Veru Inc. (NASDAQ:VERU) Q3 2020 Earnings Conference Call - Final Transcript

Aug 13, 2020 • 08:00 am ET


Veru Inc. (NASDAQ:VERU) Q3 2020 Earnings Conference Call - Final Transcript


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Good morning, ladies and gentlemen. Welcome to Veru's Inc. Investor Conference Call. [Operator Instructions] Please note that this event is being recorded.

I would now like to turn the conference over to Mr. Sam Fisch, Veru's Inc. Director of Investor Relations. Go ahead.

Samuel Fisch

Good morning. The statements made in this conference call that are not historical in nature are forward-looking statements. Such forward-looking statements reflect the Company's current assessment of the risks and uncertainties related to our businesses. Our actual results and future developments could differ materially from the results or developments in such forward-looking statements. Factors that may cause actual results or developments to differ materially include such things as the risks related to the development of the Company's product portfolio, risks related to the ability of the Company to obtain sufficient financing on acceptable terms when need to fund development and Company operations, risks related to competition, government contracting risks, and other risks detailed in the Company's press releases, shareholder communications, and Securities and Exchange Commission filings. For additional information regarding such risks, the Company urges you to view its 10-Q and 10-K SEC filings.

I'd now like to turn the conference over to Dr. Mitchell Steiner, Veru Inc.'s Chairman, CEO and President.

Mitchell Steiner

Thank you, Sam, and good morning. With me on this morning's call are Michele Greco, CFO and CAO; Phil Greenberg, Executive Vice President, Legal; and Sam Fisch, the Director of Investor Relations. Thank you for joining our call.

Veru is an oncology and urology biopharmaceutical Company with a focus on developing novel medicines for the management of prostate cancer.

Before I provide the update on the clinical development of our drug pipeline and the commercialization of our products, as well as provide financial highlights for the third quarter fiscal year 2020, it is important to reflect on the great progress we have made transforming our Company into an oncology biopharmaceutical Company that is supported in part by a growing revenue cash generating sexual health business. Not only are we planning for 2021 two Phase 3 registration trials, one for VERU-111, our novel oral tubulin targeting agent to treat metastatic castrate-resistant prostate cancer, and the other for VERU-100, our three-month GnRH antagonist long-acting depot to treat hormone-sensitive advanced prostate cancer, but also we expect to continue to grow our base sexual health business. In fact, we have had 10 quarters of continued significant growth FC2 and PREBOOST known by the brand name Roman Swipes, and we plan to submit an NDA for TADFIN, the combination of Tadalafil and Finasteride for BPH late this year to continue the prospects for even more revenue. The model is working, the transformation is near complete.

Now, let's focus on the significant progress we have made on the advancement of our drug pipeline. VERU-111 is a novel oral first-in-class tubulin targeting agent that crosslinks and disrupts alpha and beta tubulin subunits of microtubules. VERU-111 is in its clinical development to treat metastatic castration and novel androgen receptor targeting agent, which is enzalutamide