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8-K - 8-K - ACORDA THERAPEUTICS INCacor-8k_20181031.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 2018

 

 

AMPYRA® (dalfampridine) Q3 2018 net revenue of $138 million; 2018 net revenue guidance increased from $330-$350 million to more than $400 million

 

Cash balance for year-end 2018 revised from more than $300 million to more than $400 million

 

INBRIJA™ (levodopa inhalation powder) PDUFA date January 5, 2019

 

ARDSLEY, NY – October 31, 2018 – Acorda Therapeutics, Inc. (Nasdaq: ACOR) provided a financial and pipeline update for the third quarter ended September 30, 2018.

 

“Acorda’s highest priority is preparing for the expected launch of Inbrija. Our market research indicates that healthcare professionals, patients and care partners consider OFF periods, or the re-emergence of Parkinson’s symptoms, to be one of the most significant unmet needs in Parkinson’s, and that they are enthusiastic about the prospect of an inhaled formulation of levodopa as a treatment option,” said Ron Cohen, M.D., Acorda's President and CEO.

 

“We were disappointed and disagree with the decision of the Federal appeals court regarding Ampyra, and we have filed an en banc petition requesting review by the entire court. At the same time, we were prepared for that potential outcome, and our original projections had us well capitalized to fully fund the launch of Inbrija and to develop the ARCUS pipeline. We have taken several steps over the past year both to conserve and to increase cash. Based on these, as well as greater than forecasted Ampyra sales, we are in now in an even stronger financial position, and are increasing our guidance for both cash and Ampyra sales in 2018.”

 

Third Quarter 2018 Financial Results

 

AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg - For the quarter ended September 30, 2018, the Company reported AMPYRA net revenue of $137.8 million compared to $132.6 million for the same quarter in 2017.

 


Research and development (R&D) expenses for the quarter ended September 30, 2018 were $22.9 million, including $1.1 million of share-based compensation compared to $33.3 million, including $2.0 million of share-based compensation, for the same quarter in 2017.

 

Sales, general and administrative (SG&A) expenses for the quarter ended September 30, 2018 were $43.6 million, including $4.0 million of share-based compensation compared to $40.7 million, including $4.6 million of share-based compensation for the same quarter in 2017.

 

Provision for income taxes for the quarter ended September 30, 2018 was $38.0 million, including $3.1 million of cash taxes, compared to a provision for income taxes of $18.9 million, including $3.7 million of cash taxes, for the same quarter in 2017.

 

The Company reported a GAAP net loss of $(13.9) million for the quarter ended September 30, 2018, or $(0.29) per diluted share. GAAP net loss in the same quarter of 2017 was $(25.2) million, or $(0.55) per diluted share.

 

Non-GAAP net income for the quarter ended September 30, 2018 was $8.1 million, or $0.17 per diluted share. Non-GAAP net income in the same quarter of 2017 was $20.1 million, or $0.43 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, intangible asset impairment charges, and restructuring costs. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

 

At September 30, 2018, the Company had cash, cash equivalents and short-term investments of $460.9 million.

 

Guidance for 2018

 

AMPYRA 2018 net revenue guidance increased from $330-$350 million to more than $400 million.

R&D expenses for the full year 2018 reiterated and expected to be $100-$110 million including pre-launch 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 reiterated and 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 has increased projected 2018 year-end cash balance from more than $300 million to more than $400 million.

 

 

 

 


Third Quarter 2018 Highlights

 

INBRIJA™ (levodopa inhalation powder) in Parkinson’s disease

 

-

In September, the FDA extended the PDUFA goal date for its review of the New Drug Application (NDA) of INBRIJA from October 5, 2018 to January 5, 2019 based on submissions the Company made in response to requests from FDA for additional information on chemistry, manufacturing and controls (CMC). FDA determined that these submissions constituted a major amendment and will take additional time to review.

 

-

The Company reported that the inspection of its Chelsea, Massachusetts manufacturing facility and the Inbrija inhaler device manufacturer's facility were successfully completed and closed without need for any further action by the FDA.

 

-

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

 

AMPYRA (dalfampridine)

 

-

In September, the United States Court of Appeals for the Federal Circuit, by a 2-1 vote, upheld the United States District Court for the District of Delaware’s decision to invalidate four Ampyra patents.

 

-

In October, the Company filed a petition for en banc hearing with the United States Court of Appeals for the Federal Circuit.

 

-

The Company announced that it had settled with Mylan AG to market an authorized generic version of Ampyra. In mid-September, Mylan announced the U.S. launch of the authorized generic.

 

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 (833) 236-2756 (domestic) or (647) 689-4181 (international) and reference the access code 4468928. 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 October 31, 2018 until 11:59 p.m. ET on November 30, 2018. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 4468928. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

 

About Acorda Therapeutics 
Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA™ (levodopa inhalation powder), an investigational inhaled formulation of levodopa for symptoms of OFF periods for people with Parkinson’s on a carbidopa/levodopa regimen, is under FDA review with a PDUFA date of January 5, 2019. 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: 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; increasing competition and accompanying loss of revenues in the U.S. from generic versions of Ampyra (dalfampridine) following our loss of patent exclusivity; 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.

 

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 losses that pertain to a non-recurring event, (v)  expenses that pertain to non-routine restructuring events, and (vi) intangible 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 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.

 


###Financial Statements

 

Acorda Therapeutics, Inc.

Condensed Consolidated Balance Sheet Data

(in thousands)

(unaudited)

 

 

September 30,

 

 

December 31,

 

 

2018

 

 

2017

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

Cash, cash equivalents and short-term investments

$

460,946

 

 

$

307,068

 

Trade receivable, net

 

51,461

 

 

 

81,403

 

Other current assets

 

23,388

 

 

 

15,726

 

Finished goods inventory

 

10,800

 

 

 

37,501

 

Property and equipment, net

 

52,061

 

 

 

36,669

 

Goodwill

 

283,435

 

 

 

286,611

 

Intangible assets, net

 

428,575

 

 

 

430,603

 

Other assets

 

419

 

 

 

2,388

 

    Total assets

$

1,311,085

 

 

$

1,197,969

 

 

 

 

 

 

 

 

 

Liabilities and stockholders' equity

 

 

 

 

 

 

 

Accounts payable, accrued expenses and other current liabilities

$

127,370

 

 

$

127,495

 

Current portion of deferred license revenue

 

 

 

 

9,057

 

Current portion of royalty liability

 

7,714

 

 

 

6,763

 

Current portion of loans payable

 

624

 

 

 

645

 

Convertible senior notes

 

316,160

 

 

 

308,805

 

Contingent consideration

 

131,229

 

 

 

112,722

 

Non-current portion of deferred license revenue

 

 

 

 

23,398

 

Non-current portion of royalty liability

 

24,251

 

 

 

29,025

 

Non-current portion of loans payable

 

24,673

 

 

 

25,670

 

Deferred tax liability

 

70,656

 

 

 

22,459

 

Other long-term liabilities

 

9,783

 

 

 

11,943

 

Total stockholder's equity

 

598,625

 

 

 

519,987

 

    Total liabilities and stockholders' equity

$

1,311,085

 

 

$

1,197,969

 


Acorda Therapeutics, Inc.

Consolidated Statements of Operations

(in thousands, except per share amounts)

(unaudited)

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net product revenues

$

139,973

 

 

$

134,357

 

 

$

393,388

 

 

$

379,705

 

Royalty revenues

 

2,841

 

 

 

4,444

 

 

 

8,893

 

 

 

13,391

 

License revenue

 

 

 

 

2,264

 

 

 

 

 

 

6,793

 

Total revenues

 

142,814

 

 

 

141,065

 

 

 

402,281

 

 

 

399,889

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales

 

25,391

 

 

 

29,992

 

 

 

77,834

 

 

 

84,840

 

Cost of license revenue

 

 

 

 

159

 

 

 

 

 

 

476

 

Research and development

 

22,855

 

 

 

33,286

 

 

 

79,325

 

 

 

130,963

 

Selling, general and administrative

 

43,571

 

 

 

40,741

 

 

 

135,435

 

 

 

141,780

 

Asset impairment

 

 

 

 

39,446

 

 

 

 

 

 

39,446

 

Acquisition related expenses

 

 

 

 

 

 

 

 

 

 

320

 

Change in fair value of acquired

   contingent consideration

 

22,700

 

 

 

(400

)

 

 

21,900

 

 

 

16,800

 

Total operating expenses

 

114,517

 

 

 

143,224

 

 

 

314,494

 

 

 

414,625

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income (loss)

$

28,297

 

 

$

(2,159

)

 

$

87,787

 

 

$

(14,736

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other expense, (net)

 

(4,240

)

 

 

(4,168

)

 

 

(13,898

)

 

 

(14,138

)

Income (loss) before income taxes

 

24,057

 

 

 

(6,327

)

 

 

73,889

 

 

 

(28,874

)

Provision for income taxes

 

(37,968

)

 

 

(18,868

)

 

 

(49,802

)

 

 

(23,421

)

Net (loss) income

$

(13,911

)

 

$

(25,195

)

 

$

24,087

 

 

$

(52,295

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net (loss) income per common share - basic

$

(0.29

)

 

$

(0.55

)

 

$

0.51

 

 

$

(1.14

)

Net (loss) income per common share - diluted

$

(0.29

)

 

$

(0.55

)

 

$

0.51

 

 

$

(1.14

)

Weighted average common shares - basic

 

47,184

 

 

 

46,002

 

 

 

46,840

 

 

 

45,918

 

Weighted average common shares - diluted

 

47,184

 

 

 

46,002

 

 

 

47,251

 

 

 

45,918

 


Acorda Therapeutics, Inc.

Non-GAAP Income and Income per Common Share Reconciliation

(in thousands, except per share amounts)

(unaudited)

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP net (loss) income

$

(13,911

)

 

$

(25,195

)

 

$

24,087

 

 

$

(52,295

)

Pro forma adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Non-cash interest expense (1)

 

3,944

 

 

 

2,553

 

 

 

11,917

 

 

 

8,918

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Change in fair value of acquired

      contingent consideration (2)

 

22,700

 

 

 

(400

)

 

 

21,900

 

 

 

16,800

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Restructuring costs (3)

 

4

 

 

 

34

 

 

 

1,320

 

 

 

7,625

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Acquisition related expenses (4)

 

 

 

 

 

 

 

 

 

 

320

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Realized foreign currency loss (5)

 

 

 

 

 

 

 

 

 

 

247

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Asset impairment charge (6)

 

 

 

 

39,446

 

 

 

 

 

 

39,446

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Share-based compensation expenses

      included in R&D

 

1,112

 

 

 

2,041

 

 

 

4,336

 

 

 

8,401

 

   Share-based compensation expenses

      included in SG&A

 

4,023

 

 

 

4,630

 

 

 

11,910

 

 

 

17,820

 

       Total share-based compensation expenses

 

5,135

 

 

 

6,671

 

 

 

16,246

 

 

 

26,221

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total pro forma adjustments

 

31,783

 

 

 

48,304

 

 

 

51,383

 

 

 

99,577

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income tax effect of reconciling items

  above (7)

 

9,729

 

 

 

3,041

 

 

 

(6,427

)

 

 

19,877

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP net income

$

8,143

 

 

$

20,068

 

 

$

81,897

 

 

$

27,405

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income per common share - basic

$

0.17

 

 

$

0.44

 

 

$

1.75

 

 

$

0.60

 

Net income per common share - diluted

$

0.17

 

 

$

0.43

 

 

$

1.73

 

 

$

0.60

 

Weighted average common shares - basic

 

47,184

 

 

 

46,002

 

 

 

46,840

 

 

 

45,918

 

Weighted average common shares - diluted

 

47,563

 

 

 

46,174

 

 

 

47,251

 

 

 

46,049

 

 

(1) Non-cash interest expense related to convertible senior notes, asset based loan (which was terminated in Q2 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) Realized foreign currency transaction loss related to the Biotie acquisition.

(6) Impairment charge related to the intangible asset for Selincro.

 

 

 

 

 

 

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