- INBRIJA® (levodopa inhalation powder) 2Q 2020 net revenue of
$4.7 million
- AMPYRA® (dalfampridine) 2Q 2020 net revenue of $26.1
million
- INBRIJA dispensed cartons increase 13% over 1Q 2020
Acorda Therapeutics, Inc. (NASDAQ: ACOR) today provided a
business update and reported its financial results for the second
quarter ended June 30, 2020.
“We were pleased with INBRIJA’s performance in the second
quarter, especially in light of the significant disruption of
COVID-19. Net sales increased by 7% over the first quarter, and
dispensed cartons, which reflect actual demand, increased by 13%.
This trend continued into July, with dispensed cartons increasing
8% over June, to the highest number since the beginning of the
launch,” said Ron Cohen, M.D., Acorda's President and Chief
Executive Officer. “We also saw several indications that our
programs to improve the experience of patients and physicians are
having a positive effect. INBRIJA new prescription requests, which
declined dramatically beginning in mid-March, began to rebound in
late April and have continued to increase through July. We also saw
a 6% increase in new prescribers in the quarter, and the percent of
new prescription requests that converted to filled prescriptions
increased to 75%, up from 57% in Q1, the highest rate since
launch.”
Dr. Cohen continued, “We incurred higher-than-expected Medicare
rebates in the first half of the year, which impacted net sales. We
believe that such rebates are likely to be lower in the second half
of 2020, as more patients get through the Medicare Part D donut
hole.”
Second Quarter 2020 Financial Results
For the quarter ended June 30, 2020, the Company reported
INBRIJA net revenue of $4.7 million, compared to $3.0 million for
the same quarter in 2019.
For the quarter ended June 30, 2020, the Company reported AMPYRA
net revenue of $26.1 million compared to $44.2 million for the same
quarter in 2019. 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, 2020 were $5.3 million, including $0.4 million of
share-based compensation compared to $19.0 million, including $0.8
million of share-based compensation for the same quarter in
2019.
Sales, general and administrative (SG&A) expenses for the
quarter ended June 30, 2020 were $38.7 million, including $1.5
million of share-based compensation compared to $50.2 million,
including $3.5 million of share-based compensation for the same
quarter in 2019.
Change in fair value of derivative liability for the quarter
ended June 30, 2020 was $8.9 million.
Provision for income taxes for the quarter ended June 30, 2020
was $0.6 million compared to a provision for income taxes of $0.2
million for the same quarter in 2019.
The Company reported a GAAP net loss of $17.4 million for the
quarter ended June 30, 2020, or $0.37 per diluted share. GAAP net
loss in the same quarter of 2019 was $27.5 million, or $0.58 per
diluted share.
Non-GAAP net loss for the quarter ended June 30, 2020 was $16.6
million, or $0.35 per diluted share. Non-GAAP net loss in the same
quarter of 2019 was $26.3 million, or $0.55 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, and
changes in the fair value of the derivative liability. A
reconciliation of the GAAP financial results to non-GAAP financial
results is included with the attached financial statements.
At June 30, 2020, the Company had cash, cash equivalents,
short-term investments and restricted cash of $103.8 million
compared to $168.9 million at year end 2019. Restricted cash
includes $37.3 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 the 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/2395726/EF22DB54EC8EDBD04D72B50A619971E1
• To register for the Conference Call, use the link below:
http://www.directeventreg.com/registration/event/5378839
**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
August 4, 2020 until 11:59 p.m. ET on September 3, 2020. To access
the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642
(international); reference code 5378839. 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)
June 30,
December 31,
2020
2019
Assets
Cash, cash equivalents and short-term
investments
$
65,988
$
125,839
Restricted cash - short term
13,015
12,836
Trade receivable, net
14,773
22,083
Other current assets
31,308
15,134
Inventories, net
32,940
25,221
Property and equipment, net
141,685
142,527
Intangible assets, net
382,505
402,329
Restricted cash - long term
24,819
30,270
Right of use assets, net
21,166
23,450
Other assets
11
29
Total assets
$
728,210
$
799,718
Liabilities and stockholders'
equity
Accounts payable, accrued expenses and
other current liabilities
$
52,110
$
65,335
Current portion of lease liability
7,896
7,746
Current portion of royalty liability
8,470
10,836
Current portion of contingent
consideration
2,276
1,866
Current portion of loans payable
67,478
603
Convertible senior notes
131,756
192,774
Derivative liability related to conversion
option
23,953
59,409
Non-current portion of acquired contingent
consideration
67,724
78,434
Non-current portion of lease liability
20,277
22,995
Non-current portion of royalty
liability
11,769
13,565
Non-current portion of loans payable
25,532
25,495
Deferred tax liability
17,075
9,581
Other long-term liabilities
990
259
Total stockholder's equity
290,904
310,820
Total liabilities and stockholders'
equity
$
728,210
$
799,718
Acorda Therapeutics,
Inc.
Consolidated Statements of
Operations
(in thousands, except per
share amounts)
(unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
2020
2019
2020
2019
Revenues:
Net product revenues
$
30,793
$
47,191
$
55,465
$
88,525
Royalty revenues
2,824
2,862
6,251
5,665
Total net revenues
33,617
50,053
61,716
94,190
Costs and expenses:
Cost of sales
6,658
9,397
10,501
18,196
Research and development
5,255
18,959
12,960
34,987
Selling, general and administrative
38,656
50,195
79,764
102,921
Amortization of intangible assets
7,691
7,691
15,382
10,255
Asset impairment
—
—
4,131
—
Change in fair value of derivative
liability
(8,928
)
—
(35,456
)
—
Change in fair value of acquired
contingent consideration
(6,164
)
(12,800
)
(9,847
)
(5,400
)
Total operating expenses
43,168
73,442
77,435
160,959
Operating loss
$
(9,551
)
$
(23,389
)
$
(15,719
)
$
(66,769
)
Other expense, (net)
(7,299
)
(3,883
)
(14,601
)
(8,823
)
Loss before income taxes
(16,850
)
(27,272
)
(30,320
)
(75,592
)
(Provision for) benefit from income
taxes
(571
)
(214
)
6,427
501
Net loss
$
(17,421
)
$
(27,486
)
$
(23,893
)
$
(75,091
)
Net loss per common share - basic
$
(0.37
)
$
(0.58
)
$
(0.50
)
$
(1.58
)
Net loss per common share - diluted
$
(0.37
)
$
(0.58
)
$
(0.50
)
$
(1.58
)
Weighted average common shares - basic
47,705
47,486
47,704
47,480
Weighted average common shares -
diluted
47,705
47,486
47,704
47,480
Acorda Therapeutics,
Inc.
Non-GAAP Net Loss and Net Loss
per Common Share Reconciliation
(in thousands, except per
share amounts)
(unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
2020
2019
2020
2019
GAAP net loss
$
(17,421
)
$
(27,486
)
$
(23,893
)
$
(75,091
)
Pro forma adjustments:
Non-cash interest expense (1)
4,052
3,780
8,107
8,497
Change in fair value of acquired
contingent consideration (2)
(6,164
)
(12,800
)
(9,847
)
(5,400
)
Restructuring costs (3)
—
—
343
—
Asset impairment charge (4)
—
—
4,131
—
Gain on change in fair value of derivative
liability (5)
(8,928
)
—
(35,456
)
—
Share-based compensation expenses
included in Cost of Sales
86
207
167
357
Share-based compensation expenses
included in R&D
448
783
864
1,483
Share-based compensation expenses
included in SG&A
1,522
3,544
3,001
6,361
Total share-based compensation
expenses
2,056
4,534
4,032
8,201
Total pro forma adjustments
(8,984
)
(4,486
)
(28,690
)
11,298
Income tax effect of reconciling items
above (6)
(9,835
)
(5,680
)
(11,655
)
(11,023
)
Non-GAAP net loss
$
(16,570
)
$
(26,292
)
$
(40,928
)
$
(52,770
)
Net loss per common share - basic
$
(0.35
)
$
(0.55
)
$
(0.86
)
$
(1.11
)
Net loss per common share - diluted
$
(0.35
)
$
(0.55
)
$
(0.86
)
$
(1.11
)
Weighted average common shares - basic
47,705
47,486
47,704
47,480
Weighted average common shares -
diluted
47,705
47,486
47,704
47,480
(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)
Asset Impairment charge related to 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/20200804005918/en/
Tierney Saccavino (917) 783-0251 tsaccavino@acorda.com
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