-
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
ARDSLEY, N.Y.–(BUSINESS WIRE)– 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.
-
AMPYRA revenue for the fourth quarter of 2016 was $132 million, up
-
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.
-
On February 9, 2017, the Company announced
-
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.
-
In December, a special population study to evaluate safe
-
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.
-
In November, the Company discontinued the dalfampridine for
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. |
||||||||
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. |
||||||||||||||||||||||
|
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. |
|||||||||||||||||
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. |
||
Three |
Twelve |
||||||||||
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. |
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