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Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) reported adjusted earnings of 38 cents per share for the first quarter of 2024, beating the Zacks Consensus Estimate of 34 cents. The company reported adjusted earnings of 41 cents in the year-ago quarter.
Total revenues amounted to $98.5 million in the reported quarter, which surpassed the Zacks Consensus Estimate of $97 million. Total product revenues climbed 15.4% to $98.4 million, from the year-ago quarter’s $85.3 million. The top line primarily comprised product sales of Firdapse, the first approved drug for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), Fycompa (perampanel) CIII and nominal revenues from Agamree (vamorolone) sales and license and other revenues.
Year to date, shares of Catalyst have lost 12.4% compared with the industry’s 7.9% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Firdapse generated sales worth $66.8 million in the first quarter, up 16.2% year over year, beating our estimate of $61.9 million, driven by the organic sales growth of Firdapse. The drug has been witnessing strong demand and increasing prescription rates from both autoimmune and small cell lung cancer LEMS patients, as well as continued diagnosis of new LEMS patients.
Catalyst also started recording sales of its newest epilepsy asset, Fycompa, from the first quarter of 2023. In January 2023, CPRX acquired the U.S. rights for Fycompa (perampanel) CIII from Eisai Co., Ltd. This acquisition diversified the company’s portfolio by adding a commercial-stage epilepsy asset.
Fycompa generated robust net product revenues of $30.4 million in first-quarter 2024, which missed our model estimate of $32.9 million. Fycompa sales, however, recorded year-over-year growth of 9.5%.
We remind investors that in the third quarter of 2023, CPRX acquired exclusive rights to manufacture and supply Agamree from Santhera Pharmaceuticals through a licensing agreement.
In October 2023, the FDA approved Agamree for treating Duchenne Muscular Dystrophy in patients aged two years and older, which gave Catalyst a third approved product. The drug was commercially launched in the United States in the middle of March 2024.
The company reported revenues of $1.2 million from the Agamree sales in the first quarter, which reflects approximately the first two weeks of U.S. commercial availability. Per Catalyst, early indicators for the drug’s U.S. launch suggest strong demand that exceeds initial expectations.
License and other revenues in the reported quarter were $0.07 million, relatively flat year over year.
The cost of sales was $12.5 million, up 25.9% year over year.
Research and development (R&D) expenses were $2.6 million in the reported quarter, down 27.5% year over year.
Selling, general and administrative (SG&A) expenses totaled $46.9 million, up 57.9% from $29.7 million reported in the year-ago quarter. This uptick in costs is primarily due to the pre-launch investments in preparation for the launch of Agamree.
As of Mar 31, 2024, Catalyst had cash, cash equivalents and investments worth $310.4 million, which includes approximately $140.7 million in net proceeds yielded from the 10 million shares of common stock offering in January 2024 compared with $137.6 million as of Dec 31, 2023.
2024 Financial Guidance Reaffirmed
Catalyst reiterated its previously provided financial guidance for 2024 in its first-quarter earnings release.
The company continues to expect total revenues in the range of $455-$475 million for the full year, boosted by the continued growth of Firdapse, Fycompa and additional net product revenues from Agamree.
For 2024, it expects Firdapse revenues between $295 million and $310 million, Agamree revenues in the range of $25-$30 million and Fycompa revenues in the $130-$135 million band.
The company expects R&D costs to increase as it is planning to initiate a long-term safety and quality of life study on Agamree. SG&A expenses are also projected to increase significantly in 2024, due to the launch of Agamree and the cumulative commercial and marketing activities to support three commercial products compared with two in 2023.
Catalyst also expects its effective tax rate to increase slightly in 2024.
Catalyst Pharmaceuticals, Inc. Price and EPS Surprise
In October 2023, the FDA accepted CPRX’s supplemental new drug application to increase Firdapse’s approved maximum daily dosage from 80mg to 100mg for the treatment of LEMS. A decision from the regulatory body is expected on Jun 4, 2024.
Zacks Rank and Stocks to Consider
Catalyst currently carries a Zacks Rank #3 (Hold).
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share has remained constant at $4.56. During the same time frame, the estimate for Ligand’s 2025 earnings per share has remained constant at $5.27. Year to date, shares of LGND have gained 12.5%.
Ligand beat estimates in each of the trailing four quarters, delivering an average surprise of 56.02%.
In the past 30 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have risen from $4.43 to $4.44. Meanwhile, during the same period, the estimate for ANI Pharmaceuticals’ 2025 earnings per share has remained constant at $5.04. Year to date, shares of ANIP have climbed 19%.
ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average surprise of 109.06%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.35 to $2.93. During the same period, the estimate for Annovis’ 2025 loss per share has widened from $2.82 to $2.83. Year to date, shares of ANVS have plunged 74.2%.
ANVS beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.
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Catalyst (CPRX) Q1 Earnings Beat, Firdapse Sales Drive Revenues
Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) reported adjusted earnings of 38 cents per share for the first quarter of 2024, beating the Zacks Consensus Estimate of 34 cents. The company reported adjusted earnings of 41 cents in the year-ago quarter.
Total revenues amounted to $98.5 million in the reported quarter, which surpassed the Zacks Consensus Estimate of $97 million. Total product revenues climbed 15.4% to $98.4 million, from the year-ago quarter’s $85.3 million. The top line primarily comprised product sales of Firdapse, the first approved drug for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), Fycompa (perampanel) CIII and nominal revenues from Agamree (vamorolone) sales and license and other revenues.
Year to date, shares of Catalyst have lost 12.4% compared with the industry’s 7.9% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Firdapse generated sales worth $66.8 million in the first quarter, up 16.2% year over year, beating our estimate of $61.9 million, driven by the organic sales growth of Firdapse. The drug has been witnessing strong demand and increasing prescription rates from both autoimmune and small cell lung cancer LEMS patients, as well as continued diagnosis of new LEMS patients.
Catalyst also started recording sales of its newest epilepsy asset, Fycompa, from the first quarter of 2023. In January 2023, CPRX acquired the U.S. rights for Fycompa (perampanel) CIII from Eisai Co., Ltd. This acquisition diversified the company’s portfolio by adding a commercial-stage epilepsy asset.
Fycompa generated robust net product revenues of $30.4 million in first-quarter 2024, which missed our model estimate of $32.9 million. Fycompa sales, however, recorded year-over-year growth of 9.5%.
We remind investors that in the third quarter of 2023, CPRX acquired exclusive rights to manufacture and supply Agamree from Santhera Pharmaceuticals through a licensing agreement.
In October 2023, the FDA approved Agamree for treating Duchenne Muscular Dystrophy in patients aged two years and older, which gave Catalyst a third approved product. The drug was commercially launched in the United States in the middle of March 2024.
The company reported revenues of $1.2 million from the Agamree sales in the first quarter, which reflects approximately the first two weeks of U.S. commercial availability. Per Catalyst, early indicators for the drug’s U.S. launch suggest strong demand that exceeds initial expectations.
License and other revenues in the reported quarter were $0.07 million, relatively flat year over year.
The cost of sales was $12.5 million, up 25.9% year over year.
Research and development (R&D) expenses were $2.6 million in the reported quarter, down 27.5% year over year.
Selling, general and administrative (SG&A) expenses totaled $46.9 million, up 57.9% from $29.7 million reported in the year-ago quarter. This uptick in costs is primarily due to the pre-launch investments in preparation for the launch of Agamree.
As of Mar 31, 2024, Catalyst had cash, cash equivalents and investments worth $310.4 million, which includes approximately $140.7 million in net proceeds yielded from the 10 million shares of common stock offering in January 2024 compared with $137.6 million as of Dec 31, 2023.
2024 Financial Guidance Reaffirmed
Catalyst reiterated its previously provided financial guidance for 2024 in its first-quarter earnings release.
The company continues to expect total revenues in the range of $455-$475 million for the full year, boosted by the continued growth of Firdapse, Fycompa and additional net product revenues from Agamree.
For 2024, it expects Firdapse revenues between $295 million and $310 million, Agamree revenues in the range of $25-$30 million and Fycompa revenues in the $130-$135 million band.
The company expects R&D costs to increase as it is planning to initiate a long-term safety and quality of life study on Agamree. SG&A expenses are also projected to increase significantly in 2024, due to the launch of Agamree and the cumulative commercial and marketing activities to support three commercial products compared with two in 2023.
Catalyst also expects its effective tax rate to increase slightly in 2024.
Catalyst Pharmaceuticals, Inc. Price and EPS Surprise
Catalyst Pharmaceuticals, Inc. price-eps-surprise | Catalyst Pharmaceuticals, Inc. Quote
Regulatory Update
In October 2023, the FDA accepted CPRX’s supplemental new drug application to increase Firdapse’s approved maximum daily dosage from 80mg to 100mg for the treatment of LEMS. A decision from the regulatory body is expected on Jun 4, 2024.
Zacks Rank and Stocks to Consider
Catalyst currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are Ligand Pharmaceuticals (LGND - Free Report) , ANI Pharmaceuticals (ANIP - Free Report) and Annovis Bio (ANVS - Free Report) . While LGND sports a Zacks Rank #1 (Strong Buy), ANIP & ANVS carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share has remained constant at $4.56. During the same time frame, the estimate for Ligand’s 2025 earnings per share has remained constant at $5.27. Year to date, shares of LGND have gained 12.5%.
Ligand beat estimates in each of the trailing four quarters, delivering an average surprise of 56.02%.
In the past 30 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have risen from $4.43 to $4.44. Meanwhile, during the same period, the estimate for ANI Pharmaceuticals’ 2025 earnings per share has remained constant at $5.04. Year to date, shares of ANIP have climbed 19%.
ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average surprise of 109.06%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.35 to $2.93. During the same period, the estimate for Annovis’ 2025 loss per share has widened from $2.82 to $2.83. Year to date, shares of ANVS have plunged 74.2%.
ANVS beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.