Clovis Oncology, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Clovis Oncology Q2 2021 Operating Results Webcast Conference Call. At this time, all participant signs are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker, Anna Sussman, Vice President of Investor Relations. Thank you. Please go ahead.

Thank you, Phyllis. Good morning, everyone. Welcome to the Clovis Oncology Second Quarter 2021 Conference Call. Thanks for joining us. You've likely seen this morning's press release, and if not, it's available on our website at clovisoncology.com. As a reminder, this conference call is being recorded in webcast. Remarks may be accessed live on our website during the call and will be available in our archives 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 our FAP-2286 and targeted radionuclide therapy development programs. Dr. Lindsay Rolfe, our chief medical officer, Braca and FAP 2286. Then Daniel, our chief financial officer, will cover the quarter's results in greater detail. Patrick will make a few brief remarks, sorry, a brief review of corporate strategy and make a few closing remarks. And then we'll open the call for Q&A, during which time Pat, Dan, Tom, and Lindsay will be available for 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 these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statement. 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, extent, and recent filings with the SEC for a full review of the risks and uncertainties associated with our business. 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. Morning, everybody. Thanks for joining. Appreciate you taking the time. Look, while these are clearly complicated times, I'm encouraged that based on the data available to us, we have maintained our U.S. market share for Rubraka, and we have achieved meaningful growth in sales in Europe in the second-line maintenance ovarian cancer setting. Sales in Q2 2021 were $36.8 million, lower than both Q2 2020 and Q1 2021. This decline is primarily a result of the ongoing effects of the pandemic on oncology treatment and practice, and in particular, in ovarian cancer. While we fully expect this to reverse when the pandemic finally abates, and as reported by other oncology-focused companies, it has clearly had an impact on new patient diagnoses and new patient starts. We anticipate that when patient visits begin to rise, as diagnoses increase, and the urgent need to more actively manage this often fatal disease grows, the maintenance treatment of ovarian cancer patients will increase, including the use of Rubraka for women with advanced disease. We are encouraged, however, that we've successfully maintained enrollment in our clinical studies, and accordingly, we've made significant progress in our clinical trial program for Rubraka. Importantly, we are ever closer to not one but three Phase III readouts for Rubraka in the next 6 to 18 months. We anticipate basary readouts from our Athena monotherapy, Triton3, and Athena combination studies of Rubraka, all of which will occur in 2022. As a reminder, Athena is evaluating Rubraka in the first-line ovarian cancer maintenance treatment setting, first as monotherapy versus placebo, and later in a separate analysis in combination with Odevo versus Rubraka monotherapy. Triton3 is evaluating Rubraka versus physician's choice of chemotherapy or second-line androgen deprivation therapy, in patients with metastatic castration-resistant prostate cancer with BRCA and APM mutations. These offer the potential to address larger patient populations in earlier lines of therapy for both ovarian and prostate cancer, which we anticipate will drive growth in the BRCA sales in both the U.S. and Europe. Lindsay will shortly provide an update on these clinical programs. We have great enthusiasm for the early stage pipeline opportunity that targeted radiotherapeutic development offers, and we continue to advance our targeted radionuclide therapy pipeline as we seek to establish ourselves as a leader in this emerging field of oncology development. FAP2286 is the first peptide targeted radionuclide therapeutic targeting FAP to enter clinical development, and the next 18 months will be potentially transformational for this program. Tom and Lindsay will speak in more detail into developments about this program. And lastly, I'm pleased to announce that during the quarter, we raised $72.5 million in net proceeds through our at-the-market or ATM equity offering program. As of June 30th, we have $230.2 million in cash and cash equivalents and $48.1 million in available funding under the Athena financing. And Dan will speak to this in greater detail shortly. Before I turn the call over to Tom, I'd like to take a moment to welcome Dr. Romit Simantov as the newest addition to our Board of Directors. Romit is currently Chief Medical Officer at Danita Cell and has served in senior leadership roles at Pfizer, OSI, Curagen, and Bayer. We believe her experience and expertise in oncology clinical development and research will be invaluable to us as we advance our development pipeline. We're very pleased to welcome her to the Clovis Board. Now I'll turn the call over to Dr. Thomas Harding, our Chief Scientific Officer, to discuss the FAP2286 and targeted radionuclide therapeutic development programs.