- INBRIJA® (levodopa inhalation powder) Q1 2021 net
revenue of $5 million; 13% increase over Q1 2020
- INBRIJA organic growth (dispensed cartons) was 25% Q1 2021 over
Q1 2020
- AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg Q1 2021
net revenue of $20.3 million; flat to Q1 2020
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today reported its
financial results for the first quarter 2021.
“We were pleased to see the increase in INBRIJA net sales in the
first quarter of 2021 over the same quarter of 2020. In addition,
our organic growth, measured by the increase in dispensed cartons,
was 25% compared to the first quarter of 2020 and also an
acceleration versus last quarter. This is an encouraging sign that
we may be starting to see the impact of a receding pandemic on our
business,” said Ron Cohen, M.D., Acorda’s President and Chief
Executive Officer. “We continue to see renewed interest in ex-US
commercial partnerships for INBRIJA, owing to the reduced cost of
goods that resulted from the sale of our manufacturing operations
to Catalent earlier this year, as well as clarity from the GBA in
Germany indicating that an early benefit assessment would not be
required. We are in active discussions with several parties for
commercialization both in Europe and around the world.”
“We were also pleased to see stable year-over-year quarterly
sales for AMPYRA for the first time since it went generic in
September 2018 and believe this is due to the strategies we have
executed to maintain the brand. The strength of the AMPYRA brand is
an important contributor to Acorda’s financial stability and to our
goal of becoming cash-flow neutral by the end of 2022,” Cohen
continued. “We also plan to address our $69 million convertible
debt payment that is coming due in June of 2021.”
First Quarter 2021 Financial Results
For the quarter ended March 31, 2021, the Company reported
INBRIJA net revenue of $5 million, compared to $4.4 million for the
same quarter in 2020.
For the quarter ended March 31, 2021, the Company reported
AMPYRA net revenue of $20.3 million compared to $20.1 million for
the same quarter in 2020. 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, 2021 were $4.7 million, including $0.2 million of
share-based compensation compared to $7.7 million, including $0.4
million of share-based compensation for the same quarter in
2020.
Sales, general and administrative (SG&A) expenses for the
quarter ended March 31, 2021 were $34.0 million, including $0.5
million of share-based compensation compared to $41.1 million,
including $1.5 million of share-based compensation for the same
quarter in 2020.
Change in fair value of derivative liability for the quarter
ended March 31, 2021 was $0.2 million compared to $(26.5) million
for the same quarter in 2020.
Benefit from income taxes for the quarter ended March 31, 2021
was $3.2 million compared to a benefit from income taxes of $7.0
million for the same quarter in 2020.
The Company reported a GAAP net loss of $33.5 million for the
quarter ended March 31, 2021, or $3.53 per diluted share. GAAP net
loss in the same quarter of 2020 was $6.5 million, or $0.81 per
diluted share.
Non-GAAP net loss for the quarter ended March 31, 2021 was $23.3
million, or $2.46 per diluted share. Non-GAAP net loss in the same
quarter of 2020 was $24.4 million, or $3.06 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 derivative
liability related to our 2024 convertible senior secured notes, and
expenses that pertain to non-routine corporate restructurings. A
reconciliation of the GAAP financial results to non-GAAP financial
results is included with the attached financial statements.
At March 31, 2021, the Company had cash, cash equivalents,
short-term investments, and restricted cash of $148.4 million,
compared to $102.9 million at year end 2020. Restricted cash
includes $31.1 million in escrow related to the 6% semi-annual
interest portion, payable in cash or stock, of the 2024 convertible
senior secured notes. If the Company elects to pay interest due in
stock, the restricted cash will be released from escrow.
Financial Guidance
- For the full-year 2021, Acorda continues to expect AMPYRA net
revenue to be $75 - $85 million, and operating expenses to be $130
- $140 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.”
Webcast and Conference Call
The Company will host a conference call and webcast in
conjunction with its first quarter 2021 update and financial
results today at 4:30 p.m. EDT.
To participate in the Webcast/Conference Call, please note there
is a new pre-registration process.
- To register for the Webcast, use the link below:
https://event.on24.com/wcc/r/3081214/BF56AABD29A92052740E53BBED6A1B75
- To register for the Conference Call, use the link below:
http://www.directeventreg.com/registration/event/2996776
**When registering please type your phone number with no
special characters**
Once you have registered, you will receive a confirmation email
with Webcast/Conference Call details. For the Webcast you will
receive an email 2 hours prior to the start of the call with the
link to join. The presentation will be available on the Investors
section of www.acorda.com.
A replay of the call will be available from 7:30 p.m. EDT on May
6, 2021 until 11:59 p.m. EDT on June 3, 2021. To access the replay,
please dial (800) 585-8367 (domestic) or (416) 621-4642
(international); reference code 2996776. 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 2021 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 that the presentation of non-GAAP net loss,
when viewed in conjunction with actual 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
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) expenses that pertain
to corporate restructurings which are not routine to the operation
of the business, and (vi) changes in the fair value of derivative
liability relating to the 2024 convertible senior secured notes,
which is a non-cash charge and not related to the operation of the
business. 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 2021
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 this measure to the
most directly comparable GAAP financial measure 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 non-routine
corporate restructurings, 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 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 AMPYRA, 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; our ability to raise additional funds
to finance our operations, repay outstanding indebtedness or
satisfy other obligations, and our ability to control our costs or
reduce planned expenditures; risks associated with the trading of
our common stock and our reverse stock split; risks related to our
workforce, including our ability to realize the expected benefits
of our corporate restructuring; risks associated with complex,
regulated manufacturing processes for pharmaceuticals, which could
affect whether we have sufficient commercial supply of INBRIJA to
meet market demand; our reliance on third-party manufacturers for
the production of commercial supplies of AMPYRA and INBRIJA;
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)
March 31,
December 31,
2021
2020
Assets
Cash, cash equivalents and short-term
investments
$
116,773
$
71,369
Restricted cash - short term
13,054
12,917
Trade receivable, net
17,295
20,193
Other current assets
15,182
16,384
Inventories, net
27,415
28,677
Assets held for sale - current
—
71,795
Property and equipment, net
6,451
7,263
Intangible assets, net
359,245
366,981
Restricted cash - long term
18,609
18,609
Right of use assets, net
10,013
18,481
Other assets
11
11
Total assets
$
584,048
$
632,680
Liabilities and stockholders'
equity
Accounts payable, accrued expenses and
other current liabilities
$
47,611
$
50,322
Current portion of lease liability
6,198
7,944
Current portion of royalty liability
9,015
8,731
Current portion of contingent
consideration
1,698
1,624
Current portion of loans payable
68,529
68,631
Convertible senior notes
140,751
137,619
Derivative liability related to conversion
option
1,418
1,193
Non-current portion of acquired contingent
consideration
45,302
46,576
Non-current portion of lease liability
9,810
17,200
Non-current portion of royalty
liability
3,642
6,526
Non-current portion of loans payable
27,623
28,555
Deferred tax liability
15,495
19,116
Other long-term liabilities
677
688
Total stockholder's equity
206,279
237,955
Total liabilities and stockholders'
equity
$
584,048
$
632,680
Acorda Therapeutics, Inc.
Consolidated Statements of Operations (in thousands,
except per share amounts) (unaudited)
Three Months Ended
March 31,
2021
2020
Revenues:
Net product revenues
$
25,247
$
24,672
Royalty revenues
3,615
3,427
Total revenues
28,862
28,099
Costs and expenses:
Cost of sales
11,961
3,843
Research and development
4,749
7,705
Selling, general and administrative
33,968
41,108
Amortization of Intangible Asset
7,691
7,691
Asset impairment
—
4,131
Change in fair value of derivative
liability
225
(26,528
)
Change in fair value of acquired
contingent consideration
(951
)
(3,682
)
Total operating expenses
57,643
34,268
Operating loss
$
(28,781
)
$
(6,169
)
Other expense, (net)
(7,822
)
(7,301
)
Loss before income taxes
(36,603
)
(13,470
)
Benefit from income taxes
3,152
6,998
Net loss
$
(33,451
)
$
(6,472
)
Net loss per common share - basic and
diluted
$
(3.53
)
$
(0.81
)
Weighted average common shares - basic and
diluted
9,470
7,960
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,
2021
2020
GAAP net loss
$
(33,451
)
$
(6,472
)
Pro forma adjustments:
Non-cash interest expense (1)
4,271
4,054
Change in fair value of acquired
contingent consideration (2)
(951
)
(3,682
)
Restructuring costs (3)
2,124
343
Asset impairment charge (4)
—
4,131
Change in fair value of derivative
liability (5)
225
(26,528
)
Share-based compensation expenses
included in Cost of Sales
7
81
Share-based compensation expenses
included in R&D
166
416
Share-based compensation expenses
included in SG&A
534
1,479
Total share-based compensation
expenses
707
1,976
Total pro forma adjustments
6,376
(19,706
)
Income tax effect of reconciling items
above (6)
(3,732
)
(1,820
)
Non-GAAP net loss
$
(23,343
)
$
(24,358
)
Net loss per common share - basic and
diluted
$
(2.46
)
$
(3.06
)
Weighted average common shares - basic and
diluted
9,470
7,960
(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 non-routine
corporate restructurings.
(4) Asset Impairment charge related to the
2020 impairment of BTT1023 acquired in the Biotie acquisition.
(5) Increase/(decrease) in the fair value
of the derivative liability related to the 2024 convertible senior
secured notes.
(6) Represents the tax effect of the
non-GAAP adjustments.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210506005808/en/
Tierney Saccavino (914) 326-5104 tsaccavino@acorda.com
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