Clovis Oncology, Inc.

Good morning. My name is Chris, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Clovis Oncology fourth quarter and year-end 2021 operating results. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you'd like to ask a question during this time, simply press star, then the number 1 on your telephone keypad. To withdraw your question, please press star 1 again. Thank you. Anna Sussman, Vice President of Investor Relations and Corporate Communications. You may begin.

Thank you, Chris. Good morning, everyone, and welcome to the Clovis Oncology fourth quarter and full year 2021 conference call. Thank you for joining us. You've likely seen this morning's news release, and if not, it's available on our website. As a reminder, this conference call is being recorded and webcast. Remarks may be accessed live on our website during the call and will be available in our archive for the next several weeks. Today's agenda includes the following. Patrick Mahaffey, our president and CEO, will discuss the highlights of today's corporate update. And then Dr. Thomas Harding, our chief scientific officer, will present an update on the 2286 and targeted radionuclide therapy development programs. Dr. Lindsay Rawls, our chief medical officer, will discuss the anticipated upcoming clinical milestones for BRUBRACA and FAP2286. Then Dan Muehl, our chief financial officer, We'll cover the financial results for the quarter and year in greater detail. Patrick will then make a few closing remarks, and then we will open the call for Q&A, during which time Pat, Dan, Tom, and Lindsay will be available to answer questions. Before we begin, please note that during today's conference call, we may make forward-looking statements within the meaning of the federal securities laws, including statements concerning our financial outlook and expected business plans. All of these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Our actual results could differ materially due to a number of factors, including the extent and duration of the effects of the COVID-19 pandemic and the timing and extent of recovery from it. Please refer to our recent filings at the SEC for a full review of the risks and uncertainties associated with our recent statements. Forward-looking statements speak only as of the date on which they are made, and Clovis undertakes no obligation to update or revise any forward-looking statements. Additionally, please note that we'll be discussing cash burn, a non-GAAP financial measure, during today's conference call. Required disclosures related to this are in today's news release, which can be found on our website. Now I'll turn the call over to Patrick Mahaffey.

Thanks, Anna. Excuse me. Good morning. Welcome, everybody. Appreciate your time today. As usual, I'll start today's call with a review of Rubracca sales for the quarter. Sales in Q4 2021 were $36 million, 5% lower than the prior quarter and 17% lower year-over-year compared to Q4 2020. As seen over the previous quarters, this year-over-year decline is primarily due to fewer diagnoses and fewer patient starts in the U.S. and Europe, primarily caused by the ongoing COVID-19 pandemic. Despite the continuing impact of COVID-19, we believe we have maintained our U.S. market share for Rubraka in the second-line maintenance ovarian cancer setting. We do expect that as patient visits begin to rise, diagnoses increase, and the urgent need to more actively manage this often fatal disease grow, maintenance treatment of ovarian cancer patients will increase, including the use of Rubraka for women with advanced disease. Perhaps even more importantly, we see a significant opportunity to move into earlier lines of therapy with Rubraka in both the U.S. and Europe. We anticipate three Phase III readouts this year. Athenomono as monotherapy in the first-line ovarian cancer maintenance treatment setting, now expected in Q2 based on a slower-than-expected pace of progression-free survival events, or PFS events, and Athenocombo in combination with Obdevo in the first-line ovarian cancer maintenance treatment setting in Q4, and TRITON-3 in the second-line prostate cancer treatment setting for selected patients in Q2. These trials potentially allow Rubraka to address larger patient populations in earlier lines of therapy for both ovarian and prostate cancer and could drive growth in Rubraka sales in both the U.S. and Europe. Lindsay will provide an update on these clinical programs. For FAP2286, the Phase I portion of Lumiere continues to enroll and we are committed to maintaining our lead in the clinical development of an FAP-targeted radionuclide therapeutic candidate. We and our investigators remain extremely enthusiastic about this program and look forward to presenting data at nuclear medicine meetings during 2022 and initiating the Phase II portion of the Lumiere study later this year. Tom and Lindsay will speak in more detail to developments about the FAP-2026 program. In fact, to that end, I'll turn the call over to Tom, our Chief, Thomas Harding. Sorry, Tom. our Chief Scientific Officer, to discuss the FAP2286 and targeted radionuclide therapeutic development programs.