-
AMPYRA® (dalfampridine) 3Q 2016 Net Revenue of $128.8
Million; 10% Increase over 3Q 2015 Net Revenue of $117.0 Million -
Data for Dalfampridine in Post-Stroke Walking Difficulties by Year End
2016 and Phase 3 data for CVT-301 for OFF Periods in Parkinson’s
Disease in Q1 2017
ARDSLEY, N.Y.–(BUSINESS WIRE)– Acorda Therapeutics, Inc. (Nasdaq: ACOR)
provided a financial and pipeline update for the third quarter ended
September 30, 2016.
“Over the next 12 months, we expect multiple, potentially transformative
clinical and corporate milestones,” said Ron Cohen, M.D. “By year end we
plan to announce topline data from our dalfampridine post-stroke walking
difficulties and QD formulation studies and, in the first quarter of
2017, data from our Phase 3 CVT-301 program. Our clinical programs for
tozadenant in Parkinson’s disease and CVT-427 in acute migraine are also
progressing well. Regarding our defense of AMPYRA patents, we are
preparing to file our post-trial brief and continuing to defend our
patents vigorously.”
Financial Results
The Company reported a GAAP net loss attributable to Acorda of $(12.7)
million for the quarter ended September 30, 2016, or $(0.28) per diluted
share. GAAP net income in the same quarter of 2015 was $3.9 million, or
$0.09 per diluted share.
Non-GAAP net loss for the quarter ended September 30, 2016 was $(1.9)
million, or $(0.04) per diluted share. Non-GAAP net income in the same
quarter of 2015 was $3.3 million, or $0.08 per diluted share. Non-GAAP
net income (loss) excludes share based compensation charges, non-cash
interest expense, expenses associated with changes in the fair value of
acquired contingent consideration, foreign currency gains,
acquisition-related costs, 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 in the
attached financial statements.
AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg – For
the quarter ended September 30, 2016, the Company reported AMPYRA net
revenue of $128.8 million compared to $117.0 million for the same
quarter in 2015.
The Company is reiterating 2016 AMPYRA net sales guidance of $475-$485
million.
ZANAFLEX CAPSULES® (tizanidine hydrochloride), ZANAFLEX®
(tizanidine hydrochloride) tablets and authorized generic capsules – For
the quarter ended September 30, 2016, the Company reported combined net
revenue and royalties from ZANAFLEX and tizanidine of $0.5 million
compared to $26.0 million for the same quarter in 2015. Net revenue for
Zanaflex for the quarter ended September 30, 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
quarter ended September 30, 2016, the Company reported FAMPYRA royalties
from sales outside of the U.S. of $2.6 million compared to $2.5 million
for the same quarter in 2015.
Research and development (R&D) expenses for the quarter ended September
30, 2016 were $54.8 million, including $2.9 million of share-based
compensation, compared to $43.4 million, including $2.3 million of
share-based compensation, for the same quarter in 2015. R&D expenses
increased due to investment in our late-stage programs, as well as the
addition of Biotie R&D expenses.
The Company is reiterating 2016 R&D guidance of $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. »
Sales, general and administrative (SG&A) expenses for the quarter ended
September 30, 2016 were $54.4 million, including $7.1 million of
share-based compensation, compared to $51.1 million, including $6.7
million of share-based compensation, for the same quarter in 2015. SG&A
expenses exclude transaction expenses related to the Biotie acquisition
and include Biotie expenses for the quarter ended September 30, 2016.
The Company is reiterating 2016 SG&A guidance of $195-$205 million. This
guidance is a non-GAAP projection which excludes share-based
compensation for the Company and transaction expenses related to the
Biotie acquisition, as more fully described below under « Non-GAAP
Financial Measures. »
Provision for income taxes for the quarter ended September 30, 2016 was
$3.0 million compared to a provision for income taxes of $17.8 million
for the same quarter in 2015.
At September 30, 2016, the Company had cash, cash equivalents and
investments of $127.9 million.
Third Quarter 2016 Highlights
-
AMPYRA® (dalfampridine)
-
AMPYRA revenue for the third quarter of 2016 was $128.8 million,
up 10% from the third quarter of 2015. This represents the 14th
consecutive quarter of double-digit, year-over-year growth for
AMPYRA, which was launched in 2010. -
A District Court trial for the Company’s litigation against four
generic companies seeking ANDA approvals concluded in September
2016. Post-trial briefing by the parties is expected to be
completed in November.
-
AMPYRA revenue for the third quarter of 2016 was $128.8 million,
-
Dalfampridine in Post-Stroke Walking Difficulties (PSWD)
-
The Company expects to announce topline data from an unblinded
analysis of the twice-daily (BID) clinical trial in the fourth
quarter of 2016. Results from multi-dose testing of a once-daily
(QD) formulation of dalfampridine will be disclosed concurrently.
-
The Company expects to announce topline data from an unblinded
-
CVT-301 in Parkinson’s Disease
-
The Company expects last patient out (LPO) in the Phase 3 CVT-301
efficacy and safety study by the end of 2016. -
Topline data from the Phase 3 efficacy and safety study is
expected in the first quarter of 2017.
-
The Company expects last patient out (LPO) in the Phase 3 CVT-301
-
CVT-427 in Migraine
-
Upon successful completion of its ongoing Phase 1 special
population studies, the Company is planning to begin a Phase 2
study in the first half of 2017.
-
Upon successful completion of its ongoing Phase 1 special
-
Corporate
-
On September 30, Acorda acquired the remaining approximately 3% of
Biotie’s fully diluted capital stock pursuant to Finnish
redemption proceedings, and with 100% of the shares, completed the
acquisition of Biotie. Under Finnish law, the purchase price for
the 3% of the shares will be determined in accordance with the
redemption proceedings. -
In October, Michael Rogers, CFO, left the Company. David Lawrence,
Chief of Business Operations, has assumed the role of Chief,
Business Operations and Principal Accounting Officer. Andrew
Hindman, Chief Business Development Officer, has assumed
responsibility for Financial Planning and Analysis and Investor
Relations.
-
On September 30, Acorda acquired the remaining approximately 3% of
Webcast and Conference Call
The Company will host a conference call today at 8:30 a.m. ET to review
its third quarter 2016 results.
To participate in the conference call, dial (855) 542-4209 (domestic) or
(412) 455-6054 (international) and reference the access code 83356384.
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 27,
2016 until 11:59 p.m. ET on November 3, 2016. To access the replay, dial
(855) 859-2056 (domestic) or (404) 537-3406 (international) and
reference the access code 83356384.
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a biotechnology company focused
on developing therapies that restore function and improve the lives of
people with neurological disorders.
Acorda has an pipeline of novel neurological therapies addressing a
range of disorders, including Parkinson’s disease, post-stroke walking
difficulties, migraine, and multiple sclerosis. Acorda markets three
FDA-approved therapies, including AMPYRA® (dalfampridine)
Extended Release Tablets,10 mg.
For more information, please visit the Company’s website at: www.acorda.com.
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 presentation 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 presentation.
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 2016
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,
provide 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 2016 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 range of SG&A
expenditures for 2016 also excludes expenses related to the acquisition
of Biotie because of the extraordinary nature of these expenses. The
Company believes that this non-GAAP measure provides investors with a
more meaningful understanding of our ongoing and projected SG&A expenses.
A reconciliation of the historical non-GAAP financial results presented
in this release to our GAAP financial results (but not the 2016 guidance
for R&D and SG&A) is included in the attached financial statements.
Financial Statements
Acorda Therapeutics, Inc. |
||||||||||
September 30, 2016 |
December 31, 2015 |
|||||||||
Assets | ||||||||||
Cash, cash equivalents, short-term and long-term investments | $ | 127,940 | $ | 353,305 | ||||||
Trade receivable, net | 48,575 | 31,466 | ||||||||
Other current assets | 20,502 | 30,070 | ||||||||
Finished goods inventory | 40,935 | 36,476 | ||||||||
Deferred tax asset | 2,951 | 2,128 | ||||||||
Property and equipment, net | 35,777 | 40,204 | ||||||||
Goodwill | 284,029 | 183,636 | ||||||||
Intangible assets, net | 749,415 | 430,856 | ||||||||
Other assets | 8,244 | 3,153 | ||||||||
Total assets | $ | 1,318,368 | $ | 1,111,294 | ||||||
Liabilities and stockholders’ equity | ||||||||||
Accounts payable, accrued expenses and other current liabilities | $ | 107,931 | $ | 80,391 | ||||||
Current portion of deferred license revenue | 9,057 | 9,057 | ||||||||
Current portion of notes payable | 1,134 | 1,144 | ||||||||
Convertible senior notes | 297,111 | 290,420 | ||||||||
Contingent consideration | 75,400 | 63,500 | ||||||||
Non-current portion of deferred license revenue | 34,720 | 41,513 | ||||||||
Deferred tax liability | 91,429 | 12,146 | ||||||||
Other long-term liabilities | 34,820 | 10,098 | ||||||||
Total stockholder’s equity | 666,766 | 603,025 | ||||||||
Total liabilities and stockholders’ equity | $ | 1,318,368 | $ | 1,111,294 | ||||||
Acorda Therapeutics, Inc. |
|||||||||||||||||||||||||
Three Months Ended |
Nine Months Ended |
||||||||||||||||||||||||
2016 | 2015 | 2016 |
2015 |
||||||||||||||||||||||
Revenues: | |||||||||||||||||||||||||
Net product revenues | $ | 128,508 | $ | 141,330 | $ | 359,350 | $ | 342,394 | |||||||||||||||||
Royalty revenues | 4,841 | 4,605 | 12,831 | 12,571 | |||||||||||||||||||||
License revenue | 2,264 | 2,264 | 6,793 | 6,793 | |||||||||||||||||||||
Total revenues | 135,613 | 148,199 | 378,974 | 361,758 | |||||||||||||||||||||
Costs and expenses: | |||||||||||||||||||||||||
Cost of sales | 27,644 | 24,741 | 77,265 | 65,896 | |||||||||||||||||||||
Cost of license revenue | 159 | 159 | 476 | 476 | |||||||||||||||||||||
Research and development | 54,777 | 43,356 | 149,640 | 105,221 | |||||||||||||||||||||
Selling, general and administrative | 54,366 | 51,056 | 159,203 | 152,645 | |||||||||||||||||||||
Acquisition related expenses | 439 | – | 17,185 | – | |||||||||||||||||||||
Change in fair value of acquired contingent consideration | 3,700 | 3,200 | 11,900 | 7,400 | |||||||||||||||||||||
Total operating expenses | 141,085 | 122,512 | 415,669 | 331,638 | |||||||||||||||||||||
Operating (loss) income | $ | (5,472 | ) | $ | 25,687 | $ | (36,695 | ) | $ | 30,120 | |||||||||||||||
Other (expense) income, net | (4,537 | ) | (3,976 | ) | (3,500 | ) | (11,406 | ) | |||||||||||||||||
(Loss) income before income taxes | (10,009 | ) | 21,711 | (40,195 | ) | 18,714 | |||||||||||||||||||
(Provision for) benefit from income taxes | (3,023 | ) | (17,770 | ) | 7,686 | (16,861 | ) | ||||||||||||||||||
Net (loss) income | $ | (13,032 | ) | $ | 3,941 | $ | (32,509 | ) | $ | 1,853 | |||||||||||||||
Net loss attributable to noncontrolling interest | 307 | – | 985 | – | |||||||||||||||||||||
Net (loss) income attributable to Acorda Therapeutics, Inc. | $ | (12,725 | ) | $ | 3,941 | $ | (31,524 | ) | $ | 1,853 | |||||||||||||||
Net (loss) income per common share – basic | $ | (0.28 | ) | $ | 0.09 | $ | (0.70 | ) | $ | 0.04 | |||||||||||||||
Net (loss) income per common share – diluted | $ | (0.28 | ) | $ | 0.09 | $ | (0.70 | ) | $ | 0.04 | |||||||||||||||
Weighted average per common share – basic | 45,378 | 42,174 | 45,178 | 42,097 | |||||||||||||||||||||
Weighted average per common share – diluted | 45,378 | 43,432 | 45,178 | 43,434 | |||||||||||||||||||||
Acorda Therapeutics, Inc. |
||||||||||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||||||||||
September 30, | September 30, | |||||||||||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||||||||||
GAAP net (loss) income | $ | (13,032 | ) | $ | 3,941 | $ | (32,509 | ) | $ | 1,853 | ||||||||||||||
Pro forma adjustments: | ||||||||||||||||||||||||
Non-cash interest expense (1) | 2,514 | 2,153 | 7,078 | 6,383 | ||||||||||||||||||||
Change in fair value of acquired contingent consideration (2) | 3,700 | 3,200 | 11,900 | 7,400 | ||||||||||||||||||||
Acquisition related expenses (3) | 439 | – | 17,185 | – | ||||||||||||||||||||
Realized foreign currency gain (4) | – | – | (7,738 | ) | – | |||||||||||||||||||
Change in revenue recognition – Zanaflex Capsules & tablets (5) | – | (21,633 | ) | – | (21,633 | ) | ||||||||||||||||||
Share-based compensation expenses included in R&D | 2,925 | 2,250 | 7,648 | 6,231 | ||||||||||||||||||||
Share-based compensation expenses included in SG&A | 7,051 | 6,664 | 19,744 | 18,517 | ||||||||||||||||||||
Total share-based compensation expenses | 9,976 | 8,914 | 27,392 | 24,748 | ||||||||||||||||||||
Total pro forma adjustments | 16,629 | (7,366 | ) | 55,817 | 16,898 | |||||||||||||||||||
Income tax effect of reconciling items above (6) | (5,464 | ) | 6,761 | (15,379 | ) | (204 | ) | |||||||||||||||||
Non-GAAP net (loss) income (7) | $ | (1,867 | ) | $ | 3,336 | $ | 7,929 | $ | 18,547 | |||||||||||||||
Net (loss) income per common share – basic | $ | (0.04 | ) | $ | 0.08 | $ | 0.18 | $ | 0.44 | |||||||||||||||
Net (loss) income per common share – diluted | $ | (0.04 | ) | $ | 0.08 | $ | 0.17 | $ | 0.43 | |||||||||||||||
Weighted average per common share – basic | 45,378 | 42,174 | 45,178 | 42,097 | ||||||||||||||||||||
Weighted average per common share – diluted | 45,378 | 43,432 | 45,983 | 43,434 |
(1) |
Non-cash interest expense related to convertible senior notes, asset based loan, and Biotie debt. |
||
(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 September 30, 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 September 30, 2016 and 2015, cash taxes paid were $1.0M and $0.8M, respectively. In the nine months ended September 30, 2016 and 2015, cash taxes paid were $3.6M and $2.1M, respectively. A reconciliation to the previously reported non-GAAP results is presented below. |
||
Three Months |
Nine Months |
||||||||||
September 30, | |||||||||||
2015 | 2015 | ||||||||||
Non-GAAP net income – as revised (see above) | $ | 3,336 | $ | 18,547 | |||||||
Income tax effect of the reconciling items (see above) | (6,761 | ) | 204 | ||||||||
Non-cash income taxes (as previously reported) | 16,941 | 14,709 | |||||||||
Non-GAAP net income (as previously reported) | $ | 13,516 | $ | 33,460 | |||||||
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. |
View source version on businesswire.com: http://www.businesswire.com/news/home/20161027005496/en/
Source: Acorda Therapeutics, Inc.
Cet article Acorda Provides Financial and Pipeline Update for Third Quarter 2016 est apparu en premier sur EEI-BIOTECHFINANCES.