Acorda Provides Financial and Pipeline Update for Second Quarter 2018

Date : 08/02/2018 @ 10:00AM
Source : Business Wire
Stock : Acorda Therapeutics, Inc. (ACOR)
Quote : 15.89  -0.45 (-2.75%) @ 5:21AM

Acorda Provides Financial and Pipeline Update for Second Quarter 2018

Acorda Therapeutics, Inc. (NASDAQ:ACOR)
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6 Months : From Jun 2018 to Dec 2018

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  • INBRIJA™ (levodopa inhalation powder) NDA under FDA review; PDUFA date October 5, 2018
  • AMPYRA® (dalfampridine) 2Q 2018 net sales of $150.3 million; reiterating 2018 guidance of $330-$350 million
  • Awaiting AMPYRA patent decision from U.S. Court of Appeals

Acorda Therapeutics, Inc. (Nasdaq: ACOR) provided a financial and pipeline update for the quarter ended June 30, 2018.

“Our outstanding quarter reflected the continued excellence of our specialty neurology sales force and commercial, patient advocacy and affiliated teams. Our primary focus now is on the approval and launch of INBRIJA, which will benefit from these same capabilities,” said Ron Cohen, M.D., Acorda's President and CEO. “We expect INBRIJA, if approved, to help address the large unmet medical need for the approximately 350,000 people in the U.S. who are challenged by OFF periods related to Parkinson’s disease. Based on our continued market research, we believe the market opportunity for INBRIJA in the U.S. is greater than $800 million.”

“The company’s strong execution year to date is fueling our ability to launch INBRIJA, to invest in the ARCUS pipeline and remain well capitalized throughout the INBRIJA launch,” Dr. Cohen continued.

Second Quarter 2018 Financial Results

AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg - For the quarter ended June 30, 2018, the Company reported AMPYRA net revenue of $150.3 million compared to $131.6 million for the same quarter in 2017.

Research and development (R&D) expenses for the quarter ended June 30, 2018 were $25.9 million, including $1.5 million of share-based compensation compared to $51.2 million, including $3.0 million of share-based compensation for the same quarter in 2017.

Sales, general and administrative (SG&A) expenses for the quarter ended June 30, 2018 were $44.3 million, including $3.7 million of share-based compensation compared to $49.3 million, including $7.8 million of share-based compensation for the same quarter in 2017.

Provision for income taxes for the quarter ended June 30, 2018 was $8.4 million compared to a provision for income taxes of $5.5 million for the same quarter in 2017.

The Company reported GAAP net income of $46.2 million for the quarter ended June 30, 2018, or $0.98 per diluted share. GAAP net loss in the same quarter of 2017 was $8.2 million, or $0.18 per diluted share.

Non-GAAP net income for the quarter ended June 30, 2018 was $65.9 million, or $1.40 per diluted share. Non-GAAP net income in the same quarter of 2017 was $13.3 million, or $0.29 per diluted share. This quarterly non-GAAP net income 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, and restructuring costs. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At June 30, 2018, the Company had cash, cash equivalents and short-term investments of $391.7 million.

Guidance for 2018

  • The Company reiterates AMPYRA 2018 net revenue guidance of $330-$350 million.
  • R&D expenses for the full year 2018 are expected to be $100-$110 million and include manufacturing expenses associated with INBRIJA. This guidance is a non-GAAP projection that excludes share-based compensation, as more fully described below under “Non-GAAP Financial Measures.”
  • SG&A expenses for the full year 2018 are expected to be $170-$180 million. This guidance is a non-GAAP projection that excludes share-based compensation, as more fully described below under “Non-GAAP Financial Measures.”
  • The Company expects to end 2018 with a year-end cash balance in excess of $300 million.
  • This guidance may be revised with a positive outcome of the pending appeal.

Second Quarter 2018 Updates

  • INBRIJA (levodopa inhalation powder)
  • The Company’s Marketing Authorization Application (MAA) for INBRIJA was validated by the European Medicines Agency (EMA) and the application currently is under review. After the adoption of an opinion on the application by the Agency’s Committee for Medicinal Products for Human Use (CHMP), a final decision regarding the MAA will be issued by the European Commission.
  • In June, the Company presented four INBRIJA abstracts at the 2nd Pan American Parkinson’s Disease and Movement Disorders Congress in Miami. These data were previously presented at the American Academy of Neurology Annual Meeting in April 2018.
  • AMPYRA Patent Appeal
  • In June, the oral argument in the AMPYRA patent litigation took place at the U.S. Court of Appeals for the Federal Circuit. The Company is awaiting the Court’s decision.
  • On July 24, the Federal Circuit denied the Company’s motion for a preliminary injunction to prevent generic at risk launch pending the Court’s decision.

Webcast and Conference Call

Acorda will host a conference call and webcast to review its 2Q18 update and financial results on Thursday, August 2 at 8:30 a.m. ET. To participate in the conference call, dial (866) 393-4306 (domestic) or (734) 385-2616 (international) and reference the access code 4898766. 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 August 2, 2018 until 11:59 p.m. ET on September 1, 2018. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international); reference code 4898766. 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 income, adjusted to exclude the items below, and has provided 2018 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 income, 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 charges related to the Fampyra royalty monetization, the asset based loan which was terminated in 2017 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) acquisition related expenses and related foreign currency gains that pertain to a non-recurring event, and (v) expenses that pertain to non-routine restructuring events. The Company believes its non-GAAP net income 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 income, we have provided 2018 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

Founded in 1995, Acorda Therapeutics is a biopharmaceutical company focused on developing therapies that restore function and improve the lives of people with neurological disorders. Acorda has a pipeline of novel neurological therapies addressing a range of disorders, including Parkinson’s disease and multiple sclerosis. Acorda markets two FDA-approved therapies, including 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: 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; our ability to successfully market and sell Ampyra (dalfampridine) Extended Release Tablets, 10 mg in the U.S., which will likely be materially adversely affected by the March 2017 court decision in our litigation against filers of Abbreviated New Drug Applications to market generic versions of Ampyra in the U.S.; 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; we may not be able to complete development of, obtain regulatory approval for, or 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, if it receives regulatory approval; third party payers (including governmental agencies) may not reimburse for the use of Ampyra, Inbrija or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; 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; competition; 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)

           

June 30,2018

December 31,2017

  Assets Cash, cash equivalents and short-term investments $ 391,716 $ 307,068 Trade receivable, net 64,360 81,403 Other current assets 17,329 15,726 Finished goods inventory 21,147 37,501 Property and equipment, net 42,524 36,669 Goodwill 284,100 286,611 Intangible assets, net 428,762 430,603 Other assets   678   2,388 Total assets $ 1,250,616 $ 1,197,969   Liabilities and stockholders' equity Accounts payable, accrued expenses and other current liabilities $ 113,161 $ 127,495 Current portion of deferred license revenue — 9,057 Current portion of royalty liability 7,081 6,763 Current portion of loans payable 629 645 Convertible senior notes 313,679 308,805 Contingent consideration 109,174 112,722 Non-current portion of deferred license revenue — 23,398 Non-current portion of royalty liability 26,102 29,025 Non-current portion of loans payable 24,698 25,670 Deferred tax liability 37,586 22,459 Other long-term liabilities 11,871 11,943 Total stockholder's equity   606,635   519,987 Total liabilities and stockholders' equity $ 1,250,616 $ 1,197,969  

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

         

Three Months EndedJune 30,

Six Months EndedJune 30,

  2018   2017 2018   2017   Revenues: Net product revenues $ 150,412 $ 132,756 $ 253,415 $ 245,349 Royalty revenues 2,890 4,418 6,052 8,946 License revenue   —   2,264   —   4,529 Total revenues 153,302 139,438 259,467 258,824   Costs and expenses: Cost of sales 31,094 29,665 52,444 54,848 Cost of license revenue — 159 — 317 Research and development 25,910 51,184 56,470 97,677 Selling, general and administrative 44,263 49,334 91,864 101,039 Acquisition related expenses — — — 320

Change in fair value of acquiredcontingent consideration

 

  (7,000 )   6,400   (800 )   17,200 Total operating expenses 94,267 136,742 199,978 271,401                 Operating income (loss) $ 59,035 $ 2,696 $ 59,489 $ (12,577 )   Other (expense) income, net   (4,482 )   (5,421 )   (9,658 )   (9,970 ) Income (loss) before income taxes 54,553 (2,725 ) 49,831 (22,547 ) Provision for income taxes   (8,356 )   (5,471 )   (11,833 )   (4,552 ) Net income (loss) $ 46,197 $ (8,196 ) $ 37,998 $ (27,099 )   Net income (loss) per common share - basic $ 0.99 $ (0.18 ) $ 0.82 $ (0.59 ) Net income (loss) per common share - diluted $ 0.98 $ (0.18 ) $ 0.81 $ (0.59 ) Weighted average common shares - basic 46,799 45,943 46,546 45,876 Weighted average common shares - diluted 47,201 45,943 46,974 45,876  

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

         

Three Months EndedJune 30,

Six Months EndedJune 30,

  2018   2017 2018   2017   GAAP net income (loss) $ 46,197 $ (8,196 ) $ 37,998 $ (27,099 ) Pro forma adjustments: Non-cash interest expense (1) 3,970 3,785 7,973 6,365   Change in fair value of acquired

contingent consideration (2)

(7,000 ) 6,400 (800 ) 17,200   Restructuring costs (3) 278 7,590 1,316 7,590   Acquisition related expenses (4) — — — 320   Unrealized foreign currency gain (5) — — — (247 )   Share-based compensation expenses

included in R&D

1,519 2,972 3,225 5,507 Share-based compensation expenses

included in SG&A

  3,725   7,772   7,887   13,108 Total share-based compensation expenses 5,244 10,744 11,112 18,615                 Total pro forma adjustments 2,492 28,519 19,601 49,843   Income tax effect of reconciling items

above (6)

(17,233 ) 7,013 (16,156 ) 16,836                 Non-GAAP net income $ 65,922 $ 13,310 $ 73,755 $ 5,908   Net income per common share - basic $ 1.41 $ 0.29 $ 1.58 $ 0.13 Net income per common share - diluted $ 1.40 $ 0.29 $ 1.57 $ 0.13 Weighted average common shares - basic 46,799 45,943 46,546 45,876 Weighted average common shares - diluted 47,201 45,982 46,974 45,986    

(1) Non-cash interest expense related to convertible senior notes, asset based loan (which was terminated inQ2 2017), Biotie non-convertible and R&D loans and Fampyra royalty monetization.

(2) Changes in fair value of acquired contingent consideration related to the Civitas transaction. (3) Restructuring costs associated with corporate restructuring initiatives. (4) Transaction expenses related to the Biotie acquisition. (5) Unrealized foreign currency transaction gain related to the Biotie acquisition. (6) Represents the tax effect of the non-GAAP adjustments.  

Acorda Therapeutics, Inc.Felicia Vonella, (914) 326-5146fvonella@acorda.com

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