Stemline Therapeutics, Inc. (NASDAQ:STML) Q3 2019 Earnings Conference Call - Final Transcript

Nov 08, 2019 • 08:00 am ET


Stemline Therapeutics, Inc. (NASDAQ:STML) Q3 2019 Earnings Conference Call - Final Transcript


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Good day and welcome to the Stemline Earnings Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Ken Hoberman. Please go ahead, sir.

Ken Hoberman

Good morning and welcome to today's conference call to discuss our third quarter 2019 financial results. With me on today's call are members of Stemline's executive management team, including Ivan Bergstein, our Chief Executive Officer; David Gionco, our Chief Accounting Officer; and Robert Francomano, our Senior Vice President, Global Head of Commercial.

After our prepared remarks, we will open the call to take any questions. As a reminder, we may be making forward-looking statements. Our forward-looking statements are subject to a number of risks and uncertainties, that could cause our actual results to differ materially from our forecasts. A detailed description of these risks can be found in the forward-looking statements in risk factors section of our Annual Report on Form 10-K for the year ended December 31, 2018 and in our quarterly report on Form 10-Q for the quarter ended September 30, 2019.

With that, I will now turn over the call to Ivan Bergstein, our CEO. Ivan, the floor is yours.

Ivan Bergstein

Thank you, Ken, and good morning everyone. We remain very pleased with the pace of the ELZONRIS launch, and in particular, the uptake of new patient starts we are seeing across the country. Additionally, and importantly, we believe there were two factors this quarter, which when adjusted for lead to a notably higher net revenue sale increase quarter-over-quarter, meaningfully narrowing the gap between the net revenue and new patient starts. And I will let Robert Francomano provide more detail on that in a minute.

In parallel, we've made substantial progress to expand ELZONRIS' potential utility and indications within and beyond BPDCN as well as advancing our overall pipeline. For now, I'd like to highlight the CMML opportunity, which we believe is our next indication. We are on track to open the third stage of our clinical trial in CMML in the next few months, which is intended ultimately to support registration. The rationale for ELZONRIS in CMML is clear. We have presented encouraging clinical data in Stages I and II the trial at ASCO and EHA this year. The mechanistic rationale of targeting CD123 makes sense in CMML and there remains an unmet medical need, not only in relapsed refractory patients, but potentially also in certain first-line patients as well, opening the door to a focused and targeted development strategy in this aggressive difficult-to-treat malignancy. Later in the call, I will review our clinical efforts in more detail.

With that, I will now turn the call over to Robert Francomano, our Global Head our Commercial, who will provide further details on the launch. Robert?

Robert M. Francomano

Thank you, Ivan. In the third quarter, net sales of ELZONRIS reached a new high of $13.3 million, representing continued quarter-over-quarter growth. As we analyze the business and launch trajectory, and as Ivan already alluded to, we believe there were