UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 5, 2021
 
Acorda Therapeutics, Inc.
(Exact name of Registrant as Specified in Its Charter)

Delaware	001-31938	13-3831168		
(State or Other Jurisdiction
of Incorporation)	(Commission File Number)	(IRS Employer
Identification No.)		
 	 	 		
420 Saw Mill River Road,
Ardsley, NY	 	10502		
(Address of Principal Executive Offices)	 	(Zip Code)		
Registrant’s Telephone Number, Including Area Code: (914) 347-4300
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
 
☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)	
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)	
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))	
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))	
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class	 	Trading
Symbol(s)	 	Name of each exchange on which registered	
Common Stock (Par Value $0.001)	 	ACOR	 	Nasdaq Global Select Market	
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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. ☐

 

 
Item 2.02Results of Operations and Financial Condition
 
On August 5, 2021, Acorda Therapeutics, Inc. issued a press release announcing its financial performance for the second quarter ended June 30, 2021, its financial condition as of June 30, 2021, and financial guidance for 2021. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K, and incorporated by reference into this Item 2.02.
 
Item 9.01Financial Statements and Exhibits
 
(d) Exhibits

Exhibit No.
 	Description
 	
99.1	Press Release dated August 5, 2021	
104	Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)	

 

 
 
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 hereunto duly authorized.

 	Acorda Therapeutics, Inc.	
 	 	 	
August 5, 2021	By:	/s/ Robert Morales	
 	 	Name: Robert Morales	
 	 	Title: Vice President, Finance and Controller
and interim principal financial and accounting officer	

EXHIBIT 99.1

CONTACT:
Tierney Saccavino
(914) 326-5104
tsaccavino@acorda.com
 
FOR IMMEDIATE RELEASE
 
Acorda Therapeutics Reports Second Quarter 2021 Financial Results
 
 	•	INBRIJA® (levodopa inhalation powder) Q2 2021 net revenue of $6.4 million; 36% increase over Q2 2020	 	
 	•	AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg Q2 2021 net revenue of $21.8 million	 	
 	•	Agreement to commercialize INBRIJA in Spain with Esteve Pharmaceuticals	 	
 	•	$69 million of convertible senior notes repaid	 	
 
ARDSLEY, N.Y. – August 5, 2021 – Acorda Therapeutics, Inc. (Nasdaq: ACOR) today reported its financial results for the second quarter 2021.
 
“We were pleased to see a 36% increase in INBRIJA net sales in the second quarter of 2021 over the same period in 2020. We also saw increases in total prescriptions and dispensed cartons. As Inbrija is an on-demand medication and prescription can range from one to five boxes, we believe that dispensed cartons are the best indicator of demand for the product. These are encouraging signs that the impact of the pandemic is moderating, though it is still too early to project how long it will take for prescribing patterns to return to pre-pandemic levels,” said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. “We also were delighted to enter into an agreement with Esteve to commercialize INBRIJA in Spain, providing people with Parkinson’s access to this important medication to address their OFF periods. We also are in active discussions with several parties for commercialization of INBRIJA in other territories in Europe and the rest of the world.”
 
Second Quarter 2021 Financial Results
For the quarter ended June 30, 2021, the Company reported INBRIJA net revenue of $6.4 million, compared to $4.7 million for the same quarter in 2020.
 
For the quarter ended June 30, 2021, the Company reported AMPYRA net revenue of $21.8 million compared to $26.1 million for the same quarter in 2020. 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 June 30, 2021 were $2.4 million, including $0.2 million of share-based compensation compared to $5.3 million, including $0.4 million of share-based compensation for the same quarter in 2020.
 
Sales, general and administrative (SG&A) expenses for the quarter ended June 30, 2021 were $32.4 million, including $0.7 million of share-based compensation compared to $38.7 million, including $1.5 million of share-based compensation for the same quarter in 2020.
 
Change in fair value of derivative liability for the quarter ended June 30, 2021 was $(0.8) million compared to $(8.9) million for the same quarter in 2020.  
 
Benefit from income taxes for the quarter ended June 30, 2021 was $0.5 million compared to a provision for income taxes of $0.6 million for the same quarter in 2020.
 
The Company reported a GAAP net loss of $22.9 million for the quarter ended June 30, 2021, or $2.29 per diluted share. GAAP net loss in the same quarter of 2020 was $17.4 million, or $2.19 per diluted share.

Non-GAAP net loss for the quarter ended June 30, 2021 was $18.7 million, or $1.87 per diluted share. Non-GAAP net loss in the same quarter of 2020 was $16.6 million, or $2.08 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, changes in the fair value of derivative liability related to our 2024 convertible senior secured notes, and expenses that pertain to non-routine corporate restructurings. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.
 
At June 30, 2021, the Company had cash, cash equivalents, and restricted cash of $71 million, compared to $103 million at year end 2020. Restricted cash includes $25 million in escrow related to the 6% semi-annual interest portion, payable in cash or stock, of the 2024 convertible senior secured notes. If the Company elects to pay interest due in stock, the restricted cash will be released from escrow.
 
Financial Guidance
 	•	For the full-year 2021, Acorda continues to expect AMPYRA net revenue to be $75 - $85 million, and operating expenses to be $130 - $140 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.”	
 	•	Due to uncertainties caused by past and potential future impacts of the COVID-19 pandemic and other factors, the Company is not providing projected peak U.S. annual net revenue of INBRIJA at this time.	
 
Webcast
The Company will host a webcast in conjunction with its second quarter 2021 update and financial results today at 4:30 p.m. EDT.
 
 	•	To register for the webcast, use the link below:	 	
https://event.on24.com/wcc/r/3195872/22BFB32FE404D8CBC8AF8A39FB338F0E
 
Once you have registered, you will receive a confirmation email with webcast details. You will receive an email with the link to join the webcast 2 hours prior to the start time. The presentation will be available on the Investors section of www.acorda.com.
 
A replay of the call will be available from 7:30 p.m. EDT on May 6, 2021 until 11:59 p.m. EDT on June 3, 2021. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 2996776. 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 2021 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 that the presentation of non-GAAP net loss, when viewed in conjunction with actual 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 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 royalty 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) expenses that pertain to corporate restructurings which are not routine to the operation of the business, and (vi) changes in the fair value of derivative liability relating to the 2024 convertible senior secured notes, which is a non-cash charge and not related to the operation of the business. 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 2021 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 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 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 non-routine corporate restructurings, 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 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 AMPYRA, 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; 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 workforce, including our ability to realize the expected benefits of our corporate restructuring; 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 (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 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.
 
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Financial Statements
 
Acorda Therapeutics, Inc.
Condensed Consolidated Balance Sheet Data
(in thousands)

 	June 30,	 	 	December 31,	 	
 	2021	 	 	2020	 	
 	(unaudited)	 	 	 	 	 	
Assets	 	 	 	 	 	 	 	
Cash and cash equivalents	$	45,714	 	 	$	71,369	 	
Restricted cash - short term	 	12,883	 	 	 	12,917	 	
Trade receivable, net	 	14,010	 	 	 	20,193	 	
Other current assets	 	14,981	 	 	 	16,384	 	
Inventories, net	 	25,355	 	 	 	28,677	 	
Assets held for sale - current	 	—	 	 	 	71,795	 	
Property and equipment, net	 	5,715	 	 	 	7,263	 	
Intangible assets, net	 	351,481	 	 	 	366,981	 	
Restricted cash - long term	 	12,399	 	 	 	18,609	 	
Right of use assets, net	 	8,949	 	 	 	18,481	 	
Other assets	 	11	 	 	 	11	 	
    Total assets	$	491,498	 	 	$	632,680	 	

Liabilities and stockholders' equity	 	 	 	 	 	 	 	
Accounts payable, accrued expenses and other current liabilities	$	46,289	 	 	$	50,322	 	
Current portion of lease liability	 	10,708	 	 	 	7,944	 	
Current portion of royalty liability	 	9,205	 	 	 	8,731	 	
Current portion of contingent consideration	 	1,454	 	 	 	1,624	 	
Current portion of loans payable	 	—	 	 	 	68,631	 	
Convertible senior notes	 	144,025	 	 	 	137,619	 	
Derivative liability related to conversion option	 	613	 	 	 	1,193	 	
Non-current portion of acquired contingent consideration	 	39,746	 	 	 	46,576	 	
Non-current portion of lease liability	 	4,040	 	 	 	17,200	 	
Non-current portion of royalty liability	 	859	 	 	 	6,526	 	
Non-current portion of loans payable	 	28,302	 	 	 	28,555	 	
Deferred tax liability	 	15,109	 	 	 	19,116	 	
Other long-term liabilities	 	667	 	 	 	688	 	
Total stockholder's equity	 	190,481	 	 	 	237,955	 	
    Total liabilities and stockholders' equity	$	491,498	 	 	$	632,680	 	

 

 

 
Acorda Therapeutics, Inc.
Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)

 	Three Months Ended	 	 	Six Months Ended	 	
 	June 30,	 	 	June 30,	 	
 	2021	 	 	2020	 	 	2021	 	 	2020	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Revenues:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Net product revenues	$	28,199	 	 	$	30,794	 	 	$	53,446	 	 	$	55,465	 	
Royalty revenues	 	3,586	 	 	 	2,824	 	 	 	7,201	 	 	 	6,251	 	
Total net revenues	 	31,785	 	 	 	33,618	 	 	 	60,647	 	 	 	61,716	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Costs and expenses:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Cost of sales	 	11,324	 	 	 	6,658	 	 	 	23,285	 	 	 	10,501	 	
Research and development	 	2,374	 	 	 	5,255	 	 	 	7,123	 	 	 	12,960	 	
Selling, general and administrative	 	32,368	 	 	 	38,656	 	 	 	66,336	 	 	 	79,764	 	
Amortization of intangible assets	 	7,691	 	 	 	7,691	 	 	 	15,382	 	 	 	15,382	 	
Asset impairment	 	—	 	 	 	—	 	 	 	—	 	 	 	4,131	 	
Change in fair value of derivative liability	 	(805	)	 	 	(8,928	)	 	 	(580	)	 	 	(35,456	)	
Change in fair value of acquired
   contingent consideration	 	(5,478	)	 	 	(6,164	)	 	 	(6,429	)	 	 	(9,847	)	
Total operating expenses	 	47,474	 	 	 	43,168	 	 	 	105,117	 	 	 	77,435	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Operating loss	$	(15,689	)	 	$	(9,550	)	 	$	(44,470	)	 	$	(15,719	)	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Other expense, (net)	 	(7,706	)	 	 	(7,300	)	 	 	(15,528	)	 	 	(14,601	)	
Loss before income taxes	 	(23,395	)	 	 	(16,850	)	 	 	(59,998	)	 	 	(30,320	)	
(Provision for) benefit from income taxes	 	531	 	 	 	(571	)	 	 	3,683	 	 	 	6,427	 	
Net loss	$	(22,864	)	 	$	(17,421	)	 	$	(56,315	)	 	$	(23,893	)	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Net loss per common share - basic	$	(2.29	)	 	$	(2.19	)	 	$	(5.79	)	 	$	(3.00	)	
Net loss per common share - diluted	$	(2.29	)	 	$	(2.19	)	 	$	(5.79	)	 	$	(3.00	)	
Weighted average common shares - basic	 	9,992	 	 	 	7,960	 	 	 	9,733	 	 	 	7,960	 	
Weighted average common shares - diluted	 	9,992	 	 	 	7,960	 	 	 	9,733	 	 	 	7,960	 	

 

 

 

 
Acorda Therapeutics, Inc.
Non-GAAP Net Loss and Net Loss per Common Share Reconciliation
(in thousands, except per share amounts)
(unaudited)

 	Three Months Ended	 	 	Six Months Ended	 	
 	June 30,	 	 	June 30,	 	
 	2021	 	 	2020	 	 	2021	 	 	2020	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
GAAP net loss	$	(22,864	)	 	$	(17,421	)	 	$	(56,315	)	 	$	(23,893	)	
Pro forma adjustments:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
   Non-cash interest expense (1)	 	4,304	 	 	 	4,052	 	 	 	8,575	 	 	 	8,107	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
   Change in fair value of acquired
      contingent consideration (2)	 	(5,478	)	 	 	(6,164	)	 	 	(6,429	)	 	 	(9,847	)	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
   Restructuring costs (3)	 	27	 	 	 	—	 	 	 	2,151	 	 	 	343	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
   Asset impairment charge (4)	 	—	 	 	 	—	 	 	 	—	 	 	 	4,131	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
   Gain on change in fair value of derivative liability (5)	 	(805	)	 	 	(8,928	)	 	 	(580	)	 	 	(35,456	)	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
   Share-based compensation expenses
      included in Cost of Sales	 	9	 	 	 	86	 	 	 	16	 	 	 	167	 	
   Share-based compensation expenses
      included in R&D	 	208	 	 	 	448	 	 	 	374	 	 	 	864	 	
   Share-based compensation expenses
      included in SG&A	 	737	 	 	 	1,522	 	 	 	1,271	 	 	 	3,001	 	
       Total share-based compensation expenses	 	954	 	 	 	2,056	 	 	 	1,661	 	 	 	4,032	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Total pro forma adjustments	 	(998	)	 	 	(8,984	)	 	 	5,378	 	 	 	(28,690	)	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Income tax effect of reconciling items
  above (6)	 	(5,167	)	 	 	(9,835	)	 	 	(8,900	)	 	 	(11,655	)	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Non-GAAP net loss	$	(18,694	)	 	$	(16,570	)	 	$	(42,037	)	 	$	(40,928	)	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Net loss per common share - basic	$	(1.87	)	 	$	(2.08	)	 	$	(4.32	)	 	$	(5.14	)	
Net loss per common share - diluted	$	(1.87	)	 	$	(2.08	)	 	$	(4.32	)	 	$	(5.14	)	
Weighted average common shares - basic	 	9,992	 	 	 	7,960	 	 	 	9,733	 	 	 	7,960	 	
Weighted average common shares - diluted	 	9,992	 	 	 	7,960	 	 	 	9,733	 	 	 	7,960	 	
 
(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 non-routine corporate restructurings.	
(4) Asset Impairment charge related to the 2020 impairment of BTT1023 acquired in the Biotie acquisition.	
(5) Reduction in the fair value of the derivative liability related to the 2024 convertible senior secured notes.	
(6) Represents the tax effect of the non-GAAP adjustments.