- 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
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.
ThreeMonthsEnded
TwelveMonthsEnded
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170214005512/en/
Acorda TherapeuticsFelicia Vonella,
914-326-5146fvonella@acorda.com
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