-
AMPYRA® (dalfampridine) Q3 2018 net revenue of $138
million; 2018 net revenue guidance increased from $330-$350 million to
more than $400 million
-
Cash balance for year-end 2018 revised from more than $300 million to
more than $400 million
-
INBRIJA™ (levodopa inhalation powder) PDUFA date January 5, 2019
ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq:ACOR)
provided a financial and pipeline update for the third quarter ended
September 30, 2018.
“Acorda’s highest priority is preparing for the expected launch of
Inbrija. Our market research indicates that healthcare professionals,
patients and care partners consider OFF periods, or the re-emergence of
Parkinson’s symptoms, to be one of the most significant unmet needs in
Parkinson’s, and that they are enthusiastic about the prospect of an
inhaled formulation of levodopa as a treatment option,” said Ron Cohen,
M.D., Acorda's President and CEO.
“We were disappointed and disagree with the decision of the Federal
appeals court regarding Ampyra, and we have filed an en banc petition
requesting review by the entire court. At the same time, we were
prepared for that potential outcome, and our original projections had us
well capitalized to fully fund the launch of Inbrija and to develop the
ARCUS pipeline. We have taken several steps over the past year both to
conserve and to increase cash. Based on these, as well as greater than
forecasted Ampyra sales, we are in now in an even stronger financial
position, and are increasing our guidance for both cash and Ampyra sales
in 2018.”
Third Quarter 2018 Financial Results
AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg - For
the quarter ended September 30, 2018, the Company reported AMPYRA net
revenue of $137.8 million compared to $132.6 million for the same
quarter in 2017.
Research and development (R&D) expenses for the quarter ended September
30, 2018 were $22.9 million, including $1.1 million of share-based
compensation compared to $33.3 million, including $2.0 million of
share-based compensation, for the same quarter in 2017.
Sales, general and administrative (SG&A) expenses for the quarter ended
September 30, 2018 were $43.6 million, including $4.0 million of
share-based compensation compared to $40.7 million, including $4.6
million of share-based compensation for the same quarter in 2017.
Provision for income taxes for the quarter ended September 30, 2018 was
$38.0 million, including $3.1 million of cash taxes, compared to a
provision for income taxes of $18.9 million, including $3.7 million of
cash taxes, for the same quarter in 2017.
The Company reported a GAAP net loss of $(13.9) million for the quarter
ended September 30, 2018, or $(0.29) per diluted share. GAAP net loss in
the same quarter of 2017 was $(25.2) million, or $(0.55) per diluted
share.
Non-GAAP net income for the quarter ended September 30, 2018 was $8.1
million, or $0.17 per diluted share. Non-GAAP net income in the same
quarter of 2017 was $20.1 million, or $0.43 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 debt, changes in the fair
value of acquired contingent consideration, intangible asset impairment
charges, and restructuring costs. A reconciliation of the GAAP financial
results to non-GAAP financial results is included with the attached
financial statements.
At September 30, 2018, the Company had cash, cash equivalents and
short-term investments of $460.9 million.
Guidance for 2018
-
AMPYRA 2018 net revenue guidance increased from $330-$350 million to
more than $400 million.
-
R&D expenses for the full year 2018 reiterated and expected to be
$100-$110 million including pre-launch manufacturing expenses
associated with INBRIJA. This guidance is a non-GAAP projection that
excludes share-based compensation, as more fully described below under
“Non-GAAP Financial Measures.”
-
SG&A expenses for the full year 2018 reiterated and expected to be
$170-$180 million. This guidance is a non-GAAP projection that
excludes share-based compensation, as more fully described below under
“Non-GAAP Financial Measures.”
-
The Company has increased projected 2018 year-end cash balance from
more than $300 million to more than $400 million.
Third Quarter 2018 Highlights
-
INBRIJA™ (levodopa inhalation powder) in Parkinson’s disease
-
In September, the FDA extended the PDUFA goal date for its review
of the New Drug Application (NDA) of INBRIJA from October 5, 2018
to January 5, 2019 based on submissions the Company made in
response to requests from FDA for additional information on
chemistry, manufacturing and controls (CMC). FDA determined that
these submissions constituted a major amendment and will take
additional time to review.
-
The Company reported that the inspection of its Chelsea,
Massachusetts manufacturing facility and the Inbrija inhaler
device manufacturer's facility were successfully completed and
closed without need for any further action by the FDA.
-
INBRIJA is an investigational treatment for symptoms of OFF
periods in people with Parkinson’s disease taking a
carbidopa/levodopa regimen.
-
AMPYRA (dalfampridine)
-
In September, the United States Court of Appeals for the Federal
Circuit, by a 2-1 vote, upheld the United States District Court
for the District of Delaware’s decision to invalidate four Ampyra
patents.
-
In October, the Company filed a petition for en banc
hearing with the United States Court of Appeals for the Federal
Circuit.
-
The Company announced that it had settled with Mylan AG to market
an authorized generic version of Ampyra. In mid-September, Mylan
announced the U.S. launch of the authorized generic.
Webcast and Conference Call
The Company will host a conference call today at 8:30 a.m. ET. To
participate in the conference call, please dial (833) 236-2756
(domestic) or (647) 689-4181 (international) and reference the access
code 4468928. 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 October 31,
2018 until 11:59 p.m. ET on November 30, 2018. To access the replay,
please dial (800) 585-8367 (domestic) or (416) 621-4642 (international);
reference code 4468928. The archived webcast will be available in the
Investor Relations section of the Acorda website at www.acorda.com.
About Acorda Therapeutics
Acorda Therapeutics develops therapies to restore function and improve
the lives of people with neurological disorders. INBRIJA™ (levodopa
inhalation powder), an investigational inhaled formulation of levodopa
for symptoms of OFF periods for people with Parkinson’s on a
carbidopa/levodopa regimen, is under FDA review with a PDUFA date of
January 5, 2019. INBRIJA utilizes Acorda’s innovative ARCUS® pulmonary
delivery system, a technology platform designed to deliver medication
through inhalation. Acorda also markets the branded 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 acquisitions, 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; we may need to raise additional funds to
finance our operations and may not be able to do so on acceptable terms;
increasing competition and accompanying loss of revenues in the U.S.
from generic versions of Ampyra (dalfampridine) following our loss of
patent exclusivity; the risk of unfavorable results from future studies
of Inbrija (levodopa inhalation powder) 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 or any other products under
development; risks associated with complex, regulated manufacturing
processes for pharmaceuticals, which could affect whether we have
sufficient commercial supply of Inbrija to meet market demand, if it
receives regulatory approval; 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; the outcome (by
judgment or settlement) and costs of legal, administrative or regulatory
proceedings, investigations or inspections, including, without
limitation, collective, representative or class action litigation;
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 2018
guidance for R&D and SG&A expenses 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 compensation 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 the Fampyra royalty monetization, the 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
periods, (iv) acquisition related expenses and related foreign currency
losses that pertain to a non-recurring event, (v) expenses that pertain
to non-routine restructuring events, and (vi) intangible asset
impairment charges 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 2018 guidance for
R&D and SG&A expenses 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)
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
2018
|
|
|
2017
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
Cash, cash equivalents and short-term investments
|
|
$
|
460,946
|
|
|
$
|
307,068
|
Trade receivable, net
|
|
|
51,461
|
|
|
|
81,403
|
Other current assets
|
|
|
23,388
|
|
|
|
15,726
|
Finished goods inventory
|
|
|
10,800
|
|
|
|
37,501
|
Property and equipment, net
|
|
|
52,061
|
|
|
|
36,669
|
Goodwill
|
|
|
283,435
|
|
|
|
286,611
|
Intangible assets, net
|
|
|
428,575
|
|
|
|
430,603
|
Other assets
|
|
|
419
|
|
|
|
2,388
|
Total assets
|
|
$
|
1,311,085
|
|
|
$
|
1,197,969
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity
|
|
|
|
|
|
|
|
Accounts payable, accrued expenses and other current liabilities
|
|
$
|
127,370
|
|
|
$
|
127,495
|
Current portion of deferred license revenue
|
|
|
—
|
|
|
|
9,057
|
Current portion of royalty liability
|
|
|
7,714
|
|
|
|
6,763
|
Current portion of loans payable
|
|
|
624
|
|
|
|
645
|
Convertible senior notes
|
|
|
316,160
|
|
|
|
308,805
|
Contingent consideration
|
|
|
131,229
|
|
|
|
112,722
|
Non-current portion of deferred license revenue
|
|
|
—
|
|
|
|
23,398
|
Non-current portion of royalty liability
|
|
|
24,251
|
|
|
|
29,025
|
Non-current portion of loans payable
|
|
|
24,673
|
|
|
|
25,670
|
Deferred tax liability
|
|
|
70,656
|
|
|
|
22,459
|
Other long-term liabilities
|
|
|
9,783
|
|
|
|
11,943
|
Total stockholder's equity
|
|
|
598,625
|
|
|
|
519,987
|
Total liabilities and stockholders' equity
|
|
$
|
1,311,085
|
|
|
$
|
1,197,969
|
|
|
|
|
|
|
|
|
|
Acorda Therapeutics, Inc.
|
Consolidated Statements of Operations
|
(in thousands, except per share amounts)
|
(unaudited)
|
|
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
September 30,
|
|
|
September 30,
|
|
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product revenues
|
|
$
|
|
139,973
|
|
|
$
|
|
134,357
|
|
|
|
$
|
|
393,388
|
|
|
$
|
|
379,705
|
|
Royalty revenues
|
|
|
|
2,841
|
|
|
|
|
4,444
|
|
|
|
|
|
8,893
|
|
|
|
|
13,391
|
|
License revenue
|
|
|
|
—
|
|
|
|
|
2,264
|
|
|
|
|
|
—
|
|
|
|
|
6,793
|
|
Total revenues
|
|
|
|
142,814
|
|
|
|
|
141,065
|
|
|
|
|
|
402,281
|
|
|
|
|
399,889
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
|
25,391
|
|
|
|
|
29,992
|
|
|
|
|
|
77,834
|
|
|
|
|
84,840
|
|
Cost of license revenue
|
|
|
|
—
|
|
|
|
|
159
|
|
|
|
|
|
—
|
|
|
|
|
476
|
|
Research and development
|
|
|
|
22,855
|
|
|
|
|
33,286
|
|
|
|
|
|
79,325
|
|
|
|
|
130,963
|
|
Selling, general and administrative
|
|
|
|
43,571
|
|
|
|
|
40,741
|
|
|
|
|
|
135,435
|
|
|
|
|
141,780
|
|
Asset impairment
|
|
|
|
—
|
|
|
|
|
39,446
|
|
|
|
|
|
—
|
|
|
|
|
39,446
|
|
Acquisition related expenses
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
320
|
|
Change in fair value of acquired
contingent consideration
|
|
|
|
22,700
|
|
|
|
|
(400
|
)
|
|
|
|
|
21,900
|
|
|
|
|
16,800
|
|
Total operating expenses
|
|
|
|
114,517
|
|
|
|
|
143,224
|
|
|
|
|
|
314,494
|
|
|
|
|
414,625
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss)
|
|
$
|
|
28,297
|
|
|
$
|
|
(2,159
|
)
|
|
|
$
|
|
87,787
|
|
|
$
|
|
(14,736
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expense, (net)
|
|
|
|
(4,240
|
)
|
|
|
|
(4,168
|
)
|
|
|
|
|
(13,898
|
)
|
|
|
|
(14,138
|
)
|
Income (loss) before income taxes
|
|
|
|
24,057
|
|
|
|
|
(6,327
|
)
|
|
|
|
|
73,889
|
|
|
|
|
(28,874
|
)
|
Provision for income taxes
|
|
|
|
(37,968
|
)
|
|
|
|
(18,868
|
)
|
|
|
|
|
(49,802
|
)
|
|
|
|
(23,421
|
)
|
Net (loss) income
|
|
$
|
|
(13,911
|
)
|
|
$
|
|
(25,195
|
)
|
|
|
$
|
|
24,087
|
|
|
$
|
|
(52,295
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per common share - basic
|
|
$
|
|
(0.29
|
)
|
|
$
|
|
(0.55
|
)
|
|
|
$
|
|
0.51
|
|
|
$
|
|
(1.14
|
)
|
Net (loss) income per common share - diluted
|
|
$
|
|
(0.29
|
)
|
|
$
|
|
(0.55
|
)
|
|
|
$
|
|
0.51
|
|
|
$
|
|
(1.14
|
)
|
Weighted average common shares - basic
|
|
|
|
47,184
|
|
|
|
|
46,002
|
|
|
|
|
|
46,840
|
|
|
|
|
45,918
|
|
Weighted average common shares - diluted
|
|
|
|
47,184
|
|
|
|
|
46,002
|
|
|
|
|
|
47,251
|
|
|
|
|
45,918
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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,
|
|
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net (loss) income
|
|
$
|
|
(13,911
|
)
|
|
$
|
|
(25,195
|
)
|
|
|
$
|
|
24,087
|
|
|
$
|
|
(52,295
|
)
|
Pro forma adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash interest expense (1)
|
|
|
|
3,944
|
|
|
|
|
2,553
|
|
|
|
|
|
11,917
|
|
|
|
|
8,918
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of acquired
contingent consideration (2)
|
|
|
|
22,700
|
|
|
|
|
(400
|
)
|
|
|
|
|
21,900
|
|
|
|
|
16,800
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring costs (3)
|
|
|
|
4
|
|
|
|
|
34
|
|
|
|
|
|
1,320
|
|
|
|
|
7,625
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition related expenses (4)
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
320
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Realized foreign currency loss (5)
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
|
247
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset impairment charge (6)
|
|
|
|
—
|
|
|
|
|
39,446
|
|
|
|
|
|
—
|
|
|
|
|
39,446
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expenses
included in R&D
|
|
|
|
1,112
|
|
|
|
|
2,041
|
|
|
|
|
|
4,336
|
|
|
|
|
8,401
|
|
Share-based compensation expenses
included in SG&A
|
|
|
|
4,023
|
|
|
|
|
4,630
|
|
|
|
|
|
11,910
|
|
|
|
|
17,820
|
|
Total share-based compensation expenses
|
|
|
|
5,135
|
|
|
|
|
6,671
|
|
|
|
|
|
16,246
|
|
|
|
|
26,221
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total pro forma adjustments
|
|
|
|
31,783
|
|
|
|
|
48,304
|
|
|
|
|
|
51,383
|
|
|
|
|
99,577
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax effect of reconciling items
above (7)
|
|
|
|
9,729
|
|
|
|
|
3,041
|
|
|
|
|
|
(6,427
|
)
|
|
|
|
19,877
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income
|
|
$
|
|
8,143
|
|
|
$
|
|
20,068
|
|
|
|
$
|
|
81,897
|
|
|
$
|
|
27,405
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share - basic
|
|
$
|
|
0.17
|
|
|
$
|
|
0.44
|
|
|
|
$
|
|
1.75
|
|
|
$
|
|
0.60
|
|
Net income per common share - diluted
|
|
$
|
|
0.17
|
|
|
$
|
|
0.43
|
|
|
|
$
|
|
1.73
|
|
|
$
|
|
0.60
|
|
Weighted average common shares - basic
|
|
|
|
47,184
|
|
|
|
|
46,002
|
|
|
|
|
|
46,840
|
|
|
|
|
45,918
|
|
Weighted average common shares - diluted
|
|
|
|
47,563
|
|
|
|
|
46,174
|
|
|
|
|
|
47,251
|
|
|
|
|
46,049
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
Non-cash interest expense related to convertible senior notes,
asset based loan (which was terminated in Q2 2017), Biotie
non-convertible and R&D loans and Fampyra royalty monetization.
|
(2)
|
|
Changes in fair value of acquired contingent consideration related
to the Civitas transaction.
|
(3)
|
|
Restructuring costs associated with corporate restructuring
initiatives.
|
(4)
|
|
Transaction expenses related to the Biotie acquisition.
|
(5)
|
|
Realized foreign currency transaction loss related to the Biotie
acquisition.
|
(6)
|
|
Impairment charge related to the intangible asset for Selincro.
|
(7)
|
|
Represents the tax effect of the non-GAAP adjustments.
|
|
|
|
View source version on businesswire.com:
https://www.businesswire.com/news/home/20181031005200/en/
Acorda Therapeutics
Felicia Vonella, 914-326-5146
fvonella@acorda.com
Source: Acorda Therapeutics, Inc.