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Catalyst (CPRX) Q3 Earnings Miss, Sales Top, '23 View Up
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Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) reported a loss of 29 cents per share for the third quarter of 2023, wider than the Zacks Consensus Estimate of a loss of 24 cents per share. The company reported earnings of 20 cents in the year-ago quarter.
Adjusted diluted earnings (adjusted for stock-based compensation, depreciation, amortization, tax provision and in-process research and development [IPR&D]) came in at 49 cents per share in the quarter compared with 26 cents a year ago.
Total revenues amounted to $102.7 million in the reported quarter, which surpassed the Zacks Consensus Estimate of $100 million. Total product revenues rose 79.5% from the year-ago quarter’s $57.2 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 license and other revenues.
Catalyst’s stock was up about 6% on Wednesday, in the after-market hours, likely to have been driven by the raised full-year 2023 guidance. Year to date, shares of the company have plunged 32.6% compared with the industry’s fall of 14.1%.
Image Source: Zacks Investment Research
Quarter in Detail
Firdapse generated sales worth $66.2 million in the third quarter, up 15.8% year over year, beating our estimate of $64.5 million. The surge was primarily 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, starting the first quarter of 2023. In January, CPRX acquired the U.S. rights for Fycompa (perampanel) CIII from Eisai Co., Ltd. This acquisition diversified the company’s portfolio with the addition of a commercial-stage epilepsy asset.
Fycompa generated robust net product revenues of $36.4 million in third-quarter 2023, which surpassed our estimate of $34.6 million. The reported figure witnessed a 5.2% full-quarter increase compared with the previous reported quarter.
License and other revenues in the reported quarter were flat year over year at a nominal $0.07 million.
The cost of sales was $14.2 million in the third quarter of 2023, up about 46.6% year over year.
Research and development expenses were $83.7 million in the reported quarter, up significantly year over year. The massive uptick in research and development expenses was driven by a one-time charge of $81.5 million for IPR&D in connection with the asset acquisition of Agamree (vamorolone) in July 2023.
Selling, general and administrative expenses totaled $33.6 million, up 145.9% from $13.6 million reported in the year-ago quarter. This uptick in expenses is due to commercial and marketing activities related to the launch of Fycompa in the United States in the reported quarter.
As of Sep 30, 2023, CPRX had cash, cash equivalents and investments worth $121 million compared with $178.8 million as of Jun 30, 2023.
2023 Guidance Raised
Catalyst raised its full-year 2023 total revenue guidance to the range of $390-$395 million from $380-$390 million, marking an 82-84% (previously 77-82%) increase in total revenues from 2022. This guidance also includes the revenues generated from the sales of Fycompa CIII.
Catalyst Pharmaceuticals, Inc. Price and Consensus
During the quarter, Catalyst announced that the FDA has approved vamorolone oral suspension 40 mg/mL for treating Duchenne Muscular Dystrophy in patients aged two years and older.
The drug will be marketed in the United States under the brand name Agamree, expecting commercial launch by Catalyst’s neuromuscular franchise teams in the first quarter of 2024.
We remind the investors that CPRX acquired exclusive rights to manufacture and supply vamorolone from Santhera Pharmaceuticals through a licensing agreement that was closed at the beginning of the third quarter of 2023.
Also, during the third quarter, Catalyst announced that the FDA has accepted its supplemental new drug application (sNDA) seeking a label expansion for its flagship product, Firdapse. The sNDA seeks to increase the maximum daily dosage of Firdapse tablets 10 mg 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 has a Zacks Rank #3 (Hold).
Some better-ranked stocks worth mentioning are Ligand Pharmaceuticals , Apellis Pharmaceuticals (APLS - Free Report) and Anixa Biosciences (ANIX - Free Report) . While LGND sports a Zacks Rank #1 (Strong Buy), APLS and ANIX carry a Zacks Rank #2 (Buy) each at present.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2023 earnings per share has increased from $5.09 to $5.10. During the same time frame, the estimate for Ligand’s 2024 earnings per share has increased from $4.56 to $4.59. Year to date, shares of LGND have lost 21.8%.
LGND’s earnings beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average surprise of 52.47%.
In the past 30 days, the Zacks Consensus Estimate for Apellis’ 2023 loss per share has widened from $4.39 to $4.59. During the same time frame, the estimate for Apellis’ 2024 loss per share has narrowed from $2.41 to $1.92. Year to date, shares of APLS have lost 9.1%.
APLS beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative earnings surprise of 3.91%.
In the past 30 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has remained constant at 32 cents. During the same time frame, the estimate for Anixa Biosciences’ 2024 loss per share has remained constant at 37 cents. Year to date, shares of ANIX have lost 32.9%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 26.29%.
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Catalyst (CPRX) Q3 Earnings Miss, Sales Top, '23 View Up
Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) reported a loss of 29 cents per share for the third quarter of 2023, wider than the Zacks Consensus Estimate of a loss of 24 cents per share. The company reported earnings of 20 cents in the year-ago quarter.
Adjusted diluted earnings (adjusted for stock-based compensation, depreciation, amortization, tax provision and in-process research and development [IPR&D]) came in at 49 cents per share in the quarter compared with 26 cents a year ago.
Total revenues amounted to $102.7 million in the reported quarter, which surpassed the Zacks Consensus Estimate of $100 million. Total product revenues rose 79.5% from the year-ago quarter’s $57.2 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 license and other revenues.
Catalyst’s stock was up about 6% on Wednesday, in the after-market hours, likely to have been driven by the raised full-year 2023 guidance. Year to date, shares of the company have plunged 32.6% compared with the industry’s fall of 14.1%.
Image Source: Zacks Investment Research
Quarter in Detail
Firdapse generated sales worth $66.2 million in the third quarter, up 15.8% year over year, beating our estimate of $64.5 million. The surge was primarily 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, starting the first quarter of 2023. In January, CPRX acquired the U.S. rights for Fycompa (perampanel) CIII from Eisai Co., Ltd. This acquisition diversified the company’s portfolio with the addition of a commercial-stage epilepsy asset.
Fycompa generated robust net product revenues of $36.4 million in third-quarter 2023, which surpassed our estimate of $34.6 million. The reported figure witnessed a 5.2% full-quarter increase compared with the previous reported quarter.
License and other revenues in the reported quarter were flat year over year at a nominal $0.07 million.
The cost of sales was $14.2 million in the third quarter of 2023, up about 46.6% year over year.
Research and development expenses were $83.7 million in the reported quarter, up significantly year over year. The massive uptick in research and development expenses was driven by a one-time charge of $81.5 million for IPR&D in connection with the asset acquisition of Agamree (vamorolone) in July 2023.
Selling, general and administrative expenses totaled $33.6 million, up 145.9% from $13.6 million reported in the year-ago quarter. This uptick in expenses is due to commercial and marketing activities related to the launch of Fycompa in the United States in the reported quarter.
As of Sep 30, 2023, CPRX had cash, cash equivalents and investments worth $121 million compared with $178.8 million as of Jun 30, 2023.
2023 Guidance Raised
Catalyst raised its full-year 2023 total revenue guidance to the range of $390-$395 million from $380-$390 million, marking an 82-84% (previously 77-82%) increase in total revenues from 2022. This guidance also includes the revenues generated from the sales of Fycompa CIII.
Catalyst Pharmaceuticals, Inc. Price and Consensus
Catalyst Pharmaceuticals, Inc. price-consensus-chart | Catalyst Pharmaceuticals, Inc. Quote
Recent Updates
During the quarter, Catalyst announced that the FDA has approved vamorolone oral suspension 40 mg/mL for treating Duchenne Muscular Dystrophy in patients aged two years and older.
The drug will be marketed in the United States under the brand name Agamree, expecting commercial launch by Catalyst’s neuromuscular franchise teams in the first quarter of 2024.
We remind the investors that CPRX acquired exclusive rights to manufacture and supply vamorolone from Santhera Pharmaceuticals through a licensing agreement that was closed at the beginning of the third quarter of 2023.
Also, during the third quarter, Catalyst announced that the FDA has accepted its supplemental new drug application (sNDA) seeking a label expansion for its flagship product, Firdapse. The sNDA seeks to increase the maximum daily dosage of Firdapse tablets 10 mg 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 has a Zacks Rank #3 (Hold).
Some better-ranked stocks worth mentioning are Ligand Pharmaceuticals , Apellis Pharmaceuticals (APLS - Free Report) and Anixa Biosciences (ANIX - Free Report) . While LGND sports a Zacks Rank #1 (Strong Buy), APLS and ANIX 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 2023 earnings per share has increased from $5.09 to $5.10. During the same time frame, the estimate for Ligand’s 2024 earnings per share has increased from $4.56 to $4.59. Year to date, shares of LGND have lost 21.8%.
LGND’s earnings beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average surprise of 52.47%.
In the past 30 days, the Zacks Consensus Estimate for Apellis’ 2023 loss per share has widened from $4.39 to $4.59. During the same time frame, the estimate for Apellis’ 2024 loss per share has narrowed from $2.41 to $1.92. Year to date, shares of APLS have lost 9.1%.
APLS beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative earnings surprise of 3.91%.
In the past 30 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has remained constant at 32 cents. During the same time frame, the estimate for Anixa Biosciences’ 2024 loss per share has remained constant at 37 cents. Year to date, shares of ANIX have lost 32.9%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 26.29%.