Acorda Therapeutics Reports First Quarter 2022 Financial Results
Acorda Therapeutics reported Q1 2022 financial results, showing a net revenue of $3.7 million for INBRIJA and $14.9 million for AMPYRA, both representing decreases of 26% and 27% year-over-year, respectively. The company reiterated its 2022 AMPYRA net sales guidance of $68-$78 million. Significant agreements were made with Biopas Laboratories for INBRIJA's commercialization in Latin America. Despite Q1 declines, Acorda's CEO noted a sales rebound in March and ongoing growth expectations in the region.
- Sales of INBRIJA increased by approximately 85% in March compared to February 2022.
- Distribution agreements with Biopas Laboratories to commercialize INBRIJA in nine Latin American countries.
- Continued guidance for AMPYRA net revenue of $68-$78 million for 2022.
- INBRIJA and AMPYRA net revenues decreased by 26% and 27% year-over-year, respectively.
- Acorda reported a GAAP net loss of $25.6 million for Q1 2022.
-
INBRIJA® (levodopa inhalation powder) Q1 2022 net revenue of
;$3.7 million 26% decrease from Q1 2021 -
AMPYRA® (dalfampridine) Q1 2022 net revenue of
;$14.9 million 27% decrease from Q1 2021 -
2022 AMPYRA net sales guidance reiterated at
$68 -$78 million -
Agreements with
Biopas Laboratories to commercialize INBRIJA inLatin America -
Launch of INBRIJA in
Germany expected inJune 2022
“Although Q1 over Q1 net sales decreased, we believe that this is not reflective of a trend for either Inbrija or Ampyra. We were pleased to see that as the Omicron wave waned, net sales of both products rebounded substantially. In particular, Inbrija sales, which were similar in January and February, increased by approximately
INBRIJA Ex-US
Today Acorda announced distribution and supply agreements with
Esteve plans to launch INBRIJA in
First Quarter 2022 Financial Results
For the quarter ended
The Company reported AMPYRA net revenue of
Research and development (R&D) expenses for the quarter ended
Sales, general and administrative (SG&A) expenses for the quarter ended
Change in fair value of derivative liability for the quarter ended
Provision for income taxes for the quarter ended
The Company reported a GAAP net loss of
Non-GAAP net loss for the quarter ended
At
Financial Guidance
For the full year 2022, Acorda continues to expect AMPYRA net revenue to be
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Non-GAAP Financial Measures
This press release includes financial results prepared in accordance with accounting principles generally accepted in
In addition to non-GAAP net income (loss), we have provided 2022 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 this measure to the most directly comparable GAAP financial measure 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 corporate restructurings not routine to the operation of our business, 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
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 reverse stock split; 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 to meet market demand; our reliance on third-party manufacturers for the production of commercial supplies of AMPYRA and INBRIJA; third-party payers (including governmental agencies) may not reimburse for the use of INBRIJA 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
These and other risks are described in greater detail in our filings with the
Financial Statements
Condensed Consolidated Balance Sheet Data (in thousands) |
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2022 |
2021 |
||
|
|
|
|
|
Assets |
|
|
|
|
Cash and cash equivalents |
$ |
31,873 |
$ |
45,634 |
Restricted cash - short term |
|
13,393 |
|
13,400 |
Trade receivable, net |
|
11,990 |
|
17,002 |
Other current assets |
|
8,363 |
|
7,573 |
Inventories, net |
|
14,836 |
|
18,548 |
Property and equipment, net |
|
3,639 |
|
4,382 |
Intangible assets, net |
|
328,228 |
|
335,980 |
Restricted cash - long term |
|
6,189 |
|
6,189 |
Right of use assets, net |
|
5,616 |
|
6,751 |
Other assets |
|
11 |
|
11 |
Total assets |
$ |
424,138 |
$ |
455,470 |
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
Accounts payable, accrued expenses and other current liabilities |
$ |
36,096 |
$ |
39,450 |
Current portion of lease liability |
|
7,036 |
|
8,186 |
Current portion of royalty liability |
|
1,740 |
|
4,460 |
Current portion of contingent consideration |
|
2,228 |
|
1,929 |
Convertible senior notes |
|
154,764 |
|
151,025 |
Derivative liability related to conversion option |
|
7 |
|
37 |
Non-current portion of acquired contingent consideration |
|
44,172 |
|
47,671 |
Non-current portion of lease liability |
|
3,873 |
|
4,086 |
Non-current portion of loans payable |
|
27,672 |
|
27,645 |
Deferred tax liability |
|
14,117 |
|
13,930 |
Other long-term liabilities |
|
5,914 |
|
5,914 |
Total stockholder's equity |
|
126,519 |
|
151,137 |
Total liabilities and stockholders' equity |
$ |
424,138 |
$ |
455,470 |
Consolidated Statements of Operations (in thousands, except per share amounts) (unaudited) |
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Three Months Ended |
|
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|
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|
2022 |
|
2021 |
|
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|
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|
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|
|
Revenues: |
|
|
|
|
|
|
Net product revenues |
$ |
18,575 |
|
$ |
25,247 |
|
Royalty revenues |
|
3,959 |
|
|
3,615 |
|
Total revenues |
|
22,534 |
|
|
28,862 |
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
Cost of sales |
|
7,067 |
|
|
11,961 |
|
Research and development |
|
1,694 |
|
|
4,749 |
|
Selling, general and administrative |
|
26,938 |
|
|
33,968 |
|
Amortization of intangible assets |
|
7,691 |
|
|
7,691 |
|
Change in fair value of derivative liability |
|
(30 |
) |
|
225 |
|
Change in fair value of acquired contingent consideration |
|
(3,023 |
) |
|
(951 |
) |
Total operating expenses |
|
40,337 |
|
|
57,643 |
|
|
|
|
|
|
|
|
Operating loss |
$ |
(17,803 |
) |
$ |
(28,781 |
) |
|
|
|
|
|
|
|
Other expense, (net) |
|
(7,561 |
) |
|
(7,822 |
) |
Loss before income taxes |
|
(25,364 |
) |
|
(36,603 |
) |
Provision for (benefit from) income taxes |
|
(188 |
) |
|
3,152 |
|
Net loss |
$ |
(25,552 |
) |
$ |
(33,451 |
) |
|
|
|
|
|
|
|
Net loss per common share - basic and diluted |
$ |
(1.93 |
) |
$ |
(3.53 |
) |
Weighted average common shares - basic and diluted |
|
13,251 |
|
|
9,470 |
|
Non-GAAP Net Loss and Net Loss per Common Share Reconciliation (in thousands, except per share amounts) (unaudited) |
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Three Months Ended |
|
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|
|
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|
2022 |
|
2021 |
|
||
|
|
|
|
|
|
|
GAAP net loss |
$ |
(25,552 |
) |
$ |
(33,451 |
) |
Pro forma adjustments: |
|
|
|
|
|
|
Non-cash interest expense (1) |
|
4,040 |
|
|
4,271 |
|
|
|
|
|
|
|
|
Change in fair value of acquired contingent consideration (2) |
|
(3,023 |
) |
|
(951 |
) |
|
|
|
|
|
|
|
Restructuring costs (3) |
|
226 |
|
|
2,124 |
|
|
|
|
|
|
|
|
Change in fair value of derivative liability (4) |
|
(30 |
) |
|
225 |
|
|
|
|
|
|
|
|
Share-based compensation expenses included in Cost of Sales |
|
1 |
|
|
7 |
|
Share-based compensation expenses included in R&D |
|
27 |
|
|
166 |
|
Share-based compensation expenses included in SG&A |
|
457 |
|
|
534 |
|
Total share-based compensation expenses |
|
485 |
|
|
707 |
|
|
|
|
|
|
|
|
Total pro forma adjustments |
|
1,698 |
|
|
6,376 |
|
|
|
|
|
|
|
|
Income tax effect of reconciling items above (5) |
|
(1,871 |
) |
|
(3,732 |
) |
|
|
|
|
|
|
|
Non-GAAP net loss |
$ |
(21,983 |
) |
$ |
(23,343 |
) |
|
|
|
|
|
|
|
Net loss per common share - basic and diluted |
$ |
(1.66 |
) |
$ |
(2.46 |
) |
Weighted average common shares - basic and diluted |
|
13,251 |
|
|
9,470 |
|
(1) Non-cash interest expense related to convertible senior notes, Biotie non-convertible and R&D loans and Fampyra royalty monetization.
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tsaccavino@acorda.com
Source:
FAQ
What were Acorda's Q1 2022 net revenues for INBRIJA and AMPYRA?
What is Acorda's guidance for AMPYRA net sales in 2022?
What agreements did Acorda announce regarding INBRIJA?
How did Acorda's net loss in Q1 2022 compare to Q1 2021?