MEI Pharma, Inc. (NASDAQ:MEIP) Q4 2020 Earnings Conference Call - Final Transcript

Sep 09, 2020 • 05:00 pm ET

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MEI Pharma, Inc. (NASDAQ:MEIP) Q4 2020 Earnings Conference Call - Final Transcript

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Executive
Brian Drazba

pro forma with about $203 million in cash and short-term investments. We recognized revenues of $28.9 million for the year ended June 30, 2020, compared to $4.9 million for the year ended June 30, 2019.

Revenues resulted from the recognition of license revenue associated with the Kyowa Kirin license agreement, as well as fees allocated to research and development activities related to the Kyowa Kirin and Helsinn license agreements. The adjusted net loss for the fiscal year ended June 30, 2020, excluding non-cash expenses related to changes in the fair value of the warrants issued in connection with our May 2008 financing, a non-GAAP measure, was $23.1 million.

Net loss was $46 million, or $0.51 per share for the fiscal year ended June 30, 2020, compared to net loss of $16.8 million or $0.24 per share for 2019. The Company has 111,513,689 shares -- of common shares outstanding as of June 30, compared with 73,545,000 shares as of June 30, 2019.

In summary, we started fiscal year 2021 in a strong position to continue advancing our programs and general business efforts.

With that, I'll turn the call over to Dan.

Executive
Dan Gold

Thanks, Brian, and thanks to everyone for joining us this afternoon. This past year was marked by progress on multiple fronts, but particularly for ME-401, our lead drug candidate. As you may know, ME-401, our PI3-Kinase Delta inhibitor is being developed to treat various B cell malignancies as both a monotherapy and in combination with other therapeutics. It is currently in the Phase 2 TIDAL study evaluating patients with relapsed or refractory follicular lymphoma that is intended to support an accelerated approval marketing application with the FDA.

Before reviewing our achievements in the MEI-401 program and providing some insights on what to expect in the coming quarters, today we are sharing the name issued to MEI-401 by the International Nonproprietary Names or INN Programs it's zandelisib, Z-A-N-D-E-L-I-S-I-B. Regarding our achievements this past year, perhaps chief among them is the global license development and commercialization agreement with Kyowa Kirin announced in April for the global development and commercialization of zandelisib.

We see our agreement with Kyowa Kirin as validation of the potential for zandelisib as a best-in-class PI3 delta inhibitor and key to broadly developing and commercializing it inside and outside the United States. The alliance stems from our successful pre-existing Japan licensing agreement with Kyowa Kirin, and is grounded in our shared vision for the development and potential of zandelisib as a new potential option for patients and their physicians to treat B-cell malignancies.

Briefly, as you may recall, the transaction is a global development and commercialization agreement. It included a $100 million upfront payment and up to $582.5 million in potential additional milestone payments. If approved by the FDA in the United States, MEI and Kyowa Kirin will co promotes zandelisib with MEI booking all revenue from sales. MEI and Kyowa Kirin will share U.S. profits and costs, including development costs on a 50-50 basis. Outside the U.S., Kyowa