- INBRIJA™ (levodopa inhalation powder)
NDA resubmitted in December 2017
- AMPYRA 4Q 2017 Net Sales of $167
million; Full Year 2017 Net Sales of $543 million
- 2017 year-end cash and cash equivalents
of $307 million
- Prosecution of AMPYRA appeal
continues
Acorda Therapeutics, Inc. (Nasdaq:ACOR) provided a financial and
pipeline update for the fourth quarter and full year ended December
31, 2017.
“We continue to prepare for the potential approval and launch of
INBRIJA, our investigational inhaled levodopa treatment for
symptoms of OFF periods in people with Parkinson’s disease. We look
forward to working with the FDA during the NDA review process, and
to bringing this new treatment option to the Parkinson’s community
to help address an important unmet need,” said Ron Cohen, M.D.,
Acorda's President and CEO. “Based on our continued market
research, as well as the strength of our Phase 3 data, we believe
INBRIJA’s US market opportunity to be greater than $800
million.”
Fourth Quarter 2017 Financial Results
AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg - For
the quarter ended December 31, 2017, the Company reported AMPYRA
net revenue of $167.2 million compared to $132.3 million for the
same quarter in 2016.
Royalty Revenue - For the quarter ended December 31, 2017, the
Company reported royalty revenue of $16.1 million as compared to
$4.4 million for the same quarter in 2016. The Company reported
FAMPYRA royalties from sales outside of the U.S. of $3.1 million
compared to $2.7 million for the same quarter in 2016.
Additionally, the Company completed a transaction that provides a
fully paid-up, royalty-free license for Selincro in exchange for
$13.0 million which was recorded as royalty revenue in the quarter
ended December 31, 2017. During the quarter ended December 31,
2017, the Company completed a royalty purchase transaction for its
Fampyra royalty revenue in exchange for an upfront payment of $40
million. The transaction was recorded as a liability in accordance
with US GAAP which will be reduced over time as royalty revenue is
recognized.
Research and development (R&D) expenses for the quarter
ended December 31, 2017 were $35.1 million, including $2.2 million
of share-based compensation compared to $53.8 million, including
$3.0 million of share-based compensation for the same quarter in
2016.
Sales, general and administrative (SG&A) expenses for the
quarter ended December 31, 2017 were $39.5 million, including $5.4
million of share-based compensation compared to $59.0 million,
including $6.0 million of share-based compensation for the same
quarter in 2016.
The Company recorded non-cash asset impairment charges of $233.5
million for tozadenant as a result of the termination of this
program, and $23.8 million for SYN120 as a result of the trial not
meeting key primary and secondary endpoints. The Company assessed
the valuation assumptions for both programs and determined the
assets were fully impaired. Both of these charges were recorded in
the quarter ended December 31, 2017.
Benefit from income taxes for the quarter ended December 31,
2017 was $51.9 million, including $2.7 million of cash taxes,
compared to a provision for income taxes of $1.0 million, including
$0.7 million of cash taxes for the same quarter in 2016.
The Company reported a GAAP net loss attributable to Acorda of
$(171.1) million for the quarter ended December 31, 2017, or
$(3.70) per diluted share. GAAP net loss in the same quarter of
2016 was $(3.1) million, or $(0.07) per diluted share.
Non-GAAP net income for the quarter ended December 31, 2017 was
$28.5 million, or $0.61 per diluted share. Non-GAAP net income in
the same quarter of 2016 was $2.5 million, or $0.05 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, gain on sale of
assets and acquisition-related expenses. 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, 2017
AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg -
For the full year ended December 31, 2017 net revenue was
$543.3 million compared to $492.8 million for full year
2016. Full year 2017 net revenue increased 10.2% over 2016.
Royalty Revenue - For the full year ended December 31,
2017, the Company reported royalty revenue of $29.5 million
compared to $17.2 million for the full year 2016. The Company
reported FAMPYRA royalties from sales outside of the U.S. of
$11.6 million compared to $10.6 million for the full year
2016. Royalty revenue related to the authorized generic version of
Zanaflex was $2.6 million compared to $3.9 million for the full
year 2016. Additionally, the Company reported $15.3 million in
royalties for Selincro for the full year 2017, which includes $13.0
million of royalty revenue related to the Selincro royalty
transaction.
Research and development (R&D) expenses for the full year
ended December 31, 2017 were $166.1 million, including
$9.7 million of share-based compensation, compared to
$203.4 million, including $10.6 million of share-based
compensation for the full year 2016
Sales, general and administrative (SG&A) expenses for the
full year ended December 31, 2017 were $181.6 million,
including $23.1 million of share-based compensation, compared
to $235.4 million, including $25.8 million of share-based
compensation for the full year 2016.
Asset impairment charges for the full year ended December 31,
2017 include $233.5 million for tozadenant, $23.8 million for
SYN120, and $39.4 million for Selincro.
Benefit from income taxes for the full year ended
December 31, 2017 was $28.5 million, including $14.1
million of cash taxes compared to a benefit from income taxes of
$6.7 million, including $4.3 million of cash taxes for the
full year 2016.
For the full year ended December 31, 2017, the Company
reported a GAAP net loss of $(223.4) million, or
$(4.86) per diluted share. GAAP net loss for the full year
2016 was $(34.6) million, or $(0.76) 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.
Non-GAAP net income for the full year ended December 31, 2016
was $11.5 million, or $0.25 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 (gain) 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, 2017, the Company had cash and cash equivalents
of $307.1 million.
2018 Financial Guidance
- AMPYRA net revenue is expected to be
$330-$350 million. The Company expects to maintain exclusivity of
AMPYRA at least through July 30, 2018; this guidance is subject to
change based on the appellate court’s decision.
- R&D expenses for the full year 2018
are expected to be $100-$110 million and include 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 are 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.”
- Year-end cash balance for 2018 is
projected to be over $300 million
Fourth Quarter 2017 Pipeline and
Corporate Updates
- INBRIJA (levodopa inhalation powder)
Next Steps
- The Company resubmitted the NDA for
INBRIJA in December 2017. The FDA is expected to inform the Company
if the submission has been deemed complete and permits a full
review in February 2018.
- The Company expects to file a Marketing
Authorization Application (MAA) with the European Medicines Agency
(EMA) in Q1 2018.
- AMPYRA (dalfampridine) Patent
Appeal
- In November, 2017, the Company and the
defendants filed reply briefs for the appeal to the U.S. Court of
Appeals for the Federal Circuit of the District Court’s decision in
the AMPYRA patent litigation. The date for oral argument is
expected in the first half of 2018.
- Both BIO and PhRMA filed amicus briefs
in support of the Company’s appeal, raising important issues in
conjunction with biopharmaceutical innovation.
- Royalty Monetization
Transactions/ZANAFLEX® (tizanidine hydrochloride) Franchise
Sale
- In November, 2017, the Company
announced royalty monetization transactions of $53 million for
FAMPYRA® and SELINCRO®.
- The Company also announced the sale of
ZANAFLEX and ZANAFLEX® CAPSULES for $4 million.
- SYN120 Phase 2 Data in Parkinson’s
disease
- Data from the Phase 2 proof-of-concept
study for SYN120 showed that several of the outcome measures
trended in favor of drug versus placebo; neither the primary nor
key secondary endpoints achieved statistical significance.
- The Company continues to review the
data, which will be presented at an upcoming medical meeting.
- Tozadenant Program
Discontinued
- In November, 2017, the Company
discontinued its clinical development program for tozadenant, an
investigational treatment for Parkinson’s disease. The Company made
this decision based on the emergence of serious adverse events in
its Phase 3 program.
Webcast and Conference Call
The Company will host a conference call today at 8:30 a.m. ET.
To participate, dial (866) 393-4306 (domestic) or (734) 385-2616
(international); access code 8789908. 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
February 15, 2018 until 11:59 p.m. ET on March 15, 2018. To access
the replay, dial (855) 859-2056 (domestic) or (404) 537-3406
(international); reference code 8789908. The archived webcast will
be available in the Investor Relations section of the Acorda
website.
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 related to the Fampyra monetization,
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
periods, (iv) acquisition related expenses and related foreign
currency losses and gains that pertain to a non-recurring event,
(v) corporate restructuring expenses that pertain to a
non-recurring event, (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 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..
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 two 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 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; 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 March 2017 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 (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; 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.
Financial Statements
Acorda Therapeutics, Inc.
Condensed Consolidated Balance Sheet
Data
(in thousands)
(unaudited)
December 31,2017
December 31,2016 Assets Cash, cash
equivalents and short-term investments $ 307,068 $ 158,537 Trade
receivable, net 81,403 52,239 Other current assets 15,726 18,746
Finished goods inventory 37,501 43,135 Deferred tax asset
-
4,400 Property and equipment, net 36,669 34,310 Goodwill 286,611
280,599 Intangible assets, net 430,603 742,242 Other assets
2,388 8,127 Total assets $ 1,197,969 $ 1,342,335
Liabilities and stockholders' equity Accounts payable,
accrued expenses and other current liabilities $ 127,495 $ 131,823
Current portion of deferred license revenue 9,057 9,057 Current
portion of royalty liability 6,763
-
Current portion of loans payable 645 6,256 Current portion of notes
payable
-
765 Convertible senior notes 308,805 299,395 Contingent
consideration 112,722 72,100 Non-current portion of deferred
license revenue 23,398 32,456 Non-current portion of royalty
liability 29,025
-
Non-current portion of loans payable 25,670 24,635 Deferred tax
liability 22,459 92,807 Other long-term liabilities 11,943 8,830
Total stockholder's equity 519,987 664,211 Total
liabilities and stockholders' equity $ 1,197,969 $ 1,342,335
Acorda Therapeutics, Inc.
Consolidated Statements of
Operations
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended Twelve Months
Ended December 31, December 31, 2017
2016 2017 2016 Revenues:
Net product revenues $ 170,044 $ 134,008 $ 549,749 $ 493,358
Royalty revenues 16,090 4,355 29,481 17,186 License revenue
2,264 2,264 9,057 9,057 Total revenues 188,398
140,627 588,287 519,601 Costs and expenses: Cost of sales
50,240 30,210 135,080 107,475 Cost of license revenue 159 159 634
634 Research and development 35,142 53,797 166,105 203,437 Selling,
general and administrative 39,518 58,681 181,299 217,885 Asset
impairment 257,318
-
296,763
-
Acquisition related expenses
-
366 320 17,551 Change in fair value of acquired
contingent consideration
24,100 (3,300 ) 40,900 8,600 Total
operating expenses 406,477 139,913 821,101 555,582
Operating (loss) income $
(218,079 ) $ 714 $ (232,814 ) $ (35,981 ) Other (expense)
income, net (4,932 ) (2,786 ) (19,071 )
(6,287 ) Loss before income taxes (223,011 ) (2,072 ) (251,885 )
(42,268 ) Benefit from (provision for) income taxes 51,947
(1,022 ) 28,526 6,665 Net loss $ (171,064 ) $
(3,094 ) $ (223,359 ) $ (35,603 ) Net loss attributable to
non-controlling interest
-
-
-
985 Net loss attributable to Acorda Therapeutics, Inc. $ (171,064 )
$ (3,094 ) $ (223,359 ) $ (34,618 ) Net loss per common share
attributable to
Acorda Therapeutics, Inc. - basic and
diluted
$ (3.70 ) $ (0.07 ) $ (4.86 ) $ (0.76 ) Weighted average common
shares - basic and diluted 46,239 45,500 45,999 45,259
Acorda Therapeutics, Inc.
Non-GAAP Income and Income per Common
Share Reconciliation
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended Twelve Months
Ended December 31, December 31, 2017
2016 2017 2016 GAAP net
loss $ (171,064 ) $ (3,094 ) $ (223,359 ) $ (34,618 ) Pro forma
adjustments: Non-cash interest expense (1) 3,338 2,559 12,256 9,717
Change in fair value of acquired
contingent consideration (2)
24,100 (3,300 ) 40,900 8,600 Restructuring costs (3) 22
-
7,647
-
Acquisition related expenses (4)
-
366 320 17,551 Realized foreign currency loss (gain) (5)
-
-
247 (7,738 ) Asset impairment charge (6) 257,318
-
296,763
-
Gain on sale of assets (7) (3,534 )
-
(3,534 )
-
Share-based compensation expenses included
in R&D
2,154 2,961 9,683 10,610
Share-based compensation expenses included
in SG&A
5,396 6,033 23,131 25,777 Total
share-based compensation expenses 7,550 8,994 32,814 36,387
Total pro forma
adjustments 288,794 8,619 387,413 64,517 Income tax effect
of reconciling items
above (8)
89,196 3,056 83,346 18,436
Non-GAAP net income $ 28,534 $ 2,469 $ 80,708
$ 11,463 Net income per common share - basic $ 0.62 $ 0.05 $
1.75 $ 0.25 Net income per common share - diluted $ 0.61 $ 0.05 $
1.75 $ 0.25 Weighted average per common share - basic 46,239 45,500
45,999 45,259 Weighted average per common share - diluted 46,540
45,649 46,173 45,900
(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 the Q2-2017
restructuring.
(4) Transaction expenses related to the Biotie acquisition.
(5) Realized foreign currency transaction loss (gain) related to
the Biotie acquisition.
(6) Asset impairment charges related to Tozadenant, Selincro and
SYN120 acquired in the Biotie acquisition.
(7) Represents the gain from the Zanaflex asset sale.
(8) Represents the tax effect of the non-GAAP adjustments.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20180215005410/en/
Acorda Therapeutics, Inc.Felicia Vonella,
914-326-5146fvonella@acorda.com
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