- INBRIJA™ (levodopa inhalation powder)
commercially available on February 28; first and only FDA-approved
inhaled levodopa for intermittent treatment of OFF episodes in
people with Parkinson’s taking carbidopa/levodopa
- INBRIJA 1Q 2019 net sales of $1.3
million; approximately 2,000 prescription request forms received
through April 2019
- AMPYRA® (dalfampridine) 1Q 2019 net
sales of $40.1 million
Acorda Therapeutics, Inc. (NASDAQ: ACOR) provided a financial
and pipeline update for the quarter ended March 31, 2019.
“Since INBRIJA became commercially available at the end of
February, the feedback from both healthcare professionals and
people with Parkinson’s, or PWPs, has been enthusiastic, and our
Prescription Support Services center has received approximately
2,000 prescription requests. Our market research has consistently
shown that both physicians and PWPs consider OFF periods one of the
most troubling and disruptive aspects of Parkinson’s, and that they
regard INBRIJA as having the potential to address this significant
unmet need,” said Ron Cohen, M.D., Acorda's President and CEO. “We
are currently meeting with insurers to discuss formulary placement.
We are also continuing to roll out in-person and digital programs
to educate healthcare professionals and PWPs about INBRIJA.”
First Quarter 2019 Financial Results
For the quarter ended March 31, 2019, the Company reported
INBRIJA net revenue of $1.3 million. INBRIJA became commercially
available on February 28, 2019.
For the quarter ended March 31, 2019, the Company reported
AMPYRA net revenue of $40.1 million compared to $102.8 million for
the same quarter in 2018. In September 2018, AMPYRA lost its
exclusivity and generics entered the market. Consequently, the
Company expects AMPYRA revenue to continue to decline.
Research and development (R&D) expenses for the quarter
ended March 31, 2019 were $16.0 million, including $0.7 million of
share-based compensation compared to $30.6 million, including $1.7
million of share-based compensation for the same quarter in
2018.
Sales, general and administrative (SG&A) expenses for the
quarter ended March 31, 2019 were $52.7 million, including $2.8
million of share-based compensation compared to $47.6 million,
including $4.2 million of share-based compensation for the same
quarter in 2018.
Benefit from income taxes for the quarter ended March 31, 2019
was $0.7 million compared to a provision for income taxes of $3.5
million for the same quarter in 2018.
The Company reported a GAAP net loss of $47.6 million for the
quarter ended March 31, 2019, or $1.00 per diluted share. GAAP net
loss in the same quarter of 2018 was $8.2 million, or $0.18 per
diluted share.
Non-GAAP net loss for the quarter ended March 31, 2019 was $26.5
million, or $0.56 per diluted share. Non-GAAP net income in the
same quarter of 2018 was $6.8 million, or $0.14 per diluted share.
This quarterly non-GAAP net (loss) income measure, more fully
described below under “Non-GAAP Financial Measures,” excludes
share-based compensation charges, non-cash interest charges on our
debt, and changes in the fair value of acquired contingent
consideration. A reconciliation of the GAAP financial results to
non-GAAP financial results is included with the attached financial
statements.
At March 31, 2019, the Company had cash, cash equivalents and
short-term investments of $343.3 million compared to $445.6 million
at year end 2018. The decline in cash was due in large part to
non-recurring payments of approximately $45 million that were made
in the first quarter, primarily related to AMPYRA inventory
purchases. The Company does not expect to purchase additional
AMPYRA inventory in 2019.
For the remainder of 2019, the Company expects cash expenditures
to align with normal operating activities, and continues to believe
that it can become cash flow positive without raising additional
capital, based on its long-term projections.
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.”
First Quarter 2019
Highlights
INBRIJA™ (levodopa inhalation powder)
- In March, the Company submitted
responses to the INBRIJA Marketing Authorization Application (MAA)
Day 120 list of questions. A final decision from the European
Commission is expected before the end of 2019. Acorda is seeking
approval to market INBRIJA in the European Union.
- In March, new one-year safety and
exploratory efficacy outcomes data from the extension of the Phase
3 SPANSM-PD trial were presented at the Academy of Managed Care
Pharmacy (AMCP) Managed Care & Specialty Pharmacy Annual
Meeting.
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 (866) 393-4306
(domestic) or (734) 385-2616 (international) and reference the
access code 4783943. 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 May
2, 2019 until 11:59 p.m. ET on June 2, 2019. To access the replay,
please dial (855) 859-2056 (domestic) or (404) 537-3406
(international); reference code 4783943. 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 loss, 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 loss, 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, and
acquired Biotie debt, and (iii) changes in the fair value of
acquired contingent consideration which do not correlate to our
actual cash payment obligations in the relevant periods. The
Company believes its non-GAAP net loss 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 loss, 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.
Acorda Therapeutics, Inc.
Condensed Consolidated Balance Sheet
Data
(in thousands)
(unaudited)
March 31, December 31, 2019 2018
Assets Cash, cash equivalents and short-term
investments $ 343,250 $ 445,553 Trade receivables, net 20,652
23,430 Other current assets 22,537 30,110 Inventories, net 31,465
29,014 Property and equipment, net 83,032 60,519 Goodwill 280,128
282,059 Intangible assets, net 425,777 428,570 Right of use assets
26,802 — Other assets 295 411 Total assets $
1,233,938 $ 1,299,666
Liabilities and stockholders'
equity Accounts payable, accrued expenses and other current
liabilities $ 71,873 $ 125,741 Current portion of lease liability
7,458 — Current portion of royalty liability 9,173 8,985 Current
portion of acquired contingent consideration 8,179 4,914 Current
portion of loans payable 604 616 Convertible senior notes 321,210
318,670 Non-current portion of acquired contingent consideration
167,221 163,086 Non-current portion of lease liability 26,455 —
Non-current portion of royalty liability 20,174 21,731 Non-current
portion of loans payable 24,643 24,470 Deferred tax liability 5,401
7,483 Other long-term liabilities 4,961 11,987 Total stockholder's
equity 566,586 611,983 Total liabilities and
stockholders' equity $ 1,233,938 $ 1,299,666
Acorda Therapeutics, Inc.
Consolidated Statements of
Operations
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended March 31, 2019
2018 Revenues: Net
product revenues $ 41,334 $ 103,003 Royalty revenues 2,803
3,162 Total revenues 44,137 106,165 Costs and
expenses: Cost of sales 8,799 20,634 Research and development
16,028 30,560 Selling, general and administrative 52,725 47,601
Amortization of Intangible Asset 2,564 716 Change in fair value of
acquired contingent consideration 7,400 6,200 Total
operating expenses 87,516 105,711
Operating (loss) income $ (43,379 ) $ 454 Other expense,
(net) (4,941 ) (5,176 ) Loss before income taxes
(48,320 ) (4,722 ) Benefit from (Provision for) income taxes
715 (3,477 ) Net loss $ (47,605 ) $ (8,199 ) Net loss
per common share - basic and diluted $ (1.00 ) $ (0.18 ) Weighted
average common shares - basic and diluted 47,472 46,529
Acorda Therapeutics, Inc.
Non-GAAP Net (Loss) Income and Net
(Loss) Income per Common Share Reconciliation
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended March 31, 2019
2018 GAAP net loss $ (47,605 ) $
(8,199 ) Pro forma adjustments: Non-cash interest expense (1) 4,717
4,003 Change in fair value of acquired contingent
consideration (2) 7,400 6,200 Share-based compensation
expenses included in Cost of Sales 150 — Share-based compensation
expenses included in R&D 701 1,705 Share-based compensation
expenses included in SG&A 2,816 4,162 Total
share-based compensation expenses 3,667 5,867
Total pro forma adjustments 15,784 16,070 Income tax
effect of reconciling items above (3) (5,343 ) 1,077
Non-GAAP net (loss) income $ (26,478 ) $ 6,794
Net (loss) income per common share - basic $ (0.56 ) $ 0.15 Net
(loss) income per common share - diluted $ (0.56 ) $ 0.14 Weighted
average common shares - basic 47,472 46,529 Weighted average common
shares - diluted 47,472 46,983 (1) Non-cash interest expense
related to convertible senior notes, Biotie non-convertible
and R&D loans and Fampyra royalty
monetization.
(2) Changes in fair value of acquired contingent consideration
related to the Civitas acquisition. (3) Represents the tax effect
of the non-GAAP adjustments.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190502005238/en/
Felicia Vonella(914) 326-5146fvonella@acorda.com
Acorda Therapeutics (NASDAQ:ACOR)
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