Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) reported earnings of 7 cents per share in the fourth quarter of 2019, missing the Zacks Consensus Estimate of 9 cents. Meanwhile, the company reported a loss of 14 cents in the year-ago quarter.
The company’s revenues of $30.1 million were in line with the Zacks Consensus Estimate. It did not record any revenue addition in the year-ago quarter. Revenues came entirely from sales of Firdapse, the company’s first-approved drug for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). The product was launched in the United States during January 2019 after receiving an FDA nod in November 2018.
Shares of Catalyst were up 6.9% in after-hours trading following the earnings announcement on Monday. However, the stock has lost 15.3% in the past year compared with the industry’s decrease of 25.4%.
Quarter in Detail
Per the company, the number of patients who are currently being treated with Firdapse and product revenues exceeded management’s expectations. At the end of the fourth quarter of 2019, the drug was prescribed to 532 unique LEMS patients, reflecting a sequential increase of 7.7%.
Per the press release, patients, healthcare providers and investors enquired about the uninterrupted supply of Firdapse in the wake of the Covid-19 outbreak. Management declared that it has more than adequate supply of Firdapse, ready for shipment in the warehouse to meet patients' needs through this year-end.
Research and development (R&D) expenses of $6.3 million were down from $8.4 million reported 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 $11.4 million, up from $6.9 million reported 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, product launch expenses, market access and research costs.
As of Dec 31, 2019, Catalyst had cash, cash equivalents, marketable securities of $94.5 million compared with $81.6 million as of Sep 30, 2019.
For 2019, Catalyst’s generated revenues of $102.3 million. In 2018, it generated no product revenues but only recognized revenues from a collaborative arrangement of $0.5 million.
The company reported earnings of 30 cents per share in 2019 against the loss of 33 cents in 2018.
Update on Firdapse
Apart from LEMS, Catalyst is working on developing Firdapse for additional indications. The company completed enrollment in a pivotal phase III study on the drug for the symptomatic treatment of MuSK-antibody positive Myasthenia Gravis. Top-line results from the same are expected in the second quarter of 2020. If positive, the company expects to file a supplemental new drug application (sNDA) with the FDA by the end of 2020.
Firdapse is also being evaluated in a proof-of-concept study for the treatment of spinal muscular atrophy (SMA) type 3 patients. Top-line results from this study are expected in second-quarter 2020 as well.
Meanwhile, the company has submitted a regulatory filing for Firdapse to Health Canada for treating LEMS.
A potential approval of Firdapse for any of the above given indications will further boost sales of the drug and drive revenues for the company.
Along with the earnings release, Catalyst reiterated its financial outlook for the current year, which was earlier provided in January this year.
The company expects Firdapse’s net revenues in the range of $135-$155 million for 2020.
Catalyst Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Zacks Rank & Stocks to Consider
Catalyst currently has a Zacks Rank #4 (Sell).
Better-ranked stocks in the same sector include BioCryst Pharmaceuticals, Inc. (BCRX - Free Report) , Organogenesis Holdings Inc. (ORGO - Free Report) and Molecular Templates, Inc. (MTEM - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioCryst’s loss per share estimates have narrowed 16.8% for 2020 over the past 60 days.
Organogenesis’ loss per share estimates have narrowed 9.7% for 2020 over the past 60 days.
Molecular Templates’ loss per share estimates have narrowed 29.3% for 2020 over the past 60 days. The stock has skyrocketed 113% in the past year.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Today, See These 5 Potential Home Runs >>