- INBRIJA® (levodopa inhalation powder) 1Q 2020 net revenue of
$4.4 million
- AMPYRA® (dalfampridine) 1Q 2020 net revenue of $20.1
million
- Reiterates 2020 AMPYRA net revenue guidance and operating
expense guidance
- Withdraws 2020 INBRIJA net revenue guidance due to the ongoing
COVID-19 pandemic
Acorda Therapeutics, Inc. (NASDAQ: ACOR) today provided a
business update and reported its financial results for the first
quarter ended March 31, 2020.
“As we continue navigating the unprecedented operating
environment created by COVID-19, our entire team remains focused on
ensuring that the Parkinson’s disease and multiple sclerosis
communities have continued access to Acorda’s critical
medications,” said Ron Cohen, M.D., Acorda's President and Chief
Executive Officer. “I am proud of how rapidly our team has evolved
our business practices and developed new ways of working that
enable us to keep our Acorda associates safe, while continuing to
manufacture therapies that improve the lives of patients.”
Dr. Cohen continued, “Despite significant disruption in the
healthcare sector during the first quarter, INBRIJA and AMPYRA
sales were consistent with our expectations, which took into
account typical seasonal variability. We remain confident in our
full-year expectations for AMPYRA, which is an established
franchise supported by ongoing prescription renewals. For INBRIJA,
which is a newer product driven by growth in new prescriptions, we
are withdrawing our 2020 guidance. Due to COVID-19 stay-at-home
orders and a widespread decrease in physician office visits, we do
not have visibility into how changes in patient behavior may impact
new prescription starts over the remainder of the year.”
First Quarter 2020 Business Update
In response to the COVID-19 pandemic, Acorda launched a new,
remote communications program, enabling it to communicate
effectively and safely with healthcare professionals and patients
to provide product education, information and support. The Company
also launched virtual speaker programs and product webinars with
meaningful attendance, including an Inbrija patient program that
had over 500 participants. In addition, Acorda launched a new
digital marketing program to drive awareness and educate people
with Parkinson’s about INBRIJA.
First Quarter 2020 Financial Results
For the quarter ended March 31, 2020, the Company reported
INBRIJA net revenue of $4.4 million, compared to $1.3 million for
the same quarter in 2019.
For the quarter ended March 31, 2020, the Company reported
AMPYRA net revenue of $20.1 million compared to $40.1 million for
the same quarter in 2019. 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, 2020 were $7.7 million, including $0.4 million of
share-based compensation compared to $16.0 million, including $0.7
million of share-based compensation for the same quarter in
2019.
Sales, general and administrative (SG&A) expenses for the
quarter ended March 31, 2020 were $41.1 million, including $1.5
million of share-based compensation compared to $52.7 million,
including $2.8 million of share-based compensation for the same
quarter in 2019.
Change in fair value of derivative liability for the quarter
ended March 31, 2020 was $26.5 million compared to $0 for the same
quarter in 2019.
Benefit from income taxes for the quarter ended March 31, 2020
was $7.0 million compared to a benefit from income taxes of $0.7
million for the same quarter in 2019.
The Company reported a GAAP net loss of $6.5 million for the
quarter ended March 31, 2020, or $0.14 per diluted share. GAAP net
loss in the same quarter of 2019 was $47.6 million, or $1.00 per
diluted share.
Non-GAAP net loss for the quarter ended March 31, 2020 was $24.4
million, or $0.51 per diluted share. Non-GAAP net loss in the same
quarter of 2019 was $26.5 million, or $0.56 per diluted share. This
quarterly non-GAAP net loss 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,
asset impairment charges, changes in the fair value of the
derivative liability, and expenses that pertain to a non-routine
restructuring event. A reconciliation of the GAAP financial results
to non-GAAP financial results is included with the attached
financial statements.
At March 31, 2020, the Company had cash, cash equivalents,
short-term investments and restricted cash of $126.3 million
compared to $168.9 million at year end 2019. Restricted cash
includes $42.7 million in escrow related to the 6% semi-annual
interest portion, payable in cash or stock, of the convertible note
exchange completed in December 2019. If the Company elects to pay
interest due in stock, the restricted cash will be released from
escrow.
2020 Financial Guidance
For the full-year 2020, Acorda continues to expect AMPYRA net
revenue to be $85 - $110 million, and operating expenses to be $170
- $180 million. The operating expense guidance is a non-GAAP
projection that excludes restructuring costs and share-based
compensation as more fully described below under “Non-GAAP
Financial Measures.”
As a result of declines in physician office visits due to
COVID-19 stay-at-home orders, the Company is withdrawing its
previously announced 2020 INBRIJA net revenue guidance. This also
necessitates the withdrawal of 2020 total net product revenue.
Acorda continues to expect INBRIJA peak sales to be $300 - $500
million.
Webcast and Conference Call
The Company will host a conference call today at 4:30 p.m. ET.
To participate in the conference call, please dial (833) 236-2756
(domestic) or (647) 689-4181 (international) and reference the
access code 7999873. The presentation will be available on the
Investors section of www.acorda.com.
A replay of the call will be available from 8:30 p.m. ET on May
5, 2020 until 11:59 p.m. ET on June 5, 2020. To access the replay,
please dial (800) 585-8367 (domestic) or (416) 621-4642
(international); reference code 7999873. 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 2020 operating expense guidance 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,
(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) asset impairment charges
that are not routine to the operation of the business, (v) changes
in the fair value of the derivative liability which is a non-cash
charge and not related to the operation of the business, and (vi)
expenses that pertain to a non-routine restructuring event. 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 2020
operating expense guidance on a non-GAAP basis, as the guidance
excludes restructuring costs and share-based compensation charges.
Due to the forward looking nature of this information, the amount
of compensation charges 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. Non-GAAP financial measures are not an
alternative for financial measures prepared in accordance with
GAAP. However, the Company believes that the presentation of this
non-GAAP financial measure, when viewed in conjunction with actual
GAAP results, provides investors with a more meaningful
understanding of our ongoing and projected operating performance
because it excludes (i) expenses that pertain to a non-routine
restructuring, and (ii) non-cash charges that are substantially
dependent on changes in the market price of our common stock. We
believe this non-GAAP financial measure helps indicate underlying
trends in the Company’s business and is important in comparing
current results with prior period results and understanding
expected 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.
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 Statements
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; the
COVID-19 pandemic, including related quarantines and travel
restrictions, and the potential for the illness to affect our
employees or consultants or those that work for other companies we
rely upon, could have a material adverse effect on our business
operations or product sales; we may need to raise additional funds
to finance our operations, repay outstanding indebtedness or
satisfy other obligations, and we may not be able to do so on
acceptable terms or at all; 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; 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)
March 31,
December 31,
2020
2019
Assets
Cash, cash equivalents and short-term
investments
$
82,894
$
125,839
Restricted cash - short term
13,175
12,836
Trade receivable, net
14,969
22,083
Other current assets
31,681
15,134
Inventories, net
25,566
25,221
Property and equipment, net
142,500
142,527
Intangible assets, net
390,311
402,329
Restricted cash - long term
30,270
30,270
Right of use assets
22,450
23,450
Other assets
11
29
Total assets
$
753,827
$
799,718
Liabilities and stockholders'
equity
Accounts payable, accrued expenses and
other current liabilities
$
49,041
$
65,335
Current portion of lease liability
7,846
7,746
Current portion of royalty liability
11,209
10,836
Current portion of contingent
consideration
1,940
1,866
Current portion of loans payable
592
603
Convertible senior notes
195,349
192,774
Derivative liability related to conversion
option
32,881
59,409
Non-current portion of acquired contingent
consideration
74,460
78,434
Non-current portion of lease liability
21,757
22,995
Non-current portion of royalty
liability
10,964
13,565
Non-current portion of loans payable
24,713
25,495
Deferred tax liability
16,391
9,581
Other long-term liabilities
10
259
Total stockholder's equity
306,674
310,820
Total liabilities and stockholders'
equity
$
753,827
$
799,718
Acorda Therapeutics,
Inc.
Consolidated Statements of
Operations
(in thousands, except per
share amounts)
(unaudited)
Three Months Ended
March 31,
2020
2019
Revenues:
Net product revenues
$
24,672
$
41,334
Royalty revenues
3,427
2,803
Total revenues
28,099
44,137
Costs and expenses:
Cost of sales
3,843
8,799
Research and development
7,705
16,028
Selling, general and administrative
41,108
52,725
Amortization of Intangible Asset
7,691
2,564
Asset impairment
4,131
—
Change in fair value of derivative
liability
(26,528
)
—
Change in fair value of acquired
contingent consideration
(3,682
)
7,400
Total operating expenses
34,268
87,516
Operating loss
$
(6,169
)
$
(43,379
)
Other expense, (net)
(7,301
)
(4,941
)
Loss before income taxes
(13,470
)
(48,320
)
Benefit from income taxes
6,998
715
Net loss
$
(6,472
)
$
(47,605
)
Net loss per common share - basic and
diluted
$
(0.14
)
$
(1.00
)
Weighted average common shares - basic and
diluted
47,703
47,472
Acorda Therapeutics,
Inc.
Non-GAAP Net Loss and Net Loss
per Common Share Reconciliation
(in thousands, except per
share amounts)
(unaudited)
Three Months Ended
March 31,
2020
2019
GAAP net loss
$
(6,472
)
$
(47,605
)
Pro forma adjustments:
Non-cash interest expense (1)
4,054
4,717
Change in fair value of acquired
contingent consideration (2)
(3,682
)
7,400
Restructuring costs (3)
343
—
Asset impairment charge (4)
4,131
—
Gain on change in fair value of derivative
liability (5)
(26,528
)
—
Share-based compensation expenses included
in Cost of Sales
81
150
Share-based compensation expenses included
in R&D
416
701
Share-based compensation expenses included
in SG&A
1,479
2,816
Total share-based compensation
expenses
1,976
3,667
Total pro forma adjustments
(19,706
)
15,784
Income tax effect of reconciling items
above (6)
(1,820
)
(5,343
)
Non-GAAP net loss
$
(24,358
)
$
(26,478
)
Net loss per common share - basic and
diluted
$
(0.51
)
$
(0.56
)
Weighted average common shares - basic and
diluted
47,703
47,472
(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) Costs associated with a corporate
restructuring initiative.
(4) Asset Impairment charge related to
BTT1023 acquired in the Biotie acquisition.
(5) Reduction in the fair value of the
derivative liability related to the 2024 convertible notes.
(6) Represents the tax effect of the
non-GAAP adjustments.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200505005860/en/
Tierney Saccavino (917) 783-0251 tsaccavino@acorda.com
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