CPRX Filings — Catalyst Pharmaceuticals, Inc. - FilingSpy
CPRX
Catalyst Pharmaceuticals, Inc.
A Florida biopharma that targets rare diseases, Catalyst Pharmaceuticals sells three FDA-approved drugs: FIRDAPSE for Lambert-Eaton myasthenic syndrome, a rare nerve-muscle disorder; AGAMREE for Duchenne muscular dystrophy; and FYCOMPA for epilepsy. It began in 2002 working on addiction therapies before pivoting to rare neuromuscular conditions, carving out a niche in medicines with few existing options.
FYCOMPA revenue fell 61% on generic entry, but FIRDAPSE royalty relief lifted gross margin to 90.3%.
FYCOMPA's post-patent decline accelerated, but the still grew. rose 5.6% to $149.4 million and widened 3.0 points to 90.3% as FIRDAPSE's royalty rate dropped sharply, pushing net income up 12.3% to $63.7 million. The company is now a two-product story with a pending merger.
Key takeaways
FYCOMPA net product fell 61.3% to $13.8 million after both tablet and oral suspension patents expired, and the company expects further declines.
FIRDAPSE net product rose 18.1% to $98.9 million on volume growth, and its U.S. royalty rate dropped to 6% from a prior maximum of 18.5%, cutting cost of sales to $14.5 million from $17.9 million.
AGAMREE net product rose 66.6% to $36.7 million in its second full year on the market for Duchenne muscular dystrophy.
Section summaries
Management's Discussion and Analysis
Q1 FY2026 revenue rose 5.6% to $149.4M driven by FIRDAPSE and AGAMREE volume growth, while FYCOMPA fell 61% on generic entry.
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Total net product grew 5.6% to $149.3M, with FIRDAPSE up 18.1% to $98.9M and AGAMREE up 66.6% to $36.7M, offsetting a 61.3% decline in FYCOMPA to $13.8M due to .
widened 3.0 points to 90.3%, driven by the lower FIRDAPSE royalty obligation.
was $59.6 million, reduced by a $12.5 million AGAMREE sales milestone payment; the company also spent $14.6 million on share repurchases.
Cash and equivalents reached $755.9 million with no debt, while the pending Angelini Pharma merger introduces a $155.5 million termination fee and operational restrictions.
What changed
FYCOMPA's decline accelerated sharply: fell 61.3% in Q1 2026 versus a 25.8% decline in Q3 2025, as the oral suspension patent expired in December 2025, removing the last exclusivity.
The FIRDAPSE royalty rate dropped to 6% on January 26, 2026, a change flagged in the FY 2025 annual report, and it immediately reduced cost of sales by $3.4 million .
The against the last remaining FIRDAPSE generic challenger, Hetero, was flagged for a March 2026 trial; the filing now anticipates a Q2 2026 litigation avoidance payment, suggesting a settlement.
The company began deploying cash for share repurchases, spending $14.6 million in the quarter under the $200 million authorization announced in Q3 FY2025, while the cash balance continued to grow to $755.9 million.
What to watch
The magnitude of FYCOMPA's further decline in Q2 2026, now that both patents have expired and the company has ceased active marketing.
The terms and financial impact of the anticipated Hetero litigation avoidance payment in Q2 2026, which would resolve the last FIRDAPSE generic challenge.
Whether AGAMREE's sequential growth continues in Q2 2026 and whether the transition to U.S.-based manufacturing by end of 2026 affects supply or costs.
The outcome of the Angelini Pharma merger vote and whether any stockholder lawsuits delay or block the transaction, given the $155.5 million termination fee.
Cost of sales decreased to $14.5M from $17.9M, primarily due to lower FIRDAPSE royalty obligations after the 7-year U.S. commercial sale anniversary reduced the overall royalty rate to 6% from a prior maximum of 18.5%.
Selling, general and administrative expenses rose 5.1% to $49.3M, driven by higher consulting fees for business development, while research and development expenses fell 31.5% to $2.7M.
increased to $63.7M ($0.50 ) from $56.7M, supported by higher product , lower cost of sales, and a $4.8M gain on the Santhera equity investment.
Cash and equivalents stood at $755.9M at quarter-end; of $59.6M was reduced by a $12.5M AGAMREE sales milestone payment, and $14.6M was used for share repurchases.
The company expects FYCOMPA to keep declining, anticipates a Q2 2026 litigation avoidance payment for the Hetero settlement, and is transitioning AGAMREE manufacturing to a U.S. location by end of 2026.
Quantitative and Qualitative Disclosures About Market Risk
Market risk represents the risk of changes in the value of market risk-sensitive instruments caused by fluctuations in interest rates, foreign exchange rates and commodity prices. Changes in these factors could cause fluctuations in our results of operations and cash flows. Our…
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Market risk represents the risk of changes in the value of market risk-sensitive instruments caused by fluctuations in interest rates, foreign exchange rates and commodity prices. Changes in these factors could cause fluctuations in our results of operations and cash flows.
Our exposure to interest rate risk is currently confined to our cash and cash equivalents that are from time to time invested in highly liquid money market funds and U.S. Treasuries. The primary objective of our investment activities is to preserve our capital to fund acquisitions and operations. We also seek to maximize income from our investments without assuming significant risk. We do not use derivative financial instruments in our investment portfolio. Our cash and investments policy emphasizes liquidity and preservation of principal over other portfolio considerations.
Other Litigation From time to time we may become involved in legal proceedings arising in the ordinary course of business. Other than as set forth above, we believe that there is no litigation pending at this time that could have, individually or in the aggregate, a material adv…
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Other Litigation
From time to time we may become involved in legal proceedings arising in the ordinary course of business. Other than as set forth above, we believe that there is no litigation pending at this time that could have, individually or in the aggregate, a material adverse effect on our results of operations, financial condition or cash flows.
Tariffs, MFN pricing, and merger-related risks dominate Q1 FY2026 disclosures, with new emphasis on U.S. trade policy and the Angelini Pharma deal.
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A U.S. Department of Commerce probe into pharmaceutical imports under could lead to tariffs, raising costs for and finished drugs sourced from foreign suppliers like Santhera and Eisai.
The Trump Administration's push for in Medicaid, Medicare, and commercial markets may pressure drug prices, though Catalyst has not been invited to negotiate relief.
Failure to close the Angelini Pharma merger could trigger a $155.5 million termination fee, operational restrictions, and stock price declines due to uncertainty.
Merger-related restrictions limit Catalyst's ability to pursue acquisitions, access capital markets, or take other business actions without Angelini's consent.
Stockholder lawsuits challenging the merger may delay or prevent its completion and divert management attention.