Clovis Oncology, Inc.
Q1 2020 Earnings Call Transcript

Published: 6 May 2020

[Operator:]

Thank you for standing by, and welcome to the Clovis Oncology First Quarter 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised, that today's conference is being recorded. [Operator Instructions]I'd now like to hand the conference over to your speaker today, Anna Sussman, Vice President of Investor Relations. Thank you. Please go ahead.

[Anna Sussman:]

Thank you. Good afternoon, everyone. Welcome to the Clovis Oncology first quarter 2020 conference call. Thank you for joining us.You have likely seen this afternoon's news release. 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 on our archive for the next several weeks.Today's agenda includes the following

[Patrick Mahaffy:]

Thanks, Anna. Welcome, everybody. I appreciate you taking the time today. As we all know, the world has changed so much since our last early update in late-February, it's a complicated time for all of you, I know. Healthcare professionals have been and remain on the front lines of this global pandemic, and I'd like to acknowledge the contributions of healthcare workers around the world, putting their lives on the line to care for those affected by COVID-19.Closer to home, we'd also like to recognize the tremendous effort being made by our investigators and prescribers to maintain enrollment and safely manage ongoing patients on our clinical trials, and for continuing to prescribe and manage Rubraca commercial patients during this period of significant upheaval to their clinics and practices. These are time to-date to discuss the highlights of the topics you've come to expect our quarterly calls, and focus on providing additional color on how we are navigating the COVID-19 world here at Clovis. And our view of how COVID-19 may affect oncology treatment going forward, and then we'll open it up for Q&A with Dan, Lindsey, myself.Let's begin with a commercial update for Rubraca. I'm pleased to report that we had a very encouraging first quarter. Our global net revenue was $42.6 million, this represents an 8% sequential increase from Q4 2019 and 29% increase over Q1 2019. This was our best quarter of sales to-date, despite the fact that reps had to begin staying home beginning in mid-March in the United States, and could no longer call on healthcare providers in person for the last few weeks for the quarter. Also, our European launches in Italy, Spain and France are all occurring in an environment in which our field-based personnel have not been allowed to visit hospitals or clinics beginning in late February, and are therefore also working for home.Given the circumstances, we are very pleased with our sales growth in the first quarter. And now I'll share why we believe that Rubraca is well positioned as an oncology treatment option in the current acute COVID-19 era, and then the chronic COVID environment that is sure to follow.This period has been very disruptive for hospitals, clinics and patients as healthcare professionals are redirected, broadly described elective procedures are delayed, and healthcare facilities are converted to support COVID-19 treatment efforts. We do believe that oncology will be among the first healthcare specialty to return to some normalcy, well that likely means adapting to a new normal in a chronic COVID-19 world, one in which there is a focus on minimizing clinical visits to avoid risk to patients, especially cancer patients and other patients with known comorbidities. It is also clear that cancer patients will need to be diagnosed and treated given the evident risks and not actively managing their disease.We believe that Rubraca, a convenient oral therapy has significant advantages as a maintenance option in the recurrent ovarian cancer setting in an environment, and as I described, physicians are trying to reduce patient visits to their clients. Unlike Avastin [ph] as a maintenance option that requires frequent infusions and weekly monitoring for hypertension and known risk factor for COVID-19, Rubraca is an oral agent and is taken at home and only requires monthly routine monitor. Unlike observation, which on average leads to disease progression and requires a return to immunosuppressive chemotherapy after approximately five months, Rubraca has been shown to extend progression-free survival, and therefore subsequent chemotherapy on average nearly 14 months by independent assessment, nearly three times longer than placebo. In fact, observation is an invitation to infusion.And unlike Zejula, which requires weekly blood monitoring for the first month, which obviously requires weekly visits to the clinic or a laboratory; Rubraca requires only monthly routine monitor. As you can see, Rubraca offers numerous potential advantages in the chronic COVID-19 world, and we have already introduced a variety of new digital materials for our -- our now home-based field personnel who used to engage with hospitals, clinics, doctors and pharmacies. While we may see some near-term impact on revenues as physicians adapt their practices to COVID-19, we believe these advantages will remain over the course of this year and future years since as we all know COVID-19 is not likely going away in the near-term.In addition to seeking to establish Rubraca as the maintenance treatment option of choice in recurrent ovarian cancer, we also look forward to the potential launch in the United States of Rubraca in advanced mutant BRCA [ph] prostate cancer. And that brings us to our most near-term development and regulatory program in this setting.In November 2019, we submitted our planned supplemental new drug application or sNDA for Rubraca as a monotherapy treatment of adult patients with BRCA1/2 mutant recurrent metastatic CRPC. The FDA filing was based on data from the TRITON2 clinical program in advanced prostate cancer. In the US, by the way, approximately 12% of men with metastatic CRPC have a mutation of BRCA1 or BRCA2 in their tumor. In January 2020, we announced that the FDA accepted our sNDA for Rubraca and granted priority review status to the application with the PDUFA date of May 15, 2020. Based on our interactions with the FDA, we have no reason to expect any delay to our May 15 PDUFA date.We think that Rubraca represents an important hormone-free and chemotherapy-free option for men with metastatic CRPC and a BRCA1/2 mutation. Recall that we previously reported at ESMO, in last fall, a confirmed objective response rate of 44% by investigator and a confirmed PSA response of 52%. The safety data for men with CRPC were consistent with prior safety reports for patients with ovarian cancer and other solid tumors. We have been engaged by our -- encouraged by our interactions with both the medical oncology and neurology communities about the potential for Rubraca to address the unmet medical need in recurrent metastatic CRPC.We are actively engaged in launch preparations, including sales force training that was completed in early March, and we will be ready to launch upon approval. Obviously, this will be among the first group of oncology launches that will incur entirely or almost entirely virtually, and we have taken considerable effort to prepare for this virtual launch. Our field sales team is prepared to initiate zoom-based sales calls with prescribers, and we'll leverage learning's accumulated through their virtual selling efforts in the ovarian cancer setting since mid-March. All launch collateral for the sales team has been digitized to ensure they have the ability to utilize resources in virtual interactions.The promotional national broadcast has been fully converted to a virtual streaming program enabling HCP's to watch from any computer or iPad or any device in their office for all. Additional broadcast times have been added to ensure flexibility across all U.S. time zones. Program registration will be aided through targeted online advertising that will commence the date of approval. Media and advertising efforts have been weighted for digital programing versus print, the maximize impact and effectiveness of resources invested [ph]. So to be clear, we will be ready to launch in prostate even in this new environment.Let me turn now to the clinical pipeline for Rubraca and lucitanib, as well as our ongoing plans for plans for FAP-2286. To begin, we are adhering to the regulatory guidance that FDA and other agencies have provided regarding clinical trial conduct during COVID-19, and our clinical teams are working closely with investigators to ensure the safety of trial participants and investigators while maintaining compliance with good clinical practice and minimizing risk to the integrity of our trials. While we did not see any material disruption to our clinical trials as a result of COVID-19 during the first quarter, it is possible that near-term effects may begin to emerge across different aspects of our clinical trial programs. For example, new patient recruitment in certain clinical studies may be affected and the conduct of clinical trials may vary by geography as some regions or more adversely affected.I will note that we continue to anticipate completing enrollment in our larger study, the ATHENA frontline maintenance study before the end of this quarter. The LODESTAR study on Phase II pan-tumor study to evaluate Rubraca in homologous recombination repair genes across tumor types continues to enroll patients. The study will evaluate Rubraca in patients with recurrent solid tumors associated with the deleterious homologous for combination repair or HRR gene mutation. Based on our interactions with FDA, the study may be registration enabling for a targeted gene in tumor-agnostic label. If enrollment continues as planned, we could potentially file for approval in 2021.Next, I'd like to briefly highlight our combination studies with BMS for both, Rubraca and lucitanib, and then discuss our newest compound 2286. We remain enthusiastic about our ongoing clinical collaboration with Bristol-Myers Squibb, and I'll take a moment to review certain of our combination studies for both, Rubraca and lucitanib with nivolumab. I'll begin with the Rubraca combinations.FRACTION-GC is a BMS sponsored multi-arm Phase 2 study evaluating the combinations of each of Opdivo and Yervoy with Rubraca, as well as Opdivo, Yervoy and Rubraca in combination for the treatment of advanced gastric cancer. This is the first sponsored study to explore this triplet combination and it is currently enrolling patients into the safety leading portion of the study. Clovis sponsored Phase 3 ATHENA trial and first-line maintenance for advanced ovarian cancer continues to enroll well, despite the COVID-19 environment. And as I noted, we continue to anticipate completing enrollment in this 1,000 patient study in the second quarter of 2020.With ATHENA, we believe we are uniquely positioned to evaluate Rubraca in terms of two outcomes as monotherapy versus placebo in the first-line maintenance setting in the HRD population, inclusive of BRCA 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 populations. ATHENA is the first frontline switch maintenance study designed to show both, PARP monotherapy and PARP/PD-1 combination therapy in one study design.I'll take a moment to remind you of the statistical analysis plan for ATHENA. First, expected in the second half of next year, 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 in all study populations. In each of these analyses, we will first evaluate outcomes in the HRD population, including BRCA, and then step down to the entire intent-to-treat population.To wrap up Rubraca and move to lucitanib, I'll describe SEASTAR, our Clovis-sponsored Phase 1b/2 study that includes multiple single-arm Rubraca combination studies, including the combination of Rubraca with [indiscernible] for the treatment of advanced metastatic triple-negative breast cancer, relapsed platinum resistant ovarian cancer and metastatic urothelial cancers. A separate arm of SEASTAR includes the combination of Rubraca with lucitanib and invent solid tumors, which is currently in the dose finding Phase 1b portion of the study. Lucitanib of course is our investigational inhibitor of tyrosine kinases, including vascular endothelial yielding growth factor receptors 1, 2, 3; platelet-derived growth factor receptors, alpha and beta; and fibroblast growth factor receptors 1, 2, 3.In February 2019, we and Bristol-Myers Squibb expanded our clinical collaboration to include planned combinations of Opdivo with lucitanib. The Clovis sponsored Leo-1 study is a Phase 1b/2 study evaluating lucitanib in combination with Opdivo. Leo-1 is now enrolling patients with advanced solid tumors in the Phase 1b portion of the study. We anticipate submitting abstracts for presentations at a medical meeting in the fall of 2020. Lastly, the BMS sponsored CheckMate 79X study is a Phase 1/2 study evaluating multiple combinations with opdivo, including an arm in companies with lucitanib in patients with second-line non-small cell lung cancer. Sort of activity for the CheckMate 79X study are proceeding for regulatory guidelines for clinical trial conduct during COVID-19.We remain very enthusiastic about our peptide targeted radiopharmaceutical therapy program and in particular, our lead compound FAP-2286. FAP is highly expressed in cancer associated fibroblasts or CAFs, which are found in the majority of cancer types potentially making it a suitable target across a wide array of solid tumors. It is highly expressed in many epithelial cancers, including more than 90% of breast, lung, colorectal and pancreatic carcinomas. Recent preclinical data in animal models, which we expect will be reported at an upcoming medical meeting has only increased our optimism around this program. In addition, we and 3BP are collaborating on a discovery program directed at three additional targets for 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 an FAP targeted radionuclide and we are also enthusiastic about the targets of the subject of our planned on ongoing discovery collaboration. While this currently plans to submit an Investigational New Drug or IND application for FAP-2286 in the second half of 2020 followed by a Phase 1 study to determine the dose and tolerability of the FAP targeting therapeutic agent, with expansion cohorts planned in multiple tumor types as part of the global development program. Thus far, in radiotherapeutic development, physicians have used an imaging agent to identify patients with the appropriate level of tumor target, in our case FAP. We are exploring opportunities to generate imaging data for FAP-2286, potentially even before our IND is submitted. Not only would this information will be useful to gain additional experience with FAP-2286 and better understand the characteristics of FAP expression in multiple tumor types, but further it would allow us to collaborate with academic institutions eager to explore the potential of FAP-2286 as an imaging and as a treatment modality.And with that, I'll turn the call over to Dan to discuss first quarter 2020 financial results.

[Daniel Muehl:]

Thanks, Pat, and hello everyone. We reported net product revenue for Rubraca of $42.6 million for Q1 2020, which included US net product revenue of $39.3 million and ex-US net product revenue of $3.3 million. This represents a sequential increase of 8% over Q4 2019 net revenue of $39.3 million, and a 29% increase over Q1 2019 net product revenue of $33.1 million.US net product revenue was $39.3 million for the first quarter, up 9% from $36.1 million reported in Q4, 2019, and up 23% from the $31.9 million reported in Q1 2019. The supply of free drug distributed to eligible patients in the US through the Rubraca patient assistance program for Q1 2020 was 12% of overall commercial supply compared to 18% in Q4 2019. This represented $5.6 million in commercial value for Q1 2020 compared to $8 million in Q4 2019. We can't yet predict the impact of COVID-19 and related unemployment on cap utilization over the remainder of 2020.Ex-US net product revenue was $3.3 million for the first quarter of 2020, which represents a slight increase over the $3.2 million reported for Q4 2019 and the $1.2 million reported in the first partial quarter of ex-US sales in Q1 2019. We launched Rubraca in France and Spain during March 2020, so we only expect of a small contribution in Q1 for those countries. We have now recorded product revenue in each of Germany, United Kingdom, Italy, France and Spain, and we expect to launch into additional smaller European markets overtime.Gross to net adjustments totaled 22.6% in Q1 2020 compared to 17.4% in Q4 2019. The sequential increase in gross to net adjustments reflects primarily an increase in the US contracting and government-related programs and the impact of growing European sales that generally have higher GTN rates. We expect gross to net adjustments to remain in this low 20% range depending on revenue distribution mix for the US and Europe. The number of weeks and distributor inventory was flat at the end of Q1 versus Q4, so there was no buildup of inventory as a result as a reaction to COVID-19.At this point in time, we have no issues with either drug supply or distribution of drug to the patients. We have described product supply costs as a meaningful part of our cash spend over the last couple of years as we transition to a new manufacturing facility, so we are in a favorable position for some time to come.Turning now to a discussion of cash; as of March 31, we had $228.4 million in cash, cash equivalents and available for sale securities. In January 2020, the company repurchased $123.4 million aggregate principal amount of it's 4.5% convertible senior notes due 2024 that were initially issued in August 2019. In April 2020, the company exchanged approximately $36 million, an aggregate principal amount of it's 4.5% convertible senior notes due 2024 in exchange for approximately $32.8 million in aggregate principal of 2021 notes held by such holder [ph]. In May 2020, a holder of the 4.5% convertible notes due 2024 converted $24.3 million par value of note into approximately 3.3 million shares of common stock for the standard terms of the venture.Following these transactions, approximately $64.4 million aggregate principal amount of these 2021 notes remain outstanding and approximately $150.6 million in aggregate principal amount of these 2024 notes remain outstanding. Additionally, the company has $300 million aggregate principal amount of it's outstanding of it's 1.25% convertible notes due 2025. As a result of the transactions noted above, the company has reduced it's total outstanding convertible debt by $145.1 million and outstanding principal amount from December 31, 2019 through May 5, 2020. And as of March 31, we had drawn approximately $50 million under the TPG ATHENA clinical trial financing, and had upto $125 million available to draw under the agreement to fund the expenses of the ATHENA trial for Q3 2022.Based on the company's anticipated revenues, spending available financing sources and existing cash, cash equivalents and available for sale securities, we believe we have sufficient cash, cash equivalents and available for sale securities to fund our operating plan into the second half of 2021. This does not include any cash repayment that may be required to pay-off, unless we refinance earlier the remaining $64.4 million aggregate principal amount of the 2.5% convertible notes at their maturity in September 2021. While we did not see an impact in Q1 in our revenues, the effects of COVID-19 on our future sales are difficult to assess or predict and we may see some near-term impact on revenues related to COVID-19.Net cash used in operating activities was $82.5 million for Q1 2020 compared to $98.5 million for Q1 2019. In addition, borrowings under the TPG ATHENA financing provided $15.6 million in cash in Q1 2020 reducing net cash utilized in operating activities to $66.9 million during the quarter. Net cash used in operating activities for Q1 2020 included product supply costs of $12.4 million and once a year annual incentive compensation payment. We expect product supply costs will be significantly reduced from this first quarter level for the remainder of 2020 and at least the first half of 2021. We also expect significantly lower cash burn in the second half of 2020, assuming achievement of our planned revenues over that timeframe.We reported a net loss for Q1 2020 of $99.3 million or $1.39 per share compared to a net loss for the first quarter of 2019 of $86.4 million or $1.63 per share. Net loss for Q1 2020 included share-based compensation expense of $13 million, compared to $13.6 million for Q1 2019. Research and development expenses totaled 68.2 million for Q1 2020 compared to $62 million for the first quarter of 2019. The increase is primarily due to higher research and development costs for Rubraca clinical trials. We expect research and development expenses to be lower in the full year 2021 compared to 2020.Selling, general and administrative expenses totaled $42.6 million for Q1 2020 compared to $47.8 million for the comparable periods in 2019. Selling, general and administrative expenses decreased during the first quarter of 2020 primarily due to decreased commercialization expenses for Rubraca in the US and Europe. We expect savings and selling, general and administrative expenses as a result of the corporate banking situation globally. Lastly, we continue to explore ways to improve our balance sheet and capital structure and extend our cash balance beyond the second half of 2021.As noted, we expect R&D -- our R&D expenses to decrease in 2021 compared to 2020. SG&A expenses should be lower in the upcoming months than we expect there will be in line with the Q1, 2020 levels through 2021. Our inventory purchases and other non-recurring milestone payment expenses both significantly decreased through 2021, and we anticipate planned revenues to increase with growth in all geographies and with our anticipated prostate indication approval and launch in the US. All of these factors should contribute to a reduction in quarterly cash burn into and through 2021.Back to you Pat.

[Patrick Mahaffy:]

Thanks, Dan. In summary, we're pleased with our progress in the first quarter and we believe that Rubraca is well positioned as the maintenance therapy of choice for recurrent ovarian cancer patients in the acute and in the coming chronic COVID-19 environment.Physicians will continue to seek to reduce patient visits their clinics and Rubraca upper certain advantages to achieve this goal. Rubraca is an oral agent delivered to and taken at home. Rubraca has been shown to seven progression-free survival by independent assessment by nearly 14 months on average compared to placebo for observation, which is shown PFS of only five months on average. And Rubraca requires only monthly routine monitoring thus limiting patient visits to the clinic. We believe these qualities are for compelling argument for explanations to consider Rubraca in the maintenance setting for recurrent ovarian cancer.And soon, we hope to offer a new therapeutic option for BRCA mutant recurrent metastatic castrate-resistant prostate cancer patients in the US as well. We remain focused on managing our net cash utilized in operations and improving our balance sheet through convertible debt and other transactions, such as the transactions, which occurred in January, April and May of this year.And last but certainly not least, I'd like to acknowledge our employees. All of them have been working from home, since mid-March and I am grateful for their ongoing commitment to support patients, healthcare providers and each other during this challenging and unprecedented time.And with that, we're happy to answer any questions you may have.

[Operator:]

[Operator Instructions] Your first question comes from Kennen MacKay with RBC Capital Markets. Your line is open.

[Kennen MacKay:]

Hi, thanks for taking the question and congrats on the operational progress despite the pandemic. Patrick, it seems like maybe you really have had some tailwinds from COVID pandemic going on obviously arising from some of the decreased toxicity on the myeloid compartment, can you maybe talk about how this could read through to prostate cancer, given some of the alternative agents with chemotherapies that are out there, have maybe even more toxicity the PARP class?

[Patrick Mahaffy:]

Yes. As you're aware, both ASCO and FDA have incurred physicians to consider oral therapeutic. As they consider treatment options for patients. And obviously we hope and believe that we'll continue to accrue to our advantages, I discussed, not only in the ovarian cancer setting versus certain alternative infusion based products, but versus immunosuppressive chemotherapy in prostate cancer.

[Kennen MacKay:]

Okay.

[Operator:]

Your next question comes from Gena Wang with Barclays. Your line is open.

[Gena Wang:]

Thank you for taking my questions. Maybe first one is any geographic differences in terms of COVID-19 impact regarding launch? And also second question is regarding the prostate cancer, should we actually expect any revenue in second quarter?

[Patrick Mahaffy:]

Yes. So first as the geographic differences regarding the launch. Yes, we -- it's pretty evident that for instance the New York metropolitan area has been hit pretty hard. And I think we probably did see an impact on sales. And these new patient starts in New York, it maybe even during the quarter. As to the prostate cancer launch, there will likely be some hotspots, where distractions to the healthcare system occur and could temporarily impact on prescribing. I will say that I would put a PDUFA date of May 15 and being prepared to launch on or before May 15. We absolutely would expect to see sales in prostate cancer in the second quarter. We'll have six weeks of sales.

[Gena Wang:]

Okay, that's very helpful. If I may just squeeze one more question. Any thoughts on Zejula approval in the first line of any cancer and then how will that impact the competitive landscape and your ATHENA trial.

[Patrick Mahaffy:]

So one, it was totally expected and so it came as expected and they approved. It is not going to have any impact on our ATHENA readout, the trial is almost fully enrolled, so we will have no impact on enrollment, obviously. And in fact, we don't even enrolling in the United States, we've started shutting down country-by-country certain areas and we've already shutdown enrollment in the U.S. So it will have no impact on the timing of our readout for ATHENA.

[Gena Wang:]

Thank you.

[Patrick Mahaffy:]

You bet. Thanks.

[Operator:]

Your next question comes from Michael Schmidt with Guggenheim Securities. Your line is open.

[Unidentified Analyst:]

Hi, good afternoon. This is Young [ph] for Michael. Thanks for taking our questions, and congrats on the quarter. We got a few questions on Rubraca commercialization prostate cancer. I guess the first one, in terms of the development of the companion diagnostic with partners, in the context of COVID-19, can you maybe target out the latest dialog with partners in terms of the advancing regulatory preparation for the prostate cancer?

[Patrick Mahaffy:]

Yes, I would be uncomfortable talking about any dialog with our partner Foundation Medicine has ongoing with FDA, especially as we get closer to this approval, that's more for them I think to comment on. We certainly are aware as all of us are that a lot of resources at FDA, both at the therapeutics division and as the diagnostics division are being directed to COVID-19. But I think that I will limit my comments to that; we don't believe there will be any impact on our -- the timing of our potential approval and by our PDUFA date.

[Unidentified Analyst:]

Got you, thanks. And then, the next one may -- so once launched in prostate cancer, how should we think of free drug supply there? Will it be more similar to ovarian cancer or should we think it differently?

[Patrick Mahaffy:]

There is a slightly higher percentage we think of Medicare patients, just given the demographic of the population. But we have, as you saw in Q1 have done an increasingly good job of managing that program. Now as Dan said in his prepared remarks, there may be some impact on the path as unemployment impacts on insurance coverage for people in this country. But again, that's less likely to be for our older population than it is for service based or other individuals who suffered greatly and lost their jobs in this environment. But I think that we have learned how to manage the past program and we'll continue to apply those learning's from ovarian to the prostate cancer setting.

[Unidentified Analyst:]

Got you, thanks. And if I may squeeze last question. What's the confirmatory TRITON3, I think label, Rubraca can then be used either pre or post-chemotherapy in prostate cancer? So with respect to the sequencing, I guess based on our interaction with physicians, do you think Rubraca should be best used pre or post-chemo to maximize the benefit of this therapeutic class?

[Patrick Mahaffy:]

Obviously, the owner and developer of Rubraca, I think it should be using in just about everybody. But the reality is, we have evidence now of tremendous activity in the post-chemo setting and that would be our immediate priority.

[Unidentified Analyst:]

Got you. Thanks, very helpful. Congrats, again.

[Operator:]

Your next question comes from Paul Choi of Goldman Sachs. Your line is open.

[Paul Choi:]

Thank you. And let me also offer my congratulations on the commercial progress. I have two questions. And first, just maybe help us think about the outlook for the remainder of the year given the backdrop and with COVID. Pat, I think on the last call you talked about maybe potentially offering up guidance here at mid-year. But with that in mind, can you maybe talk about how you think about the payer mix evolving this year at perhaps and into next year, just given the changing landscape and more people struggling to have insurance and so forth. And maybe just what you think the reliance on Medicare and/or Medicaid might be over the course of the remainder of the year and next year? And then I had a follow-up with a clinical question.

[Patrick Mahaffy:]

Yes, I think most companies in this moment in time are not very excited about giving formal guidance. We tried to give you directionally how we think things are going. I'll turn it over to Dan to answer the payer mix question. Dan?

[Daniel Muehl:]

Yes, so somewhat hard to predict, somewhat demographics play into it. As Pat alluded to before; so within ovarian, we wouldn't necessarily see much of a shift, but within prostate it could have a different profile than ovarian. And that could be with a higher age demographic that could be more Part-D patients which could potentially have some effect on GTN. And so, I think that's probably the one area where he may have a little bit more of a shift from regular commercial to Part-D under prostate, but it's hard to predict any other changes around the ovarian section.

[Paul Choi:]

Okay, thanks for that. And then with regard to the next set of trials for lucitanib program. I know you guys talked about having some data presentations in the fall in the press release, can you maybe just confirm for us if that means ESMO? And then second, as you think about recruiting for the next leg of your lucitanib trials, you may be just -- help us sort of understand timelines where you would be poised because I think you should have certain dose finding data relatively soon. And just -- how do you think about maybe potential next steps in data readouts after this upcoming sort of data readouts in the fall? Thank you.

[Patrick Mahaffy:]

Yes. I would expect that we will submit to ESMO. And we are targeting ESMO. Obviously, we don't even know if there is going to be in ESMO or if there isn't ESMO almost certainly I think going to be virtual, but they haven't said that yet. So that's the first answer. I would anticipate hitting enrollment patterns that by either ASCO or at the latest as going next year we'd have a more complete presentation of the combination data.

[Paul Choi:]

Okay.

[Operator:]

Your next question comes from Cory Kasimov with JP Morgan. Your line is open.

[Unidentified Analyst:]

Hi, this is Gavin [ph] on for Cory. Thanks for taking our questions. I wish I had one on the competitive landscape within prostate, trying to get your sense of, any updated thoughts on the launch and in the context going up against a competitor with a potentially broader label with randomized Phase III data, just trying to get your updated thoughts. I think you provided some last quarter but any updates there would be great. Thank you.

[Patrick Mahaffy:]

Yes. So a couple of things. We're delighted that there will only be two of us unlike ovarian where there are three and we were the third. With regard to the randomized data, it's a very small study. And so it doesn't have the power of a large study and in particular, the control arm is a control arm that has proven to be extremely ineffective in the setting. And so if anything, they validated that their control arm isn't a very active control arm. So I think we can make these points, our data stand -- we're very encouraged by our data. We've got good responses back from clinicians to our data. And we look forward to getting out there.We would prefer and we'll be glad when TRITON3 readouts and we have an earlier line of therapy. I do expect, as a question got asked, that there may be some use earlier, just given the fact that it's an oral agent and physicians may try hard to get that earlier line use.

[Unidentified Analyst:]

Great, thank you.

[Patrick Mahaffy:]

You bet.

[Operator:]

Your next question comes from Tazeen Ahmad with Bank of America. Your line is open.

[Tazeen Ahmad:]

Hi guys, thanks for taking my questions. Maybe just a quick one on the PAP program. I know you've answered a couple of questions on this already, but can you just talk about the dynamics that help to improve the trend that you saw between 4Q '19 and the first quarter on the patient assist program. And then I have a quick question on prostate.

[Patrick Mahaffy:]

Yes, so one is, as you may remember the funding -- the independent funding of these foundations and provide copay support is highly variable. That funding was -- it was a good quarter in terms of foundation funding in Q1. And so, that always has an impact when a patient can easily get access to the copay. We have taken some other steps. I won't get too far into the weeds, but to ensure that before a patient is enrolled in PAP, all opportunities are exhausted to determine if they do have sufficient insurance to get that co-pay manage, and in particular before our provider of the PAP service enrolls a patient in PAP, they refer patients for a benefits review to one of our specialty pharmacies who are adept at evaluating that benefit package. So it's just some logistical work plus better funding to the foundations.

[Tazeen Ahmad:]

Okay, thanks for the color. Maybe one question on prostate. Since this launch as you mentioned at the beginning is going to be on, mostly, if not all, at least initially through virtual contact points, would it be unreasonable to think that you could potentially make more points of contact with your targeted physicians rather than the traditional approach where you've got boots on the ground with sales people trying to see doctors in person? Is that the right way of thinking about it?

[Patrick Mahaffy:]

Yes, I thought a lot about this, not only in the context of the prostate launch, but just managing our ovarian business and I don't think anybody would say that we don't prefer personal contact, in office visits to many people within the clinic. Obviously, the physician, the pharmacists, admin staff, etcetera. That being said, it's a lot of car travel, in some cases plane travel and it's pretty limited. So the number of people we can see -- and we've talked a lot about the fact, and I'm sure you've heard this from other companies, that we are absolutely directing our team, encouraging our team to reach beyond those who we know are known.Prescribers of Rubraca are likely to prescribe Rubraca if and when [indiscernible] get the prostate approval. And I think it is reasonable to assume that we will reach more customers with a little less wonderful way of reaching them, that is digitally and electronically, maybe a phone call or Zoom, rather than an in-office visit. But I agree with the premise of your question, we should be able to reach more people.

[Operator:]

Your next question comes from Andrew Berens with SVB. Your line is open.

[Andrew Berens:]

Thanks. Maybe one on the COVID impact on the quarter and one on the balance sheet. We've heard from some companies that there has been stockpiling, that's created tailwinds for a number of cancer drugs. I was just wondering, have you guys seen an uptick in the 90-day Rubraca scripts this quarter and how do we think about that going forward?

[Patrick Mahaffy:]

No, no, our scripts are 30 days, we had 11 patients, 11 patients in the quarter who got greater than 45 days. So no, we see no stockpile. And second, our inventory levels were flat to down from the prior quarter. So there was also no stockpiling by our distributors or specialty pharmacies.

[Andrew Berens:]

Okay. And then I know you previously suggested that you could monetize lucitanib as a way to lessen the cash and debt overhang, I was wondering how you think about that opportunity now with the data potentially coming by year-end amidst the COVID environment?

[Patrick Mahaffy:]

Well, you still see activity in the COVID environment. Admittedly, people are trying to get used to how to be active in the COVID environment. When I've talked about that and I definitely have, I've suggested that that was more likely to be a '21 event as not only safety and other data emerge, but where we have enough patients treated that any potential partner could make a reasonable comparison with all of the caveats associated with cross trial comparisons to the evident competitor combination which is pembro plus lenvatinib. So I wouldn't, -- I would be hoping for something like that in 2021, not expecting it in 2020.

[Andrew Berens:]

Okay. Thanks, Pat.

[Patrick Mahaffy:]

You bet.

[Operator:]

[Operator Instructions] Your next question comes from Ed White with HC Wainwright, your line is open.

[Edward White:]

Hi, Pat. Thanks for taking my question. So you had mentioned so July and about patient monitoring in perhaps in the new treatment paradigm with COVID, that Rubraca might have a leg up on that. I'm just wondering if you're hearing anything about the use of Avastin in second-line maintenance as far as infusion every three weeks and then needing weekly monitoring, if that's also perhaps not favored in the current environment. And then also just thinking again about the market share of Avastin and if you have any thoughts on the market share of Avastin in second line versus the PAP versus observation. Thanks.

[Patrick Mahaffy:]

Yes, we think, first of all, we had one physician come to us and say that she has a number of patients on Avastin maintenance, and she was converting all of them to Rubraca. And I think that's an anecdote, but I think reflective of the concerns people have about Avastin, not only that it's an infusion product and requires a visit to the clinic, but there have been three primary co-morbidities associated with COVID-19 as a real risk factor, that's diabetes, obesity and hypertension and the grade 3.4 [ph] incidents hypertension Avastin is pretty high. And physicians are well aware of that. They know how to manage it and have been able to manage it easily. But they are probably a little more nervous in an environment of COVID.So, I think it is going to have an impact. I actually did mention that in my prepared remarks, Ed. But I think we are going to see some advantages there. A lot of Avastin use is in frontline, but probably about 20% to 25% of patients get Avastin in second-line maintenance.

[Edward White:]

Okay, thanks.

[Operator:]

There are no further questions, I turn the call back to Anna for any closing remarks.

[Anna Sussman:]

Thanks, Jesse. Thanks everyone for your interest in Clovis Oncology today. If you have any follow-up questions, you can call me at 303-55-5022 or Breanne 303-65-5023. This call can be accessed via replay on our website beginning in about an hour, and will be available for 30 days. Again, we appreciate your interest and time. Thank you and have a good day. Goodbye.

[Operator:]

This concludes today's conference call. You may now disconnect.