Sarepta Therapeutics, Inc. SRPT incurred an adjusted loss of $1.42 per share for the third quarter of 2020, wider than the year-ago adjusted loss of $1.14 per share. The wider year-over-year loss can be primarily attributed to a significant rise in operating expenses.

Notably, the adjusted figure excludes one-time items, depreciation & amortization expenses, interest expenses, income tax benefit, stock-based compensation expense and other items. Including all these items, the company incurred a loss of $2.50 per share, wider than the loss of $1.70 in the year-ago quarter. The Zacks Consensus Estimate was pegged at a loss of $1.89 per share.

Sarepta recorded total revenues of $143.90 million, up 45.3% year over year. Revenues beat the Zacks Consensus Estimate of $131.49 million.

Shares of Sarepta were down 2.9% in after-market trading on Nov 5, following the earnings release. However, the company’s shares have increased 12.4% so far this year against the industry’s decrease of 1.2%.

 

Quarter in Details

Sarepta’s commercial portfolio includes two drugs approved for treating Duchenne muscular dystrophy (“DMD”) — Exondys 51 and Vyondys 53.

The company derived product revenues of $121.4 million, up 22.6% year over year, reflecting higher demand for its drugs. The company stated that COVID-19 had modest impact on sales of its drugs during the third quarter.

The company recorded $22.5 million in collaboration revenues related to its licensing agreement with Roche (RHHBY) for commercialization of its gene therapy candidate, SRP-9001 as DMD therapy in ex-U.S. markets.

Adjusted research and development (R&D) expenses totaled $159.9 million in the third quarter, up 44.7% year over year. The increase was primarily due to increased clinical and manufacturing activities related to its micro-dystrophin programs.

Adjusted selling, general & administrative (SG&A) expenses were $57.2 million, down 4% year over year.

Pipeline Update

Sarepta is on track to receive FDA approval for its third DMD drug — Amondys 45 (casimersen) — in February 2021.

Sarepta is progressing well with the development of the micro-dystrophin gene therapy candidate, SRP-9001, in a phase II study in DMD patients and study data readout remains on track, which is anticipated in the first quarter of 2021. The company plans to initiate an open-label study by year-end to evaluate commercial process material for SRP-9001. In September, Sarepta announced two-year follow up results from a study evaluating single administration of SRP-9001 in DMD patients. Data from the studies demonstrated continued safety and tolerability of SRP-9001 after two years of administration. All patients showed a durable response.

The company plans to start a pivotal study on its other gene therapy candidate, SRP-9003, in 2021 to evaluate it in patients with limb-girdle muscular dystrophy type 2E.In September, Sarepta announced18-month functional data from the ongoing study of SRP-9003, evaluating a single administration of the candidate in LGMD type 2E patients, demonstrating continued functional improvements in the low-dose cohort.Moreover, six-month functional data from the high dose cohort demonstrated improvements from baseline across all functional measures.

Zacks Rank and Stocks to Consider

Sarepta currently has a Zacks Rank #3 (Hold).

Some better-ranked stocks from the biotech/drug sector include Emergent Biosolutions Inc. EBS, miRagen Therapeutics, Inc. MGEN and BioLineRx Ltd. BLRX. While Emergent sports a Zacks Rank #1 (Strong Buy), miRagen and BioLineRx carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent Biosolutions’ earnings per share estimates have moved up from $6.17 to $8.42 for 2021 in the past 60 days. The company delivered an earnings surprise of 127.41%, on average, in the last four quarters. The stock has risen 79.8% so far this year.

Miragen Therapeutics’ loss per share estimates narrowed from 51 cents to 42 cents for 2021 in the past 60 days. The stock has risen 150% so far this year.

BioLineRx loss per share estimates have narrowed from $1.44 to $1.36 for 2021 in the past 60 days. The company delivered an earnings surprise of 10.36%, on average, in the last four quarters. The stock has risen 25.7% so far this year.

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