Q4 2020 Clovis Oncology Inc Earnings Call
Okay.
Yes.
Ladies and gentlemen, thank you for standing by and welcome to the Clovis Oncology 2020 operating results webcast conference call.
At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question during the session Elite 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 MS. Anna Sussman VP of Investor Relations and corporate Communications. Please go ahead.
Thank you very much good morning, everyone and welcome to the Clovis oncology fourth quarter fiscal year 2020 conference call. Thank you for joining us you've likely seen this morning's news release, if not it is available on our website at Clovis oncology dotcom.
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, our President and CEO will review the highlights of today's corporate update and Rebecca commercial progress.
Dr. Thomas Harding, our Chief Scientific Officer will review the S. E T. Two to eight six program Dr.
Dr. Lindsey Rolfe, our Chief Medical Officer will discuss the anticipated clinical milestones from US we broke out in the fitness during 2021.
Then Dan Muehl, our Chief Financial Officer will cover the quarter on years financial results in more detail Patrick.
Patrick will make a few closing remarks, and then we'll open the call for Q&A during which time, Pat downtown and Lindsay will be available to answer questions.
Before we begin please note that during today's conference call. We may make forward looking statements from the means of the federal securities laws, including statements concerning our financial outlook unexpected business plan.
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 extension of 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.
Additionally, please note that we'll be discussing cash burn a non-GAAP financial measure during todays conference call required disclosures related to this are in todays news release, which can be found on our website now I'll turn the call over to Patrick Mahaffey.
Thanks Dana.
And welcome everybody appreciate your time today.
We're pleased with our overall sales performance from 2020, given the ongoing effects from COVID-19 on fusion diagnoses patient visits and access one call would be called practices, which we get them on March last year.
Even though patients diagnosed people down approximately 15% in January this year compared to January 'twenty based on data we've seen.
We are not currently providing 2021 sales guidance of the ongoing effects from the tightening of the recovery from Covid are difficult to predict.
I'm extremely pleased with the progress made in 2020, EBIT single pipeline, which positions us for meaningful milestones in 'twenty and 'twenty, one, including initiating clinical development program for F. 'twenty 286 in the first half of the true announcing top line that seem to be there for the back on monotherapy versus placebo arm and the <unk>.
Half of the true.
Presenting initial efficacy data from a legal one sitting here at the home depot combination at medical meetings later this year.
Turning now to other rubric for a commercial update for <unk>.
Global net revenue from the fourth quarter of 2020 was $43 3 million and for the fiscal year 2020, $164 5 million up 10, and 15% respectively over the comparable prior year period.
And of course describe these results in greater detail.
Over the course of 2020 revenues were impacted by COVID-19, due to pure diagnose income fueled is at school and too few patients going to in person office visits is on all of your practices and patients are adapted to the impact of the virus.
An additional effect of COVID-19.
Substantially accelerated what was already a trend towards reduced in person access to academic and community based clinics for sales reps.
This reduced access to oncology practices will continue.
And then if you've ultimately controlled.
Practices increasingly preferred digital programming communications can be access on their own time.
To address the changing environment last quarter, we announced a new commercial strategy can you be perfect.
That strategy embraces a hybrid approach that elevates easily accessible digital programming virtual communication and peer to peer interactions.
In person promotion will be reduced and those remaining in prison activities will be much more targeted.
We are energized about this from the strategy and believe that we are in fact, an early adopter of a trend that will be increasingly come from from all of your marketers in.
In fact, several companies across the industry given that similar changes in recent months.
We are adopting this hybrid strategy in order to better position the way they want it.
Utilizing resources customized to their practices with the goal of accelerating growth in particular as the ongoing impact from the virus from bolt.
It's a little early to provide performance indicators from this program, but as the year goes on we will be providing updates on progress from this hybrid model.
With regard to the U S prostate indication fulfill a modest contributor to U S revenue sales of a bracket in the prostate indication continued to grow in Q4 over Q2.
Turning to Europe, we're very pleased with our progress to be despite the third COVID-19, Lockdowns is currently in place.
As in the U S from its difficult to predict the impact of COVID-19 on cancer patient visits from diagnosis.
On the longer term impact on cancer patient care.
We have a smaller commercial organization in Europe and had been utilizing virtual communication with each of our primary territories as regulations allow.
While national regulations vary among European countries, and as compared to the United States. We are seeking to tailor our hybrid digital strategy for each country to better reach our clinical condition. Good Friday.
Now, let me turn on the call over to Dr. Thomas Harding, our Chief Scientific officer to discuss the F. 22, 86 program, which was a topic of growing interest.
Move toward clinical development during the first half from 2020 months from.
Thanks Pat.
Hello, Oh I'm.
In total Thomas housing in some places to speak to each day.
As mentioned, we are very enthusiastic about our peptide targeted radionuclide therapeutic program and in particular, our lead compound.
<unk> 22, 86, which we expect to enter into clinical development in the next few months.
Peptide targeted radionuclide therapy juices cancer targeting peptides to deliver radiation limiting isotopes specifically to tumors.
When injected into a patient's bloodstream targeting peptide attaches to cancer cells, delivering high doses of radiation to the tumor while sparing normal tissue.
Our lead compound FAP.
Two P 22, 86, which we license as part of ongoing collaboration with <unk> Pharmaceuticals is our first therapeutic candidate that targets fibroblast activation protein.
A P.
S. A P is highly expressed on cancer associated fibroblasts or cash, which represent one of the most abundant cell components in tumors and they found in the majority of cancer types potentially making it a suitable target across a wider range of solid tumors, including breast lung colorectal and pancreatic carcinomas.
Hence associated fibroblast play a critical role in tumor initiation progression and metastasis and therapeutic resistance.
For example, recent studies have demonstrated F a pigs per cent cash.
Potent immunosuppressive activity.
Promote tumor progression and confer resistance to immune based therapies, such as PD, one on PD lone blockade.
And certain cell types, such as sarcoma mesothelioma.
<unk> may also be expressed on the tumor cells. In addition to the cancer associated fibroblasts.
F. 22, 86 consists of two functional elements first the targeting peptide that binds to F. P Express from cash from tumor cells and second a site that can be used for the attached radioactive isotopes.
Depending on the specific radioactive isotope attached to.
I say P. 22, 86 can be used for patient imaging and selections for therapeutic use.
And on phase one to Lumi S. W. S.
22, 86 would be attached to the isotope gallium 68 to allow positron emission tomography or pet imaging and selection of patients for inclusion into the study.
For the therapeutic agent.
22, 86 will be attached to the isotype lutetium 177 in the midst of beta particle ionizing radiation that causes DNA damage and cell death.
Non clinical studies, including animal models presented at ESMO last year shows a S. A P.
<unk> hundred 86, Potently and selectively binds to S. P.
In addition, antitumor efficacy in F. 'twenty 286 linked lutetium.
You're expressing tumor models.
We look forward to sharing additional preclinical and clinical data from future medical meetings.
We submitted two investigational new drug applications rapid treat P 2026 pieces in imaging and treatment agent at the end of 2020 to support on Lumia study to evaluate F. 'twenty 386 for use as a therapeutic.
The expansion cohorts planned in multiple tumor types as part of a global development program.
I N things were expected to become effective pending acceptance by the FDA CMC data from all clinical sites, which by their nature are extremely short half life with gallium 68, we're effectively serving as real time manufacturers, but the imaging agent that each clinical sites.
Yes, a P toxic imaging agent will be utilized to flip patients with treatment and new media.
On Lumia study is planned to start the first half of this year to determine the dose.
'twenty 'twenty six therapeutic to be used in phase two development.
Phase two expansion cohorts planned in multiple tumor types from studies of FY 'twenty 286 linked alternative radioisotopes, including a potent alcopops clip on combination studies are also under consideration.
Given the role of SVP expressing cancer associated Fibroblast Media, Inc.
Oppression combination with PD, one on PD lone blockade will be a priority.
In addition to our own program a separate investigator sponsored imaging study with F. 22, 86 is currently underway at UCSF.
To evaluate if a pizza question in multiple tumor types and is currently enrolling patients.
Results from this study along with preclinical data we are generating we expect it to help inform selection of tumor types for a phase two expansion cohorts.
In addition, we and three be pharmaceuticals are collaborating on a discovery program directed at three additional targets for <unk>.
Type targeted radionuclide therapy to which we have global rights.
We were drawn to this program for many reasons, including of course, the opportunity to be a leader in the emerging field of Tom's radiotherapy for the treatment of solid tumors.
In this case, we have the opportunity to be the first to clinically develop a peptide targeted radionuclide therapy targeting S E T.
And we are also enthusiastic about the targets with subjects from our plan on discovery collaboration.
And now I'll turn the call over to our Chief Medical Officer, Dr. Lindsey Rolfe to discuss the pipeline from the breaker and we sit on it.
Thank you.
Good morning, good morning, I'm glad to see Hayward each day to.
Some of the clinical milestones expected profit on the Fitbit in 2021.
So the backlog we expect your line.
Top line clinical data from the monotherapy on the second half of 2021.
Is that timing is dependent on achieving the required number of PFS events.
Athena is a phase III 1000 patient study in front line newly diagnosed advanced ovarian cancer maintenance.
Well the thing that we believe we are uniquely positioned to evaluate and thoughtful in terms of two independent outcomes.
As monotherapy versus placebo in the first line maintenance setting in the HRD population inclusive of BRCA.
And then the all comers or intent to treat population.
As well as any potential advantage of the combination of Nebraska and Opdivo in the same patient population.
The thing that is it is the first frontline switch maintenance study designed to evaluate monotherapy.
Monotherapy.
He does.
On top of PD, one combination therapy.
With monotherapy in one study design.
I'll take a moment to review the statistical analysis plan.
That's expected in the second half from 2021, we will see the results from monotherapy versus placebo in all study populations.
And then probably a year or more later, we will see the results.
Plus opdivo versus passing them on.
Kathy.
From population.
And each of these analyses we will first evaluate outcomes in the HRD population, including platform and then step down to the entire intent to treat population.
We believe this study also has an opportunity to truly differentiate yourself in the first line maintenance setting.
As I mentioned on yet.
That's all dependent on the timing of things from the Cherokee didn't buy PFS is on.
Once top line results from favorable we would plan to file an S. NDA shortly thereafter.
Continuing with potential 2020, or my son's group assets the late sales.
Phase two country in this study to evaluate Nebraska in homologous recombination repair genes, including backer across genotypes continues to enroll patients.
The study evaluated <unk> in patients with recurrent solid tumors associated with it.
H a G mutation.
Based on on interactions with FDA. This study may be registration, enabling per targeted gene on tumor agnostic label.
Pending data, we could potentially fast approval in the United States for this indication at the end of 'twenty 'twenty, one or in the first half of 'twenty 'twenty two.
On the newest phase III clinical trial for the Packer is the test the study being sponsored by the in line with clinical trials in oncology, which is part of the National Cancer Institute.
Tesla is a phase three study comparing sandy and Rebecca.
On the in placebo.
Regimen in first line M C. L. P C on an all comers population.
The approximately 1000 patient study he's just open for enrollment.
Chip knowledge the lead investigator Dr.
On Collaborates us up to Chuck Ryan on.
Your line is team for achieving this milestone.
Now I'll discuss this disconnect.
He said Smith is our investigational angiogenesis inhibitor.
Vascular endothelial growth factor receptor one through three.
It drives growth factor receptor alpha and beta on.
Fibroblast growth factor receptor one through three.
The Clovis sponsored here one study is a phase one day two study evaluating <unk> in combination with Opdivo.
The phase II portion of the Li one study guidance logic cancer, there's a million patients on me.
We anticipate presenting updates from the study.
Medical meeting in 2021.
Would you expect it to include interim results from the ovarian and endometrial cancer expansion cohorts.
Let's see on case reports, but on the developments on the.
The effects of COVID-19 on our clinical trial enrollment remained minimal.
We continue to adhere to the regulatory guidance.
Yeah, and other agencies have provided regarding trial conduct during COVID-19.
And we're very grateful for chemical team on investigators who work tirelessly to ensure the safety of trial participants whilst maintaining compliance the GCC on minimizing the risk to the integrity of our price.
And with that I'll turn the call over to Dan to discuss fourth quarter and fiscal year 2020 financial results.
Thanks, Lindsey and Hello, everyone. We reported net product revenues for <unk> of $43 3 million for Q4, 2020, which included U S. Net product revenues of $36 4 million and ex U S. Net product revenues of $6 9 million. This includes sequential quarterly growth in net revenues from.
Our prostate indication in the U S from Q3 to Q4 2020.
Fourth quarter 2020, net revenues represents a 10% increase over Q4 2019 in which we reported net revenues of $39 3 million, including net product revenues in the U S of $36 1 million and ex U S. A $3 2 million.
For fiscal year 2020, we reported global net product revenues for BRCA, $164 5 million compared to 143 million in fiscal year 2019, an increase of 15 per cent for.
For 2020. This included U S net product revenues of $146 3 million and $18 2 million ex U S compared to 2019, which totaled $137 2 million and $5 $8 million in the U S and ex U S respectively.
Sequentially net product revenues increased 12% from Q3 to Q4 2020, including an 8% increase in U S. Net revenues and a 39% increase in ex U S, which is encouraging giving the effects of COVID-19 in our sales which remain difficult to predict.
For this reason as Patrick noted we are not providing 2021 sales guidance at this time.
Gross to net adjustments totaled 25, 6% globally in Q4 of 2020 compared to 25, 1% in Q3 2020 relatively flat from last quarter.
Gross debt was 23, 3% globally for the full year this metric fluctuates quarter to quarter on its difficult to estimate on future revenues, but a range in the mid to high 20% seems likely depending on the revenue and distribute you shouldn't mix between the U S and Europe.
As European revenue revenue was increase in proportion to the U S global gross to net will increase correspondingly.
<unk> free goods percentage in the U S sales decreased from 29% from Q3 to 19, 1% in Q4 and weeks of distributor inventory increased slightly.
At the end of Q4 versus Q3 <unk>.
Research and development expenses totaled $56 7 million for Q4, 2020, and $257 7 million for fiscal year, 2020 down, 22% and 19, 9%, respectively compared to $72 5 million and $283 1 million for the comparable periods in 2000.
19 research and development expenses decreased for the quarter and year compared to the same periods in the prior year due primarily to lower spending on Nebraska clinical trials.
We expect research and development expenses to be lower than the full year 2021 compared to full year of 2020.
Selling general and administrative expenses totaled $40 8 million for Q4, 2020, and $163 $9 million per fiscal year 2020, both down 10% compared to $45 2 million and $182 8 million for the comparable periods in 2019.
Selling general and administrative expenses decreased during the quarter and the year compared to the same periods in the prior year with savings due to the COVID-19 situation globally and overall cost reduction efforts.
Further we expect SG&A expenses to decrease from 2021 compared to 2002 on it.
We reported a net loss for Q4 of 99 million from $1 <unk> per share compared to a net loss for the fourth quarter.
2019 of $99 5 million or $1 81 per share we reported a net loss for the full year of 2020 of $369 2 million or $4 38 per share compared to a net loss of $404 million or $7 43 per share per full year of 2019.
Yeah.
Net loss for Q4 and fiscal year 2020 included share based compensation expense of $12 million and $58 million compared to $12 6 million from $54 3 million per comparable periods of 2019.
Turning now to a discussion of cash as of December 31, we had $240 2 million in cash and equivalents and as of December 31, we had drawn approximately $100 million under the sixth Street partners LLC, Athena clinical trial financing and had up to $75 million available to draw under the frame and on the.
As of the Athena trial.
Based on the company's anticipated revenue spending available financing sources and existing cash and cash equivalents. We believe we have sufficient cash on cash equivalents to fund our operations into early 2023, including any cash repayment unless financed earlier of the remaining $64 4 million aggregate principal amount of the two five <unk>.
<unk> convertible notes at their maturity in September 2021.
Cash burn in Q4, 2020 was $40 9 million down 29, 27% from Q4 2019 quarter cash burn at $56 3 million.
Cash burn for the 12 months ended December 31, 2020 was $195 6 million down 36% from the 12 months ended 2019 cash burn of $304 7 million.
As we've been saying and working on for the last year on longer we ever reduce both our R&D and SG&A expenses considerably compared to prior years. These efforts combined with our increasing revenues and lower inventory purchases and milestone payments on product approvals are significantly reduced our cash burn in 2020 over 2019, we.
Spec this trend of lower cash burn to continue in 2021.
One last point you will see in the next day or so that we have filed a shelf registration statement for up to $200 million. We do not have any immediate plans to conduct an operating under the shelf and in any case. The registry registration statement would have to be declared effective by the SEC before we could show on your securities under it. So this is an important housekeeping measure.
Common for biotechnology companies and intended to provide us flexibility in the future.
Now I'll turn the call back to Pat.
Thanks, Dan.
Despite the evident challenges related to the global pandemic from 2020, we are pleased to tobacco sales performance during the year.
With the recently announced changes to our U S. Commercial strategy. We believe we are well positioned for growth, especially when the ongoing impact from COVID-19 is behind us.
Our development pipeline progress achieved in 2020 positions us with several key clinical development and regulatory milestones in 2021.
Which include the planning initiatives from linear to phase one two clinical study for F. 'twenty 286, a peptide targeted radionuclide therapeutic candidate in the first half of 2021.
Top line, Rebecca monotherapy versus placebo data from the Athena study in the <unk>.
Frontline's with treatment for ovarian cancer setting in the second half of 2021.
Initial efficacy data from the phase II portion of the legal one combination study submit people at.
2021 medical meetings.
Sufficient data from the Rebecca Lube store trial to support a potential filing for a targeted gene and tumor agnostic supplemental NDA.
And as Dan pointed out we remain focused on disciplined cost control and that's an example of this commitment we reduced our cash burn from 2020.
In 2020 from 2019 by 36%.
We anticipate that our cash burn will be still lower in 2021 than in 2020.
Finally based on current revenue on expense forecast, we believe we have sufficient resources to other operations into early 2023.
Thanks for joining and with that we will be happy to answer any questions you may have.
If you'd like to ask a question at this time. Please press Star then the number one on your telephone keypad. If you would like to withdraw your question press. The pound key first question comes from Cory <unk> with JP Morgan.
Hey, good morning, guys. Thank you for thank you for taking the questions wanted to ask on the SAP program and can you talk about the kind of potential combination approaches you believe hold the most biologic rationale and kind of on that front how much of the development do you expect to be focused on the monistat.
ERP side of things versus advancing into combinations.
I have one for I'm going to turn that over.
And you have a follow up for Tom why don't you take that.
Yes.
Hello. Thanks.
Thanks for the question.
The majority of our work and Jimmy Yeah, we'll be focused on the monotherapy.
So once you find the dose and then move into phase III, we will move into at least five different expansion cohorts will focus on F 22, 86 as a monotherapy.
But in addition to the monotherapy data.
As a compelling therapeutic rationale for us to combine with PD, one PDL one blockade.
On the role of cancer associated fibroblasts, and driving immuno suppression.
And in addition to that there on some other combinations that make sense.
Potentially including a combination with them on pump inhibitor breaker.
The DNA damage caused by radiation.
Is repaired in some cases by pop related pathways, and maybe augmented and this COVID-19.
Is the focus of some ongoing phase one studies.
With alternative profit new business in Australia, So I think PD one projects the top of our list, but there are other candidates that we are considering.
Okay. That's helpful. And then the follow up question is just for the Pan tumor Lodestar study.
What will determine whether this is ultimately registrational is that the number of tumor types across what you show efficacy or just is it just the efficacy overall no matter how many tumor types. That's demonstrated in thank you.
Yes Lindsay.
I think it'll be a bigger funds will need to show activity across a range of tumor types.
Wow.
On <unk>.
Already indicated for those teams.
But also on that will be a threshold response rates.
Hum.
Okay.
But we'll have to demonstrate.
As well.
For acceptability by FTE on so it will depend on both of those things don't forget.
Oh, there's more complexity, particularly on looking across five separate James.
Right. Okay. Thank you for taking the questions.
Thanks for the question next question comes from Ed White with H C. Wainwright.
Good morning, Thanks for taking my question so.
Just on <unk> sales in prostate.
You said you had modest growth I'm just wondering what are the.
How should we be thinking about the penetration in that market and what perhaps are you seeing for <unk>.
Sticking points and prostate.
Yeah on.
So there there are issues, we face given the breadth.
Of the label that.
<unk> achieved including the multiple mutations they didn't even have data.
And of course, there's been earlier line of therapy that we do have NCC and guidelines.
Debt, but allow for reimbursement.
And patients who can't tolerate or from chemotherapy would be inappropriate.
But on.
<unk>.
Yes.
Advantage on that disadvantage will likely continue.
Until the.
The completion and submission of the Triton free data, which was earlier line.
And broader than bracket does include ATM patients.
And we would anticipate data from that trial next year.
In the short term, though.
Our focus group.
Calling on both urologists, well virtually calling on both urologists and <unk>.
Medical oncologists.
Participants in the trial have been active prescribers because of their experience in the trial and we do anticipate growth will continue albeit off a relatively small.
Okay. Thanks Pat.
And perhaps just a question.
On.
The F.
22 86.
Once the study starts.
I believe you had said that you expect to have.
Good day within 12 months.
Is it possible to see some interim data from.
From the phase one this year or are we looking for data to be a 'twenty 'twenty two event.
Yes, I would say any formal presentation.
At a scientific meeting is going to be next year right.
I don't anticipate that we would we.
We would have a sufficient data set maybe.
Trials in progress type thing, but that doesn't include data from the trial.
Given the interest in the program.
We are aware.
But people are going to want to get some sense of how we're doing we haven't perfectly decided how we'll do that but I would imagine, we'll probably direct will provide directional.
Reviews on our quarterly calls.
Once the trial begins.
We've enrolled a sufficient number of patients.
To be able to describe to some extent general tolerability and safety events or any evidence of activity.
Okay. Thanks, Pat and then just my last question on the.
Litle, one study youre looking to present interim data at medical meetings. This year I'm just wondering if it's.
Perhaps possible.
On to see the the combination with Opdivo in ovarian as early as Vasco with endometrial later in the year by ESMO is that is that a reasonable.
Possibility for timing.
We submitted an abstract.
<unk>, it's up to them of course to accepted but we submitted an abstract on the ovarian on the serious ovarian on.
So hopefully we'll be able to present initial data.
From the ovarian arm.
Right now we are anticipating.
Submitting the endometrial.
It is enrolling a little bit slower than the ovarian.
To ESMO.
That's our thinking right now.
Okay. Thanks Pat.
You bet next question next question comes from Paul Choi with Goldman Sachs.
Hi, everyone. Good morning. Thank you so much for taking our questions. This is Charlie on for Paul I just had a quick question on fact as well.
No I'm talking about the linear study with the pet imaging program to start you're talking about identifying these patients with the gallium isotope imaging modality do you see foresee going forward that you would continue identifying eligible patients on a patient to patient basis in this way or is this sort of a way of identifying.
Target tumor types that you would then kind of users.
Blankets sort of.
Way of identifying patients going forward. Thank you so much for taking our questions.
Come on.
I'll take a first crack at that from than you.
Follow up for or correct anything I've said it before.
For the phase one and the expansion cohort for the entirety of the phase one two we anticipate screening every patient.
With a gallium labeled.
22 of the six.
Yes. It is.
The practice of those in nuclear Medicine, I don't know, how many times I've heard.
And tell me that we.
You can see what we treat and the true what we've seen so it is it is an embedded practice image first treat second.
And that of course is how he is on.
On the $6 seven if approved it will ultimately be approved and similarly, that's true today for the approved greater than the prior to <unk>.
Whether it's gallium however remains to be seen.
We are evaluating copper as an imaging modality.
And and we are we are considering even other.
Other modalities that might be a little easier that has had a little longer half life when GAAP.
Gallium besides the half life of six to eight minutes, which is complicated.
It has been gallium brief emerging index is the basis for both the two from <unk> and <unk>.
From matrix on incentives.
Tom.
That was perfect I have nothing to add.
Great.
Thank you very much guys.
You bet.
Question comes from <unk> <unk> with Bank of America.
Hi, good morning, Thanks for taking my questions.
Pat maybe a couple from me. The first one is with regards to your expectation of sales for the year on appreciating.
Packed with Covid is there.
It your view that if we do move back to a more normal normal environment as the year progresses that you would be in a position to maybe offer up.
From sales guidance later in the year.
And then the second question I have is as it relates to Athena.
You've talked about the benefits that you would incur from having a broader label, especially as it relates to competing with other approved PARP, but.
And I guess from your vantage point do you think of that position as long as the study's data was positive position would be in a position from appreciate that label change immediately or would that require any kind of education. Thank you.
Yes.
So I answered the question of guidance.
We made and we.
You did talk about even including that in the script that we will evaluate that over the course of the year.
We are well aware.
Debt investors.
And the investment community.
I would prefer that we provide guidance.
If we become comfortable as early as next quarter or in the middle of the year during the second quarter call.
Had pretty good visibility on.
We would definitely consider providing occurred.
Later on for that.
That's one two with regard to front line maintenance.
There were hundreds of participant per file in the U S. There is a well known it's well known amongst the community.
From the Athena trial that is fully enrolled and we expect data will publicize.
Top line data, we anticipate in the second half of this year.
<unk>.
We are confident that just as we did.
Third day market.
Hum.
In the second line maintenance.
We ultimately got to a.
But 20% to 25% share, which we hold on.
We are hoping the hybrid model allows us to change some habits of targeted prescribers away from prescribing.
Elaborate or a jeweler and drive toward more experience with <unk> and to the extent that we create.
More habitual Rebecca prescribers.
That would be extremely helpful to us over the course of this year as we prepare for launch.
The top line maintenance next year, so, yes, there'll be education there'll be pending data of course.
But I anticipate we will be.
Yes.
At least as competitive in the frontline setting as we are on the second line.
Okay, and then would you expect any increase in SG&A.
If you start promoting for front line.
Yeah.
There may be from.
A modest spike in marketing expenses.
To support the launch.
We would not anticipate.
Knowing what we know right now on increase in personnel other than maybe a small number of office based people related to marketing.
I don't think it would be very visible.
To you we would not anticipate.
A huge increase it's mainly <unk>.
The thing about the data.
Rebecca is pretty good on the community that we would be selling to and of course.
The frontline prescribers are exactly the second line prescribers.
Right. Okay. Thank you.
Once again to ask a question. Please press star one on your telephone keypad once again Thats star one to ask a question you have a question from Joe Catanzaro with Piper Sandler.
Hey, guys. Thanks for taking my questions here. So so Pat you mentioned that patient visits and diagnoses are still down just wondering if you've seen a differential impact from that when you compare the maintenance versus treatment setting it, especially when we think about getting physicians to move away from watch and wait.
I don't think it is.
As I would like.
R R.
Missing office visits to a lesser extent now.
But are still missing office visits.
And.
And this isn't only an oncology I'm sure if you're from.
Cardiovascular companies or other cause.
Visits of patients too.
Physician practices to hospitals.
Broadly down.
Our nervous enough about the risks of Covid.
But they would reduce their concerned about underlying chronic med.
Medical issues.
We launched a campaign at the time.
When Covid started and this is probably neutral on me now called.
Called maintenance matters, where we actively try to get position to reconsider maintenance, both who have have continued to.
Practice.
Some of our accretion from Watson weight.
On that we can keep them out of our out of the clinic per far longer keeps them away from immunosuppressive therapy for Paul longer if they go on maintenance rather than Washington, weighted which is effectively placebo, which is effectively five months before you're on your next round of chemo.
On.
It had some modest success, we do get some good reaction to it.
[laughter].
It's why we move to this hybrid model it was pretty hard could be to make it actionable when we were not.
When they have no access to current et cetera on Europe, and the United States that is a part of the digital campaign.
Hopefully it will it will remind people that maintenance is not only an appropriate option.
And the timing of Covid than any time in our view.
Supported by data that suggests it's a far better.
Approach to patient management.
Then Washington wage.
I did note debt.
In the.
Presentation I think it was by GSK about the jewel in the frontline maintenance setting day.
Refer to again to the vast number of patients who are still being treated now on the frontline zone with Washington place. So it is it is an issue that has plagued the class. It appears that we will continue to price declines for a while including the front line setting.
So.
I don't know if I exactly answered your question, but I don't.
Things are recovering I think they'll continue to recover over the course of this year practices have adapted to COVID-19. They have adapted to telemedicine.
So it's not as if things always bad debt, obviously, we're an equal amount despite.
The surge that occurred in December January but it's.
I don't think we'll be fully back to whatever normal is intent on second half of this year.
Okay.
Okay got it thanks.
That's helpful and if I could just ask a follow up maybe a little housekeeping question can you remind us of whether the Athena readout. You expect later this year for Rebecca versus placebo, what would trigger anything with regards to the Athena financing agreement and repayment.
Yes.
No it's no approval that would trigger that Denmark.
Exactly yeah yeah.
Repayments starts regardless of the approval timeframe.
On the fourth quarter of 'twenty two.
So it's just a matter of do anything that gets affected by approval is how much the payment capacity base.
Okay got it thanks, so much for taking my question.
And at this time I'd like to share.
And at this time I will turn the call over to MS. Sussman for closing remarks.
Great. Thank you Sharon we think each of you today for your interest in Clovis. If you have any follow up questions. Please call me at three of 365, five O true two or Breanna at three of 365 502 free.
This call can be accessed via replay of our webcast at Clovis oncology Dot com beginning in about an hour and it will be available for 30 day again, we appreciate your interest and time, Thank you and have a good day.
This concludes today's conference call you may now disconnect.
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Okay.
Yes.
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