Catalyst Pharmaceuticals, Inc. CPRX reported earnings of 13 cents per share in the third quarter of 2019, which beat the Zacks Consensus Estimate of 11 cents. The company reported a loss of 8 cents in the year-ago quarter.
The company’s revenues of $30.8 million missed the Zacks Consensus Estimate of $34 million. It did not record any revenue in the year-ago quarter. Revenues came entirely from Firdapse, the company’s first approved drug for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). The drug was launched in the United States in January 2019 after receiving FDA approval in November 2018.
So far this year, Catalyst’s shares have soared 155.7% year to date compared with the
industry’s growth of 4.2%. Quarter in Detail
Per the company, Firdapse had a strong start. At the end of the third quarter, the drug was prescribed to 494 unique LEMS patients.
Research and development (R&D) expenses were $4.6 million, up from $4.5 million in the year-ago quarter. The R&D costs included expenses in medical, regulatory affairs and quality assurance programs along with those from the Firdapse clinical studies and the Expanded Access Program.
Selling, general and administrative (SG&A) expenses totaled $8.1 million, up from $3.6 million in the year-ago quarter. The increase is attributable to higher selling expenses, including the costs of commercial system implementation of the company’s sales force and supporting personnel, product launch expenses, and market access and research costs. The company expects SG&A expenses to increase in 2019 and 2020, as it continues to build the infrastructure and invest in commercial and patient programs to support Firdapse sales activities, and prosecutes its lawsuit against the FDA.
Catalyst is also working on developing Firdapse for additional indications. The company is currently conducting phase III studies on the drug for the treatment of congenital myasthenic syndromes (“CMS”) and anti-MuSK -antibody positive myasthenia gravis (MuSK-MG). The company announced top-line results from CMS-001 phase III study of Firdapse for CMS. It expects to meet with the FDA before the end of 2019 to discuss CMS-001 study outcome and path forward. It expects to report top-line results from the phase III study for MuSK-MG in the first half of 2020.
Catalyst is conducting a proof-of-concept study, evaluating Firdapse as a symptomatic treatment for patients with SMA type III. The company expects to report top-line results in the first half of 2020.
2019 and 2020 Guidance
Catalystexpects full-year 2019 net revenues to be approximately $100 million. It expects full-year 2020 net revenues to be in the range of $135-$155 million.
Zacks Rank & Stocks to Consider
Catalyst currently has a Zacks Rank #3 (Hold).
A few better-ranked stocks in the biotech sector are Alkermes Plc.
ALKS, Anika Therapeutics Inc. ANIK and Agenus Inc. ( AGEN Quick Quote AGEN - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here .
Alkermes’ earnings per share estimates have increased from 36 cents to 52 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 236.80% on average.
Anika’s earnings per share estimates have increased from $1.75 to $2.03 for 2019 and from $1.36 to $1.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 53.31% on average.
Agenus’ loss per share estimates have narrowed from $1.04 to 96 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters by 23.79% on average.
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