- INBRIJA™ (levodopa inhalation powder) 2Q 2019 net sales of $3.0
million
- CHMP issues positive opinion on INBRIJA
- AMPYRA® (dalfampridine) 2Q 2019 net sales of $44.0 million
Acorda Therapeutics, Inc. (NASDAQ: ACOR) provided a financial
and pipeline update for the quarter ended June 30, 2019.
“We made significant progress on the launch of Inbrija during
the second quarter. Effective May 24, 2019, Inbrija became
preferred on the Express Scripts National Preferred, Basic, and
High Performance commercial national formularies, and we expect to
reach agreements with other key payers in the near future,” said
Ron Cohen, M.D., Acorda's President and CEO. “We have also been
receiving encouraging feedback on Inbrija from both people with
Parkinson’s and health care professionals. This is consistent with
our market research and supports our expectation that Inbrija will
become a standard of care.”
Second Quarter 2019 Financial Results
For the quarter ended June 30, 2019, the Company reported
INBRIJA net revenue of $3.0 million. INBRIJA became commercially
available on February 28, 2019.
For the quarter ended June 30, 2019, the Company reported AMPYRA
net revenue of $44.2 million compared to $150.3 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 June 30, 2019 were $19.0 million, including $0.8 million of
share-based compensation compared to $25.9 million, including $1.5
million of share-based compensation for the same quarter in
2018.
Sales, general and administrative (SG&A) expenses for the
quarter ended June 30, 2019 were $50.2 million, including $3.5
million of share-based compensation compared to $44.3 million,
including $3.7 million of share-based compensation for the same
quarter in 2018.
Provision for income taxes for the quarter ended June 30, 2019
was $0.2 million compared to a provision for income taxes of $8.4
million for the same quarter in 2018.
The Company reported a GAAP net loss of $27.5 million for the
quarter ended June 30, 2019, or $0.58 per diluted share. GAAP net
income in the same quarter of 2018 was $46.2 million, or $0.98 per
diluted share.
Non-GAAP net loss for the quarter ended June 30, 2019 was $26.3
million, or $0.55 per diluted share. Non-GAAP net income in the
same quarter of 2018 was $65.9 million, or $1.40 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 restructuring costs. A reconciliation of the
GAAP financial results to non-GAAP financial results is included
with the attached financial statements.
At June 30, 2019, the Company had cash, cash equivalents and
short-term investments of $296.9 million. The Company has $345
million of convertible senior notes due in 2021 with a conversion
price of $42.56.
2019 Financial Guidance
- During INBRIJA’s launch year, the Company does not expect to
provide INBRIJA revenue guidance.
- The Company expects AMPYRA net revenue for the full year 2019
to be greater than $140 million.
- R&D expenses for the full year 2019 are expected to be
$70-$80 million and SG&A expenses for the full year 2019 are
expected to be $200-$210 million. This guidance is a non-GAAP
projection that excludes share-based compensation as more fully
described below under “Non-GAAP Financial Measures.”
Second Quarter 2019 Highlights
- INBRIJA launch metrics through July 2019
- ~4,500
prescription request forms (PRFs)
- > 1,900
patients received a first dispense
- > 6,200
total cartons dispensed
- > 1,250
unique prescribers; ~50% repeat prescribers
- Effective May 24, 2019, INBRIJA was made preferred on the
Express Scripts National Preferred, Basic, and High Performance
commercial national formularies.
- In July, the European Medicines Agency’s (EMA) Committee for
Medicinal Products for Human Use (CHMP) issued a positive opinion
recommending INBRIJA’s approval by the European Commission (EC).
The final EC decision is expected before the end of the year.
Acorda is in discussions with potential partners to market INBRIJA
in Europe.
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 (866) 393-4306
(domestic) or (734) 385-2616 (international) and reference the
access code 2287274. 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
August 1, 2019 until 11:59 p.m. ET on August 31, 2019. To access
the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406
(international); reference code 2287274. 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, and (iii) changes
in the fair value of acquired contingent consideration which do not
correlate to our actual cash payment obligations in the relevant
periods, and (iv) 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
guidance for R&D and SG&A expenses on a non-GAAP basis. Due
to the forward looking nature of this information, the amount of
compensation charges and benefits 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. The Company believes that these
non-GAAP measures, when viewed in conjunction with our GAAP
results, provide investors with a more meaningful understanding of
our ongoing and projected R&D and SG&A expenses. 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)
(unaudited)
June 30, 2019
December 31,
2018
Assets
Cash, cash equivalents and short-term
investments
$
296,890
$
445,553
Trade receivables, net
21,010
23,430
Other current assets
12,384
30,110
Inventories, net
28,086
29,014
Property and equipment, net
113,455
60,519
Goodwill
281,467
282,059
Intangible assets, net
418,000
428,570
Right of use assets
25,876
—
Other assets
294
411
Total assets
$
1,197,462
$
1,299,666
Liabilities and stockholders'
equity
Accounts payable, accrued expenses and
other current liabilities
$
71,318
$
125,741
Current portion of lease liability
7,644
—
Current portion of royalty liability
9,384
8,985
Current portion of acquired contingent
consideration
4,993
4,914
Current portion of loans payable
612
616
Convertible senior notes
323,780
318,670
Non-current portion of acquired contingent
consideration
157,544
163,086
Non-current portion of lease liability
25,766
—
Non-current portion of royalty
liability
18,491
21,731
Non-current portion of loans payable
25,237
24,470
Deferred tax liability
3,069
7,483
Other long-term liabilities
4,787
11,987
Total stockholders' equity
544,837
611,983
Total liabilities and stockholders'
equity
$
1,197,462
$
1,299,666
Acorda Therapeutics, Inc.
Consolidated Statements of Operations (in thousands, except per
share amounts) (unaudited)
Three Months Ended June
30,
Six Months Ended June
30,
2019
2018
2019
2018
Revenues:
Net product revenues
$
47,191
$
150,412
$
88,525
$
253,415
Royalty revenues
2,862
2,890
5,665
6,052
Total revenues
50,053
153,302
94,190
259,467
Costs and expenses:
Cost of sales
9,397
30,378
18,196
51,012
Research and development
18,959
25,910
34,987
56,470
Selling, general and administrative
50,195
44,263
102,921
91,864
Amortization of Intangible Asset
7,691
716
10,255
1,432
Change in fair value of acquired
contingent consideration
(12,800
)
(7,000
)
(5,400
)
(800
)
Total operating expenses
73,442
94,267
160,959
199,978
Operating (loss) income
$
(23,389
)
$
59,035
$
(66,769
)
$
59,489
Other expense, (net)
(3,883
)
(4,482
)
(8,823
)
(9,658
)
(Loss) income before income taxes
(27,272
)
54,553
(75,592
)
49,831
(Provision for) benefit from income
taxes
(214
)
(8,356
)
501
(11,833
)
Net (loss) income
$
(27,486
)
$
46,197
$
(75,091
)
$
37,998
Net (loss) income per common share -
basic
$
(0.58
)
$
0.99
$
(1.58
)
$
0.82
Net (loss) income per common share -
diluted
$
(0.58
)
$
0.98
$
(1.58
)
$
0.81
Weighted average common shares - basic
47,486
46,799
47,480
46,546
Weighted average common shares -
diluted
47,486
47,201
47,480
46,974
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 June
30,
Six Months Ended June
30,
2019
2018
2019
2018
GAAP net (loss) income
$
(27,486
)
$
46,197
$
(75,091
)
$
37,998
Pro forma adjustments:
Non-cash interest expense (1)
3,780
3,970
8,497
7,973
Change in fair value of acquired
contingent consideration (2)
(12,800
)
(7,000
)
(5,400
)
(800
)
Restructuring costs (3)
—
278
—
1,316
Share-based compensation expenses
included in Cost of Sales
207
—
357
—
Share-based compensation expenses
included in R&D
783
1,519
1,483
3,225
Share-based compensation expenses
included in SG&A
3,544
3,725
6,361
7,887
Total share-based compensation
expenses
4,534
5,244
8,201
11,112
Total pro forma adjustments
(4,486
)
2,492
11,298
19,601
Income tax effect of reconciling items
above (4)
(5,680
)
(17,233
)
(11,023
)
(16,156
)
Non-GAAP net (loss) income
$
(26,292
)
$
65,922
$
(52,770
)
$
73,755
Net (loss) income per common share -
basic
$
(0.55
)
$
1.41
$
(1.11
)
$
1.58
Net (loss) income per common share -
diluted
$
(0.55
)
$
1.40
$
(1.11
)
$
1.57
Weighted average common shares - basic
47,486
46,799
47,480
46,546
Weighted average common shares -
diluted
47,486
47,201
47,480
46,974
(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)
Restructuring costs associated with
corporate restructuring initiatives.
(4)
Represents the tax effect of the non-GAAP
adjustments.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190801005921/en/
Felicia Vonella (914) 326-5146 fvonella@acorda.com
Acorda Therapeutics (NASDAQ:ACOR)
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