Q3 2019 Earnings Call
At this time, all participants' lines Aryan they listen only mode.
After the speakers presentation, there will be a question did answer session to ask your question do you will need to press star one upon your telephone.
I would now like to have the conference over to Mr. Brianna Burkart, Vice President Investor Relations. Please go ahead.
Thank you Dennis.
Good morning, and welcome to the Clovis oncology third quarter 2019 conference call. Thank you for joining us.
Likely seen this morning news release, it's not it's available on our website at harvests oncology Dot com.
As a reminder, this conference call is being recorded and webcast.
Remarks may be accessed live on our website. During this call will be available in our archive for the next separately.
Today's agenda includes the following Patrick Mahaffy, our president and CEO will discuss the key components and highlights today's corporate testing.
Daniel Club is just Chief financial Officer will cover the quarter's financial results in greater detail.
Patrick will make a few closing remarks, and though we will open the call for Q1 day during which time Dr. Lin zero, our Chief Medical Officer will also be available to answer your question.
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 expect it says Oh.
All of these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the fourth looking statements.
Please refer to our current filings with the FCC for a full review of the risks and uncertainties associated with our business.
Forward looking statements speak only as of today on which they are made in Columbus undertakes no obligation to update or revise any forward looking statement.
Now I'd like to turn the call over Patrick Mahaffy looks real welcome everybody. We appreciate you taking time.
Well begin with the commercial update for Rebecca.
I'm pleased to report that our global revenue for this quarter was 37.6 million.
14% over the last quarter and 65% over Q3 2080.
This growth was driven by encouraging progress a new patient starts and didn't duration abuse. We also continued to make slow progress in reducing the supply freedom.
For key near term objectives remain the same.
To grow U.S. ovarian cancer revenues by increasing market share in an adoption of the maintenance treatment indication in the recurrent ovarian cancer setting.
To increase you revenues through launches in England, Italy, France, and Spain, along with continued revenue growth in Germany.
And as early as mid 2020 real revenue through the addition of the central new indications beyond over into the U.S., but bracket advanced prostate cancer.
And that brings us to where most near term development program in the advanced prostate cancer setting.
As you know we have two ongoing studies and the training program threaten to and Triton free and we continue to enroll patients into both studies.
I will focus on the data presented at ESMO and the regulatory path moving forward.
In September we presented updated Triton through data in patients with metastatic castration resistant prostate cancer at the ESMO 29, King Congress in Barcelona.
The updated train two data presented showed a 43.9% confirmed objective response rate by investigators assessment and 57 resist the valuable patients with the breadth of one or two mutation.
And results by independent Radiological review, which was the primary endpoint at the trial were consistent at 40.4 per se.
In addition, a 52% confirmed prostate specific antigen or P.S.A. response rate was observed a 98 PS eight response evaluable patients with the Braca, one or two mutation.
Confirmed radiographic responses were durable, 60% blessing 24 weeks or longer.
Preliminary safety data from Nebraska in men and the syndication were consistent with those observed.
<unk> reports from quite into and in patients with ovarian cancer and other solid tumors.
These striking to data presented at ESMO will be included airplanes supplemental NDA filing for rector in Brecher, one or two mutant advanced prostate cancer. Although this supplemental India dataset will also include additional patients and additional data maturity for the patients reported as I suppose.
The filing will be based on confirmed resets for sponsors.
Following the successful pre supplemental India meeting with FDA in October we continue to file a continued to play into bile or supplemental NDA submission for accelerated approval for breakfast as treatment men with record one or two mutated advanced prostate cancer by the end of this year.
Our other planned monotherapy study is the pan tumor basket study.
The first discuss with you earlier this year.
It is designed to support the registration for bracketed across solid tumors in patients with deleterious mutations in homologous for comedy from repaired.
We anticipate that the study will initiate by year end 2019, or perhaps early next year.
Next I'd like to briefly highlight our combination studies with BMS for both through bracket incentives and discuss our newest compound fab 22 anything.
We remain very enthusiastic about our ongoing clinical collaboration with Bristol Myers Squibb.
I'll take your but lets review our combination studies for both through Braca. It was sitting that puts the roadmap.
I'll begin with the rack accommodations.
The new BMS sponsored phase two combination study of Opdivo and Yervoy withdrew bracco for the treatment of advanced gastric cancer is moving forward with the planned initiation in early 2020 as an arm of the fraction Advamed gastric cancer study.
This will be the first sponsored studies that exports this triplet combination.
The BMS sponsored checkmate ITD phase two trial in metastatic castrate resistant prostate cancer continues to enroll.
Well the sponsored phase three Athena trial in first line maintenance of advanced ovarian cancer continues to enroll well and we anticipate completing enrollment in this 1000 patients study by mid year 2020.
With the FIDA, we believe we're uniquely positioned to evaluate Rebecca in terms of two key outcome.
As monotherapy versus placebo in the first line maintenance setting the HRG population inclusive of Braca and then the all comers or intend to treat population as well as any potential advantage for the combination of lubricant it'll diva opdivo in the same patient population.
Athena is the first front lines, which maintenance study designed to show both part monotherapy impart plus PD one combination therapy in one study design.
It may be helpful to make sure that everyone understands the statistical analysis plan here first probably in the second half of 2021, we will see the results of Rebecca monotherapy versus placebo in old study population and then a year or more later, we will see the results of record social vivo versus Rebecca you know study population.
In each of these analyses, we will first evaluate outcomes in the each our depopulation inclusive of Brexit and then stepped down to the entire intend to treat population.
To wrap up from Brexit inclusiveness, let's turn to see start or Clovis sponsored phase one be two studies that includes multiple single arm peppered combination studies, which currently includes the following cohorts.
Right in combination with the sitting there in ovarian cancer, which is currently enrolling those finding phase one be portion of the study.
And also Rebecca in combination with immunomedics.
So as a to submit build to teach him for the treatment of advanced metastatic triple negative breast cancer relapse platinum resistant ovarian cancer and metastatic Baroque urothelial cancers, which is currently enrolling the phase one dose finding portion of the study in patients with solid tumors.
Now to Lucitanib.
The sitting there was an investigational inhibitor tyrosine kinases, including vascular endothelial growth factors receptors one through three.
Platelet derived growth factor of sectors Alpha and beta.
And fibroblast growth factor receptors, one truth is free.
As we've discussed on prior calls, they're very encouraging data in studies of a drug similar to Lucitanib, which inhibits the same three pathways when combined with the PD one inhibitor.
This provides a compelling clinical rationale for the development of Lucitanib in combination with the PD one.
We believe the combination of lucid and then with the PD one targeting monoclonal antibody represents a large potential market opportunity in multiple solid tumor types.
Indeed, Genesis has been shown to be immunosuppressive within the tumor microenvironment.
Opening anti tumor immune responses.
Preclinical data demonstrate that the anti tumor activity of the PD. One inhibitor is enhanced through the inhibition of and you Genesis by the sitting at.
Targets pretty relevant pro and eugenic pathways as well to simultaneously targeting tumor cell proliferation in anti VEGF receptor therapy resistance, driven by PDGF and FCF receptors.
Earlier this year, we now see expansion of our clinical collaboration with Bristol Myers Squibb twin food and combinations of of Diva.
The citadel.
Our Clovis sponsored phase one be two study lucitanib in combination with Opdivo was that enrolling patients deneke logical and other solid tumors.
We hope to have preliminary data from this study and the recaptured Lucitanib combination to this part of the feedstock study at medical meetings beginning in mid 2012.
In addition, as posted on clinical trials Dot Gov. This week a phase one two combination studies sponsored by Vms, we'll evaluate multiple combinations with other people, including an arm in combination that lucitanib.
Since the state for non small cell lung cancer that has spread they occurred after failure of chemotherapy and immuno therapy.
This study is expected to start by the end of the year.
As a reminder, be a global rights to the sitting at excluding China in in terms of intellectual property. The said its composition of matter in the U.S. expires in 2030 and in Europe in 2028 with up to five years patent term extensions available in each jurisdiction.
For an updated overview blissett niche the events.
Sure.
Based on our website.
Now I'd like to briefly describe the newest addition to the pull this pipeline fab 20 280 cents.
In September we in three be pharmaceuticals, and as the global licensing and collaboration agreement with an initial focus on fell 20 286.
Tied targeted radio duplex therapy, and imaging agent targeting fibroblast activation protein elfa or fat.
That is highly expressed in cancer associated fiberglass forecasts, 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 of the field cancers, including more than 90% of breast lung colorectal and pancreatic carcinomas.
Both will conduct global clinical trials obtained U.S. and global rights, excluding Europe , where three BP retains rights.
We are currently planning to file and I'd for past 20, 286 in the second half of 2020.
We had three VP of also agreed to collaborate on a discovery program directed the three additional targets for radian inside therapies to which we have global rights.
We're very enthusiastic about the opportunity to develop this novel class are targeted radiopharmaceutical therapies with an initial focus on that 22 wouldn't six.
We were drawn under this program for many reasons not the least of which is our opportunity to be a leader in the emerging field are targeted radio therapy.
Well, we're as enthusiastic as everybody is about the potential Levine of immuno oncology is extremely crowded field dominated by larger pharmaceutical companies and clearly there remains significant unmet medical need animal tumor types.
In this case, we have the opportunity to be the first to clinically developer Pat targeted radio in the flood and we're also enthusiastic about the targets for the subject of our plane discovery collaboration.
Finally, while our initial development focus is on monotherapy. There is an evidenced biological rationale to combine targeted radio decide therapy with an anti PD, one agent as well as with record and we intend to explore these combinations preclinically and potentially clinically inflow.
Well some of you may be familiar with the history of P. estimate targeted radionuclides in particular, Lou PS amazed six seven team, which was used under named patient use in hundreds of patients in Germany and certain other countries prior to initiation of any form of clinical development program.
[noise] already one of the German centers has begun to image and treat patients with that 20 286 under the same name you shouldn't use guidelines that were applied to the pmeight targeted products.
It is important to note here that this is not the clinical trial and that the treating physician is solely responsible for any imaging or treatment.
As a result of this.
Use it is possible, but the physician to administer fab 20 286 under name patient use guideline may described their clinical experience at upcoming medical meetings, and we will keep you up to date on any such presentations as appropriate.
And with that I'll turn the call over to Dan to discuss third quarter 2019 financial results.
Thanks, Brad and good morning, everyone. The Q3 2019 financial results are included in todays press release, we reported net product revenue for bracket of 37.6 million for Q3, 2019, which included US net product revenue of 36.5 million, an ex us net product revenue of 1.1 million compared to the.
You asked net product revenue for Q3 2018 of 22.8 million. This represents a 14% increase over Q2, 2019, and 65% increase year over year.
You asked net.
Product revenue increased 12% sequentially from Q2, 2019, and 60% year over year.
Actually U.S. revenue increase sequentially from Q2, 2019 to Q3 2019 as anticipated.
Supply of free drug distributed to eligible patients through the refractive patients assistance program for Q3, 2019 was lower at 20% of overall commercial supply compared to 22% in Q2 2019.
This represented 9 million in commercial value for Q3, 2019 compared to 9.3 million in Q2 2019.
So net adjustments were flat from Q2, 2019 to Q3 2019 at 14.2% and 14.1%.
Respectively.
Last quarter, we provided global net product revenue guidance for 2019 in the range of 137 million to 147 million for the full year today, we update that guidance to a range of 141 million to 147 million to reflect the potential for continued growth during the fourth quarter 2019.
Turning now to a discussion of cash as of September Thirtyth, We had 354.1 million and cash cash equivalents and available for sale Securities. In August we raised 255 million net proceeds from a private placement sale of $263 million of convertible notes due in 2024.
A total of 171.8 million of those proceeds were used to repurchase 190.3 million a par value of convertible notes due in 2021 with the remaining 83.2 million available for general corporate purposes.
In addition, as of September Thirtyth, we still had up to 154 million remaining to draw under the TPG financing for the Athena clinical trial financing agreement to fund the expenses of 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 the remaining 97 million principal amount of convertible notes at their maturity in September 2021.
Cash used in operating activities was 57 million for Q3, 2019, and 253.5 million for the first nine months of 2019, compared with 72.5 million for Q3, 2018, and 283.3 million for the first nine months of 2018.
It's worth mentioning that on a sequential basis Q3 operating cash used was 42% lower in Q2 2019.
In addition to these decreases in cash used in operations. The TPG Athena financing provided 12.2 million and cash from Q3, resulting in a net cash reduction of 44.8 million during the quarter.
We reported a net loss for Q3 2019 at 94.1 million or one dollar and 72 cents per share and 300.9 million for a net loss of $5.62 per share for the first nine months of 2019.
Net loss for Q3, 2018 was 89.9 89.9 million or $1.71 cents per share and 268.8 million or a net loss of $5. An 18 cents per share for the first nine months of 2018.
Net loss for Q3 in the first nine months of 2019 included share based compensation expense of 14 million and 41.7 million compared to 10.9 million and 37.7 million for the comparable periods of 2018.
Research and development expenses totaled 77.9 million for Q3, 2019, and 210.7 million for the first nine months of 2019 compared to 63.9 million and 160.1 million for the comparable periods in 2018.
The increase is primarily due to higher research and development costs for bracket clinical trials.
We expect research and development cost to trend lower for the full year, starting in 2020 and in the following years compared to 2019 as the largest of our sponsored clinical trials in your completion and as the company reduce the spending related to clinical programs and other activities.
Selling general and administrative expenses totaled 41.8 million for Q3, 2019, and 137.6 million for the first nine months of 2019 compared to 42.5 million and 126.6 million for the comparable periods in 2018.
Selling general and administrative expenses decreased year over year for Q3, 2019, and also sequentially by 13% from 48 million in Q2 2019 to 41.8 million in Q3 2019 based on cost reduction efforts by the company.
Now I'll turn it back to Pat Thanks, Dan We're pleased with our progress in the third quarter.
Demonstrated strong sales performance in the us market bracket, the second line ovarian cancer maintenance setting.
Where we remain focused on growing our share of the ovarian cancer purpose space as well as expanding the second line maintenance part of opportunity overall.
We're seeing initial progress and that you reckon that reimbursed to the cancer drugs fund in England, and we continue to focus on Germany and prepared to bring on additional you countries. Later in 2019 early 2020.
In addition to our sales progress. We also showed a significant reduction in our net cash from which was reduced to 45 million in Q3.
We presented updated data from Nebraska in advanced prostate cancer patients in September and our Q4 2019 supplemental NDA filing and Braca one into the advanced prostate cancer. This plane before year end.
Potential for us revenues from the prostate indication beginning in mid 2020.
Our clinical collaboration with BMS now includes the additional Vms funds or combination study of Opdivo and Yervoy with Rebecca in advance gastric cancer as an arm of the fraction study and we continue to have active discussions about other possible combination study.
We remain very enthusiastic about the potential for Lucitanib with two combination studies that will open for enrollment one with through bracket and advanced ovarian cancer is part of C store as well as one in combination with Opdivo in advance gynecological cancers and other solid tumors. We hope to have initial data from these trials at medical meetings next year, beginning as early as mid 22.
Yeah.
In addition to phase one through combination studies sponsored by Vms, we'll evaluate the sitting they've been combination with opdivo in patients with stage for non small cell lung cancer that is spread or re occurred after failure chemotherapy and immunotherapy.
And lastly, we're enthusiastic about the opportunity to develop that 20, 286 and potentially up to three additional preclinical rating, but there.
Threepi Pharmaceuticals is an expert in this emerging field and through this collaboration we believe we have the opportunity become a leader in the development of important new treatment modality for multiple tumor types and with that I'd be happy to answer any questions. You may now.
At this time I would like to remind everyone in order to asking a question simply press star one on your telephone.
And your first question from lineup Kennen Mackay with RBC capital markets. Please go ahead.
Hi, Thanks for taking my question congrats on the quarter and continued growth here, Dan maybe just a quick question on your.
Narrowed guidance and some of the commentary there last quarter.
Provided from positive commentary that.
We could expect continued growth ahead in Q3, we saw that just wondering.
That's how we should be thinking about.
For impairment done rather be.
Majority of the growth coming ahead in due course coming from the rest for Europe .
Secondly.
Very different.
Strategy, bringing bracket too to frontline ovarian versus some of the other competitive agents out there as well as prostate wondering.
What's the feedback from physicians has been on on the combo therapy purchase and sort of broader.
In population.
Our especially coming out of the ESMO conference, where some of the Pio part combinations were really okay. Thanks much.
Sure.
We did we did up the lower end of the range.
And on the last call I said, we were beginning to see some green shoots in the United States.
In terms of both commercial new patient starts and in terms of duration that I think that that.
It is seen now in the Q3 numbers.
We're cautiously optimistic you'll note that we didnt take the lower end of our guidance.
Markedly higher than what we delivered in Q3.
And we caution everybody that this is a quarter by quarter effort. We're we're really pleased with our progress in the upper being made in the field, but but it remains an effort to convince many physicians to to move beyond observation or watch and wait and to consider active part therapy in the more progress we make.
In converting those physicians and their patients.
And frankly, the more progress or or or classmates make in making that same effort.
We're going to see continued growth for the class and continued growth hopefully for US we do anticipate now as we launched formally.
Under reimbursement in the UK you may recall, we were selling in the UK to the sort of.
5% to 6% of patients who are private pay but that is pretty limited now with reimbursement in the UK. We formally launched in mid October we anticipate launch in Italy before the end of the year, we anticipate launches in Spain, and France, and the first quarter. So we will begin to see contribution to our growth in sales from these European countries.
As to the frontline strategy.
Yes, I think the enrollment in the trials speaks speaks to the enthusiasm.
Physicians have for the potential for this combination.
The.
The the enrollment in this 1000 patient study will take somewhere probably less than two years to fully enrolled which is which is a really rapid trial enrollment, especially in light of competing trials and commercially available product for limited populations in this class and that Theres.
Anything that came out of the important data presentations and the reaction to those data presentation.
At ESMO is that particularly in the HRG and biomarker negative population. There is a need for accommodations that came deliver greater duration, a benefit and potentially a curative regimen at least in a in a population of those treated and I will say that the enthusiasm for the trial remains as high as it's been for.
Looking not only as a monotherapy results, which we'll see first quarter Braca, but also looking beyond that to the combination with opdivo.
And how that I think I was referring to.
Ovarian.
Tantrum. It maybe also some only four for the strategy and in prostate moving up in terms of sort of post chemo into into some of the earlier of therapy better as well potentially in.
Combination.
We didnt have a ton of conversation that ESMO that the combination of for instance, PD one with.
With rubric in prostate there was a lot of focus on the Triton to results with great enthusiasm by both the medical oncology community and not so much at ESMO, but it other meetings than one on ones with the urology community here in the United States I think that.
It's interesting if approved it will be the one of if that's the first approved in a in a.
Targeted population in prostate and the community is excited about having a targeted therapy that may provide meaningfully greater benefit than than chemo, where other agents at an all comers population.
And I think the adoption unlike we've seen in.
In maintenance in ovarian, which kind of kept out at 35 or 40% and now we're slowly gradually improving that I think given that this as a treatment regimen and particularly for men and advanced age of disease. I think we're going to see a much more rapid adoption for the class in the in the treatment of prostate the enthusiasm for.
It is very hot.
Got you. Thank you again.
Your next question from a line, that's causing Ahmad with Bank of America. Please go ahead.
Hi, good morning, Thanks for taking my questions.
Just.
View about the European market.
We've talked now for a while about some of the dynamics that have impacted the ability of our braca how about take any you asked I was just wondering.
If you can share with us some of your thoughts about certain dynamics that might be specific to the European markets and how you're thinking about the general ramp opportunity. There first of how it's ramped here in the U.S. and then I've a follow up thanks.
Yep.
It's going to be.
Both very similar and have some of its own nuances and some of those will will differ by.
By territory in general.
The adoption of maintenance, thus far second line maintenance in in ovarian appears to be kind of following the U.S. example, where there is a group of early adopters that take adoption to kind of 35% rate and it's going to take an effort by us and our competitor and peers to drive that higher.
It looks to us as I interpret.
And and do a currency.
Change too.
To the GSK number in Europe that they're doing it on an annualized basis around 135 million. So they they've seen some success in Europe .
Penetrating in there they're still in launch mode in several territories. So I think it represents the fact that there is an opportunity for us as we gain approvals and these territories to come into a market with a differentiated offering and some degree of of physician population who are committed to an interested in.
Prescribing a PARP inhibitor in the second line maintenance setting one difference compared to the United States is that in certain countries.
Only.
Niraparib.
Is reimbursed for patients beyond Braca. So olafur of is reimbursed in all second line maintenance patients who are mutant BRCA.
But it only about half the territories do they have an approval.
For use beyond the bracco population, so while we will continue to.
Or plan to compete for those BRCA patients the the the competition for the Frac, a wild type patients, which represents 75% of the of the patient population is going to be limited to us and direct for it. So there will be a different dynamic territory by territory, but I think the till performance by the jeweler represents the fact that there is an opportune.
30 in Europe , even at the much lower prices.
We are reimbursed at compared to in the United States and so we we look forward to these launches.
Okay. Thank you and then on the commercial opportunity for prostate you talked about your some of your early thoughts about what kind of commercial organization, you would need and I just wanted to take at some more updated thoughts from you about whether or not you can leverage any of your current sales force to move into prostate and if you did.
Me to increase your sales organization by how much do you think you would need to do that and what would be or areas of focus that that really part of them on.
Yes, we.
We're going to leverage all of our commercial organization in the United States to launch into the prostate market.
And our intent now.
It is not to add field based.
Personnel.
To support the launch we have around 140 people in the field right now we may increase slightly but this includes a mix of sales reps.
Of.
Regional account managers that allow us to have a dialogue at both the business and and physician level within large important centers.
Nurse educators to provide support.
For.
The nursing and administrative staff at the clinics and of course, not a commercial group, but the MSL group results in the field equal to answer any medical inquiries, we think we're well situated to address.
All the medical oncology centers that we addressed today for rubric and the focus for us will be primarily.
To the medical oncology community, but we do believe that for these larger urology practices that have a history of for instance, prescribing ever after owner Enzalutamide that the organization. We have we'll be able to call on these which are almost always adjacent to these large medical.
Primarily academic hospital.
Okay. Thank you.
You bet.
Your next question from a line of Gena Wang with Barclays. Please go ahead.
Thank you for taking my question that the first one was to be the commercial question licensing or this quarter has a strong quarter.
Pat just wondering if you can give a little more color regarding how much.
The new patients.
How much is driven by the longer treatment duration of treatment.
Hi, John .
Yes, it's pretty hard to give you on.
A distinct.
Quantitative view of what with the primary driver is we we are pleased with the new patient starts were seeing in particularly to be fair. The commercial new patient starts given the modest production in the amount of patients number of patients or percentage of patients who are getting access to free drug through the through the.
Pat program.
The duration continues to improve.
In in in relatively modest increments, but we now know that the duration of use is somewhere between.
It's definitely over seven months is probably around seven and a half lunch and we think it's continuing to improve so we will see a benefit.
As that continues it does speak to the general Tolerability of record one of the things we talk about a lot is that.
In in oncology in United States.
Only about 50% go up therapy, because because it progressive disease. The remainder go up therapy because of side effects are because they've just having difficulty.
Moving on continuous treatment.
The fact that we're seeing this increase in duration kind of flies in the base, so that and speaks to the general Tolerability of Rebecca.
Okay, and then second question I have to check in late Ninetys.
Prostate cancer trial, just wondering how to get the trial started already for Q1 7, well wondering when should we.
See that they need.
Don't really have an answer for that we have a great.
Clinical collaboration with Bristol Myers, and a close relation to to them.
But but they are in charge of both enrollment in that trial management that trial in any any any.
Predicted time for.
Any any reported data from that trial is going to be on them, we don't really have abilities.
Well, maybe a rephrase like the.
The trial is enrolling patients.
Do you have a sense.
Can you share with US you know like how many patients already in Rome and.
The.
That is at this moment.
No we were pretty comfortable with our policy of letting Bristol Myers speak to their their trial activities. The trial does continue to enroll.
And I would imagine that when when did when they have completed enrollment that would go up on clinical trials dot Gov than we would certainly report that as as and when it does.
Okay. Thank you.
You bet.
Your next question from lineup Cory Kasimov with JP Morgan. Please go ahead.
Hi, This is Kevin on for Corey. Thanks for taking my questions. We had one on prostate as well actually.
How are you feeling the prostate market with Astra similar timeframe.
Timeframe.
But with PFS data in a randomized trial, just trying to get your thoughts kind of on the potential competitive landscape there.
This is metallic more challenging are you confident enough in the Triton two data that was that we've seen thank you.
Yep.
So you're right there will likely be two of us in the market in 2020, and Kent know for sure. When they are for that matter. When we will be approved but we are planning is if we're going to be approved on a relatively.
Consistent timeframe.
It is true that that they're there.
Their approval will be based on PFS based on a randomized trial.
It will also be true that the number of patients treated in that trial in their package. There in the a package is going to be the same or slightly lower in terms of number of frac one two patients.
So I I think that.
It isn't necessarily going to be an advantage to come in with what is still a fairly limited dataset compared to the.
Because that will be submitted by the end of year as the PFS versus response rate.
The reality is these are both important endpoints to true treating physicians.
Response rate is a little easier for.
Patients to understand because of its evidence that the tumor is going away, which is what they really want to see so I have never believed that somewhat more abstract endpoint like PFS is more important than response, which is how it does have a patient thinks about what's happening inside his body.
And further what we both will probably focus on.
Certainly the treating physicians patients will focus on is in fact PS. A response now those will be in the publications that will be a subject of discussion we did not PPSA data for Astra zeneca in their presentation that as well I'm confident it's good but I would imagine that this is how most advanced and for that matter even.
Earlier stage prostate cancer patients and their physician think mostly about the benefit or sadly the progression there seeing on any given treatment.
Great. Thank you for the color.
You bet.
Your next question from a line of Paul Choi with Goldman Sachs. Please go ahead.
Hi, Good morning, everyone and thank you for taking our question I had two pipeline questions on Lucitanib.
First Pat I think I heard you say earlier that the initial data with rubber ACA could potentially be seen mid next year, but from the C. Star study, but I was also wondering what would the potential timing before the combination arm with.
Sacituzumab Govitecan LTC is that something we could see in 2020 as well and if not what is sort of a gating factor there.
I think I said that we would expect to see hope to see data for just to be clear for both lucitanib plus for Bracken.
And Lucitanib plus opdivo.
In by Middle of 2020, so to be clear there were two populations or regimens for which we hope to have data.
Yes, oddly enough Paul I haven't discussed with the team when we think we would have data for the combination with immunomedics and I don't know to what extent. The team has had much dialogue with immunomedics. So I am not going to give you a date.
I'm not going to give you a date for for that combination but.
But I would hope we would see initial data before the end of next year.
Okay, great. Thank you for that and then with regard to the combination with with Nivolumab <unk>.
I think clin trials indicates that you are initial starting dose for the lucitanib.
Portion would be six Meg QD to start and I guess.
Since in prior trials, you you down dose that.
15, Megs down to 10, Megs I guess, you should potentially have visibility on.
The go forward Dallas for the phase two dose expansion portion relatively quickly is that the right way to think about it and when would you I think being a position to sort of talk about the go forward phase two dose for the Nivolumab Lucitanib combination. Thank you very much for taking your questions.
You bet on your right starting dose the six mix.
And we purposely chose a dose it was lower than what ultimately was a monotherapy dose of 10 milligrams.
With the the belief that we would at least go up one one dose level.
By the end of this year will have treated patients at both six makes an eight makes up my expectation is that.
Around the end of the year early next year.
We will choose between the six make an eight make dose as our go forward dose and that would be the time, when we would initiate the expansion cohorts.
Gynecological another solid tumors.
At the time, we do initiate those expansion cohorts we would.
At a at JP Morgan if its then or at our February call make sure everyone is aware of the dose we chose and the fact that we were at that time be beginning those expansion cohort, but that's kind of the general timeframe and the general dose, but I would I would I would guesstimate.
Or going to be but one of the two doses that we would choose to move forward.
Great. Thanks for taking your questions.
You bet.
At this time I would like to remind everyone in order to ask any questions simply press star one onto our telephone.
Your next question from a line of Andrew Barron's, where the SCB lingering. Please go ahead.
Yes. Thanks.
Hi, Pat I just wanted to go.
Deeper into the prostate opportunity and when pars.
What are your expectations for their potential label in regards to 18.
And what are the.
Commercial implications, if they actually get ATM on their label.
So so I don't think there's going to have any impact.
On on the opportunity a mutant BRCA.
If they have ATM more if they don't have the these are going to be distinct populations.
And and physicians will make the choice about how they treat ATM patients in the same way, they're going to make a choice about having refractory patients.
Obviously for them.
And it for them potentially for us from Triton three.
The ATM population with nearly double.
The number of patients that would LLC eligible for PARP inhibitor therapy from 12% to 15% or mutant BRCA.
Through a total of something like 25% so for as a commercial opportunity it's important.
Its impact on the Brexit population I think will be limited.
As to whether they get it in their label.
Or not.
It's hard for us to interpret the data as they were presented.
At.
At ESMO.
And it's important to us because it has implications for how we think about what may happen with Triton three. So we're obviously you know kind of conflicted we never wish them well because were competitors, but in this case I kind of hope they get ATM, because I think that that would be good for us in the context of filing for for approval based on trailing three.
So the big issue is what is the benefit in ATM patients and does it matter. So they definitely hit their primary endpoint of the combination population of Braca an ATM.
So that they hit it.
The ATM.
Data at the median.
We didn't see hazard ratios, we didn't see the capital Meyer curves. So we can't really dissect it.
But at the median.
Showed pretty similar results in terms of of median PFS.
It's going to be up to.
FDA to.
To decide how they're going to interpret that and whether to go with the fact that they hit it for all covered.
All comers, beating Bracken ATM.
Or whether they're going to look at the distinct populations individually and determined for those subset populations in this case bracket.
What the benefit as the benefit in practice two's was superb as one would expect.
ATM not so much and it's consistent with data we've reported and others have reported for elaborate when you look at responses for patients on ATM.
The one but one thing that would be really helpful to see in those curves.
Is is if there were a reasonable number of dropouts that were censored because of the PSC spike.
But didnt count as progressive disease, because they've never got to the point of radiological progression.
So if that number is.
A reasonably high number that's going to impact on the FDA view of benefit in the ATM population, but we weren't able to interpret those data they didn't show them that at ESMO.
Okay. Thanks, Thanks for that color.
Do you get a sense from physicians that if they do get the ATM in a label we could be the perception that lynparza, even more active drug and prostate or.
Going to be like ovarian cancer, where most of the physicians feel like drugs are basically the same on efficacy of there maybe some differences on safety Tolerability.
I think for sure thank whether I'd like to think this or not that is going to be the latter I don't think that evidence of the of a modest PFS benefit at almost indistinguishable PFS benefit.
Versus an unapproved agent.
In this in this indication second line ever after owner Enzalutamide is going to sway anybodys.
Believes that that PARP inhibitors, as a class world that active in ATM patients.
I think they're going to be seen is generally similar.
Okay, and then just one last one on prostate.
You get a sense that the bar at the appropriate could change based on.
Gullibility with drug.
From a randomized trial were PFS endpoint.
Well I don't have left to say about that we're we're confident based on the.
Yes, Indeed meeting that we have a very good and encouraging dialogue with FDA and is highly related to the for the data set that we presented them.
So I I think that.
For instance, if you're asking about an accelerated approval versus.
A full approval you may note that on the Quadro data set which was exceptionally limited dataset. They actually achieved full approval for that so if he has has a lot of discretion.
Okay and then just one last question then I'll jump back in the queue can you just give us some color on the free drug decrease in the patient assistance program is that an overall trend that we should see and other.
In the market and other drugs.
And is it sustainable going forward.
You know if there is a trend you see it's a modest reduction.
In the use of path from 22% to 20%. So it's not dramatic for US what's important is it isn't the 26%. We saw an average last year I think we're going to continue to see it slowly go down for two reasons specific to second line ovarian and in our case to record.
One is we've worked really closely with our third party.
Provider of this assistance program to ensure they are actively looking at at multiple options for reimbursement for the patients and so I think we've done a better job of ensuring those who who are not really eligible for the program.
Don't don't benefit from the program. So some of that is on us through through efforts to make sure those are truly needed get the free drug, but those who don't.
Do not and then the second.
In fact is last year after a little bit of funding in Q1 of the foundations that do provide co pay assistance to patients in ovarian.
That funding dried up and it was non existant for for the majority of if not all of.
Post January 2018.
This most recent quarter and this year it isn't everyday and at our provider checks every day at the foundation, but there has been intermittent funding of the foundation. So some additional support has been available to.
Two patients.
With with Medicare and ovarian cancer.
Okay and I did just have one more question if you'll allow me you mentioned the program.
Metrics and Socrates amount.
Something in 2021 or beyond what what type of dosing protocol or you guys thinking about the limit some of the overlapping pocketbook miles crushing.
First I'll say I said I hope we have data by the end of next year I, just don't want to commit to a but thats what I said at the end of 20 before the end of 2020.
Let lindsay is on the phone and it might be better Lindsay if you entered the dosing.
Strategy question.
Yes, you're welcome Pat.
Question Andy.
You're right there are potential overlapping toxicities.
It means that we thought with lower doses upholstery cap rate.
I'm not sacituzumab.
On.
Clinical trial and.
I would not anticipate that this would be fairly straight forward.
Paul.
But we will.
We will make how wasteful would adjusting.
Dose of one or both.
Necessary.
Okay, good to be like a maintenance typesetting within a very extensive.
Ultimately.
We could consider that but the trial.
Going at the moment theme.
A classical phase one the.
Well shouldn't it looks at treatment in patients who have.
Exhausted standard therapy.
Okay. Thanks for all the questions guys and congrats on growing the top line and shrinking the expenses.
Thank you.
Your next question from a line of Joe Kevin's Aro with Piper Jaffray. Please go ahead.
Hey, guys. Thanks for taking the question congrats on the nice quarter here I'm just a quick one here on a dina. So we've seen some other competitive frontline maintenance combination trials incorporate an adaptive design that allows them to sort of adjusts how they randomized patients based on how standard of care evolves and I'm talking about branca patients receiving.
Pardon.
Maintenance and I'm, just curious whether you're seeing and he has it ends from from physicians with it the nine and in terms of enrolling Brad to patients and potentially enrolling them on to non TARP arms or had rapid enrollment sort of preceded inline with your expectations.
Okay.
Lindsay.
Thanks to answer the question.
Hey, Matt is enrolling in very many countries.
Some countries.
Popping into is available to standard of care, the frontline maintenance of patients with breast disease and many other countries. It's not so.
Generally speaking in the countries where.
Sorry, no started PARP inhibitor therapy available with saying.
We're saying.
The enrollments at or above the expected level.
And then in countries where is available.
Correspondingly with big brother enrollment less frequently.
But.
Yes overall.
The.
Trial it.
Designed to minimize any risks associated with that.
And then I'm confident with.
The stats on analysis.
Described from Tonight shot the two IC team.
Based on the strong result.
My maintenance studies of other pop and typically is not only in braca, but also in Braca wild type HR because the pricing.
Well this includes successful.
Okay, Great. That's Super helpful. And then maybe just one quick one for Dan around cash utilization. So should we expect net cash in operations to continue along inline with what we saw this quarter or were there some onetime items that that will go away.
No onetime items necessarily.
But we tried to give the end range of into second half a 21 to address some of the volatility by quarter.
But as we've we've guided previously to a lower cash burn on our last call and so it won't be necessarily exactly the same but.
It's at a lower rate compared to where it was before.
Okay, great. Thanks for taking the questions.
You bet.
And today's final question will come from a line of Michael Schmidt with Guggenheim Securities. Please go ahead.
Hey, good morning, this easy on for Michael Thanks for taking my question.
Maybe just two quick questions on tried and tried on to you previously said FDM would want around a 100 resisting valuable bronco patient for the ethane DNA just wondering based tower leasing interaction with the FDA.
In October are you still tiny wanting patient to being put into India package and then we also noticed the are some European clinical sites enrolling patients for Triton to.
I mean, what's your if you can help us understand what are you strategy for best print prostate cancer are you more specially are you going to some meat trying to two umass boulware I'm dealing with quite a confirmatory phase three.
Right.
Okay.
Yes, the number of patients I think beginning in.
Our may call, we said its.
It's going to be in the range of 100, So we haven't given a precise number but you should assume that the number that we have.
Billable for the SMB eight is acceptable to FDA, given our our successful pre SMB a meeting.
For the Europeans like yes, we are enrolling patients in Europe in trying to win for that matter and tried and three.
We are not optimistic that Triton two will be on.
Something that we can use for a submission in the EU was we are approved in assuming an approval in the U.S.
We may approach the m- for discussion, but your profoundly aware that m- is not in love with single arm studies as the basis of an approval.
And also Triton three is going to be near term enough for us and it's going to be a much more robust data set with with a large number of patients.
We're likely to use trailing three as the basis of the with supporting data from tried to train three is the basis of an ultimate EMEA.
Hey submission.
Okay very helpful. Thank you.
Thank you.
And at this time there are no further questions do you have any closing comments.
Thanks, Dennis we thank all of you for your interest in Corpus. If you have any follow up question. Please call me at 303.
Two 550 to three or Anna trio, three six to five but yes it to.
The call will be available via replay on our web cast.
The website Clovis oncology dot com beginning in about one hour. Thank you and have a good day.
Good bye.
Ladies and gentlemen, this does conclude the Clovis oncology third quarter 2019 earnings conference call. Thank you for joining you may now disconnect.