- Sale of Manufacturing Operations to Catalent with net proceeds
of ~$74 million
- Annual operating expenses cut by ~$40 million via sale,
restructuring, and other reductions
- Total 2021 non-GAAP operating expense expected to be $130-$140
million1
- AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg 2021
net revenue expected to be $75-$85 million
- INBRIJA® (levodopa inhalation powder) 2020 net revenue $24
million
- AMPYRA 2020 net revenue $99 million
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today provided a
business update and reported its financial results for the fourth
quarter and full year ended December 31, 2020.
“We have improved our financial position materially through the
sale of our manufacturing operations in Chelsea and our
restructuring, which also have reduced both our annual operating
expenses and cost of goods for INBRIJA,” said Ron Cohen, M.D.,
Acorda’s President and Chief Executive Officer. “In 2020, we
continued to improve access to INBRIJA and saw excellent results
from our new patient education and training programs; for example,
approximately 1,250 patients who had either never filled or had
discontinued their original INBRIJA prescriptions responded to our
educational outreach and training by returning to therapy. We also
saw quarter over quarter growth in INBRIJA despite the substantial
negative impact of COVID-19, and believe we are well-positioned for
further growth when the pandemic subsides. We also believe that the
reduced cost of goods for INBRIJA will help potentiate commercial
partnerships outside the US.”
Fourth Quarter 2020 Financial Results
For the fourth quarter ended December 31, 2020, the Company
reported AMPYRA net revenue of $25.3 million compared to $40.8
million for the same quarter in 2019 and INBRIJA net revenue of
$9.3 million compared to $6.1 million for the same quarter in
2019.
Research and development (R&D) expenses for the quarter
ended December 31, 2020 were $4.3 million, including $0.3 million
of share-based compensation, compared to $9.0 million, including
$0.6 million of share-based compensation, for the same quarter in
2019.
Sales, general and administrative (SG&A) expenses for the
quarter ended December 31, 2020 were $32.9 million, including $1.2
million of share-based compensation, compared to $41.2 million,
including $2.0 million of share-based compensation, for the same
quarter in 2019.
Benefit from income taxes for the quarter ended December 31,
2020 was $3.1 million, compared to a benefit from income taxes of
$0.8 million for the same quarter in 2019.
The Company recorded a loss on assets held for sale related to
the sale of the manufacturing operations in Chelsea, Massachusetts
to Catalent. The Company recorded a loss on the assets held for
sale of $57.9 million as of December 31, 2020, which represents the
amount by which the carrying value of the assets to be sold exceeds
the purchase price less estimated selling costs. The Company
segregated the assets held for sale on the balance sheet at the
resulting carrying amount of $71.8 million as of December 31,
2020.
The Company reported GAAP net loss of $83.0 million for the
quarter ended December 31, 2020, or $9.82 per diluted share. GAAP
net income in the same quarter of 2019 was $65.7 million, or $8.26
per diluted share.
Non-GAAP net loss for the quarter ended December 31, 2020 was
$21.1 million, or $2.50 per diluted share. Non-GAAP net loss in the
same quarter of 2019 was $7.1 million, or $0.89 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,
restructuring expenses, changes in the fair value of acquired
contingent consideration, losses on assets held for sale, gain on
extinguishment of debt, and changes in the fair value of derivative
liability related to the 2024 convertible notes. A reconciliation
of the GAAP financial results to non-GAAP financial results is
included with the attached financial statements.
Full Year Ended December 31, 2020 Financial Results
For the full year ended December 31, 2020, the Company reported
AMPYRA net revenue of $98.9 million compared to $163.2 million for
the full year 2019 and INBRIJA net revenue of $24.2 million
compared to $15.3 million for the full year 2019.
Research and development (R&D) expenses for the full year
ended December 31, 2020 were $23.0 million, including $1.7 million
of share-based compensation, compared to $60.1 million, including
$2.8 million of share-based compensation for the full year
2019.
Sales, general and administrative (SG&A) expenses for the
full year ended December 31, 2020 were $152.6 million, including
$6.0 million of share-based compensation, compared to $192.8
million, including $10.8 million of share-based compensation for
the full year 2019.
Benefit from income taxes for the full year ended December 31,
2020 was $8.0 million, compared to a benefit from income taxes of
$1.3 million for the full year 2019.
For the full year ended December 31, 2020, the Company reported
GAAP net loss of $99.6 million, or $12.32 per diluted share,
compared to a GAAP net loss for the full year 2019 of $273.0
million, or $34.43 per diluted share.
Non-GAAP net loss for the full year ended December 31, 2020 was
$72.9 million, or $9.02 per diluted share. Non-GAAP net loss for
the full year ended December 31, 2019 was $81.8 million, or $10.31
per diluted share. This full year 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, restructuring expenses, changes in the fair value of acquired
contingent consideration, asset impairment charges, losses on
assets held for sale, gain on extinguishment of debt, and changes
in the fair value of derivative liability related to the 2024
convertible notes. A reconciliation of the GAAP financial results
to non-GAAP financial results is included with the attached
financial statements.
At December 31, 2020, the Company had cash, cash equivalents,
investments, and restricted cash of $102.9 million. Restricted cash
includes $31 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.
Financial Guidance
- Operating expenses for the full year 2021 are expected to be
$130 - $140 million. This guidance is a non-GAAP projection that
excludes restructuring costs and share-based compensation as more
fully described below under “Non-GAAP Financial Measures.”
- AMPYRA net revenue for the full year 2021 is expected to be
$75-$85 million.
Recent Highlights
- In February 2021, the Company announced that it has closed the
deal to sell its manufacturing operations in Chelsea, Massachusetts
to Catalent. Under the terms of the agreement, Catalent has paid
Acorda $80 million in cash, resulting in expected net proceeds to
Acorda of approximately $74 million after transaction fees and
expenses and settlement of customary post-closing adjustments.
- In connection with the sale, Acorda and Catalent have entered
into a long-term global supply agreement under which Catalent will
manufacture and package INBRIJA for Acorda, ensuring an
uninterrupted drug supply for Acorda’s patients and continued
adherence to best-in-class manufacturing quality and safety
standards.
- In January 2021, the Company announced a corporate
restructuring, reducing its combined Ardsley, Waltham, and field
headcount by approximately 16%.
- The sale of the manufacturing operations, restructuring and
other operating expense reductions are expected to reduce annual
operating expenses by approximately $40 million.
- On December 31, 2020, Acorda implemented a 1-for-6 reverse
stock split of the Company’s shares of common stock and a
proportionate reduction in the number of authorized shares of
common stock. This was done to regain compliance with the $1.00 per
share minimum closing price required to maintain continued listing
on the Nasdaq Global Select Market.
Webcast and Conference Call
The Company will host a conference call and webcast in
conjunction with its fourth quarter/year end 2020 update and
financial results today at 4:30 p.m. EST.
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/2947830/F4FC65582F7AC5A2D3AF5880C359F67D
- To register for the Conference Call, use the link below:
http://www.directeventreg.com/registration/event/9854802
**When registering please type your phone number with no
special characters**
A replay of the call will be available from 7:30 p.m. EST on
March 4, 2021 until 11:59 p.m. EDT on April 4, 2021. To access the
replay, please dial (800) 585-8367 (domestic) or (416) 621-4642
(international); reference code 9854802. 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) gain on
extinguishment of debt that pertains to an event that is not
routine to the operation of the business, (vi) expenses that
pertain to our 2019 restructuring, which is not routine to the
operation of the business, (vii) changes in the fair value of
derivative liability relating to the 2024 convertible notes, which
is a non-cash charge and not related to the operation of the
business, and (viii) losses on assets held for sale that pertain to
a non-routine sale of manufacturing operations. 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 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 non-routine
restructuring events, 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)
December 30,
December 31,
2020
2019
(unaudited)
Assets
Cash, cash equivalents and short-term
investments
$
71,369
$
125,839
Restricted cash - short term
12,917
12,836
Trade receivable, net
20,193
22,083
Other current assets
16,384
15,134
Inventories, net
28,677
25,221
Assets held for sale - current
71,795
—
Property and equipment, net
7,263
142,527
Intangible assets, net
366,981
402,329
Restricted cash - long term
18,609
30,270
Right of use assets, net
18,481
23,450
Other assets
11
29
Total assets
$
632,680
$
799,718
Liabilities and stockholders'
equity
Accounts payable, accrued expenses and
other current liabilities
$
50,322
$
65,335
Current portion of lease liability
7,944
7,746
Current portion of royalty liability
8,731
10,836
Current portion of contingent
consideration
1,624
1,866
Current portion of loans payable
68,631
603
Convertible senior notes non-current
137,619
192,774
Derivative liability related to conversion
option
1,193
59,409
Non-current portion of acquired contingent
consideration
46,576
78,434
Non-current portion of lease liability
17,200
22,995
Non-current portion of royalty
liability
6,526
13,565
Non-current portion of loans payable
28,555
25,495
Deferred tax liability
19,116
9,581
Other long-term liabilities
688
259
Total stockholder's equity
237,955
310,820
Total liabilities and stockholders'
equity
$
632,680
$
799,718
Acorda Therapeutics,
Inc.
Consolidated Statements of
Operations
(in thousands, except per
share amounts)
(unaudited)
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2020
2019
2020
2019
Revenues:
Net product revenues
$
34,679
$
47,411
$
124,831
$
180,736
Milestone revenues
—
—
15,000
—
Royalty revenues
3,481
3,086
13,136
11,672
Total net revenues
38,160
50,497
152,967
192,408
Costs and expenses:
Cost of sales
10,842
8,666
33,513
34,849
Research and development
4,323
9,023
23,012
60,083
Selling, general and administrative
32,876
41,224
152,576
192,846
Amortization of intangible assets
7,691
7,691
30,763
25,636
Asset impairment
—
—
4,131
277,561
Loss on assets held for sale
57,896
—
57,896
—
Change in fair value of derivative
liability
361
—
(39,959
)
—
Change in fair value of acquired
contingent consideration
2,566
(30,593
)
(30,889
)
(86,935
)
Total operating expenses
116,555
36,011
231,043
504,040
Operating (loss) income
$
(78,395
)
$
14,486
$
(78,076
)
$
(311,632
)
Gain on extinguishment of debt
—
55,073
—
55,073
Other expense, (net)
(7,764
)
(4,697
)
(29,591
)
(17,689
)
Loss (income) before income taxes
(86,159
)
64,862
(107,667
)
(274,248
)
Benefit from income taxes
3,111
798
8,073
1,282
Net (loss) income
$
(83,048
)
$
65,660
$
(99,594
)
$
(272,966
)
Net (loss) income per common share -
basic
$
(9.82
)
$
8.27
$
(12.32
)
$
(34.43
)
Net (loss) income per common share -
diluted
$
(9.82
)
$
8.26
$
(12.32
)
$
(34.43
)
Weighted average common shares - basic
8,454
7,938
8,084
7,927
Weighted average common shares -
diluted
8,454
7,947
8,084
7,927
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
Twelve Months Ended
December 31,
December 31,
2020
2019
2020
2019
GAAP net (loss) income
$
(83,048
)
$
65,660
$
(99,594
)
$
(272,966
)
Pro forma adjustments:
Non-cash interest expense (1)
4,203
3,522
16,422
15,724
Change in fair value of acquired
contingent consideration (2)
2,566
(30,593
)
(30,889
)
(86,935
)
Restructuring costs (3)
—
4,401
343
4,401
Loss on assets held for sale (4)
57,896
—
57,896
—
Asset impairment charge (5)
—
—
4,131
277,561
Loss (gain) on change in fair value
of derivative liability (6)
361
—
(39,959
)
—
Gain on extinguishment of debt (7)
—
(55,073
)
—
(55,073
)
Share-based compensation expenses
included in Cost of Sales
75
118
335
624
Share-based compensation expenses
included in R&D
327
609
1,745
2,812
Share-based compensation expenses
included in SG&A
1,187
2,029
6,020
10,814
Total share-based compensation
expenses
1,589
2,756
8,100
14,250
Total pro forma adjustments
66,615
(74,987
)
16,045
169,928
Income tax effect of reconciling items
above (8)
4,698
(2,264
)
(10,634
)
(21,284
)
Non-GAAP net loss
$
(21,131
)
$
(7,063
)
$
(72,915
)
$
(81,754
)
Net loss per common share - basic and
diluted
$
(2.50
)
$
(0.89
)
$
(9.02
)
$
(10.31
)
Weighted average common shares - basic and
diluted
8,454
7,938
8,084
7,927
(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 the 2019
corporate restructuring.
(4)
Impairment loss on Chelsea
manufacturing assets held for sale at December 31, 2020.
(5)
Charges related to the 2020
impairment of BTT1023 acquired in the Biotie acquisition and the
2019 impairment of goodwill associated with the Civitas and Biotie
acquisitions.
(6)
Changes in the fair value of the
derivative liability related to the 2024 convertible senior
notes.
(7)
Gain on December 2019
extinguishment of a portion of the convertible senior notes due
June 2021.
(8)
Represents the tax effect of the non-GAAP
adjustments.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210304005901/en/
Tierney Saccavino (914) 326-5104 tsaccavino@acorda.com
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