On May 5, 2016 Sarepta Therapeutics, Inc.(NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, reported financial results for the three months ended March 31, 2016, and provided an update of recent corporate developments (Press release, Sarepta Therapeutics, MAY 5, 2016, View Source;p=RssLanding&cat=news&id=2165380 [SID:1234512019]).
"The Peripheral and Central Nervous System Advisory Committee met last week to review eteplirsen for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping, and we await our May 26 PDUFA date," said Edward Kaye, M.D., Sarepta’s interim chief executive officer and chief medical officer. "Following the FDA’s decision, we plan to provide a clinical and corporate update."

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!

Financial Results
For the first quarter of 2016, Sarepta reported a non-GAAP net loss of $52.5 million, or $1.15 per share, compared to a non-GAAP net loss of $47.4 million for the first quarter of 2015, or $1.15 per share. The incremental loss of $5.1 million was primarily the result of increased operating expenses.

On a GAAP basis, the net loss for the first quarter of 2016 was $59.8 million, or $1.31 per share (including $7.2 million of stock-based compensation and restructuring expenses), compared to a net loss of $61.6 million, or $1.49 per share (including $14.2 million of stock-based compensation) for the first quarter of 2015.

No revenue was recognized for the three months ended in both March 31, 2016 and 2015.
Non-GAAP research and development expenses were $35.9 million for the first quarter of 2016, compared to $36.7 million for the first quarter of 2015, a decrease of $0.8 million. GAAP research and development expenses were $38.8 million for the first quarter of 2016 (including $3.0 million of stock-based compensation and restructuring expenses), compared to $39.2 million for the first quarter of 2015 (including $2.4 million of stock-based compensation), a decrease of $0.3 million.

Non-GAAP general and administrative expenses were $16.6 million for the first quarter of 2016, compared to $11.0 million for the first quarter of 2015, an increase of $5.6 million. GAAP general and administrative expenses were $20.9 million for the first quarter of 2016 (including $4.3 million of stock-based compensation and restructuring expenses), compared to $22.7 million for the first quarter of 2015 (including $11.7 million of stock-based compensation), a decrease of $1.8 million.

The Company had $140.6 million in cash, cash equivalents, short-term investments and restricted cash as of March 31, 2016 compared to $204.0 million as of December 31, 2015, a decrease of $63.4 million. The decrease was due to the use of cash to fund the Company’s ongoing operations, commercial launch activities and related inventory build.

In addition to the GAAP financial measures set forth in this press release, the Company has included certain non-GAAP measurements: non-GAAP research and development expenses, non-GAAP general and administrative expenses, non-GAAP operating expense adjustments, non-GAAP net loss, and non-GAAP basic and diluted net loss per share, which present operating results on a basis adjusted for certain items. The Company uses these non-GAAP measures as key performance measures for the purpose of evaluating performance internally. The Company also believes these non-GAAP measures provide the Company’s investors with useful information regarding the Company’s historical operating results. These non-GAAP measures are not intended to replace the presentation of the Company’s financial results in accordance with GAAP. Use of the terms non-GAAP research and development expenses, non-GAAP general and administrative expenses, non-GAAP operating expense adjustments, non-GAAP net loss, and non-GAAP basic and diluted net loss per share may differ from similar measures reported by other companies. All relevant non-GAAP measures are reconciled from their respective GAAP measures in the attached table "Reconciliation of GAAP to Non-GAAP Net Loss."

Recent Corporate Developments
Duchenne Muscular Dystrophy Program
–Sarepta Issues Statement on Advisory Committee Meeting Outcome for Use of Eteplirsen in the Treatment for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
–Sarepta Therapeutics Announces FDA Advisory Committee Meeting to Review Eteplirsen as a Treatment for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
Corporate Updates
–Sarepta Therapeutics Announces Long Term Plan to Consolidate Facilities within Massachusetts