Edited Transcript of CLVS earnings conference call or presentation 5-May-20 8:30pm GMT


Boulder May 23, 2020 (Thomson StreetEvents) — Edited Transcript of Clovis Oncology Inc earnings conference call or presentation Tuesday, May 5, 2020 at 8:30:00pm GMT

Clovis Oncology, Inc. – VP of IR

* Daniel W. Muehl

Clovis Oncology, Inc. – Executive VP & CFO

* Patrick J. Mahaffy

Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director

SVB Leerink LLC, Research Division – MD of Targeted Oncology & Senior Research Analyst

H.C. Wainwright & Co, LLC, Research Division – MD of Equity Research & Senior Healthcare Analyst

* Kennen B. MacKay

RBC Capital Markets, Research Division – MD & Co-Head of US Biotechnology Research

Thank you for standing by, and welcome to the Clovis Oncology First Quarter 2020 Financial Results Conference Call. (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, Clovis Oncology, Inc. – VP of IR [2]

Thanks, Jessie. Good afternoon, everyone. Welcome to the Clovis Oncology First Quarter 2020 Conference Call. Thank you for joining us. You’ve 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 in our archive for the next several weeks.

Today’s agenda includes the following: Pat Mahaffy, our President and CEO, will discuss the key components and highlights of today’s corporate update, including commentary about any potential impact related to COVID-19; then Dan Muehl, Clovis’ 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, Lindsey Rolfe, our Chief Medical Officer, will also be available to answer questions.

Before we begin, please note that during today’s conference call, we may make forward-looking statements within the means 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.

Now I’ll turn the call over to Pat Mahaffy.

Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [3]

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Thanks, Anna. Welcome, everybody. Appreciate you taking the time today. As we all know, the world has changed so much since our last quarterly update in late February. It’s a complicated time for all of you, I know. Health care professionals have been and remain on the front lines of this global pandemic, and I’d like to acknowledge the contributions of health care 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 in our clinical trials and for continuing to prescribe and manage Rubraca commercial patients during this period of significant upheaval to their clinics and practices.

I’ll use our time today to discuss the highlights of the topics you’ve come to expect on 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 and myself.

Let’s begin with the 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 health care providers in person for the last few weeks of 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 from home.

Given these 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 in the chronic COVID environment, that is sure to follow. This period has been very disruptive for hospitals, clinics and patients as health care professionals are redirected, broadly described elective procedures are delayed and health care facilities are converted to support COVID-19 treatment efforts. We do believe that oncology will be among the first health care specialty to return to some normalcy so 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 in 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 in, as I described, physicians are trying to reduce patient visits to their clinics. Unlike Avastin as a maintenance option that requires frequent infusions and weekly monitoring for hypertension, a 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 5 months, Rubraca has been shown to extend progression-free survival, and therefore, subsequent chemotherapy, on average, nearly 14 months by independent assessment, nearly 3x 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 monitoring. As you can see, Rubraca offers numerous potential advantages in a chronic COVID-19 world, and we have already introduced a variety of new digital materials for our now home-based field personnel we use 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, and 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 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 U.S., by the way, approximately 12% of men with metastatic CRPC have a mutation of BRCA1/2 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’ve previously reported at ESMO 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’ve been engaged by — encouraged by our interactions with both the medical oncology and urology 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 we’ll 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 will leverage learnings 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 HCPs to watch from any computer or iPad or any device in their office or home. 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 day of approval. Media and advertising efforts have been weighted toward digital programming versus print to maximize impact and effectiveness of resources invested.

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 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 assure 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 are more adversely affected. I will note that we continue to anticipate completing enrollment in our largest study, the ATHENA frontline maintenance study before the end of this quarter. The LODESTAR study, our 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 recombination repair, or HRR, gene mutation. Based on our interactions with FDA, this study may be registration-enabling for a targeted gene and 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 II 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 lead-in portion of the study.

The Clovis-sponsored Phase III ATHENA trial in 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 2 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 described SEASTAR, our Clovis-sponsored Phase Ib/II study that includes multiple single-arm Rubraca combination studies, including the combination of Rubraca with sacituzumab govitecan, now known as Trodelvy, 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 in advanced solid tumors, which is currently in the dose-finding Phase Ib portion of the study.

Lucitanib, of course, is our investigational inhibitor of tyrosine kinases, including vascular endothelial growth factor receptors 1 through 3, platelet-derived growth factor receptors alpha and beta and fibroblast growth factor receptors 1 through 3. In February 2019, we and Bristol-Myers Squibb expanded our clinical collaboration to include planned combinations of Opdivo with lucitanib. The Clovis-sponsored LIO-1 study is a Phase Ib/II study evaluating lucitanib in combination with Opdivo. LIO-1 is now enrolling patients with advanced solid tumors in the Phase Ib 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 I/II study evaluating multiple combinations with Opdivo including an arm in combination with lucitanib in patients with second-line non-small cell lung cancer. Start-up activities 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 3 additional targets for radionuclide therapy, to which we have global rights. We’ve regarded 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 that are the subject of our planned — or our ongoing discovery collaboration.

Clovis currently plans to submit an investigational new drug, or IND, application for FAP-2286 in the second half of 2020, followed by a Phase I 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 be useful to gain additional experience with FAP-2286 and better understand the characteristics of FAP expression in multiple tumor types, but further will allow us to collaborate with other 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.

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Daniel W. Muehl, Clovis Oncology, Inc. – Executive VP & CFO [4]

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Thanks, Pat, and hello, everyone. We reported net product revenue for Rubraca of $42.6 million for Q1 2020, which included U.S. net product revenue of $39.3 million, and ex U.S., 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.

U.S. 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 U.S. 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 U.S., 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 U.S. sales in Q1 2019. We launched Rubraca in France and Spain during March 2020, so we only expected 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 over time.

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 U.S. 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 and distribution mix for the U.S. and Europe. The number of weeks in 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 patient. We have described product supply costs as a meaningful part of our cash spend over the last couple of years as we transitioned 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 its 4.5% convertible senior notes due 2024 that were initially issued in August 2019. In April 2020, the company exchanged approximately $36 million in aggregate principal amount of its 4.5% convertible senior notes due 2024 in exchange for approximately $32.8 million in aggregate principal of 2021 notes held by such holder. In May 2020, a holder of the 4.5% convertible notes due 2024 converted $24.3 million par value of notes into approximately 3.3 million shares of common stock per the standard terms of the indenture.

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 — outstanding of its 1.25% convertible notes due 2025.

As a result of the transactions noted above, the company has reduced its total outstanding convertible debt by $145.1 million in 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 up to $125 million available to draw under the agreement to fund the expenses of the ATHENA trial through 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 on 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 time frame.

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 U.S. and Europe. We expect savings in selling, general and administrative expenses as a result of the COVID-19 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 our R&D expenses to decrease in 2021 compared to 2020. SG&A expenses should be lower in the upcoming months, and we expect they will be in line with the Q1 2020 levels through 2021. Our inventory purchases and other nonrecurring milestone payment expenses will significantly decrease 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 U.S. All of these factors should contribute to a reduction in quarterly cash burn into and through 2021.

Back to you, Pat.

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Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [5]

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Thanks, Dan. In summary, we’re pleased with our progress in the first quarter, and we believe that Rubraca is well positioned as a 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 to their clinics, and Rubraca offers certain advantages to achieve this goal.

Rubraca is an oral agent delivered to and taken at home. Rubraca has been shown to extend progression-free survival by independent assessment by nearly 14 months on average compared to placebo or observation, which has shown PFS of only 5 months on average. And Rubraca requires only monthly routine monitoring, thus limiting patient visits to the clinic. We believe these qualities offer a compelling argument for clinicians 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 U.S. as well.

We remain focused on managing our net cash utilized ini 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 whom have been working from home since mid-March, and I am grateful for their ongoing commitment to support patients, health care providers and each other during this challenging and unprecedented time.

And with that, we’re happy to answer any questions you may have.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Your first question comes from Kennen MacKay with RBC Capital Markets.

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Kennen B. MacKay, RBC Capital Markets, Research Division – MD & Co-Head of US Biotechnology Research [2]

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Congrats on the operational progress despite the pandemic. Pat, it seems like maybe you really have had some tailwinds from the 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 and the chemotherapies that are out there have maybe even more toxicity than the PARP class?

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Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [3]

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Yes. As you’re aware, both ASCO and FDA have encouraged physicians to consider oral therapeutics as they consider treatment options for patients. And obviously, we hope and believe that, that will 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.

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Operator [4]

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Your next question comes from Gena Wang with Barclays.

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Huidong Wang, Barclays Bank PLC, Research Division – Research Analyst [5]

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Maybe first one is, any geographic differences in terms of a COVID-19 impact regarding launch? And also, second question is regarding the prostate cancer. Should we actually expect any revenue in second quarter?

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Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [6]

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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, at least new patient starts in New York, maybe even during the quarter. As to the prostate cancer launch, there will likely be some hotspots, where distractions to the health care system occur and could temporarily impact on prescribing. I will say that with a PDUFA date on 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 6 weeks of sales.

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Huidong Wang, Barclays Bank PLC, Research Division – Research Analyst [7]

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Okay. That’s very helpful. If I may just squeeze one more question. Any thoughts on ZEJULA approval in the first-line ovarian cancer? And then, how would that impact the competitive landscape and your ATHENA trial readout?

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Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [8]

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

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Operator [9]

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Your next question comes from Michael Schmidt with Guggenheim Securities.

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Yige Guo, Guggenheim Securities, LLC, Research Division – Associate [10]

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This is Yige on for Michael. Congrats on the quarter. We got a few questions on Rubraca commercialization in 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 talk about the latest dialogue with partners in terms of the advancing regulatory preparation for prostate cancer?

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Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [11]

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Yes. I would be uncomfortable talking about any dialogue that 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 at the diagnostics division are being directed to COVID-19. But I think that I’d 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.

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Yige Guo, Guggenheim Securities, LLC, Research Division – Associate [12]

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

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Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [13]

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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 we, as Dan said in his prepared remarks, there may be some impact on PAP 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’ve suffered greatly and lost their jobs in this environment. But I think that we have learned how to manage the PAP program, and we’ll continue to apply those learnings from ovarian to the prostate cancer setting.

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Yige Guo, Guggenheim Securities, LLC, Research Division – Associate [14]

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

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Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [15]

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Obviously, as the owner and developer of Rubraca, I think, it should be used 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.

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Operator [16]

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Your next question comes from Paul Choi with Goldman Sachs.

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Kyuwon Choi, Goldman Sachs Group Inc., Research Division – Equity Analyst [17]

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And let me also offer my congratulations on the commercial progress. I have 2 questions. And first is just maybe to 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 and perhaps 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 have a follow-up with a clinical question.

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Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [18]

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

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Daniel W. Muehl, Clovis Oncology, Inc. – Executive VP & CFO [19]

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Yes. So somewhat hard to predict them. So many demographics playing to 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 in more Part D patients, which could potentially have some effect on GTN. And so I think that’s probably the one area where you 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.

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Kyuwon Choi, Goldman Sachs Group Inc., Research Division – Equity Analyst [20]

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Okay. And then with regard to the next set of trials for the 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, can you maybe just help us sort of understand time lines, where you would be poised, because I think you should have sort of dose-finding data relatively soon, and just how you think about maybe potential next steps and data readouts after this upcoming set of data readouts in the fall?

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Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [21]

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Yes. I would expect that we will submit to ESMO, and we are targeting ESMO. Obviously, we don’t even know if there’s going to be an ESMO, or if there is an ESMO, if it’s still — almost certainly, I think, it will be virtual, but they haven’t said that yet. So that’s the first answer.

I would anticipate pending enrollment pattern that by either ASCO, or at the latest, ESMO next year, we’d have a more complete presentation of the combination data.

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Operator [22]

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Your next question comes from Cory Kasimov with JPMorgan.

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Gavin Scott, JP Morgan Chase & Co, Research Division – Analyst [23]

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This is Gavin on for Cory. We just had one on the competitive landscape within prostate. Trying to get your sense of — or any updated thoughts on the launch in the context of 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.

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Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [24]

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Yes. So a couple of things. We’re delighted that there will only be 2 of us, unlike ovarian where there are 3, 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 this 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 reads out 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.

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Operator [25]

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

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Tazeen Ahmad, BofA Merrill Lynch, Research Division – VP [26]

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Pat, maybe just a quick one on the PAP program. I know you’ve answered a couple 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.

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Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [27]

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Yes. So one is, as you may remember, the funding — the independent funding of these foundations that can 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 the 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 copay managed. 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.

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Tazeen Ahmad, BofA Merrill Lynch, Research Division – VP [28]

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Okay. And maybe one question on prostate. Since this launch, as you mentioned at the beginning, is going to be done mostly, if not all, at least initially, through a virtual contact point, 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 salespeople trying to see doctors in person? Is that the right way of thinking about it?

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Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [29]

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Yes. I’ve 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, but the pharmacists, admin staff, et cetera. That being said, it’s a lot of car travel, in some cases, plane travel, and it’s pretty limited to 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 and encouraging our team to reach beyond those who we know are known prescribers of Rubraca or likely to prescribe Rubraca if and when — assuming we get the prostrate 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 a Zoom, rather than an in-office visit. But I agree with the premise of your question. We should be able to reach more people.

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Operator [30]

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Your next question comes from Andrew Berens with SVB.

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Andrew Scott Berens, SVB Leerink LLC, Research Division – MD of Targeted Oncology & Senior Research Analyst [31]

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Maybe one on the COVID impact on the quarter and one on the balance sheet. I’ve heard from some companies that there’s 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 should we think about that going forward?

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Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [32]

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No, no, no. We did not. Our scripts are 30 days. We had 11 patients — 11 patients in the quarter who got greater than 45 days. So no, we’ve seen no stockpiling. 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.

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Andrew Scott Berens, SVB Leerink LLC, Research Division – MD of Targeted Oncology & Senior Research Analyst [33]

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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 and amidst the COVID environment?

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Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [34]

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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 have 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.

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Operator [35]

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(Operator Instructions) Your next question comes from Ed White with H.C. Wainwright.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division – MD of Equity Research & Senior Healthcare Analyst [36]

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So you had mentioned ZEJULA 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 3 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, if you have any thoughts on the market share of Avastin with second-line versus the PARPs versus observation?

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Patrick J. Mahaffy, Clovis Oncology, Inc. – Co-Founder, CEO, President & Executive Director [37]

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Yes. We think — first of all, we had one physician come to us and say that she had 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 would have about Avastin, not only that it’s an infusion product and requires a visit to the clinic but there have been 3 primary comorbidities associated with COVID-19 as a real risk factor, that’s diabetes, obesity and hypertension. And the grade 3/4 incidence of hypertension on 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’re 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 the second-line maintenance.

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Operator [38]

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

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Anna Sussman, Clovis Oncology, Inc. – VP of IR [39]

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Thanks, Jessie. Thanks, everyone, for your interest in Clovis Oncology today. If you have any follow-up questions, you can call me at (303) 625-5022 or Breanna, (303) 625-5023. This call can be accessed via replay on our website 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. Goodbye.

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Operator [40]

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



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