Attached files

file filename
8-K - 8-K - ACORDA THERAPEUTICS INCacor-8k_20170214.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

Fourth Quarter and Year End 2016

 

 

AMPYRA® (dalfampridine) 4Q 2016 Net Revenue of $132 Million; Full-Year Net Revenue of $493 Million

 

AMPYRA 2017 Net Sales Guidance of $535-$545 Million

 

Positive CVT-301 Phase 3 Data Support 2Q 2017 NDA Filing

 

ARDSLEY, N.Y. – February 14, 2017 – Acorda Therapeutics, Inc. (Nasdaq: ACOR) today provided a financial and pipeline update for the fourth quarter and full year ended December 31, 2016.

 

“The positive Phase 3 data from our pivotal trial of CVT-301 represents a major milestone for Acorda, potentially bringing an important new therapy to people with Parkinson’s,” said Ron Cohen, M.D., Acorda's President and CEO. “We plan to file a New Drug Application in the second quarter of 2017, pending the results of two long-term safety studies. Data from these studies are expected in the first quarter of 2017.”

 

“Our corporate priorities continue to be advancing our Phase 3 Parkinson’s programs and maximizing the value of AMPYRA.”

 

Financial Results - Quarter Ended December 31, 2016

 

The Company reported a GAAP net loss of $3.1 million for the quarter ended December 31, 2016, or $(0.07) per diluted share. GAAP net income in the same quarter of 2015 was $9.2 million, or $0.21 per diluted share.

 

Non-GAAP net income for the quarter ended December 31, 2016 was $2.5 million, or $0.05 per diluted share. Non-GAAP net income in the same quarter of 2015 was $13.8 million, or $0.31 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 convertible debt, changes in the fair value of acquired contingent consideration and acquisition related

 


 

expenses. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

 

AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg - For the quarter ended December 31, 2016, the Company reported AMPYRA net revenue of $132.3 million compared to $122.0 million for the same quarter in 2015, an increase of 8.4%.

 

ZANAFLEX CAPSULES® (tizanidine hydrochloride), ZANAFLEX® (tizanidine hydrochloride) tablets and authorized generic capsules - For the quarter ended December 31, 2016, the Company reported combined net revenue and royalties from ZANAFLEX and tizanidine of $2.3 million compared to $3.3 million for the same quarter in 2015.

 

FAMPYRA® (prolonged-release fampridine tablets) - For the quarter ended December 31, 2016, the Company reported FAMPYRA royalties from sales outside of the U.S. of $2.7 million compared to $3.3 million for the same quarter in 2015.

 

Research and development (R&D) expenses for the quarter ended December 31, 2016 were $53.8 million, including $3.0 million of share-based compensation, compared to $44.0 million, including $2.2 million of share-based compensation, for the same quarter in 2015.

 

Sales, general and administrative (SG&A) expenses for the quarter ended December 31, 2016 were $59.0 million, including $6.0 million of share-based compensation and $0.4 million of acquisition costs, compared to $53.0 million, including $6.5 million of share-based compensation, for the same quarter in 2015.

 

Provision for income taxes for the quarter ended December 31, 2016 was $1.0 million compared to an $8.6 million benefit from income taxes for the same quarter in 2015.

 

Financial Results - Full Year Ended December 31, 2016

 

For the full year ended December 31, 2016, the Company reported a GAAP net loss of $34.6 million, or $(0.76) per diluted share. GAAP net income for the full year 2015 was $11.1 million, or $0.25 per diluted share.

 

Non-GAAP net income for the full year ended December 31, 2016 was $11.5 million, or $0.25 per diluted share. Non-GAAP net income for the full year ended December 31, 2015 was $32.3 million, or $0.74 per diluted share. This full year 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 convertible debt, changes in the fair value of acquired contingent consideration, acquisition related expenses, foreign currency transaction gain and the impact of a change in accounting policy for ZANAFLEX revenue recognition. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

 

 


 

AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg - For the full year ended December 31, 2016 net revenue was $492.8 million compared to $436.9 million for full year 2015. Full year 2016 net revenue increased 12.8% over 2015.

 

ZANAFLEX CAPSULES® (tizanidine hydrochloride), ZANAFLEX® (tizanidine hydrochloride) tablets and authorized generic capsules - For the full year ended December 31, 2016 combined net revenue and royalties from ZANAFLEX and tizanidine were $3.4 million compared to $35.1 million for full year 2015. Net revenue for Zanaflex for the full year ended December 31, 2015 includes the impact of a one-time net adjustment of $22.2 million, representing the cumulative impact of the Company’s conversion from the sell-through to the sell-in method of revenue recognition.

 

FAMPYRA® (prolonged-release fampridine tablets) - For the full year ended December 31, 2016, the Company reported FAMPYRA royalties from sales outside of the U.S. of $10.6 million compared to $10.5 million for the full year 2015.

 

Research and development (R&D) expenses for the full year ended December 31, 2016 were $203.4 million, including $10.6 million of share-based compensation, compared to $149.2 million, including $8.5 million of share-based compensation, for the full year 2015.

 

Sales, general and administrative (SG&A) expenses for the full year ended December 31, 2016 were $235.4 million, including $25.8 million of share-based compensation and $17.6 million of acquisition costs, compared to $205.6 million, including $25.0 million of share-based compensation, for the full year 2015.

 

Benefit from income taxes for the full year ended December 31, 2016 was $6.7 million compared to a provision for income taxes of $8.3 million for the full year 2015.

 

At December 31, 2016 the Company had cash and cash equivalents of $158.5 million.

 

Guidance for 2017

 

The Company expects AMPYRA 2017 full year net revenue of $535-$545 million.

R&D expenses for the full year 2017 are expected to be $185-$195 million. This guidance is a non-GAAP projection which excludes share-based compensation, as more fully described below under “Non-GAAP Financial Measures.”

SG&A expenses for the full year 2017 are expected to be $195-$205 million. This guidance is a non-GAAP projection which excludes share-based compensation, as more fully described below under “Non-GAAP Financial Measures.”

 


 


 

Fourth Quarter 2016 Highlights

 

AMPYRA (dalfampridine)

-

AMPYRA revenue for the fourth quarter of 2016 was $132 million, up 8% from the fourth quarter of 2015. AMPYRA revenue for the full year 2016 was $493 million, a 13% increase over 2015.

-

Approximately 120,000 people with multiple sclerosis in the United States have tried AMPYRA since its launch in 2010.

-

In February 2017, the Company announced it had entered into a settlement agreement with Apotex Corporation and Apotex Inc. (together, “Apotex”) to resolve pending patent litigation related to AMPYRA. As a result of the settlement agreement, Apotex will be permitted to market a generic version of AMPYRA in the United States at a specified date in 2025, or potentially earlier under certain circumstances.

 

CVT-301 in Parkinson’s disease

-

On February 9, 2017, the Company announced Phase 3 clinical data of CVT-301, showing a statistically significant improvement in motor function in people with Parkinson’s disease experiencing OFF periods.

-

CVT-301 is being studied as a treatment for OFF periods in people with Parkinson’s disease taking an oral carbidopa/levodopa regimen.

-

Cough was the most common adverse event, reported by approximately 15% of subjects who received CVT-301. When reported, it was typically mild and reported once per participant during the course of treatment. Three of 227 participants receiving CVT-301 discontinued the study due to cough.

-

The Company is currently conducting two studies to assess the long-term safety of CVT-301. Up to 12-month data from these studies are expected by the end of the first quarter of 2017.

 

CVT-427 in Acute Migraine

-

In December, a special population study to evaluate safe inhalation in patients with asthma and in smokers was completed. Some subjects in this study showed evidence of acute, reversible bronchoconstriction, post-inhalation.  

-

The Company plans to discuss these results with outside advisors and the FDA and, pending agreement, to advance the program into Phase 2 study by the end of 2017.

 

Other Pipeline

-

In November, the Company discontinued the dalfampridine for post-stroke walking difficulties (PSWD) program after data from the MILESTONE study did not show sufficient efficacy to support further development.

 

 

 


 

Webcast and Conference Call

Acorda will host a conference call today at 8:30 a.m. ET to review the Company’s fourth quarter and full year 2016 results.

 

To participate in the conference call, please dial (844) 543-5233 (domestic) or (678) 276-7225 (international) and reference the access code 60207678. The presentation will be available via a live webcast on the Investors section of www.acorda.com.

 

A replay of the call will be available from 11:30 a.m. ET on February 14, 2017 until 11:59 p.m. ET on February 21, 2017. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference the access code 60207678. The archived webcast will be available in the Investor Relations section of the Acorda website.

 

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, migraine 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 and Civitas’ operations, respectively, into our operations; we may need to raise additional funds to finance our expanded 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.; third party payers (including governmental agencies) may not reimburse for the use of Ampyra or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; the risk of unfavorable results from future studies of Ampyra or from our other research and development programs, including CVT-301 or any other acquired or in-licensed programs; we may not be able to complete development of, obtain regulatory approval for, or successfully market CVT-301, any other products under development, or the products that we acquired with the Biotie transaction; the occurrence of adverse safety events with our products; delays in obtaining or failure to obtain and 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 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) realized foreign currency transaction gain (v) acquisition related expenses that pertain to a non-recurring event, and (vi) the impact of a one-time change in accounting policy for Zanaflex revenue recognition due to a one-time, 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)

 

 

December 31,

 

 

December 31,

 

 

2016

 

 

2015

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

Cash, cash equivalents and short-term investments

$

158,537

 

 

$

353,305

 

Trade receivable, net

 

52,239

 

 

 

31,466

 

Other current assets

 

18,746

 

 

 

30,070

 

Finished goods inventory

 

43,135

 

 

 

36,476

 

Deferred tax asset

 

4,400

 

 

 

2,128

 

Property and equipment, net

 

34,310

 

 

 

40,204

 

Goodwill

 

280,599

 

 

 

183,636

 

Intangible assets, net

 

742,242

 

 

 

430,856

 

Other assets

 

8,127

 

 

 

3,153

 

    Total assets

$

1,342,335

 

 

$

1,111,294

 

 

 

 

 

 

 

 

 

Liabilities and stockholders' equity

 

 

 

 

 

 

 

Accounts payable, accrued expenses and other current liabilities

$

131,823

 

 

$

80,391

 

Current portion of deferred license revenue

 

9,057

 

 

 

9,057

 

Current portion of loans payable

 

6,256

 

 

 

 

Current portion of notes payable

 

765

 

 

 

1,144

 

Convertible senior notes

 

299,395

 

 

 

290,420

 

Contingent consideration

 

72,100

 

 

 

63,500

 

Non-current portion of deferred license revenue

 

32,456

 

 

 

41,513

 

Non-current portion of loans payable

 

24,635

 

 

 

 

Deferred tax liability

 

92,807

 

 

 

12,146

 

Other long-term liabilities

 

8,830

 

 

 

10,098

 

Total stockholder's equity

 

664,211

 

 

 

603,025

 

    Total liabilities and stockholders' equity

$

1,342,335

 

 

$

1,111,294

 

 


 

Acorda Therapeutics, Inc.

Consolidated Statements of Operations

(in thousands, except per share amounts)

(unaudited)

 

 

Three Months Ended

 

 

Twelve Months Ended

 

 

December 31,

 

 

December 31,

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net product revenues

$

134,008

 

 

$

123,717

 

 

$

493,358

 

 

$

466,111

 

Royalty revenues

 

4,355

 

 

 

4,921

 

 

 

17,186

 

 

 

17,492

 

License revenue

 

2,264

 

 

 

2,264

 

 

 

9,057

 

 

 

9,057

 

Total revenues

 

140,627

 

 

 

130,902

 

 

 

519,601

 

 

 

492,660

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales

 

30,210

 

 

 

26,401

 

 

 

107,475

 

 

 

92,297

 

Cost of license revenue

 

159

 

 

 

159

 

 

 

634

 

 

 

634

 

Research and development

 

53,797

 

 

 

43,988

 

 

 

203,437

 

 

 

149,209

 

Selling, general and administrative

 

58,681

 

 

 

52,984

 

 

 

217,885

 

 

 

205,630

 

Acquisition related expenses

 

366

 

 

 

 

 

 

17,551

 

 

 

 

Change in fair value of acquired

   contingent consideration

 

(3,300

)

 

 

3,500

 

 

 

8,600

 

 

 

10,900

 

Total operating expenses

 

139,913

 

 

 

127,032

 

 

 

555,582

 

 

 

458,670

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income (loss)

$

714

 

 

$

3,870

 

 

$

(35,981

)

 

$

33,990

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other (expense) income, net

 

(2,786

)

 

 

(3,215

)

 

 

(6,287

)

 

 

(14,621

)

(Loss) income before income taxes

 

(2,072

)

 

 

655

 

 

 

(42,268

)

 

 

19,369

 

(Provision for) benefit from income taxes

 

(1,022

)

 

 

8,550

 

 

 

6,665

 

 

 

(8,311

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net (loss) income

$

(3,094

)

 

$

9,205

 

 

$

(35,603

)

 

$

11,058

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss attributable to noncontrolling interest

 

 

 

 

 

 

 

985

 

 

 

 

Net (loss) income attributable to Acorda

   Therapeutics, Inc.

$

(3,094

)

 

$

9,205

 

 

$

(34,618

)

 

$

11,058

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net (loss) income per common share - basic

$

(0.07

)

 

$

0.22

 

 

$

(0.76

)

 

$

0.26

 

Net (loss) income per common share - diluted

$

(0.07

)

 

$

0.21

 

 

$

(0.76

)

 

$

0.25

 

Weighted average per common share - basic

 

45,500

 

 

 

42,624

 

 

 

45,259

 

 

 

42,230

 

Weighted average per common share - diluted

 

45,500

 

 

 

44,179

 

 

 

45,259

 

 

 

43,621

 

 


 

Acorda Therapeutics, Inc.

Non-GAAP Income and Income per Common Share Reconciliation

(in thousands, except per share amounts)

(unaudited)

 

 

Three Months Ended

 

 

Twelve Months Ended

 

 

December 31,

 

 

December 31,

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP net (loss) income

$

(3,094

)

 

$

9,205

 

 

$

(34,618

)

 

$

11,058

 

Pro forma adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Non-cash interest expense (1)

 

2,559

 

 

 

2,178

 

 

 

9,717

 

 

 

8,562

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Change in fair value of acquired

      contingent consideration (2)

 

(3,300

)

 

 

3,500

 

 

 

8,600

 

 

 

10,900

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Acquisition related expenses (3)

 

366

 

 

 

 

 

 

17,551

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Realized foreign currency gain (4)

 

 

 

 

 

 

 

(7,738

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Change in revenue recognition -

      Zanaflex Capsules & tablets (5)

 

 

 

 

 

 

 

 

 

 

(21,633

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Share-based compensation expenses

      included in R&D

 

2,961

 

 

 

2,243

 

 

 

10,610

 

 

 

8,474

 

   Share-based compensation expenses

      included in SG&A

 

6,033

 

 

 

6,476

 

 

 

25,777

 

 

 

24,992

 

       Total share-based compensation

          expenses

 

8,994

 

 

 

8,719

 

 

 

36,387

 

 

 

33,466

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total pro forma adjustments

 

8,619

 

 

 

14,397

 

 

 

64,517

 

 

 

31,295

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income tax effect of reconciling items

  above (6)

 

3,056

 

 

 

9,838

 

 

 

18,436

 

 

 

10,042

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP net income (7)

$

2,469

 

 

$

13,764

 

 

$

11,463

 

 

$

32,311

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income per common share - basic

$

0.05

 

 

$

0.32

 

 

$

0.25

 

 

$

0.77

 

Net income per common share - diluted

$

0.05

 

 

$

0.31

 

 

$

0.25

 

 

$

0.74

 

Weighted average per common share - basic

 

45,500

 

 

 

42,624

 

 

 

45,259

 

 

 

42,230

 

Weighted average per common share - diluted

 

45,649

 

 

 

44,179

 

 

 

45,900

 

 

 

43,621

 

 

(1)

Non-cash interest expense related to convertible senior notes, asset based loan, and Biotie non-convertible and R&D loans.

(2)

Changes in fair value of acquired contingent consideration related to Civitas transaction.

(3)

Transaction expenses related to the Biotie acquisition.

(4)

Realized foreign currency gain related to the Biotie acquisition.

(5)

Change from "sell-through" (deferred) revenue recognition to "sell-in" (traditional) revenue recognition.

(6)

Represents the tax effect of the non-GAAP adjustments.

(7)

Prior to the quarter ended September 30, 2016, non-GAAP adjustments included a separate income tax expense adjustment from GAAP tax expense to the amount of cash taxes paid or payable for the

 


 

respective period.  As of December 31, 2016, the presentation includes the tax effect of the non-GAAP adjustments as prescribed by the updated Compliance and Disclosure Interpretations issued by the SEC in May, 2016.  In the three months ended December 31, 2016 and 2015, cash taxes paid were $0.7 million and $2.5 million, respectively.  In the twelve months ended December 31, 2016 and 2015, cash taxes paid were $4.3 million and $4.7 million, respectively.  A reconciliation to the previously reported non-GAAP results is presented below.

 

 

Three

Months

Ended

 

 

Twelve

Months

Ended

 

 

December 31,

 

 

2015

 

 

2015

 

Non-GAAP net income - as revised (see above)

$

13,764

 

 

$

32,311

 

Income tax effect of the reconciling items (see above)

 

9,838

 

 

 

10,042

 

Non-cash income taxes (as previously reported)

 

(11,095

)

 

 

3,614

 

Non-GAAP net income (as previously reported)

$

12,507

 

 

$

45,967

 

 

Note:

Non-GAAP net income per share basic and diluted as presented above were also revised as a result of the changes to the income tax effect of the non-GAAP adjustments as noted above.