggregate Intrinsic Value Exercisable, Ending Balance | $ $ 5,105
v3.20.2
Share Based Compensation - Summary of PSU and RSU Award Activity Under Plan (Detail)
9 Months Ended
Sep. 30, 2020
$ / shares
shares
Performance Stock Units [Member]  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Number of Shares, Beginning Balance 1,841,000
Number of Shares, Granted 605,000
Number of Shares, Incremental shares earned 77,000
Number of Shares, Vested/settled (388,000)
Number of Shares, Forfeited/expired (494,000)
Number of Shares, Ending Balance 1,641,000
Weighted Average Grant Date Fair Value, Beginning Balance | $ / shares $ 3.00
Weighted Average Grant Date Fair Value, Granted | $ / shares 2.00
Weighted Average Grant Date Fair Value, Vested/settled | $ / shares 3.11
Weighted Average Grant Date Fair Value, Forfeited/expired | $ / shares 3.02
Weighted Average Grant Date Fair Value, Ending Balance | $ / shares $ 2.61
Restricted Stock Units [Member]  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Number of Shares, Beginning Balance 1,401,000
Number of Shares, Granted 1,078,000
Number of Shares, Vested/settled (785,000)
Number of Shares, Forfeited/expired (128,000)
Number of Shares, Ending Balance 1,566,000
Weighted Average Grant Date Fair Value, Beginning Balance | $ / shares $ 2.82
Weighted Average Grant Date Fair Value, Granted | $ / shares 2.73
Weighted Average Grant Date Fair Value, Vested/settled | $ / shares 2.80
Weighted Average Grant Date Fair Value, Forfeited/expired | $ / shares 2.83
Weighted Average Grant Date Fair Value, Ending Balance | $ / shares $ 2.77
v3.20.2
Share Based Compensation - Additional Information (Detail) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]    
Shares withheld to meet employees' statutory income tax obligation 425,000 365,000
Amounts paid to taxing authorities for employees’ tax obligations $ 1,366 $ 1,077
Employees Tax Obligations [Member]    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]    
Amounts paid to taxing authorities for employees’ tax obligations $ 1,366 $ 1,077
Performance Stock Units [Member] | Long Term Incentive Program [Member]    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]    
Vesting period 3 years  
Performance Stock Units [Member] | Long Term Incentive Program [Member] | Minimum [Member]    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]    
Share based compensation award percentage 0.00%  
Performance Stock Units [Member] | Long Term Incentive Program [Member] | Maximum [Member]    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]    
Share based compensation award percentage 150.00%  
v3.20.2
Share Based Compensation - Summary of Share Based Compensation Allocation Expense (Detail) - Long Term Incentive Program [Member] - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2020
Sep. 30, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Total share-based compensation expense $ 1,804 $ 1,645 $ 5,769 $ 4,645
Stock Options [Member]        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Total share-based compensation expense 1,045 888 2,801 2,555
Restricted Stock Units [Member]        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Total share-based compensation expense 579 565 1,661 1,267
Performance Stock Units [Member]        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Total share-based compensation expense $ 180 $ 192 $ 1,307 $ 823
v3.20.2
Revenues, Significant Customers and Concentrations of Risk - Summary of Revenue Disaggregated by Types of Goods and Services and Major Product (Detail) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2020
Sep. 30, 2019
Disaggregation Of Revenue [Line Items]        
Total revenue $ 40,003 $ 34,306 $ 105,466 $ 86,025
Total Product Revenue [Member]        
Disaggregation Of Revenue [Line Items]        
Total revenue 28,947 24,687 80,709 63,607
Total Product Revenue [Member] | Proprietary Product [Member]        
Disaggregation Of Revenue [Line Items]        
Total revenue 15,765 11,458 43,177 25,213
Total Product Revenue [Member] | Partnered Product [Member]        
Disaggregation Of Revenue [Line Items]        
Total revenue 13,182 13,229 37,532 38,394
Licensing and Development Revenue [Member]        
Disaggregation Of Revenue [Line Items]        
Total revenue 4,321 1,211 8,763 4,365
Royalties [Member]        
Disaggregation Of Revenue [Line Items]        
Total revenue $ 6,735 $ 8,408 $ 15,994 $ 18,053
v3.20.2
Revenues, Significant Customers and Concentrations of Risk - Summary of Revenues Disaggregated by Customer Location (Detail) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2020
Sep. 30, 2019
Disaggregation Of Revenue [Line Items]        
Total revenues $ 40,003 $ 34,306 $ 105,466 $ 86,025
United States of America [Member]        
Disaggregation Of Revenue [Line Items]        
Total revenues 39,371 33,684 103,638 82,411
Europe [Member]        
Disaggregation Of Revenue [Line Items]        
Total revenues $ 632 566 $ 1,828 3,444
Other [Member]        
Disaggregation Of Revenue [Line Items]        
Total revenues   $ 56   $ 170
v3.20.2
Revenues, Significant Customers and Concentrations of Risk - Summary of Significant Customers from which the Company Derived 10% or More of Total Revenue (Detail) - Customer Concentration Risk [Member]
3 Months Ended 9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2020
Sep. 30, 2019
Teva [Member]        
Concentration Risk [Line Items]        
Total revenue by customer, percentage 45.00% 41.00% 42.00% 43.00%
AMAG [Member]        
Concentration Risk [Line Items]        
Total revenue by customer, percentage   20.00% 10.00% 19.00%
AMAG [Member] | Maximum [Member]        
Concentration Risk [Line Items]        
Total revenue by customer, percentage 10.00%      
AmerisourceBergen Corporation [Member]        
Concentration Risk [Line Items]        
Total revenue by customer, percentage 11.00% 10.00% 12.00%  
AmerisourceBergen Corporation [Member] | Maximum [Member]        
Concentration Risk [Line Items]        
Total revenue by customer, percentage       10.00%
McKesson Corporation [Member]        
Concentration Risk [Line Items]        
Total revenue by customer, percentage 12.00%   12.00%  
McKesson Corporation [Member] | Maximum [Member]        
Concentration Risk [Line Items]        
Total revenue by customer, percentage   10.00%   10.00%
Cardinal Health [Member]        
Concentration Risk [Line Items]        
Total revenue by customer, percentage 11.00%   11.00%  
Cardinal Health [Member] | Maximum [Member]        
Concentration Risk [Line Items]        
Total revenue by customer, percentage   10.00%   10.00%
v3.20.2
Earnings per Share - Summary of Computation for Basic and Diluted Net Earnings (Loss) per Share (Detail) - USD ($)
$ / shares in Units, shares in Thousands, $ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2020
Sep. 30, 2019
Sep. 30, 2020
Sep. 30, 2019
Numerator        
Numerator for basic and diluted earnings (loss) per share $ 4,996 $ 1,043 $ 4,815 $ (6,722)
Weighted average common shares outstanding:        
Basic weighted average common shares outstanding 166,375 163,119 165,838 162,109
Dilutive effects of stock options and share-based awards issuable under equity compensation plans 3,280 5,384 3,921  
Diluted weighted average common shares outstanding 169,655 168,503 169,759 162,109
Computation of:        
Basic net earnings (loss) per share $ 0.03 $ 0.01 $ 0.03 $ (0.04)
Diluted net earnings (loss) per share $ 0.03 $ 0.01 $ 0.03 $ (0.04)
Anti-dilutive common stock equivalents [1] 8,596 5,000 6,719 19,080
[1] These common stock equivalents were outstanding for the period but were not included in the computation of diluted EPS for those periods as their inclusion would have had an anti-dilutive effect.
v3.20.2
Subsequent Event - Additional Information (Detail) - Subsequent Event [Member] - License Agreement [Member] - Ferring International Center S.A. and its Affiliates [Member]
Oct. 01, 2020
USD ($)
Subsequent Event [Line Items]  
Upfront payment paid $ 5,000,000.0
Additional upfront payment made at one year from execution 2,500,000
Maximum [Member]  
Subsequent Event [Line Items]  
Tiered royalties and additional commercial milestone payments $ 17,500,000