On August 1, 2019 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported a financial and pipeline update for the quarter ended June 30, 2019 (Press release, Acorda Therapeutics, AUG 1, 2019, View Source [SID1234538068]).

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"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.