- INBRIJA™ (levodopa inhalation powder)
approved December 21, 2018 – first and only FDA-approved inhaled
levodopa for intermittent treatment of OFF episodes in people with
Parkinson’s taking carbidopa/levodopa
- INBRIJA commercially available in
1Q19
- AMPYRA® (dalfampridine) 4Q18 net
revenue of $64.2 million
- 2018 year-end cash, cash equivalents
and investments of $445 million
Acorda Therapeutics, Inc. (NASDAQ: ACOR) provided financial and
pipeline updates for the fourth quarter and full year ended
December 31, 2018.
“Our top priority for 2019 is to ensure a successful launch of
INBRIJA,” said Ron Cohen, M.D., Acorda’s President and CEO. “Our
field sales and medical teams have been meeting with Movement
Disorder specialists and their office staffs to educate them about
INBRIJA’s clinical profile, proper use of the inhaler and our
comprehensive patient support services. We are finding strong
receptiveness to this novel on-demand treatment for OFF
periods.”
“The approval of INBRIJA has now validated the innovative ARCUS
technology, which allows relatively large doses of drug to be
delivered through inhalation. We plan to apply the ARCUS platform
to develop therapies for additional indications, including acute
migraine, and we look forward to discussing future development
milestones later this year.”
Fourth Quarter 2018 Financial Results
For the quarter ended December 31, 2018, the Company reported
AMPYRA net revenue of $64.2 million compared to $167.2 million for
the same quarter in 2017. In September 2018, AMPYRA lost its
exclusivity and generics entered the market. Acorda has stated that
there would be a significant decline in AMPYRA revenue as a
result.
Research and development (R&D) expenses for the quarter
ended December 31, 2018 were $27.1 million, including $1.2 million
of share-based compensation compared to $35.1 million, including
$2.2 million of share-based compensation for the same quarter in
2017.
Sales, general and administrative (SG&A) expenses for the
quarter ended December 31, 2018 were $36.8 million, including $3.8
million of share-based compensation compared to $39.5 million,
including $5.4 million of share-based compensation for the same
quarter in 2017.
Benefit from income taxes for the quarter ended December 31,
2018 was $63.1 million, compared to a benefit from income taxes of
$51.9 million for the same quarter in 2017.
The Company reported GAAP net income of $9.6 million for the
quarter ended December 31, 2018, or $0.20 per diluted share. GAAP
net loss in the same quarter of 2017 was $(171.1) million, or
$(3.70) per diluted share.
Non-GAAP net income for the quarter ended December 31, 2018 was
$21.5 million, or $0.45 per diluted share. Non-GAAP net income in
the same quarter of 2017 was $28.5 million, or $0.61 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, restructuring expenses, changes in the fair value of acquired
contingent consideration, asset impairment charges and gain on sale
of assets. A reconciliation of the GAAP financial results to
non-GAAP financial results is included with the attached financial
statements.
Financial Results - Full Year Ended December 31, 2018
For the full year ended December 31, 2018, the Company
reported Ampyra net revenue of $455.1 million compared to
$543.3 million for the full year 2017. In September 2018,
AMPYRA lost its exclusivity and generics entered the market. Acorda
has stated that there would be a significant decline in AMPYRA
revenue as a result.
Research and development (R&D) expenses for the full year
ended December 31, 2018 were $106.4 million, including
$5.6 million of share-based compensation, compared to $166.1
million, including $9.7 million of share-based compensation for the
full year 2017.
Sales, general and administrative (SG&A) expenses for the
full year ended December 31, 2018 were $172.3 million,
including $15.7 million of share-based compensation, compared
to $181.6 million, including $23.1 million of share-based
compensation for the full year 2017.
Benefit from income taxes for the full year ended
December 31, 2018 was $13.3 million, compared to a
benefit from income taxes of $28.5 million for the full year
2017.
For the full year ended December 31, 2018, the Company
reported GAAP net income of $33.7 million, or $0.71 per
diluted share. GAAP net loss for the full year 2017 was $(223.4)
million, or $(4.86) per diluted share.
Non-GAAP net income for the full year ended December 31,
2018 was $103.4 million, or $2.18 per diluted share.
Non-GAAP net income for the full year ended December 31, 2017
was $80.7 million, or $1.75 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 debt, restructuring
expenses, changes in the fair value of acquired contingent
consideration, asset impairment charges, gain on sale of assets,
realized foreign currency loss and acquisition related expenses. A
reconciliation of the GAAP financial results to non-GAAP financial
results is included with the attached financial statements.
At December 31, 2018, the Company had cash, cash equivalents and
investments of $445 million.
2019 Financial Guidance
- During INBRIJA’s launch year, the
Company does not expect to provide INBRIJA revenue guidance.
- The Company will no longer provide
revenue guidance for AMPYRA, due to the unpredictable trajectory of
revenue decline given the entrance of generics.
- R&D expenses for the full year 2019
are expected to be $70-$80 million and SG&A expenses for the
full year 2019 are expected to be $200-$210 million. This guidance
is a non-GAAP projection that excludes share-based compensation as
more fully described below under “Non-GAAP Financial
Measures.”
Fourth Quarter 2018
Highlights
- INBRIJA™ (levodopa inhalation
powder)
- On December 21, 2018, INBRIJA was
approved by the FDA for intermittent treatment of OFF episodes in
people with Parkinson’s taking carbidopa/levodopa. It is not known
if INBRIJA is safe or effective in children.
- The Company’s Marketing Authorization
Application (MAA) for INBRIJA is currently under review by the
European Medicines Agency (EMA). After the adoption of a CHMP
(Committee for Medicinal Products for Human Use) opinion, the
Company expects a final decision from the European Commission
before the end of 2019.
- In January 2019, The Lancet Neurology
published results from SPAN℠-PD, the Phase 3 pivotal trial of
INBRIJA.
- AMPYRA (dalfampridine) Patent
Appeal
- In January 2019, the Federal Circuit
denied Acorda’s petition for an en banc hearing in the AMPYRA
patent appeal process. The Company intends to file a petition for
certiorari appealing the case to the U.S. Supreme Court.
Webcast and Conference Call
The Company will host a conference call and webcast in
conjunction with its fourth quarter/year end 2018 update and
financial results today at 4:30 p.m. ET. To participate in the
conference call, please dial (866) 393-4306 (domestic) or (734)
385-2616 (international) and reference the access code 2726179. The
presentation will be available on the Investors section of
www.acorda.com.
A replay of the call will be available from 5:30 p.m. ET on
February 14, 2019 until 11:59 p.m. ET on March 16, 2019. To access
the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406
(international); reference code 2726179. The archived webcast will
be available in the Investor Relations section of the Acorda
website at www.acorda.com.
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 2019 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 related to the Fampyra 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, (vi) asset impairments which are non-cash
charges that relate to program terminations that are not routine to
the operation of the business, and (vii) gain on sale of assets
that pertains to non-routine events. 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 2019
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.
About Acorda Therapeutics
Acorda Therapeutics develops therapies to restore function and
improve the lives of people with neurological disorders. INBRIJA™
(levodopa inhalation powder) is approved for intermittent treatment
of OFF episodes in adults with Parkinson’s disease treated with
carbidopa/levodopa. INBRIJA is not to be used by patients who take
or have taken a nonselective monoamine oxidase inhibitor such as
phenelzine or tranylcypromine within the last two weeks. 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: we may not be able to 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; third party
payers (including governmental agencies) may not reimburse for the
use of Inbrija or our other products at acceptable rates or at all
and may impose restrictive prior authorization requirements that
limit or block prescriptions; competition for Inbrija, Ampyra and
other products we may develop and market in the future, including
increasing competition and accompanying loss of revenues in the
U.S. from generic versions of Ampyra (dalfampridine) following our
loss of patent exclusivity; 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; 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
; 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; 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.
Financial Statements
Acorda Therapeutics, Inc.
Condensed Consolidated Balance Sheet
Data
(in thousands)
(unaudited)
December 31, December 31,
2018 2017 Assets Cash, cash equivalents
and short-term investments $ 445,553 $ 307,068 Trade receivable,
net 23,430 81,403 Other current assets 30,110 15,726 Finished goods
inventory 29,014 37,501 Property and equipment, net 60,519 36,669
Goodwill 282,059 286,611 Intangible assets, net 428,570 430,603
Other assets 411 2,388 Total assets $ 1,299,666 $
1,197,969
Liabilities and stockholders' equity
Accounts payable, accrued expenses and other current liabilities $
125,741 $ 127,217 Current portion of deferred license revenue —
9,057 Current portion of royalty liability 8,985 6,763 Current
portion of contingent consideration 4,914 278 Current portion of
loans payable 616 645 Convertible senior notes 318,670 308,805
Non-current portion of contingent consideration 163,086 112,722
Non-current portion of deferred license revenue — 23,398
Non-current portion of royalty liability 21,731 29,025 Non-current
portion of loans payable 24,470 25,670 Deferred tax liability 7,483
22,459 Other long-term liabilities 11,987 11,943 Total
stockholder's equity 611,983 519,987 Total
liabilities and stockholders' equity $ 1,299,666 $ 1,197,969
Acorda Therapeutics, Inc.
Consolidated Statements of
Operations
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended Twelve Months
Ended December 31, December 31, 2018
2017 2018 2017 Revenues:
Net product revenues $ 66,351 $ 170,044 $ 459,739 $ 549,749 Royalty
revenues 2,801 16,090 11,694 29,481 License revenue —
2,264 — 9,057 Total revenues 69,152 188,398 471,433
588,287 Costs and expenses: Cost of sales 21,476 50,240
99,310 135,080 Cost of license revenue — 159 — 634 Research and
development 27,058 35,142 106,383 166,105 Selling, general and
administrative 36,819 39,518 172,254 181,299 Asset impairment —
257,318 — 296,763 Acquisition related expenses — — — 320 Change in
fair value of acquired
contingent consideration
33,100 24,100 55,000 40,900 Total
operating expenses 118,453 406,477 432,947 821,101
Operating (loss) income $
(49,301 ) $ (218,079 ) $ 38,486 $ (232,814 ) Other expense,
(net) (4,166 ) (4,932 ) (18,063 )
(19,071 ) (Loss) income before income taxes (53,467 ) (223,011 )
20,423 (251,885 ) Benefit from income taxes 63,062
51,947 13,259 28,526 Net income (loss) $ 9,595 $
(171,064 ) $ 33,682 $ (223,359 ) Net income (loss) per
common share - basic $ 0.20 $ (3.70 ) $ 0.72 $ (4.86 ) Net income
(loss) per common share - diluted $ 0.20 $ (3.70 ) $ 0.71 $ (4.86 )
Weighted average common shares - basic 47,515 46,239 47,010 45,999
Weighted average common shares - diluted 47,606 46,239 47,341
45,999
Acorda Therapeutics, Inc.
Non-GAAP Net Income and Net Income per
Common Share Reconciliation
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended Twelve Months
Ended December 31, December 31, 2018
2017 2018 2017 GAAP net
income (loss) $ 9,595 $ (171,064 ) $ 33,682 $ (223,359 ) Pro forma
adjustments: Non-cash interest expense (1) 3,905 3,338 15,822
12,256 Change in fair value of acquired
contingent consideration (2)
33,100 24,100 55,000 40,900 Restructuring costs (3) (4 ) 22
1,316 7,647 Acquisition related expenses (4) — — — 320
Realized foreign currency loss (5) — — — 247 Asset
impairment charge (6) — 257,318 — 296,763 Gain on sale of
assets (7) (7,837 ) (3,534 ) (7,837 ) (3,534 ) Share-based
compensation expenses
included in R&D
1,224 2,154 5,560 9,683 Share-based compensation expenses
included in SG&A
3,782 5,396 15,692 23,131 Total
share-based compensation expenses 5,006 7,550 21,252 32,814
Total pro forma
adjustments 34,170 288,794 85,553 387,413 Income tax effect
of reconciling items
above (8)
22,241 89,196 15,814 83,346
Non-GAAP net income $ 21,524 $ 28,534 $
103,421 $ 80,708 Net income per common share - basic $ 0.45
$ 0.62 $ 2.20 $ 1.75 Net income per common share - diluted $ 0.45 $
0.61 $ 2.18 $ 1.75 Weighted average common shares - basic 47,515
46,239 47,010 45,999 Weighted average common shares - diluted
47,606 46,540 47,341 46,173
(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)
Asset impairment charges related to
Tozadenant, Selincro and SYN 120 acquired in the Biotie
acquisition.
(7)
Gain on the sales of Qutenza and Zanaflex
assets.
(8)
Represents the tax effect of the non-GAAP
adjustments.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190214005821/en/
Felicia Vonella(914) 326-5146fvonella@acorda.com
Acorda Therapeutics (NASDAQ:ACOR)
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