Sarepta Therapeutics, Inc.


SRPT

incurred an adjusted loss of $1.54 per share in the first quarter of 2021, wider than the year-ago adjusted loss of $1.04 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 $2.10 per share, significantly wider than loss of 23 cents in the year-ago quarter. The Zacks Consensus Estimate was pegged at a loss of $2.01 per share.

Sarepta had recorded $108 million from sale of a priority review voucher in the year-ago quarter that resulted in significantly lower reported loss compared to the first quarter of 2020.

Sarepta recorded total revenues of $146.9 million, up 29.3% year over year. Revenues beat the Zacks Consensus Estimate of $140.7 million.

Shares of Sarepta have declined 57.3% so far this year compared with the

industry

’s decrease of 6%.

Quarter in Details

Sarepta’s commercial portfolio includes three drugs approved for treating Duchenne muscular dystrophy (“DMD”) — Exondys 51, Vyondys 53 and Amondys 45. The company launched Amondys 45 for treating patients amenable to skipping exon 45 in February. The company stated that these three drugs together can treat nearly 30% of the total DMD patients in the United States.

The company derived product revenues of $124.9 million, up 24% year over year, reflecting higher demand for Exondys 51 and additional revenues from Vyondys 53, which was launched in December 2019.

Sales of Exondys 51 Vyondys 53 and Amondys 45 during the first quarter were $107.2 million, $17.5 million and $0.2 million, respectively.

The company recorded $22 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. In the year-ago quarter, the company had recorded $13.2 million in collaboration revenues.

Adjusted research and development (R&D) expenses totaled $173.5 million in the first quarter, up 51.9% year over year. The increase was primarily due to increased clinical and manufacturing activities related to its micro-dystrophin gene therapy program as well as other gene therapy programs.

Adjusted selling, general & administrative (SG&A) expenses were $51.5 million, down 5.5% year over year.

Pipeline Update

During the quarter, Sarepta reported encouraging data from one cohort of the part A of phase II MOMENTUM study evaluating its next-generation PPMO technology candidate, SRP-5051, in DMD patients amenable to skipping exon 51, a similar patient population to the company’s lead drug, Exondys 51. The cohort evaluated 30 mg/kg dose of the candidate once a month. Data showed that the candidate achieved 18-fold increase in exon skipping and an eight-fold increase in the percentage of normal dystrophin compared to 30mg/kg weekly dose of Exondys 51. Data for Exondys 51 use for comparison were taken from previously completed PROMOVI study on the drug. The company will start part B of the study after discussion with the FDA. Data from the part B of the MOMENTUM study may support regulatory application for accelerated approval for SRP-5001 in the United States.

The company presented first expression data from ongoing study on SRP-9003-101, its gene therapy candidate for limb-girdle muscular dystrophy Type 2E (LGMD2E) at a medical conference in March. Data showed that treatment with SRP-9003, can lead to improved clinical motor outcomes measures in LGMD2E patients.

In January, Sarepta announced top-line results from part 1 of Study 102 evaluating SRP-9001 for treating DMD. The study met the primary biological endpoint of micro-dystrophin protein expression. However, it failed to achieve statistical significance for primary functional endpoint. The company plans to initiate a new clinical study — Study 301 —  designed based on outcomes from Study 102. Part 2 of Study 102 is ongoing.

Zacks Rank and Stocks to Consider

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

Some better-ranked stocks from the drug/biotech sector include

Atea Pharmaceuticals, Inc.


AVIR

and

Nabriva Therapeutics AG


NBRV

, both carrying a Zacks Rank #2 (Buy). You can see


the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here


.

Atea’s earnings per share estimates have moved up from $3.79 to $8.34 for 2021 and from $16.76 to $17.25 for 2022 in the past 30 days. The stock has soared 757.3% in the past year.

Nabriva’s loss per share estimates narrowed from $2.03 to $1.95 for 2021 and from $1.35 to $1.22 in the past 30 days. The company delivered an earnings surprise of 46.50%, on average, in the last four quarters.

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