Spectrum Pharmaceuticals, Inc. (SPPI) Q1 2022 Results Conference Call May 12, 2022 4:30 PM ET

Company Participants

Michael Grabow - Senior Vice President of Corporate Strategy and Operations

Thomas Riga - President and CEO

Francois Lebel - Chief Medical Officer

Conference Call Participants

Maury Raycroft - Jefferies

Edward White - H.C. Wainwright

Mayank Mamtani - B. Riley Securities

Operator

Thank you for standing by. And welcome to the Spectrum Pharmaceuticals First Quarter 2022 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions]

I would now like to hand the conference over to Mr. Michael Grabow, Senior Vice President of Corporate Strategy and Operations. Please go ahead.

Michael Grabow

Thank you, operator. Good afternoon to everyone. Thank you for joining us today for Spectrum Pharmaceuticals first quarter 2022 financial results conference call. Our first quarter financial results press release was sent out earlier this afternoon and is available on our website at www.sppirx.com.

Joining me on the call today from Spectrum Pharmaceuticals will be Tom Riga, President and CEO; and Dr. Francois Lebel, Chief Medical Officer.

Before we get started, I would like to reference the notice regarding Forward-Looking Statements included in today’s press release. This notice emphasizes the major uncertainties and risks inherent in the forward-looking statements that we will make this afternoon. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.

With that, let me hand the call over to Tom Riga, CEO of Spectrum.

Thomas Riga

Good afternoon and thank you for joining us on the call today. The year is off to a strong start as we anticipate FDA approvals later this year for our late stage assets Poziotinib and eflapegrastim, both are under active review with the agency.

In the first quarter, we continued to make progress on our core business objectives, which are one, gaining FDA approvals and further advancing our two late stage assets. Two, streamlining our company and optimizing our cash burn and three, ensuring we are prepared to successfully launch both products.

Let me provide some highlights starting with Poziotinib. Our NDA is under active review, and the agency has set a PDUFA date of November 24, 2022. With the initial indication for the treatment of patients with previously treated locally advanced or metastatic, non-small cell lung cancer harboring HER2 exon 20 insertion mutations. This product is a fast track designation, and there are currently no approved treatments for this indication.