Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) Q3 2019 Earnings Conference Call Transcript

Oct 31, 2019 • 08:00 am ET

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Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) Q3 2019 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good morning and welcome to Agios' Third Quarter 2019 Conference Call.

[Operator Instructions]

I'd now like to turn the call over to Kendra Adams, Vice President, External Communication and Investor Relations.

Executive
Kendra Adams

Thank you Kevin. Good morning, everyone and welcome to Agios' third quarter 2019 conference call. You can access slides for today's call by going to the Investors section of our website, agios.com.

With me on the call today with prepared remarks are Dr. Jackie Fouse, our Chief Executive Officer. Dr. Chris Bowden, our Chief Medical Office. Darrin Miles, our Senior Vice President of US Commercial and Global Marketing and Andrew Hirsch, our Chief Financial Officer and Head of Corporate Development. Dr. Scott Biller, our Chief Scientific Officer, will also be available for Q&A.

Before we get started, I'd like to remind everyone that some of the statements we make on this call, will include forward-looking statements. Actual results could differ materially from those expressed or implied by any forward-looking statements, as a result of various risks, uncertainties and other factors, including those set forth in the Risk Factors section of our most recent Form 10-Q, filed with the SEC and any other filings that we may make with the SEC.

With that I'll turn the call over to Jackie.

Executive
Jacqualyn Fouse

Thanks Kendra. Good morning everyone and thanks for joining us on our third quarter 2019 results call. Q3 was an exciting one for us, as we achieved several of the ambitious goals we set for 2019 across our research, clinical and commercial activities. As Chris will describe in detail, we achieved several clinical milestones within our oncology portfolio that sets the foundation for multiple opportunities.

In September, at ESMO we shared the first full data from our positive Phase III ClarIDHy study of TIBSOVO and previously treated IDH1 mutant cholangiocarcinoma. We believe TIBSOVO has the potential to be the first targeted therapy for these patients and our team is now focused on preparing that supplemental NDA.

During the quarter, we've obtained guidance from the FDA and EMA on the endpoints for our Phase III trial of vorasidenib in low-grade IDH mutant glioma. We are now preparing for trial initiation. And earlier this week at the triple meeting, we presented data from the dose escalation portion of our Phase I study of AG-270 in a variety of MTAP-deleted tumors. The trial has advanced the dose expansion and patients are now enrolling in two combination arms evaluating AG-270 plus standard of care in non-small-cell lung and pancreatic cancers.

Within our rare genetic disease portfolio, we published updated data in the New England Journal of Medicine from the Phase II drive PK study of mitapivat in PK deficiency. These data represents the first publication of clinical data in adults with PK deficiency and demonstrate the clinical benefit of mitapivat in this chronic anemia. On the commercial side TIBSIVO US revenue grew by 27%, during the third quarter and Darrin will get into more commercial detail later in the call.

Outside the US our team