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Catalyst (CPRX) Reports Wider Q4 Loss, Focuses on Firdapse

Zacks Equity Research

Catalyst Pharmaceuticals, Inc. CPRX reported a loss of 14 cents per share in the fourth quarter of 2018, wider than the Zacks Consensus Estimate of a loss of 12 cents and the year-ago loss of 6 cents.

During the fourth quarter of 2018, Catalyst had revenues of $0.5 million from its collaboration with Endo International Plc. ENDP to market the generic version of Sabril tablets.   

On Dec 18, 2018, Catalyst signed a definitive agreement with Endo International PLC’s subsidiary, Endo Ventures Limited (“Endo”), for development/commercialization of generic Sabril tablets through Endo’s United States Generic Pharmaceuticals segment, Par Pharmaceutical.  Pursuant to the agreement, the company received an up-front payment, and will receive milestone payments based on regulatory approvals, and a share of defined net profits upon commercialization and certain expenses for development.

Catalyst had no revenues for the fourth quarter of 2017.

So far this year, Catalyst’s shares have increased 15%, against the industry’s 15.3% decline.


Quarter in Detail

During the fourth quarter, the FDA approvedFirdapse (amifampridine phosphate) tablets, the first and only evidence-based treatment for patients with Lambert-Eaton myasthenic syndrome (LEMS). In January 2019, the company launched Firdapse in the United States. The CEO of the company stated that they are pleased with the launch of the drug.

Catalystis also working on developing Firdapse for additional indications. The company is currently conducting phase III studies, evaluating Firdapse for the treatment of congenital myasthenic syndromes (“CMS”) and anti- MuSK -antibody positive myasthenia gravis (MuSK-MG).

The company expects to report top-line results from the phase III MuSK-MG and CMS studiesin the second half of 2019.

Catalys is conducting a proof-of-concept clinical study, evaluating Firdapse as a symptomatic treatment for patients with SMA type III and expects to report top-line results from proof-of-concept study on SMAin the first half of 2020.

Research and development (R&D) expenses were $8.4 million, up from $3.4 million in the year-ago quarter. Costs during 2018 increased due to rise in consulting expenses, expenses from Catalyst’s medical affairs program and higher personnel costs to support currently ongoing studies. Catalyst expects R&D costs to be substantial in 2019.

General and administrative expenses totaled $6.9 million, up 228.7% from the year-ago quarter. The increase is attributable to higher pre-commercialization expenses, headcount costs and corporate expenses, as Catalyst builds its infrastructure and commercial programs to support Firdapse’s launch.

2018 Results

The company reported a loss of 33 cents per share in 2018 compared with a loss of 21 cents in 2017.

Catalyst recorded revenues of $0.5 million in 2018 compared with no revenues in 2017.

Zacks Rank & Stocks to Consider

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

Some better-ranked stocks worth considering are Celgene Corp. CELG and BioDelivery Sciences International, Inc. BDSI, While Celgene carries a Zacks Rank #1 (Strong Buy), BioDelivery carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Celgene’s earnings per share estimates have increased from $10.34 to $10.73 for 2019 and from $12.28 to $12.76 for 2020 in the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 2.65%.

BioDelivery Sciences’ loss per share estimates have narrowed from 25 cents to 20 cents for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average of 16.53%.

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