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Clovis Oncology (NASDAQ: CLVS) 3Q20 Earnings Call Transcript


Ladies and gentlemen, thank you for standing by, and welcome to the Clovis Oncology Third Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. To ask your question during the session, you will need to press star one on your telephone. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Anna Sussman, Vice President, Investor Relations. Thank you. Please go ahead.

Anna Sussman

Thank you, Tamia. Good morning, everyone, and welcome to the Clovis Oncology third quarter 2020 conference call. Thank you for joining us. You’ve likely seen this morning’s news releases. If not, they’re 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: Pat Mahaffy, our President and CEO, will review the highlights of today’s corporate update. Then Dan Muehl, Clovis’ Chief Financial Officer, will cover the quarter’s financial results in greater detail. Patrick 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.

Some of our analysts have alerted us that today is a heavy reporting day for Q3 results. If you’re unable to stay for Q&A and haven’t already let us know, please send us an e-mail, and we’ll set up the time to speak post-call.

Before we begin, please note that during today’s conference call, we may make forward-looking statements within the meaning of the federal securities laws, including statements concerning our financial outlook and expected business plans. All these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in 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, we will be discussing cash burn and non-GAAP financial measures 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 Mahaffy

Thanks, Anna. Good morning, and welcome, everybody. We appreciate your time on what I understand is a pretty busy earnings day. Despite the ongoing effects of COVID-19 on oncology practices, we achieved $38.8 million in Q3 revenues and achieved year-over-year sales growth. Today, we are also providing fourth quarter guidance of $38 million to $40 million, in line with third quarter revenues as we anticipate the ongoing impact of COVID-19 on patient diagnosis, patient visits and access to oncology practices to continue. Reflecting particularly any issues related to in-person access by sales reps and significant changes in how physicians increasingly prefer to access information related to promotional products, I’ll discuss some changes we are making to our U.S. commercial strategy, with the goal of returning to growth as rapidly as possible, especially as the ongoing impact of COVID-19 is resolved over time.

I’ll begin with the quarter’s commercial update for Rubraca. Our global net revenue for the third quarter of 2020 was $38.8 million. Dan will describe these results in greater detail. Broadly, we saw year-over-year growth, and on a sequential basis, softening in U.S. revenues and growth in ex U.S. revenues compared to the prior quarter. Importantly, about half of the U.S. sequential decline from Q2 to Q3 was increased gross to net adjustments, and the other half was due to lower volume primarily due to increased free goods. Of course, in each of Q2 and Q3, revenues were impacted by COVID-19 due to fewer diagnoses and fewer patients going to in-person office visits as oncology practices and patients continue to adapt to the impact of the virus.

Commercial patient starts in Q3 were consistent with what was observed in Q2. An additional effect of COVID-19 is that it substantially accelerated what was already a trend toward reduced in-person access by 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 and communication that can be accessed on their own time. Accordingly, we have adopted a new commercial strategy to meet these preferences. Our new 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. This hyper strategy does not require a larger U.S. commercial organization, so we’ve made the difficult decision to reduce the size of our organization by approximately 45 employees. As a result, our U.S. commercial team now numbers approximately 85 people.

For those of you who may wonder if this reflects a reduced commitment to Rubraca, it is in fact the opposite. 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. While we do anticipate a net cost savings of approximately $10 million on an annual basis due to this reduction, including the effect of an increased investment in digital promotion, that was not the primary driver of these changes. We are adopting this hybrid strategy in order to better reach physicians the way they want to be reached, utilizing resources customized to their practices with the goal of returning to growth, in particular the ongoing impact of the virus resolves over time.

Turning to Europe, we did see our best sales performance ever during the third quarter. While we are pleased with our progress in Europe, as you’ve all read, like in the United States, COVID-19 has made a significant return to Europe, and clinics that had reopened to in-person promotion are again shut down. It is hard to predict the impact of the second lockdown on cancer patient visits and diagnoses.

With regard to about being a similar hybrid model in Europe, we already have a smaller commercial organization and have been utilizing virtual communication in each of our primary territories as regulations allow. National regulations vary among European countries and as compared to the United States. So it would also be much more complicated to adopt exactly the same hybrid model in Europe as we are doing in the United States.

In late August, Foundation Medicine was granted FDA approval for the FoundationOne Liquid CDx, their companion plasma-based diagnostic for multiple indications, including Rubraca. Prior to this, other diagnostics were available, but we could not actively promote them. In early October, the FDA-approved companion diagnostic was added to the Rubraca U.S. label. So as of about a month ago, we can now direct clinicians to an FDA-approved companion diagnostic for use with Rubraca in prostate cancer.

Also during the quarter, data from the TRITON2 study of Rubraca for the treatment of metastatic CRPC harboring BRCA 1 or 2 mutations were published in the Journal of Clinical Oncology. These data supported the accelerated approval and provide additional details about the study and about Rubraca as a treatment option for eligible patients. While still a modest contributor to U.S. revenues, sales in this prostate indication more than doubled in Q3 compared to Q2.

Let me turn to our pipeline for Rubraca and lucitanib as well as our clinical plan for FAP-2286. As usual, we hope to provide a more detailed update on milestones in January at the JPMorgan Virtual Conference. I’m pleased to report that on the development front, the effect of COVID-19 on our clinical trials enrollment remains minimal. We continue to adhere to the regulatory guidance that FDA and other agencies have provided regarding clinical trial conduct or in COVID-19, and we are grateful to our clinical teams and investigators who work tirelessly to assure the safety of trial participants and investigators while maintaining compliance with good clinical practice and minimize risk to the integrity of our trials.

At the virtual ESMO Conference in September, we were pleased to present data for each of our 3 compounds: Rubraca, lucitanib and FAP-2286. This included initial data from the Phase 1b part of the LIO-1 trial of lucitanib, combined with Opdivo in advanced metastatic solid tumors as both identified a recommended Phase 2 dose of lucitanib for the combo and showed promising signs of anti-tumor activity. Phase 2 part of the study is now enrolling, and the trials in progress e-poster presented at ESMO characterizes the safety-based dose titration approach utilized in Phase 2 to manage tolerability and optimize dose intensity of the lucitanib and Opdivo combination. It also included our first presentation of preclinical data for FAP-2286, our novel peptide targeted radionuclide therapy.

Data presented show that the compound potently and selectively bind fibroblast activating protein and FAP expressing tumor models for compelling anti-tumor activity. I’ll discuss the planning for clinical development program for this compound shortly.

Initial Phase 1b data from the SEASTAR evaluating Rubraca in combination of Trodelvy suggests encouraging initial activity for the combination. Obviously, with the acquisition of Immunomedics by Gilead, we don’t know presently where this combination may fit into Gilead’s priorities. We’re glad to hold the first major conference presence of our increasing pipeline activities and we anticipate multiple clinical development and regulatory milestones for our pipeline compounds in 2021. I’ll highlight some of them here.

For Rubraca, we anticipate clinical data from the ATHENA monotherapy arm in the second half of 2021, following the successful completion of enrollment in the Phase 3 1,000-patient study in frontline newly diagnosed advanced ovarian cancer earlier this year. With ATHENA, we believe we are uniquely positioned to evaluate Rubraca in terms of 2 outcomes. First, as monotherapy versus placebo in the frontline 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, secondly, in the same patient population. ATHENA is the first frontline maintenance study designed to show both PARP monotherapy and PARP PD-1 combination therapy from one study design.

I’ll take a moment to review the analysis plan for ATHENA. First, as expected in the second half of 2021, we’ll see the results of Rubraca monotherapy versus placebo in all study populations. And then probably about a year later, we will see the results of Rubraca plus Opdivo versus Rubraca in all study populations. In each of these analyses, we will evaluate first the outcomes in the HRD population, which includes BRCA and then step down to the entire intent-to-treat population. We believe this study offers an opportunity to truly differentiate Rubraca in the firstline maintenance setting.

Continuing with potential 2021 milestone for Rubraca, the LODESTAR study, our Phase 2 pan-tumor study to evaluate Rubraca in homologous recombination with [pyridine], including BRCA1 and BRCA2 across tumor type, continues to enroll patients. The study will evaluate Rubraca in patients with recurrent solid tumors associated with deleterious homologous recombination repair, or HRR, gene mutation. Based on our interaction with FDA, the study may be registration-enabling for a targeted gene and tumor-agnostic label. Pending data would be potentially viable for approval in United States for this indication in the second half of 2021.

And the newest Phase 3 clinical trial for Rubraca is the CASPER study being sponsored by the Alliance for Clinical Trials in Oncology, which is part of the National Cancer Institute. CASPER is a Phase 3 study comparing enzalutamide in Rubraca to monotherapy enzalutamide and placebo as a novel therapy topline CRPC in an all-comer population. Approximately 1,000-patient study is expected to commence enrollment soon.

Let me turn to lucitanib, which of course 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. In addition to the Rubraca and Opdivo combos being evaluated, our clinical collaboration with Bristol-Myers Squibb includes both ongoing and in combination of Opdivo with lucitanib. The Clovis-sponsored LIO-1 study is a Phase 1b/2 study evaluating lucitanib in combination with Opdivo. As discussed, the Phase 2 portion of the LIO-1 study in gynecological cancers is enrolling patients, and we anticipate presenting interim updates from this study at medical meetings into 2021.

Let me turn to FAP-2286 and our radionuclide therapy development program. We remain very enthusiastic about this 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. We are very encouraged by the recent preclinical data for FAP-2286 in animal models presented in the e-poster at ESMO and we look forward to sharing additional preclinical and clinical data at future medical meetings.

In addition, we and 3BP are collaborating on a discovery program directed to 3 additional targets for radionuclide therapy, to which we have global rights. We 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 discovery collaboration.

Both have currently planned to submit to investigational new drug applications for FAP-2286 in relatively close succession during this quarter to evaluate FAP-2286 for use both in imaging and treatment agents. Overall for the INDs by the FDA, we intend to initiate a Phase 1 clinical study to determine the dose and tolerability of the FAP-targeting therapeutic agent, with the expansion cohorts planned in multiple tumor types as part of a broad development program. The FAP targeting imaging agent will be utilized to identify tumors that contain FAP for treatment in the Phase 1 clinical study.

In addition to our own science studies, a leading U.S. academic institution is sponsoring a separate imaging-only study with FAP-2286 to evaluate FAP expression in multiple tumor types, and I’m pleased to say that their IND has already been authorized by the FDA, and they are expected to initiate their study in the next several weeks. Results from this study, along with preclinical data we are generating are expected to help inform selection of tumor types for our planned Phase 2 expansion cohorts.

In my experience, it’s fairly unusual that an academic institution would conduct a study so early in the development of a drug, and I think it speaks to the enthusiasm we see largely in academic settings about targeted radionuclides in general and more specifically to FAP as an actionable target.

And with that, I’ll turn the call over to Dan to discuss third quarter 2020 financial results.

Daniel Muehl

Thanks, Pat, and hello, everyone. We reported net product revenue for Rubraca of $38.8 million for Q3 2020, which included U.S. net product revenue of $33.9 million and ex-U.S. net product revenue of $4.9 million. This includes a modest amount of net revenue from our new prostate indication in the U.S. for the first full quarter of revenues. Third quarter 2020 net revenue represents a 3% increase over Q3 2019, in which we reported net revenue of $37.6 million, including net product revenues in the U.S. of $36.5 million and ex U.S. of $1.1 million.

For the 9 months — first 9 months of 2020, we reported net product revenue for Rubraca of $121.2 million compared to $103.7 million for the first 9 months of 2019, an increase of 17%. Net product revenue decreased 2.8% sequentially from Q2 into Q3 2020. U.S. product revenues decreased 7.8% sequentially from Q2 to Q3 2020. This was offset by an increase in the ex-U.S. net revenue from $3.2 million in Q2 2020 to $4.9 million in Q3 2020, a 56.2% increase.

It is important to note, however, that about half of the U.S. sequential decline from Q2 to Q3 was increased gross to net adjustments, and the other half was due to lower commercial volume, primarily due to increased free goods. The effects of COVID-19 on our business and operating results are difficult to assess or predict, in particular given the increase in cases in major markets in the U.S. and Europe. As our guidance of $38 million to $40 million suggests, we anticipate a continued impact on revenues related to COVID-19 for the remainder of 2020.

Gross to net adjustments totaled 25.1% in Q3 2020 compared to 19.4% in Q2 2020. The sequential increase in gross to net adjustments reflect primarily an increase in the U.S. contracting and government-related programs and increasing ex-U.S. net revenues, which have a higher percentage gross to net compared to the U.S. Gross to net is 22.4% for the year through the end of the third quarter and fluctuates quarter-to-quarter. It is difficult to estimate our future revenues, but a range of the low to mid-20% seems likely, depending on the revenue and distribution mix for the U.S. and Europe. Additionally, our free goods percentage increased from 16.5% in Q2 to 20.9% in Q3. Weeks of distributor inventory was comparable at the end of Q3 versus Q2, so no meaningful impact.

Research and development expenses totaled $62.9 million for Q3 2020 compared to $77.9 million for the third quarter of 2019. R&D for the first 9 months of 2020 totaled $201 million compared to $210.7 million for the first 9 months of 2019. R&D expenses were lower in the quarter and the first 9 months of 2020 compared to 2019, primarily as a result of lower spending on 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 $38.6 million for Q3 2020 compared to $41.8 million for Q3 2019. Selling, general and administrative expenses for the first 9 months of 2020 was $123.1 million compared to $137.6 million for the first 9 months of 2019. Selling, general and administrative expenses decreased during the third quarter and the first 9 months of 2020, partly resulting from savings due to the COVID-19 situation globally. And disciplined cost control efforts. We expect continued decreases in SG&A expenses related to the restructuring of the U.S. commercial organization, amounting to approximately $10 million annually.

We reported a net loss for Q3 2020 of $78.7 million or $0.89 per share compared to a net loss for the third quarter of 2019 of $94.1 million or $1.72 per share. We reported a net loss for the first 9 months of 2020 of $270.3 million or $3.37 per share compared to a net loss of $300.9 million or $5.62 per share in the comparable period in 2019. Net loss for the third quarter and the first 9 months of 2020 included share-based compensation expense of $12.5 million and $38.8 million compared to $14 million and $41.7 million for the same periods in 2019.

Turning now to a discussion of cash. As of the end of September 30, we had $224.7 million in cash and equivalents. And as of September 30, we had drawn approximately $85 million under the TPG ATHENA clinical trial financing and had up to $90 million available to draw under the agreement to fund expenses of ATHENA trial through Q3 2022. Based on the company’s anticipated revenue spending, available financing sources and existing cash and cash equivalents, and not including the convertible notes sale announced today, we believe we have sufficient cash and cash equivalents to fund our operations into early 2022, including any cash repayment unless financed earlier of the remaining $64.42 million in aggregate principal of the 2.5% convertible notes at the maturity in September 2021. Assuming the completion of the sale of the $50 million of convertible notes announced earlier today, the addition of proceeds are anticipated to fund the company’s operating plan into early 2023.

Net cash used in operating activities was $54.3 million for Q3 2020 compared to $59.9 million for Q2 2020 and $57 million for Q3 2019. Similarly, net cash used in operating activities for the first 9 months of 2020 was $196.7 million compared to $253.5 million for the same period in 2019.

Cash burn in Q3 2020 was $37.7 million, a 25% sequential decrease from Q2 2020 cash burn of $50.1 million. Borrowings under the TPG ATHENA financing provided $16 million in cash in Q3 2020. Cash burn in the first 9 months of 2020 was $154.7 million. We continue to manage cash carefully to manage our runway into 2022. And including the potential proceeds from the financing announced today, into 2023. We expect cash burn to decrease for the second half of 2020 compared to the first half of 2020 and for the full year 2021 compared to 2020.

Now I’ll turn the call back to Pat.

Patrick Mahaffy

Thanks, Dan. Despite the evident challenges of COVID-19, we were able to deliver a year-over-year increase in Rubraca sales. And with the optimization of our U.S. commercial strategy, we believe we are well-positioned for growth, especially when the ongoing impact of COVID-19 is reduced.

During the third quarter, we were pleased to present for the first time data across our pipeline, including Rubraca lucitanib and FAP-2286 at the virtual ESMO Conference. We remain focused on our growing pipeline activities. And in 2021, we anticipate multiple meaningful clinical development and regulatory milestones across our pipeline. Critical to that pipeline is FAP-2286, and we remain on track both in imaging and the treatment IND for FAP-2286 by the end of this year.

In 2021, we anticipate the following milestones: initial monotherapy data from the ATHENA study, which is the first frontline switch maintenance study designed to evaluate PARP monotherapy and PARP plus PD-1 combination therapy in one study design; presentation of interim data from the LIO-1 combination study of lucitanib and Opdivo at medical meetings; sufficient data from the Rubraca LODESTAR trial to support a potential filing for a targeted gene and tumor-agnostic supplemental NDA; and initiation of the Phase 1 clinical program for FAP-2286.

We also remain focused on disciplined cost control. And as an example of this commitment, even with a modest decline in sales compared to Q2, we reduced our cash burn by 25% in Q3 compared to Q2. And as Dan described, assuming the completion of the sale of the $50 million of convertible notes announced today, we believe we have sufficient resources to fund our operations into early 2023 or over 2 years of cash.

With that, I’ll be happy to answer any questions here.

Question-and-Answer Session


Your first question comes from the line of Paul Choi with Goldman Sachs.


This is [Kim Jennings] on for Paul. I was wondering if you could about the productivity of your virtual selling efforts related to in-person activities? And how much you could actually expand the number of doctors you’re in contact via this new model?

Patrick Mahaffy

Yes. I think you’re going to hear this from just about everybody. A model where we have a large number of sales reps trying to contact physician-customers from home is pretty hard. And access is still very limited to in-person promotion in the United States. And probably, in most of our territories, there may be a clinic, maybe a physician who would be willing to see a sales rep. But for the most part, it’s a really limited number now. And I will tell you, I think it is not as productive as in-person meeting. In-person meetings allow you to go into the clinic and talk to the nurses and the administrators and hope to get a little time with the physician. So it’s hard to arrange all of that on Zoom calls or WhatsApp in Europe?

The switch we’ve made in the United States, which we initiated in October, is to target our in-person promotion over time to a smaller number of physicians who we know are active PARP inhibitor writers, and to augment that with a significant amount of digital communication, which can be anything from banner ads to peer-to-peer communications and chat rooms that allow the physician to access the information he or she desires to get, in the methods they prefer and at the time of their own choosing, not just when the rep may be trying to schedule a call.

I am — we have spent a ton of time on the development of this hybrid model. We made the painful decision to reduce our commercial organization by 45, because we think this targeted group will be more effective and be highly aided by the digital approaches we’ve begun to initiate in October, and we’ll continue to roll out over the course of this quarter and into next year.


And then as you think about FAP-2286 and then radionuclide therapies more broadly, do you expect this to move forward as monotherapy, either as a potential combination agent? And what kind of combinations would make sense for those kinds of assets?

Patrick Mahaffy

Yes. So I suspect almost any development program, we will initially evaluate 2286 as monotherapy, radio-labeled with Lutetium, which is the same radionuclide that is in LUTATHERA, the approved somatostatin targeted radionuclide and is the same radionuclide being used in the VISION trial of Novartis PSMA-617. We have spent quite a bit of time trying to prioritize what we would be most excited about pursuing next. And I think in order — rather than initiating immediately a combination therapy, the hope we have is that we can label — we know we can label 2286 with actinium, which is an alpha emitter. And we think that could result in even greater efficacy than that would be seen with lutetium. We’re going to get a sense of — a very good sense from the academic center I referenced in imaging as well as our own Phase 1 trial with lutetium about distribution beyond, of course, the tumor. And if we see that we don’t, as we believe we won’t see accumulation in off-target organs other than if the drug is eliminated, we think we would be able to deliver actinium and that could lead to greater activity. So our number 2 priority is actinium. Number three would be a combination of either a lutetium or actinium label 2286 with the PD-1 — an anti PD-1 antibody.


Our next question comes from the line of Andrew Berens with SVB Leerink.

Andrew Berens

Sorry if I missed this in the prepared comments, but we’re juggling a number of calls. I was wondering if you could share any of the commercial metrics you have regarding the prostate cancer expansion for Rubraca. How is the PARP class doing as a whole and what market share do you have? And then I have a question on LODESTAR and on tumor-agnostic label after that one if it’s okay?

Patrick Mahaffy

Yes. We don’t have good metrics yet, Andy, on market share. We are definitely behind AstraZeneca. They have a better label than we do. When they were given by FDA all of those mutations beyond BRCA, it created a disadvantage for us, which we have to acknowledge. I think utilization will increase of PARP inhibitors in prostate cancer and has been adopted by, in particular, many urology practices. And I think that our share will be low until we get through the — our own ongoing Phase 3 study, which would allow us potentially to have an additional mutation, which is ATM and definitely the earlier line.

On the other hand, we do have some early adoption. And while our sales numbers are relatively modest thus far, we did see growth in Q2, and we anticipate — in Q3, excuse me. And we see continuing growth over the course of the next several quarters as our drug is adopted and as physicians, and particularly urologists, become familiar with managing any side effects of any PARP inhibitor.

Andrew Berens

And then with regards to the tumor-agnostic label, I think we probably talked about this before, but I know there’s been some subsequent approvals for the PARPs and other tumor types. How many do you need to have to convince the regulatory authorities to grant such a label? And then do all the tumor types that are in the trial have to share meaningful responses over the alternative therapies?

Patrick Mahaffy

It’s going to be just around 100 patients in total in 4 or 5 different tumor types. And to remind you, it’s — while we’ve talked about BRCA1 and BRCA2, there’s a total of 5 inclusive of BRCA1 and BRCA2 in patients, I think it’s likely, FDA is going to evaluate the efficacy of Rubraca against what other agents have already been approved for use in those tumor types. I think that’s highly realistic.

Andrew Berens

Okay. And if it’s 1 out of the 5 is not better than the standard of care, is that potentially a problem? Or will they look at the totality of the other tumor types?

Patrick Mahaffy

Tough to know. I would hope they would look at the totality of the tumor types. I’ll give you an example, if they were to apply the standard that they applied to AstraZeneca’s approval and Part C of their prostate study, then I think we would get it all.


Your next question comes from the line of Joe Catanzaro with Piper Sandler.

Joe Catanzaro

Maybe similar to the last question but a different indication. I’m wondering if you could speak to the market share trends for Rubraca in the recurrent maintenance setting and whether it’s remained stable as others face the same headwinds. And at this point, are you seeing any impact from the adoption of first line maintenance? And just as a follow-up to that, with regards to 4Q guidance, just wondering what your assumptions are around the U.S. and EU trajectory, whether you expect to see something similar that you saw in 3Q or the expectations that both geographies will remain stable quarter-over-quarter.

Patrick Mahaffy

Yes. I think things have been fairly consistent in the second-line maintenance market as to our market share and our competitors. Each of AstraZeneca and GSK attributed the growth they saw in Q3 to adoption in the frontline maintenance setting. And I’m not surprised by that. It’s one of the reasons we’re so excited about the opportunity to compete in that market and to see the data from our ongoing ATHENA trial. We do not see an impact from adoption of frontline maintenance on the second-line maintenance market.

When you think about patient flows, those frontline approvals and launches will have to have occur somewhere between 15, 16, maybe as many as 20 to 24 months post-launch before from a patient flow standpoint, it’s going to start impacting on second-line maintenance studies — second-line maintenance, excuse me, use.

And I forgot the last part of your question. So if you can ask that last part again, I’ll answer.

Joe Catanzaro

Yes. Yes, sure. No, that was helpful. But the last part was just around 4Q guidance and your assumptions there, whether you expect to see something similar with regards to U.S.-EU trends, or are they expected to be stable quarter-over-quarter in both geographies?

Patrick Mahaffy

We think they’re going to be stable in both geographies.


Your next question comes from the line of Cory Kasimov with JPMorgan.

Gavin Scott

This is Gavin on for Cory. I just had a quick question on the patient recruitment rate for Phase 2 LIO-1 study. I know on the call you said there was limited impact to recruitment across the board. But how is this going to be impacted given the resurgence we’re seeing in COVID-19? And any potential timing?

Patrick Mahaffy

Yes. We did not see any impact on enrollment in any of our trials from the first wave of COVID-19, and that resulted in a lot more — that — the impact at that time was huge, just given the huge impact on managing practices that had not considered pandemic as a part of their practice management. They’ve gotten used to managing this. I think they know how to manage their patients and patient visits. And we have been exceptionally pleased with the pace of enrollment in LIO-1 thus far, and I think — in the expansion cohort. And I think that reflects on the great desire for new options — new treatment options in gynecological cancers. We do not think we’re going to see a meaningful impact on that continuing enrollment, even with the resurgence in the United States. The majority of that trial, in fact maybe all of the centers so far, are in the United States. But we aren’t anticipating an impact. Obviously, if COVID were to get completely out of hand, and it could be. But at its present rate, we don’t expect an impact.


At this time, there are no further questions. I would like to turn it back over to Anna Sussman for closing remarks.

Anna Sussman

Thank you. Thanks, everyone, for your interest and your time today. If you have any follow-up questions, you can reach me at (303) 625-5022 or Breanna at (303) 625-5023. This call will be accessed via replay on our website beginning 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. .


Ladies and gentlemen, this concludes today’s conference call. Thank you for participating. You may now disconnect.

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