-
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
ARDSLEY, N.Y.--(BUSINESS WIRE)--
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)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
Six Months Ended
|
|
|
|
|
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/
Source: Acorda Therapeutics, Inc.