- AMPYRA® (dalfampridine) 2Q 2016 Net
Revenue of $122.1 Million; 16% Increase over 2Q 2015 Net Revenue of
$105.5 Million
- Company Reiterates AMPYRA 2016 Net
Sales Guidance and Provides Updates on 2016 R&D and SG&A
Guidance
- Upcoming Clinical Trial Data on
Dalfampridine in Post-Stroke Walking Difficulties (2H 2016) and
CVT-301 for OFF Periods in Parkinson’s Disease (1Q 2017)
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today provided a
financial and pipeline update for the second quarter ended June 30,
2016.
“AMPYRA’s continued growth is fueling investment in our late
stage pipeline. We expect several important milestones in the
second half of 2016 and early 2017, including data from our Phase 3
dalfampridine post-stroke and CVT-301 trials. These near-term
opportunities target large, unmet needs and have the potential to
improve the lives of people with these serious neurological
diseases,” said Ron Cohen, M.D., Acorda's President and CEO. “We
are working towards concluding our acquisition of Biotie later this
year and excited about the addition of the tozadenant Phase 3
program to our pipeline of late stage assets.”
Financial Results
The Company reported a GAAP net loss attributable to Acorda of
$18.3 million for the quarter ended June 30, 2016, or $0.40 per
diluted share. GAAP net income in the same quarter of 2015 was $1.0
million, or $0.02 per diluted share.
Non-GAAP net income for the quarter ended June 30, 2016, was
$3.4 million, or $0.07 per diluted share. Non-GAAP net income in
the same quarter of 2015 was $13.5 million, or $0.31 per diluted
share. Non-GAAP net income excludes share based compensation
charges, non-cash interest expense, acquisition-related expenses,
expenses associated with changes in the fair value of acquired
contingent consideration, foreign currency losses/(gains) and tax
adjustments. 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 June 30, 2016, the Company reported AMPYRA net
revenue of $122.1 million compared to $105.5 million for the same
quarter in 2015.
ZANAFLEX CAPSULES® (tizanidine hydrochloride), ZANAFLEX®
(tizanidine hydrochloride) tablets and authorized generic capsules
- For the quarter ended June 30, 2016, the Company reported
combined net revenue and royalties from ZANAFLEX and tizanidine of
$(0.7) million compared to $3.2 million for the same quarter in
2015. Combined net revenue and royalties for the period ended June
30, 2016, includes a charge of $3.0 million due to an increase in
current and estimated future returns for ZANAFLEX.
FAMPYRA® (prolonged-release fampridine tablets) - For the
quarter ended June 30, 2016, the Company reported FAMPYRA royalties
from sales outside of the U.S. of $2.7 million compared to $2.5
million for the same quarter in 2015.
Research and development (R&D) expenses for the quarter
ended June 30, 2016, were $50.3 million, including $2.6 million of
share-based compensation, compared to $31.2 million, including $2.2
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 from
the date of acquisition.
Sales, general and administrative (SG&A) expenses for the
quarter ended June 30, 2016, were $53.1 million, including $6.7
million of share-based compensation, compared to $52.8 million,
including $6.5 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 June 30, 2016, from the date of acquisition.
Benefit from income taxes for the quarter ended June 30, 2016,
was $1.0 million, including $2.4 million of cash taxes, compared to
a provision for income taxes of $1.1 million, including $0.6
million of cash taxes, for the same quarter in 2015.
At June 30, 2016, the Company had cash, cash equivalents and
investments of $137.4 million. The decrease in cash from December
31, 2015, is primarily attributable to the Company’s acquisition of
Biotie. In June 2016, the Company entered into a three-year senior
secured revolving credit agreement with JP Morgan Chase Bank, N.A.
for up to $60 million.
2016 Financial Guidance
- The Company reiterates AMPYRA 2016 net
sales guidance of $475-$485 million.
- R&D guidance is revised from
$165-$175 million to $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.” The increase
in R&D expense is primarily driven by the addition of
tozadenant, a Phase 3 asset for the treatment of OFF periods for
people with Parkinson’s disease.
- SG&A guidance remains unchanged at
$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.” SG&A guidance
reflects the addition of the Biotie operations, offset by
reductions in current and projected SG&A expenses.
- The Company expects to be approximately
cash flow neutral for the second half of 2016.
Second Quarter 2016
Highlights
Commercial
- AMPYRA®
(dalfampridine)
- AMPYRA revenues for the second quarter
of 2016 were $122.1 million, up 16% from the second quarter in
2015. This represents the 13th consecutive quarter of double-digit,
year-over-year growth for AMPYRA, which was launched in 2010.
- In June, the United States Court of
Appeals for the Federal Circuit denied a request by Mylan
Pharmaceuticals for a rehearing of the Court's previous decision to
uphold a lower court ruling that Acorda’s Abbreviated New Drug
Application (ANDA) litigation against Mylan can continue in the
District Court of Delaware. Mylan has indicated that it intends to
file a petition for certiorari to the United States Supreme
Court.
- In July, the Company submitted its
responses to four Inter Partes Review (IPR) petitions to the United
States Patent and Trademark Office (USPTO). A decision on the IPR
is expected in March 2017.
- A District Court trial for Company’s
litigation against six generic companies seeking ANDA approvals is
scheduled for September 2016. The Company has five Orange
Book-listed patents on AMPYRA and will vigorously defend its
intellectual property rights.
Late Stage Clinical Pipeline
- Dalfampridine in Post-Stroke Walking
Difficulties (PSWD)
- Data from an unblinded analysis of the
current twice-daily (BID) clinical trial are expected in the fourth
quarter of 2016. Data from the Phase 1 multi-dose pharmacokinetic
(PK) testing for once-daily (QD) dalfampridine are also expected in
the fourth quarter of 2016.
- If the multi-dose PK and BID analyses
are positive, the Company plans to move forward with two
concurrent, pivotal Phase 3 trials of dalfampridine in PSWD in
mid-2017 using a QD formulation.
- CVT-301 in Parkinson’s Disease
- In June, data from the CVT-301 Phase 2b
clinical trial were presented in three posters during the 20th
International Congress of Parkinson’s Disease and Movement
Disorders in Berlin, Germany.
- Last patient out (LPO) of the ongoing
Phase 3 efficacy study is expected by the end of 2016.
Early Stage Pipeline
- CVT-427 in Migraine
- Data from a Phase 1 pharmacokinetic
(PK) study of CVT-427, an inhaled formulation of zolmitriptan,
showed increased bioavailability and faster absorption compared to
oral and nasal administration of the same active ingredient. The
trial enrolled 21 healthy adults.
- The data showed that median TMAX was
about 12 minutes for all CVT-427 doses compared to 1.5 hours for
the oral tablet and 3.0 hours for the nasal spray.
- There were no serious adverse events,
dose limiting toxicities, or study discontinuations due to adverse
events reported after administration. The most commonly reported
treatment-emergent AEs were cough, chest discomfort, headache and
feeling hot. Apart from cough, single dose CVT-427 tolerability was
generally consistent with the known safety profile of
zolmitriptan.
- The data were presented at the 58th
Annual Scientific Meeting of the American Headache Society in San
Diego, CA.
- The Company plans to initiate a special
population study in the second half of 2016, and expects to advance
this program into Phase 2 in 2017.
- Other Pipeline
- In May, development of PLUMIAZTM, an
investigational therapy for the treatment of seizure clusters in
people with epilepsy, was discontinued after data from the Phase 3
clinical trials did not demonstrate its bioequivalence to Diastat®
(diazepam) rectal gel.
Corporate Updates
- The Company has received more than 97%
of Biotie’s outstanding shares in the tender offer and expects to
complete the purchase of 100% of Biotie’s shares in the second half
of this year.
- In June, Biotie delisted its American
Depositary Shares from the NASDAQ following the filing of an
application on Form 25 with the U.S. Securities and Exchange
Commission.
- In July, Dr. Burkhard Blank assumed the
role of Chief Medical Officer (CMO). Dr. Blank was named interim
CMO in January 2016, and previously served as CMO for several
biopharmaceutical companies, including Boehringer Ingelheim,
Inc.
Webcast and Conference Call
The Company will host a conference call today at 8:30 a.m. ET to
review its second quarter 2016 results.
To participate in the conference call, please dial (855)
542-4209 (domestic) or (412) 455-6054 (international) and reference
the access code 40809722. The presentation will be available on the
Investors section of www.acorda.com. Please log in approximately 5
minutes before the scheduled time of the presentation to ensure a
timely connection.
A replay of the call will be available from 11:30 a.m. ET on
July 28, 2016, until 11:59 p.m. ET on August 4, 2016. To access the
replay, please dial (855) 859-2056 (domestic) or (404) 537-3406
(international) and reference the access code 40809722. 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 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 complete the Biotie
transaction on a timely basis; 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 will
acquire when we complete 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) non-cash tax expenses related to our tax accounting
which do not correlate to our actual tax payment obligations, (v)
realized foreign currency transaction gains and losses, and (vi)
acquisition related expenses. 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 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 revised
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) June 30, December 31,
2016 2015 Assets
Cash, cash equivalents, short-term and long-term investments $
137,400 $ 353,305 Trade receivable, net 45,886 31,466 Other current
assets 24,325 30,070 Finished goods inventory 55,553 36,476
Deferred tax asset 13,245 2,128 Property and equipment, net 36,754
40,204 Goodwill 284,504 183,636 Intangible assets, net 751,524
430,856 Other assets 8,465 3,153 Total assets $
1,357,656 $ 1,111,294
Liabilities and stockholders'
equity Accounts payable, accrued expenses and other current
liabilities $ 125,942 $ 80,391 Current portion of deferred license
revenue 9,057 9,057 Current portion of notes payable 1,126 1,144
Convertible senior notes 294,854 290,420 Contingent consideration
71,700 63,500 Non-current portion of deferred license revenue
36,984 41,513 Deferred tax liability 101,077 12,146 Other long-term
liabilities 35,374 10,098 Total stockholder's equity - Acorda
Therapeutics 671,638 603,025 Noncontrolling interest
9,904 - Total Stockholders' equity 681,542
603,025 Total liabilities and stockholders' equity $
1,357,656 $ 1,111,294
Acorda
Therapeutics, Inc. Consolidated Statements of Operations
(in thousands, except per share amounts) (unaudited)
Three Months Ended Six Months Ended June
30, June 30, 2016 2015 2016
2015 Revenues: Net product revenues $ 120,695 $ 107,565 $
230,842 $ 201,064 Royalty revenues 4,499 3,878 7,990 7,966 License
revenue 2,264 2,264 4,529
4,529 Total revenues 127,458 113,707 243,361 213,559
Costs and expenses: Cost of sales 26,435 22,708 49,621
41,155 Cost of license revenue 159 159 317 317 Research and
development 50,293 31,229 94,863 61,865 Selling, general and
administrative 53,056 52,819 104,838 101,589 Acquisition related
expenses 9,548 - 16,746 - Change in fair value of acquired
contingent consideration 2,000 1,100
8,200 4,200 Total operating expenses
141,491 108,015 274,585 209,126
Operating (loss)
income $ (14,033 ) $ 5,692 $ (31,224 ) $ 4,433 Other
(expense) income, net (5,896 ) (3,565 ) 1,037
(7,430 ) (Loss) income before income taxes (19,929 )
2,127 (30,187 ) (2,997 ) Benefit from (provision for) income taxes
972 (1,130 ) 10,709 909
Net (loss) income $
(18,957 ) $ 997 $ (19,478 ) $ (2,088 ) Net loss attributable
to noncontrolling interest 678 -
678 - Net (loss) income attributable to Acorda
Therapeutics, Inc. $ (18,279 ) $ 997 $ (18,800 ) $ (2,088 )
Net (loss) income per common share - basic $ (0.40 ) $ 0.02
$ (0.42 ) $ (0.05 ) Net loss per common share - diluted $ (0.40 ) $
0.02 $ (0.42 ) $ (0.05 ) Weighted average per common share - basic
45,338 42,085 45,077 42,058 Weighted average per common share -
diluted 45,338 43,282 45,077 42,058
Acorda Therapeutics, Inc. Non-GAAP Income and
Income per Common Share Reconciliation (in thousands, except
per share amounts) (unaudited) Three Months
Ended Six Months Ended June 30, June 30,
2016 2015 2016 2015 GAAP net
(loss) income $ (18,957 ) $ 997 $ (19,478 ) $ (2,088 ) Pro forma
adjustments: Non-cash interest expense (1) 2,360 2,128 4,564 4,230
Non-cash tax benefit (2) (3,393 ) 550 (13,287 ) (2,232 )
Change in fair value of acquired contingent consideration
(3) 2,000 1,100 8,200 4,200 Acquisition related expenses (4)
9,548 - 16,746 - Realized foreign currency loss (gain) (5)
2,551 - (7,738 ) - Share-based compensation expenses
included in R&D 2,616 2,159 4,737 3,982 Share-based
compensation expenses included in SG&A 6,656
6,549 12,694 11,853 Total
share-based compensation expenses 9,272 8,708 17,431 15,835
Total pro forma adjustments 22,338 12,486 25,916
22,033
Non-GAAP net income $ 3,381 $
13,483 $ 6,438 $ 19,945 Net income per
common share - basic $ 0.07 $ 0.32 $ 0.14 $ 0.47 Net income per
common share - diluted $ 0.07 $ 0.31 $ 0.14 $ 0.46 Weighted average
per common share - basic 45,338 42,085 45,077 42,058 Weighted
average per common share - diluted 46,028 43,282 46,036 43,434
(1) Non-cash interest expense related to convertible senior
notes, asset based loan, and Biotie debt. (2) $2.4 million and $0.6
million paid in cash taxes in the three months ended 2016 and 2015,
respectively; $2.6 million and $1.3 million paid in cash taxes in
the six months ended 2016 and 2015, respectively. (3) Changes in
the fair value of the acquired contingent consideration related to
the Civitas acquisition. (4) Transaction expenses related to the
Biotie acquisition. (5) Realized foreign currency loss (gain)
related to the Biotie transaction included in Other (expense)
income, net in the Consolidated Statements of Operations.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160728005563/en/
Acorda Therapeutics, Inc.Felicia Vonella,
914-326-5146fvonella@acorda.com
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