- NDA submitted for INBRIJA™ (levodopa
inhalation powder)
- Tozadenant Phase 3 data expected Q1
2018
- AMPYRA® (dalfampridine) 2Q 2017 net
revenue of $131.6 Million; 8% increase over 2Q 2016
- AMPYRA 2017 net sales guidance of $535
- $545 million reiterated
- Projected year-end cash balance greater
than $200 million
Acorda Therapeutics, Inc. (Nasdaq:ACOR)
provided a financial and pipeline update for the second quarter
ended June 30, 2017.
“INBRIJA and tozadenant are being developed as
therapies with complementary roles for people with Parkinson’s.
They have the potential to position Acorda as a leader in
Parkinson’s therapy, creating substantial value for shareholders,”
said Ron Cohen, M.D., Acorda's President and CEO.
“We submitted our NDA for INBRIJA on schedule.
This key milestone was achieved thanks to intensive work by many
dedicated Acorda associates. We expect the FDA to notify us by the
end of September if the submission is accepted for full review.
Commercial preparations for the launch of INBRIJA are well underway
and we expect to submit a Marketing Authorization Application to
the European Medicines Agency by the end of 2017. We are also on
track to announce top-line data from our Phase 3 study of
tozadenant in the first quarter of 2018.”
Second Quarter 2017 Financial
Results
AMPYRA® (dalfampridine) Extended Release
Tablets, 10 mg - For the quarter ended June 30, 2017, the Company
reported AMPYRA net revenue of $131.6 million compared to $122.1
million for the same quarter in 2016.
FAMPYRA® (prolonged-release fampridine tablets)
- For the quarter ended June 30, 2017, the Company reported FAMPYRA
royalties from sales outside of the U.S. of $2.9 million compared
to $2.7 million for the same quarter in 2016.
Research and development (R&D) expenses for
the quarter ended June 30, 2017 were $51.2 million, including $3.0
million of share-based compensation and $5.6 million of
restructuring expenses, compared to $50.3 million, including $2.6
million of share-based compensation for the same quarter in
2016.
Sales, general and administrative (SG&A)
expenses for the quarter ended June 30, 2017 were $49.3 million,
including $7.8 million of share-based compensation and $2.0 million
of restructuring expenses, compared to $53.1 million, including
$6.7 million of share-based compensation for the same quarter in
2016.
Provision for income taxes for the quarter
ended June 30, 2017 was $5.5 million, including $5.8 million of
cash taxes, compared to a benefit from income taxes of $1.0
million, including $2.4 million of cash taxes, for the same quarter
in 2016.
The Company reported a GAAP net loss
attributable to Acorda of $8.2 million for the quarter ended June
30, 2017, or $0.18 per diluted share. GAAP net loss in the same
quarter of 2016 was $18.3 million, or $0.40 per diluted share.
Non-GAAP net income for the quarter ended June
30, 2017 was $13.3 million, or $0.29 per diluted share. Non-GAAP
net loss in the same quarter of 2016 was $9.7 million, or $0.21 per
diluted share. This quarterly non-GAAP net income measure, more
fully described below under “Non-GAAP Financial Measures,” excludes
share-based compensation charges, unrealized foreign currency
losses (gains), non-cash interest charges on our debt,
restructuring expenses, 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.
At June 30, 2017, the Company had cash and cash
equivalents of $141.1 million.
Guidance for 2017
- The Company reiterates AMPYRA 2017 net
revenue of $535-$545 million.
- R&D expenses for the full year 2017
are expected to be $160-$170 million. This guidance is a non-GAAP
projection that excludes share-based compensation and restructuring
costs, as more fully described below under “Non-GAAP Financial
Measures.”
- SG&A expenses for the full year
2017 are expected to be $170-$180 million. This guidance is a
non-GAAP projection that excludes share-based compensation and
restructuring costs, as more fully described below under “Non-GAAP
Financial Measures.”
- The Company expects to be cash flow
positive in 2017, with a projected year-end cash balance in excess
of $200 million.
Second Quarter 2017
Highlights
- INBRIJA (levodopa inhalation powder)
in Parkinson’s disease
- In June, the Company submitted a New
Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for INBRIJA. The NDA was submitted as a 505(b)(2)
application.
- In June, data from the Phase 3 SPAN-PD
clinical trial of INBRIJA was presented at the International
Congress of Parkinson’s Disease and Movement Disorders (MDS).
- Tozadenant in Parkinson’s
disease
- In June, data from clinical and
preclinical studies of tozadenant were presented at the 2017
International Congress of Parkinson’s Disease and Movement
Disorders (MDS). One of the three posters presented, “Efficacy of
tozadenant in animal models of non-motor symptoms of Parkinson's
disease,” was selected by MDS for the Blue Ribbon Session, which
highlights the best scientific posters at the conference.
- AMPYRA (dalfampridine)
- In May, the Company filed a notice of
appeal to the United States District Court for the District of
Delaware, initiating the appeal process pertaining to the AMPYRA
patents that were invalidated by the Court in March 2017. Acorda’s
opening brief is due on August 7, 2017.
- The Company expects to maintain
exclusivity of AMPYRA at least through July 2018.
Webcast and Conference Call
The Company will host a conference call today
at 8:30 a.m. ET to review its second quarter 2017 results.
To participate in the conference call, please
dial (877) 201-0168 (domestic) or (647) 788-4901 (international)
and reference the access code 86092728. 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 July 27, 2017
until 11:59 p.m. ET on August 10, 2017. To access the replay,
please dial (800) 585-8367 (domestic) or (416) 621-4642
(international) and reference the access code 86092728. The webcast
(live and archived) will be available in the Investor Relations
section of the Acorda website at www.acorda.com.
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 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 into our operations; we
may need to raise additional funds to finance our 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., which will likely be materially
adversely affected by the recently announced court decision in our
litigation against filers of Abbreviated New Drug Applications to
market generic versions of Ampyra in the U.S.; the risk of
unfavorable results from future studies of Inbrija (CVT-301,
levodopa inhalation powder), tozadenant or from our other research
and development programs, or any other acquired or in-licensed
programs; we may not be able to complete development of, obtain
regulatory approval for, or successfully market Inbrija,
tozadenant, or any other products under development; third party
payers (including governmental agencies) may not reimburse for the
use of Ampyra, Inbrija or our other products at acceptable rates or
at all and may impose restrictive prior authorization requirements
that limit or block prescriptions; the occurrence of adverse safety
events with our products; failure to 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 which was
terminated in 2017 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) unrealized foreign currency losses (gains) related to
the Biotie acquisition, (v) acquisition related expenses that
pertain to a non-recurring event, and (vi) corporate restructuring
expenses that pertain to a 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)
June 30, December 31, 2017 2016
Assets Cash, cash equivalents and short-term
investments $ 141,135 $ 158,537 Trade receivable, net 55,626 52,239
Other current assets 14,935 18,746 Finished goods inventory 43,914
43,135 Deferred tax asset 4,400 4,400 Property and equipment, net
37,368 34,310 Goodwill 281,896 280,599 Intangible assets, net
742,704 742,242 Other assets 10,464 8,127 Total
assets $ 1,332,442 $ 1,342,335
Liabilities and
stockholders' equity Accounts payable, accrued expenses and
other current liabilities $ 97,469 $ 131,823 Current portion of
deferred license revenue 9,057 9,057 Current portion of loans
payable 615 6,256 Current portion of notes payable — 765
Convertible senior notes 304,045 299,395 Contingent consideration
89,300 72,100 Non-current portion of deferred license revenue
27,927 32,456 Non-current portion of loans payable 24,052 24,635
Deferred tax liability 79,556 92,807 Other long-term liabilities
10,701 8,830 Total stockholder's equity 689,720
664,211 Total liabilities and stockholders' equity $ 1,332,442 $
1,342,335
Acorda Therapeutics, Inc.
Consolidated Statements of
Operations
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended Six Months Ended June
30, June 30, 2017 2016 2017
2016 Revenues: Net product revenues $ 132,756
$ 120,695 $ 245,349 $ 230,842 Royalty revenues 4,418 4,499 8,946
7,990 License revenue 2,264 2,264 4,529
4,529 Total revenues 139,438 127,458 258,824 243,361 Costs
and expenses: Cost of sales 29,665 26,435 54,848 49,621 Cost of
license revenue 159 159 317 317 Research and development 51,184
50,293 97,677 94,863 Selling, general and administrative 49,334
53,056 101,039 104,838 Acquisition related expenses — 9,548 320
16,746 Change in fair value of acquired
contingent consideration
6,400 2,000 17,200 8,200 Total
operating expenses 136,742 141,491 271,401 274,585
Operating income (loss) $
2,696 $ (14,033 ) $ (12,577 ) $ (31,224 ) Other (expense)
income, net (5,421 ) (5,896 ) (9,970 )
1,037 Loss before income taxes (2,725 ) (19,929 ) (22,547 ) (30,187
) (Provision for) benefit from income taxes (5,471 )
972 (4,552 ) 10,709 Net loss $ (8,196 ) $ (18,957 ) $
(27,099 ) $ (19,478 ) Net loss attributable to non-controlling
interest - 678 - 678 Net loss attributable to Acorda Therapeutics,
Inc. $ (8,196 ) $ (18,279 ) $ (27,099 ) $ (18,800 ) Net loss per
common share attributable to
Acorda Therapeutics, Inc. - basic
$ (0.18 ) $ (0.40 ) $ (0.59 ) $ (0.42 ) Weighted average per common
share - basic 45,943 45,338 45,876 45,077
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, 2017 2016 2017
2016 GAAP net loss $ (8,196 ) $ (18,957 ) $
(27,099 ) $ (19,478 ) Pro forma adjustments: Non-cash interest
expense (1) 3,785 2,360 6,365 4,564 Change in fair value of
acquired
contingent consideration (2)
6,400 2,000 17,200 8,200 Restructuring costs (3) 7,590 —
7,590 — Acquisition related expenses (4) — 9,548 320 16,746
Unrealized foreign currency loss (gain) (5) — 2,551 (247 )
(7,738 ) Share-based compensation expenses
included in R&D
2,972 2,616 5,507 4,737 Share-based compensation expenses
included in SG&A
7,772 6,656 13,108 12,694 Total
share-based compensation expenses 10,744 9,272 18,615 17,431
Total pro forma
adjustments 28,519 25,731 49,843 39,203 Income tax effect of
reconciling items
above (6)
7,013 16,507 16,836 17,061
Non-GAAP net income (loss) (7) $ 13,310 $
(9,733 ) $ 5,908 $ 2,664 Net income (loss) per common share
- basic $ 0.29 $ (0.21 ) $ 0.13 $ 0.06 Net income (loss) per common
share - diluted $ 0.29 $ (0.21 ) $ 0.13 $ 0.06 Weighted average per
common share - basic 45,943 45,338 45,876 45,077 Weighted average
per common share - diluted 45,982 45,338 45,986 46,036 (1)
Non-cash interest expense related to convertible senior
notes, asset based loan, and Biotie non-convertible and R&D
loans. (2) Changes in the fair value of acquired contingent
consideration related to the Civitas transaction. (3) Restructuring
costs associated with the 2017 restructuring. (4) Transaction
expenses related to the Biotie acquisition. (5) Unrealized foreign
currency transaction gain (loss) related to the Biotie acquisition.
(6) Represents the tax effect of the non-GAAP adjustments. (7)
Prior year 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 June 30,
2017, 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 June 30, 2017 and 2016, cash taxes paid were $5.8 million and
$2.4 million, respectively. In the six months ended June 30, 2017
and 2016, cash taxes paid were $7.7 million and $2.6 million,
respectively. A reconciliation to the previously reported non-GAAP
results is presented below.
Acorda Therapeutics, Inc.
Non-GAAP Income and Income per Common
Share Reconciliation
(in thousands, except per share
amounts)
(unaudited)
ThreeMonthsEnded
SixMonthsEnded
June 30, June 30, 2016 2016 Non-GAAP
net (loss) income - as revised (see above) $ (9,733 ) $ 2,664
Income tax effect of the reconciling items (see above) 16,507
17,061 Non-cash income taxes (as previously reported) (3,393
) (13,287 ) Non-GAAP net income (as previously reported) $
3,381 $ 6,438
Note: Non-GAAP net income (loss) 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/20170727005381/en/
Acorda TherapeuticsFelicia Vonella,
914-326-5146fvonella@acorda.com
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