- AMPYRA® (dalfampridine) 3Q 2015 Net
Revenue of $117.0 Million; 21% increase over 3Q 2014
- Raising Full Year 2015 Guidance for
AMPYRA Net Revenue from $410-$420 Million to $420-$430 Million
- Company Remains Cash Flow Positive
While Funding Late Stage Pipeline
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today provided a
financial and pipeline update for the third quarter ended September
30, 2015.
“AMPYRA continued to grow robustly in the third quarter,
supporting our ongoing investment in an exciting late stage
pipeline, while the Company remained cash flow positive. Our top
priority is the successful development of our clinical pipeline,”
said Ron Cohen, M.D., Acorda Therapeutics’ President and CEO. “We
expect several data milestones in 2016 for our most advanced
programs, led by CVT-301 for the treatment of off episodes in
Parkinson’s disease, PLUMIAZ for seizure clusters in epilepsy and
dalfampridine for the treatment of post-stroke walking
deficits.”
“We were also encouraged by positive developments in defending
our intellectual property around AMPYRA. Our legal team has been
recognized nationally for its achievements in the area of patent
litigation.”
Financial Results
The Company reported GAAP net income of $3.9 million for the
quarter ended September 30, 2015, or $0.09 per diluted share. GAAP
net income in the same quarter of 2014 was $12.0 million, or $0.28
per diluted share.
Non-GAAP net income for the quarter ended September 30, 2015 was
$13.5 million, or $0.31 per diluted share. Non-GAAP net income in
the same quarter of 2014 was $27.6 million, or $0.65 per diluted
share. Non-GAAP net income excludes share based compensation
charges, non-cash convertible debt, changes in the fair value of
acquired contingent consideration, acquisition related expenses,
the impact of a change in accounting policy for Zanaflex revenue
recognition, and non-cash tax expenses. 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, 2015, the Company reported AMPYRA
net revenue of $117.0 million compared to $96.4 million for the
same quarter in 2014.
ZANAFLEX CAPSULES® (tizanidine hydrochloride), ZANAFLEX®
(tizanidine hydrochloride) tablets and authorized generic capsules
- For the quarter ended September 30, 2015, the Company reported
combined net revenue and royalties from ZANAFLEX and tizanidine of
$26.0 million compared to $4.5 million for the same quarter in
2014. 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. Under the sell-in method of revenue recognition,
revenue is recognized when the product is shipped to the
distributor, whereas, under the sell-through method, revenue is
recognized when the product is prescribed to the patient. Going
forward, Zanaflex revenue will be recognized under the sell-in
method of revenue recognition.
FAMPYRA® (prolonged-release fampridine tablets) - For the
quarter ended September 30, 2015, the Company reported FAMPYRA
royalties from sales outside of the U.S. of $2.5 million compared
to $2.5 million for the same quarter in 2014.
Research and development (R&D) expenses for the quarter
ended September 30, 2015 were $43.4 million, including $2.3 million
of share-based compensation, compared to $16.6 million including
$1.4 million of share-based compensation for the same quarter in
2014.
The Company reiterated 2015 R&D guidance of 140-$150
million. This guidance excludes share-based compensation.
Sales, general and administrative (SG&A) expenses for the
quarter ended September 30, 2015 were $51.1 million, including $6.7
million of share-based compensation, compared to $47.8 million
including $5.8 million of share-based compensation for the same
quarter in 2014.
The Company reiterated 2015 SG&A guidance of $180-$190
million. This guidance excludes share-based compensation.
Provision for income taxes for the quarter ended September 30,
2015 was $17.8 million, including $0.8 million of cash taxes,
compared to $4.5 million, including $0.6 million of cash taxes for
the same quarter in 2014.
At September 30, 2015 the Company had cash, cash equivalents and
investments of $323.4 million. The Company expects to be cash flow
positive in 2015.
Quarterly Highlights
- AMPYRA (dalfampridine)
- In August, the Company announced that
the United States Patent and Trademark Office (USPTO) Patent Trials
and Appeal Board (PTAB) denied the institution of the two inter
partes review (IPR) petitions against two of its AMPYRA patents.
These patents are two of five Orange Book-listed patents that apply
to AMPYRA. The filing party has moved for reconsideration of the
PTAB’S decision.
- In September, four IPR petitions were
filed with the PTAB by the same party, challenging the validity of
four of the five AMPYRA Orange Book-listed patents. The Company
will oppose these IPR petitions, and if one or more is allowed to
proceed, the Company will defend its patents against them.
- In October, the Company announced it
had entered into two settlement agreements with Actavis
Laboratories FL (“Actavis”), Inc. and Sun Pharmaceutical Industries
Ltd. and its subsidiary (collectively, “Sun”) to resolve pending
patent litigation related to AMPYRA. As a result of the settlement
agreements, both Actavis and Sun will be permitted to market a
generic version of AMPYRA in the United States at a specified date
in 2027, or potentially earlier under certain circumstances. These
settlements do not resolve pending patent litigation brought by the
Company against other parties who have submitted ANDAs to the FDA
seeking marketing approval for generic versions of AMPYRA.
- In October, the Company presented
5-year post-marketing safety data for dalfampridine extended
release tablets in multiple sclerosis at the 31st Congress of the
European Committee for the Treatment and Research in Multiple
Sclerosis (ECTRIMS) annual meeting in Barcelona. The data presented
continue to be consistent with those reported in double-blind
clinical trials, with incidence of reported seizure remaining
stable over time.
- rHIgM22
- In October, the Company presented
pharmacokinetics from the rHIgM22 Phase 1 clinical trial in
patients with stable multiple sclerosis, confirming that rHIgM22
penetrates the CNS. This data was presented at the 31st Congress of
the European Committee for the Treatment and Research in Multiple
Sclerosis (ECTRIMS) annual meeting in Barcelona.
- CVT-427
- The Company has selected zolmitriptan
as the active ingredient for CVT-427, an inhaled triptan in
development for relief of acute migraine using the ARCUS
technology. Its Phase 1 study of CVT-427 is expected to begin
before the end of 2015.
- Corporate
- The Company’s legal team, led by Jane
Wasman, President, International and General Counsel, was the
recipient of a 2015 "Hatch Waxman Impact Case of the Year" award
from LMG Life Sciences. The annual LMG Life Sciences awards
recognizes leading attorneys, law firms, and in-house counsel teams
that have played a significant role in the life sciences industry
over the last 12 months.
- Acorda was named one of the 100 Best
Workplaces for Women, based on an independent survey by Fortune and
Great Place to Work.
Webcast and Conference Call
Ron Cohen, President and Chief Executive Officer, and Michael
Rogers, Chief Financial Officer, will host a conference call today
at 8:30 a.m. ET to review the Company’s third quarter 2015
results.
To participate in the conference call, please dial (855)
542-4209 (domestic) or (404) 455-6054 (international) and reference
the access code 51315974. 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 1:30 p.m. ET on
October 22, 2015 until 11:59 pm on October 29, 2015. To access the
replay, please dial (855) 859-2056 (domestic) or (404) 537-3406
(international) and reference the access code 51315974. The
archived webcast will be available in the Investor Relations
section of the Acorda website at www.acorda.com.
About AMPYRA (dalfampridine)
AMPYRA is a potassium channel blocker approved as a treatment to
improve walking in patients with multiple sclerosis (MS). This was
demonstrated by an increase in walking speed. AMPYRA, which was
previously referred to as Fampridine-SR, is an extended release
tablet formulation of dalfampridine (4-aminopyridine, 4-AP), and is
known as prolonged-, modified, or sustained-release fampridine
(FAMPYRA®) in some countries outside the United States (U.S).
In laboratory studies, dalfampridine extended release tablets
has been found to improve impulse conduction in nerve fibers in
which the insulating layer, called myelin, has been damaged. The
mechanism by which dalfampridine exerts its therapeutic effect has
not been fully elucidated. AMPYRA is being developed and
commercialized in the U.S. by Acorda Therapeutics; FAMPYRA is being
developed and commercialized by Biogen International GmbH in
markets outside the U.S. based on a licensing agreement with
Acorda. AMPYRA and FAMPRYA are manufactured globally by Alkermes
Pharma Ireland Limited, a subsidiary of Alkermes plc, based on a
supply agreement with Acorda.
AMPYRA is available by prescription in the United States. For
more information about AMPYRA, including patient assistance and
co-pay programs, healthcare professionals and people with MS can
contact AMPYRA Patient Support Services at 888-881-1918. AMPYRA
Patient Support Services is available Monday through Friday, from
8:00 a.m. to 8:00 p.m. Eastern Time.
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 markets
three FDA-approved therapies, including AMPYRA®(dalfampridine). The
Company has one of the leading pipelines in the industry of novel
neurological therapies. Acorda is currently developing a number of
clinical and preclinical stage therapies. This pipeline addresses a
range of disorders including post-stroke walking deficits,
Parkinson’s disease, epilepsy, heart failure, MS and spinal cord
injury. For more information, please visit the Company’s website
at: www.acorda.com.
Forward-Looking Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. 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 Civitas transaction and to
successfully integrate Civitas' operations into our operations; our
ability to successfully market and sell Ampyra 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, Plumiaz, 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, Plumiaz, or any other products under development;
we may need to raise additional funds to finance our expanded
operations and may not be able to do so on acceptable terms; the
occurrence of adverse safety events with our products; delays in
obtaining or failure to obtain regulatory approval of or to
successfully market Fampyra outside of the U.S. and our dependence
on our collaboration partner Biogen International GmbH 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 Acorda
Therapeutics' filings with the Securities and Exchange Commission.
Acorda may not actually achieve the goals or plans described in its
forward-looking statements, and investors should not place undue
reliance on these statements. Forward-looking statements made in
this release are made only as of the date hereof, and Acorda
disclaims any intent or obligation to update any forward-looking
statements as a result of developments occurring after the date of
this 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 income, adjusted to exclude the items below. These
non-GAAP financial measures are not an alternative for financial
measures prepared in accordance with GAAP. However, the Company
believes the presentation of these non-GAAP financial measures when
viewed in conjunction with our GAAP results, provide investors with
a more meaningful understanding of our ongoing and projected
operating performance because they exclude (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, (iii) changes in the fair value of acquired contingent
consideration which do not correlate to our actual cash payment
obligations in the current period, (iv) non-cash tax expenses
related to our tax accounting which do not correlate to our actual
tax payment obligations, (v) the impact of a change in accounting
policy with regards to revenue recognition for our Zanaflex product
line due to a one-time, non-recurring event, and (vi) acquisition
related expenses that pertain to a non-recurring event. The Company
believes these non-GAAP financial measures help indicate underlying
trends in the company’s business and are important in comparing
current results with prior period results and understanding
projected operating performance. 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. A reconciliation of the historical non-GAAP financial
results presented in this release to our GAAP financial results is
included in the attached financial statements.
Financial Statements
Acorda Therapeutics, Inc.
Condensed Consolidated Balance Sheet Data (in
thousands) (unaudited) September 30,
December 31, 2015 2014
Assets
Cash, cash equivalents, short-term and long-term investments $
323,430 $ 307,618 Trade receivable, net 31,755 32,211 Other current
assets 22,578 24,052 Finished goods inventory 46,838 26,837
Deferred tax asset 4,967 18,420 Property and equipment, net 42,415
46,090 Goodwill 183,636 182,952 Intangible assets, net 431,279
432,822 Other assets 13,380 9,677 Total assets $
1,100,278 $ 1,080,679
Liabilities and stockholders'
equity Accounts payable, accrued expenses and other liabilities
$ 82,477 $ 73,869 Deferred product revenue - 29,420 Current portion
of deferred license revenue 9,057 9,057 Current portion of revenue
interest liability 561 893 Current portion of notes payable 1,144
1,144 Convertible senior notes 293,492 287,699 Contingent
consideration 60,000 52,600 Non-current portion of deferred license
revenue 43,777 50,570 Deferred tax liability 24,568 23,885 Other
long-term liabilities 10,314 11,287 Stockholders' equity
574,888 540,255 Total liabilities and stockholders' equity $
1,100,278 $ 1,080,679
Acorda Therapeutics, Inc.
Consolidated Statements of Operations
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended
Nine Months Ended September 30, September 30,
2015 2014 2015 2014
Revenues:
Net product revenues $ 141,330 $ 98,481 $ 342,394 $ 262,662 Royalty
revenues 4,605 5,216 12,571 14,153 License revenue 2,264
2,264 6,793 6,793
Total revenues 148,199 105,961 361,758 283,608 Costs and
expenses: Cost of sales 24,741 20,575 65,896 55,004 Cost of license
revenue 159 159 476 476 Research and development 43,356 16,578
105,221 47,548 Selling, general and administrative 51,056 47,820
152,645 145,357 Change in fair value of acquired contingent
consideration 3,200 - 7,400
- Total operating expenses 122,512 85,132
331,638 248,385 Operating income $
25,687 $ 20,829 $ 30,120 $ 35,223 Other expense, net
(3,976 ) (4,340 ) (11,406 ) (4,520 ) Income
before income taxes 21,711 16,489 18,714 30,703 Provision for
income taxes (17,770 ) (4,536 ) (16,861 ) (13,361 )
Net income $ 3,941 $ 11,953 $ 1,853
$ 17,342 Net income per common share - basic $
0.09 $ 0.29 $ 0.04 $ 0.42 Net income per common share - diluted $
0.09 $ 0.28 $ 0.04 $ 0.41 Weighted average per common share - basic
42,174 41,094 42,097 41,022 Weighted average per common share -
diluted 43,432 42,365 43,434 42,346
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, 2015 2014 2015
2014 GAAP net income $ 3,941 $ 11,953 $ 1,853 $
17,342 Pro forma adjustments: Non-cash interest expense (1) 2,153
2,069 6,383 2,226 Non-cash tax expenses (2) 16,941 3,921
14,709 11,532 Acquisition related expenses (3) - 2,355 -
2,355 Change in revenue recognition - Zanaflex Capsules
& tablets (4) (21,633 ) - (21,633 ) - Change in fair
value of acquired contingent consideration (5) 3,200 - 7,400 -
Share-based compensation expenses included in R&D 2,250
1,423 6,231 4,089 Share-based compensation expenses included in
SG&A 6,664 5,848 18,517
16,555 Total share-based compensation expenses 8,914 7,271
24,748 20,644 Total pro forma
adjustments 9,575 15,616 31,607 36,757
Non-GAAP net income $ 13,516 $ 27,569 $ 33,460 $
54,099 Net income per common share - basic $ 0.32 $ 0.67 $
0.79 $ 1.32 Net income per common share - diluted $ 0.31 $ 0.65 $
0.77 $ 1.28 Weighted average per common share - basic 42,174 41,094
42,097 41,022 Weighted average per common share - diluted 43,432
42,365 43,434 42,346
(1) Non-cash interest expense related to
the convertible senior notes.
(2) $0.8 million and $0.6 million paid in
cash taxes in the three months ended 2015 and 2014, respectively;
$2.1 million and $1.8 million paid in cash taxes
in the nine months ended 2015 and 2014,
respectively.
(3) Transaction related expenses for the Civitas acquisition. (4)
Change from "sell-through" (deferred) revenue recognition to
"sell-in" (traditional) revenue recognition. (5) Changes in fair
value of acquired contingent consideration related to the Civitas
acquisition.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20151022005477/en/
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
Acorda Therapeutics (NASDAQ:ACOR)
Historical Stock Chart
From Mar 2024 to Apr 2024
Acorda Therapeutics (NASDAQ:ACOR)
Historical Stock Chart
From Apr 2023 to Apr 2024