2020 Guidance:
- Total net product revenue expected to be $120 - $150
million
- INBRIJA® (levodopa inhalation powder) net revenue expected to
be $35 - $40 million
- INBRIJA peak sales revised to $300 - $500 million
- AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. net
revenue expected to be $85 - $110 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, 2019.
“INBRIJA’s launch was an important milestone for Acorda in 2019.
It is the first and only approved inhalation therapy for the
treatment of OFF periods in Parkinson’s disease. In 2020, our focus
will be on increasing awareness of and driving demand for INBRIJA
among people with Parkinson’s,” said Ron Cohen, M.D., Acorda’s
President and Chief Executive Officer.
Dr. Cohen added, “Another top priority for 2020 is continuing to
strengthen our capital structure and balance sheet. In December
2019 we successfully restructured the great majority of our
convertible debt, and we have also reduced expenses significantly.
We are working to identify additional opportunities to manage
costs. These actions have helped position Acorda to deliver
long-term value for our shareholders.”
Fourth Quarter 2019 Financial Results
For the fourth quarter ended December 31, 2019, the Company
reported AMPYRA net revenue of $40.8 million compared to $64.2
million for the same quarter in 2018 and INBRIJA net revenue of
$6.1 million.
Research and development (R&D) expenses for the quarter
ended December 31, 2019 were $9.0 million, including $0.6 million
of share-based compensation, compared to $27.1 million, including
$1.2 million of share-based compensation, for the same quarter in
2018.
Sales, general and administrative (SG&A) expenses for the
quarter ended December 31, 2019 were $41.2 million, including $2.0
million of share-based compensation, compared to $36.8 million,
including $3.8 million of share-based compensation, for the same
quarter in 2018.
Benefit from income taxes for the quarter ended December 31,
2019 was $0.8 million, compared to a benefit from income taxes of
$63.1 million for the same quarter in 2018.
The Company reported GAAP net income of $65.7 million for the
quarter ended December 31, 2019, or $1.38 per diluted share. GAAP
net income in the same quarter of 2018 was $9.6 million, or $0.20
per diluted share.
Non-GAAP net loss for the quarter ended December 31, 2019 was
$7.1 million, or $0.15 per diluted share. Non-GAAP net income in
the same quarter of 2018 was $21.5 million, or $0.45 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, restructuring expenses, changes in the fair value of acquired
contingent consideration, goodwill impairment charges, gain on
extinguishment of debt, and gain on sale of assets. A
reconciliation of the GAAP financial results to non-GAAP financial
results is included with the attached financial statements.
Full Year Ended December 31, 2019 Financial Results
For the full year ended December 31, 2019, the Company reported
AMPYRA net revenue of $163.2 million compared to $455.1 million for
the full year 2018 and INBRIJA net revenue of $15.3 million.
Research and development (R&D) expenses for the full year
ended December 31, 2019 were $60.1 million, including $2.8 million
of share-based compensation, compared to $106.4 million, including
$5.6 million of share-based compensation for the full year
2018.
Sales, general and administrative (SG&A) expenses for the
full year ended December 31, 2019 were $192.8 million, including
$10.8 million of share-based compensation, compared to $172.3
million, including $15.7 million of share-based compensation for
the full year 2018.
Benefit from income taxes for the full year ended December 31,
2019 was $1.3 million, compared to a benefit from income taxes of
$13.3 million for the full year 2018.
For the full year ended December 31, 2019, the Company reported
GAAP net loss of $273.0 million, or $5.75 per diluted share. GAAP
net income for the full year 2018 was $33.7 million, or $0.71 per
diluted share.
Non-GAAP net loss for the full year ended December 31, 2019 was
$81.8 million, or $1.72 per diluted share. Non-GAAP net income for
the full year ended December 31, 2018 was $103.4 million, or $2.18
per diluted share. This full year 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, restructuring expenses, changes in
the fair value of acquired contingent consideration, goodwill
impairment charges, gain on extinguishment of debt, and gain on
sale of assets. A reconciliation of the GAAP financial results to
non-GAAP financial results is included with the attached financial
statements.
At December 31, 2019, the Company had cash, cash equivalents,
investments and restricted cash of $168.9 million. 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
- Total product net revenue for the full year 2020 is expected to
be $120 - $150 million, with total revenue expected to be $130 -
$160 million. Product revenue excludes royalty revenue, primarily
Fampyra royalty revenue obligations owed to Healthcare Royalty
Partners.
- INBRIJA net revenue for the full year 2020 is expected to be
$35 - $40 million.
- Expected INBRIJA U.S. annual peak sales has been revised to
$300 - $500 million
- AMPYRA net revenue for the full year 2020 is expected to be $85
- $110 million.
- Operating expenses for the full year 2020 are expected to be
$170 - $180 million, reduced from previous guidance of $180 - $190
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.”
Fourth Quarter 2019 Highlights
- In December 2019, the Company successfully exchanged $276
million notional value of 2021 convertible notes, at a 5% discount,
for $207 million of December 2024 secured convertible notes,
convertible at a significant premium, and $55 million of cash.
- In October 2019, the Company announced a corporate
restructuring and 25% headcount reduction; more than $21 million in
expected annualized cost savings expected.
Webcast and Conference Call
The Company will host a conference call and webcast in
conjunction with its fourth quarter/year end 2019 update and
financial results today at 8:30 a.m. ET. To participate in the
conference call, please dial (833) 236-2756 (domestic) or (647)
689-4181 (international) and reference the access code 4665685. 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
February 13, 2020 until 11:59 p.m. ET on March 12, 2020. To access
the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642
(international); reference code 4665685. 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) income, 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)
income, 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
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) goodwill impairment which
is a non-cash charge that relates to a reduction in the market
capitalization of the Company and is 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 non-routine restructuring events, and
(vii) gain on sale of assets that pertains to a non-routine event.
The Company believes its non-GAAP net (loss) income 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) income, 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 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 INBRIJA or any other products under development; 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)
December 31,
December 31,
2019
2018
(unaudited)
Assets
Cash, cash equivalents and short-term
investments
$
125,839
$
445,553
Restricted cash - short term
12,836
532
Trade receivables, net
22,083
23,430
Other current assets
15,134
29,578
Inventories, net
25,221
29,014
Property and equipment, net
142,527
60,519
Goodwill
—
282,059
Intangible assets, net
402,329
428,570
Restricted cash - long term
30,270
255
Right of use assets
23,450
—
Other assets
29
156
Total assets
$
799,718
$
1,299,666
Liabilities and stockholders'
equity
Accounts payable, accrued expenses and
other current liabilities
$
65,335
$
125,741
Current portion of lease liability
7,746
—
Current portion of royalty liability
10,836
8,985
Current portion of acquired contingent
consideration
1,866
4,914
Current portion of loans payable
603
616
Convertible senior notes
192,774
318,670
Derivative liability related to conversion
option
59,409
—
Non-current portion of acquired contingent
consideration
78,434
163,086
Non-current portion of lease liability
22,995
—
Non-current portion of royalty
liability
13,565
21,731
Non-current portion of loans payable
25,495
24,470
Deferred tax liability
5,158
7,483
Other long-term liabilities
4,682
11,987
Total stockholders' equity
310,820
611,983
Total liabilities and stockholders'
equity
$
799,718
$
1,299,666
Acorda Therapeutics, Inc. Consolidated
Statements of Operations (in thousands, except per share amounts)
(unaudited)
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2019
2018
2019
2018
Revenues:
Net product revenues
$
47,411
$
66,351
$
180,736
$
459,739
Royalty revenues
3,085
2,801
11,672
11,694
Total revenues
50,496
69,152
192,408
471,433
Costs and expenses:
Cost of sales
8,666
21,476
34,849
97,640
Research and development
9,023
27,058
60,083
106,383
Selling, general and administrative
41,223
36,819
192,845
172,254
Goodwill impairment
—
—
277,561
—
Amortization of intangible asset
7,691
—
25,636
1,670
Change in fair value of acquired
contingent consideration
(30,593
)
33,100
(86,935
)
55,000
Total operating expenses
36,010
118,453
504,039
432,947
Operating income (loss)
$
14,486
$
(49,301
)
$
(311,631
)
$
38,486
Gain on extinguishment of debt
55,073
—
55,073
—
Other income (expense), (net)
(4,697
)
(4,166
)
(17,689
)
(18,063
)
Income (loss) before income taxes
64,862
(53,467
)
(274,247
)
20,423
Benefit from income taxes
798
63,062
1,282
13,259
Net income (loss)
$
65,660
$
9,595
$
(272,965
)
$
33,682
Net income (loss) per common share -
basic
$
1.38
$
0.20
$
(5.75
)
$
0.72
Net income (loss) per common share -
diluted
$
1.38
$
0.20
$
(5.75
)
$
0.71
Weighted average common shares - basic
47,573
47,515
47,512
47,010
Weighted average common shares -
diluted
47,627
47,606
47,512
47,341
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,
2019
2018
2019
2018
GAAP net income (loss)
$
65,660
$
9,595
$
(272,965
)
$
33,682
Pro forma adjustments:
Non-cash interest expense (1)
3,522
3,905
15,724
15,822
Change in fair value of acquired
contingent consideration (2)
(30,593
)
33,100
(86,935
)
55,000
Restructuring costs (3)
4,401
(4
)
4,401
1,316
Goodwill impairment charge (4)
—
—
277,561
—
Gain on extinguishment of debt (5)
(55,073
)
—
(55,073
)
—
Gain on sale of assets (6)
—
(7,837
)
—
(7,837
)
Share-based compensation expenses included
in Cost of Sales
118
—
624
—
Share-based compensation expenses included
in R&D
609
1,224
2,812
5,560
Share-based compensation expenses included
in SG&A
2,029
3,782
10,814
15,692
Total share-based compensation
expenses
2,756
5,006
14,250
21,252
Total pro forma adjustments
(74,987
)
34,170
169,928
85,553
Income tax effect of reconciling items
above (7)
(2,264
)
22,241
(21,284
)
15,814
Non-GAAP net (loss) income
$
(7,063
)
$
21,524
$
(81,753
)
$
103,421
Net (loss) income per common share -
basic
$
(0.15
)
$
0.45
$
(1.72
)
$
2.20
Net (loss) income per common share -
diluted
$
(0.15
)
$
0.45
$
(1.72
)
$
2.18
Weighted average common shares - basic
47,573
47,515
47,512
47,010
Weighted average common shares -
diluted
47,573
47,606
47,512
47,341
(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 corporate
restructuring initiatives.
(4) Impairment of goodwill associated with
the Civitas and Biotie acquisitions.
(5) Gain on extinguishment of convertible
senior notes due June 2021.
(6) Gain on sale of Qutenza.
(7) Represents the tax effect of the
non-GAAP adjustments.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200213005202/en/
Tierney Saccavino (914) 326-5104 tsaccavino@acorda.com
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