Acorda Reports First Quarter 2020 Financial Results and Provides Business Update

  • INBRIJA® (levodopa inhalation powder) 1Q 2020 net revenue of $4.4 million
  • AMPYRA® (dalfampridine) 1Q 2020 net revenue of $20.1 million
  • Reiterates 2020 AMPYRA net revenue guidance and operating expense guidance
  • Withdraws 2020 INBRIJA net revenue guidance due to the ongoing COVID-19 pandemic

ARDSLEY, N.Y.--()--Acorda Therapeutics, Inc. (NASDAQ: ACOR) today provided a business update and reported its financial results for the first quarter ended March 31, 2020.

“As we continue navigating the unprecedented operating environment created by COVID-19, our entire team remains focused on ensuring that the Parkinson’s disease and multiple sclerosis communities have continued access to Acorda’s critical medications,” said Ron Cohen, M.D., Acorda's President and Chief Executive Officer. “I am proud of how rapidly our team has evolved our business practices and developed new ways of working that enable us to keep our Acorda associates safe, while continuing to manufacture therapies that improve the lives of patients.”

Dr. Cohen continued, “Despite significant disruption in the healthcare sector during the first quarter, INBRIJA and AMPYRA sales were consistent with our expectations, which took into account typical seasonal variability. We remain confident in our full-year expectations for AMPYRA, which is an established franchise supported by ongoing prescription renewals. For INBRIJA, which is a newer product driven by growth in new prescriptions, we are withdrawing our 2020 guidance. Due to COVID-19 stay-at-home orders and a widespread decrease in physician office visits, we do not have visibility into how changes in patient behavior may impact new prescription starts over the remainder of the year.”

First Quarter 2020 Business Update

In response to the COVID-19 pandemic, Acorda launched a new, remote communications program, enabling it to communicate effectively and safely with healthcare professionals and patients to provide product education, information and support. The Company also launched virtual speaker programs and product webinars with meaningful attendance, including an Inbrija patient program that had over 500 participants. In addition, Acorda launched a new digital marketing program to drive awareness and educate people with Parkinson’s about INBRIJA.

First Quarter 2020 Financial Results

For the quarter ended March 31, 2020, the Company reported INBRIJA net revenue of $4.4 million, compared to $1.3 million for the same quarter in 2019.

For the quarter ended March 31, 2020, the Company reported AMPYRA net revenue of $20.1 million compared to $40.1 million for the same quarter in 2019. In September 2018, AMPYRA lost its exclusivity and generics entered the market. Consequently, the Company expects AMPYRA revenue to continue to decline.

Research and development (R&D) expenses for the quarter ended March 31, 2020 were $7.7 million, including $0.4 million of share-based compensation compared to $16.0 million, including $0.7 million of share-based compensation for the same quarter in 2019.

Sales, general and administrative (SG&A) expenses for the quarter ended March 31, 2020 were $41.1 million, including $1.5 million of share-based compensation compared to $52.7 million, including $2.8 million of share-based compensation for the same quarter in 2019.

Change in fair value of derivative liability for the quarter ended March 31, 2020 was $26.5 million compared to $0 for the same quarter in 2019.

Benefit from income taxes for the quarter ended March 31, 2020 was $7.0 million compared to a benefit from income taxes of $0.7 million for the same quarter in 2019.

The Company reported a GAAP net loss of $6.5 million for the quarter ended March 31, 2020, or $0.14 per diluted share. GAAP net loss in the same quarter of 2019 was $47.6 million, or $1.00 per diluted share.

Non-GAAP net loss for the quarter ended March 31, 2020 was $24.4 million, or $0.51 per diluted share. Non-GAAP net loss in the same quarter of 2019 was $26.5 million, or $0.56 per diluted share. This quarterly non-GAAP net loss measure, more fully described below under “Non-GAAP Financial Measures,” excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, asset impairment charges, changes in the fair value of the derivative liability, and expenses that pertain to a non-routine restructuring event. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At March 31, 2020, the Company had cash, cash equivalents, short-term investments and restricted cash of $126.3 million compared to $168.9 million at year end 2019. Restricted cash includes $42.7 million in escrow related to the 6% semi-annual interest portion, payable in cash or stock, of the convertible note exchange completed in December 2019. If the Company elects to pay interest due in stock, the restricted cash will be released from escrow.

2020 Financial Guidance

For the full-year 2020, Acorda continues to expect AMPYRA net revenue to be $85 - $110 million, and operating expenses to be $170 - $180 million. The operating expense guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation as more fully described below under “Non-GAAP Financial Measures.”

As a result of declines in physician office visits due to COVID-19 stay-at-home orders, the Company is withdrawing its previously announced 2020 INBRIJA net revenue guidance. This also necessitates the withdrawal of 2020 total net product revenue. Acorda continues to expect INBRIJA peak sales to be $300 - $500 million.

Webcast and Conference Call

The Company will host a conference call today at 4:30 p.m. ET. To participate in the conference call, please dial (833) 236-2756 (domestic) or (647) 689-4181 (international) and reference the access code 7999873. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 8:30 p.m. ET on May 5, 2020 until 11:59 p.m. ET on June 5, 2020. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 7999873. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Non-GAAP Financial Measures

This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net loss, adjusted to exclude the items below, and has provided 2020 operating expense guidance on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes the presentation of non-GAAP net loss, when viewed in conjunction with our GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our outstanding convertible debt which are in excess of the actual interest expense owing on such convertible debt, as well as non-cash interest related to the Fampyra monetization, and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (iv) asset impairment charges that are not routine to the operation of the business, (v) changes in the fair value of the derivative liability which is a non-cash charge and not related to the operation of the business, and (vi) expenses that pertain to a non-routine restructuring event. The Company believes its non-GAAP net loss measure helps indicate underlying trends in the Company's business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company's business and to evaluate its performance.

In addition to non-GAAP net loss, we have provided 2020 operating expense guidance on a non-GAAP basis, as the 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 these measures to the most directly comparable GAAP financial measures 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 measures prepared in accordance with GAAP. However, the Company believes 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 a non-routine restructuring, 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 the Company’s business and is important in comparing current results with prior period results and understanding expected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company's business and to evaluate its performance.

About Acorda Therapeutics

Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA™ (levodopa inhalation powder) is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa. 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. INBRIJA utilizes Acorda’s innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.

Forward-Looking Statements

This press release includes forward-looking statements. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: we may not be able to successfully market INBRIJA or any other products under development; the COVID-19 pandemic, including related quarantines and travel restrictions, and the potential for the illness to affect our 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; we may need to raise additional funds to finance our operations, repay outstanding indebtedness or satisfy other obligations, and we may not be able to do so on acceptable terms or at all; risks associated with complex, regulated manufacturing processes for pharmaceuticals, which could affect whether we have sufficient commercial supply of INBRIJA to meet market demand; third party payers (including governmental agencies) may not reimburse for the use of INBRIJA or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; competition for INBRIJA, AMPYRA and other products we may develop and market in the future, including increasing competition and accompanying loss of revenues in the U.S. from generic versions of AMPYRA (dalfampridine) 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 (levodopa inhalation powder) or from our 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 and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Financial Statements

Acorda Therapeutics, Inc.

Condensed Consolidated Balance Sheet Data

(in thousands)

(unaudited)

 

 

March 31,

 

 

December 31,

 

 

2020

 

 

2019

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

Cash, cash equivalents and short-term investments

$

82,894

 

 

$

125,839

 

Restricted cash - short term

 

13,175

 

 

 

12,836

 

Trade receivable, net

 

14,969

 

 

 

22,083

 

Other current assets

 

31,681

 

 

 

15,134

 

Inventories, net

 

25,566

 

 

 

25,221

 

Property and equipment, net

 

142,500

 

 

 

142,527

 

Intangible assets, net

 

390,311

 

 

 

402,329

 

Restricted cash - long term

 

30,270

 

 

 

30,270

 

Right of use assets

 

22,450

 

 

 

23,450

 

Other assets

 

11

 

 

 

29

 

Total assets

$

753,827

 

 

$

799,718

 

 

 

 

 

 

 

 

 

Liabilities and stockholders' equity

 

 

 

 

 

 

 

Accounts payable, accrued expenses and other current liabilities

$

49,041

 

 

$

65,335

 

Current portion of lease liability

 

7,846

 

 

 

7,746

 

Current portion of royalty liability

 

11,209

 

 

 

10,836

 

Current portion of contingent consideration

 

1,940

 

 

 

1,866

 

Current portion of loans payable

 

592

 

 

 

603

 

Convertible senior notes

 

195,349

 

 

 

192,774

 

Derivative liability related to conversion option

 

32,881

 

 

 

59,409

 

Non-current portion of acquired contingent consideration

 

74,460

 

 

 

78,434

 

Non-current portion of lease liability

 

21,757

 

 

 

22,995

 

Non-current portion of royalty liability

 

10,964

 

 

 

13,565

 

Non-current portion of loans payable

 

24,713

 

 

 

25,495

 

Deferred tax liability

 

16,391

 

 

 

9,581

 

Other long-term liabilities

 

10

 

 

 

259

 

Total stockholder's equity

 

306,674

 

 

 

310,820

 

Total liabilities and stockholders' equity

$

753,827

 

 

$

799,718

 

Acorda Therapeutics, Inc.

Consolidated Statements of Operations

(in thousands, except per share amounts)

(unaudited)

 

 

Three Months Ended

 

 

March 31,

 

 

2020

 

 

2019

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

Net product revenues

$

24,672

 

 

$

41,334

 

Royalty revenues

 

3,427

 

 

 

2,803

 

Total revenues

 

28,099

 

 

 

44,137

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

Cost of sales

 

3,843

 

 

 

8,799

 

Research and development

 

7,705

 

 

 

16,028

 

Selling, general and administrative

 

41,108

 

 

 

52,725

 

Amortization of Intangible Asset

 

7,691

 

 

 

2,564

 

Asset impairment

 

4,131

 

 

 

 

Change in fair value of derivative liability

 

(26,528

)

 

 

 

Change in fair value of acquired contingent consideration

 

(3,682

)

 

 

7,400

 

Total operating expenses

 

34,268

 

 

 

87,516

 

 

 

 

 

 

 

 

 

Operating loss

$

(6,169

)

 

$

(43,379

)

 

 

 

 

 

 

 

 

Other expense, (net)

 

(7,301

)

 

 

(4,941

)

Loss before income taxes

 

(13,470

)

 

 

(48,320

)

Benefit from income taxes

 

6,998

 

 

 

715

 

Net loss

$

(6,472

)

 

$

(47,605

)

 

 

 

 

 

 

 

 

Net loss per common share - basic and diluted

$

(0.14

)

 

$

(1.00

)

Weighted average common shares - basic and diluted

 

47,703

 

 

 

47,472

 

Acorda Therapeutics, Inc.

Non-GAAP Net Loss and Net Loss per Common Share Reconciliation

(in thousands, except per share amounts)

(unaudited)

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2020

 

 

2019

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss

$

(6,472

)

 

$

(47,605

)

 

Pro forma adjustments:

 

 

 

 

 

 

 

 

Non-cash interest expense (1)

 

4,054

 

 

 

4,717

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of acquired contingent consideration (2)

 

(3,682

)

 

 

7,400

 

 

 

 

 

 

 

 

 

 

 

Restructuring costs (3)

 

343

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Asset impairment charge (4)

 

4,131

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gain on change in fair value of derivative liability (5)

 

(26,528

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation expenses included in Cost of Sales

 

81

 

 

 

150

 

 

Share-based compensation expenses included in R&D

 

416

 

 

 

701

 

 

Share-based compensation expenses included in SG&A

 

1,479

 

 

 

2,816

 

 

Total share-based compensation expenses

 

1,976

 

 

 

3,667

 

 

 

 

 

 

 

 

 

 

 

Total pro forma adjustments

 

(19,706

)

 

 

15,784

 

 

 

 

 

 

 

 

 

 

 

Income tax effect of reconciling items above (6)

 

(1,820

)

 

 

(5,343

)

 

 

 

 

 

 

 

 

 

 

Non-GAAP net loss

$

(24,358

)

 

$

(26,478

)

 

 

 

 

 

 

 

 

 

 

Net loss per common share - basic and diluted

$

(0.51

)

 

$

(0.56

)

 

Weighted average common shares - basic and diluted

 

47,703

 

 

 

47,472

 

 

(1) Non-cash interest expense related to convertible senior notes, Biotie non-convertible and R&D loans and Fampyra royalty monetization.

(2) Changes in fair value of acquired contingent consideration related to the Civitas acquisition.

(3) Costs associated with a corporate restructuring initiative.

(4) Asset Impairment charge related to BTT1023 acquired in the Biotie acquisition.

(5) Reduction in the fair value of the derivative liability related to the 2024 convertible notes.

(6) Represents the tax effect of the non-GAAP adjustments.

 

Contacts

Tierney Saccavino
(917) 783-0251
tsaccavino@acorda.com

Contacts

Tierney Saccavino
(917) 783-0251
tsaccavino@acorda.com