Clovis Oncology, Inc.

Thank you for standing by, and welcome to the Clovis Oncology Quarter 1 Conference Call. At this time, all participants are in a 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 0. I would now like to hand the conference over to your speaker today, Ms. Anna Sussman. Please go ahead.

Thank you, Polly. Good morning, everyone. Welcome to the Clovis Oncology First Quarter 2021 Conference Call. Thank you for joining us. You've likely seen this morning's news release. If not, it's available on our website at ClovisOncology.com. 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 review the highlights of today's corporate update and Rubreca commercial progress. Then Dr. Thomas Harding, our chief scientific officer, will review the FAP2286 program and targeted radionuclide therapy development program. Dr. Lindsay Rolf, our chief medical officer, will discuss the anticipated clinical milestones for both Rubreca and lucitinib during 2021. And then Daniel, our Chief Financial Officer, will cover the quarter's financial results in greater detail. Pat will 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 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 the COVID-19 pandemic. Please refer to our recent filing to the SEC for a full review of the risks and uncertainties associated with our business. Forward-looking statements speak only as 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. Recorded disclosures related to this are in today's news release, which can be found on our website. Now I'd like to turn the call over to Patrick Mahaffey.

Thanks, Anna. Good morning. Welcome, everybody. Appreciate you taking the time today. While the continuing headwinds from COVID-19 impacted rubrica sales in the U.S. and in Europe this quarter, we believe the effect of the pandemic on patient diagnoses is Patient visits and access to oncology practices, which began in late March last year, will lessen over the course of 2021. Sales in Q1 2021 were $38.1 million, which were lower than both Q1 2020, our last pre-pandemic quarter and our best U.S. sales quarter ever, and also lower than Q4 2020. It is extremely important to note that the sequential decline that we experienced in Q1 2021 in the U.S. is consistent with the minimal growth or decline for other approved PARP inhibitors indicated for ovarian cancer in the U.S., which is a result or appears to be a result of the ongoing impact of COVID-19. We are hoping that Q2 2021 represents the beginning of a return to a more normal post-pandemic environment. While it is encouraging that office visits at the end of 2020 had returned to pre-pandemic levels, Office visits are only a leading indicator. The number of ovarian cancer diagnoses and debulking surgeries declined 15% or more during the fall and winter. The reduced number of ovarian cancer debulking surgeries and reduced administration of platinum-based chemotherapy had a continuing impact on the maintenance use of PARP inhibitors broadly, and as a consequence, rubraca specifically. We do anticipate that as 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 Rebecca for women with advanced disease. In terms of advancing our pipeline, I'm extremely pleased to announce that we achieved an important milestone in our commitment to target radionuclide therapies with the FDA clearance of our INDs for FAP2286 for treatment and imaging, which enables us to open for enrollment the Lumiere Phase I-II trial this quarter. In addition, we anticipate announcing top-line Athena data for the rubracomonotherapy versus placebo arms in the first-line ovarian cancer maintenance treatment setting in the second half of this year. Interim efficacy data from the non-clear cell ovarian cancer Phase II court of the leolucitinib and Odevo combination will be presented in a poster at ASCO in June. And while evidence of clinical activity has been observed, We do not believe that the efficacy data support further development in non-clear cell ovarian cancer. Enrollment continues in the other three expansion cohorts in gynecological cancers, and we plan to provide an update on the endometrial cohort later this year at a medical meeting. Let me turn now to a rubrica commercial update. Our global net revenue for the first quarter of 2021 was $38.1 million, down 11% over the comparable prior year period. Dan will describe these results in greater detail. As we've discussed previously, an additional effect of COVID-19 is the substantial acceleration of what was already a trend toward reduced in-person access to academic and community-based clinics by sales reps. We believe this reduced access to oncology practices will continue, even once the pandemic is ultimately under control, as practices increasingly prefer digital programming and communication that can be accessed on their own time. We believe the commercial strategy we introduced last fall will enable us to meet these preferences as the effects of COVID-19 lessen over time. This strategy embraces a hybrid approach that elevates easily accessible digital programming, virtual communication, and peer-to-peer interactions. In-person promotion is reduced, and those remaining in-person activities are much more targeted. We remain energized about our strategy and believe that we are an early adopter of a trend that will be increasingly common for oncology marketers. In fact, several companies across the industry have announced similar changes in recent months. We adopted this hybrid strategy to better reach physicians the way they want to be reached, utilizing resources customized to their practices with the goal of accelerating growth as the ongoing impact of the virus resolves over time. Despite our lower sales in Q1 compared to Q4, we believe we maintained our U.S. market share given that our competitors also appeared to experience COVID-related impact on U.S. sales. While this is not yet proof of the potential for our hybrid commercial model, we maintained our share in a difficult environment with the hybrid model and with the 30% reduction in SG&A compared to Q1 2020. Not all of this reduction was specific to selling costs, but we clearly believe we have found a more cost-effective commercial model to address our position customers in the U.S. Obviously, as we come out of COVID-19, we hope our model will also accelerate growth. With regard to the U.S. prostate indication, while still a modest contributor to U.S. revenues, sales over BRCA in the prostate indication were consistent with our sales in Q4 2020. Turning to Europe, we're very pleased with our progress to date, despite the COVID-19 lockdowns that remain in place in most countries. Sales over BRCA were up significantly compared to the first quarter of 2020. As in the U.S., we believe that a more normal oncology practice will reemerge as Europe reopens. We have a smaller commercial organization in Europe and have been utilizing virtual communication in each of our primary territories as regulations allow. While national regulations vary among European countries and as compared to the U.S., we are tailoring a hybrid digital strategy for each country to better reach our clinician prescribers. As we explained previously, December 19, 2020, was the earliest date that an ANDA could have been filed for rubrica. Since that time, generic entities have been permitted to file an ANDA for Rubratka with a paragraph 4 certification, asserting that one or more patents listed in the Orange Book for Rubratka are either not infringed, invalid, or not enforceable. We have not received any paragraph 4 certification notice letters, and to our knowledge, no ANDA filings for Rucaparib have been made to date. Because Rucaparib Camsulate is considered a cytotoxic drug, The published FDA guidance requires any party seeking approval for a generic form of rucaparib to file a bio-IND and recommend showing bioequivalence in, I'm quoting here, female patients with a deleterious BRCA mutation associated with advanced cancer who have been treated with two or more chemotherapies and are receiving a regimen of rucaparib camphlate. The guidance sets forth additional criteria, including the demonstration of bioequivalence to a 90% confidence interval. Demonstrating bioequivalence with Rubraca would only be an initial step in the ANDA approval process. In a potential ANDA litigation, a generic challenger would also need to successfully challenge or design around Orange Book-listed patents, some of which do not expire until 2035. Now, let me turn the call over to Dr. Thomas Harding, our Chief Scientific Officer, to briefly discuss the FAP-2286 and targeted nucleotide therapeutic programs topics of growing interest as we are now moving into clinical development with FAP2286. Tom? Thanks, Pat.