Acorda Provides Update for First Quarter Ended March 31, 2019

May 2, 2019 10:00 UTC
  • INBRIJA™ (levodopa inhalation powder) commercially available on February 28; first and only FDA-approved inhaled levodopa for intermittent treatment of OFF episodes in people with Parkinson’s taking carbidopa/levodopa
  • INBRIJA 1Q 2019 net sales of $1.3 million; approximately 2,000 prescription request forms received through April 2019
  • AMPYRA® (dalfampridine) 1Q 2019 net sales of $40.1 million

ARDSLEY, N.Y.--(BUSINESS WIRE)-- Acorda Therapeutics, Inc. (NASDAQ: ACOR) provided a financial and pipeline update for the quarter ended March 31, 2019.

“Since INBRIJA became commercially available at the end of February, the feedback from both healthcare professionals and people with Parkinson’s, or PWPs, has been enthusiastic, and our Prescription Support Services center has received approximately 2,000 prescription requests. Our market research has consistently shown that both physicians and PWPs consider OFF periods one of the most troubling and disruptive aspects of Parkinson’s, and that they regard INBRIJA as having the potential to address this significant unmet need,” said Ron Cohen, M.D., Acorda's President and CEO. “We are currently meeting with insurers to discuss formulary placement. We are also continuing to roll out in-person and digital programs to educate healthcare professionals and PWPs about INBRIJA.”

First Quarter 2019 Financial Results

For the quarter ended March 31, 2019, the Company reported INBRIJA net revenue of $1.3 million. INBRIJA became commercially available on February 28, 2019.

For the quarter ended March 31, 2019, the Company reported AMPYRA net revenue of $40.1 million compared to $102.8 million for the same quarter in 2018. 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, 2019 were $16.0 million, including $0.7 million of share-based compensation compared to $30.6 million, including $1.7 million of share-based compensation for the same quarter in 2018.

Sales, general and administrative (SG&A) expenses for the quarter ended March 31, 2019 were $52.7 million, including $2.8 million of share-based compensation compared to $47.6 million, including $4.2 million of share-based compensation for the same quarter in 2018.

Benefit from income taxes for the quarter ended March 31, 2019 was $0.7 million compared to a provision for income taxes of $3.5 million for the same quarter in 2018.

The Company reported a GAAP net loss of $47.6 million for the quarter ended March 31, 2019, or $1.00 per diluted share. GAAP net loss in the same quarter of 2018 was $8.2 million, or $0.18 per diluted share.

Non-GAAP net loss for the quarter ended March 31, 2019 was $26.5 million, or $0.56 per diluted share. Non-GAAP net income in the same quarter of 2018 was $6.8 million, or $0.14 per diluted share. This quarterly non-GAAP net (loss) income measure, more fully described below under “Non-GAAP Financial Measures,” excludes share-based compensation charges, non-cash interest charges on our debt, and changes in the fair value of acquired contingent consideration. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At March 31, 2019, the Company had cash, cash equivalents and short-term investments of $343.3 million compared to $445.6 million at year end 2018. The decline in cash was due in large part to non-recurring payments of approximately $45 million that were made in the first quarter, primarily related to AMPYRA inventory purchases. The Company does not expect to purchase additional AMPYRA inventory in 2019.

For the remainder of 2019, the Company expects cash expenditures to align with normal operating activities, and continues to believe that it can become cash flow positive without raising additional capital, based on its long-term projections.

2019 Financial Guidance

  • During INBRIJA’s launch year, the Company does not expect to provide INBRIJA revenue guidance.
  • The Company will no longer provide revenue guidance for AMPYRA, due to the unpredictable trajectory of revenue decline given the entrance of generics.
  • R&D expenses for the full year 2019 are expected to be $70-$80 million and SG&A expenses for the full year 2019 are expected to be $200-$210 million. This guidance is a non-GAAP projection that excludes share-based compensation as more fully described below under “Non-GAAP Financial Measures.”

First Quarter 2019 Highlights

INBRIJA™ (levodopa inhalation powder)

  • In March, the Company submitted responses to the INBRIJA Marketing Authorization Application (MAA) Day 120 list of questions. A final decision from the European Commission is expected before the end of 2019. Acorda is seeking approval to market INBRIJA in the European Union.
  • In March, new one-year safety and exploratory efficacy outcomes data from the extension of the Phase 3 SPANSM-PD trial were presented at the Academy of Managed Care Pharmacy (AMCP) Managed Care & Specialty Pharmacy Annual Meeting.

Webcast and Conference Call

The Company will host a conference call today at 8:30 a.m. ET. To participate in the conference call, please dial (866) 393-4306 (domestic) or (734) 385-2616 (international) and reference the access code 4783943. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 11:30 a.m. ET on May 2, 2019 until 11:59 p.m. ET on June 2, 2019. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international); reference code 4783943. 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 2019 guidance for R&D and SG&A expenses 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, and (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods. 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 2019 guidance for R&D and SG&A expenses on a non-GAAP basis. Due to the forward looking nature of this information, the amount of compensation charges and benefits 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. The Company believes that these non-GAAP measures, when viewed in conjunction with our GAAP results, provide investors with a more meaningful understanding of our ongoing and projected R&D and SG&A expenses. Also, management uses these non-GAAP financial measures 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 Statement

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; 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; we may need to raise additional funds to finance our operations and may not be able to do so on acceptable terms; 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.

                     

Acorda Therapeutics, Inc.

Condensed Consolidated Balance Sheet Data

(in thousands)

(unaudited)

                     
        March 31,           December 31,
        2019           2018
                         
Assets                        
Cash, cash equivalents and short-term investments       $ 343,250           $ 445,553
Trade receivables, net         20,652             23,430
Other current assets         22,537             30,110
Inventories, net         31,465             29,014
Property and equipment, net         83,032             60,519
Goodwill         280,128             282,059
Intangible assets, net         425,777             428,570
Right of use assets         26,802            
Other assets         295             411
Total assets       $ 1,233,938           $ 1,299,666
                         
Liabilities and stockholders' equity                        
Accounts payable, accrued expenses and other current liabilities       $ 71,873           $ 125,741
Current portion of lease liability         7,458            
Current portion of royalty liability         9,173             8,985
Current portion of acquired contingent consideration         8,179             4,914
Current portion of loans payable         604             616
Convertible senior notes         321,210             318,670
Non-current portion of acquired contingent consideration         167,221             163,086
Non-current portion of lease liability         26,455            
Non-current portion of royalty liability         20,174             21,731
Non-current portion of loans payable         24,643             24,470
Deferred tax liability         5,401             7,483
Other long-term liabilities         4,961             11,987
Total stockholder's equity         566,586             611,983
Total liabilities and stockholders' equity       $ 1,233,938           $ 1,299,666
           

Acorda Therapeutics, Inc.

Consolidated Statements of Operations

(in thousands, except per share amounts)

(unaudited)

           
        Three Months Ended  
        March 31,  
        2019           2018  
                           
Revenues:                          
Net product revenues       $ 41,334           $ 103,003  
Royalty revenues         2,803             3,162  
Total revenues         44,137             106,165  
                           
Costs and expenses:                          
Cost of sales         8,799             20,634  
Research and development         16,028             30,560  
Selling, general and administrative         52,725             47,601  
Amortization of Intangible Asset         2,564             716  
Change in fair value of acquired                          
contingent consideration         7,400             6,200  
Total operating expenses         87,516             105,711  
                           
Operating (loss) income       $ (43,379 )         $ 454  
                           
Other expense, (net)         (4,941 )           (5,176 )
Loss before income taxes         (48,320 )           (4,722 )
Benefit from (Provision for) income taxes         715             (3,477 )
Net loss       $ (47,605 )         $ (8,199 )
                           
Net loss per common share - basic and diluted       $ (1.00 )         $ (0.18 )
Weighted average common shares - basic and diluted         47,472             46,529  
           

Acorda Therapeutics, Inc.

Non-GAAP Net (Loss) Income and Net (Loss) Income per Common Share Reconciliation

(in thousands, except per share amounts)

(unaudited)

           
        Three Months Ended  
        March 31,  
        2019         2018  
                         
GAAP net loss       $ (47,605 )       $ (8,199 )
Pro forma adjustments:                        
Non-cash interest expense (1)         4,717           4,003  
                         
Change in fair value of acquired                        
contingent consideration (2)         7,400           6,200  
                         
Share-based compensation expenses                        
included in Cost of Sales         150            
Share-based compensation expenses                        
included in R&D         701           1,705  
Share-based compensation expenses                        
included in SG&A         2,816           4,162  
Total share-based compensation expenses         3,667           5,867  
                         
Total pro forma adjustments         15,784           16,070  
                         
Income tax effect of reconciling items                        
above (3)         (5,343 )         1,077  
                         
Non-GAAP net (loss) income       $ (26,478 )       $ 6,794  
                         
Net (loss) income per common share - basic       $ (0.56 )       $ 0.15  
Net (loss) income per common share - diluted       $ (0.56 )       $ 0.14  
Weighted average common shares - basic         47,472           46,529  
Weighted average common shares - diluted         47,472           46,983  
(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) Represents the tax effect of the non-GAAP adjustments.
 

Contacts

Felicia Vonella
(914) 326-5146
fvonella@acorda.com

 

Source: Acorda Therapeutics, Inc.

Back to news