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ACOR Acorda Therapeutics

Filed: 12 Nov 21, 4:07pm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

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

For the quarterly period ended September 30, 2021

OR

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

For the transition period from          to          

Commission File Number 001-31938

 

ACORDA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

13-3831168

(State or other jurisdiction of incorporation

or organization)

 

(I.R.S. Employer

Identification No.)

 

420 Saw Mill River Road, Ardsley, New York

 

10502

(Address of principal executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (914) 347-4300

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

 

Title of each class

 

Trading Symbol

 

Name of each exchange on which registered

 

 

Common Stock $0.001 par value per share

 

ACOR

 

Nasdaq Global Select 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 (§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 the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

 

Class

 

Outstanding at November 5, 2021

Common Stock, $0.001 par value per share

 

11,202,242 shares

 

 


 

 

ACORDA THERAPEUTICS, INC.

TABLE OF CONTENTS

 

 

 

Page

PART I—FINANCIAL INFORMATION

 

 

Item 1.

Financial Statements

 

1

 

Consolidated Balance Sheets as of September 30, 2021 (unaudited) and December 31, 2020

 

1

 

Consolidated Statements of Operations (unaudited) for the Three and Nine-month Periods Ended September 30, 2021 and 2020

 

2

 

Consolidated Statements of Comprehensive Income (Loss) (unaudited) for the Three and Nine-month Periods Ended September 30, 2021 and 2020

 

3

 

Consolidated Statements of Changes in Stockholders’ Equity (unaudited) for the Three and Nine-month Periods Ended September 30, 2021 and 2020

 

4

 

Consolidated Statements of Cash Flows (unaudited) for the Nine-month Periods Ended September 30, 2021 and 2020

 

6

 

Notes to Consolidated Financial Statements (unaudited)

 

7

Item 2.

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

 

25

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

40

Item 4.

Controls and Procedures

 

41

PART II—OTHER INFORMATION

 

 

Item 1.

Legal Proceedings

 

42

Item 1A.

Risk Factors

 

42

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

43

Item 5

Other Information

 

43

Item 6.

Exhibits

 

45

Signatures

 

 

46

 

 


 

 

This Quarterly Report on Form 10-Q contains forward‑looking statements relating to future events and our future performance 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. Stockholders are cautioned that such statements involve risks and uncertainties, including: We may not be able to successfully market Ampyra, Inbrija or any other products under development; the COVID-19 pandemic, including related restrictions on in-person interactions and travel, and the potential for illness, quarantines, and vaccine mandates to affect our management, employees or consultants or those that work for other companies we rely upon, could have a material adverse effect on our business operations or product sales; our ability to attract and retain key management and other personnel, or maintain access to expert advisors; our ability to raise additional funds to finance our operations, repay outstanding indebtedness or satisfy other obligations, and our ability to control our costs or reduce planned expenditures; risks associated with the trading of our common stock and our reverse stock split; risks related to our corporate restructurings, including our ability to outsource certain operations, realize expected cost savings and maintain the workforce needed for continued operations; risks associated with complex, regulated manufacturing processes for pharmaceuticals, which could affect whether we have sufficient commercial supply of Inbrija to meet market demand; our reliance on third-party manufacturers for the production of commercial supplies of Ampyra and Inbrija; third-party payers (including governmental agencies) may not reimburse for the use of Inbrija at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; reliance on collaborators and distributors to commercialize Inbrija and Ampyra outside the U.S.; competition for Inbrija and Ampyra, including increasing competition and accompanying loss of revenues in the U.S. from generic versions of Ampyra following our loss of patent exclusivity; the ability to realize the benefits anticipated from acquisitions, among other reasons because acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the risk of unfavorable results from future studies of Inbrija or from other research and development programs, or any other acquired or in-licensed programs; the occurrence of adverse safety events with our products; the outcome (by judgment or settlement) and costs of legal, administrative or regulatory proceedings, investigations or inspections, including, without limitation, collective, representative or class action litigation; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s beliefs and assumptions. All statements, other than statements of historical facts, included in this report regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make, and investors should not place undue reliance on these statements. In addition to the risks and uncertainties described above, we have included important factors in the cautionary statements included in this report and in our Annual Report on Form 10-K for the year ended December 31, 2020, particularly in the “Risk Factors” section (as updated by the disclosures in our subsequent quarterly reports, including this report), that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. Forward-looking statements in this report are made only as of the date hereof, and we do not assume any obligation to publicly update any forward-looking statements as a result of developments occurring after the date of this report.

We and our subsidiaries own several registered trademarks in the U.S. and in other countries. These registered trademarks include, in the U.S., the marks “Acorda Therapeutics,” our stylized Acorda Therapeutics logo, “Biotie Therapies,” “Ampyra,” “Inbrija,” and “ARCUS.” Also, our marks “Fampyra” and “Inbrija” are registered marks in the European Community Trademark Office and we have registrations or pending applications for these marks in other jurisdictions. Our trademark portfolio also includes several registered trademarks and pending trademark applications in the U.S. and worldwide for potential product names or for disease awareness activities. Third party trademarks, trade names, and service marks used in this report are the property of their respective owners.

 

 

 


 

 

PART I

Item 1.  Financial Statements

ACORDA THERAPEUTICS, INC. AND SUBSIDIARIES

Consolidated Balance Sheets

 

(In thousands, except share data)

 

September 30, 2021

 

 

December 31, 2020

 

 

 

(unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

36,168

 

 

$

71,369

 

Restricted cash

 

 

13,353

 

 

 

12,917

 

Trade accounts receivable, net of allowances of $1,245 and $1,266, as of

   September 30, 2021 and December 31, 2020, respectively

 

 

13,587

 

 

 

20,193

 

Prepaid expenses

 

 

11,192

 

 

 

14,807

 

Inventory, net

 

 

20,595

 

 

 

28,677

 

Assets held for sale

 

 

 

 

 

71,795

 

Other current assets

 

 

2,174

 

 

 

1,577

 

Total current assets

 

 

97,069

 

 

 

221,335

 

Property and equipment, net of accumulated depreciation

 

 

5,016

 

 

 

7,263

 

Intangible assets, net of accumulated amortization

 

 

343,731

 

 

 

366,981

 

Right of use asset, net of accumulated amortization

 

 

7,861

 

 

 

18,481

 

Restricted cash

 

 

12,399

 

 

 

18,609

 

Other assets

 

 

11

 

 

 

11

 

Total assets

 

$

466,087

 

 

$

632,680

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

15,500

 

 

$

12,155

 

Accrued expenses and other current liabilities

 

 

34,158

 

 

 

38,167

 

Current portion of loans payable

 

 

 

 

 

68,631

 

Current portion of liability related to sale of future royalties

 

 

7,452

 

 

 

8,731

 

Current portion of lease liabilities

 

 

9,316

 

 

 

7,944

 

Current portion of acquired contingent consideration

 

 

1,845

 

 

 

1,624

 

Total current liabilities

 

 

68,271

 

 

 

137,252

 

Convertible senior notes

 

 

147,447

 

 

 

137,619

 

Derivative liability

 

 

325

 

 

 

1,193

 

Non-current portion of acquired contingent consideration

 

 

41,155

 

 

 

46,576

 

Non-current portion of lease liabilities

 

 

4,287

 

 

 

17,200

 

Non-current portion of loans payable

 

 

27,929

 

 

 

28,555

 

Deferred tax liability

 

 

11,912

 

 

 

19,116

 

Non-current portion of liability related to sale of future royalties

 

 

 

 

 

6,526

 

Other non-current liabilities

 

 

286

 

 

 

688

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value. Authorized 1,000,000 shares at September 30,

   2021 and December 31, 2020; 0 shares issued as of September 30,

   2021 and December 31, 2020, respectively

 

 

 

 

 

 

Common stock, $0.001 par value. Authorized 61,666,666 shares at September 30,

   2021 and December 31, 2020; issued 11,193,741 and 9,475,631 shares,

   including those held in treasury, as of September 30, 2021 and

   December 31, 2020, respectively

 

 

11

 

 

 

9

 

Treasury stock at cost (5,543 shares at September 30, 2021 and

  December 31, 2020)

 

 

(638

)

 

 

(638

)

Additional paid-in capital

 

 

1,016,448

 

 

 

1,007,790

 

Accumulated deficit

 

 

(849,789

)

 

 

(766,403

)

Accumulated other comprehensive loss

 

 

(1,557

)

 

 

(2,803

)

Total stockholders’ equity

 

 

164,475

 

 

 

237,955

 

Total liabilities and stockholders’ equity

 

$

466,087

 

 

$

632,680

 

 

See accompanying Unaudited Notes to Consolidated Financial Statements

1


 

ACORDA THERAPEUTICS, INC. AND SUBSIDIARIES

Consolidated Statements of Operations

(unaudited)

 

(In thousands, except per share data)

 

Three-month period ended September 30, 2021

 

 

Three-month period ended September 30, 2020

 

 

Nine-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2020

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net product revenues

 

$

27,851

 

 

$

34,687

 

 

$

81,297

 

 

$

90,153

 

Milestone revenues

 

 

 

 

 

15,000

 

 

 

 

 

 

15,000

 

Royalty revenues

 

 

3,605

 

 

 

3,403

 

 

 

10,807

 

 

 

9,654

 

Total net revenues

 

 

31,456

 

 

 

53,090

 

 

 

92,104

 

 

 

114,807

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales

 

 

13,303

 

 

 

12,170

 

 

 

36,589

 

 

 

22,670

 

Research and development

 

 

1,931

 

 

 

5,729

 

 

 

9,054

 

 

 

18,689

 

Selling, general and administrative

 

 

29,623

 

 

 

39,935

 

 

 

95,959

 

 

 

119,700

 

Amortization of intangible assets

 

 

7,691

 

 

 

7,691

 

 

 

23,073

 

 

 

23,073

 

Asset impairment

 

 

 

 

 

 

 

 

 

 

 

4,131

 

Change in fair value of derivative liability

 

 

(288

)

 

 

(4,864

)

 

 

(868

)

 

 

(40,320

)

Changes in fair value of acquired contingent consideration

 

 

2,205

 

 

 

(23,608

)

 

 

(4,224

)

 

 

(33,455

)

Total operating expenses

 

 

54,465

 

 

 

37,053

 

 

 

159,583

 

 

 

114,488

 

Operating loss

 

 

(23,009

)

 

 

16,037

 

 

 

(67,479

)

 

 

319

 

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest and amortization of debt discount expense

 

 

(7,167

)

 

 

(7,760

)

 

 

(22,697

)

 

 

(22,810

)

Interest income

 

 

1

 

 

 

317

 

 

 

4

 

 

 

807

 

Other income (expense)

 

 

 

 

 

19

 

 

 

1

 

 

 

(16

)

Gain on disposal of property and equipment

 

 

 

 

 

200

 

 

 

 

 

 

200

 

Realized loss on foreign currency transactions

 

 

(1

)

 

 

(1

)

 

 

(4

)

 

 

(8

)

Total other expense, net

 

 

(7,167

)

 

 

(7,225

)

 

 

(22,696

)

 

 

(21,827

)

Income (loss) before taxes

 

 

(30,176

)

 

 

8,812

 

 

 

(90,175

)

 

 

(21,508

)

Benefit from (Provision for) income taxes

 

 

3,105

 

 

 

(1,465

)

 

 

6,788

 

 

 

4,962

 

Net income (loss)

 

$

(27,071

)

 

$

7,347

 

 

$

(83,387

)

 

$

(16,546

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share—basic

 

$

(2.43

)

 

$

0.92

 

 

$

(8.17

)

 

$

(2.08

)

Net income (loss) per share—diluted

 

$

(2.43

)

 

$

0.32

 

 

$

(8.17

)

 

$

(2.08

)

Weighted average common shares outstanding used in

   computing net loss per share—basic

 

 

11,131

 

 

 

7,960

 

 

 

10,204

 

 

 

7,960

 

Weighted average common shares outstanding used in

   computing net loss per share—diluted

 

 

11,131

 

 

 

27,700

 

 

 

10,204

 

 

 

7,960

 

 

See accompanying Unaudited Notes to Consolidated Financial Statements

2


 

ACORDA THERAPEUTICS, INC. AND SUBSIDIARIES

Consolidated Statements of Comprehensive Income (Loss)

(unaudited)

 

(In thousands)

Three-month period ended September 30, 2021

 

 

Three-month period ended September 30, 2020

 

 

Nine-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2020

 

Net income (loss)

$

(27,071

)

 

$

7,347

 

 

$

(83,387

)

 

$

(16,546

)

Other comprehensive income (loss), net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustment

 

276

 

 

 

(1,018

)

 

 

1,246

 

 

 

(1,096

)

Unrealized loss on available for sale debt securities

 

 

 

 

(45

)

 

 

 

 

 

(21

)

Other comprehensive income (loss), net of tax

 

276

 

 

 

(1,063

)

 

 

1,246

 

 

 

(1,117

)

Comprehensive income (loss)

$

(26,795

)

 

$

6,284

 

 

$

(82,141

)

 

$

(17,663

)

 

See accompanying Unaudited Notes to Consolidated Financial Statements

3


 

ACORDA THERAPEUTICS, INC. AND SUBSIDIARIES

Consolidated Statements of Changes in Stockholders’ Equity

(unaudited)

 

 

 

Common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(In thousands)

 

Number

of

shares

 

 

Par

value

 

 

Treasury stock

 

 

Additional

paid-in

capital

 

 

Accumulated

deficit

 

 

Accumulated

other

comprehensive (loss)

income

 

 

Total

stockholders

equity

 

Balance at December 31, 2020

 

 

9,476

 

 

$

9

 

 

$

(638

)

 

$

1,007,790

 

 

$

(766,403

)

 

$

(2,803

)

 

$

237,955

 

Compensation expense for

   issuance of stock options

   to employees

 

 

 

 

 

 

 

 

 

 

 

483

 

 

 

 

 

 

 

 

 

483

 

Compensation expense for

   issuance of restricted

   stock to employees

 

 

 

 

 

 

 

 

 

 

 

224

 

 

 

 

 

 

 

 

 

224

 

Other comprehensive income,

   net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,069

 

 

 

1,069

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(33,451

)

 

 

 

 

 

(33,451

)

Balance at March 31, 2021

 

 

9,476

 

 

$

9

 

 

$

(638

)

 

$

1,008,497

 

 

 

(799,854

)

 

$

(1,734

)

 

$

206,279

 

Compensation expense for

   issuance of stock options

   to employees

 

 

 

 

 

 

 

 

 

 

 

498

 

 

 

 

 

 

 

 

 

498

 

Compensation expense for

   issuance of restricted

   stock to employees

 

 

 

 

 

 

 

 

 

 

 

456

 

 

 

 

 

 

 

 

 

456

 

Interest payment for convertible notes

 

 

1,636

 

 

 

2

 

 

 

 

 

 

6,208

 

 

 

 

 

 

 

 

 

6,210

 

Other comprehensive loss, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(99

)

 

 

(99

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,864

)

 

 

 

 

 

(22,864

)

Balance at June 30, 2021

 

 

11,112

 

 

$

11

 

 

$

(638

)

 

$

1,015,659

 

 

$

(822,718

)

 

$

(1,833

)

 

$

190,481

 

Compensation expense for

   issuance of stock options

   to employees

 

 

 

 

 

 

 

 

 

 

 

455

 

 

 

 

 

 

 

 

 

455

 

Compensation expense and

   issuance of restricted

   stock to employees

 

 

82

 

 

 

 

 

 

 

 

 

334

 

 

 

 

 

 

 

 

 

334

 

Other comprehensive (loss) income,

   net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

276

 

 

 

276

 

Net income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(27,071

)

 

 

 

 

 

(27,071

)

Balance at September 30, 2021

 

 

11,194

 

 

$

11

 

 

$

(638

)

 

$

1,016,448

 

 

$

(849,789

)

 

$

(1,557

)

 

$

164,475

 

 

See accompanying Unaudited Notes to Consolidated Financial Statements

 

4


 

 

ACORDA THERAPEUTICS, INC. AND SUBSIDIARIES

Consolidated Statements of Changes in Stockholders’ Equity (Continued)

(unaudited)

 

 

 

Common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(In thousands)

 

Number

of

shares

 

 

Par

value

 

 

Treasury stock

 

 

Additional

paid-in

capital

 

 

Accumulated

deficit

 

 

Accumulated

other

comprehensive (loss)

income

 

 

Total

stockholders

equity

 

Balance at December 31, 2019

 

 

7,964

 

 

$

8

 

 

$

(638

)

 

$

979,428

 

 

$

(666,809

)

 

$

(1,169

)

 

$

310,820

 

Compensation expense for

   issuance of stock options

   to employees

 

 

 

 

 

 

 

 

 

 

 

1,976

 

 

 

 

 

 

 

 

 

1,976

 

Compensation expense for

   issuance of restricted

   stock to employees

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

350

 

 

 

350

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(6,472

)

 

 

 

 

 

(6,472

)

Balance at March 31, 2020

 

 

7,965

 

 

$

8

 

 

$

(638

)

 

$

981,404

 

 

$

(673,281

)

 

$

(819

)

 

$

306,674

 

Compensation expense for

   issuance of stock options

   to employees

 

 

 

 

 

 

 

 

 

 

 

2,056

 

 

 

 

 

 

 

 

 

2,056

 

Other comprehensive loss, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(404

)

 

 

(404

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(17,421

)

 

 

 

 

 

(17,421

)

Balance at June 30, 2020

 

 

7,965

 

 

 

8

 

 

 

(638

)

 

 

983,460

 

 

 

(690,702

)

 

 

(1,223

)

 

 

290,905

 

Compensation expense for

   issuance of stock options

   to employees

 

 

 

 

 

 

 

 

 

 

 

2,480

 

 

 

 

 

 

 

 

 

2,480

 

Compensation expense for

   issuance of restricted

   stock to employees

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reclassification of derivative liability to equity, net of tax of $4.4 million

 

 

 

 

 

 

 

 

 

 

 

13,862

 

 

 

 

 

 

 

 

 

13,862

 

Other comprehensive (loss) income,

   net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,063

)

 

 

(1,063

)

Net income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7,347

 

 

 

 

 

 

7,347

 

Balance at September 30, 2020

 

 

7,965

 

 

$

8

 

 

$

(638

)

 

$

999,802

 

 

$

(683,355

)

 

$

(2,286

)

 

$

313,531

 

 

See accompanying Unaudited Notes to Consolidated Financial Statements

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5


 

 

ACORDA THERAPEUTICS, INC. AND SUBSIDIARIES

Consolidated Statements of Cash Flows

(unaudited)

 

(In thousands)

 

Nine-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2020

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(83,387

)

 

$

(16,546

)

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

   operating activities:

 

 

 

 

 

 

 

 

Share-based compensation expense

 

 

2,515

 

 

 

6,512

 

Amortization of net premiums and discounts on investments

 

 

 

 

 

(28

)

Amortization of debt discount and debt issuance costs

 

 

12,672

 

 

 

12,219

 

Depreciation and amortization expense

 

 

25,482

 

 

 

30,919

 

Asset impairment

 

 

 

 

 

4,131

 

Change in acquired contingent consideration obligation

 

 

(4,224

)

 

 

(33,455

)

Non-cash royalty revenue

 

 

(8,889

)

 

 

(8,496

)

Deferred tax (benefit) provision

 

 

(6,788

)

 

 

8,801

 

Change in derivative liability

 

 

(868

)

 

 

(40,320

)

Gain on disposal of property and equipment

 

 

 

 

 

(200

)

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

Decrease in accounts receivable

 

 

6,606

 

 

 

8,698

 

Decrease (increase) in prepaid expenses and other current assets

 

 

2,629

 

 

 

(16,712

)

Decrease (increase) in inventory

 

 

5,813

 

 

 

(4,899

)

Decrease in other assets

 

 

 

 

 

17

 

Increase (decrease) in accounts payable, accrued expenses and other current

   liabilities

 

 

4,875

 

 

 

(13,391

)

Increase (decrease) in other non-current liabilities

 

 

(1,024

)

 

 

296

 

Net cash used in operating activities

 

 

(44,588

)

 

 

(62,454

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(164

)

 

 

(4,074

)

Purchases of intangible assets

 

 

(26

)

 

 

 

Proceeds from maturities of investments

 

 

 

 

 

58,415

 

Net cash (used in) provided by investing activities

 

 

(190

)

 

 

54,341

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

   Repayment of Convertible Senior Notes Due 2021

 

 

(69,000

)

 

 

 

Debt issuance costs

 

 

 

 

 

(1,071

)

Proceeds from sale of Chelsea facility, net

 

 

73,969

 

 

 

 

Repayment of loans payable

 

 

(655

)

 

 

(597

)

Net cash provided by (used in) financing activities

 

 

4,314

 

 

 

(1,668

)

Effect of exchange rate changes on cash, cash equivalents and restricted cash

 

 

(511

)

 

 

519

 

Net decrease in cash, cash equivalents and restricted cash

 

 

(40,975

)

 

 

(9,262

)

Cash, cash equivalents and restricted cash at beginning of period

 

 

102,895

 

 

 

105,192

 

Cash, cash equivalents and restricted cash at end of period

 

$

61,920

 

 

$

95,930

 

Supplemental disclosure:

 

 

 

 

 

 

 

 

Cash paid for interest

 

$

6

 

 

$

6,067

 

Cash paid for taxes

 

 

46

 

 

 

250

 

 

See accompanying Unaudited Notes to Consolidated Financial Statements

 

 

6


 

 

ACORDA THERAPEUTICS, INC. AND SUBSIDIARIES

Notes to Consolidated Financial Statements

(unaudited)

(1) Organization and Business Activities

Acorda Therapeutics, Inc. (“Acorda” or the “Company”) is a biopharmaceutical company focused on developing therapies that restore function and improve the lives of people with neurological disorders.

The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information, Accounting Standards Codification (ASC) Topic 270-10 and with the instructions to Form 10-Q. Accordingly, these financial statements do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, all adjustments considered necessary for a fair presentation have been included in the interim periods presented and all adjustments are of a normal recurring nature. The Company has evaluated subsequent events through the date of this filing. Operating results for the three and nine-month periods ended September 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021. When used in these notes, the terms “Acorda” or “the Company” mean Acorda Therapeutics, Inc. The December 31, 2020 consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. You should read these unaudited interim condensed consolidated financial statements in conjunction with the consolidated financial statements and footnotes included in the Company's Annual Report on Form 10-K, for the year ended December 31, 2020.

(2) Summary of Significant Accounting Policies

Our significant accounting policies are detailed in our Annual Report on Form 10-K for the year ended December 31, 2020. Effective January 1, 2021, the Company adopted ASU 2019-12, “Simplifying the Accounting for Income Taxes” (Topic 740). Other than the adoption of the new accounting guidance, our significant accounting policies have not changed materially from December 31, 2020.

Basis of Presentation

On December 31, 2020, we filed an amendment to our Certificate of Incorporation which effected, as of 4:01 p.m. Eastern Time on December 31, 2020, a 1-for-6 reverse stock split of the shares of our outstanding common stock and proportionate reduction in the number of authorized shares of our common stock from 370,000,000 to 61,666,666. Our common stock began trading on a split-adjusted basis on The Nasdaq Global Select Market commencing upon market open on January 4, 2021. The common stock continued to trade under the symbol “ACOR” after the reverse stock split became effective. The reverse stock split applied equally to all outstanding shares of the common stock and did not modify the rights or preferences of the common stock. As such, all figures in this report relating to shares of our common stock (such as share amounts, per share amounts, and conversion rates and prices), including in the financial statements and accompanying notes to the financial statements, have been retroactively restated to reflect the 1-for-6 reverse stock split of our common stock.

Restricted Cash

The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the statement of financial position that sum to the total of the same amounts shown in the statement of cash flows:

 

Nine-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2020

 

(In thousands)

Beginning of period

 

 

End of period

 

 

Beginning of period

 

 

End of period

 

Cash and cash equivalents

$

71,369

 

 

$

36,168

 

 

$

62,085

 

 

$

57,910

 

Restricted cash

 

12,917

 

 

 

13,353

 

 

 

12,836

 

 

 

13,200

 

Restricted cash non-current

 

18,609

 

 

 

12,399

 

 

 

30,270

 

 

 

24,819

 

Total Cash, cash equivalents and restricted cash per statement of cash flows

$

102,895

 

 

$

61,920

 

 

$

105,191

 

 

$

95,929

 

7


 

 

 

Restricted cash represents an escrow account with funds to maintain the interest payments for an amount equal to all remaining scheduled interest payments on the outstanding convertible senior secured notes due 2024 through the interest payment date of June 1, 2023; and a bank account with funds to cover the Company’s self-funded employee health insurance. At September 30, 2021, the Company also held $0.3 million of restricted cash related to cash collateralized standby letters of credit in connection with obligations under facility leases and $12.1 million related to the escrow account for interest payments included in restricted cash non-current in the consolidated balance sheet due to the long-term nature of the letters of credit and interest payments. (see Note 10).

Inventory

The major classes of inventory were as follows:

(In thousands)

 

September 30, 2021

 

 

December 31, 2020

 

Raw materials

 

$

969

 

 

$

3,434

 

Work-in-progress

 

 

 

 

 

6,602

 

Finished goods

 

 

19,626

 

 

 

18,641

 

Total

 

$

20,595

 

 

$

28,677

 

The Company reviews inventory, including inventory purchase commitments, for slow moving or obsolete amounts based on expected product sales volume and provides reserves against the carrying amount of inventory as appropriate. On February 10, 2021, we completed the sale of our Chelsea, Massachusetts manufacturing operations to Catalent Pharma Solutions. In connection with the sale of the manufacturing operations, we transferred approximately $2.3 million of raw materials to Catalent (see Note 12). Additionally, in reviewing the inventory for slow moving or obsolete amounts we recorded a charge of $1.3 million for the remaining work-in-progress inventory that was scrapped or discarded during the nine-month period ended September 30, 2021.

Foreign Currency Translation

The functional currency of operations outside the United States of America is deemed to be the currency of the local country, unless otherwise determined that the United States dollar would serve as a more appropriate functional currency given the economic operations of the entity. Accordingly, the assets and liabilities of the Company’s foreign subsidiary, Biotie, are translated into United States dollars using the period-end exchange rate; income and expense items are translated using the average exchange rate during the period; and equity transactions are translated at historical rates. Cumulative translation adjustments are reflected as a separate component of equity. Foreign currency transaction losses and gains are recognized in the period incurred and are reported as other (expense) income, net in the statement of operations.

Segment and Geographic Information

The Company is managed and operated as 1 business which is focused on developing therapies that restore function and improve the lives of people with neurological disorders. The entire business is managed by a single management team that reports to the Chief Executive Officer, who is the chief operating decision maker. The Company does not operate separate lines of business with respect to any of its products or product candidates and the Company does not prepare discrete financial information with respect to separate products or product candidates or by location. Accordingly, the Company views its business as 1 reportable operating segment. Net product revenues reported are derived from the sales of Inbrija and Ampyra in the U.S. for the three and nine-month periods ended September 30, 2021 and 2020.

Impairment of Long-Lived Assets

The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful lives of its long-lived assets, including identifiable intangible assets subject to amortization and property plant and equipment, may warrant revision or that the carrying value of the assets may be impaired. Factors the Company considers important that could trigger an impairment review include significant changes in the use of any assets, changes in historical trends in operating performance, changes in projected operating performance, results of clinical trials, stock price,

8


 

loss of a major customer and significant negative economic trends.  The decline in the trading price of the Company’s common stock during the quarter ended June 30, 2021, and related decrease in the Company’s market capitalization, was determined to be a triggering event in connection with the Company’s review of the recoverability of its long-lived assets for the three-month period ended June 30, 2021. The Company performed a recoverability test as of June 30, 2021 using the undiscounted cash flows, which are the sum of the future undiscounted cash flows expected to be derived from the direct use of the long-lived assets to the carrying value of the long-lived assets. Estimates of future cash flows were based on the Company’s own assumptions about its own use of the long-lived assets. The cash flow estimation period was based on the long-lived assets’ estimated remaining useful life to the Company. After performing the recoverability test, the Company determined that the undiscounted cash flows exceeded the carrying value and the long-lived assets were not impaired. Changes in these assumptions and resulting valuations or further declines in our stock price could result in future long-lived asset impairment charges. Management will continue to monitor any changes in circumstances for indicators of impairment. Any write-downs are treated as permanent reductions in the carrying amount of the assets.

Liquidity

  The Company’s ability to meet its future operating requirements, repay its liabilities, and meet its other obligations are dependent upon a number of factors, including its ability to generate cash from product sales, reduce planned expenditures, and obtain additional financing. If the Company is unable to generate sufficient cash flow from the sale of its products, it will be required to adopt one or more alternatives, subject to the restrictions contained in the indenture governing its convertible senior secured notes due 2024, such as further reducing expenses, selling assets, restructuring debt, or obtaining additional equity capital on terms that may be onerous and which are likely to be highly dilutive. Also, the Company’s ability to raise additional capital and repay or restructure its indebtedness will depend on the capital markets and its financial condition at such time, among other factors. In addition, financing may not be available when needed, at all, on terms acceptable to us or in accordance with the restrictions described above. As a result of these factors, the Company may not be able to engage in any of the alternative activities, or engage in such activities on desirable terms, which could harm the Company’s business, financial condition and results of operations, as well as result in a default on the Company’s debt obligations. If the Company is unable to take these actions, it may be forced to significantly alter its business strategy, substantially curtail its current operations, or cease operations altogether.

At September 30, 2021, the Company had $36.2 million of cash and cash equivalents, compared to $71.4 million at December 31, 2020. The Company’s September 30, 2021 cash and cash equivalents balance does not include restricted cash, currently held in escrow under the terms of its convertible senior secured notes due 2024, which may potentially be released from escrow if the Company pays interest on those notes using shares of its common stock. The Company incurred a net loss of $83.4 million for the nine-month period ended September 30, 2021.

Based on the Company’s cash and cash equivalents at September 30, 2021, and the Company’s obligations that are due within the next twelve months, management has concluded that there is no substantial doubt regarding the Company’s ability to meet its obligations within one year after the date the consolidated financial statements included in this report are issued.

Subsequent Events

Subsequent events are defined as those events or transactions that occur after the balance sheet date, but before the financial statements are filed with the Securities and Exchange Commission. The Company completed an evaluation of the impact of any subsequent events through the date these financial statements were issued, and determined there were no subsequent events that required disclosure or adjustment in these financial statements. 

Accounting Pronouncements Adopted

In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes. The ASU enhances and simplifies various aspects of the income tax accounting guidance in ASC 740 and removes certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocation and calculating income taxes in interim periods. The ASU also adds guidance to reduce complexity in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group. This ASU is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years with early adoption permitted. The Company adopted this guidance effective January 1, 2021. The adoption of this guidance did not have a significant impact on the consolidated financial statements.

9


 

Accounting Pronouncements Not Yet Adopted

In March 2020, the FASB issued ASU 2020-03, “Codification Improvements to Financial Instruments”: The amendments in this update are to clarify, correct errors in, or make minor improvements to a variety of ASC topics. The changes in ASU 2020-03 are not expected to have a significant effect on current accounting practices. The ASU improves various financial instrument topics in the Codification to increase stakeholder awareness of the amendments and to expedite the improvement process by making the Codification easier to understand and easier to apply by eliminating inconsistencies and providing clarifications. The ASU is effective for smaller reporting companies for fiscal years beginning after December 15, 2022 with early application permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements.

In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This update simplifies the accounting for convertible instruments by eliminating the cash conversion and beneficial conversion feature models which require separate accounting for embedded conversion features. This update also amends the guidance for the derivatives scope exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusions and requires the application of the if-converted method for calculating diluted earnings per share. ASU 2020-06 is effective for smaller reporting companies for fiscal periods beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements.

In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt – Modifications and Extinguishments (Subtopic 470-50), Compensation – Stock Compensation (Topic 718), and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. The FASB is issuing this update to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. The amendments in this update are effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements.

(3) Revenue

In accordance with ASC 606, the Company recognizes revenue when the customer obtains control of a promised good or service, in an amount that reflects the consideration to which the Company expects to be entitled in exchange for the good or service. ASC 606 requires entities to record a contract asset when a performance obligation has been satisfied or partially satisfied, but the amount of consideration has not yet been received because the receipt of the consideration is conditioned on something other than the passage of time. ASC 606 also requires an entity to present a revenue contract as a contract liability in instances when a customer pays consideration, or an entity has a right to an amount of consideration that is unconditional (e.g. receivable), before the entity transfers a good or service to the customer. We did not have any contract assets or any contract liabilities as of September 30, 2021 and 2020.

The following table disaggregates our revenue by major source. The Company’s Royalty Revenue set forth below relates to Fampyra royalties payable under the Company’s License and Collaboration Agreement with Biogen. See Note 9 for additional information on the Company’s related payment obligation to HealthCare Royalty Partners, or HCRP, in connection with a 2017 royalty purchase agreement with HCRP.

 

10


 

 

(In thousands)

Three-month period ended September 30, 2021

 

 

Three-month period ended September 30, 2020

 

 

Nine-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2020

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net product revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ampyra

$

20,026

 

 

$

27,343

 

 

$

62,035

 

 

$

73,546

 

Inbrija

 

7,804

 

 

 

5,833

 

 

 

19,240

 

 

 

14,901

 

Other

 

21

 

 

 

1,511

 

 

 

22

 

 

 

1,706

 

Total net product revenues

 

27,851

 

 

 

34,687

 

 

 

81,297

 

 

 

90,153

 

Milestone revenues

 

 

 

 

15,000

 

 

 

 

 

 

15,000

 

Royalty revenues

 

3,605

 

 

 

3,403

 

 

 

10,807

 

 

 

9,654

 

Total net revenues

$

31,456

 

 

$

53,090

 

 

$

92,104

 

 

$

114,807

 

 

(4) Share-based Compensation

During the three‑month periods ended September 30, 2021 and 2020, the Company recognized share-based compensation expense of $0.9 million and $2.5 million, respectively. During the nine-month periods ended September 30, 2021 and 2020, the Company recognized share-based compensation expense of $2.5 and $6.5 million, respectively. Activity in options and restricted stock during the nine-month period ended September 30, 2021 and related balances outstanding as of that date are reflected below. The weighted average fair value per share of options granted to employees for the three-month periods ended September 30, 2021 and 2020 were approximately $2.56 and $2.31, respectively. The weighted average fair value per share of options granted to employees for the nine-month periods ended September 30, 2021 and 2020 were approximately $2.58 and $3.96, respectively.

The following table summarizes share-based compensation expense included within the consolidated statements of operations:

 

 

 

For the three-month period ended September 30,

 

 

For the nine-month period ended September 30,

 

(In thousands)

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Research and development expense

 

$

225

 

 

$

555

 

 

$

599

 

 

$

1,418

 

Selling, general and administrative expense

 

 

627

 

 

 

1,832

 

 

 

1,898

 

 

 

4,834

 

Cost of Sales

 

 

2

 

 

 

93

 

 

 

18

 

 

 

260

 

Total

 

$

854

 

 

$

2,480

 

 

$

2,515

 

 

$

6,512

 

 

A summary of share-based compensation activity for the nine-month period ended September 30, 2021 is presented below:

Stock Option Activity

 

 

 

Number of

Shares

(In thousands)

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Remaining

Contractual

Term

 

 

Intrinsic

Value

(In thousands)

 

Balance at January 1, 2021

 

 

1,331

 

 

$

127.13

 

 

 

 

 

 

 

 

 

Granted

 

 

61

 

 

 

3.78

 

 

 

 

 

 

 

 

 

Cancelled

 

 

(309

)

 

 

109.27

 

 

 

 

 

 

 

 

 

Exercised

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2021

 

 

1,083

 

 

$

125.27

 

 

 

4.2

 

 

$

43

 

Vested and expected to vest at

    September 30, 2021

 

 

1,082

 

 

$

125.33

 

 

 

4.2

 

 

$

42

 

Vested and exercisable at

    September 30, 2021

 

 

1,001

 

 

$

133.65

 

 

 

3.9

 

 

$

13

 

11


 

 

Restricted Stock and Performance Stock Unit Activity

 

(In thousands)

 

 

 

 

Restricted Stock and Performance Stock Units

 

Number of Shares

 

Nonvested at January 1, 2021

 

 

31

 

Granted

 

 

261

 

Vested

 

 

(97

)

Forfeited

 

 

(53

)

Nonvested at September 30, 2021

 

 

142

 

 

Unrecognized compensation cost for unvested stock options, restricted stock awards, and restricted stock units as of September 30, 2021 totaled $2.6 million and is expected to be recognized over a weighted average period of approximately 0.9 years.

During the three and nine‑month periods ended September 30, 2021, the Company did 0t make any repurchases of shares.

(5) Loss Per Share

The following table sets forth the computation of basic and diluted loss per share for the three and nine-month periods ended September 30, 2021 and 2020:

 

(In thousands, except per share data)

 

Three-month period ended September 30, 2021

 

 

Three-month period ended September 30, 2020

 

 

Nine-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2020

 

Basic and diluted

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)—basic

 

$

(27,071

)

 

$

7,347

 

 

$

(83,387

)

 

$

(16,546

)

Plus: Dilutive effect of convertible notes, net of tax

 

 

 

 

 

 

1,476

 

 

 

 

 

 

 

Net income (loss)—diluted

 

$

(27,071

)

 

$

8,823

 

 

$

(83,387

)

 

$

(16,546

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding used in

   computing net loss per share—basic

 

 

11,131

 

 

 

7,960

 

 

 

10,204

 

 

 

7,960

 

Plus: net effect of dilutive stock options and restricted

   common shares

 

 

 

 

 

19,740

 

 

 

 

 

 

 

Weighted average common shares outstanding used in

   computing net loss per share—diluted

 

 

11,131

 

 

 

27,700

 

 

 

10,204

 

 

 

7,960

 

Net income (loss) per share—basic

 

$

(2.43

)

 

$

0.92

 

 

$

(8.17

)

 

$

(2.08

)

Net income (loss) per share—diluted

 

$

(2.43

)

 

$

0.32

 

 

$

(8.17

)

 

$

(2.08

)

 

Securities that could potentially be dilutive are excluded from the computation of diluted loss per share when a loss from continuing operations exists or when the exercise price exceeds the average closing price of the Company’s common stock during the period, because their inclusion would result in an anti-dilutive effect on per share amounts.

The following amounts were not included in the calculation of net loss per diluted share because their effects were anti-dilutive:

 

(In thousands)

 

Three-month period ended September 30, 2021

 

 

Three-month period ended September 30, 2020

 

 

Nine-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2020

 

Denominator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options and restricted common shares

 

 

1,370

 

 

 

1,465

 

 

 

1,368

 

 

 

1,423

 

 

Performance share units are excluded from the calculation of net loss per diluted share as the performance criteria has not been met for the three and nine-month periods ended September 30, 2021 and 2020. The impact of the convertible senior notes was determined to be anti-dilutive and excluded from the calculation of net loss per diluted share for the three and nine-

12


 

month periods ended September 30, 2021. Additionally, for the three and nine month periods ended September 30, 2020, the impact of our outstanding convertible notes was determined to be dilutive and anti-dilutive, respectively.  

(6) Income Taxes

The Company’s effective income tax rate differs from the U.S. statutory rate primarily due to an increase in the valuation allowance and expense recorded on the equity forfeiture.

For the three-month periods ended September 30, 2021 and 2020, the Company recorded a benefit of $3.1 million and a provision of $(1.5) million for income taxes, respectively. The effective income tax rates for the Company for the three-month periods ended September 30, 2021 and 2020 were 10.2% and 16.6%, respectively. The variances in the effective tax rates for the three-month period ended September 30, 2021 as compared to the three-month period ended September 30, 2020 was due primarily to the valuation allowance recorded on deferred tax assets for which no tax benefit can be recognized and the benefit recorded on the net operating loss carryback under the CARES Act recorded at 21% to recover taxes paid at the previous statutory rate of 35%.

For the nine-month periods ended September 30, 2021 and 2020, the Company recorded a benefit of $6.8 million and a benefit of $5.0 million for income taxes, respectively. The effective income tax rates for the Company for the nine-month periods ended September 30, 2021 and 2020 were 7.53% and 23.1%, respectively. The variance in effective tax rates for the nine-month period ended September 30, 2021 as compared to the nine-month period ended September 30, 2020 was due primarily to the valuation allowance recorded on deferred tax assets for which no tax benefit can be recognized, forfeitures of equity based awards and the benefit recorded on the net operating loss carryback under the CARES Act recorded at 21% to recover taxes paid at the previous statutory rate of 35%.

The Company continues to evaluate the realizability of its deferred tax assets on a quarterly basis and will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation, rulings by relevant tax authorities, the progress of ongoing tax audits and the regulatory approval of products currently under development. Any changes to the valuation allowance or deferred tax assets and liabilities in the future would impact the Company's income taxes.

The Company was notified during the first quarter of 2021 that it is being audited by the state of Massachusetts for the tax years 2018 and 2019. There have been no proposed adjustments at this stage of the examination.

The Company also has an ongoing state examination in New Jersey which for the tax periods, 2015 – 2018. There have been no proposed adjustments at this stage of the examination.  The Minnesota examinations for 2016 and 2017 were closed during the quarter with no changes.

13


 

(7) Fair Value Measurements

The following table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis as of September 30, 2021 and December 31, 2020 and indicates the fair value hierarchy of the valuation techniques utilized to determine such fair value. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are observable, such as quoted prices, interest rates, exchange rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability. The Company’s Level 1 assets consist of investments in a Treasury money market fund and U.S. government securities. The Company’s level 2 assets consist of investments in corporate bonds and commercial paper which are categorized as short-term investments for investments with original maturities between three months and one year. The Company’s Level 3 liabilities represent acquired contingent consideration related to the acquisition of Civitas which are valued using a probability weighted discounted cash flow valuation approach and derivative liabilities related to conversion options for the convertible senior notes due December 2024 which are valued using a binomial model. For assets and liabilities not accounted for at fair value, the carrying values of these accounts approximates their fair values at September 30, 2021, except for the fair value of the Company’s convertible senior notes due December 2024, which was approximately $167.7 million as of September 30, 2021. The Company estimates the fair value of its notes utilizing market quotations for the debt (Level 2).

 

(In thousands)

 

Level 1

 

 

Level 2

 

 

Level 3

 

September 30, 2021

 

 

 

 

 

 

 

 

 

 

 

 

Assets Carried at Fair Value:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

12,192

 

 

$

 

 

$

 

Corporate bonds

 

 

 

 

 

 

 

 

 

Liabilities Carried at Fair Value:

 

 

 

 

 

 

 

 

 

 

 

 

Acquired contingent consideration

 

 

 

 

 

 

 

 

43,000

 

Derivative liability - conversion option

 

 

 

 

 

 

 

 

325

 

December 31, 2020

 

 

 

 

 

 

 

 

 

 

 

 

Assets Carried at Fair Value:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

36,693

 

 

$

 

 

$

 

Commercial paper

 

 

 

 

 

 

 

 

 

Corporate bonds

 

 

 

 

 

 

 

 

 

Liabilities Carried at Fair Value:

 

 

 

 

 

 

 

 

 

 

 

 

Acquired contingent consideration

 

 

 

 

 

 

 

 

48,200

 

Derivative liability - conversion option

 

 

 

 

 

 

 

 

1,193

 

 

The following table presents additional information about liabilities measured at fair value on a recurring basis and for which the Company utilizes Level 3 inputs to determine fair value.

Acquired contingent consideration

 

(In thousands)

 

Three-month period ended September 30, 2021

 

 

Three-month period ended September 30, 2020

 

 

Nine-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2020

 

Acquired contingent consideration:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, beginning of period

 

$

41,200

 

 

$

70,000

 

 

$

48,200

 

 

$

80,300

 

Fair value change to contingent consideration

   included in the statement of operations

 

 

2,205

 

 

 

(23,608

)

 

 

(4,224

)

 

 

(33,455

)

Royalty payments

 

 

(405

)

 

 

(292

)

 

 

(976

)

 

 

(745

)

Balance, end of period

 

$

43,000

 

 

$

46,100

 

 

$

43,000

 

 

$

46,100

 

 

14


 

 

The Company estimates the fair value of its acquired contingent consideration using a probability weighted discounted cash flow valuation approach based on estimated future sales expected from Inbrija (levodopa inhalation powder), an FDA approved drug for the treatment of OFF periods in Parkinson’s disease. Using this approach, expected probability adjusted future cash flows are calculated over the expected life of the agreement and discounted to estimate the current value of the liability at the period end date. Some of the more significant assumptions made in the valuation include (i) the estimated revenue forecast for Inbrija, (ii) probabilities of success, and (iii) discount periods and rate. The milestone payments ranged from $1.0 million to $22.0 million for Inbrija. The discount rate used in the valuation was 20.5% for the three and nine-month periods ended September 30, 2021. The valuation is performed quarterly and changes in the fair value of the contingent consideration are included in the statement of operations. For the three and nine-month periods ended September 30, 2021 and 2020, changes in the fair value of the acquired contingent consideration were primarily due to updates to certain revenue and expense forecast assumptions.

The acquired contingent consideration is classified as a Level 3 liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for the various inputs to the valuation approach, including but not limited to, assumptions involving sales estimates for Inbrija and estimated discount rates, the estimated fair value could be significantly higher or lower than the fair value determined.

Derivative Liability-Conversion Option

The following table represents a reconciliation of the derivative liability recorded in connection with the issuance of the convertible senior secured notes due 2024:

(In thousands)

Three-month period ended September 30, 2021

 

 

Three-month period ended September 30, 2020

 

 

Nine-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2020

 

Derivative Liability-Conversion Option

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, beginning of period

$

613

 

 

$

23,953

 

 

$

1,193

 

 

$

59,409

 

Fair value adjustment

 

(288

)

 

 

(4,864

)

 

 

(868

)

 

 

(40,320

)

Fair value re-classification to shareholder's equity

 

 

 

 

(18,257

)

 

 

 

 

 

(18,257

)

Balance, end of period

$

325

 

 

$

832

 

 

$

325

 

 

$

832

 

During 2019, a derivative liability was initially recorded as a result of the issuance of the 6.00% Convertible Senior Secured Notes due 2024 (see Note 10). The fair value measurement of the derivative liability is classified as Level 3 under the fair value hierarchy as it has been valued using certain unobservable inputs. These inputs include: (1) share price as of the valuation date, (2) assumed timing of conversion of the Notes, (3) historical volatility of the share price, and (4) the risk-adjusted discount rate used to present value the probability-weighted cash flows. Significant increases or decreases in any of those inputs in isolation could result in a significantly lower or higher fair value measurement. The fair value of the derivative liability was determined using a binomial model that calculates the fair value of the Notes with the conversion feature as compared to the fair value of the Notes without the conversion feature, with the difference representing the value of the conversion feature, or the derivative liability. There are several embedded features within the Notes which, upon issuance, did not meet the conditions for equity classification. As a result, these features were aggregated together and recorded as a derivative liability conversion option. The derivative liability conversion feature is measured at fair value on a quarterly basis and changes in the fair value will be recorded in the consolidated statement of operations. The Company received stockholder approval on August 28, 2020 to increase the number of authorized shares of the Company’s common stock from 13,333,333 shares to 61,666,666 shares. As a result of the share approval, the Company determined that multiple embedded conversion options met the conditions for equity classification. The Company performed a valuation of these conversion options as of September 17, 2020, which was the date the Company completed certain securities registration obligations. The resulting fair value of these conversion options was calculated to be  $18.3 million which was reclassified to equity and presented in the statement of stockholder’s equity as of September 30, 2020 net of the $4.4 million tax impact. The equity component is not re-measured as long as it continues to meet the conditions for equity classification. The Company performed a valuation of the derivative liability related to certain embedded conversion features that are precluded from equity classification. The fair value of these conversion features was calculated to be $0.3 million as of September 30, 2021. Key inputs used in the calculation of the fair value include stock price, volatility, risky (bond) rate, and the last observed bond price during the nine-month period ended September 30, 2021.

15


 

(8) Investments

There were 0 available-for-sale investments at September 30, 2021 and December 31, 2020, respectively. 

Short-term investments with maturities of three months or less from date of purchase have been classified as cash equivalents, and amounted to approximately $12.2 million and $36.7 million as of September 30, 2021 and December 31, 2020, respectively. There were 0 short-term investments will original maturities of greater than 3 months but less than 1 year as of September 30, 2021 and December 31, 2020, respectively. Additionally, there were no short-term investments in an unrealized loss position as of September 30, 2021 and December 31, 2020, respectively. Long-term investments have original maturities of greater than 1 year. There were 0 investments classified as long-term at September 30, 2021 or December 31, 2020. The Company has determined that there were no other-than-temporary declines in the fair values of its investments as of September 30, 2021 as the Company does not intend to sell its investments and it is not more likely than not that the Company will be required to sell its investments prior to the recovery of its amortized cost basis.

Unrealized holding gains and losses, which relate to debt instruments, are reported within accumulated other comprehensive income (AOCI) in the statements of comprehensive income. There were no changes in AOCI associated with unrealized holding gains or losses on available-for-sale investments during the nine-month period ended September 30, 2021.  

(9) Liability Related to Sale of Future Royalties

As of October 1, 2017, the Company completed a royalty purchase agreement with HealthCare Royalty Partners, or HCRP (“Royalty Agreement”). In exchange for the payment of $40 million to the Company, HCRP obtained the right to receive Fampyra royalties payable by Biogen under the License and Collaboration Agreement between the Company and Biogen, up to an agreed upon threshold of royalties. When this threshold is met, if ever, the Fampyra royalty revenue will revert back to the Company and the Company will continue to receive the Fampyra royalty revenue from Biogen until the revenue stream ends (see Note 3). The transaction does not include potential future milestones to be paid.

The Company maintained the rights under the license and collaboration agreement with Biogen, therefore, the Royalty Agreement has been accounted for as a liability that will be amortized using the effective interest method over the life of the arrangement, in accordance with the relevant accounting guidance. The Company recorded the receipt of the $40 million payment from HCRP and established a corresponding liability in the amount of $40 million, net of transaction costs of approximately $2.2 million. The net liability is classified between the current and non-current portion of liability related to the sale of future royalties in the consolidated balance sheets based on the recognition of the interest and principal payments to be received by HCRP in the next 12 months from the financial statement reporting date. The total net royalties to be paid, less the net proceeds received will be recorded to interest expense using the effective interest method over the life of the Royalty Agreement. The Company will estimate the payments to be made to HCRP over the term of the Agreement based on forecasted royalties and will calculate the interest rate required to discount such payments back to the liability balance. Over the course of the Royalty Agreement, the actual interest rate will be affected by the amount and timing of net royalty revenue recognized and changes in forecasted revenue. On a quarterly basis, the Company will reassess the effective interest rate and adjust the rate prospectively as necessary.

The following table shows the activity within the liability account for September 30, 2021 and December 31, 2020, respectively:

 

(In thousands)

 

September 30, 2021

 

 

December 31, 2020

 

Liability related to sale of future royalties - beginning balance

 

$

15,257

 

 

$

24,401

 

Deferred transaction costs amortized

 

 

193

 

 

 

401

 

Non-cash royalty revenue payable to HCRP

 

 

(8,889

)

 

 

(11,486

)

Non-cash interest expense recognized

 

 

891

 

 

 

1,941

 

Liability related to sale of future royalties - ending balance

 

$

7,452

 

 

$

15,257

 

 

 

 

 

 

 

 

 

 

 

16


 

 

(10) Debt

Convertible Senior Secured Notes Due 2024

On December 24, 2019, the Company completed the private exchange of $276.0 million aggregate principal amount of then-outstanding 1.75% Convertible Senior Notes due 2021 (the “2021 Notes”) for a combination of newly-issued 6.00% Convertible Senior Secured Notes due 2024 (the “2024 Notes”) and cash. For each $1,000 principal amount of exchanged 2021 Notes, the Company issued $750 principal amount of the 2024 Notes and made a cash payment of $200 (the “Exchange”). In the aggregate, the Company issued approximately $207.0 million aggregate principal amount of the 2024 Notes and paid approximate $55.2 million in cash to participating holders. The Exchange was conducted with a limited number of institutional holders of the 2021 Notes pursuant to Exchange Agreements dated as of December 20, 2019 (each, an “Exchange Agreement”).

The 2024 Notes were issued pursuant to an Indenture, dated as of December 23, 2019, among the Company, its wholly owned subsidiary, Civitas Therapeutics, Inc. (along with any domestic subsidiaries acquired or formed after the date of issuance, the “Guarantors”), and Wilmington Trust, National Association, as trustee and collateral agent (the “2024 Indenture”). The 2024 Notes are senior obligations of the Company and the Guarantors, secured by a first priority security interest in substantially all of the assets of the Company and the Guarantors, subject to certain exceptions described in the Security Agreement, dated as of December 23, 2019, between the grantors party thereto and Wilmington Trust, National Association, as collateral agent (the “Security Agreement”).

The 2024 Notes will mature on December 1, 2024 unless earlier converted in accordance with their terms prior to such date. Interest on the 2024 Notes is payable semi-annually in arrears at a rate of 6.00% per annum on each June 1 and December 1, beginning on June 1, 2020. The Company may elect to pay interest in cash or shares of the Company’s common stock, subject to the satisfaction of certain conditions. If the Company elects to pay interest in shares of common stock, such common stock will have a per share value equal to 95% of the daily volume-weighted average price for the 10 trading days ending on and including the trading day immediately preceding the relevant interest payment date. In June 2021, the Company issued 1,635,833 shares of common stock in satisfaction of the interest payable to holders of the 2024 Notes on June 1, 2021. In connection with this stock-based interest payment approximately $6.2 million of accrued interest was released from restricted cash and became available to the Company for other purposes.

The 2024 Notes are convertible at the option of the holder into shares of common stock of the Company at any time prior to the close of business on the second scheduled trading day immediately preceding the maturity date. The adjusted conversion rate for the 2024 Notes is 47.6190 shares of the Company’s common stock per $1,000 principal amount of 2024 Notes, representing an adjusted conversion price of approximately $21.00 per share of common stock. The conversion rate was adjusted to reflect the 1-for-6 reverse stock split effected on December 31, 2020 and is subject to additional adjustments in certain circumstances as described in the 2024 Indenture.

The Company may elect to settle conversions of the 2024 Notes in cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock. Holders who convert their 2024 Notes prior to June 1, 2023 (other than in connection with a make-whole fundamental change) will also be entitled to an interest make-whole payment equal to the sum of all regularly scheduled stated interest payments, if any, due on such 2024 Notes on each interest payment date occurring after the conversion date for such conversion and on or before June 1, 2023. In addition, the Company will have the right to cause all 2024 Notes then outstanding to be converted automatically if the volume-weighted average price per share of the Company’s common stock equals or exceeds 130% of the adjusted conversion price for a specified period of time and certain other conditions are satisfied.

Holders of the 2024 Notes will have the right, at their option, to require the Company to purchase their 2024 Notes if a fundamental change (as defined in the 2024 Indenture) occurs, in each case, at a repurchase price equal to 100% of the principal amount of the 2024 Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date. If a make-whole fundamental change occurs, as described in the 2024 Indenture, and a holder elects to convert its 2024 Notes in connection with such make-whole fundamental change, such holder may be entitled to an increase in the adjusted conversion rate as described in the 2024 Indenture.

Subject to a number of exceptions and qualifications, the 2024 Indenture restricts the ability of the Company and certain of its subsidiaries to, among other things, (i) pay dividends or make other payments or distributions on their capital stock, or purchase, redeem, defease or otherwise acquire or retire for value any capital stock, (ii) make certain investments, (iii) incur indebtedness or issue preferred stock, other than certain forms of permitted debt, which includes, among other

17


 

items, indebtedness incurred to refinance the 2021 Notes, (iv) create liens on their assets, (v) sell their assets, (vi) enter into certain transactions with affiliates or (vii) merge, consolidate or sell of all or substantially all of their assets. The 2024 Indenture also requires the Company to make an offer to repurchase the 2024 Notes upon the occurrence of certain asset sales.

The 2024 Indenture provides that a number of events will constitute an event of default, including, among other things, (i) a failure to pay interest for 30 days, (ii) failure to pay the 2024 Notes when due at maturity, upon any required repurchase, upon declaration of acceleration or otherwise, (iii) failure to convert the 2024 Notes in accordance with the 2024 Indenture and the failure continues for five business days, (iv) not issuing certain notices required by the 2024 Indenture within a timely manner, (v) failure to comply with the other covenants or agreements in the 2024 Indenture for 60 days following the receipt of a notice of non-compliance, (vi) a default or other failure by the Company to make required payments under other indebtedness of the Company or certain subsidiaries having an outstanding principal amount of $30.0 million or more, (vii) failure by the Company or certain subsidiaries to pay final judgments aggregating in excess of $30.0 million, (viii) certain events of bankruptcy or insolvency and (ix) the commercial launch in the United States of a product determined by the U.S. FDA to be bioequivalent to Inbrija. In the case of an event of default arising from certain events of bankruptcy or insolvency with respect to the Company, all outstanding 2024 Notes will become due and payable immediately without further action or notice. If any other event of default occurs and is continuing, the trustee or the holders of at least 25% in aggregate principal amount of the then outstanding 2024 Notes may declare all the notes to be due and payable immediately.

The 2021 Notes received by the Company in the Exchange were cancelled in accordance with their terms. Accordingly, upon completion of the Exchange, $69.0 million of the 2021 Notes remained outstanding.

The Company determined that the exchange of the 2021 Notes for 2024 Notes qualified for a debt extinguishment and recognized a gain on extinguishment of $55.1 million for the year ended December 31, 2019, representing the difference between the fair value of the liability component immediately before the exchange and the carrying value of the debt. The Company recorded an adjustment of $38.4 million to additional paid-in capital to adjust the equity component of 2021 Notes in connection with the extinguishment.

The Company assessed all terms and features of the 2024 Notes in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the 2024 Notes, including the conversion, put and call features. The Company concluded the conversion features required bifurcation as a derivative. The fair value of the conversion feature derivative was determined based on the difference between the fair value of the 2024 Notes with the conversion options and the fair value of the 2024 Notes without the conversion options using a binomial model. The Company determined that the fair value of the derivative upon issuance of the 2024 Notes was $59.4 million and recorded this amount as a derivative liability with an offsetting amount as a debt discount as a reduction to the carrying value of the 2024 Notes on the closing date, or December 24, 2019. There are several embedded features within the 2024 Notes which, upon issuance, did not meet the conditions for equity classification. As a result, these features were aggregated together and recorded as the derivative liability conversion option. The conversion feature is measured at fair value on a quarterly basis and the changes in the fair value of the conversion feature for the period will be recognized in the consolidated statements of operations.   

The Company received stockholder approval on August 28, 2020 to increase the number of authorized shares of the Company’s common stock from 13,333,333 shares to 61,666,666 shares. As a result of the share approval, the Company determined that multiple embedded conversion options met the conditions for equity classification. The Company performed a valuation of these conversion options as of September 17, 2020, which was the date the Company completed certain securities registration obligations. The resulting fair value of these conversion options was $18.3 million, which was reclassified to equity and presented in the statement of stockholder’s equity as of September 30, 2020, net of the $4.4 million tax impact. The equity component is not re-measured as long as it continues to meet the conditions for equity classification. The Company performed a valuation of the derivative liability related to certain embedded conversion features that are precluded from equity classification. The fair value of these conversion features was calculated to be $0.3 million representing a decrease of $0.9 million that is recognized in the consolidated statement of operations for the nine-month period ended September 30, 2021.

18


 

The outstanding 2024 Note balances as of September 30, 2021 and December 31, 2020 consisted of the following:

 

(In thousands)

 

September 30, 2021

 

 

December 31, 2020

 

Liability component:

 

 

 

 

 

 

 

 

Principal

 

 

207,000

 

 

$

207,000

 

Less: debt discount and debt issuance costs, net

 

 

(59,553

)

 

 

(69,381

)

Net carrying amount

 

$

147,447

 

 

$

137,619

 

Equity component

 

$

18,257

 

 

$

18,257

 

Derivative liability-conversion option

 

$

325

 

 

$

1,193

 

 

The Company determined that the expected life of the 2024 Notes was equal to the period through December 1, 2024 as this represents the point at which the 2024 Notes will mature unless earlier converted in accordance with their terms prior to such date. Accordingly, the total debt discount of $75.1 million, inclusive of the fair value of the embedded conversion feature derivative at issuance, is being amortized using the effective interest method through December 1, 2024. For the three and nine-month periods ended September 30, 2021, the Company recognized $6.5 million and $19.1 million, respectively, of interest expense related to the 2024 Notes at the effective interest rate of 18.1%. The fair value of the Company’s 2024 Notes was approximately $167.7 million as of September 30, 2021.

In connection with the issuance of the 2024 Notes, the Company incurred approximately $5.7 million of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs to the liability component and recorded as a reduction in the carrying amount of the debt liability on the balance sheet. The portion allocated to the 2024 Notes is amortized to interest expense over the expected life of the 2024 Notes using the effective interest method.

The following table sets forth total interest expense recognized related to the 2024 Notes for the three and nine-month periods ended September 30, 2021 and 2020:

 

(In thousands)

 

Three-month period ended September 30, 2021

 

 

Three-month period ended September 30, 2020

 

 

Nine-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2020

 

Contractual interest expense

 

$

3,105

 

 

$

3,105

 

 

$

9,315

 

 

$

9,315

 

Amortization of debt issuance costs

 

 

243

 

 

 

204

 

 

 

698

 

 

 

585

 

Amortization of debt discount

 

 

3,179

 

 

 

2,663

 

 

 

9,130

 

 

 

7,647

 

Total interest expense

 

$

6,527

 

 

$

5,972

 

 

$

19,143

 

 

$

17,547

 

 

Convertible Senior Notes Due 2021

On June 17, 2014, the Company issued $345 million aggregate principal amount of 1.75% Convertible Senior Notes due 2021 (the “2021 Notes”). On December 24, 2019, the Company completed the private exchange of $276.0 million aggregate principal amount of then-outstanding 2021 Notes for a combination of newly-issued 6.00% Convertible Senior Secured Notes due 2024 and cash. The 2021 Notes received by the Company in the exchange were cancelled in accordance with their terms. Accordingly, upon completion of the exchange, $69.0 million of the 2021 Notes remained outstanding. On June 15, 2021, the Company repaid the outstanding balance of the 2021 Notes at their maturity date using cash on hand.            

In accounting for the issuance of the 2021 Notes, the Company separated the 2021 Notes into liability and equity components. The carrying amount of the liability component was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The carrying amount of the equity component representing the conversion option was determined by deducting the fair value of the liability component from the par value of the 2021 Notes as a whole. The equity component is not re-measured as long as it continues to meet the conditions for equity classification.

19


 

The outstanding 2021 Note balances as of September 30, 2021 and December 31, 2020 consisted of the following:

 

(In thousands)

 

September 30, 2021

 

 

December 31, 2020

 

Liability component:

 

 

 

 

 

 

 

 

Principal

 

$

 

 

$

69,000

 

Less: debt discount and debt issuance costs, net

 

 

 

 

 

(1,029

)

Net carrying amount

 

$

 

 

$

67,971

 

Equity component

 

$

 

 

$

22,791

 

 

In connection with the issuance of the 2021 Notes, the Company incurred approximately $7.5 million of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs to the liability and equity components based on the allocation of the proceeds. Of the total $7.5 million of debt issuance costs, $1.3 million were allocated to the equity component and recorded as a reduction to additional paid-in capital and $6.2 million were allocated to the liability component and recorded as a reduction in the carrying amount of the debt liability on the balance sheet. The portion allocated to the liability component is amortized to interest expense over the expected life of the 2021 Notes using the effective interest method. The Company wrote off $1.2 million of issuance cost associated with the exchange of the 2021 Notes.  

On June 15, 2021, the Company repaid the outstanding balance of the 2021 Notes at their maturity date using cash on hand.  The effective interest rate on the liability component was approximately 4.8% for the period from the date of issuance through June 15, 2021.  

The following table sets forth total interest expense recognized related to the 2021 Notes for the three and nine-month periods ended September 30, 2021 and 2020:

 

(In thousands)

 

Three-month period ended September 30, 2021

 

 

Three-month period ended September 30, 2020

 

 

Nine-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2020

 

Contractual interest expense

 

$

 

 

$

302

 

 

$

428

 

 

$

906

 

Amortization of debt issuance costs

 

 

 

 

 

50

 

 

 

95

 

 

 

150

 

Amortization of debt discount

 

 

 

 

 

495

 

 

 

934

 

 

 

1,467

 

Total interest expense

 

$

 

 

$

847

 

 

$

1,457

 

 

$

2,523

 

 

(11) Leases

In February 2016, the FASB issued ASU 2016-02, “Leases” Topic 842, which amends the guidance in former ASC Topic 840, Leases.

The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.

Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred, if any. Our leases have remaining lease terms of 0.75 year to 5.25 years. The Company has exercised the option to terminate the Ardsley lease with a termination date of June 22, 2022.   

Operating Leases

We lease certain office and lab space under arrangements classified as leases under ASC 842. Leases with an initial term of 12 months or less are not recorded on the balance sheet; we recognize lease expense for these leases on a straight-line basis over the lease term.    

20


 

Ardsley, New York

In June 2011, the Company entered into a 15-year lease for an aggregate of approximately 138,000 square feet of office and laboratory space in Ardsley, New York. In 2014, the Company exercised its option to expand into an additional 25,405 square feet of office space, which the Company occupied in January 2015. On September 17, 2021, the Company sent the landlord of the Ardsley lease notice of exercise of the Company’s early termination option (the “Early Termination Option”) under the lease. Pursuant to the Early Termination Option, the lease will terminate on June 22, 2022 (the “Early Termination Date”), subject to the conditions that (a) on the last business day before the Early Termination Date, the Company pays an early termination fee of approximately $4.7 million, (b) on the day immediately prior to the Early Termination Date, the Company is not in “Default” under the Lease beyond applicable cure periods, and (c) as of the Early Termination Date, the Company has complied with its end-of-term obligations.     

The Ardsley lease provides for monthly payments of rent during the lease term. These payments consist of base rent, which takes into account the costs of the facility improvements funded by the facility owner prior to the Company’s occupancy, and additional rent covering customary items such as charges for utilities, taxes, operating expenses, and other facility fees and charges. The base rent is currently $5.0 million per year, which reflects an annual 2.5% escalation factor.  

Chelsea, Massachusetts

Our Civitas subsidiary leased a manufacturing facility in Chelsea, Massachusetts which we used to manufacture Inbrija through February 10, 2021. Civitas leased this facility from North River Everett Ave, LLC pursuant to a lease with a term that expires on December 31, 2025, and Civitas had 2 additional extension options of five years each.  On February 10, 2021, the Company completed the sale of its Chelsea manufacturing operations to Catalent Pharma Solutions. In connection with the sale, Civitas assigned the lease of the Chelsea facility to a Catalent affiliate (see Note 12).

  In 2018, the Company initiated a renovation and expansion of a building within the Chelsea manufacturing facility that increased the size of the facility to approximately 95,000 square feet. The project added a new manufacturing production line for Inbrija and other ARCUS products that has greater capacity than the existing manufacturing line, and created additional warehousing space for manufactured product. All costs to renovate and expand the facility through the date of assignment were borne by the Company. Catalent is now responsible for finalizing the expansion, including obtaining needed regulatory approvals.

Additional Facilities

In October 2016, we entered into a 10-year lease agreement with a term commencing January 1, 2017, for approximately 26,000 square feet of lab and office space in Waltham, MA. The lease provides for monthly rental payments over the lease term. The base rent under the lease is currently $1.1 million per year.

Our leases have remaining lease terms of 0.75 year to 5.25 years, which reflects the exercise of the early termination of our Ardsley, NY lease as described above. The calculation of the lease liability reflects the exercise of the Ardsley early termination option as described above. The weighted-average remaining lease term for our operating leases was 2.6 years at September 30, 2021. The weighted-average discount rate was 7.13% at September 30, 2021.

ROU assets and lease liabilities related to our operating leases are as follows:

 

(In thousands)

 

Balance Sheet Classification

 

September 30, 2021

 

 

December 31, 2020

 

Right-of-use assets

 

Right of use assets

 

$

7,861

 

 

$

18,481

 

Current lease liabilities

 

Current portion of lease liabilities

 

 

9,316

 

 

 

7,944

 

Non-current lease liabilities

 

Non-current portion of lease liabilities

 

 

4,287

 

 

 

17,200

 

 

21


 

 

We have lease agreements that contain both lease and non-lease components. We account for lease components together with non-lease components (e.g., common-area maintenance). The components of lease costs were as follows:

 

(In thousands)

 

Three-month period ended September 30, 2021

 

 

Three-month period ended September 30, 2020

 

 

Nine-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2020

 

Operating lease cost

 

$

1,600

 

 

$

1,775

 

 

$

4,593

 

 

$

5,572

 

Variable lease cost

 

 

948

 

 

 

1,052

 

 

 

3,283

 

 

 

2,687

 

Short-term lease cost

 

 

339

 

 

 

443

 

 

 

829

 

 

 

1,248

 

Total lease cost

 

$

2,887

 

 

$

3,270

 

 

$

8,705

 

 

$

9,507

 

 

Future minimum commitments under all non-cancelable operating leases are as follows:

 

(In thousands)

 

 

 

 

2021 (excluding the nine months ended September 30, 2021)

 

$

1,553

 

2022

 

 

8,354

 

2023

 

 

1,216

 

2024

 

 

1,252

 

2025

 

 

1,290

 

Later years

 

 

1,327

 

Total lease payments

 

 

14,992

 

Less: Imputed interest

 

 

(1,389

)

Present value of lease liabilities

 

$

13,603

 

 

Supplemental cash flow information related to our operating leases are as follows:

 

(In thousands)

 

Nine-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2020

 

Operating cash flow information:

 

 

 

 

 

 

 

 

Cash paid for amounts included in the measurement of lease liabilities

 

$

4,605

 

 

$

5,818

 

 

(12) Disposal of Assets

On January 12, 2021 the Company and Catalent entered into an asset purchase agreement, pursuant to which the Company agreed to sell to Catalent certain assets related to the Company’s manufacturing operations located at the facilities situated in Chelsea, Massachusetts (the “Chelsea Facility”) and Waltham, Massachusetts (the “Waltham Facility”), for a purchase price of $80 million, plus an additional $2.3 million for raw materials transferred, and the assumption by Catalent of certain liabilities relating to such manufacturing activities. The Company determined that the criterion to classify the property and equipment and prepaid expenses related to the Chelsea manufacturing operations as assets held for sale within the Company’s consolidated balance effective December 31, 2020 were met. Accordingly, the assets were classified as current assets held for sale at December 31, 2020 as the Company, at that time, expected to divest the Chelsea manufacturing operations within the next twelve months.

The classification to assets held for sale impacted the net book value of the assets expected to be transferred upon sale. The estimated fair value of the Chelsea manufacturing operations was determined using the purchase price in the purchase agreement along with estimated broker, accounting, legal, and other selling expenses, which resulted in a fair value less costs to sell of approximately $71.8 million. The carrying value of the assets classified as held for sale was approximately $129.7 million, which included property and equipment of $129.6 million and prepaid expenses of $0.1 million. The Company recorded a loss on assets held for sale of $57.9 million against the Chelsea manufacturing operations as of December 31, 2020. Additionally, the expected divestiture of the Chelsea Facility group was not deemed to represent a fundamental strategic shift that would have a major effect on the Company’s operations, and accordingly, the operating results of the Chelsea manufacturing operations were not reported as discontinued operations in the Company’s consolidated statement of income as of December 31, 2020.

22


 

The Company closed the transaction on February 10, 2021. In addition to the property and equipment, prepaid expenses, and raw materials, the Company also assigned the lease of the Chelsea Facility to a Catalent affiliate, which had a net carrying value of $(0.5) million as of the close date. During the three-month period ended March 31, 2021, the Company recorded a gain on disposal of approximately $0.5 million based on the net assets transferred and final net proceeds received at the close.

(13) Corporate Restructuring

In January 2021 and September 2021, we announced corporate restructurings to reduce costs, more closely align operating expenses with expected revenue, and focus our resources on Inbrija. As part of the January 2021 restructuring, we reduced headcount by approximately 16% through a reduction in force (excluding the employees that transferred to Catalent at the closing of the sale of our Chelsea manufacturing operations). All of the reduction in personnel in connection with the January 2021 restructuring took place during the three-month period ended March 31, 2021. As part of the September 2021 restructuring, we reduced headcount by approximately 15% through a reduction in force. Most of this reduction in force took place in September 2021, and it will be completed in the first quarter of 2022.

During the nine-month period ended September 30, 2021, the Company incurred $4.6 million of restructuring charges, substantially all of which were cash expenditures for severance and other employee separation-related costs. Of the restructuring charges, $0.6 million were recorded in research and development expenses and $4.0 million were recorded in selling, general and administrative expenses for the nine-month period ended September 30, 2021.

A summary of the restructuring charges for the nine-month period ended September 30, 2021 is as follows:

(In thousands)

 

Restructuring Costs

 

Restructuring Liability as of December 31, 2020

 

$

 

Q1 Restructuring Costs

 

 

2,124

 

Q1 Restructuring Payments

 

 

(1,891

)

Restructuring Liability as of March 31, 2021

 

$

233

 

Q2 Restructuring Costs

 

 

27

 

Q2 Restructuring Payments

 

 

(128

)

Restructuring Liability as of June 30, 2021

 

$

132

 

Q3 Restructuring Costs

 

 

2,432

 

Q3 Restructuring Payments

 

 

(882

)

Restructuring Liability as of September 30, 2021

 

$

1,682

 

 

(14) Commitments and Contingencies

On November 9, 2020, Drug Royalty III, L.P., and LSRC III S.ar.l. (collectively, “DRI”) filed an arbitration claim against us with the American Arbitration Association under a September 26, 2003 License Agreement that we originally entered into with Rush-Presbyterian St. Luke’s Medical Center (“Rush”). DRI previously purchased license royalty rights under the license agreement from Rush. DRI alleges a dispute over the last-to-expire patent covering sales of the drug Ampyra under the license agreement, and is claiming damages based on unpaid license royalties of $6 million plus interest. We believe we have valid defenses against this claim and intend to defend ourselves vigorously. While the Company is unable to determine the ultimate outcome of the dispute, and believes it has valid defenses and intends to defend itself vigorously, the Company determined that it is probable that the Company may incur a liability related to the dispute which the Company estimated could be $2 million, inclusive of its legal costs. The Company recorded a liability of $2 million for the year ended December 31, 2020 related to the dispute, however, the Company notes that depending upon the ultimate outcome of the dispute, the potential liability could be more or less than the amount recorded. As of September 30, 2021, the Company continues to believe that the recorded liability established as of December 31, 2020 is appropriate.

In addition to the arbitration described above, from time to time the Company is involved in litigation or other legal proceedings relating to claims arising out of operations in the normal course of business. The Company has assessed all litigation and legal proceedings and does not believe that it is probable that a liability has been incurred or that the amount of any potential liability or range of losses can be reasonably estimated. As a result, the Company did not record any loss contingencies for these other matters. Litigation expenses are expensed as incurred.

23


 

On February 10, 2021, we sold our Chelsea manufacturing operations to Catalent Pharma Solutions. In connection with the sale, we entered into a long-term, global manufacturing services (supply) agreement with a Catalent affiliate pursuant to which they have agreed to manufacture Inbrija for us at the Chelsea facility. The manufacturing services agreement provides that Catalent will manufacture Inbrija (levodopa inhalation powder), to our specifications, and we will purchase Inbrija exclusively from Catalent during the term of the manufacturing services agreement; provided that such exclusivity requirement will not apply to Inbrija intended for sale in China. Under our agreement with Catalent, we are obligated to make minimum purchase commitments for Inbrija through the expiration of the agreement on December 31, 2030. During the three and nine-month periods ended September 30, 2021, the Company incurred approximately $4.0 million and $10.2 million, respectively, of minimum purchase commitments with Catalent, which are recognized as cost of sales within the Company’s consolidated statement of operations for the period. As of September 30, 2021, the minimum remaining purchase commitment to Catalent was $4.0 million through December 31, 2021, and $18.0 million annually each year thereafter.

24


 

Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our consolidated financial condition and results of operations should be read in conjunction with our unaudited consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q.

Background

We are a biopharmaceutical company focused on developing therapies that restore function and improve the lives of people with neurological disorders. We market Inbrija (levodopa inhalation powder), which is approved in the U.S. for intermittent treatment of OFF episodes, also known as OFF periods, in people with Parkinson’s disease treated with carbidopa/levodopa. Inbrija is for as needed use and utilizes our ARCUS pulmonary delivery system, a technology platform designed to deliver medication through inhalation that we believe has potential to be used in the development of a variety of inhaled medicines. We also market branded Ampyra (dalfampridine) Extended Release Tablets, 10 mg.

Inbrija

Our New Drug Application, or NDA, for Inbrija was approved by the U.S. Food and Drug Administration, or FDA, on December 21, 2018. The approval is for a single dose of 84 mg (administered as two capsules), which may be taken up to five times per day. Inbrija became commercially available in the U.S. on February 28, 2019. Currently, Inbrija is available in the U.S. without the need for a medical exception for approximately 96% of commercial health insurance plans and approximately 27% of Medicare plan lives. Approximately one million people in the U.S. and 1.2 million Europeans are diagnosed with Parkinson’s; it is estimated that approximately 40% of people with Parkinson’s in the U.S. experience OFF periods. Net revenue for Inbrija was $7.8 million for the quarter ended September 30, 2021 and $5.8 million for the quarter ended September 30, 2020. Due to uncertainties caused by past and potential future impacts of the COVID-19 pandemic and other factors, we are no longer able to provide projected peak U.S. annual net revenue of Inbrija. Actual peak U.S. Inbrija net revenue will likely be lower and could be materially lower than our prior projected peak sales range if, for example, disruptions to the healthcare system caused by the COVID-19 pandemic or other prescribing challenges continue into 2022 and beyond.

In September 2019, we announced that the European Commission, or EC, approved our Marketing Authorization Application, or MAA, for Inbrija. The approved dose is 66 mg (administered as two capsules) up to five times per day (per European Union, or EU, convention, this reflects emitted dose and is equivalent to the 84 mg labelled dose in the U.S.). Under the MAA, Inbrija is indicated in the EU for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease treated with a levodopa/dopa-decarboxylase inhibitor. Following the ratification of the Withdrawal Agreement between the United Kingdom and the EU, the UK left the EU on January 31, 2020. Effective January 1, 2021, Acorda was granted a grandfathered Marketing Authorization (MA) by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK subject to completion of an administrative process that was approved by the MHRA in November 2021.

In July and November 2021, we announced that we entered into distribution and supply agreements with Esteve Pharmaceuticals to commercialize Inbrija in Spain and Germany, respectively. Under the terms of the Germany distribution agreement, we will receive a €5 million upfront payment, and we will receive additional sales-based milestones. Under the terms of both the Spain and Germany supply agreements, we will receive a significant double-digit percent of the selling price of Inbrija in exchange for supply of the product. Esteve will have the exclusive distribution rights to Inbrija in Spain and Germany and we will supply the product to Esteve for sale. Esteve expects to launch Inbrija in Spain in the fourth quarter of 2022, and in Germany by mid-2022. We are in discussions with potential partners for commercialization of Inbrija in other jurisdictions outside of the U.S., including in Europe and other countries.

Ampyra

Ampyra became subject to competition from generic versions of Ampyra starting in late 2018 as a result of an adverse U.S. federal district court ruling that invalidated certain Ampyra Orange Book-listed patents. We have experienced a significant decline in Ampyra sales due to competition from several generic versions of Ampyra. Additional manufacturers may market generic versions of Ampyra, and we expect our Ampyra sales will continue to decline over time. Net revenue for Ampyra was $20.0 million for the quarter ended September 30, 2021 and $27.3 million for the quarter ended September 30, 2020.

25


 

Convertible Notes

In December 2019, we announced the successful completion of a private exchange of $276 million of our convertible senior notes due in 2021 in exchange for a combination of approximately $207 million aggregate principal amount of newly-issued convertible senior secured notes due 2024 and $55.2 million in cash. The convertible senior secured notes due 2024 have an adjusted conversion price of approximately $21.00 per share. As a result of the exchange, approximately $69 million of convertible senior notes due in 2021 remained outstanding. On June 15, 2021, we repaid the outstanding balance of the 2021 convertible senior notes at their maturity date using cash on hand. More information about the terms and conditions of the 2024 convertible notes is set forth in Note 10 to our Consolidated Financial Statements included in this report as well as in Financing Arrangements in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of this report.

Sale of Chelsea, Massachusetts Manufacturing Operations

In February 2021, we completed the sale of our Chelsea, Massachusetts manufacturing operations to Catalent Pharma Solutions. Pursuant to the transaction, Catalent paid us $80 million in cash, resulting in net proceeds to us of approximately $74 million after transaction fees and expenses and settlement of customary post-closing adjustments. In connection with the sale of the manufacturing operations, we entered into a long-term, global manufacturing services agreement with a Catalent affiliate for the supply of Inbrija. As part of the transaction, Catalent hired substantially all of our prior employees at the Chelsea facility as well as certain of our other employees at our Waltham, Massachusetts facility. We expect to save approximately $10 million in annual operating expenses related to the operation of the manufacturing facility.

Financial Management

In January 2021 and September 2021, we announced corporate restructurings to reduce costs, more closely align operating expenses with expected revenue, and focus our resources on Inbrija. As part of the January 2021 restructuring, we reduced headcount by approximately 16% through a reduction in force (excluding the employees that transferred to Catalent at the closing of the sale of our Chelsea manufacturing operations). As a result, we expect to realize estimated annualized cost savings related to the January 2021 headcount reduction of approximately $6 million beginning in the second quarter of 2021. As part of the September 2021 restructuring, we reduced headcount by approximately 15% through a reduction in force. Most of this reduction in force took place in September 2021, and it will be completed in the first quarter of 2022. The company expects to realize estimated annualized cost savings of approximately $20 million from the September corporate restructuring beginning in 2022. The Company estimates that it will incur approximately $5.5 million of pre-tax charges, substantially all of which are cash expenditures, for severance and other employee separation-related costs in connection with the restructurings, approximately $4.6 million of which were incurred during the nine-month period ended September 30, 2021.

In January 2021, we entered into an At The Market (ATM) Offering Agreement with H.C. Wainwright & Co., LLC as sales agent. Pursuant to the ATM agreement, we may offer and sell shares of our common stock having an aggregate value of up to $15.25 million in an at-the-market offering, subject to a 3% sales commission payable to H.C. Wainwright. If we elect to use the ATM agreement, H.C. Wainwright would be obligated to use commercially reasonable efforts consistent with its normal trading and sales practices and applicable law and regulations to sell shares in accordance with our instructions (including as to price, time or size limit or other parameters or conditions that we may impose). We have not yet sold any shares under the ATM agreement.

On September 17, 2021, we sent to BMR-Ardsley Park LLC (“BMR”) notice of exercise of our early termination option (the “Early Termination Option”) under our Lease dated as of June 23, 2011, between us and BMR (as amended, the “Lease”). The Lease is for the Company’s Ardsley, N.Y. corporate headquarters, which we believe is substantially larger than our needs for the foreseeable future. Pursuant to the Early Termination Option, the Lease will terminate on June 22, 2022 (the “Early Termination Date”), subject to the conditions that (a) on the last business day before the Early Termination Date, we pay an early termination fee of approximately $4.7 million, (b) on the day immediately prior to the Early Termination Date, we are not in “Default” under the Lease beyond applicable cure periods, and (c) as of the Early Termination Date, we have complied with our end-of-term obligations.

As of September 30, 2021, we had cash, cash equivalents and restricted cash of approximately $61.9 million. Restricted cash includes $24.8 million in escrow related to the 6% semi-annual interest portion of the convertible senior secured notes due 2024, which is payable in cash or stock. As further described in Note 10 to our Consolidated Financial

26


 

Statements included in this report as well as in Financing Arrangements in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of this report, if we are permitted under the notes indenture and we elect to pay interest due in stock, a corresponding amount of restricted cash equivalent will be released from escrow. We intend to pay the interest due on December 1, 2021 in stock.

Reverse Stock Split

On December 31, 2020, we filed an amendment to our Certificate of Incorporation which effected, as of 4:01 p.m. Eastern Time on December 31, 2020, a 1-for-6 reverse stock split of the shares of our outstanding common stock and proportionate reduction in the number of authorized shares of our common stock from 370,000,000 to 61,666,666. Our common stock began trading on a split-adjusted basis on The Nasdaq Global Select Market commencing upon market open on January 4, 2021. The common stock continued to trade under the symbol “ACOR” after the reverse stock split became effective. The reverse stock split applied equally to all outstanding shares of the common stock and did not modify the rights or preferences of the common stock. The reverse stock split also resulted in a corresponding adjustment to outstanding equity awards as well as shares reserved for future issuance under our incentive compensation plans. All figures in this report relating to shares of our common stock (such as share amounts, per share amounts, and conversion rates and prices), including in the financial statements and accompanying notes to the financial statements, have been retroactively restated to reflect the 1-for-6 reverse stock split of our common stock.

COVID-19 Pandemic

Our business and financial condition have been impacted by, and are subject to risks resulting from, the COVID-19 (novel coronavirus) pandemic. The COVID-19 pandemic has caused significant disruptions in the healthcare industry. The duration of the pandemic is difficult to predict, and it is likely to have ongoing impacts as it continues. The travel restrictions, “shelter in place” orders, quarantine policies, vaccine mandates and general concerns about the spread of COVID-19 have disrupted the delivery of healthcare to patients, for example making it more difficult for some patients to visit with their physician and obtain pharmaceutical prescriptions. Also, healthcare office staffing shortages may delay the administrative work, and particularly insurance-related documentation, needed to obtain reimbursement for prescriptions. We believe these factors contributed to volatility in new Inbrija prescriptions during 2020 and are continuing to impact prescriptions in 2021.

The COVID-related policies, restrictions, mandates, and concerns may disrupt our operations and those of our customers and suppliers. Also, our operations could be interrupted if we or our customers or suppliers lose the services of key employees or consultants who become ill from COVID-19. These types of disruptions could potentially affect any of our critical business functions, and thus harm our business, including for example our manufacturing, sales and marketing operations as well compliance and certain general and administrative functions. The ultimate impact of the COVID-19 pandemic, or any other health epidemic, is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, healthcare systems or the global economy as a whole. As the pandemic continues, it may result in sustained impacts on demand for our products and our ability to access capital on reasonable terms, or at all.

Inbrija (levodopa inhalation powder)/Parkinson’s Disease

Inbrija (levodopa inhalation powder) is the first and only inhaled levodopa, or L-dopa, for intermittent treatment of OFF episodes, also known as OFF periods, in people with Parkinson’s disease treated with carbidopa/levodopa regimen. Our New Drug Application, or NDA, for Inbrija was approved by the U.S. Food and Drug Administration, or FDA, on December 21, 2018. The approval is for a single dose of 84 mg (administered as two capsules), which may be taken up to five times per day. Inbrija became commercially available in the U.S. on February 28, 2019. Currently, Inbrija is available in the U.S. without the need for a medical exception for approximately 96% of commercial health insurance plans and approximately 27% of Medicare plan lives. Net revenue for Inbrija was $7.8 million for the quarter ended September 30, 2021 and $5.8 million for the quarter ended September 30, 2020. Due to uncertainties caused by past and potential future impacts of the COVID-19 pandemic and other factors, we are no longer able to provide projected peak U.S. annual net revenue of Inbrija. Actual peak U.S. Inbrija net revenue will likely be lower and could be materially lower than our prior projected peak sales range if, for example, disruptions to the healthcare system caused by the COVID-19 pandemic or other prescribing challenges continue into 2022 and beyond.

In September 2019, we announced that the European Commission, or EC, approved our Marketing Authorization Application, or MAA, for Inbrija. The approved dose is 66 mg (administered as two capsules) up to five times per day (per

27


 

European Union, or EU, convention, this reflects emitted dose and is equivalent to the 84 mg labelled dose in the U.S.). Under the MAA, Inbrija is indicated in the EU for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease treated with a levodopa/dopa-decarboxylase inhibitor. The MAA approved Inbrija for use in what were then the 27 countries of the EU, as well as Iceland, Norway and Liechtenstein. Following the ratification of the Withdrawal Agreement between the United Kingdom and the EU, the UK left the EU on January 31, 2020. Effective January 1, 2021, Acorda was granted a grandfathered Marketing Authorization (MA) by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK subject to completion of an administrative process that was approved by the MHRA in November 2021.

In July and November 2021, we announced that we entered into distribution and supply agreements with Esteve Pharmaceuticals to commercialize Inbrija in Spain and Germany, respectively. Under the terms of the Germany distribution agreement, we will receive a €5 million upfront payment, and we will receive additional sales-based milestones. Under the terms of both the Spain and Germany supply agreements, we will receive a significant double-digit percent of the selling price of Inbrija in exchange for supply of the product. Esteve will have the exclusive distribution rights to Inbrija in Spain and Germany and we will supply the product to Esteve for sale. Esteve expects to launch Inbrija in Spain in the fourth quarter of 2022, and in Germany by mid-2022. We are in discussions with potential partners for commercialization of Inbrija in other jurisdictions outside of the U.S., including in Europe and other countries.

We market Inbrija in the U.S. using field-based teams supported by our corporate marketing personnel. Our own neuro-specialty sales representatives work in combination with sales representatives provided by a contract commercial organization, and collectively they are currently focused on a priority list of approximately 2,000 physicians who are high volume prescribers of levodopa/carbidopa. Our field-based teams also include reimbursement and market access specialists, who provide information to physicians and payers on our marketed products, as well as market development specialists who work collaboratively with field-sales teams and corporate personnel to assist in the execution of our strategic initiatives. Our Inbrija field-based and marketing activities are focused on physician awareness and market access as well as patient awareness, education and training. Inbrija is distributed in the U.S. primarily through:  AllianceRx Walgreens Prime, or Walgreens, a specialty pharmacy that delivers the medication to patients by mail; and ASD Specialty Healthcare, Inc. (an AmeriSource Bergen affiliate).

We have established Prescription Support Services for Inbrija, which we sometimes refer to as the Inbrija hub. Prescription Support Services is designed to help patients navigate their insurance coverage and offer reimbursement support services, when appropriate. Services fall into one of these categories: insurance verification, to research patient insurance benefits and confirm insurance coverage; prior authorization support, to identify prior authorization requirements; and appeals support. For patients that may need assistance paying for their medication, Prescription Support Services offers several support options, including: a program that provides no cost medication to patients who meet specific program eligibility requirements; co-pay support, which may help commercially insured (non-government funded) patients lower their out-of-pocket costs; and a bridge program, for federally-insured patients who experience a delay in coverage determination. We have a no-cost sample program, available at physician offices, to enable patients and their physicians to assess the value of Inbrija before the patient incurs out-of-pocket co-pay or co-insurance costs. In addition, we have a first dispense zero-dollar copay program for commercially-insured patients (which has replaced our previous free trial program) to enable those patients to assess the value of Inbrija before incurring out-of-pocket co-pay or co-insurance costs.

Parkinson’s disease is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons in the brain. These neurons are responsible for producing dopamine and that loss causes a range of symptoms including impaired movement, muscle stiffness and tremors. The standard baseline treatment of Parkinson’s disease is oral carbidopa/levodopa, but oral medication can be associated with wide variability in the timing and amount of absorption and there are significant challenges in creating a regimen that consistently maintains therapeutic effects. As Parkinson’s progresses, people are likely to experience OFF periods, which are characterized by the return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa. OFF periods are often highly disruptive to people with Parkinson’s. Approximately one million people in the U.S. and 1.2 million Europeans are diagnosed with Parkinson’s; it is estimated that approximately 40% of people with Parkinson’s in the U.S. experience OFF periods.

Inbrija is for as needed use and utilizes our ARCUS platform for inhaled therapeutics. ARCUS is a dry-powder pulmonary drug delivery technology that we believe has potential to be used in the development of a variety of inhaled medicines. The ARCUS platform allows systemic delivery of medication through inhalation, by transforming molecules into a light, porous dry powder. This allows delivery of substantially higher doses of medication than can be delivered via conventional dry powder technologies. We acquired the ARCUS technology platform as part of our 2014 acquisition of Civitas Therapeutics. We have worldwide rights to our ARCUS drug delivery technology, which is protected by extensive

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know-how and trade secrets and various U.S. and foreign patents, including patents that protect the Inbrija dry powder capsules beyond 2030. We have several patents listed in the Orange Book for Inbrija, including patents expiring between 2022 and 2032, and Inbrija is entitled to three years of new product exclusivity, through December 2021, as posted in the Orange book. We have patents in Europe for Inbrija expiring between 2022 and 2033. One of our European patents, EP 3090773B, has been opposed by an unnamed party. Inbrija also has 10 years of market exclusivity in Europe that is set to expire in 2029.

FDA and European Commission approvals of Inbrija were based on a clinical program that included approximately 900 people with Parkinson’s on a carbidopa/levodopa regimen experiencing OFF periods. The Phase 3 pivotal trial for Inbrija – SPAN-PD – was a 12-week, randomized, placebo controlled, double blind study evaluating the effectiveness of Inbrija in patients with mild to moderate Parkinson’s experiencing OFF periods. In January 2019, we announced that The Lancet Neurology published results from the SPAN-PD clinical trial.

The SPAN-PD trial met its primary endpoint, with patients showing a statistically significant improvement in motor function at the week 12 visit, as measured by a reduction in Unified Parkinson’s Disease Rating Scale (UPDRS) Part III score for Inbrija 84 mg (n=114) compared to placebo (n=112) at 30 minutes post-dose (-9.83 points and -5.91 points respectively; p=0.009). Onset of action was seen as early as 10 minutes. Maintenance of effect continued to 60 minutes post-dose, which is the longest time point assessed in the trial. UPDRS III is a validated scale, which measures Parkinson’s disease motor impairment.

The most common adverse reactions with Inbrija (at least 5% and greater than placebo) in the pivotal trial were cough (15% vs. 2%), upper respiratory tract infection (6% vs. 3%), nausea (5% vs. 3%) and discolored sputum (5% vs. 0%).

Inbrija was also studied in a Phase 3 long-term, active-controlled, randomized, open-label study (N=398) assessing safety and tolerability over one year. This study showed the average reduction in FEV1 (forced expiratory volume in 1 second) from baseline was the same (-0.1 L) for the Inbrija and observational cohorts. Patients with chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory disease within the last five years were excluded from this study.

Inbrija is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks.

It is not known if Inbrija is safe or effective in children.

Ampyra

Ampyra was approved by the FDA in January 2010 to improve walking in adults with multiple sclerosis. To our knowledge, Ampyra is the first drug approved for this indication. Efficacy was shown in people with all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). Ampyra became subject to competition from generic versions of Ampyra starting in late 2018 as a result of an adverse U.S. federal district court ruling that invalidated certain Ampyra Orange Book-listed patents. We have experienced a significant decline in Ampyra sales due to competition from several generic versions of Ampyra. Additional manufacturers may market generic versions of Ampyra, and we expect our Ampyra sales will continue to decline over time. Net revenue for Ampyra was $20.0 million for the quarter ended September 30, 2021 and $27.3 million for the quarter ended September 30, 2020.

License and Collaboration Agreement with Biogen

Ampyra is marketed as Fampyra outside the U.S. by Biogen International GmbH, or Biogen, under a license and collaboration agreement that we entered into in June 2009. Fampyra has been approved in a number of countries across Europe, Asia and the Americas. In May 2021, Biogen announced that Fampyra was approved by the National Medical Products Administration in China, and Biogen is evaluating commercial launch options in that country. Under our agreement with Biogen, we are entitled to receive double-digit tiered royalties on net sales of Fampyra and we are also entitled to receive additional payments based on achievement of certain regulatory and sales milestones. In November 2017, we announced a $40 million Fampyra royalty monetization transaction with HealthCare Royalty Partners, or HCRP. In return for the payment to us, HCRP obtained the right to receive these Fampyra royalties up to an agreed-upon threshold. Until this threshold is met, we will not receive Fampyra royalties although we retained the right to receive any potential future

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milestone payments. The HCRP transaction is accounted for as a liability, as described in Note 9 to our Consolidated Financial Statements included in this report.

Ampyra Patent Update

There are no patents listed in the Orange Book for Ampyra. Ampyra became subject to competition from generic versions of Ampyra starting in late 2018 as a result of an adverse U.S. federal district court ruling that invalidated certain Ampyra Orange Book-listed patents.

There are two European patents, EP 1732548 and EP 2377536, with claims directed to use of a sustained release dalfampridine composition (known under the trade name Fampyra in the European Union) to increase walking speed in a patient with multiple sclerosis. Both European patents are set to expire in 2025, absent any additional exclusivity granted based on regulatory review timelines. Nullity actions have been filed in Germany against both of the German national patents derived from EP 1732548 and EP 2377536 by ratiopharm GmbH, a generic manufacturer affiliated with Teva. Fampyra had 10 years of market exclusivity in the European Union that expired in July 2021.

We will vigorously defend our intellectual property rights.

ARCUS Product Development

We have been exploring opportunities for other proprietary products in which inhaled (pulmonary) delivery of medicine using our ARCUS drug delivery technology can provide a significant therapeutic benefit to patients. We believe there are potential opportunities with central nervous system, or CNS, as well as non-CNS, disorders.

Our ARCUS development had previously been focused on a program for acute treatment of migraine. We had been evaluating therapeutic candidates for their suitability to move forward with this program. Due to several corporate restructurings since 2017 and associated cost-cutting measures, including the corporate restructurings we announced in January and September 2021, we deferred consideration of further investment into potential new ARCUS applications in migraine or any other indication pending additional progress with the Inbrija commercial launch in the U.S. Although we have deferred internal investment in ARCUS programs, we are discussing potential collaborations with other companies that have expressed interest in formulating their novel molecules for pulmonary delivery with ARCUS, and feasibility studies are ongoing for a number of these opportunities.

Should we decide to proceed with any ARCUS development programs, we would be reliant on Catalent or another third party supplier for the manufacture of product for that program. Our global supply agreement with Catalent does not provide for the terms and conditions under which Catalent would supply any product or product candidate other than Inbrija. We would be unable to advance the development of any ARCUS inhaled therapeutic candidate unless Catalent is willing to manufacture the candidate for us on commercially reasonable terms, or we could identify another third party manufacturer that would be capable and willing to manufacture the candidate for us on commercially reasonable terms. Also, due to reductions in force, employee attrition and the 2021 sale of our Chelsea manufacturing operations, we believe we lack certain personnel needed for, and would need to hire replacements before continuing with, this research and development work.

Financial Guidance for 2021

We are providing the following guidance with respect to our 2021 financial performance:

 

Net revenue from the sale of Ampyra in 2021 is expected to range from $75 million to $85 million.

 

Operating expenses in 2021 are expected to range from $130 million to $140 million. This is a non-GAAP projection that excludes restructuring costs and share-based compensation charges, as more fully described below.

The projected range of operating expenses in 2021 specified above was not prepared in accordance with accounting principles generally accepted in the United States (GAAP) because this guidance excludes restructuring costs and share-based compensation charges. Due to the forward looking nature of this information, the amount of compensation charges needed to reconcile this measure to the most directly comparable GAAP financial measure is dependent on future changes in the market price of our common stock and is not available at this time. Non-GAAP financial measures are not an alternative for financial

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measures prepared in accordance with GAAP. However, we believe that the presentation of this non-GAAP financial measure, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because it excludes (i) expenses that pertain to corporate restructurings that are not routine to the operation of our business, and (ii) non-cash charges that are substantially dependent on changes in the market price of our common stock. We believe this non-GAAP financial measure helps indicate underlying trends in our business and is important in comparing current results with prior period results and understanding expected operating performance. Also, our management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage our business and to evaluate its performance.

Results of Operations

Three-Month Period Ended September 30, 2021 Compared to September 30, 2020

Net Product Revenues

Inbrija

For the three-month period ended September 30, 2020 we recognized product sales of Inbrija following receipt of product by companies in our distribution network, which primarily includes specialty pharmacy providers and ASD Specialty Healthcare, Inc. During the three-month period ended December 31, 2020, we completed the transition from a network of several specialty pharmacies to AllianceRx Walgreens Prime, or Walgreens, as the sole specialty pharmacy for U.S. sales of Inbrija, which we believe has potential benefits to patients and our business. We recognized net revenue from the sale of Inbrija of $7.8 million and $5.8 million for the three-month periods ended September 30, 2021 and 2020, respectively, an increase of $2.0 million or 34.4%. The increase in Inbrija net revenue was due to an increase in net volume of $3.3 million partially offset by discount and allowance adjustments of $1.3 million for the three-month period ended September 30, 2021.

Discounts and allowances which are included as an offset in net revenue consist of allowances for customer credits, including estimated chargebacks, rebates, returns and discounts. Discounts and allowances are recorded following shipment of our products to our customers. Adjustments are recorded for estimated chargebacks, rebates, and discounts. Discounts and allowances also consist of discounts provided to Medicare beneficiaries whose prescription drug costs cause them to be subject to the Medicare Part D coverage gap (i.e., the “donut hole”). Payment of coverage gap discounts is required under the Affordable Care Act, the health care reform legislation enacted in 2010. Discounts and allowances may increase as a percentage of sales as we enter into new managed care contracts in the future.

We believe that first and fourth quarter revenue for our products is subject to certain recurring seasonal factors relating to the commencement of a new calendar year. For example, some patients refill their prescriptions earlier ahead of the new year, in the fourth quarter, in anticipation of the year-end reset of health plan deductibles and the Medicare donut hole, or a year-end switch of their insurance plans or pharmacy benefit providers. Also, we believe that AllianceRx Walgreens Prime, the specialty pharmacy that we use for Inbrija distribution, may increase their Inbrija stock, within contractual limits, in anticipation of the holidays and new year. These factors may seasonally have a positive impact on fourth quarter revenues and a negative impact on first quarter revenues. Also, discounts and allowances typically are highest in the first quarter, and lowest in the fourth quarter, and when this occurs this increases fourth quarter revenues, and decreases first quarter revenues, on a relative basis.

Ampyra

We recognize product sales of Ampyra following receipt of product by companies in our distribution network, which primarily includes specialty pharmacy providers. We recognized net revenue from the sale of Ampyra of $20.0 million and $27.3 million for the three-month periods ended September 30, 2021 and 2020, respectively, a decrease of $7.3 million, or 26.7%. The net revenue decrease is due primarily to a decrease in net volume of $10.8 million partially offset by discount and allowance adjustments of $3.5 million for the three-month period ended September 30, 2021.

Discounts and allowances which are included as an offset in net revenue consist of allowances for customer credits, including estimated chargebacks, rebates, returns and discounts. Discounts and allowances are recorded following shipment of our products to our customers. Adjustments are recorded for estimated chargebacks, rebates, and discounts. Discounts and

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allowances also consist of discounts provided to Medicare beneficiaries whose prescription drug costs cause them to be subject to the Medicare Part D coverage gap (i.e., the “donut hole”). Payment of coverage gap discounts is required under the Affordable Care Act, the health care reform legislation enacted in 2010. Discounts and allowances may increase as a percentage of sales as we enter into managed care contracts in the future.

We believe that first and fourth quarter revenue for our products is subject to certain recurring seasonal factors relating to the commencement of a new calendar year. For example, some patients refill their prescriptions earlier ahead of the new year, in the fourth quarter, in anticipation of the year-end reset of health plan deductibles and the Medicare donut hole, or a year-end switch of their insurance plans or pharmacy benefit providers. Also, we believe specialty pharmacies may increase their Ampyra stock in anticipation of the holidays and new year. These factors may seasonally have a positive impact on fourth quarter revenues and a negative impact on first quarter revenues. Also, discounts and allowances typically are highest in the first quarter, and lowest in the fourth quarter, and when this occurs this increases fourth quarter revenues, and decreases first quarter revenues, on a relative basis.

Other Product Revenue

We recognized negligible revenue from the sale of other products for the three-month period ended September 30, 2021 as compared to $1.5 million for the three-month period ended September 30, 2020, a decrease of $1.5 million, or 98.6%.

Milestone Revenue

We recognized $0 million and $15 million in milestone revenue for the three-month periods ended September 30, 2021 and 2020, respectively.

Royalty Revenue

We recognized $3.6 million and $3.4 million in royalty revenue for the three-month periods ended September 30, 2021 and 2020, respectively, an increase of $0.2 million, or 5.9%.

Cost of Sales

We recorded cost of sales of $13.3 million for the three-month period ended September 30, 2021 as compared to $12.2 million for the three-month period ended September 30, 2020. Cost of sales for the three-month period ended September 30, 2021 consisted primarily of $13.0 million in inventory costs related to recognized revenues and $0.3 million in royalty fees based on net product shipments. Cost of sales for the three-month period ended September 30, 2020 consisted primarily of $8.8 million in inventory costs related to recognized revenues and $3.3 million in royalty fees based on net product shipments.

Amortization of intangibles

We recorded amortization of intangible asset related to Inbrija of $7.7 million for the three-month periods ended September 30, 2021 and 2020.

Research and Development

Research and development expenses for the three-month period ended September 30, 2021 were $1.9 million as compared to $5.7 million for the three-month period ended September 30, 2020, a decrease of approximately $3.8 million, or 66.7%. The decrease was primarily due to reductions in Civitas spending of $2.3 million due to the commercialization of Inbrija, reductions of $1.6 million due to restructuring and decrease in several programs to shift focus on Inbrija launch, partially offset by an increase of $0.1 million in research and development expenses.

Selling, General and Administrative

Sales and marketing expenses for the three-month period ended September 30, 2021 were $14.5 million compared to $21.9 million for the three-month period ended September 30, 2020, a decrease of approximately $7.4 million, or 33.8%. The

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decrease was primarily due to a decrease in marketing related spending of $5.9 million due to launch activities for Inbrija, and a decrease in overall salaries and benefits of $2.9 million, partially offset by a reclassification of departmental costs from general and administrative expenses of $1.4 million due to a change in the overhead expense allocation method.

General and administrative expenses for the three-month period ended September 30, 2021 were $15.1 million compared to $18.1 million for the three-month period ended September 30, 2020, a decrease of approximately $3.0 million, or 16.6%. The decrease was primarily due to an increase in legal expenses of $0.7 million and an increase of $2.2 million in restructuring costs, partially offset by a decrease in overall salaries and benefit costs of $3.7 million, a decrease in Civitas spending of $2.0 million due to the sale of the Chelsea facility manufacturing operations, and a decrease in other departmental spending of $0.2 million.

Change in Fair Value of Derivative Liability

A derivative liability was recorded in December 2019 as a result of the issuance of the 6.00% Convertible Senior Secured Notes due 2024. The derivative liability is measured at fair value on a quarterly basis and changes in the fair value are recorded in the consolidated statement of operations. We recorded income of $0.3 million due to the change in the fair value of the derivative liability for the three-month period ended September 30, 2021.

Changes in Fair Value of Acquired Contingent Consideration

As a result of the original spin out of Civitas from Alkermes, part of the consideration to Alkermes was a future royalty to be paid to Alkermes on Inbrija. Acorda acquired this contingent consideration as part of the Civitas acquisition. The fair value of that future royalty is assessed quarterly. We recorded a loss pertaining to changes in the fair value of our acquired contingent consideration of $2.2 million for the three-month period ended September 30, 2021 as compared to income of $23.6 million for the three-month period ended September 30, 2020. The changes in the fair-value of the acquired contingent consideration were primarily due to updates to certain revenue and expense forecast assumptions.

Other Expense, Net

Other expense, net was $7.2 million for the three-month periods ended September 30, 2021 and 2020, respectively.

Benefit/(Provision) from Income Taxes

For the three-month periods ended September 30, 2021 and 2020, the Company recorded a benefit from income taxes of $3.1 million and a provision of $(1.5) million, respectively. The effective income tax rates for the Company for the three-month periods ended September 30, 2021 and 2020 were 10.2% and 16.6%, respectively.

The variance in the effective tax rates for the three-month period ended September 30, 2021 as compared to the three-month period ended September 30, 2020 was due primarily to an increase in the valuation allowance offset by the benefit of net operating loss carryback under the CARES Act recorded at 21% to recover taxes paid at the previous statutory rate of 35%.

The Company continues to evaluate the realizability of its deferred tax assets on a quarterly basis and will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation, rulings by relevant tax authorities, the progress of ongoing tax audits and the regulatory approval of products currently under development. Any changes to the valuation allowance or deferred tax assets and liabilities in the future would impact the Company's income taxes.

The Company has ongoing state examinations in Massachusetts and New Jersey which cover multiple years. There have been no proposed adjustments at this stage of the examination.

The Minnesota examinations for 2016 and 2017 were closed during the quarter with no changes.

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Nine-Month Period Ended September 30, 2021 Compared to September 30, 2020


Net Product Revenues

 

Inbrija

 

We recognize product sales of Inbrija following receipt of product by companies in our distribution network, which primarily includes specialty pharmacy providers and ASD Specialty Healthcare, Inc. We recognized net revenue from the sale of Inbrija of $19.2 million and $14.9 million for the nine-month periods ended September 30, 2021 and September 30, 2020, respectively, an increase of $4.3 million, or 28.9%. The increase in Inbrija net revenue was due to an increase in net volume of $6.1 million partially offset by discount and allowance adjustments of $1.8 million for the nine-month period ended September 30, 2021.

 

Discounts and allowances which are included as an offset in net revenue consist of allowances for customer credits, including estimated chargebacks, rebates, returns and discounts. Discounts and allowances are recorded following shipment of our products to our customers. Adjustments are recorded for estimated chargebacks, rebates, and discounts. Discounts and allowances also consist of discounts provided to Medicare beneficiaries whose prescription drug costs cause them to be subject to the Medicare Part D coverage gap (i.e., the “donut hole”). Payment of coverage gap discounts is required under the Affordable Care Act, the health care reform legislation enacted in 2010. Discounts and allowances may increase as a percentage of sales as we enter into managed care contracts in the future.

 

 

We believe that first and fourth quarter revenue for our products is subject to certain recurring seasonal factors relating to the commencement of a new calendar year. For example, some patients refill their prescriptions earlier ahead of the new year, in the fourth quarter, in anticipation of the year-end reset of health plan deductibles and the Medicare donut hole, or a year-end switch of their insurance plans or pharmacy benefit providers. Also, we believe that AllianceRx Walgreens Prime, the specialty pharmacy that we use for Inbrija distribution, may increase their Inbrija stock, within contractual limits, in anticipation of the holidays and new year. These factors may seasonally have a positive impact on fourth quarter revenues and a negative impact on first quarter revenues. Also, discounts and allowances typically are highest in the first quarter, and lowest in the fourth quarter, and when this occurs this increases fourth quarter revenues, and decreases first quarter revenues, on a relative basis.

Ampyra

 

We recognize product sales of Ampyra following receipt of product by companies in our distribution network, which primarily includes specialty pharmacy providers. We recognized net revenue from the sale of Ampyra of $62.0 million and $73.5 million for the nine-month periods ended September 30, 2021 and 2020, respectively, a decrease of $11.5 million, or 15.6%. The net revenue decrease is due primarily to decreased net volume of $17.6 million partially offset by discount and allowance adjustments of $6.4 million. Net revenue from sales of Ampyra decreased for the nine-month period ended September 30, 2021 compared to the nine-month period ended September 30, 2020 due to the entry of generic versions of Ampyra as a result of the invalidation of certain of our Ampyra patents in 2017.

 

Discounts and allowances which are included as an offset in net revenue consist of allowances for customer credits, including estimated chargebacks, rebates, returns and discounts. Discounts and allowances are recorded following shipment of our products to our customers. Adjustments are recorded for estimated chargebacks, rebates, and discounts. Discounts and allowances also consist of discounts provided to Medicare beneficiaries whose prescription drug costs cause them to be subject to the Medicare Part D coverage gap (i.e., the “donut hole”). Payment of coverage gap discounts is required under the Affordable Care Act, the health care reform legislation enacted in 2010. Discounts and allowances may increase as a percentage of sales as we enter into managed care contracts in the future.

 

We believe that first and fourth quarter revenue for our products is subject to certain recurring seasonal factors relating to the commencement of a new calendar year. For example, some patients refill their prescriptions earlier ahead of the new year, in the fourth quarter, in anticipation of the year-end reset of health plan deductibles and the Medicare donut hole, or a year-end switch of their insurance plans or pharmacy benefit providers. Also, we believe specialty pharmacies may increase their Ampyra stock in anticipation of the holidays and new year. These factors may seasonally have a positive impact on fourth quarter revenues and a negative impact on first quarter revenues. Also, discounts and allowances typically are highest in the first quarter, and lowest in the fourth quarter, and when this occurs this increases fourth quarter revenues, and decreases first quarter revenues, on a relative basis.

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Other Product Revenues

 

We recognized negligible revenue from the sale of other products for the nine-month period ended September 30, 2021 as compared to $1.7 million for the nine-month period ended September 30, 2020.

 

Milestone Revenue

 

We recognized $0 million and $15 million in milestone revenue for the nine-month periods ended September 30, 2021 and 2020, respectively.

 

Royalty Revenue

 

We recognized $10.8 million and $9.7 million in royalty revenue for the nine-month periods ended September 30, 2021 and 2020, respectively related to ex-U.S. sales of Fampyra by Biogen.

 

Cost of Sales

 

We recorded cost of sales of $36.6 million for the nine-month period ended September 30, 2021 as compared to $22.7 million for the nine-month period ended September 30, 2020. Cost of sales for the nine-month period ended September 30, 2021 consisted primarily of $34.4 million in inventory costs related to recognized revenues, $0.8 million in royalty fees based on net product shipments, idle capacity costs of $0.1 million, and $1.3 million in period costs related to expired inventory, freight, stability testing, and packaging. Cost of sales for the nine-month period ended September 30, 2020 consisted primarily of $18.6 million in inventory costs related to recognized revenues and $3.8 million in royalty fees based on net product shipments.

 

Amortization of intangibles

 

We recorded amortization of intangible asset related to Inbrija of $23.1 million for the nine-month periods ended September 30, 2021 and September 30, 2020.

 

Research and Development

 

Research and development expenses for the nine-month period ended September 30, 2021 were $9.1 million as compared to $18.7 million for the nine-month period ended September 30, 2020, a decrease of approximately $9.6 million, or 51.3%. The decrease was due primarily to reductions in Civitas spending of $4.9 million due to the commercialization of Inbrija, reductions of $4.6 million due to restructuring and decrease in several programs to shift focus on Inbrija launch, and reductions of $0.1 million in research and development expenses.

 

Selling, General and Administrative

 

Sales and marketing expenses for the nine-month period ended September 30, 2021 were $44.4 million compared to $65.2 million for the nine-month period ended September 30, 2020, a decrease of approximately $20.8 million, or 31.9%. The decrease was attributable primarily to a decrease in overall salaries and benefits of $7.9 million, a decrease in Inbrija spending of $13.2 million, and a decrease in marketing for Ampyra of $1.1 million, partially offset by a reclassification of departmental costs from general and administrative expenses of $1.4 million due to a change in the overhead expense allocation method.

 

General and administrative expenses for the nine-month period ended September 30, 2021 were $51.6 million compared to $54.5 million for the nine-month period ended September 30, 2020, a decrease of $2.9 million, or 5.3%. The decrease was primarily due to an increase in legal expenses of $4.9 million, an increase in restructuring costs of $4.0 million, and an increase of $1.3 million in other departmental spending, partially offset by a decrease in overall salaries and benefit costs of $7.3 million and a decrease in Civitas spending of $5.8 million due to the sale of the Chelsea facility manufacturing operations.

 

Change in Fair Value of Derivative Liability

 

A derivative liability was recorded in December 2019 as a result of the issuance of the 6.00% Convertible Senior Secured Notes due 2024. The derivative liability is measured at fair value on a quarterly basis and changes in the fair value

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are recorded in the consolidated statement of operations. We recorded income of $0.9 million due to the change in the fair value of the derivative liability for the nine-month period ended September 30, 2021.

 

Changes in Fair Value of Acquired Contingent Consideration

 

As a result of the original Civitas spin out of Alkermes, part of the consideration to Alkermes was a future royalty to be paid to Alkermes on Inbrija. Acorda acquired this contingent consideration as part of the Civitas acquisition. The fair value of that future royalty is assessed quarterly. We recorded an income pertaining to changes in the fair-value of acquired contingent consideration of $4.2 million for the nine-month period ended September 30, 2021 as compared to $33.5 million for the nine-month period ended September 30, 2020. The changes in the fair-value of the acquired contingent consideration were primarily due to updates to certain product revenue and expense forecast assumptions.

 

Other Expense, Net

 

Other expense, net was $22.7 million for the nine-month period ended September 30, 2021 as compared to $21.8 million for the nine-month period ended September 30, 2020. The change was due primarily to a decrease in gain on disposal of property and equipment of $0.2 million and a reduction in interest income of $0.8 million, partially offset by a decrease in amortization of debt discount expense of $0.1 million.

 

Benefit from Income Taxes

 

For the nine-month periods ended September 30, 2021 and 2020, the Company recorded a benefit of $6.8 million and a benefit of $5.0 million for income taxes, respectively. The effective income tax rates for the Company for the nine-month periods ended September 30, 2021 and 2020 were 7.53% and 23.07%, respectively. The variance in the effective tax rates for the nine-month period ended September 30, 2021 as compared to the nine-month period ended September 30, 2020 was due primarily to the valuation allowance recorded on deferred tax assets for which no tax benefit can be recognized, forfeitures of equity based awards and the benefit recorded on the net operating loss carryback under the CARES Act recorded at 21% to recover taxes paid at the previous statutory rate of 35%.

 

The Company continues to evaluate the realizability of its deferred tax assets on a quarterly basis and will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation, rulings by relevant tax authorities, the progress of ongoing tax audits and the regulatory approval of products currently under development. Any changes to the valuation allowance or deferred tax assets and liabilities in the future would impact the Company's income taxes.

 

The Company has ongoing state examinations in Massachusetts and New Jersey which cover multiple years. There have been no proposed adjustments at this stage of the examination.

The Minnesota examinations for 2016 and 2017 were closed during the quarter with no changes.

Liquidity and Capital Resources

Since our inception, we have financed our operations primarily from: private placements and public offerings of our capital stock; borrowing money through loans and the issuance of debt instruments; payments received under our collaboration and licensing agreements; revenue from sales of Ampyra, Fampyra, and Inbrija, as well as our former products, Zanaflex and Qutenza; royalty monetizations and our revenue interest financing arrangement; and, to a lesser extent, funding from government grants. Also, in February 2021, we obtained additional capital from the sale of our Chelsea manufacturing operations.

At September 30, 2021, we had $36.2 million of cash and cash equivalents, compared to $71.4 million at December 31, 2020. Our September 30, 2021 cash and cash equivalents balance does not include restricted cash, currently held in escrow under the terms of our convertible senior secured notes due 2024, further described below under Financing Arrangements, which may potentially be released from escrow if we pay interest on those notes using shares of our common stock. We incurred a net loss of $83.4 million and $99.6 million for the nine-month period ended September 30, 2021 and the year ended December 31, 2020.

Our future capital requirements will depend on a number of factors, including:

 

the amount of revenue generated from sales of Inbrija and Ampyra;

36


 

 

 

our ability to manage operating expenses;

 

the amount and timing of purchase price, milestone or other payments that we may owe or have a right to receive under collaboration, license, asset sale, acquisition, or other agreements or transactions; and the extent to which the terms and conditions of our convertible senior secured notes due 2024 restrict or direct our use of proceeds from such transactions;

 

our ability to make required payments relating to our convertible senior secured notes due 2024 (the “2024 Notes”), as described below under Financing Arrangements, using shares of our common stock rather than cash;

 

the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims and other intellectual property rights; and

 

capital required or used for future acquisitions, to in-license new products, programs or compounds, or for research and development relating to existing or future acquired or in-licensed programs or compounds.

Our ability to meet our future operating requirements, repay our liabilities, and meet our other obligations are dependent upon a number of factors, including our ability to generate cash from product sales, reduce planned expenditures, and obtain additional financing. If we are unable to generate sufficient cash flow from the sale of our products, we may be required to adopt one or more alternatives, subject to the restrictions contained in the indenture governing our 2024 Notes, such as further reducing expenses, selling assets, restructuring debt, or obtaining additional equity capital on terms that may be onerous and which are likely to be highly dilutive. Also, our ability to raise additional capital and repay or restructure our indebtedness will depend on the capital markets and our financial condition at such time, among other factors. In addition, financing may not be available when needed, at all, on terms acceptable to us or in accordance with the restrictions described above.

Financing Arrangements

Convertible Senior Secured Notes Due 2024

On December 24, 2019, the Company completed the private exchange of $276.0 million aggregate principal amount of then-outstanding 1.75% Convertible Senior Notes due 2021 (the “2021 Notes”) for a combination of newly-issued 6.00% Convertible Senior Secured Notes due 2024 (the “2024 Notes”) and cash. For each $1,000 principal amount of exchanged 2021 Notes, the Company issued $750 principal amount of the 2024 Notes and made a cash payment of $200 (the “Exchange”). In the aggregate, the Company issued approximately $207.0 million aggregate principal amount of the 2024 Notes and paid approximate $55.2 million in cash to participating holders. The Exchange was conducted with a limited number of institutional holders of the 2021 Notes pursuant to Exchange Agreements dated as of December 20, 2019 (each, an “Exchange Agreement”).

The 2024 Notes were issued pursuant to an Indenture, dated as of December 23, 2019, among the Company, its wholly owned subsidiary, Civitas Therapeutics, Inc. (along with any domestic subsidiaries acquired or formed after the date of issuance, the “Guarantors”), and Wilmington Trust, National Association, as trustee and collateral agent (the “2024 Indenture”). The 2024 Notes are senior obligations of the Company and the Guarantors, secured by a first priority security interest in substantially all of the assets of the Company and the Guarantors, subject to certain exceptions described in the Security Agreement, dated as of December 23, 2019, between the grantors party thereto and Wilmington Trust, National Association, as collateral agent (the “Security Agreement”).

The 2024 Notes will mature on December 1, 2024 unless earlier converted in accordance with their terms prior to such date. Interest on the 2024 Notes is payable semi-annually in arrears at a rate of 6.00% per annum on each June 1 and December 1, beginning on June 1, 2020. The Company may elect to pay interest in cash or shares of the Company’s common stock, subject to the satisfaction of certain conditions. If the Company elects to pay interest in shares of common stock, such common stock will have a per share value equal to 95% of the daily volume-weighted average price for the 10 trading days ending on and including the trading day immediately preceding the relevant interest payment date. In June 2021, the Company issued 1,635,833 shares of common stock in satisfaction of the interest payable to holders of the 2024 Notes on June 1, 2021. In connection with this stock-based interest payment approximately $6.2 million of accrued interest was released from restricted case and became available to the Company for other purposes.

37


 

The 2024 Notes are convertible at the option of the holder into shares of common stock of the Company at any time prior to the close of business on the second scheduled trading day immediately preceding the maturity date. The adjusted conversion rate for the 2024 Notes is 47.6190 shares of the Company’s common stock per $1,000 principal amount of 2024 Notes, representing an adjusted conversion price of approximately $21.00 per share of common stock. The conversion rate was adjusted to reflect the 1-for-6 reverse stock split effected on December 31, 2020 and is subject to additional adjustments in certain circumstances as described in the 2024 Indenture.

The Company may elect to settle conversions of the 2024 Notes in cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock. Holders who convert their 2024 Notes prior to June 1, 2023 (other than in connection with a make-whole fundamental change) will also be entitled to an interest make-whole payment equal to the sum of all regularly scheduled stated interest payments, if any, due on such 2024 Notes on each interest payment date occurring after the conversion date for such conversion and on or before June 1, 2023. In addition, the Company will have the right to cause all 2024 Notes then outstanding to be converted automatically if the volume-weighted average price per share of the Company’s common stock equals or exceeds 130% of the adjusted conversion price for a specified period of time and certain other conditions are satisfied.

Holders of the 2024 Notes will have the right, at their option, to require the Company to purchase their 2024 Notes if a fundamental change (as defined in the 2024 Indenture) occurs, in each case, at a repurchase price equal to 100% of the principal amount of the 2024 Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date. If a make-whole fundamental change occurs, as described in the 2024 Indenture, and a holder elects to convert its 2024 Notes in connection with such make-whole fundamental change, such holder may be entitled to an increase in the adjusted conversion rate as described in the 2024 Indenture.

Subject to a number of exceptions and qualifications, the 2024 Indenture restricts the ability of the Company and certain of its subsidiaries to, among other things, (i) pay dividends or make other payments or distributions on their capital stock, or purchase, redeem, defease or otherwise acquire or retire for value any capital stock, (ii) make certain investments, (iii) incur indebtedness or issue preferred stock, other than certain forms of permitted debt, which includes, among other items, indebtedness incurred to refinance the 2021 Notes, (iv) create liens on their assets, (v) sell their assets, (vi) enter into certain transactions with affiliates or (vii) merge, consolidate or sell of all or substantially all of their assets. The 2024 Indenture also requires the Company to make an offer to repurchase the 2024 Notes upon the occurrence of certain asset sales.

The 2024 Indenture provides that a number of events will constitute an event of default, including, among other things, (i) a failure to pay interest for 30 days, (ii) failure to pay the 2024 Notes when due at maturity, upon any required repurchase, upon declaration of acceleration or otherwise, (iii) failure to convert the 2024 Notes in accordance with the 2024 Indenture and the failure continues for five business days, (iv) not issuing certain notices required by the 2024 Indenture within a timely manner, (v) failure to comply with the other covenants or agreements in the 2024 Indenture for 60 days following the receipt of a notice of non-compliance, (vi) a default or other failure by the Company to make required payments under other indebtedness of the Company or certain subsidiaries having an outstanding principal amount of $30.0 million or more, (vii) failure by the Company or certain subsidiaries to pay final judgments aggregating in excess of $30.0 million, (viii) certain events of bankruptcy or insolvency and (ix) the commercial launch in the United States of a product determined by the U.S. FDA to be bioequivalent to Inbrija. In the case of an event of default arising from certain events of bankruptcy or insolvency with respect to the Company, all outstanding 2024 Notes will become due and payable immediately without further action or notice. If any other event of default occurs and is continuing, the trustee or the holders of at least 25% in aggregate principal amount of the then outstanding 2024 Notes may declare all the notes to be due and payable immediately.

The 2021 Notes received by the Company in the Exchange were cancelled in accordance with their terms. Accordingly, upon completion of the Exchange, $69.0 million of the 2021 Notes remained outstanding.

The Company assessed all terms and features of the 2024 Notes in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the 2024 Notes, including the conversion, put and call features. The Company concluded the conversion features required bifurcation as a derivative. The fair value of the conversion feature derivative was determined based on the difference between the fair value of the 2024 Notes with the conversion options and the fair value of the 2024 Notes without the conversion options using a binomial model. The Company determined that the fair value of the derivative upon issuance of the 2024 Notes was $59.4 million and recorded this amount as a derivative liability with an offsetting amount as a debt discount as a reduction to the carrying value of the 2024 Notes on the closing date, or December 24, 2019. There are several embedded features within the 2024 Notes which, upon issuance, did not meet the conditions for equity classification. As a

38


 

result, these features were aggregated together and recorded as the derivative liability conversion option. The conversion feature is measured at fair value on a quarterly basis and the changes in the fair value of the conversion feature for the period will be recognized in the consolidated statements of operations.

The Company received stockholder approval on August 28, 2020 to increase the number of authorized shares of the Company’s common stock from 13,333,333 shares to 61,666,666 shares. As a result of the share approval, the Company determined that multiple embedded conversion options met the conditions for equity classification. The Company performed a valuation of these conversion options as of September 17, 2020, which was the date the Company completed certain securities registration obligations. The resulting fair value of these conversion options was $18.3 million, which was reclassified to equity and presented in the statement of stockholder’s equity as of September 30, 2020, net of the $4.4 million tax impact. The equity component is not re-measured as long as it continues to meet the conditions for equity classification. The Company performed a valuation of the derivative liability related to certain embedded conversion features that are precluded from equity classification. The fair value of these conversion features was calculated to be $0.3 million, representing a change of $0.9 million that is recognized in the consolidated statement of operations for the nine-month period ended of September 30, 2021.

The outstanding 2024 Note balance as of September 30, 2021 consisted of the following:

 

(In thousands)

 

September 30, 2021

 

Liability component:

 

 

 

 

Principal

 

$

207,000

 

Less: debt discount and debt issuance costs, net

 

 

(59,553

)

Net carrying amount

 

$

147,447

 

Equity component

 

$

18,257

 

Derivative liability-conversion Option

 

$

325

 

Convertible Senior Notes Due 2021

In June 2014, the Company issued $345 million aggregate principal amount of 1.75% Convertible Senior Notes due 2021 (the “2021 Notes”). On December 24, 2019, the Company completed the private exchange of $276.0 million aggregate principal amount of then-outstanding 2021 Notes for a combination of newly-issued 6.00% Convertible Senior Secured Notes due 2024 and cash. Accordingly, upon completion of the exchange, $69.0 million of the 2021 Notes remained outstanding. On June 15, 2021, the Company repaid the outstanding balance of the 2021 Notes at their maturity date using cash on hand.

Non-Convertible Capital Loans

Non-convertible capital loans were granted by Business Finland (formerly Tekes), with an adjusted acquisition-date fair value of $20.5 million (€18.2 million) and a carrying value of $28.0 million as of September 30, 2021. The loans are composed of fourteen non-convertible loans. The loans bear interest based on the greater of 3% or the base rate set by Finland’s Ministry of Finance minus one (1) percentage point. The maturity dates for these loans range from eight to ten years from the date of issuance, however, according to certain terms and conditions of the loans, the Company may repay the principal and accrued and unpaid interest of the loans only when the consolidated retained earnings of Biotie is sufficient to fully repay the loans.

Research and Development Loans

Research and Development Loans (“R&D Loans”) were granted by Business Finland with an acquisition-date fair value of $2.9 million (€2.6 million) and a carrying value of $0.0 million as of September 30, 2021. The R&D Loans bear interest based on the greater of 1% or the base rate set by Finland’s Ministry of Finance minus three (3) percentage points. The repayment of these loans began in January 2017. The loan principal is paid in equal annual installments over a 5 year period, which ended January 2021.

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Cash, Cash Equivalents and Investments

At September 30, 2021, cash and cash equivalents were approximately $36.2 million, as compared to $71.4 million at December 31, 2020. Our cash equivalents consist of highly liquid investments with original maturities of three months or less at date of purchase and consist of investments in a Treasury money market fund. Also, we maintain cash balances with financial institutions in excess of insured limits. We do not anticipate any losses with respect to such cash balances. Our September 30, 2021 cash and cash equivalents balance does not include restricted cash, currently held in escrow under the terms of our convertible senior secured notes due 2024, further described above under Financing Arrangements, which may potentially be released from escrow if we pay interest on those notes using shares of our common stock.

Net Cash Used in Operations

Net cash used in operations was $44.6 million for the nine-month period ending September 30, 2021. Cash used by operations for the nine-month period ended September 30, 2021 was primarily due to net loss of $83.4 million, a change in acquired contingent consideration obligation of $4.2 million, non-cash royalty revenue of $8.9 million, deferred tax benefit of $6.8 million, a decrease in other non-current liabilities of $1.0 million, and a change in the derivative liability of $0.9 million. This was partially offset by share based compensation expense of $2.5 million, amortization of debt discount and debt issuance costs of $12.7 million, depreciation and amortization of $25.5 million, an increase in accounts payable, accrued expenses and other current liabilities of $4.9 million, a decrease in accounts receivable of $6.6 million, a decrease in inventory of $5.8 million, and a decrease in prepaid expenses and other assets of $2.6 million.

Net Cash Used in Investing

Net cash used in investing activities for the nine-month period ended September 30, 2021 was $0.2 million, which was due primarily to purchases of property and equipment and intangible assets of $0.2 million.

Net Cash Provided by Financing

Net cash provided by financing activities for the nine-month period ended September 30, 2021 was $4.3 million, which was primarily due to net proceeds from the sale of the Chelsea facility of $74.0 million, partially offset by the repayment of Convertible Senior Notes due in June 2021 of $69.0 million, and the repayment of loans payable of $0.7 million.

Contractual Obligations and Commitments

A summary of our minimum contractual obligations related to our material outstanding contractual commitments is included in Note 13 of our Annual Report on Form 10-K for the year ended December 31, 2020. Our long-term contractual obligations include commitments and estimated purchase obligations entered into in the normal course of business.

Under certain agreements, we are required to pay royalties or license fees and milestones for the use of technologies and products in our research and development activities and in the commercialization of products. The amount and timing of any of the foregoing payments are not known due to the uncertainty surrounding the successful research, development and commercialization of the products. As of September 30, 2021, we have inventory-related purchase commitments of approximately $0.7 million, as compared to $2.5 million as of September 31, 2020. Under our agreement with Catalent, we are obligated to make minimum purchase commitments for Inbrija through the expiration of the agreement on December 31, 2030. As of September 30, 2021, the minimum remaining purchase commitment to Catalent was $4 million through December 31, 2021, and $18 million annually each year thereafter.

Critical Accounting Policies and Estimates

Our critical accounting policies are detailed in our Annual Report on Form 10-K for the year ended December 31, 2020. Effective January 1, 2021, the Company adopted ASU 2019-12, “Simplifying the Accounting for Income Taxes” (Topic 740). Other than the adoption of the new accounting guidance, our significant accounting policies have not changed materially from December 31, 2020. 

40


 

 

Item 3.  Quantitative and Qualitative Disclosures About Market Risk

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this item.

Item 4.  Controls and Procedures

Evaluation of disclosure controls and procedures

As required by Rule 13a-15 under the Securities Exchange Act of 1934 (the Exchange Act) we carried out an evaluation of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of the end of the third quarter of 2021, the period covered by this report. This evaluation was carried out under the supervision and with the participation of our management, including our President and Chief Executive Officer and our Chief Financial Officer. Based on that evaluation, these officers have concluded that, as of September 30, 2021, our disclosure controls and procedures were effective to achieve their stated purpose.

Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules, regulations, and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is accumulated and communicated to management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding disclosure.

Change in internal control over financial reporting

In connection with the evaluation required by Exchange Act Rule 13a-15(d), our management, including our President and Chief Executive Officer and our Chief Financial Officer, concluded that there were no changes in our internal control over financial reporting during the quarter ended September 30, 2021, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Limitations on the effectiveness of controls

Our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within a company have been detected.

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PART II—OTHER INFORMATION

From time to time, we may be involved in litigation or other legal proceedings relating to claims arising out of operations in the normal course of our business, including the DRI matter described below. The outcome of litigation and other legal proceedings is unpredictable, and regardless of outcome, they can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.

On November 9, 2020, Drug Royalty III, L.P., and LSRC III S.ar.l. (collectively, “DRI”) filed an arbitration claim against us with the American Arbitration Association under a September 26, 2003 License Agreement that we originally entered into with Rush-Presbyterian St. Luke’s Medical Center (“Rush”). DRI previously purchased license royalty rights under the license agreement from Rush. DRI alleges a dispute over the last-to-expire patent covering sales of the drug Ampyra under the license agreement, and is claiming damages based on unpaid license royalties of $6 million plus interest. We believe we have valid defenses against this claim and intend to defend ourselves vigorously.

Item 1 of Part II of our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2021 and June 30, 2021 include prior updates to the legal proceeding described above.

Item 1A.  Risk Factors

In addition to the other information set forth 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, as updated in our Quarterly Reports subsequently filed during the current fiscal year, including this report, all of which could materially affect our business, financial condition and/or operating results. These risks are not the only risks facing our Company. 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.

Following is the restated text of certain risk factor changes since our publication of risk factors in our 2020 Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2021 and June 30, 2021.

Our restructurings and associated organizational changes may not adequately reduce our expenses, may lead to additional workforce attrition, and may cause operational disruptions.

In January and September 2021, we implemented corporate restructurings to reduce costs, more closely align operating expenses with expected revenue, and focus our resources on Inbrija (levodopa inhalation powder). As part of these restructurings, we substantially reduced employee headcount. Further restructuring activities may be required in the future, depending in particular on the rate of decline in our sales of Ampyra due to generic competition and whether we are able to sufficiently increase sales of Inbrija. Our restructurings may have other unintended consequences as well, including, for example, making it more difficult for us to attract and retain highly skilled personnel in a competitive environment (particularly given that we have implemented four corporate restructurings since 2017). We have recently experienced workforce attrition in various functions across our business, which may be attributable to our corporate restructurings, our current business circumstances, a combination of both, or other factors. Our efforts to adjust our operations with the reduced workforce may not be successful in preventing disruption to our business, and with the reduced workforce we lack redundancy in important functions across our business. We are increasingly relying on the services of a contract commercial organization to provide sales representatives in response to substantial sales force attribution. Further loss of one or more of our key employees, additional loss of multiple employees in particular functions, and/or our inability to attract replacement or additional qualified personnel could substantially impair our ability to operate our business and implement our business plan, particularly our efforts to successfully commercialize Inbrija.

Our inability to attract and retain key management and other personnel, or maintain access to expert advisors, may hinder our ability to execute our business plan.

We are highly dependent on the services of Dr. Ron Cohen, our President and Chief Executive Officer, as well as the other principal members of our management and scientific, regulatory, and commercial personnel. Our success depends in large part upon our ability to attract and retain highly qualified personnel with the knowledge and experience needed for these

42


 

and other areas of our business. We do not maintain "key man" life insurance policies on the lives of our officers, directors or employees.

We face intense competition in our hiring efforts with other pharmaceutical and biotechnology companies, as well as universities and nonprofit research organizations. We may be unable to attract or retain qualified personnel because their competitive salaries and other compensation may increase to levels that we are unwilling or unable to provide. In addition, material adverse developments with our business, including the 2017 adverse patent decision relating to our Orange Book-listed Ampyra patents, the termination or suspension of research and development programs, four reductions in force since 2017, and the current progress of our Inbrija commercial launch, may impede our ability to attract and retain highly qualified personnel. We have recently experienced workforce attrition in various functions across our business, which may be attributable to one or more of the factors described above or other factors. Our efforts to adjust our operations with the reduced workforce may not be successful in preventing disruption to our business, and with the reduced workforce we lack redundancy in important functions across our business. We are increasingly relying on the services of a contract commercial organization to provide sales representatives in response to substantial sales force attribution. Further loss of one or more of our key employees, additional loss of multiple employees in particular functions, and/or our inability to attract replacement or additional qualified personnel could substantially impair our ability to operate our business and implement our business plan, particularly our efforts to successfully commercialize Inbrija. Also, due to the recent attrition, four reductions in force since 2017, and our 2021 sale of our Chelsea manufacturing operations, we believe we lack personnel needed for, and would need to hire replacements before continuing with, research and development and clinical programs. Our inability to attract qualified replacements needed for research and development and clinical programs could substantially impair our ability to advance those programs, if we determine to make further investments in those programs.

We also have scientific, medical, clinical, marketing and other advisors who assist us in our research and development, clinical, and commercial strategies. These advisors are not our employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us. Similarly, they may have arrangements with other companies to assist in the development and commercialization of products that may compete with ours.

Item 2.  Unregistered Sales of Equity Securities and Use of Proceeds

This table provides information about our purchases of shares of Company stock during the three-month period ended September 30, 2021.

 

 

 

 

Period

 

 

Total Number of Shares Purchased (1)

 

 

Average Price Paid per Share

Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs

Maximum Number (or Approximate Dollar Value) of Shares that May Yet Be Purchased Under the Plans or Programs

September 1-30, 2021

14,973

$4.38

-

-

August 1-31, 2021

-

-

-

-

July 1-31, 2021

-

-

-

-

Total

14,973

$4.38

-

-

 

 

(1)

Share repurchases reported in this column consist of shares of Acorda’s common stock withheld from employees in September 2021 to cover tax liability in connection with settlement of restricted stock units (14,973 shares) for an aggregate amount of $65,581.74.

Item 5.  Other Information

On November 12, 2021, Dr. Ron Cohen, our President and CEO, was granted options to purchase 100,000 shares of our common stock under our 2015 Omnibus Incentive Compensation Plan. The stock options have an exercise price equal to the closing price of our common stock on the grant date, vest over four years from the grant date in equal quarterly installments, and have a 10 year term. Our Board awarded these stock options after considering the current value of Dr. Cohen’s equity awards in light of the current market price of our common stock, and also reductions to Dr. Cohen’s compensation implemented in connection with our recent corporate restructuring. Based on these considerations, the Board awarded Dr. Cohen these options as an incentive to better align his long-term interests with those of our stockholders and for

43


 

retention of his employment. These options will be taken into account by the Board in connection with any annual equity award program that is implemented in 2022.

44


 

Item 6.  Exhibits

 

Exhibit No.

 

Description

10.1*

 

Employment Agreement dated September 1, 2020, by and between the Company and Kerry Clem. Incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on 8-K filed on September 9, 2021.

 

31.1

 

Certification by the Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.

31.2

 

Certification by the Principal Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.

32.1

 

Certification by the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2

 

Certification by the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS

 

Inline XBRL Instance Document.

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document.

 

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

 

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document.

 

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document.

 

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

 

104

 

Cover Page Interactive Data File, formatted in Inline XBRL (included in Exhibit 101).

 

* Indicates management contract or compensatory plan or arrangement.

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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.

 

 

Acorda Therapeutics, Inc.

 

 

 

By:

 

/s/ Ron Cohen

Date:  November 12, 2021

 

 

Ron Cohen, M.D.

President, Chief Executive Officer and Director

 

 

 

 

 

By:

 

/s/ Michael A. Gesser

Date:  November 12, 2021

 

 

Michael A. Gesser

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

 

46