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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark one)

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

For the quarterly period ended September 30, 2020

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

For the transition period from                        to                       .

Commission File Number 001-31812

ANI PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware

58-2301143

(State or other jurisdiction of
incorporation or organization)  

(IRS Employer
Identification Number)

210 Main Street West

Baudette, Minnesota 56623

(Address of principal executive offices)

(218) 634-3500

(Registrant’s telephone number including area code)

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

 

ANIP

 

NASDAQ Global Market

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 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 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

As of October 29, 2020, there were 12,347,554 shares of common stock and 10,864 shares of class C special stock of the registrant outstanding.

Table of Contents

ANI PHARMACEUTICALS, INC.

FORM 10-Q — Quarterly Report

For the Quarterly Period Ended September 30, 2020

TABLE OF CONTENTS

 

 

Page

PART I —FINANCIAL INFORMATION

Item 1.

Financial Statements (unaudited)

1

Condensed Consolidated Balance Sheets — As of September 30, 2020 and December 31, 2019

5

Condensed Consolidated Statements of Operations — For the Three and Nine Months Ended September 30, 2020 and 2019

6

Condensed Consolidated Statements of Comprehensive Income — For the Three and Nine Months Ended September 30, 2020 and 2019

7

Condensed Consolidated Statements of Changes in Stockholders’ Equity — For the Three and Nine Months Ended September 30, 2020 and 2019

8

Condensed Consolidated Statements of Cash Flows — For the Nine Months Ended September 30, 2020 and 2019

10

Notes to Condensed Consolidated Financial Statements

11

Item 2.

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

36

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

48

Item 4.

Controls and Procedures

48

PART II —OTHER INFORMATION

Item 1.

Legal Proceedings

49

Item 1A.

Risk Factors

49

Item 2.

Recent Sales of Unregistered Securities and Use of Proceeds from Registered Securities

50

Item 3.

Defaults upon Senior Securities

50

Item 4.

Mine Safety Disclosures

50

Item 5.

Other Information

50

Item 6.

Exhibits

51

Signatures

52

2

Table of Contents

CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q and certain information incorporated herein by reference contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Exchange Act. Such statements include, but are not limited to, statements about future operations, the revenue potential (licensing, royalty and sales) of products we sell, development timelines, expected timeframe for submission of new drug applications or supplemental new drug applications to the U.S. Food and Drug Administration (the “FDA”), pipeline or potential markets for our products , impact of accounting principles, litigation expenses, liquidity and capital resources, the impact of the novel coronavirus (“COVID-19”) global pandemic on our business, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words, and the use of future dates. Such forward-looking statements are based on the reasonable beliefs of our management as well as assumptions made by and information currently available to our management. Readers should not put undue reliance on these forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified; therefore, our actual results may differ materially from those described in any forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in our periodic reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Reports on Form 10-Q for the three months ended June 30, 2020 and March 31, 2020, as well as those discussed elsewhere in this Quarterly Report on Form 10-Q, and the following factors:

risks that we may face with respect to importing raw materials;
delays or failure in obtaining approvals by the FDA of the products we sell;
changes in policy or actions that may be taken by the FDA and other regulatory agencies, including drug recalls;
the ability of our manufacturing partners to meet our product demands and timelines;
our dependence on single source suppliers of ingredients due to the time and cost to validate a second source of supply;
acceptance of our products at levels that will allow us to achieve profitability;
our ability to develop, license or acquire, and commercialize new products;
the level of competition we face and the legal, regulatory and/or legislative strategies employed by our competitors to prevent or delay competition from generic alternatives to branded products;
our ability to protect our intellectual property rights;
the impact of legislative or regulatory reform on the pricing for pharmaceutical products;
the impact of any litigation to which we are, or may become a party;
our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries;
our ability to maintain the services of our key executives and other personnel; and
general business and economic conditions and the effects and duration of outbreak of public health emergencies, such as COVID-19.

3

Table of Contents

These factors should not be construed as exhaustive and should be read in conjunction with our other disclosures, including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2019, including the factors described in “Item 1A. Risk Factors.” Other risks may be described from time to time in our filings made under the securities laws, including our quarterly reports on Form 10-Q and our current reports on Form 8-K. New risks emerge from time to time. It is not possible for our management to predict all risks. The forward-looking statements contained in this document are made only as of the date of this document. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

NOTE REGARDING TRADEMARKS

Cortenema®, Cortrophin® Gel, Cortrophin-Zinc®, Inderal® LA, Inderal® XL, InnoPran XL®, Lithobid®, Reglan®, and Vancocin® are registered trademarks subject to trademark protection and are owned by ANI Pharmaceuticals, Inc. and its consolidated subsidiaries. Atacand® and Atacand HCT® are the property of AstraZeneca AB and are licensed to ANI Pharmaceuticals, Inc. for U.S. sales of those products. Arimidex® and Casodex® are the property of AstraZeneca UK Limited and are licensed to ANI Pharmaceuticals, Inc. for U.S. sales of those products.

4

Table of Contents

Part I — FINANCIAL INFORMATION

Item 1.   Financial Statements

ANI PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

(unaudited)

    

September 30, 

    

December 31, 

2020

2019

Assets

Current Assets

 

  

 

  

Cash and cash equivalents

$

17,900

$

62,332

Accounts receivable, net of $86,418 and $59,946 of adjustments for chargebacks and other allowances at September 30, 2020 and 2019, respectively

 

83,745

 

72,129

Inventories, net

 

59,195

 

48,163

Prepaid income taxes

 

1,621

 

1,076

Prepaid expenses and other current assets

 

3,358

 

3,995

Total Current Assets

 

165,819

 

187,695

Property and equipment, net

 

40,444

 

40,551

Restricted cash

 

5,003

 

5,029

Deferred tax assets, net of deferred tax liabilities and valuation allowance

 

48,130

 

38,326

Intangible assets, net

 

198,620

 

180,388

Goodwill

 

3,580

 

3,580

Other non-current assets

 

985

 

1,220

Total Assets

$

462,581

$

456,789

Liabilities and Stockholders’ Equity

 

  

 

  

Current Liabilities

 

  

 

  

Current debt, net of deferred financing costs

$

12,785

$

9,941

Accounts payable

 

13,460

 

14,606

Accrued expenses and other

 

2,534

 

2,362

Accrued royalties

 

6,088

 

5,084

Accrued compensation and related expenses

 

5,993

 

3,736

Accrued government rebates

 

11,678

 

8,901

Returned goods reserve

 

23,250

 

16,595

Deferred revenue

 

112

 

451

Total Current Liabilities

 

75,900

 

61,676

Non-current Liabilities

 

  

 

  

Non-current debt, net of deferred financing costs and current component

 

175,161

 

175,808

Derivatives and other non-current liabilities

 

16,420

 

6,514

Total Liabilities

$

267,481

$

243,998

Commitments and Contingencies (Note 11)

 

  

 

  

Stockholders’ Equity

 

  

 

  

Common Stock, $0.0001 par value, 33,333,334 shares authorized; 12,423,061 shares issued and 12,347,543 outstanding at September 30, 2020; 12,104,875 shares issued and 12,089,565 shares outstanding at December 31, 2019

 

1

 

1

Class C Special Stock, $0.0001 par value, 781,281 shares authorized; 10,864 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively

 

 

Preferred Stock, $0.0001 par value, 1,666,667 shares authorized; 0 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively

 

 

Treasury stock, 75,518 shares of common stock, at cost, at September 30, 2020 and 15,310 shares of common stock, at cost, at December 31, 2019

 

(2,246)

 

(723)

Additional paid-in capital

 

211,792

 

200,800

(Accumulated deficit)/retained earnings

 

(1,337)

 

17,584

Accumulated other comprehensive loss, net of tax

 

(13,110)

 

(4,871)

Total Stockholders’ Equity

 

195,100

 

212,791

Total Liabilities and Stockholders’ Equity

$

462,581

$

456,789

The accompanying notes are an integral part of these condensed consolidated financial statements.

5

Table of Contents

ANI PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

(in thousands, except per share amounts)

(unaudited)

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2020

    

2019

    

2020

    

2019

    

Net Revenues

$

52,979

$

51,337

$

151,223

$

158,581

Operating Expenses

 

  

 

  

 

  

 

  

Cost of sales (excluding depreciation and amortization)

 

20,118

 

15,002

 

62,617

 

45,359

Research and development

 

2,939

 

4,982

 

12,318

 

15,128

Selling, general, and administrative

 

15,725

 

14,357

 

50,621

 

41,829

Depreciation and amortization

 

11,358

 

9,473

 

33,739

 

35,048

Cortrophin pre-launch charges

37

195

8,275

195

Total Operating Expenses

 

50,177

 

44,009

 

167,570

 

137,559

Operating Income/(Loss)

 

2,802

 

7,328

 

(16,347)

 

21,022

Other Expense, net

 

  

 

  

 

  

 

  

Interest expense, net

 

(2,510)

 

(3,336)

 

(6,898)

 

(10,096)

Other expense, net

 

(229)

 

(33)

 

(335)

 

(117)

Income/(Loss) Before Benefit/(Provision) for Income Taxes

 

63

 

3,959

 

(23,580)

 

10,809

Benefit/(provision) for income taxes

 

371

 

(64)

 

4,667

 

120

Net Income/(Loss)

$

434

$

3,895

$

(18,913)

$

10,929

Basic and Diluted Earnings/(Loss) Per Share:

 

  

 

  

 

  

 

  

Basic Earnings/(Loss) Per Share

$

0.04

$

0.32

$

(1.58)

$

0.91

Diluted Earnings/(Loss) Per Share

$

0.04

$

0.32

$

(1.58)

$

0.89

Basic Weighted-Average Shares Outstanding

 

11,991

 

11,879

 

11,953

 

11,826

Diluted Weighted-Average Shares Outstanding

 

12,003

 

12,085

 

11,953

 

12,060

The accompanying notes are an integral part of these condensed consolidated financial statements.

6

Table of Contents

ANI PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Comprehensive (Loss)/Income

(in thousands)

(unaudited)

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2020

    

2019

    

2020

    

2019

    

Net income/(loss)

$

434

$

3,895

$

(18,913)

$

10,929

Other comprehensive income/(loss), net of tax:

 

  

 

  

 

  

 

  

Change in fair value of interest rate swap, net of tax

 

939

 

(1,024)

 

(8,239)

 

(5,658)

Total other comprehensive income/(loss), net of tax

 

939

 

(1,024)

 

(8,239)

 

(5,658)

Total comprehensive income/(loss), net of tax

$

1,373

$

2,871

$

(27,152)

$

5,271

The accompanying notes are an integral part of these condensed consolidated financial statements.

7

Table of Contents

ANI PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Changes in Stockholders’ Equity

For the Three Months Ended September 30, 2020 and 2019

(in thousands)

(unaudited)

    

Common

    

Common

    

Class C

    

Additional

    

Treasury

    

    

Accumulated

    

    

Stock

Stock

Special

Paid-in

Stock

Treasury

Other Comprehensive

Retained Earnings

Par Value

Shares

Stock

Capital

Shares

Stock

Gain/(Loss), Net of Tax

(Accumulated Deficit)/

Total

Balance, June 30, 2019

$

1

 

12,086

$

$

194,867

 

12

$

(723)

$

(5,013)

$

18,524

$

207,656

Stock-based Compensation Expense

 

 

 

 

2,470

 

 

 

 

 

2,470

Issuance of Common Shares upon Stock Option and ESPP Exercise

 

 

3

 

 

133

 

 

 

 

 

133

Change in Fair Value of Interest Rate Swap, Net of Tax

 

(1,024)

(1,024)

Net Income

 

 

 

 

 

 

 

 

3,895

 

3,895

Balance, September 30, 2019

$

1

 

12,089

$

$

197,470

 

12

$

(723)

$

(6,037)

$

22,419

$

213,130

Balance, June 30, 2020

$

1

 

12,380

$

$

209,409

 

58

$

(2,246)

$

(14,049)

$

(1,771)

$

191,344

Stock-based Compensation Expense

 

2,383

 

2,383

Treasury Stock Purchases for Restricted Stock Vests

 

18

Issuance of Restricted Stock Awards

 

43

Change in Fair Value of Interest Rate Swap, Net of Tax

 

939

939

Net Income

 

 

 

 

 

 

434

 

434

Balance, September 30, 2020

$

1

12,423

$

$

211,792

76

$

(2,246)

$

(13,110)

$

(1,337)

$

195,100

8

Table of Contents

ANI PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Changes in Stockholders’ Equity

For the Nine Months Ended September 30, 2020 and 2019

(in thousands)

(unaudited)

    

Common

    

Common

    

Class C

    

Additional

    

Treasury

    

    

Accumulated

    

    

Stock

Stock

Special

Paid-in

Stock

Treasury

Other Comprehensive

Retained Earnings

Par Value

Shares

Stock

Capital

Shares

Stock

Loss, Net of Tax

(Accumulated Deficit)/

Total

Balance, December 31, 2018

$

1

 

11,863

$

$

186,812

 

11

$

(659)

$

(379)

$

11,488

$

197,263

Cumulative Effect of Change in Accounting Principle, Net of Tax

 

 

 

 

 

 

 

 

2

 

2

Stock-based Compensation Expense

 

 

 

 

6,773

 

 

 

 

 

6,773

Treasury Stock Purchases for Restricted Stock Vests

 

 

 

 

 

17

 

(1,031)

 

 

 

(1,031)

Issuance of Common Shares upon Stock Option and ESPP Exercise

 

 

120

 

 

4,852

 

 

 

 

 

4,852

Issuance of Restricted Stock Awards

 

 

106

 

 

(967)

 

(16)

 

967

 

 

 

Change in Fair Value of Interest Rate Swap, Net of Tax

(5,658)

(5,658)

Net Income

10,929

10,929

Balance, September 30, 2019

$

1

12,089

$

$

197,470

12

$

(723)

$

(6,037)

$

22,419

$

213,130

Balance, December 31, 2019

$

1

 

12,105

$

$

200,800

 

15

$

(723)

$

(4,871)

$

17,584

$

212,791

Cumulative Effect of Change in Accounting Principle, Net of Tax

 

 

 

 

 

 

 

 

(8)

 

(8)

Stock-based Compensation Expense

 

 

 

 

10,543

 

 

 

 

 

10,543

Treasury Stock Purchases for Restricted Stock Vests

 

 

 

 

 

61

 

(1,523)

 

 

 

(1,523)

Issuance of Common Shares upon Stock Option and ESPP Exercise

 

 

14

 

 

449

 

 

 

 

 

449

Issuance of Restricted Stock Awards

 

304

 

 

 

 

 

 

 

Change in Fair Value of Interest Rate Swap, Net of Tax

 

 

 

 

 

 

(8,239)

 

 

(8,239)

Net Loss

(18,913)

(18,913)

Balance, September 30, 2020

$

1

12,423

$

$

211,792

76

$

(2,246)

$

(13,110)

$

(1,337)

$

195,100

The accompanying notes are an integral part of these condensed consolidated financial statements.

9

Table of Contents

ANI PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(in thousands)

(unaudited)

Nine Months Ended September 30, 

2020

2019

Cash Flows From Operating Activities

 

  

 

  

 

Net (loss)/income

$

(18,913)

$

10,929

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

 

  

 

  

Stock-based compensation

 

10,543

 

6,773

Deferred taxes

 

(9,032)

 

(6,433)

Depreciation and amortization

 

33,739

 

35,048

Acquired in-process research and development ("IPR&D")

 

3,753

 

2,653

Non-cash interest

 

1,288

 

5,679

Asset impairment charge

 

104

 

Changes in operating assets and liabilities:

 

 

  

Accounts receivable, net

 

(11,616)

 

(5,858)

Inventories, net

 

(1,151)

 

(5,671)

Prepaid expenses and other current assets

 

637

 

(510)

Accounts payable

 

(146)

 

2,130

Accrued royalties

 

1,004

 

(2,929)

Current income taxes, net

 

(545)

 

(5,836)

Accrued government rebates

 

2,777

 

210

Returned goods reserve

 

6,456

 

3,393

Accrued expenses, accrued compensation, and other

 

2,078

 

1,250

Net Cash and Cash Equivalents Provided by Operating Activities

 

20,976

 

40,828

Cash Flows From Investing Activities

 

  

 

  

Acquisition of product rights, IPR&D, and other related assets

 

(62,178)

 

(21,243)

Acquisition of property and equipment, net

 

(4,025)

 

(4,932)

Net Cash and Cash Equivalents Used in Investing Activities

 

(66,203)

 

(26,175)

Cash Flows From Financing Activities

 

  

 

  

Payments on Term Loan and Delayed Draw Term Loan agreements

 

(5,657)

 

(1,805)

Borrowings under Revolver agreement

15,000

Payments on Revolver agreement

(7,500)

 

Proceeds from stock option exercises and ESPP purchases

 

449

 

4,852

Treasury stock purchases for restricted stock vests

 

(1,523)

 

(1,031)

Net Cash and Cash Equivalents Provided by Financing Activities

 

769

 

2,016

Net Change in Cash and Cash Equivalents

 

(44,458)

 

16,669

Cash and cash equivalents, beginning of period

 

67,361

 

48,029

Cash and cash equivalents, end of period

$

22,903

$

64,698

Reconciliation of cash, cash equivalents, and restricted cash, beginning of period

 

  

 

  

Cash and cash equivalents

$

62,332

$

43,008

Restricted cash

 

5,029

 

5,021

Cash, cash equivalents, and restricted cash, beginning of period

$

67,361

$

48,029

Reconciliation of cash, cash equivalents, and restricted cash, end of period

 

  

 

  

Cash and cash equivalents

$

17,900

$

59,673

Restricted cash

 

5,003

 

5,025

Cash, cash equivalents, and restricted cash, end of period

$

22,903

$

64,698