- 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
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.
- 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.
- 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.
- 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.
- 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.
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.Condensed Consolidated Balance Sheet Data(in
thousands)(unaudited)
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.Consolidated Statements of Operations(in
thousands, except per share amounts)(unaudited)
Three Months EndedSeptember
30,
Nine Months EndedSeptember
30,
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.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, 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 MonthsEnded
Nine Months Ended
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/
Acorda TherapeuticsFelicia Vonella,
914-326-5146fvonella@acorda.com
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