- Corporate restructuring implemented to reduce costs and focus
resources on INBRIJA® (levodopa inhalation powder) launch
- INBRIJA 3Q 2019 net sales of $5 million
- INBRIJA approved in the European Union
- AMPYRA® (dalfampridine) 3Q 2019 net sales of $38 million
- 2019 year end cash balance expected to be greater than $225
million
Acorda Therapeutics, Inc. (NASDAQ: ACOR) provided a financial
update for the quarter ended September 30, 2019.
“Our focus has been on ensuring physician awareness and clearing
a pathway for access to Inbrija. We have been receiving encouraging
feedback on Inbrija from physicians suggesting it should become
standard of care for the treatment of Parkinson’s. This is
consistent with market research from healthcare professionals and
people living with Parkinson’s indicating that Inbrija will become
a significant product,” said Ron Cohen, M.D., Acorda's President
and CEO. “Acorda’s recent restructuring, albeit difficult,
substantially reduced our expense structure, so that we may more
effectively focus our resources on the launch of Inbrija and the
restructuring of our convertible debt.”
Third Quarter 2019 Financial Results
For the quarter ended September 30, 2019, the Company reported
INBRIJA net revenue of $4.9 million. INBRIJA became commercially
available on February 28, 2019.
For the quarter ended September 30, 2019, the Company reported
AMPYRA net revenue of $37.6 million compared to $137.8 million for
the same quarter in 2018. 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 September 30, 2019 were $16.1 million, including $0.7 million
of share-based compensation compared to $22.9 million, including
$1.1 million of share-based compensation for the same quarter in
2018.
Sales, general and administrative (SG&A) expenses for the
quarter ended September 30, 2019 were $48.7 million, including $2.4
million of share-based compensation compared to $43.6 million,
including $4.0 million of share-based compensation for the same
quarter in 2018.
The Company reviewed its goodwill for the quarter ended
September 30, 2019 as part of its normal reporting process. The
Company determined that a triggering event occurred due to a
decline in the trading price of the Company’s common stock at and
around the end of the quarter ended September 30, 2019. Based on
the analysis performed, the Company determined that the goodwill
was fully impaired and recorded a non-cash impairment charge of
$277.6 million.
Provision for income taxes for the quarter ended September 30,
2019 was $0.02 million compared to a provision for income taxes of
$38.0 million for the same quarter in 2018.
The Company reported a GAAP net loss of $263.5 million for the
quarter ended September 30, 2019, or $5.55 per diluted share. GAAP
net loss in the same quarter of 2018 was $13.9 million, or $0.29
per diluted share.
Non-GAAP net loss for the quarter ended September 30, 2019 was
$21.9 million, or $0.46 per diluted share. Non-GAAP net income in
the same quarter of 2018 was $8.1 million, or $0.17 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, changes in the fair value of acquired contingent
consideration, and goodwill impairment charges. A reconciliation of
the GAAP financial results to non-GAAP financial results is
included with the attached financial statements.
At September 30, 2019, the Company had cash, cash equivalents
and short-term investments of $253 million. The Company has $345
million of convertible senior notes due in 2021 with a conversion
price of $42.56.
Revised 2019 Financial Guidance; 2020 Financial
Guidance
- 2019: R&D expenses for the full year 2019 are expected to
be $55 - $60 million, reduced from $70 - $80 million. SG&A
expenses for the full year 2019 are expected to be $185 - $190
million, reduced from $200 - $210 million.
- 2020: R&D expenses for the full year 2020 are expected to
be $20 - $25 million and SG&A expenses for the full year 2020
are expected to be $160 - $165 million.
- These are non-GAAP projections that exclude restructuring costs
and share-based compensation, as more fully described below under
“Non-GAAP Financial Measures.”
Highlights
- In October, the Company announced a
corporate restructuring to reduce costs and focus its resources on
the launch of INBRIJA. As part of this restructuring, Acorda is
reducing headcount by approximately 25% through a reduction in
force which is expected to be completed in Q1 2020. In connection
with the restructuring, the Company also announced the reduced
estimated 2019 operating expenses and 2020 operating expense
guidance described above.
- The Company expects to realize estimated
annualized cost savings related to headcount reduction of
approximately $21 million beginning in 2020. Acorda estimates that
it will incur approximately $8 million of pre-tax charges for
severance and other costs related to the restructuring, through the
first quarter of 2020.
- Total operating expenses in 2020 are
estimated to be ~$60 million less than in 2019.
- INBRIJA launch metrics through October 2019
- ~ 6,400 prescription request forms
(PRFs)
- > 3,100 patients received a first
dispense
- > 12,750 total cartons dispensed
- > 1,600 unique prescribers; ~55% repeat
prescribers
- As of October 30, 2019, INBRIJA is available in the U.S.
without the need for a medical exception for ~66% of commercial and
~25% of Medicare plan lives.
- On September 24, the European Commission (EC) granted Marketing
Authorization for Inbrija 33 mg inhalation powder, hard capsules.
The Marketing Authorization approves Inbrija for use in the 28
countries of the European Union, as well as Iceland, Norway and
Liechtenstein.
- On October 7, the U. S. Supreme Court denied the Company’s
petition for certiorari requesting review of the Federal Circuit
Court of Appeals’ decision in Acorda Therapeutics, Inc. v. Roxane
Laboratories, et al. That decision upheld the invalidation of
certain Ampyra patents in litigation against various generics
manufacturers.
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 5464078. 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. ET on
November 4, 2019 until 11:59 p.m. ET on December 4, 2019. To access
the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642
(international); reference code 5464078. 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 2019 guidance for R&D and
SG&A expenses 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 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) 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, and (v)
expenses that pertain to non-routine restructuring events. 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 2019
and 2020 guidance for R&D and SG&A expenses on a non-GAAP
basis, as both exclude 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 these non-GAAP measures, when viewed in conjunction
with our GAAP results, provides investors with a more meaningful
understanding of our projected operating performance because they
exclude (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. Also,
management uses these non-GAAP financial measures 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 Statement
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; 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; we may need to raise additional funds to finance our
operations and may not be able to do so on acceptable terms; 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)
September 30,
December 31,
2019
2018
(unaudited)
Assets
Cash, cash equivalents and short-term
investments
$
253,158
$
445,553
Trade receivables, net
17,553
23,430
Other current assets
16,230
30,110
Inventories, net
27,396
29,014
Property and equipment, net
130,585
60,519
Goodwill
-
282,059
Intangible assets, net
410,023
428,570
Right of use assets
24,675
—
Other assets
293
411
Total assets
$
879,913
$
1,299,666
Liabilities and stockholders'
equity
Accounts payable, accrued expenses and
other current liabilities
$
70,011
$
125,741
Current portion of lease liability
7,696
—
Current portion of royalty liability
9,811
8,985
Current portion of acquired contingent
consideration
3,887
4,914
Current portion of loans payable
587
616
Convertible senior notes
326,381
318,670
Non-current portion of acquired contingent
consideration
107,313
163,086
Non-current portion of lease liability
24,394
—
Non-current portion of royalty
liability
16,437
21,731
Non-current portion of loans payable
24,518
24,470
Deferred tax liability
2,804
7,483
Other long-term liabilities
4,732
11,987
Total stockholders' equity
281,342
611,983
Total liabilities and stockholders'
equity
$
879,913
$
1,299,666
Acorda Therapeutics,
Inc.
Consolidated Statements of
Operations
(in thousands, except per
share amounts)
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2019
2018
2019
2018
Revenues:
Net product revenues
$
44,800
$
139,973
$
133,325
$
393,388
Royalty revenues
2,922
2,841
8,587
8,893
Total revenues
47,722
142,814
141,911
402,281
Costs and expenses:
Cost of sales
7,986
25,152
26,183
76,164
Research and development
16,073
22,855
51,060
79,325
Selling, general and administrative
48,702
43,571
151,622
135,435
Goodwill impairment
277,561
—
277,561
—
Amortization of Intangible Asset
7,692
239
17,945
1,670
Change in fair value of acquired
contingent consideration
(50,942
)
22,700
(56,342
)
21,900
Total operating expenses
307,072
114,517
468,029
314,494
Operating (loss) income
$
(259,350
)
$
28,297
$
(326,118
)
$
87,787
Other expense, (net)
(4,168
)
(4,240
)
(12,992
)
(13,898
)
(Loss) income before income taxes
(263,518
)
24,057
(339,110
)
73,889
(Provision for) benefit from income
taxes
(17
)
(37,968
)
484
(49,802
)
Net (loss) income
$
(263,535
)
$
(13,911
)
$
(338,626
)
$
24,087
Net (loss) income per common share -
basic
$
(5.55
)
$
(0.29
)
$
(7.13
)
$
0.51
Net (loss) income per common share -
diluted
$
(5.55
)
$
(0.29
)
$
(7.13
)
$
0.51
Weighted average common shares - basic
47,511
47,184
47,491
46,840
Weighted average common shares -
diluted
47,511
47,184
47,491
47,251
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
Nine Months Ended
September 30,
September 30,
2019
2018
2019
2018
GAAP net (loss) income
$
(263,535
)
$
(13,911
)
$
(338,626
)
$
24,087
Pro forma adjustments:
Non-cash interest expense (1)
3,705
3,944
12,202
11,917
Change in fair value of acquired
contingent consideration (2)
(50,942
)
22,700
(56,342
)
21,900
Restructuring costs (3)
—
4
—
1,320
Goodwill impairment charge (4)
277,561
—
277,561
—
Share-based compensation expenses
included in Cost of Sales
149
—
505
—
Share-based compensation expenses
included in R&D
720
1,112
2,203
4,336
Share-based compensation expenses
included in SG&A
2,424
4,023
8,785
11,910
Total share-based compensation
expenses
3,292
5,135
11,494
16,246
Total pro forma adjustments
233,617
31,783
244,914
51,383
Income tax effect of reconciling items
above (5)
(7,997
)
9,729
(19,020
)
(6,427
)
Non-GAAP net (loss) income
$
(21,921
)
$
8,143
$
(74,692
)
$
81,897
Net (loss) income per common share -
basic
$
(0.46
)
$
0.17
$
(1.57
)
$
1.75
Net (loss) income per common share -
diluted
$
(0.46
)
$
0.17
$
(1.57
)
$
1.73
Weighted average common shares - basic
47,511
47,184
47,491
46,840
Weighted average common shares -
diluted
47,511
47,563
47,491
47,251
(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) Represents the tax effect of the
non-GAAP adjustments.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191104005657/en/
Felicia Vonella (914) 326-5146 fvonella@acorda.com
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