Global Blood Therapeutics, Inc.

Greetings and welcome to the Global Blood Therapeutics conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the prepared remarks. Should anyone require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the call over to Stephen Immergut. Please go ahead.

Thank you, and welcome to GBT's conference call to discuss the company's financial results for the third quarter 2021 and to provide a business update. I'm Stephen Emmergat, Head of Communications and Investor Relations. With me today on the call are Dr. Ted Love, our President and CEO, Jeff Farrow, Chief Financial Officer, David Johnson, or DJ, Chief Commercial Officer, and Dr. Kim Smith-Whitley, Executive Vice President and Head of Arts. During today's call, Ted will provide an update on our progress in the third quarter. Jeff will review our financial results. DJ will give an update on the Oxbrite launch. Kim will discuss our pipeline. And then Ted will give a few closing remarks before opening up the call for questions. Earlier this afternoon, we issued a press release announcing GBT's business progress and financial results for the third quarter ended September 30, 2021. This morning, we issued a press release announcing six data presentations at the upcoming ASH annual meeting in December. We will also hold an R&D event for investors and analysts on November 11th. Before we begin, I would like to remind you that certain statements we make on this call that are not historical facts may be forward-looking statements that are subject to risks and uncertainties. Information concerning factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements are contained in our SEC filings, including but not limited to our most recent quarterly report on Form 10-Q, as well as in today's press release. Copies of our SEC filings and press releases can be obtained from the Investors page of our company website at GBT.com. The forward-looking statements made on this call are only as of the time they are made, and you should not place undue reliance on such statements. Future events or simply the passage of time may cause our beliefs to change, We disclaim any obligation to update any forward-looking statements other than that as required by law. With that, I'll turn the call over to Ted.

Thank you, Stephen, and good afternoon, everyone. GBT continues to make solid progress on our mission to transform the care of sickle cell disease and improve the lives of patients around the world. We are well-positioned for long-term success, both with Oxprida, which has several upcoming catalyst for potential growth in our robust pipeline, which we believe can help further improve clinical care and SED and expand the market. Turning to the quarter, we delivered approximately 850 new prescriptions in Q3, a decrease compared to the second quarter. This reflects headwinds from the spike in new COVID-19 cases in the U.S. in August and September, which were at their highest levels since early January. In many states, as widely reported in the news, ICU capacity was strained. Many sickle cell healthcare providers were diverted to address this urgent need. Sadly, in early October, COVID deaths in 2021 surpassed the number of deaths in 2020. despite the availability of vaccines this year. While the surges in the pandemic infection rates, especially in areas where many sickle cell patients live, did not subside in Q3, we remain very optimistic for the future, given the tremendous unmet need in this disease. We also continue to refine and expand our commercial efforts to drive Oxprata awareness education, and access. Oxpride's strong fundamental and long-term potential give us confidence heading into 2022. Let's consider the following. The net number of patients taking Oxpride continues to increase each quarter, which contributed to us delivering on our third quarter revenue expectations. The growing body of real-world evidence including new data covering nearly 2,700 patients that will be presented at ASH, validates the role of Oxprida as potential foundational therapy for sickle cell disease. Our market research demonstrates high levels of satisfaction among prescribers and patients who have tried Oxprida. We also have received positive feedback and results from our educational and marketing programs, including our groundbreaking direct-to-consumer advertising campaign. And we have near-term opportunities to significantly expand the number of patients eligible for Oxprida. Importantly, we have an FDA action date of December 25th on our approval application to expand Oxprida label to include patients as young as four years old, along with a new pediatric formulation. In Europe, the market authorization application is on track for potential approval in the first half of 2022. We are in position to further build on these positive fundamentals and near-term catalysts as the pandemic subsides and healthcare visits return to normal. We believe these factors will gradually contribute to new prescription growth in 2022, with potentially more robust growth in the second half of the year. In addition, we believe this timing will coincide with achieving broad payer coverage for children ages 4 to 11, which will help fuel our growth. We are also advancing our pipeline and will have exciting updates at ASHE. For Nclacomab, we will have new phase one data to present that we believe supports the best in class potential. For GBT601, we will present the first data from our phase one study in both healthy volunteers and sickle cell patients. We believe these 601 data will be positioned to provide proof of concept for this program and start to fulfill the tremendous potential we see for GBT-601 to provide a functional cure and appeal for sickle cell disease. All of this activity demonstrates GBT's commitment to this community. And in September, we launched the GBT Foundation, a nonprofit charitable organization that will fund programs that support the sickle cell disease community and beyond through education, empowerment, access, and health equity. Also in September, GBT co-hosted the 10th Annual Sickle Cell Disease Therapeutics Conference, which brings together community leaders to discuss the latest advances and future trends in SED. Importantly, there were several sessions on COVID-19 vaccines, including education on how they work and people sharing their experiences getting the vaccine. This is a critical part of our work, and we will continue to support the sickle cell community. With that, I will turn the call over to Jeff to review our third quarter results.