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8-K - 8-K - ACORDA THERAPEUTICS INCacor-8k_20171031.htm

EXHIBIT 99.1

CONTACT:

Felicia Vonella

Acorda Therapeutics

(914) 326-5146

fvonella@acorda.com

 

FOR IMMEDIATE RELEASE

 

Acorda Provides Financial and Pipeline Update for Third Quarter 2017

 

 

INBRIJA™ (levodopa inhalation powder) NDA resubmission expected in Q4 2017

 

Tozadenant Phase 3 efficacy data expected Q1 2018

 

AMPYRA® (dalfampridine) Q3 2017 net revenue of $133 million

 

Company vigorously pursuing AMPYRA appeal

 

ARDSLEY, NY – October 31, 2017 – Acorda Therapeutics, Inc. (Nasdaq: ACOR) provided a financial and pipeline update for the third quarter ended September 30, 2017.

 

“We have had a constructive dialogue with the FDA since the issuance of its Refusal to File letter, and we plan to resubmit the INBRIJA NDA in the fourth quarter. We believe our resubmission reflects a strong package that incorporates feedback we received from FDA,” said Ron Cohen, M.D., Acorda's President and CEO. “We are also on track to announce top-line data from our Phase 3 study of tozadenant in the first quarter of 2018.”

 

“INBRIJA and tozadenant are being developed as therapies for people with Parkinson’s, INBRIJA for on-demand use to treat symptoms of OFF periods and tozadenant as a daily oral treatment to increase overall ON time. If approved, they have the potential to position Acorda as a leader in the development of Parkinson’s therapy, creating substantial value for shareholders.”

 

Third Quarter 2017 Financial Results

 

AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg - For the quarter ended September 30, 2017, the Company reported AMPYRA net revenue of $132.6 million compared to $128.8 million for the same quarter in 2016.

 

FAMPYRA® (prolonged-release fampridine tablets) - For the quarter ended September 30, 2017, the Company reported FAMPYRA royalties from sales outside of the U.S. of $3.1 million compared to $2.6 million for the same quarter in 2016.

 

Research and development (R&D) expenses for the quarter ended September 30, 2017 were $33.3 million, including $2.0 million of share-based compensation and $.03 million of

 


 

restructuring expenses compared to $54.8 million, including $2.9 million of share-based compensation, for the same quarter in 2016.

 

Sales, general and administrative (SG&A) expenses for the quarter ended September 30, 2017 were $40.7 million, including $4.6 million of share-based compensation and $0.01 million of restructuring expenses compared to $54.4 million, including $7.1 million of share-based compensation for the same quarter in 2016.

 

The Company recorded a non-cash intangible asset impairment charge of $39.4 million in the quarter ended September 30, 2017 for Selincro®. Selincro is currently marketed in Europe by the licensor for the reduction of alcohol consumption in alcohol dependent adults. The Company re-assessed its valuation assumptions, including expected future growth related to the expansion into new markets, and determined that the intangible asset was impaired.

 

Provision for income taxes for the quarter ended September 30, 2017 was $18.9 million, including $3.7 million of cash taxes, compared to a provision for income taxes of $3.0 million, including $1.0 million of cash taxes, for the same quarter in 2016.

 

The Company reported a GAAP net loss attributable to Acorda of $(25.2) million for the quarter ended September 30, 2017, or $(0.55) per diluted share. GAAP net loss in the same quarter of 2016 was $(12.7) million, or $(0.28) per diluted share.

 

Non-GAAP net income for the quarter ended September 30, 2017 was $20.1 million, or $0.43 per diluted share. Non-GAAP net loss in the same quarter of 2016 was $(1.9) million, or $(0.04) 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, restructuring expenses, changes in the fair value of acquired contingent consideration, intangible asset impairment charges and acquisition-related expenses. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

 

At September 30, 2017, the Company had cash and cash equivalents of $192.5 million.

 

Guidance for 2017

 

The Company reiterates AMPYRA 2017 net revenue of $535-$545 million.

R&D expenses for the full year 2017 are expected to be $160-$170 million. This guidance is a non-GAAP projection that excludes share-based compensation and restructuring costs, as more fully described below under “Non-GAAP Financial Measures.”

The Company is reducing its SG&A expense guidance for the full year 2017 from $170-$180 million to $160-$170 million. This guidance is a non-GAAP projection that excludes share-based compensation and restructuring costs, as more fully described below under “Non-GAAP Financial Measures.”

 


 

The Company expects to be cash flow positive in 2017, with a projected year-end cash balance in excess of $200 million.

 

 

Third Quarter 2017 Highlights

 

INBRIJA (levodopa inhalation powder) in Parkinson’s disease

 

-

In August, the Company received a Refusal to File (RTF) letter regarding its NDA for INBRIJA. After constructive dialogue with the FDA, the Company expects to resubmit the NDA in Q4 2017.

 

-

As a result, the Company has revised the timing for its end-of-year submission of the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) to Q1 2018.

 

-

INBRIJA is an investigational treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.

 

Tozadenant in Parkinson’s disease

 

-

The Company expects to report topline Phase 3 in Q1 2018.

 

-

Tozadenant is an investigational treatment for the reduction of OFF time in people with Parkinson’s disease.

 

AMPYRA (dalfampridine)

 

-

The Company filed its opening brief for its appeal to the U.S. Court of Appeals for the Federal Circuit of the District Court’s decision in the AMPYRA patent litigation. The defendants have filed their opposition and cross-appeal opening brief.  Reply briefs from both parties are expected to be filed in November 2017, followed by oral argument to be scheduled by the appellate court.

 

-

Both BIO and PhRMA filed amicus briefs in support of the Company’s appeal, raising important issues in conjunction with biopharmaceutical innovation.

 

-

The Company expects to maintain exclusivity of AMPYRA at least through July 2018.

 

Webcast and Conference Call

The Company will host a conference call today at 8:30 a.m. ET. To participate, please dial (844) 579-6824 (domestic) or (763) 488-9145 (international) and reference the access code 95686626. A replay of the call will be available from 11:30 a.m. ET on October 31, 2017 until 2:59 p.m. ET on November 30, 2017. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference the access code 95686626. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

 

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 three 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 the Biotie and Civitas transactions, 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 ability to successfully integrate Biotie’s operations into our operations; 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 (CVT-301, levodopa inhalation powder), tozadenant 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, tozadenant, or any other products under development; 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; failure to maintain regulatory approval of or to successfully market Fampyra outside of the U.S. and our dependence on our collaborator Biogen in connection therewith; 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.

 

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 2017 guidance for R&D and SG&A 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 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 our 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 period, (iv) acquisition related expenses and related foreign currency losses and gains that pertain to a non-recurring event, (v) corporate restructuring expenses that pertain to a non-recurring event, and (vi) asset impairment charges that pertain to a non-recurring event. 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 2017 guidance for R&D and SG&A 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.

###

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

Financial Statements

 

Acorda Therapeutics, Inc.

Condensed Consolidated Balance Sheet Data

(in thousands)

(unaudited)

 

 

 

September 30,

 

 

December 31,

 

 

2017

 

 

2016

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

Cash, cash equivalents and short-term investments

$

192,496

 

 

$

158,537

 

Trade receivable, net

 

53,825

 

 

 

52,239

 

Other current assets

 

17,224

 

 

 

18,746

 

Finished goods inventory

 

39,870

 

 

 

43,135

 

Deferred tax asset

 

4,400

 

 

 

4,400

 

Property and equipment, net

 

36,484

 

 

 

34,310

 

Goodwill

 

285,317

 

 

 

280,599

 

Intangible assets, net

 

705,141

 

 

 

742,242

 

Other assets

 

10,300

 

 

 

8,127

 

    Total assets

$

1,345,057

 

 

$

1,342,335

 

 

 

 

 

 

 

 

 

Liabilities and stockholders' equity

 

 

 

 

 

 

 

Accounts payable, accrued expenses and other current liabilities

$

100,045

 

 

$

131,823

 

Current portion of deferred license revenue

 

9,057

 

 

 

9,057

 

Current portion of loans payable

 

636

 

 

 

6,256

 

Current portion of notes payable

 

 

 

 

765

 

Convertible senior notes

 

306,411

 

 

 

299,395

 

Contingent consideration

 

88,900

 

 

 

72,100

 

Non-current portion of deferred license revenue

 

25,663

 

 

 

32,456

 

Non-current portion of loans payable

 

25,174

 

 

 

24,635

 

Deferred tax liability

 

98,537

 

 

 

92,807

 

Other long-term liabilities

 

10,644

 

 

 

8,830

 

Total stockholder's equity

 

679,990

 

 

 

664,211

 

    Total liabilities and stockholders' equity

$

1,345,057

 

 

$

1,342,335

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

Acorda Therapeutics, Inc.

Consolidated Statements of Operations

(in thousands, except per share amounts)

(unaudited)

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net product revenues

$

134,357

 

 

$

128,508

 

 

$

379,705

 

 

$

359,350

 

Royalty revenues

 

4,444

 

 

 

4,841

 

 

 

13,391

 

 

 

12,831

 

License revenue

 

2,264

 

 

 

2,264

 

 

 

6,793

 

 

 

6,793

 

Total revenues

 

141,065

 

 

 

135,613

 

 

 

399,889

 

 

 

378,974

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales

 

29,992

 

 

 

27,644

 

 

 

84,840

 

 

 

77,265

 

Cost of license revenue

 

159

 

 

 

159

 

 

 

476

 

 

 

476

 

Research and development

 

33,286

 

 

 

54,777

 

 

 

130,963

 

 

 

149,640

 

Selling, general and administrative

 

40,741

 

 

 

54,366

 

 

 

141,780

 

 

 

159,203

 

Asset impairment

 

39,446

 

 

 

 

 

 

39,446

 

 

 

 

Acquisition related expenses

 

 

 

 

439

 

 

 

320

 

 

 

17,185

 

Change in fair value of acquired

   contingent consideration

 

(400

)

 

 

3,700

 

 

 

16,800

 

 

 

11,900

 

Total operating expenses

 

143,224

 

 

 

141,085

 

 

 

414,625

 

 

 

415,669

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating loss

$

(2,159

)

 

$

(5,472

)

 

$

(14,736

)

 

$

(36,695

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other (expense) income, net

 

(4,168

)

 

 

(4,537

)

 

 

(14,138

)

 

 

(3,500

)

Loss before income taxes

 

(6,327

)

 

 

(10,009

)

 

 

(28,874

)

 

 

(40,195

)

(Provision for) benefit from income taxes

 

(18,868

)

 

 

(3,023

)

 

 

(23,421

)

 

 

7,686

 

Net loss

$

(25,195

)

 

$

(13,032

)

 

$

(52,295

)

 

$

(32,509

)

Net loss attributable to non-controlling interest

 

 

 

 

307

 

 

 

 

 

 

985

 

Net loss attributable to Acorda Therapeutics, Inc.

$

(25,195

)

 

$

(12,725

)

 

$

(52,295

)

 

$

(31,524

)

Net loss per common share attributable to

   Acorda Therapeutics, Inc. - basic and diluted

$

(0.55

)

 

$

(0.28

)

 

$

(1.14

)

 

$

(0.70

)

Weighted average common shares - basic and diluted

 

46,002

 

 

 

45,378

 

 

 

45,918

 

 

 

45,178

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

Acorda Therapeutics, Inc.

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

(in thousands, except per share amounts)

(unaudited)

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss

$

(25,195

)

 

$

(13,032

)

 

$

(52,295

)

 

$

(32,509

)

Pro forma adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Non-cash interest expense (1)

 

2,553

 

 

 

2,514

 

 

 

8,918

 

 

 

7,078

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Change in fair value of acquired

      contingent consideration (2)

 

(400

)

 

 

3,700

 

 

 

16,800

 

 

 

11,900

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Restructuring costs (3)

 

34

 

 

 

 

 

 

7,625

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Acquisition related expenses (4)

 

 

 

 

439

 

 

 

320

 

 

 

17,185

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Realized foreign currency loss (gain) (5)

 

 

 

 

 

 

 

247

 

 

 

(7,738

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Asset impairment charge (6)

 

39,446

 

 

 

 

 

 

39,446

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Share-based compensation expenses

      included in R&D

 

2,041

 

 

 

2,925

 

 

 

8,401

 

 

 

7,648

 

   Share-based compensation expenses

      included in SG&A

 

4,630

 

 

 

7,051

 

 

 

17,820

 

 

 

19,744

 

       Total share-based compensation expenses

 

6,671

 

 

 

9,976

 

 

 

26,221

 

 

 

27,392

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total pro forma adjustments

 

48,304

 

 

 

16,629

 

 

 

99,577

 

 

 

55,817

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income tax effect of reconciling items

  above (7)

 

3,041

 

 

 

(5,464

)

 

 

19,877

 

 

 

15,379

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP net income (loss)

$

20,068

 

 

$

(1,867

)

 

$

27,405

 

 

$

7,929

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per common share - basic

$

0.44

 

 

$

(0.04

)

 

$

0.60

 

 

$

0.18

 

Net income (loss) per common share - diluted

$

0.43

 

 

$

(0.04

)

 

$

0.60

 

 

$

0.17

 

Weighted average per common share - basic

 

46,002

 

 

 

45,378

 

 

 

45,918

 

 

 

45,178

 

Weighted average per common share - diluted

 

46,174

 

 

 

45,378

 

 

 

46,049

 

 

 

45,983

 

 

(1) Non-cash interest expense related to convertible senior notes, asset based loan (which was cancelled in

     Q2 2017), and Biotie non-convertible and R&D loans.

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

(3) Restructuring costs associated with the Q2-2017 restructuring.

(4) Transaction expenses related to the Biotie acquisition.

(5) Realized foreign currency transaction loss (gain) related to the Biotie acquisition.

(6) Impairment charge related to Selincro acquired in the Biotie acquisition.

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