- INBRIJA® (levodopa inhalation powder) Q3 2022 U.S.
net revenue of $7.8 million; 1% increase over Q3 2021
- AMPYRA® (dalfampridine) Q3 2022 net revenue of $21.1 million;
5% increase over Q3 2021
- $16.5M award and royalty/supply relief in AMPYRA arbitration
case
- Special Meeting of Stockholders scheduled for November 4,
2022
- Company will not use shares for December 2022 interest payment
on secured debt
- 2022 guidance reaffirmed, 2023 through 2027 guidance
provided
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today provided a
business update and reported its financial results for the third
quarter ended September 30, 2022.
“The AMPYRA arbitration ruling was a major milestone for Acorda,
providing a significant cash infusion and, even more importantly,
the ability for us to obtain AMPYRA supply at far more competitive
rates. We expect this to significantly enhance the value of this
product to the company,” said Ron Cohen, M.D., Acorda’s President
and Chief Executive Officer. “We are also pleased that INBRIJA
continued to recover from the impact of the pandemic surge in the
first quarter of this year. Independent sources show that INBRIJA
is the market leader for on-demand treatments in Parkinson’s
disease, with a 67% share. Our highest priority now is to increase
the size of the overall on-demand market by educating health care
professionals and people with Parkinson’s about how important it is
to address OFF periods.”
Regarding the Special Meeting of Stockholders, Dr. Cohen added,
“The board of directors and I urge all shareholders to vote FOR
Proposal 2, to authorize the reverse stock split, in advance of the
meeting on November 4. This is critical to ensure that we are not
de-listed from Nasdaq, which could hamper our ability to execute on
our business plan and could result in our being in default to our
debtholders.”
Third Quarter 2022 Financial Results For the quarter
ended September 30, 2022, the Company reported INBRIJA worldwide
net revenue of $8.8 million, of which $7.8 million was derived from
sales in the U.S., a 1% increase compared to the same quarter in
2021. The Company also reported Ex-U.S. INBRIJA net revenue of $1.0
million in the third quarter related to the Esteve launch in
Germany.
For the quarter ended September 30, 2022, the Company reported
AMPYRA net revenue of $21.1 million, compared to $20.0 million for
the same quarter in 2021. As previously disclosed, AMPYRA lost its
exclusivity and generics entered the market in 2018, and the
Company expects AMPYRA revenue to continue to decline.
Research and development (R&D) expenses for the quarter
ended September 30, 2022 were $1.4 million, including negligible
share-based compensation expenses, compared to $1.9 million,
including $0.2 million of share-based compensation for the same
quarter in 2021.
Sales, general and administrative (SG&A) expenses for the
quarter ended September 30, 2022 were $23.0 million, including $0.4
million of share-based compensation, compared to $29.6 million,
including $0.6 million of share-based compensation for the same
quarter in 2021.
Change in fair value of derivative liability for the quarter
ended September 30, 2022 was negligible, compared to $(0.3) million
for the same quarter in 2021.
Provision for income taxes for the quarter ended September 30,
2022 was $1.4 million, compared to a benefit from income taxes of
$3.1 million for the same quarter in 2021.
The Company reported a GAAP net loss of $13.9 million for the
quarter ended September 30, 2022, or $0.57 per diluted share. GAAP
net loss in the same quarter of 2021 was $27.1 million, or $2.43
per diluted share.
Non-GAAP net loss for the quarter ended September 30, 2022 was
$13.3 million, or $0.55 per diluted share. Non-GAAP net loss in the
same quarter of 2021 was $15.9 million, or $1.43 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,
changes in the fair value of derivative liability related to our
2024 convertible senior secured notes, and expenses that pertain to
non-routine corporate restructurings. A reconciliation of the GAAP
financial results to non-GAAP financial results is included with
the attached financial statements.
At September 30, 2022, the Company had cash, cash equivalents,
and restricted cash of $34.2 million, compared to $65.2 million at
year end 2021. Restricted cash includes $12.4 million in escrow
related to the semi-annual interest payment to the holders of its
6.00% convertible senior secured notes (Convertible Notes). Cash at
September 30, 2022 does not include the $16.5 million arbitration
award, which amount was received in October 2022.
Special Meeting of Stockholders November 4, 2022 Acorda
will hold a Special Meeting of Stockholders on Friday, November 4
(the Special Meeting). Acorda’s CEO, board, and the three leading
proxy advisory firms recommend that shareholders vote FOR both of
the following proposals to be addressed at the meeting:
- Reverse Stock Split Proposal: To authorize Acorda’s Board of
Directors to implement a reverse stock split of its common stock at
a ratio of any whole number in the range of 1-for-2 to 1-for-20
within one year of the Special Meeting. This proposal is critical
to get Acorda’s stock price above $1.00 per share in order to avoid
being delisted from Nasdaq. Delisting could put the company in
default to the holders of its Convertible Notes, potentially
requiring Acorda to liquidate or file for bankruptcy. In a reverse
stock split, shareholders would hold the exact same percentage of
Acorda stock, with the same value as they did prior to the
split.
- Adjournment Proposal: To approve one or more adjournments of
the Special Meeting to a later date or dates, if necessary or
appropriate, to solicit additional proxies if there are
insufficient votes to approve the Reverse Stock Split Proposal at
the time of the Special Meeting, or in the absence of a
quorum.
AMPYRA Arbitration On October 16, 2022 we announced that
an arbitration panel issued a final decision in a dispute with
Alkermes PLC (Nasdaq: ALKS) regarding licensing royalties relating
to AMPYRA (dalfampridine). Acorda was awarded $15 million plus
prejudgment interest of $1.5 million from Alkermes. In addition, as
a result of the panel’s ruling, Acorda will no longer have to pay
Alkermes any royalties on net sales for license and supply of
AMPYRA, and Acorda is now free to use alternative sources for
supply of AMPYRA, which it has already secured.
2022 – 2027 Financial Guidance For the full year 2022,
Acorda continues to expect AMPYRA net revenue to be $68 – $78
million, and adjusted operating expenses to be $110 – $120 million.
The financial guidance provided below includes non-GAAP projections
of adjusted operating expenses (adjusted OPEX) and adjusted
earnings before income taxes depreciation and amortization
(adjusted EBITDA), as described below under “Non-GAAP Financial
Measures.”
Guidance Ranges in U.S.$M
2022
2023
2024
2025
2026
2027
(unaudited)
NET REVENUE
Inbrija U.S.
$27.8 - $28.7
$37.1 - $41.1
$50.1 - $55.3
$59.7 - $65.9
$64.1 - $70.9
$71.4 - $78.9
Inbrija OUS
$2.8 - $2.9
$7.3 - $8.1
$12.0 - $13.2
$22.7 - $25.1
$33.1 - $36.6
$45.0 - $49.7
Inbrija Sales
$30.6 - $31.6
$44.4 - $49.2
$62.1 - $68.5
$82.4 - $91.0
$97.2 - $107.5
$116.4 - $128.6
Ampyra U.S.
$71.4 - $73.6
$64.6 - $71.4
$61.5 - $68.0
$59.5 - $65.8
$57.6 - $63.7
$55.8 - $61.7
Fampyra Royalty
$12.0 - $12.4
$9.5 - $10.5
$8.6 - $9.5
$7.6 - $8.4
$7.6 - $8.4
$6.7 - $7.4
Ampyra Sales
$83.4 - $86.0
$74.1 - $81.9
$70.1 - $77.5
$67.1 - $74.2
$65.2 - $72.1
$62.5 - $69.1
ARCUS Development
$0.0 - $0.0
$1.1 - $1.3
$1.5 - $1.6
$1.5 - $1.6
$1.5 - $1.6
$1.5 - $1.6
Neurelis Royalty
$2.0 - $2.1
$1.7 - $1.9
$0.4 - $0.5
$0.0 - $0.0
$0.0 - $0.0
$0.0 - $0.0
Net Revenue
$116.0 - $119.7
$121.3 - $134.3
$134.1 - $148.1
$151.0 - $166.8
$163.9 - $181.2
$180.4 - $199.3
Adjusted OPEX
$113.7 - $117.1
$90.0 - $99.4
$90.6 - $100.2
$93.5 - $103.3
$96.3 - $106.4
$99.2 - $109.6
Adjusted EBITDA
$(13.5) - $(13.9)
$29.0 - $32.1
$40.8 - $45.1
$58.3 - $64.5
$72.1 - $79.7
$89.3 - $98.7
Ending Cash Balance
$43.2 - $44.5
$51.6 - $57.0
$72.8 - $80.4
$102.2 - $113.0
$138.5 - $153.1
$183.5 - $202.8
Cash Flow
$(21.0) - $(21.7)
$9.9 - $11.0
$21.2 - $23.4
$29.4 - $32.5
$36.3 - $40.1
$45.0 - $49.7
Webcast and Conference Call The Company will host a
webcast in conjunction with its third quarter update and financial
results today at 4:30 p.m. ET.
To participate in the Webcast, please use the following
registration link:
-
https://event.on24.com/wcc/r/4001897/47AF8C7CC150301C8AFD48F0F7E389AF
If you register for the Webcast, you will have the opportunity
to submit a written question for the Q&A portion of the
presentation. After you have registered, you will receive a
confirmation email with the Webcast details. On the day of the
Webcast, you will receive an email 2 hours prior to the start of
the Webcast with the link to join. 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 1, 2022 until 11:59 p.m. ET on December 1, 2022. To access
the replay, please dial 1 866 813 9403 (domestic) or +44 204 525
0658 (international); reference code 945092. 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 income (loss),
adjusted to exclude the items below, and has provided 2022-2027
adjusted operating expense and adjusted EBITDA 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 income
(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 royalty 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) expenses that
pertain to corporate restructurings which are not routine to the
operation of the business, and (v) changes in the fair value of
derivative liability relating to the 2024 convertible senior
secured notes, which is a non-cash charge and not related to the
operation of the business. The Company believes its non-GAAP net
income (loss) measure helps indicate underlying trends in the
Company's business and is important in comparing current results
with prior period results and understanding the Company’s projected
operating performance. In addition, management uses this non-GAAP
financial measure to establish budgets and operational goals, to
manage the Company's business, and to evaluate its performance.
In addition to non-GAAP net income (loss), we have provided
non-GAAP projections of adjusted OPEX and adjusted EBITDA. Adjusted
OPEX includes (i) research and development expenses and (ii)
selling, general, and administrative expenses and excludes (i)
costs of goods sold, (ii) amortization of intangible assets, (iii)
change in fair value of derivative liability, and (iv) change in
fair value of acquired contingent liability. Adjusted EBITDA is
GAAP net income (loss) before income taxes excluding (i) non-cash
compensation charges and benefits that are substantially dependent
on changes in the market price of our common stock, (ii) interest
due on our convertible debt, (iii) 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 royalty
monetization and acquired Biotie debt, (iv) changes in the fair
value of acquired contingent consideration which do not correlate
to our actual cash payment obligations in the relevant periods, (v)
expenses that pertain to corporate restructurings which are not
routine to the operation of the business, and (vi) changes in the
fair value of derivative liability relating to the 2024 convertible
senior secured notes, which is a non-cash charge and not related to
the operation of the business. We are unable to reconcile these
forward-looking non-GAAP measures to GAAP due to the
forward-looking nature of the adjustments that are needed to
determine this information, which includes information regarding
future compensation charges, future changes in the market price of
our common stock, and changes in the fair value of derivative and
contingent liabilities, none of which are available at this
time.
Non-GAAP financial measures are not an alternative for financial
measures prepared in accordance with GAAP, and the calculation of
the non-GAAP financial measures included herein may differ from
similarly titled measures used by other companies. The Company
believes that the presentation of these non-GAAP financial
measures, 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 corporate restructurings not routine to
the operation of our business, (ii) non-cash charges that are
substantially dependent on changes in the market price of our
common stock, and (iii) other items as set forth above that are not
ascertainable at the present time. We believe these non-GAAP
financial measures help indicate underlying trends in the Company’s
business and are important in comparing current results with prior
period results and understanding expected operating performance.
Also, management uses these non-GAAP financial measures to
establish budgets and operational goals, and to manage the
Company's business and 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
restrictions on in-person interactions and travel, and the
potential for illness, quarantines and vaccine mandates affecting
our management, 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 attract
and retain key management and other personnel, or maintain access
to expert advisors; 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 credit agreements, including the potential
delisting of our common stock from the Nasdaq Global Select Market
which could result in a default under the indenture dated as of
December 23, 2019 for Acorda’s 6.00% convertible senior secured
notes, and could prevent the implementation of our business plan,
and the success of actions that we may take, such as a reverse
stock split, in order to attempt to maintain such listing and avoid
a default; risks related to the successful implementation of our
business plan, including the accuracy of its key assumptions; risks
related to our corporate restructurings, including our ability to
outsource certain operations, realize expected cost savings and
maintain the workforce needed for continued operations; risks
associated with complex, regulated manufacturing processes for
pharmaceuticals, which could affect whether we have sufficient
commercial supply of INBRIJA or AMPYRA to meet market demand; our
reliance on third-party manufacturers for the timely production of
commercial supplies of INBRIJA and AMPYRA; third-party payers
(including governmental agencies) may not reimburse for the use of
INBRIJA or AMPYRA at acceptable rates or at all and may impose
restrictive prior authorization requirements that limit or block
prescriptions; reliance on collaborators and distributors to
commercialize INBRIJA and AMPYRA outside the U.S.; our ability to
satisfy our obligations to distributors and collaboration partners
outside the U.S. relating to commercialization and supply of
INBRIJA and AMPYRA; competition for INBRIJA and AMPYRA, 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 because, among other reasons,
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 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, except as may be required by law.
The Proxy Statement On September 22, 2022, the Company
filed the Notice of Special Meeting and Proxy Statement (the
“Proxy Statement”) and definitive form
of proxy card with the United States Securities and Exchange
Commission (the “SEC”) in connection
with its solicitation of proxies from the Company’s stockholders.
On October 7, 2022, the Company filed a Supplement to the Proxy
Statement (the “Supplement”).
Investors and stockholders are strongly encouraged to read the
Proxy Statement and Supplement, the accompanying proxy card, and
other documents filed by the Company in their entirety, as they
contain important information.
We urge Stockholders to review the Proxy Statement. Stockholders
can obtain copies of the Proxy Statement, Supplement, any other
amendments or supplements to the Proxy Statement, and other
documents filed by the Company with the SEC for no charge at the
SEC’s website at www.sec.gov. Copies are also available at no
charge on the Investors section of our website at www.acorda.com.
You may also obtain additional copies of the Proxy Statement and
other proxy solicitation materials by contacting our proxy
solicitor, D.F. King & Co., Inc., as directed above.
Financial Statements
Acorda Therapeutics,
Inc.
Condensed Consolidated Balance
Sheet Data
(in thousands)
September 30,
December 31,
2022
2021
(unaudited)
Assets
Cash and cash equivalents
$
20,696
$
45,634
Restricted cash - short term
13,232
13,400
Trade receivable, net
14,690
17,002
Other current assets
7,822
7,573
Inventories, net
15,252
18,548
Property and equipment, net
2,825
4,382
Intangible assets, net
312,779
335,980
Restricted cash - long term
255
6,189
Right of use assets, net
5,541
6,751
Other assets
247
11
Total assets
$
393,339
$
455,470
Liabilities and stockholders'
equity
Accounts payable, accrued expenses and
other current liabilities
$
38,210
$
39,450
Current portion of lease liability
1,454
8,186
Current portion of royalty liability
—
4,460
Current portion of contingent
consideration
2,359
1,929
Convertible senior notes
162,760
151,025
Derivative liability related to conversion
option
—
37
Non-current portion of acquired contingent
consideration
35,241
47,671
Non-current portion of lease liability
4,612
4,086
Non-current portion of loans payable
24,929
27,645
Deferred tax liability
42,228
13,930
Other long-term liabilities
5,780
5,914
Total stockholder's equity
75,766
151,137
Total liabilities and stockholders'
equity
$
393,339
$
455,470
Acorda Therapeutics,
Inc.
Consolidated Statements of
Operations
(in thousands, except per
share amounts)
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2022
2021
2022
2021
Revenues:
Net product revenues
$
29,964
$
27,851
$
76,023
$
81,297
Royalty revenues
$
3,047
$
3,605
$
10,573
$
10,807
License revenue
$
500
$
-
$
500
$
-
Total revenues
33,511
31,456
87,096
92,104
Costs and expenses:
Cost of sales
11,005
13,303
25,772
36,589
Research and development
1,383
1,931
4,602
9,054
Selling, general and administrative
22,997
29,623
80,002
95,959
Amortization of intangible assets
7,691
7,691
23,073
23,073
Change in fair value of derivative
liability
—
(288
)
(37
)
(868
)
Change in fair value of acquired
contingent consideration
(4,576
)
2,205
(10,709
)
(4,224
)
Total operating expenses
38,500
54,465
122,703
159,583
Operating loss
$
(4,989
)
$
(23,009
)
$
(35,607
)
$
(67,479
)
Other expense, (net)
(7,449
)
(7,167
)
(21,214
)
(22,696
)
Loss before income taxes
(12,438
)
(30,176
)
(56,821
)
(90,175
)
(Provision for) benefit from income
taxes
(1,416
)
3,105
(28,237
)
6,788
Net loss
$
(13,854
)
$
(27,071
)
$
(85,058
)
$
(83,387
)
Net loss per common share - basic and
diluted
$
(0.57
)
$
(2.43
)
$
(4.69
)
$
(8.17
)
Weighted average common shares - basic and
diluted
24,290
11,131
18,148
10,204
Acorda Therapeutics,
Inc.
Non-GAAP Net Loss and Net Loss
per Common Share Reconciliation
(in thousands, except per
share amounts)
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2022
2021
2022
2021
GAAP net loss
$
(13,854
)
$
(27,071
)
$
(85,058
)
$
(83,387
)
Pro forma adjustments:
Non-cash interest expense (1)
4,077
4,097
12,356
12,672
Change in fair value of acquired
contingent consideration (2)
(4,576
)
2,205
(10,709
)
(4,224
)
Restructuring costs (3)
—
2,432
251
4,582
Change in fair value of derivative
liability (4)
—
(288
)
(37
)
(868
)
Share-based compensation expenses included
in Cost of Sales
—
2
1
18
Share-based compensation expenses included
in R&D
13
225
65
599
Share-based compensation expenses included
in SG&A
351
627
1,253
1,898
Total share-based compensation
expenses
364
854
1,319
2,515
Total pro forma adjustments
(135
)
9,300
3,180
14,677
Income tax effect of reconciling items
above (5)
(673
)
(1,827
)
5,201
(10,727
)
Non-GAAP net loss
$
(13,316
)
$
(15,944
)
$
(87,079
)
$
(57,983
)
Non-GAAP net loss per common share - basic
and diluted
$
(0.55
)
$
(1.43
)
$
(4.80
)
$
(5.68
)
Weighted average common shares - basic and
diluted
24,290
11,131
18,148
10,204
(1) Non-cash interest expense related to
convertible senior notes, Biotie non-convertible and R&D loans
and Fampyra royalty monetization.
(2) Change in fair value of acquired
contingent consideration related to the Civitas acquisition.
(3) Costs associated with corporate
restructurings which are not routine to the operation of the
business.
(4) Change in the fair value of the
derivative liability related to the 2024 convertible senior secured
notes.
(5) Represents the tax effect of the
non-GAAP adjustments.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221101006228/en/
Tierney Saccavino (914) 326-5104 tsaccavino@acorda.com
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