U.S. markets open in 7 minutes
  • S&P Futures

    +5.75 (+0.15%)
  • Dow Futures

    +143.00 (+0.45%)
  • Nasdaq Futures

    -42.25 (-0.33%)
  • Russell 2000 Futures

    +18.70 (+0.85%)
  • Crude Oil

    -0.40 (-0.61%)
  • Gold

    -5.30 (-0.31%)
  • Silver

    +0.06 (+0.23%)

    -0.0047 (-0.39%)
  • 10-Yr Bond

    +0.0280 (+1.80%)
  • Vix

    -2.52 (-8.82%)

    +0.0015 (+0.11%)

    +0.3080 (+0.28%)

    +183.82 (+0.36%)
  • CMC Crypto 200

    +85.51 (+9.07%)
  • FTSE 100

    +15.76 (+0.24%)
  • Nikkei 225

    -121.07 (-0.42%)

Edited Transcript of CLVS.OQ earnings conference call or presentation 23-Feb-21 1:30pm GMT

·34 min read

Q4 2020 Clovis Oncology Inc Earnings Call Boulder Feb 23, 2021 (Thomson StreetEvents) -- Edited Transcript of Clovis Oncology Inc earnings conference call or presentation Tuesday, February 23, 2021 at 1:30:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Anna Sussman Clovis Oncology, Inc. - VP of IR * Daniel W. Muehl Clovis Oncology, Inc. - Executive VP & CFO * Lindsey Rolfe Clovis Oncology, Inc. - Executive VP of Clinical, Preclinical Development & Pharmacovigilance and Chief Medical Officer * Patrick J. Mahaffy Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director * Thomas Fuglsang Harding Clovis Oncology, Inc. - Chief Scientific Officer ================================================================================ Conference Call Participants ================================================================================ * Charles Ferranti * Cory William Kasimov JPMorgan Chase & Co, Research Division - Senior Biotechnology Analyst * Edward Patrick White H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst * Joseph Michael Catanzaro Piper Sandler & Co., Research Division - VP & Senior Biotech Analyst * Tazeen Ahmad BofA Securities, Research Division - VP ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Ladies and gentlemen, thank you for standing by, and welcome to the Clovis Oncology 2020 Operating Results Webcast Conference call. (Operator Instructions) I would now like to hand the conference over to Ms. Anna Sussman, VP of Investor Relations and Corporate Communications. Please go ahead. -------------------------------------------------------------------------------- Anna Sussman, Clovis Oncology, Inc. - VP of IR [2] -------------------------------------------------------------------------------- Thank you very much. Good morning, everyone, and welcome to the Clovis Oncology Fourth Quarter Fiscal Year 2020 Conference Call. Thank you for joining us. You've likely seen this morning's news release. If not, it is 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 Mahaffy, our President and CEO, will review the highlights of today's corporate update and Rubraca's commercial progress. Then Dr. Thomas Harding, our Chief Scientific Officer, will review the FAP-2286 program; Dr. Lindsey Rolfe, our Chief Medical Officer, will discuss the anticipated clinical milestones for both Rubraca and lucitanib during 2021. Then Dan Muehl, our Chief Financial Officer, will cover the quarter and year's financial results in more detail. Patrick will make a few closing remarks, and then we'll open the call for Q&A, during which time, Pat, Dan, Tom and Lindsey 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. Please refer to our 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 Mahaffy. -------------------------------------------------------------------------------- Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [3] -------------------------------------------------------------------------------- Thanks, Anna. Good morning, and welcome, everybody. I appreciate your time today. We are pleased with our overall sales performance in 2020, given the ongoing effects of COVID-19 on patient diagnoses, patient visits and access to oncology practices, which began around March last year. Even now, patient diagnoses were down approximately 15% in January this year compared to January 2020 based on data we've seen. We are not currently providing 2021 sales guidance as the ongoing effects and the timing of the recovery from COVID are difficult to predict. I am extremely pleased with the progress made in 2020 advancing our pipeline programs, which positions us for meaningful milestones in 2021, including initiating the clinical development program for FAP-2286 in the first half of this year, announcing top line ATHENA data for the Rubraca monotherapy versus placebo arm in the second half of this year and presenting initial efficacy data for the LIO-1 lucitanib and Opdivo combination at medical meetings later this year. Turning now to a Rubraca commercial update. Our global net revenue for the fourth quarter of 2020 was $43.3 million and for the fiscal year 2020, $164.5 million, up 10% and 15%, respectively, over the comparable prior year periods. Dan, of course, will describe these results in greater detail. Over the course of 2020, revenues were impacted by COVID-19 due to fewer diagnoses and fewer patient visits going to -- fewer patients going to in-person office visits as oncology practices and patients adapted to the impact of the virus. An additional effect of COVID-19 is that it has substantially accelerated what was already a trend toward reduced in-person access to academic and community-based clinics for sales reps. We believe this reduced access to oncology practices will continue, even once the pandemic is ultimately controlled as practices increasingly prefer digital programming communication, which can be accessed on their own time. To address this changing environment, last quarter, we announced our new commercial strategy to meet these preferences. That strategy embraces a hybrid approach that elevates easily accessible digital programming, virtual communication and peer-to-peer interactions. In-person promotion will be reduced and those remaining in-person activities will be much more targeted. We are energized about this new strategy and believe that we are, in fact, 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 are adopting this hybrid strategy in order to better meet physicians the way they wanted to meet, utilizing resources customized to their practices with the goal of accelerating growth, in particular, as the ongoing impact of the virus resolves over time. It's a little early to provide performance indicators from this program, but as the year goes on, we will be providing updates on progress from this hybrid model. With regard to the U.S. prostate indication, while still a modest contributor to U.S. revenue, sales of Rubraca in the prostate indication continued to grow in Q4 over Q3. Turning to Europe. We're very pleased with our progress to date despite the third COVID-19 lockdown that is currently in place. As in the U.S., it is difficult to predict the impact of COVID-19 on cancer patient visits and diagnoses and the longer-term impact on cancer patient care. 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 United States, we are seeking to tailor a hybrid digital strategy for each country to better reach our clinical -- our clinician prescribers. Now let me turn the call over to Dr. Thomas Harding, our Chief Scientific Officer, to discuss the FAP-2286 program, which is a topic of growing interest as we move toward clinical development during the first half of 2021. Tom? -------------------------------------------------------------------------------- Thomas Fuglsang Harding, Clovis Oncology, Inc. - Chief Scientific Officer [4] -------------------------------------------------------------------------------- Thanks, Pat. Hello, all. I'm Dr. Thomas Harding, and it's a pleasure to speak with you today. As Pat has mentioned, we are very enthusiastic about our peptide-targeted radionuclide therapeutic program, and in particular, our lead compound FAP-2286, which we expect to enter into clinical development in the next few months. Peptide-targeted radionuclide therapy uses cancer targeting peptides to deliver radiation-emitting isotope specifically to tumors. When injected into a patient's bloodstream, the targeting peptide attaches to cancer cells delivering high doses of radiation to the tumor, while sparing normal tissue. Our lead compound, FAP-2286, which we licensed as part of our ongoing collaboration with 3B Pharmaceuticals, is our first therapeutic candidate that targets fibroblast activation protein, or FAP. FAP is highly expressed on cancer associated fibroblast, or CAF, which represent one of the most abundant cell components in tumors and are found in a majority of cancer types, potentially making a suitable target across a wide range of solid tumors, including breast, lung, colorectal and pancreatic carcinomas. Cancer associated fibroblasts play a critical role in tumor initiation, progression, metastasis and therapeutic resistance. For example, recent studies have demonstrated the FAP expressing CAFs exert a potent immunosuppressive activity that can promote tumor progression and confer resistance to immune-based therapies, such as PD-1 and PD-L1 blockade. In certain cell types, such as sarcoma and mesothelioma, FAP may also be expressed on the tumor cells, in addition to the cancer associated fibroblasts. FAP-2286 consists of 2 functional elements: first, the targeting peptide that binds to FAP expressing CAFs and tumor cells; and second, a site that can be used for the attachment of radioactive isotopes. Depending on the specific radioactive isotope attached, FAP-2286 can be used for patient imaging and selection for therapeutic use. In our Phase I/II LuMIERE study, FAP-2286 will be attached to the isotope gallium-68 to allow positron emission tomography, or PET, imaging on selection of patients for inclusion into the study. For the therapeutic agent, FAP-2286 will be attached to the isotope lutetium-177 and a mixture of beta particle, ionizing radiation that causes DNA damage and cell death. Nonclinical studies, including animal models presented at ESMO last year, show that FAP-2286 potently and selectively biased FAP. In addition, antitumor efficacy of FAP-2286 with lutetium was observed in FAP expressing tumor models. We look forward to sharing additional preclinical and clinical data at future medical meetings. We submitted 2 investigational new drug applications for FAP-2286 for use as an imaging and treatment agent at the end of 2020 to support our LuMIERE study to evaluate FAP-2286 use as a therapeutic, with expansion cohorts planned in multiple tumor types as part of a global development program. Our INDs are expected to become effective pending acceptance by the FDA of CMC data from our clinical sites, which by the nature of the extremely short half-life of gallium-68 were effectively serving as real-time manufacturers of the imaging agent at each clinical site. The FAP targeting imaging agent will be utilized to select patients for treatment in LuMIERE. Our LuMIERE study is planned to start in the first half of this year to determine the dose of FAP-2286 therapeutic to be used in Phase II development. Phase II expansion cohorts are planned in multiple tumor types and studies of FAP-2286 linked to alternative radioisotopes, including a potent alpha-particle emitter and combination studies are also under consideration. Given the role of FAP expressing cancer associated fibroblasts in mediated [tumor] immunosuppression, combination with PD-1 and PD-L1 blockade will be a priority. In addition to our own program, a separate investigator-sponsored imaging study with FAP-2286 is currently underway at UCSF to evaluate FAP expression in multiple tumor types and is currently enrolling patients. Results from this study, along with preclinical data we are generating are expected to help inform selection of tumor types for our Phase II expansion cohorts. In addition, we and 3B Pharmaceuticals are collaborating on a discovery program directed at 3 additional targets for peptide-targeted radionuclide therapy, to which we have global rights. We were drawn to this program for many reasons, including, of course, the opportunity to be a leader in the emerging field of targeted radiotherapy for the treatment of solid tumors. In this case, we have the opportunity to be the first to clinically develop a peptide-targeted radionuclide therapy targeting FAP. And we are also enthusiastic about the targets that we'll subject to our planned discovery collaboration. And now I'll turn the call over to our Chief Medical Officer, Dr. Lindsey Rolfe, to discuss the pipeline for Rubraca and lucitanib. Lindsey? -------------------------------------------------------------------------------- Lindsey Rolfe, Clovis Oncology, Inc. - Executive VP of Clinical, Preclinical Development & Pharmacovigilance and Chief Medical Officer [5] -------------------------------------------------------------------------------- Thanks, Tom. Good morning. I'm glad to be here with you today to discuss some of the clinical milestones expected for Rubraca and lucitanib in 2021. For Rubraca, we expect to announce top line clinical data from the ATHENA monotherapy arm in the second half of 2021, although exact timing is dependent on achieving the required number of PFS events. ATHENA is a Phase III 1,000 patient study in front-line newly diagnosed advanced ovarian cancer maintenance. With ATHENA, we believe we are uniquely positioned to evaluate Rubraca in terms of 2 independent outcomes, as monotherapy versus placebo in the first-line maintenance setting in the HRD population, inclusive of Rubraca and in the all-comers or intent-to-treat population as well as any potential advantage of the combination of Rubraca and Opdivo in the same patient population. ATHENA is the first frontline switch maintenance study designed to evaluate both PARP monotherapy versus placebo and PARP PD-1 combination therapy versus PARP monotherapy in one study design. I'll take a moment to review the statistical analysis plan to ATHENA. First, expected in the second half of 2021, we will see the results of Rubraca monotherapy versus placebo in all study populations. And then probably a year or more later, we will see the results of Rubraca plus Opdivo versus Rubraca monotherapy in all study populations. In each of these analyses, we will first evaluate outcomes in the HRD population, including Rubraca, and then step down to the entire intent-to-treat population. We believe this study offers an opportunity to truly differentiate Rubraca in the first-line maintenance setting. As I mentioned earlier, the ATHENA readouts are dependent on the timing of data maturity driven by PFS events. Once top line results are available, we would plan to file an sNDA shortly thereafter. Continuing with these potential 2021 milestones for Rubraca, the LODESTAR study, our Phase II pan-tumor study to evaluate Rubraca in homologous recombination repair genes, including BRCA across tumor types, continues to enroll patients. The study evaluates Rubraca in patients with recurrent solid tumors associated with a deleterious HRR gene mutation. Based on our interactions with FDA, this study may be registration-enabling for targeted gene and tumor-agnostic labels. Pending data, we could potentially file for approval in the United States for this indication at the end of 2021 or in the first half of 2022. And the newest Phase III clinical trial for Rubraca is the CASPAR study being sponsored by the Alliance for Clinical Trials in Oncology, which is part of the National Cancer institute. CASPAR is a Phase III study comparing XTANDI and Rubraca to XTANDI and placebo as a novel regimen in first-line mCRPC in an all-comers population. The approximately 1,000 patient study is just opened for enrollment, and I'd like to acknowledge the lead investigator, Dr. Arpit Rao; our collaborator, Dr. Chuck Ryan; and all the Alliance team for achieving this milestone. Now I'll discuss lucitanib. Lucitanib is our investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3, platelet-derived growth factor receptors, alpha and beta, and fibroblast growth factor receptors 1 through 3. The Clovis-sponsored LIO-1 study is a Phase Ib/II study evaluating lucitanib in combination with Opdivo. The Phase II portion of the LIO-1 study in gynecologic cancers is enrolling patients, and we anticipate presenting updates from the study at medical meetings in 2021, which we're expecting to include interim results in the ovarian and endometrial cancer expansion cohorts. Lastly, I'm pleased to report that on the development front, the effect of COVID-19 on our clinical trial enrollment remains minimal. We continue to adhere to the regulatory guidance the FDA and other agencies have provided regarding trial conduct during COVID-19, and we're very grateful to our clinical team and investigators who work tirelessly to assure the safety of trial participants whilst maintaining compliance with GCP and minimizing the risk to the integrity of our trials. And with that, I'll turn the call over to Dan to discuss fourth quarter and fiscal year 2020 financial results. -------------------------------------------------------------------------------- Daniel W. Muehl, Clovis Oncology, Inc. - Executive VP & CFO [6] -------------------------------------------------------------------------------- Thanks, Lindsey, and hello, everyone. We reported net product revenues for Rubraca of $43.3 million for Q4 2020, which included U.S. net product revenues of $36.4 million and ex U.S. net product revenues of $6.9 million. This includes sequential quarterly growth in net revenues from our prostate indication in the U.S. from Q3 to Q4 of 2020. Fourth quarter 2020 net revenues represent a 10% increase over Q4 2019, in which we reported net revenues of $39.3 million including net product revenues in the U.S. of $36.1 million and ex U.S. of $3.2 million. For fiscal year 2020, we reported global net product revenues for Rubraca of $164.5 million compared to $143 million in fiscal year 2019, an increase of 15%. For 2020, this included U.S. net product revenues of $146.3 million and $18.2 million ex U.S. compared to 2019, which totaled $137.2 million and $5.8 million in the U.S. and ex U.S., respectively. Sequentially, net product revenues increased 12% from Q3 to Q4 2020, including an 8% increase in U.S. net revenues and a 39% increase in ex U.S., which is encouraging, given the effects of COVID-19 in our sales, which remain difficult to predict. For this reason, as Patrick noted, we are not providing 2021 sales guidance at this time. Gross to net adjustments totaled 25.6% globally in Q4 2020 compared to 25.1% in Q3 2020, relatively flat from last quarter. Gross to net was 23.3% globally for the full year. This metric fluctuates quarter-to-quarter and is difficult to estimate on future revenues. But a range in the mid- to high 20% seems likely, depending on the revenue and distribution mix between the U.S. and Europe. As European revenue -- revenues increase in proportion to the U.S., global gross to net will increase correspondingly. Additionally, free goods percentage in the U.S. sales decreased from 20.9% in Q3 to 19.1% in Q4 and weeks of distributor inventory increased slightly at the end of Q4 versus Q3. Research and development expenses totaled $56.7 million for Q4 2020 and $257.7 million for fiscal year 2020, down 22% and 19% -- 9%, respectively, compared to $72.5 million and $283.1 million for the comparable periods in 2019. Research and development expenses decreased for the quarter and year compared to the same periods in the prior year, due primarily to lower spending on Rubraca clinical trials. We expect research and development expenses to be lower in the full year 2021 compared to full year of 2020. Selling, general and administrative expenses totaled $40.8 million for Q4 2020 and $163.9 million for fiscal year 2020, both down 10% compared to $45.2 million and $182.8 million for the comparable periods in 2019. Selling, general and administrative expenses decreased during the quarter and the year compared to the same periods in the prior year with savings due to the COVID-19 situation globally and overall cost reduction efforts. Further, we expect SG&A expenses to decrease in 2021 compared to 2020. We reported a net loss for Q4 of $99 million or $1.02 per share compared to a net loss for the fourth quarter of 2019 of $99.5 million or $1.81 per share. We reported a net loss for the full year of 2020 of $369.2 million or $4.38 per share compared to a net loss of $400.4 million or $7.43 per share for full year 2019. Net loss for Q4 and fiscal year 2020 included share-based compensation expense of $12 million and $50.8 million compared to $12.6 million and $54.3 million for comparable periods of 2019. Turning now to a discussion of cash. As of December 31, we had $240.2 million in cash and equivalents. And as of December 31, we had drawn approximately $100 million under the Sixth Street Partners, LLC ATHENA clinical trial financing and had up to $75 million available to draw under the agreement to fund the expenses of the ATHENA trial. Based on the company's anticipated revenue spending, available financing sources and existing cash and cash equivalents, we believe we have sufficient cash and cash equivalents to fund our operations in early 2023, including any cash repayment, unless financed earlier, of the remaining $64.4 million aggregate principal amount of the 2.5% convertible notes at their maturity in September of 2021. Cash burn in Q4 2020 was $40.9 million, down 27% from the Q4 2019 quarter cash burn of $56.3 million. Cash burn for the 12 months ended December 31, 2020, was $195.6 million down 36% from the 12 months ended 2019 cash burn of $304.7 million. As we have been saying and working on for the last year and longer, we have reduced both our R&D and SG&A expenses considerably compared to prior years. These efforts, combined with our increasing revenues and lower inventory purchases and milestone payments on product approvals, have significantly reduced our cash burn in 2020 over 2019, and we expect this trend of lower cash burn to continue in 2021. One last point. You will see in the next day or so that we have filed a shelf registration statement for up to $200 million. We do not have any immediate plans to conduct an offering under the shelf. And in any case, the registration statement would have to be declared effective by the SEC before we could sell any securities under it. So this is an important housekeeping measure common for biotechnology companies and intended to provide us flexibility in the future. Now I'll turn the call back to Pat. -------------------------------------------------------------------------------- Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [7] -------------------------------------------------------------------------------- Thanks, Dan. Despite the evident challenges related to the global pandemic in 2020, we are pleased with Rubraca's sales performance during the year. With the recently announced changes to our U.S. commercial strategy, we believe we are well positioned for growth, especially when the ongoing impact of COVID-19 is behind us. Our development pipeline progress achieved in 2020 positions us for several key clinical, development and regulatory milestones in 2021, which include the planned initiation of LuMIERE, the Phase I/II clinical study for FAP-2286, a peptide-targeted radionuclide therapeutic candidate in the first half of 2021; top line Rubraca monotherapy versus placebo data from the ATHENA study in the front lines for treatments in ovarian cancer setting in the second half of 2021; initial efficacy data from the Phase II portion of the LIO-1 combination study of lucitanib and Opdivo at 2021 medical meetings; sufficient data from the Rubraca LODESTAR potential filing for a targeted gene in tumor-agnostic supplemental NDA. And as Dan pointed out, we remain focused on disciplined cost control, and as an example of this commitment, we reduced our cash burn from 2020 -- in 2020 from 2019 by 36%, and we anticipate that our cash burn will be still lower in 2021 than in 2020. Finally, based on current revenue and expense forecasts, we believe we have sufficient resources to fund our operations into early 2023. Thanks for joining. And with that, we will be happy to answer any questions you may have. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) First question comes from Cory Kasimov with JPMorgan. -------------------------------------------------------------------------------- Cory William Kasimov, JPMorgan Chase & Co, Research Division - Senior Biotechnology Analyst [2] -------------------------------------------------------------------------------- I wanted to ask on the FAP program. And can you talk about the kind of potential combination approaches you believe hold the most biologic rationale? And kind of on that front, how much of the development do you expect to be focused on the monotherapy side of things versus advancing into combinations? And I have one follow up. -------------------------------------------------------------------------------- Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [3] -------------------------------------------------------------------------------- I'm going to turn that over -- and you have a follow-up. So Tom, why don't you take that? -------------------------------------------------------------------------------- Thomas Fuglsang Harding, Clovis Oncology, Inc. - Chief Scientific Officer [4] -------------------------------------------------------------------------------- Cory, thanks for the question. The majority of our work in LuMIERE will be all focused on the monotherapy. So once you find the dose and then move into Phase II, we will move into at least 5 different expansion cohorts, all that will focus on FAP-2286 as a monotherapy. But in addition to the monotherapy data, there is a compelling therapeutic rationale for us to combine with PD-1 or PD-L1 blockade given the role of cancer associated fibroblasts in driving immunosuppression. And in addition to that, there are some other combinations that make sense, potentially including a combination with our own PARP inhibitor with Rubraca. The DNA damage caused by radiation is repaired, in some cases, by PARP-related pathways and may be augmented. And this obviously is the focus of some ongoing Phase I studies with alternative PARP inhibitors in Australia. So I think PD-1 rises to the top of our list, but there are other candidates that we are considering. -------------------------------------------------------------------------------- Cory William Kasimov, JPMorgan Chase & Co, Research Division - Senior Biotechnology Analyst [5] -------------------------------------------------------------------------------- Okay. That's helpful. And then the follow-up question is just for the pan-tumor LODESTAR study. What will determine whether this is ultimately registrational? Is it the number of tumor types across which you show efficacies? Or is it just the efficacy overall, no matter how many tumor types that's demonstrated in? -------------------------------------------------------------------------------- Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [6] -------------------------------------------------------------------------------- Yes, Lindsey? -------------------------------------------------------------------------------- Lindsey Rolfe, Clovis Oncology, Inc. - Executive VP of Clinical, Preclinical Development & Pharmacovigilance and Chief Medical Officer [7] -------------------------------------------------------------------------------- I think it will be a bit of both. We need to show activity across a range of tumor types where Rubraca isn't already indicated for those genes. But also there will be a threshold response rate. There'll be a level of activity that we'll have to demonstrate as well for acceptability by FDA. So it will depend on both of those things and don't forget, perhaps has more complexity because we're also looking across 5 separate genes. -------------------------------------------------------------------------------- Operator [8] -------------------------------------------------------------------------------- Next question comes from Ed White with H.C. Wainwright. -------------------------------------------------------------------------------- Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [9] -------------------------------------------------------------------------------- So just on Rubraca sales in prostate, you said you had modest growth. I'm just wondering what are the -- how should we be thinking about the penetration in that market? And what perhaps are you seeing for sticking points in prostate? -------------------------------------------------------------------------------- Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [10] -------------------------------------------------------------------------------- Yes. So there are issues we face, given the breadth of the label that AZ achieved, including the multiple mutations where they didn't even have data. And of course, this has been earlier line of therapy. Now we do have NCCN guidelines that allow for reimbursement in patients who can't tolerate or for whom chemotherapy would be inappropriate. But we have a disadvantage. And that disadvantage will likely continue until the completion and submission of the TRITON3 data, which is earlier line and broader than BRCA, does include ATM patients. And we would anticipate data from that trial next year. The -- In the short term though, we have a focused group calling on both urologists, well, virtually, calling on both urologists and medical oncologists. Participants in the trial have been active prescribers because of their experience in the trial. And we do anticipate growth will continue, albeit off a relatively small base. -------------------------------------------------------------------------------- Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [11] -------------------------------------------------------------------------------- And perhaps just a second question on the FAP-2286. Once the study starts, I believe you had said that you expect to have data within 12 months. Could -- is it possible to see some interim data from the Phase I this year? Or are we looking for data to be a 2022 event? -------------------------------------------------------------------------------- Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [12] -------------------------------------------------------------------------------- Yes. I would say any formal presentation at a scientific meeting is going to be next year, right? I don't anticipate that we would have a sufficient data set, maybe a trials-in-progress type thing, but that doesn't include data from the trial. Given the interest in the program, we are aware that people are going to want to get some sense of how we're doing. We haven't perfectly decided how we'll do that. But I would imagine we'll provide directional reviews on our quarterly calls once the trial begins and we've enrolled sufficient number of patients to be able to describe, to some extent, general tolerability and the events or any evidence of activity. -------------------------------------------------------------------------------- Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [13] -------------------------------------------------------------------------------- Okay. And then just my last question on the LIO-1 study. You're looking to present interim data at medical meetings this year. I'm just wondering if it's perhaps possible to see the combination with Opdivo in ovarian as early as ASCO with endometrial later in the year by ESMO, is that a reasonable possibility for timing? -------------------------------------------------------------------------------- Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [14] -------------------------------------------------------------------------------- We've submitted an abstract for ASCO, it's up to them, of course, to accept it. But we submitted an abstract on the ovarian arm, the serious ovarian arm. So hopefully, we'll be able to present initial data from the ovarian arm. Right now, we are anticipating submitting the endometrial, which is rolling a little bit slower than the ovarian, to ESMO. So that's our thinking right now. -------------------------------------------------------------------------------- Operator [15] -------------------------------------------------------------------------------- Next question comes from Paul Choi with Goldman Sachs. -------------------------------------------------------------------------------- Charles Ferranti, [16] -------------------------------------------------------------------------------- This is Charlie on for Paul. I just had a quick question on FAP as well. Talking about the LuMIERE study with the PET imaging program, to start, you're talking about identifying these patients with the gallium isotope imaging modality. Do you see -- foresee going forward that you would continue identifying eligible patients on a patient-to-patient basis in this way? Or is this sort of a way of identifying target tumor types that you would then kind of use as a blanket sort of way of identifying patients going forward? -------------------------------------------------------------------------------- Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [17] -------------------------------------------------------------------------------- Tom, I'll take a first crack at this and then you follow-up or correct anything I said. For the Phase I and the expansion cohort, so for the entirety of the Phase I/II, we anticipate screening every patient with a gallium labeled 2286. It is the practice of those in nuclear medicine, I don't know how many times I've heard physicians tell me that we see what we treat and we treat what we've seen. So it is an embedded practice to image first treat second. And that, of course, is how PSMA-617 if approved, and it will ultimately be approved, and similarly that's true today for the approved radionuclide Lutathera. Whether it's gallium, however, remains to be seen. We are evaluating copper as an imaging modality. And we are considering even other modalities that might be a little easier, that is have a little longer half-life than gallium, which has a half-life of 68 minutes, which is complicated. So it has been gallium-based imaging that is the basis for both lutetium -- Lutathera and PSMA-617. Tom? -------------------------------------------------------------------------------- Thomas Fuglsang Harding, Clovis Oncology, Inc. - Chief Scientific Officer [18] -------------------------------------------------------------------------------- That was perfect. I have nothing to add. -------------------------------------------------------------------------------- Operator [19] -------------------------------------------------------------------------------- Next question comes from Tazeen Ahmad with Bank of America. -------------------------------------------------------------------------------- Tazeen Ahmad, BofA Securities, Research Division - VP [20] -------------------------------------------------------------------------------- Pat, maybe a couple for me. The first one is with regards to your expectations of sales for the year and appreciating the impact of COVID, is it your view that if we do move back to a more normal environment as the year progresses, that you would be in a position to maybe offer up some sales guidance later in the year? And then the second question I have is, as it relates to ATHENA, you talked about the benefits that you would incur from having a broader label, especially as it relates to competing with other approved PARPs. But I guess from your vantage point, do you think that physicians -- as long as the study data was positive, physicians would be in a position to appreciate that label change immediately? Or would that require any kind of education? -------------------------------------------------------------------------------- Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [21] -------------------------------------------------------------------------------- Yes. To answer the question of guidance, we may. And we did talk about even including that in the script, that we will evaluate that over the course of the year. We are well aware that investors and the investment community would prefer that we provide guidance. If we become comfortable as early as next quarter or in the middle of the year during the second quarter call that we had pretty good visibility, we would definitely consider providing it later in the year. So that's one. Two, with regard to frontline maintenance, there were hundreds of participants in our trial in the U.S. It's a well-known -- it's well-known amongst the community that we run the ATHENA trial that is fully enrolled and they expect data. We'll publicize top line data we anticipate in the second half of this year. And we are confident that just as we did third to market in the second-line maintenance, we ultimately got to a 20% to 25% share, which we hold. We are hoping the hybrid model allows us to change some habits of targeted subscribers away from prescribing olaparib or ZEJULA and drive toward more experience with Rubraca. And to the extent that we create more habitual Rubraca prescribers, that would be extremely helpful to us over the course of this year, as we prepare for launch into top line maintenance next year. So yes, there will be education, will depend on data, of course. But I anticipate we will be at least as competitive in the frontline setting as we are in the second line setting. -------------------------------------------------------------------------------- Tazeen Ahmad, BofA Securities, Research Division - VP [22] -------------------------------------------------------------------------------- Okay. And then would you expect any increase in SG&A if you start promoting for frontline? -------------------------------------------------------------------------------- Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [23] -------------------------------------------------------------------------------- There may be some -- a modest spike in marketing expenses to support the launch. We would not anticipate, knowing what we know right now, an increase in personnel other than maybe a small number of office-based people related to marketing. But I don't think it would be very visible to you. We would not anticipate a huge increase. It's mainly talking about the data. Rubraca is pretty well-known in the community that we'd be selling to. And of course, the frontline prescribers are exactly the second line prescribers. -------------------------------------------------------------------------------- Operator [24] -------------------------------------------------------------------------------- (Operator Instructions) We have a question from Joe Catanzaro with Piper Sandler. -------------------------------------------------------------------------------- Joseph Michael Catanzaro, Piper Sandler & Co., Research Division - VP & Senior Biotech Analyst [25] -------------------------------------------------------------------------------- So Pat, you mentioned that patient visits and diagnoses are still down. Just wondering if you've seen a differential impact from that when you compare the maintenance versus treatment setting, especially when we think about getting physicians to move away from watch and wait. -------------------------------------------------------------------------------- Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [26] -------------------------------------------------------------------------------- I don't think it's as different as I would like. Patients are missing office visits to a lesser extent now, but are still missing office visits. And this isn't only in oncology. I'm sure if you follow cardiovascular companies or others, just visits of patients to physician practices, to hospitals is broadly down as people are nervous enough about the risks of COVID that they reduce their concern about underlying chronic medical issues. We launched a campaign at the time of -- when COVID started, and this was probably in April or May now called Maintenance Matters, where we actively try to get physicians to reconsider maintenance, those who have continued to practice in all or some of their patients watch and wait. Meaning that we can keep them out of the clinic for far longer, keep them away from immunosuppressive therapy for far longer, if they go on maintenance rather than watch and wait, which is effectively placebo, which is effectively 5 months before you're on your next round of chemo. It had some modest success. We do get some good reaction to it. It's why we moved to this hybrid model. It was pretty hard to make it actionable when we were not -- where we have no access to clinics, either in Europe or in the United States. That is a part of the digital campaign. Hopefully, it will remind people that maintenance is not only an appropriate option, but it is -- in the time of COVID and then any time in our view supported by data that suggests it's a far better approach to patient management than watch and wait. I did note that in the presentation, I think it was by GSK, about the due in frontline maintenance setting date. They referred again to the vast number of patients who are still being treated now in the frontline setting with watch and wait. So it is an issue that has plagued the class. It appears that it will continue to plague the class for a while, including the frontline setting. So I don't know if I exactly answered your question, but I don't -- things are recovering, I think they'll continue to recover over the course of this year. Practices have adapted to COVID, they have adapted to telemedicine. So it's not as if things are as bad now as they were in April and May, despite the surge that occurred in December, January. But it's -- I don't think we'll be fully back to whatever normal is until the second half of this year. -------------------------------------------------------------------------------- Joseph Michael Catanzaro, Piper Sandler & Co., Research Division - VP & Senior Biotech Analyst [27] -------------------------------------------------------------------------------- Okay. Got it. That is helpful. And if I could just ask a follow-up, maybe a little housekeeping question. Can you remind us of whether the ATHENA readout you expect later this year for Rubraca versus placebo would trigger anything with regards to the ATHENA financing agreement and repayment? -------------------------------------------------------------------------------- Patrick J. Mahaffy, Clovis Oncology, Inc. - Co-Founder, CEO, President & Executive Director [28] -------------------------------------------------------------------------------- No. It's the approval that would trigger that, Dan, right? -------------------------------------------------------------------------------- Daniel W. Muehl, Clovis Oncology, Inc. - Executive VP & CFO [29] -------------------------------------------------------------------------------- Exactly. Yes. Yes. And we -- the repayment starts regardless of the approval time frame in the fourth quarter of '22. So it's just a matter of -- the only thing that gets affected by approval is how much the payment could possibly be. -------------------------------------------------------------------------------- Operator [30] -------------------------------------------------------------------------------- And at this time, I'll turn the call over to Ms. Sussman for closing remarks. -------------------------------------------------------------------------------- Anna Sussman, Clovis Oncology, Inc. - VP of IR [31] -------------------------------------------------------------------------------- Great. Thank you, Sharon. We thank each of you today for your interest in Clovis. If you have any follow-up questions, please call me at (303) 625-5022, or Breanna at (303) 625-5023. This call can be accessed via a replay of our webcast at clovisoncology.com beginning in about an hour, and it will be available for 30 days. Again, we appreciate your interest and time. Thank you, and have a good day. -------------------------------------------------------------------------------- Operator [32] -------------------------------------------------------------------------------- This concludes today's conference call. You may now disconnect.