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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 June 30, 2021

    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 August 1, 2021, the registrant had 169,967,638, 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 June 30, 2021 and December 31, 2020 (Unaudited)

 

3

 

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2021 and 2020 (Unaudited)

 

4

 

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Comprehensive Income (Loss) for the three and six months ended June 30, 2021 and 2020 (Unaudited)

 

5

 

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three and six months ended June 30, 2021 and 2020 (Unaudited)

 

6

 

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2021 and 2020 (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

 

27

 

 

 

 

 

 

 

 

 

Item 3.

 

Default Upon Senior Securities

 

27

 

 

 

 

 

 

 

 

 

Item 4.

 

Mine Safety Disclosures

 

27

 

 

 

 

 

 

 

 

 

Item 5.

 

Other Information

 

27

 

 

 

 

 

 

 

 

 

Item 6.

 

Exhibits

 

28

 

 

 

 

 

 

 

 

 

 

 

SIGNATURES

 

29

 

 

 

2


 

 

PART I – FINANCIAL INFORMATION

Item 1.

FINANCIAL STATEMENTS

ANTARES PHARMA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except per share amounts)

(UNAUDITED)

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Assets

 

 

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

45,126

 

 

$

53,137

 

Accounts receivable

 

 

54,224

 

 

 

42,221

 

Inventories

 

 

18,644

 

 

 

18,216

 

Contract assets

 

 

5,725

 

 

 

8,140

 

Prepaid expenses and other current assets

 

 

4,244

 

 

 

4,877

 

Total current assets

 

 

127,963

 

 

 

126,591

 

Deferred tax assets, net

 

 

45,249

 

 

 

46,982

 

Property and equipment, net

 

 

25,590

 

 

 

24,020

 

Operating lease right-of-use assets

 

 

4,014

 

 

 

4,621

 

Intangibles, net

 

 

7,280

 

 

 

7,693

 

Other assets

 

 

2,523

 

 

 

2,624

 

Total Assets

 

$

212,619

 

 

$

212,531

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

15,797

 

 

$

16,194

 

Accrued expenses and other liabilities

 

 

29,655

 

 

 

25,635

 

Long-term debt, current portion

 

 

22,813

 

 

 

16,230

 

Operating lease liabilities, current portion

 

 

1,035

 

 

 

1,203

 

Deferred revenue

 

 

2,675

 

 

 

3,943

 

Total current liabilities

 

 

71,975

 

 

 

63,205

 

Long-term debt

 

 

3,338

 

 

 

24,669

 

Operating lease liabilities, long-term

 

 

4,552

 

 

 

4,816

 

Other long-term liabilities

 

 

726

 

 

 

726

 

Total liabilities

 

 

80,591

 

 

 

93,416

 

Stockholders’ Equity:

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

Common Stock: $0.01 par; 300,000 shares authorized; 169,584 and

    166,836 issued and outstanding at June 30, 2021 and

   December 31, 2020, respectively

 

 

1,696

 

 

 

1,668

 

Additional paid-in capital

 

 

345,431

 

 

 

340,756

 

Accumulated deficit

 

 

(214,413

)

 

 

(222,626

)

Accumulated other comprehensive loss

 

 

(686

)

 

 

(683

)

 

 

 

132,028

 

 

 

119,115

 

Total Liabilities and Stockholders’ Equity

 

$

212,619

 

 

$

212,531

 

 

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 Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

$

27,904

 

 

$

24,665

 

 

$

57,039

 

 

$

51,762

 

Licensing and development revenue

 

 

7,167

 

 

 

2,687

 

 

 

12,151

 

 

 

4,442

 

Royalties

 

 

9,907

 

 

 

5,032

 

 

 

17,871

 

 

 

9,259

 

Total revenue

 

 

44,978

 

 

 

32,384

 

 

 

87,061

 

 

 

65,463

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales

 

 

11,630

 

 

 

10,927

 

 

 

24,128

 

 

 

24,941

 

Cost of development revenue

 

 

4,810

 

 

 

1,550

 

 

 

8,757

 

 

 

2,583

 

Research and development

 

 

4,047

 

 

 

2,417

 

 

 

6,687

 

 

 

5,398

 

Selling, general and administrative

 

 

17,704

 

 

 

14,448

 

 

 

35,311

 

 

 

30,870

 

Total operating expenses

 

 

38,191

 

 

 

29,342

 

 

 

74,883

 

 

 

63,792

 

Operating income

 

 

6,787

 

 

 

3,042

 

 

 

12,178

 

 

 

1,671

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(1,135

)

 

 

(967

)

 

 

(2,097

)

 

 

(2,028

)

Other, net

 

 

(89

)

 

 

100

 

 

 

(135

)

 

 

176

 

Total other expense, net

 

 

(1,224

)

 

 

(867

)

 

 

(2,232

)

 

 

(1,852

)

Net income (loss) before income taxes

 

 

5,563

 

 

 

2,175

 

 

 

9,946

 

 

 

(181

)

Income tax expense

 

 

(1,143

)

 

 

 

 

 

(1,733

)

 

 

 

Net income (loss)

 

$

4,420

 

 

$

2,175

 

 

$

8,213

 

 

$

(181

)

Net income (loss) per common share, basic

 

$

0.03

 

 

$

0.01

 

 

$

0.05

 

 

$

(0.00

)

Net income (loss) per common share, diluted

 

$

0.03

 

 

$

0.01

 

 

$

0.05

 

 

$

(0.00

)

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

169,043

 

 

 

165,703

 

 

 

168,436

 

 

 

165,566

 

Diluted

 

 

174,813

 

 

 

169,228

 

 

 

174,851

 

 

 

165,566

 

 

 

 

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 Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net income (loss)

 

$

4,420

 

 

$

2,175

 

 

$

8,213

 

 

$

(181

)

Foreign currency translation adjustment

 

 

7

 

 

 

4

 

 

 

(3

)

 

 

6

 

Comprehensive income (loss)

 

$

4,427

 

 

$

2,179

 

 

$

8,210

 

 

$

(175

)

 

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

 

March 31, 2021

 

 

168,798

 

 

$

1,688

 

 

$

344,063

 

 

$

(218,833

)

 

$

(693

)

 

$

126,225

 

Common stock issued under equity

   compensation plan, net of

   shares withheld for taxes

 

 

525

 

 

 

5

 

 

 

(1,228

)

 

 

 

 

 

 

 

 

 

 

(1,223

)

Exercise of options

 

 

261

 

 

 

3

 

 

 

535

 

 

 

 

 

 

 

 

 

538

 

Share-based compensation

 

 

 

 

 

 

 

 

2,061

 

 

 

 

 

 

 

 

 

2,061

 

Net income

 

 

 

 

 

 

 

 

 

 

 

4,420

 

 

 

 

 

 

4,420

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7

 

 

 

7

 

June 30, 2021

 

 

169,584

 

 

$

1,696

 

 

$

345,431

 

 

$

(214,413

)

 

$

(686

)

 

$

132,028

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional

Paid-In

Capital

 

 

Accumulated

Deficit

 

 

Other

Comprehensive

Loss

 

 

Total

Stockholders’

Equity

 

December 31, 2020

 

 

166,836

 

 

$

1,668

 

 

$

340,756

 

 

$

(222,626

)

 

$

(683

)

 

$

119,115

 

Common stock issued under equity

   compensation plan, net of

   shares withheld for taxes

 

 

942

 

 

 

10

 

 

 

(2,851

)

 

 

 

 

 

 

 

 

(2,841

)

Exercise of options

 

 

1,806

 

 

 

18

 

 

 

3,860

 

 

 

 

 

 

 

 

 

3,878

 

Share-based compensation

 

 

 

 

 

 

 

 

3,666

 

 

 

 

 

 

 

 

 

3,666

 

Net income

 

 

 

 

 

 

 

 

 

 

 

8,213

 

 

 

 

 

 

8,213

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3

)

 

 

(3

)

June 30, 2021

 

 

169,584

 

 

$

1,696

 

 

$

345,431

 

 

$

(214,413

)

 

$

(686

)

 

$

132,028

 

 

See accompanying notes to condensed consolidated financial statements.

 

6


 

 

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

 

March 31, 2020

 

 

165,560

 

 

$

1,656

 

 

$

334,025

 

 

$

(281,183

)

 

$

(700

)

 

$

53,798

 

Common stock issued under equity

   compensation plan, net of

   shares withheld for taxes

 

 

451

 

 

 

4

 

 

 

(757

)

 

 

 

 

 

 

 

 

(753

)

Exercise of options

 

 

74

 

 

 

1

 

 

 

117

 

 

 

 

 

 

 

 

 

118

 

Share-based compensation

 

 

 

 

 

 

 

 

1,987

 

 

 

 

 

 

 

 

 

1,987

 

Net income

 

 

 

 

 

 

 

 

 

 

 

2,175

 

 

 

 

 

 

2,175

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4

 

 

 

4

 

June 30, 2020

 

 

166,085

 

 

$

1,661

 

 

$

335,372

 

 

$

(279,008

)

 

$

(696

)

 

$

57,329

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

669

 

 

 

7

 

 

 

(1,357

)

 

 

 

 

 

 

 

 

(1,350

)

Exercise of options

 

 

195

 

 

 

2

 

 

 

387

 

 

 

 

 

 

 

 

 

389

 

Share-based compensation

 

 

 

 

 

 

 

 

3,965

 

 

 

 

 

 

 

 

 

3,965

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(181

)

 

 

 

 

 

(181

)

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6

 

 

 

6

 

June 30, 2020

 

 

166,085

 

 

$

1,661

 

 

$

335,372

 

 

$

(279,008

)

 

$

(696

)

 

$

57,329

 

 

See accompanying notes to condensed consolidated financial statements.

 

7


 

 

ANTARES PHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(UNAUDITED)

 

 

Six Months Ended

 

 

 

June 30,

 

 

 

2021

 

 

2020

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net income (loss)

 

$

8,213

 

 

 

(181

)

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

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

3,666

 

 

 

3,965

 

Depreciation and amortization

 

 

1,815

 

 

 

1,132

 

Other

 

 

353

 

 

 

519

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(12,007

)

 

 

785

 

Inventories

 

 

(427

)

 

 

(3,605

)

Contract assets

 

 

2,415

 

 

 

1,222

 

Prepaid expenses and other assets

 

 

633

 

 

 

(106

)

Deferred taxes

 

 

1,733

 

 

 

 

Accounts payable

 

 

(960

)

 

 

3,680

 

Accrued expenses and other liabilities

 

 

4,242

 

 

 

1,247

 

Deferred revenue

 

 

(1,265

)

 

 

603

 

Net cash provided by operating activities

 

 

8,411

 

 

 

9,261

 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(2,457

)

 

 

(2,444

)

Proceeds from maturities of investment securities

 

 

 

 

 

14,500

 

Net cash provided by (used in) investing activities

 

 

(2,457

)

 

 

12,056

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Principal payments on long-term debt

 

 

(15,000

)

 

 

 

Proceeds from exercise of stock options

 

 

3,878

 

 

 

389

 

Taxes paid related to net share settlement of equity awards

 

 

(2,841

)

 

 

(1,350

)

Net cash used in financing activities

 

 

(13,963

)

 

 

(961

)

Effect of exchange rate changes on cash

 

 

(2

)

 

 

1

 

Net increase (decrease) in cash and cash equivalents

 

 

(8,011

)

 

 

20,357

 

Cash and cash equivalents:

 

 

 

 

 

 

 

 

Beginning of period

 

 

53,137

 

 

 

23,201

 

End of period

 

$

45,126

 

 

$

43,558

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

Cash paid for interest

 

$

1,719

 

 

$

1,810

 

Supplemental disclosure of non-cash investing activities:

 

 

 

 

 

 

 

 

Purchases of property and equipment recorded in accounts payable

   and accrued expenses

 

$

2,534

 

 

$

3,334

 

 

 

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 specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies in targeted therapeutic areas. 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, convenience, improved tolerability, and enhanced patient comfort and adherence. We also seek product opportunities that complement and leverage our commercial platform. We have a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. We have formed significant strategic alliances and partnership arrangements with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (“Teva”), AMAG Pharmaceuticals, Inc. (“AMAG”), Pfizer Inc. (“Pfizer”) and Idorsia Pharmaceuticals Ltd (“Idorsia”).

Our marketed proprietary products include:

 

XYOSTED® (testosterone enanthate) injection, indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, and is the first and only subcutaneous testosterone enanthate product for once-weekly, at-home self-administration to be approved by the U.S. Food and Drug Administration (“FDA”);

 

OTREXUP® (methotrexate) injection, indicated for adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis; and

 

NOCDURNA® (desmopressin acetate), marketed in the U.S. for the treatment of nocturia due to nocturnal polyuria (NP) in adults who awaken at least two times per night to urinate.

The Company is also party to various partnered product development and supply arrangements:

 

We developed and are the exclusive supplier of devices for Teva’s Epinephrine Injection USP products, the generic equivalent of EpiPen® and EpiPen® Jr., indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and certain pediatric patients;

 

Through our commercialization partner Teva, we sell Sumatriptan Injection USP, a generic equivalent to the Imitrex® STATdose Pen®, indicated in the U.S. for the acute treatment of migraine headaches 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; and

 

We developed and are the exclusive supplier of devices for Teva’s generic equivalent of Forsteo® (Teriparatide Injection) which is approved and currently sold by Teva in various countries outside the United States.

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 advancing other internal research and development programs.

 

 

2.

Summary of Significant Accounting Policies

Basis of Presentation

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, 2020.  Operating results

9


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

for the three and six months ended June 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021.

Reclassifications

Certain reclassifications have been made to prior year amounts to conform with the current year presentation. Beginning as of and for the year ended December 31, 2020, the cost of product sales and the cost of development revenue are being classified under the heading Operating expenses in the accompanying consolidated statement of operations, and the corresponding prior period amounts have been reclassified to conform to this presentation. The reclassifications have no impact on the Company’s operating income (loss) or net income (loss) as previously reported.

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 $36,140 and $36,133 as of June 30, 2021 and December 31, 2020, respectively.

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.

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.

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.

10


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

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 product sales.

Proprietary Product Sales

The Company sells its proprietary commercial products 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, 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 as follows:

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 right of return. Revenue is recognized at the transaction price, which includes the contractual per unit selling price and estimated variable consideration, such as volume-based pricing arrangements or profit sharing arrangements, if any.  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 the Company’s partner.  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.

11


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

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 $2,776 in licensing and development revenue in connection with contract liabilities that were outstanding as of December 31, 2020 and satisfied during the six months ended June 30, 2021.

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 June 30, 2021, the aggregate value of remaining performance obligations, excluding contracts with an original expected length of one year or less, was $14,409. The Company expects to recognize revenue on the remaining performance obligations over the next three years.

3.

Inventories

Inventories consisted of the following:

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Raw material

 

$

325

 

 

$

325

 

Work in process

 

 

7,660

 

 

 

7,120

 

Finished goods

 

 

10,659

 

 

 

10,771

 

 

 

$

18,644

 

 

$

18,216

 

 

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 $777 and $619 at June 30, 2021 and December 31, 2020, respectively.

12


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

4.

Property and Equipment

The Company’s property and equipment consisted of the following:

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Production molds, tooling and equipment

 

$

21,020

 

 

$

20,260

 

Leasehold improvements

 

 

7,321

 

 

 

6,298

 

Furniture, fixtures and office equipment

 

 

877

 

 

 

865

 

Computer equipment and software

 

 

1,071

 

 

 

756

 

Construction and tooling in process

 

 

7,018

 

 

 

6,214

 

Less: accumulated depreciation

 

 

(11,717

)

 

 

(10,373

)

 

 

$

25,590

 

 

$

24,020

 

 

5.

Long-Term Debt

In June 2017, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Capital, Inc. (the “Lender”), for a term loan of up to $35.0 million (the “Term Loan”), under which the Company initially borrowed $25.0 million (“Tranche I”.) 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%, and initially provided for payments of interest-only until August 1, 2019 with a maturity date of July 1, 2022.

In June 2019, the Company entered into a First Amendment (the “Amendment”) to the Loan Agreement, which increased the aggregate principal amount available under the Term Loan from $35.0 million to $50.0 million and extended the interest-only payment period of the Term Loan to August 1, 2021. Under the Amendment, the interest only period could be further extended to August 1, 2022 if the Company achieved a certain loan extension milestone, requested such extension by July 31, 2021, and paid an extension fee equal to one half of one percent of the principal amount outstanding. Upon signing of the Amendment, an additional $15.0 million (“Tranche II”) was funded to the Company. The Term Loan maturity date remained July 1, 2022, which could be extended to July 1, 2024.

The Company is required to pay an end of term fee (“End of Term Charge”) equal to 4.25% of Tranche I and 3.95% of the borrowings under Tranche II, payable upon the earlier of July 1, 2022 or full repayment of the loan. The Loan Agreement also imposes a prepayment fee of 1.0% to 3.0% if any or all of the balance is prepaid prior to the maturity date.

On June 30, 2021, the Company made a $15.0 million prepayment of principal and paid a 1.0% prepayment fee. The carrying value of the Term Loan was $26,151 and $40,899 as of June 30, 2021 and December 31, 2020, respectively, which consisted of the principal amounts outstanding and the End of Term Charge accrual, less unamortized debt issuance costs that are being amortized/accrued to interest expense over the term of the Term Loan using the effective interest method. As of June 30 2021, the future principal payments under the Term Loan consisted of $10,144 due in 2021 and $14,856 due in 2022, excluding the contractual End of Term Charges.

In July 2021, having previously met the loan extension milestone, the Company requested that the interest-only period be extended to August 1, 2022 and the maturity date be extended to July 1, 2024 in accordance with the terms of the Amendment. The Lender granted the extension of the interest-only period and maturity date and waived the extension fee.

13


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

6.

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 Plan was amended and restated in June 2021 to increase the total number of shares available for grant under the Plan by 10 million shares. 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 six months ended June 30, 2021:   

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

Average

 

 

 

 

 

 

 

 

 

 

 

Average

 

 

Remaining

 

 

Aggregate

 

 

 

Number of

 

 

Exercise

 

 

Contractual

 

 

Intrinsic

 

 

 

Shares

 

 

Price

 

 

Term (Years)

 

 

Value

 

Outstanding at December 31, 2020

 

 

15,521

 

 

$

2.49

 

 

 

 

 

 

 

 

 

Granted

 

 

2,572

 

 

 

4.40

 

 

 

 

 

 

 

 

 

Exercised

 

 

(1,806

)

 

 

2.15

 

 

 

 

 

 

 

 

 

Cancelled/Forfeited

 

 

(195

)

 

 

2.75

 

 

 

 

 

 

 

 

 

Outstanding at June 30, 2021

 

 

16,092

 

 

 

2.83

 

 

 

6.95

 

 

$

24,824

 

Exercisable at June 30, 2021

 

 

11,094

 

 

$

2.46

 

 

 

5.88

 

 

$

21,060

 

 

The following is a summary of PSU and RSU award activity under the Plan as of and for the six months ended June 30, 2021:   

 

 

 

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, 2020

 

 

1,641

 

 

$

2.61

 

 

 

1,567

 

 

$

2.77

 

Granted

 

 

243

 

 

 

5.55

 

 

 

769

 

 

 

4.42

 

Incremental shares earned

 

 

210

 

 

 

3.18

 

 

 

 

 

 

 

Vested/settled

 

 

(766

)

 

 

2.86

 

 

 

(832

)

 

 

2.76

 

Outstanding at June 30, 2021

 

 

1,328

 

 

$

3.04

 

 

 

1,504

 

 

$

3.62

 

 

The LTIP awards that vested during the six months ended June 30, 2021 and 2020 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 626 and 419 shares during the six months ended June 30, 2021 and 2020, 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 $2,841 and $1,350 during the six months ended June 30, 2021 and 2020, 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.

 

Members of the Company’s Board of Directors also receive grants of restricted stock units that vest in full one year from the date of grant. Directors may elect to defer receipt of vested shares until retirement or separation from the Board; 30 shares were vested and deferred during the six months ended June 30, 2021.

 

14


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

 

In connection with Plan awards, the Company recognized share-based compensation expense for the three and six months ended June 30, 2021 and 2020 as follows:

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Stock options

 

$

890

 

 

$

875

 

 

$

1,777

 

 

$

1,756

 

Restricted stock units

 

 

607

 

 

 

525

 

 

 

1,172

 

 

 

1,082

 

Performance stock units

 

 

564

 

 

 

587

 

 

 

717

 

 

 

1,127

 

Total share-based compensation expense

 

$

2,061

 

 

$

1,987

 

 

$

3,666

 

 

$

3,965

 

 

 

7.

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

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Proprietary product sales

 

$

18,953

 

 

$

14,846

 

 

$

37,685

 

 

$

27,412

 

Partnered product sales

 

 

8,951

 

 

 

9,819

 

 

 

19,354

 

 

 

24,350

 

Total product revenue

 

 

27,904

 

 

 

24,665

 

 

 

57,039

 

 

 

51,762

 

Licensing and development revenue

 

 

7,167

 

 

 

2,687

 

 

 

12,151

 

 

 

4,442

 

Royalties

 

 

9,907

 

 

 

5,032

 

 

 

17,871

 

 

 

9,259

 

Total revenue

 

$

44,978

 

 

$

32,384

 

 

$

87,061

 

 

$

65,463

 

 

Revenues disaggregated by customer location are as follows: 

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

United States of America

 

$

44,008

 

 

$

31,798

 

 

$

84,639

 

 

$

64,268

 

Europe

 

 

970

 

 

 

586

 

 

 

2,422

 

 

 

1,195

 

 

 

$

44,978

 

 

$

32,384

 

 

$

87,061

 

 

$

65,463

 

 

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

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Teva

 

44%

 

 

40%

 

 

43%

 

 

41%

 

McKesson Corporation

 

12%

 

 

11%

 

 

12%

 

 

11%

 

AmerisourceBergen Corporation

 

11%

 

 

13%

 

 

12%

 

 

13%

 

Cardinal Health

 

11%

 

 

13%

 

 

11%

 

 

11%

 

AMAG

 

<10%

 

 

<10%

 

 

<10%

 

 

12%

 

 

 

8.

Income Taxes

The Company’s gross unrecognized tax benefits as of June 30, 2021 was $2,127 and there were no material changes during the quarter and six months then ended.  There are no interest or penalties accrued in relation to unrecognized tax benefits. The Company will classify any future interest and penalties as a component of income tax expense.  The Company is subject to federal and state examinations for the years 2017 and thereafter.

15


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

 

9.

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 six months ended June 30, 2021 and 2020:

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Numerator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Numerator for basic and diluted earnings (loss) per share

 

$

4,420

 

 

$

2,175

 

 

$

8,213

 

 

$

(181

)

Denominator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic weighted average common shares outstanding

 

 

169,043

 

 

 

165,703

 

 

 

168,436

 

 

 

165,566

 

Dilutive effects of stock options and share-based awards

     issuable under equity compensation plans

 

 

5,770

 

 

 

3,525

 

 

 

6,415

 

 

 

 

Diluted weighted average common shares outstanding

 

 

174,813

 

 

 

169,228

 

 

 

174,851

 

 

 

165,566

 

Computation of:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic net earnings (loss) per share

 

$

0.03

 

 

$

0.01

 

 

$

0.05

 

 

$

(0.00

)

Diluted net earnings (loss) per share

 

$

0.03

 

 

$

0.01

 

 

$

0.05

 

 

$

(0.00

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Anti-dilutive common stock equivalents (1)

 

 

849

 

 

 

6,361

 

 

 

530

 

 

 

5,145

 

 

 

(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.

 

 

10.

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

16


ANTARES PHARMA, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(in thousands, except per share amounts)

 

 

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. On February 26, 2021, the court granted defendants’ motion to dismiss with prejudice, and on March 29, 2021 the plaintiff filed a notice of appeal. On June 21, 2021, plaintiff-appellant filed his opening brief. Defendants-appellees’ response brief is due on August 4, 2021 and plaintiff-appellant’s reply is due on August 25, 2021. The Company believes that the claims in the Smith action lack merit and intends to continue 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; the motion to dismiss in Smith was granted on February 26, 2021 and a notice of appeal was filed on March 29, 2021.

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; the motion to dismiss in Smith was granted on February 26, 2021 and a notice of appeal was filed on March 29, 2021. After the expiration of all appeals related to the Smith dismissal, the parties shall submit a proposed order regarding the derivative action.

 

 

 

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 ongoing 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 and the continued growth in prescriptions and revenues related thereto;

 

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

 

our expectations regarding the commercialization of NOCDURNA® (desmopressin acetate) in the U.S. under a licensing agreement with Ferring International Center S.A. and its affiliates, (“Ferring”) and future sales and revenue from the same;

 

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

 

our expectations regarding the ability of AMAG Pharmaceuticals, Inc. (“AMAG”) to continue to 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”) 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 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 continued product development with Teva of the teriparatide and exenatide disposable pen injectors, Teva’s ability to obtain FDA approval and AB-rating for each of those products, and if approved, Teva’s ability to successfully commercialize the teriparatide disposable pen injector product outside the U.S.;

 

our expectations about the development of a rescue pen for an undisclosed drug with our partner Pfizer, Inc. (“Pfizer”) and potential future regulatory approval and future revenue from the same;

 

our expectations about our development activities with Idorsia Pharmaceuticals Ltd (“Idorsia”) and the timing and results of the 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 the development of ATRS-1902 for adrenal crisis rescue, including the timing and results of clinical trials and our anticipated 505(b)(2) NDA filing with the FDA;

 

our expectations about our other internal research and development projects, including but not limited to ATRS-1901, 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, assemble and package 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


 

 

 

expectation about our future revenues, including the 2021 revenue guidance, our cash flows and our ability to support our operations and maintain profitability;

 

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

 

our expectations and estimates made in connection with current accounting practices, including but not limited to, the carrying value of our deferred tax assets and our ability to utilize net operating loss and other credit carryforwards to offset future U.S. federal taxable income;

 

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 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, partners and manufacturers;

 

changes or delays in the regulatory review and approval process;

 

our inability to effectively protect our intellectual property;

 

costs associated with future litigation and the outcome of such litigation;

 

our inability to attract and retain key personnel; and

 

adverse economic and political conditions.

In addition, you should refer to the “Risk Factors” section 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

19


 

publicly any forward-looking statements to reflect circumstances or events that occur after the date the forward-looking statements are 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 specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address unmet needs in targeted therapeutic areas. 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, convenience, improved tolerability, and enhanced patient comfort and adherence. We also seek product opportunities that complement and leverage our commercial platform. We have a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. We have formed significant strategic alliances and partnership arrangements with industry leading pharmaceutical companies including Pfizer, Idorsia, Teva and AMAG.  

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 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 began detailing NOCDURNA® with a soft launch in the fourth quarter of 2020 and are currently executing a reintroduction of the product through a comprehensive re-launch strategy to increase awareness and demand.

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 the 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.

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

20


 

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.

We are also collaborating with Teva on a multi-dose pen for a generic form of Forteo® (teriparatide [rDNA origin] injection) for the treatment of osteoporosis, and another multi-dose pen for a generic form of BYETTA® (exenatide injection) for the treatment of type 2 diabetes. 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 several countries outside the United States. 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 development 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 are developing the product and Pfizer will be responsible for obtaining FDA approval of the combination product. We entered into a separate commercial 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 global agreement with Idorsia to develop a novel, drug-device product containing selatogrel. The new chemical entity selatogrel 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.

In June 2021, Idorsia announced it is initiating its Phase 3 registration study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia’s P2Y12 receptor antagonist, in suspected AMI utilizing Antares’ Quickshot® auto-injector.  The study is an international, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the clinical efficacy and safety of 16 mg selatogrel when self-administered (on top of standard-of-care) upon occurrence of symptoms suggestive of an acute myocardial infarction. The primary efficacy endpoint is the occurrence of death from any cause, or non-fatal AMI after any study treatment self-administration. The study will enroll approximately 14,000 patients who are at high risk of recurrent AMI, at approximately 250 sites in approximately 30 countries. A Special Protocol Assessment has been agreed with the FDA for Idorsia’s selatogrel, which indicates the FDA is in agreement with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., entry criteria, dose selection, endpoints and planned analyses) for a study intended to support a future marketing application. In December 2020, the FDA designated Idorsia’s investigation of selatogrel for the treatment of a suspected AMI in adult patients with a history of AMI as a “fast-track” development program. This designation is intended to promote communication and collaboration between the FDA and pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need.

We are also 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.

In 2019, we initiated development of a proprietary drug device combination product for the urology oncology market, identified as ATRS-1901. We have conducted formulation development work and non-clinical studies to help advance this program. In 2020, we received a response from the FDA regarding our pre-IND (Investigational New Drug) submission and believe we have determined our clinical and regulatory pathway forward.  We expect to file an IND for this program with the FDA in the second half of 2021.

In 2019, we identified a program to develop a proprietary drug device combination product for the endocrinology market, identified as ATRS-1902.  We conducted initial formulation work and developed a working prototype of a new device to support this

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program. We received a response from the FDA regarding our pre-IND submission and believe we have determined the regulatory and clinical path forward.

In June 2021, we submitted an IND application with the FDA for the initiation of a Phase 1 clinical study of ATRS-1902 for adrenal crisis rescue. The IND application for ATRS-1902, and its corresponding development program, supports a proposed indication for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver hydrocortisone. The IND application includes the protocol for an initial clinical study to compare the pharmacokinetic profile of our novel formulation of hydrocortisone versus Solu-Cortef®, which is an anti-inflammatory glucocorticoid and is the current standard of care for the management of acute adrenal crises.

In July 20201, the FDA accepted our IND for ATRS-1902 enabling us to initiate our Phase 1 clinical study. After this study is completed, we expect a second study will then be conducted utilizing our proprietary auto-injector technology which has been developed for high reliability and ease-of-use in emergency situations by the patient or caregiver. We believe these two studies will be the basis of our anticipated 505(b)(2) NDA filing with the FDA towards the end of 2022.

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 outbreak. The Pandemic has impacted global economic activity and lead to disruptions in supply chain, labor shortages, business closures, travel restrictions and other health, safety and social distancing requirements.

We have taken several measures to help minimize the impact of the Pandemic on our business and have implemented safety measures and protocols to protect the health and safety of our employees and comply with governmental and public health regulations while working to ensure the sustainability of our business operations and continuity of product supply. We continue to monitor the situation and potential effects on our business, suppliers, partners and workforce.

Most of our employees, including our corporate and administrative functions, have returned to work onsite at our facilities. Our sales force has resumed in-person office visits in most areas and continue to reach healthcare providers virtually in other territories based on the varying restrictions, protocols and phased re-openings. The restrictions and closures during the Pandemic have, to some extent, limited or reduced patient access to physicians for non-essential services.  These limitations have had, and may continue to have, an impact on 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 Pandemic or the related restrictions. Although we have not experienced any significant delays or disruption in our development programs due to the Pandemic, a worsening or sustained outbreak could also impact our or our partners’ clinical trials or lead to delays or disruptions in activities with the FDA.

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 continued uncertainty around the timing and duration of the 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” in our most recent annual report on Form 10-K as filed with the Securities and Exchange Commission.

Results of Operations

We reported net income of $4.4 million and $8.2 million for the three and six months ended June 30, 2021 as compared to net income of $2.2 million and a net loss of $0.2 million for the three and six months ended June 30, 2020, respectively. Our earnings per share were $0.03 and $0.05 for the three and six months ended June 30, 2021 as compared to $0.01 and $0.0 per share for the three and six months ended June 30, 2020, respectively. Operating results for the three and six months ended June 30, 2021 are not necessarily indicative of the results that may be expected for the full year ending December 31, 2021. The following is an analysis and discussion of our operations for the three and six months ended June 30, 2021 as compared to the same periods in 2020.

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Revenues

We generate revenue from proprietary and partnered product sales, license and development activities and royalty arrangements.  Total revenue for the three months ended June 30, 2021 and 2020 was $45.0 million and $32.4 million, respectively, representing an increase in total revenue of 39% on a comparative basis. Total revenue for the six months ended June 30, 2021 and 2020 was $87.1 and $65.5 million, respectively, representing an increase of 33%. The following table provides details about the components and drivers of our overall revenue growth (in thousands):

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Proprietary product sales

 

$

18,953

 

 

$

14,846

 

 

$

37,685

 

 

$

27,412

 

Partnered product sales

 

 

8,951

 

 

 

9,819

 

 

 

19,354

 

 

 

24,350

 

Total product revenue

 

 

27,904

 

 

 

24,665

 

 

 

57,039

 

 

 

51,762

 

Licensing and development revenue

 

 

7,167

 

 

 

2,687

 

 

 

12,151

 

 

 

4,442

 

Royalties

 

 

9,907

 

 

 

5,032

 

 

 

17,871

 

 

 

9,259

 

Total revenue

 

$

44,978

 

 

$

32,384

 

 

$

87,061

 

 

$

65,463

 

 

Product Revenue

Revenue from product sales was $27.9 million and $24.7 million for the three months ended June 30, 2021 and 2020, respectively, an increase of 13% on a period over period basis. The increase was driven primarily by increased sales of our proprietary product XYOSTED® offset by a decrease in shipments of epinephrine auto injectors to Teva and sales of other partnered products, as discussed below. For the six months ended June 30, 2021 and 2020, revenue from product sales was $57.0 million and $51.8 million, respectively, an increase of 10% on a period over period basis. The increase for the comparative six-month period was primarily attributable to an increase in XYOSTED® sales and sales of epinephrine auto injectors to Teva, offset by a reduction in sales of Makena® subcutaneous auto-injectors to AMAG.  

Sales of our proprietary products XYOSTED®, OTREXUP® and NOCDURNA®, which are presented net of estimated product returns and sales allowances, generated revenue of $19.0 million and $14.8 million for the three months ended June 30, 2021 and 2020, respectively, representing a 28% increase on a comparative basis. For the six months ended June 30, 2021 and 2020, proprietary product sales were $37.7 million and $27.4 million, respectively, representing a 37% increase. The increases in proprietary product sales for the three and six months ended June 30, 2021 as compared to the three and six months ended June 30, 2020 was principally attributable to continued growth in prescriptions and sales of XYOSTED®, and to new sales of NOCDURNA®, which we in-licensed and began detailing in the fourth quarter of 2020.

We also manufacture and sell devices, components and fully assembled and packaged product to our partners. Partnered product sales were $9.0 million and $9.8 million for the three months ended June 30, 2021 and 2020, respectively, representing a decrease of 9% on a comparative basis. For the six months ended June 30, 2021 and 2020, partnered product revenue was $19.4 million and $24.4 million, respectively. The net decreases in partnered product sales for the three and six months ended June 30, 2021 as compared to the same periods in 2020 is primarily attributable to a decrease in sales sumatriptan to Teva and a decrease in production and sales of Makena® product for AMAG.   

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 $7.2 million and $2.7 million for the three months ended June 30, 2021 and 2020, respectively, and $12.2 million and $4.4 million for the six months ended June 30, 2021 and 2020, respectively. The increase in licensing and development revenue recognized for the three and six months ended June 30, 2021 as compared to the same periods in 2020 was primarily a result of incremental development and maintenance activities with Teva related to the epinephrine auto injector production line and continuing development activities under the other ongoing partnered development projects.

Royalties

Royalty revenue was $9.9 million and $5.0 million for the three months ended June 30, 2021 and 2020, respectively and $17.9 million and $9.3 million for the six months ended June 30, 2021 and 2020, respectively. The net increase in royalty revenue was principally a result of an increase in royalties from Teva on its net sales of generic EpiPens®.

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Cost of Revenues

The following table summarizes our cost of product sales and development revenue (in thousands):

 

 

 

Three Months Ended June 30,

 

 

Six months ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Cost of product sales

 

$

11,630

 

 

$

10,927

 

 

$

24,128

 

 

$

24,941

 

Cost of development revenue

 

 

4,810

 

 

 

1,550

 

 

 

8,757

 

 

 

2,583

 

Total cost of revenue

 

$

16,440

 

 

$

12,477

 

 

$

32,885

 

 

$

27,524

 

 

The increase and decrease in our cost of product sales for the three and six months ended June 30, 2021 as compared to 2020, respectively, is a function of the product revenue mix in the respective periods. Proprietary products generally have a lower cost of sales as a percentage of revenue than partnered product sales.

 

The increase in our cost of development revenue is attributable to, and consistent with, the significant growth in development revenue from partnered development activities for the three and six months ended June 30, 2021 as compared to the three and six months ended June 30, 2020, as shown in the revenue table above.

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 $4.0 million and $2.4 million for the three months ended June 30, 2021 and 2020, respectively, and $6.7 million and $5.4 million for the six months ended June 30, 2021 and 2020, 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 and timing of clinical studies and external development costs incurred. As discussed above, we submitted an IND application with the FDA in June 2021 for the initiation of a Phase 1 clinical study of ATRS-1902 for adrenal crisis rescue.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $17.7 million and $14.4 million for the three months ended June 30, 2021 and 2020, respectively, and totaled $35.3 million and $30.9 million for the six months ended June 30, 2021 and 2020, respectively. The increases in selling, general and administrative expenses for the three and six months ended June 30, 2021 compared to 2020 was primarily due to an increase in sales and marketing costs, which were down in 2020 due to the Pandemic as the various restrictions and limitations imposed during the Pandemic lead to decreased spending that has now returned to pre-Pandemic levels. The increase is also attributable to sales and marketing costs associated with our new proprietary product NOCDURNA®, which we in-licensed and began detailing in the fourth quarter of 2020. We also experienced an increase in general and administrative expenses, primarily employee compensation, professional services and facility costs, to support the continued growth of the business.  

Income Taxes

We recorded income tax expense of $1.1 million and $1.7 million for the three and six months ended June 30, 2021, respectively, or 20.8% and 17.4% of earnings before income taxes. Income tax expense was $0 in 2020, or 0% of our net income (loss) before taxes, as a result of our full valuation allowance on our deferred taxes that was released in the fourth quarter of 2020.  The effective income tax rate for the three and six months ended June 30, 2021 reflected a net discrete income tax benefit related to share-based compensation expense in connection with stock option exercises and vesting of performance and restricted stock units, which favorably impacted the effective tax rate by 5.3% for the quarter and 8.6% year to date.

Liquidity and Capital Resources

At June 30, 2021, we had cash and cash equivalents of $45.1 million. Our principal liquidity needs are to fund our product manufacturing costs, research and development activities, sales and marketing and other general operating expenses, as well as capital expenditures and debt service. We believe that the combination of our current cash and cash equivalents, 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.

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Long-term Debt Financing

The Company is party to a loan and security agreement, as amended, with Hercules Capital, Inc. (the “Term Loan”). The amortizing Term Loan is secured by substantially all of the Company’s assets, excluding intellectual property and accrues interest at a prime-based variable rate with a maximum of 9.5%, which was 8.5% at June 30, 2021. On June 30, 2021, we made a $15.0 million prepayment of principal due under the Term Loan along with a 1.0% prepayment fee. The outstanding principal balance under the Term Loan was $25.0 million and $40.0 million as of June 30, 2021 and December 31, 2020, respectively.  

The Term Loan, as amended, provided for payments of interest-only until August 1, 2021 with a maturity date of July 1, 2022, both of which could be extended contingent upon satisfaction of a certain loan extension milestones and upon formal request of such extension. In July 2021, we requested, and the lender granted, the extension of the interest-only period to August 1, 2022 and maturity date to July 1, 2024 in accordance with the loan and security agreement, as amended.

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 full repayment of the loan.

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 $8.4 million for the six months ended June 30, 2021 as compared $9.3 million for the six months ended June 30, 2020. The change in the net cash from operating activities was primarily a result of our net income(loss) for the period and the changes in operating assets and liabilities due to timing of cash receipts and cash disbursements, principally driven by our growth in sales and accounts receivable in 2021.  

Net Cash Flows from Investing Activities

Net cash used in investing activities was $2.5 million for the six months ended June 30, 2021 and was primarily for capital expenditures for our manufacturing facility. Net cash provided by investing activities for the six months ended June 30, 2020 was $12.1 million and was comprised of $14.5 million in cash receipts from maturities of short-term investments offset by capital expenditures of $2.4 million.

Net Cash Flows from Financing Activities

The net cash flow used in financing activities was $14.0 million for the six months ended June 30, 2021, and consisted of $3.9 million in proceeds received from exercises of stock options offset by a $15.0 million prepayment of principal on our Term Loan and $2.8 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 used in financing activities for the six months ended June 30, 2020 was $1.0 million, which included $0.4 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.  

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 valuation of deferred tax assets, which are fully described in our Annual Report on Form 10-K for the year ended December 31, 2020.

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.

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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 June 30, 2021 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 $25.0 million accrues interest at a calculated prime-based variable rate, which was 8.5% as of June 30, 2021, 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 $250,000.

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.

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.

The information set forth under “Note 10—Commitments and Contingencies—Pending Litigation” to the consolidated financial statements included in Part I, Item 1 in this Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 and is incorporated herein by reference.

Item 1A.

RISK FACTORS

In addition to the information contained in this report, you should carefully consider the risk factors discussed in Part I, “Item 1A.  Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, which could materially affect our business, financial condition or future results.  The risks described in our Annual Report on Form 10-K are not the only risks we face.  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.

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.

 

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Item 6.

EXHIBITS

(a)

Exhibit Index

 

Exhibit No.

 

Description

10.1

 

Antares Pharma, Inc. Equity Compensation Plan, as amended and restated, and approved by stockholders (Filed as Exhibit 4.1 to the Company’s Form S-8 filed June 24, 2021 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.

 

28


 

 

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.

 

 

 

August 5, 2021

 

/s/ Robert F. Apple

 

 

Robert F. Apple

 

 

President and Chief Executive Officer

 

 

(Principal Executive Officer)

 

 

 

August 5, 2021

 

/s/ Fred M. Powell

 

 

Fred M. Powell

 

 

Executive Vice President and Chief Financial Officer

 

 

(Principal Financial and Accounting Officer)

 

 

29