On August 5, 2021 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial results for the second quarter 2021 (Press release, Acorda Therapeutics, AUG 5, 2021, View Source [SID1234585858]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We were pleased to see a 36% increase in INBRIJA net sales in the second quarter of 2021 over the same period in 2020. We also saw increases in total prescriptions and dispensed cartons. As Inbrija is an on-demand medication and prescription can range from one to five boxes, we believe that dispensed cartons are the best indicator of demand for the product. These are encouraging signs that the impact of the pandemic is moderating, though it is still too early to project how long it will take for prescribing patterns to return to pre-pandemic levels," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "We also were delighted to enter into an agreement with Esteve to commercialize INBRIJA in Spain, providing people with Parkinson’s access to this important medication to address their OFF periods. We also are in active discussions with several parties for commercialization of INBRIJA in other territories in Europe and the rest of the world."

Second Quarter 2021 Financial Results

For the quarter ended June 30, 2021, the Company reported INBRIJA net revenue of $6.4 million, compared to $4.7 million for the same quarter in 2020.

For the quarter ended June 30, 2021, the Company reported AMPYRA net revenue of $21.8 million compared to $26.1 million for the same quarter in 2020. 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, 2021 were $2.4 million, including $0.2 million of share-based compensation compared to $5.3 million, including $0.4 million of share-based compensation for the same quarter in 2020.

Sales, general and administrative (SG&A) expenses for the quarter ended June 30, 2021 were $32.4 million, including $0.7 million of share-based compensation compared to $38.7 million, including $1.5 million of share-based compensation for the same quarter in 2020.

Change in fair value of derivative liability for the quarter ended June 30, 2021 was $(0.8) million compared to $(8.9) million for the same quarter in 2020.

Benefit from income taxes for the quarter ended June 30, 2021 was $0.5 million compared to a provision for income taxes of $0.6 million for the same quarter in 2020.

The Company reported a GAAP net loss of $22.9 million for the quarter ended June 30, 2021, or $2.29 per diluted share. GAAP net loss in the same quarter of 2020 was $17.4 million, or $2.19 per diluted share.

Non-GAAP net loss for the quarter ended June 30, 2021 was $18.7 million, or $1.87 per diluted share. Non-GAAP net loss in the same quarter of 2020 was $16.6 million, or $2.08 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 June 30, 2021, the Company had cash, cash equivalents, and restricted cash of $71 million, compared to $103 million at year end 2020. Restricted cash includes $25 million in escrow related to the 6% semi-annual interest portion, payable in cash or stock, of the 2024 convertible senior secured notes. If the Company elects to pay interest due in stock, the restricted cash will be released from escrow.

Financial Guidance

For the full-year 2021, Acorda continues to expect AMPYRA net revenue to be $75 – $85 million, and operating expenses to be $130 – $140 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."
Due to uncertainties caused by past and potential future impacts of the COVID-19 pandemic and other factors, the Company is not providing projected peak U.S. annual net revenue of INBRIJA at this time.
Webcast

The Company will host a webcast in conjunction with its second quarter 2021 update and financial results today at 4:30 p.m. EDT.

To register for the webcast, use the link below:
View Source
Once you have registered, you will receive a confirmation email with webcast details. You will receive an email with the link to join the webcast 2 hours prior to the start time. 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. EDT on May 6, 2021 until 11:59 p.m. EDT on June 3, 2021. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 2996776. 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 2021 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 that the presentation of non-GAAP net 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) asset impairment charges that are not routine to the operation of the business, (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. 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 2021 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 non-routine corporate restructurings, 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.