- INBRIJA® (levodopa inhalation powder) 3Q 2020 net revenue of
$5.8 million; 24% increase over 2Q 2020
- AMPYRA® (dalfampridine) 3Q 2020 net revenue of $27.3 million;
5% increase over Q2 2020
- $15 million FAMPYRA® milestone payment received from
Biogen
Acorda Therapeutics, Inc. (NASDAQ:ACOR) today reported its
financial results for the third quarter ended September 30,
2020.
“We are encouraged by the 24% increase in INBRIJA net sales over
the second quarter, even with the challenges posed by the second
wave of COVID-19. We are also pleased that coverage for INBRIJA
continued to increase during the quarter, with over 96% of
commercially-insured patients now having access to it,” said Ron
Cohen, M.D., Acorda's President and Chief Executive Officer. “In
addition, AMPYRA’s performance and the milestone payment we
received for FAMPYRA have further strengthened our financial
position. We are also continuing our work to reduce operating costs
and monetize excess capacity at our Chelsea facility, to help drive
long-term value for all shareholders.”
Third Quarter 2020 Financial Results For the quarter
ended September 30, 2020, the Company reported INBRIJA net revenue
of $5.8 million, compared to $4.9 million for the same quarter in
2019.
For the quarter ended September 30, 2020, the Company reported
AMPYRA net revenue of $27.3 million compared to $39.3 million for
the same quarter in 2019. As previously announced, AMPYRA lost its
exclusivity in September 2018.
Research and development (R&D) expenses for the quarter
ended September 30, 2020 were $5.7 million, including $0.6 million
of share-based compensation compared to $16.1 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 September 30, 2020 were $39.9 million, including $1.8
million in share-based compensation compared to $48.7 million,
including $2.4 million in share-based compensation for the same
quarter in 2019.
The Company received a $15 million milestone payment from Biogen
International GmbH under its license and collaboration agreement
with Biogen, based on Biogen’s ex-U.S. net sales of FAMPYRA
exceeding $100 million over the four consecutive quarters ending
with the third quarter of 2020. The Company will retain
approximately $14 million of the milestone payment net of the
Company’s payment obligations to another party.
Change in fair value of derivative liability for the quarter
ended September 30, 2020 was $4.9 million.
Provision for income taxes for the quarter ended September 30,
2020 was $1.5 million compared to a provision for income taxes of
$0.02 million for the same quarter in 2019.
The Company reported GAAP net income of $7.3 million for the
quarter ended September 30, 2020, or $.05 per diluted share. GAAP
net loss in the same quarter of 2019 was $263.5 million, or $5.55
per diluted share.
Non-GAAP net loss for the quarter ended September 30, 2020 was
$10.9 million, or $0.23 per diluted share. Non-GAAP net loss in the
same quarter of 2019 was $21.9 million, or $0.46 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,
changes in the fair value of the derivative liability and asset
impairment charges. A reconciliation of the GAAP financial results
to non-GAAP financial results is included with the attached
financial statements.
At September 30, 2020, the Company had cash, cash equivalents,
short-term investments and restricted cash of $101 million compared
to $253 million at September 30, 2019. Restricted cash includes $37
million in escrow related to the 6% semi-annual interest portion of
the convertible note exchange completed in December 2019. If the
Company is permitted under the terms of the notes and elects to pay
interest due in stock, the restricted cash will be released from
escrow.
For 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.”
Webcast and Conference Call The Company will host a
conference call today at 4:30 p.m. ET. 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/2632602/8ADE226D375B6A5A6547386F6E26E270
- To register for the Conference Call, use the link below:
http://www.directeventreg.com/registration/event/4177747 **When
registering please type your phone number with no special
characters**.
A replay of the call will be available from 8:30 p.m. ET on
November 3, 2020 until 11:59 p.m. ET on December 3, 2020. To access
the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642
(international); reference code 4177747. 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; 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 and take other
actions which are necessary for us to continue as a going concern;
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)
September 30,
December 31,
2020
2019
Assets
Cash, cash equivalents and short-term
investments
$
63,256
$
125,839
Restricted cash - short term
13,200
12,836
Trade receivable, net
13,385
22,083
Other current assets
31,853
15,134
Inventories, net
30,120
25,221
Property and equipment, net
139,255
142,527
Intangible assets, net
374,743
402,329
Restricted cash - long term
24,819
30,270
Right of use assets, net
19,805
23,450
Other assets
157
29
Total assets
$
710,593
$
799,718
Liabilities and stockholders'
equity
Accounts payable, accrued expenses and
other current liabilities
$
51,792
$
65,335
Current portion of lease liability
7,893
7,746
Current portion of royalty liability
8,624
10,836
Current portion of contingent
consideration
2,391
1,866
Current portion of loans payable
68,050
603
Convertible senior notes
134,622
192,774
Derivative liability related to conversion
option
—
59,409
Non-current portion of acquired contingent
consideration
43,709
78,434
Non-current portion of lease liability
18,747
22,995
Non-current portion of royalty
liability
9,147
13,565
Non-current portion of loans payable
26,978
25,495
Deferred tax liability
23,120
9,581
Other long-term liabilities
1,012
259
Total stockholder's equity
314,508
310,820
Total liabilities and stockholders'
equity
$
710,593
$
799,718
Acorda Therapeutics,
Inc.
Consolidated Statements of
Operations
(in thousands, except per
share amounts)
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
Revenues:
Net product revenues
$
34,687
$
44,800
$
90,153
$
133,325
Milestone revenues
15,000
—
15,000
—
Royalty revenues
3,403
2,922
9,654
8,587
Total net revenues
53,090
47,722
114,807
141,911
Costs and expenses:
Cost of sales
12,170
7,986
22,670
26,183
Research and development
5,729
16,073
18,689
51,060
Selling, general and administrative
39,935
48,702
119,700
151,622
Amortization of intangible assets
7,691
7,692
23,073
17,945
Asset impairment
—
277,561
4,131
277,561
Change in fair value of derivative
liability
(4,864
)
—
(40,320
)
—
Change in fair value of acquired
contingent consideration
(23,608
)
(50,942
)
(33,455
)
(56,342
)
Total operating expenses
37,053
307,072
114,488
468,029
Operating income (loss)
$
16,037
$
(259,350
)
$
319
$
(326,118
)
Other expense, (net)
(7,225
)
(4,168
)
(21,827
)
(12,992
)
Income (loss) before income taxes
8,812
(263,518
)
(21,508
)
(339,110
)
(Provision for) benefit from income
taxes
(1,465
)
(17
)
4,962
484
Net income (loss)
$
7,347
$
(263,535
)
$
(16,546
)
$
(338,626
)
Net income (loss) per common share -
basic
$
0.15
$
(5.55
)
$
(0.35
)
$
(7.13
)
Net income (loss) per common share -
diluted
$
0.05
$
(5.55
)
$
(0.35
)
$
(7.13
)
Weighted average common shares - basic
47,705
47,511
47,704
47,491
Weighted average common shares -
diluted
166,145
47,511
47,704
47,491
Acorda Therapeutics,
Inc.
Non-GAAP Net Loss and Net Loss
per Common Share Reconciliation
(in thousands, except per
share amounts)
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
GAAP net income (loss)
$
7,347
$
(263,535
)
$
(16,546
)
$
(338,626
)
Pro forma adjustments:
Non-cash interest expense (1)
4,113
3,705
12,219
12,202
Change in fair value of acquired
contingent consideration (2)
(23,608
)
(50,942
)
(33,455
)
(56,342
)
Restructuring costs (3)
—
—
343
—
Asset impairment charge (4)
—
277,561
4,131
277,561
Gain on change in fair value of derivative
liability (5)
(4,864
)
—
(40,320
)
—
Share-based compensation expenses included
in Cost of Sales
93
149
260
505
Share-based compensation expenses included
in R&D
555
720
1,418
2,203
Share-based compensation expenses included
in SG&A
1,833
2,424
4,834
8,785
Total share-based compensation
expenses
2,481
3,292
6,512
11,494
Total pro forma adjustments
(21,878
)
233,617
(50,570
)
244,914
Income tax effect of reconciling items
above (6)
(3,677
)
(7,997
)
(15,332
)
(19,020
)
Non-GAAP net loss
$
(10,854
)
$
(21,921
)
$
(51,784
)
$
(74,692
)
Net loss per common share - basic
$
(0.23
)
$
(0.46
)
$
(1.09
)
$
(1.57
)
Net loss per common share - diluted
$
(0.23
)
$
(0.46
)
$
(1.09
)
$
(1.57
)
Weighted average common shares - basic
47,705
47,511
47,704
47,491
Weighted average common shares -
diluted
47,705
47,511
47,704
47,491
(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)
Charges related to the 2019 impairment of
goodwill associated with the Civitas and Biotie acquisitions and
the 2020 impairment of 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/20201103005735/en/
Tierney Saccavino (917) 783-0251 tsaccavino@acorda.com
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