Global Blood Therapeutics, Inc.

Greetings, and welcome to the Global Blood Therapeutics' fourth quarter and full year 2021 conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the prepared remarks. If anyone should 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 fourth quarter and full year of 2021, and to provide a business update. I'm Stephen Emmergut, 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 R&D. During today's call, Ted will give an update on our progress in Q4 and the full year. Jeff will review our financial results. DJ will give an update on the Ospreyda launch. Kim will discuss our pipeline. And then Ted will give a few closing remarks before we open the line for questions. Earlier this afternoon, we issued a press release announcing GBT's financial results and business progress for the fourth quarter and full year ended December 31st, 2021. 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 annual report on Form 10-K, as well as in today's press release. Copies of our SEC filings and press releases can be obtained from the investors page for our company website at gvt.com. The forward-looking statements made on this call are only as of the time they are made and should not place undue reliance on such statements. Future events or simply the passage of time may cause our beliefs to change, and we disclaim any obligation to update any forward-looking statements other than as required by law. I'll now turn the call over to Ted.

Thank you, Stephen, and good afternoon, everyone. 2021 was a year of significant advancement and growth for GPT as we made progress on our goal to transform the lives of patients with sickle cell disease. More healthcare providers and patients are aware of OxyPrida and using it to address the root cause of this terrible disease. And in December, our broad label got even broader. It now covers patients as young as four years old. Outside the U.S., we advanced our regulatory efforts and launch preparations in Europe while gaining valuable experience through our early access program. And we are very pleased with the progress on our robust late-stage pipeline. Going forward, our focus is on driving Ocfrida adoption, advancing our pipeline, and supporting the patient community. The fundamentals of OxFighter are strong. Every quarter since launch, we have grown the net number of patients on therapy. Physician and patient feedback continues to be very positive, and we continue to have broad payer coverage. Our key initiatives to increase adoption include executing on our pediatric launch, continuing to invest in our DTC campaign, in developing more real-world evidence of clinical benefit. And in the European Union, we just received full marketing authorization for OXPREDAT, making it the first and only therapy approved to treat the hemolytic anemia of sickle cell disease. This is an exciting and long-awaited milestone for patients, physicians, the sickle cell community, and GBT. We will now work towards launching in Germany, beginning reimbursement discussions in France, and educating healthcare providers across Europe. In the UK, we have submitted for marketing authorization and anticipate a potential approval by mid-year. Importantly for the UK, OXPRATA was granted EAMS designation, which provides two key advantages. First, patients that meet the eligibility criteria can gain early pre-licensed access to Oxbrita. Second, medicines under EAMS that receive marketing authorization by the MHRA, as well as a positive assessment by NICE, benefit from accelerated NHS England commissioning. While we work through the process in the EU and UK, we are working to build momentum with early access programs with patients enrolled in France, the UK, and Germany, markets where the majority of sickle cell patients live. Our strategy continues to address sickle cell through various therapeutic approaches, and we believe our R&D program is the most comprehensive in the industry. We are focused on aggressively advancing the development of Enclaquimab and GBT-601, both of which remain on track. And our research team is exploring additional therapeutic targets in SCD and other red blood cell disorders. GBT's mission and commitment to underserved communities is stronger than ever. We've talked a lot about COVID-19, and its outside impact on the sickle cell disease patient community. In 2021, we established the GPT Foundation, which extends our corporate giving in areas of critical need and strategic importance. We have and will continue to expand our investment in the SCD community and overall health equity. We will continue to meet patients where they are to support their overall health and well-being. We expect that our initiatives will gradually contribute to new prescription rules over 2022. We are also hopeful that the COVID-19 environment will improve. We've recently seen encouraging trends in new prescriptions as cases began to drop. We are hopeful that these trends will continue And our team is working extremely hard on all the factors that are within our control. Longer term, we remain optimistic for the future, given the tremendous unmet need in this disease and the compelling clinical data on Oxypride and our pipeline. With that, I will turn the call over to Jeff to review our fourth quarter and 2021 results.