Catalyst Pharmaceuticals Achieves U.S. Commercial Rights to FYCOMPA (Perampanel) CIII From Eisai Co.Ltd.

The company remains committed to growth within neurology through active business development into synergistic adjacencies.

FREMONT, CA: “This agreement broadens our commercial portfolio and provides an option to add a late-stage rare neurology asset that would further build upon our core competencies with differentiated medicines that treat rare neurological and epileptic disorders,” says Patrick J. McEnany, Chairman and CEO of Catalyst. Catalyst Pharmaceuticals, a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, has entered into a definitive agreement with Eisai Co., Ltd. (Eisai) whereby Catalyst will acquire the U.S. rights for FYCOMPA® (perampanel) CIII and an exclusive option period to review, evaluate, and negotiate to acquire a rare The acquisition adds a highly complementary and well-established neurology product to Catalyst's commercial product portfolio, diversifies Catalyst's commercial product portfolio, and sets the road for additional development into other rare neurological illnesses with unmet medical needs.

"Over the course of this year, our team has followed a focused and diligent process in pursuit of value-added transaction opportunities, and we are pleased to have delivered on this objective which we believe serves as a strategic catalyst for sustained future growth to our current strong revenues from FIRDAPSE®. Our portfolio expansion efforts and business development pipeline of prospects continue to remain robust, with several additional opportunities under active due diligence that offer the potential to further implement our near and long-term growth strategy. We look forward to working closely with the Eisai FYCOMPA U.S. leadership to ensure a smooth and orderly transition of certain employees to the Catalyst team," adds McEnany.

According to information provided to Catalyst, Eisai's U.S. FYCOMPA net revenues for the 2022 fiscal year ending on March 31, 2023, will be about $136 million. Catalyst expects the purchase to accrue to its 2023 earnings before interest, taxes, depreciation, amortization (EBITDA), and earnings per share (EPS) upon closure.

The acquisition of FYCOMPA® is anticipated to afford Catalyst the following:

A broader commercial product portfolio that includes the first and only non-competitive AMPA receptor antagonist that has been approved for the treatment of epilepsy.

FIRDAPSE® has an expanding revenue base and a synergistic asset, contributing to the company's already robust revenue growth.

A well-marketed product that increases Catalyst's neurology reach by adding a dedicated epilepsy sales force with a complimentary call point.

The company can analyze and potentially acquire a rare epilepsy asset that could facilitate its expansion into uncommon neurological and epilepsy diseases.

FYCOMPA's outstanding performance in neurology provides the opportunity to boost the company's development potential.

Catalyst anticipates purchasing FYCOMPA would accelerate revenue growth and contribute to EBITDA and earnings per share in 2023. After concluding this acquisition in the early first quarter of the following year, we will be able to provide complete revenue projections for 2023.

Patent protection for FYCOMPA is anticipated to last until at least May 23, 2025, with likely protection beyond 2026.

In accordance with the terms of the agreement, Eisai will receive an upfront payment of $160 Million in connection with this transaction. Furthermore, Eisai may be eligible to collect future milestone payments and royalties. Eisai has awarded catalyst an exclusive option period to analyze and negotiate the acquisition of a rare epilepsy drug in Eisai's pipeline.

The purchase is designed as a cash-only transaction with no financing contingencies. The deal is anticipated to close in the first quarter of 2023, subject to usual closing conditions and regulatory approvals in the United States, and has no impact on Catalyst's previously disclosed full-year 2022 FIRDAPSE revenue projection. As part of the acquisition transaction, Catalyst and Eisai will collaborate closely to ensure a smooth transition of certain key members of the FYCOMPA U.S. business unit to Catalyst. To this end, the companies have negotiated a rigorous, short-term Transition Services Agreement and a longer-term Supply Agreement.