Q1 2021 Clovis Oncology Inc Earnings Call
Okay.
Yeah.
Good day, and thank you for standing by and welcome to the Clovis oncology quarter. One 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 you will need to press star one on your telephone.
Please be advised that today's conference is being recorded if you require any further assistance. Please press star zero I would now like to hand, the conference over to your speaker today Ms. Anna.
Sussman. Please go ahead.
Thank you Polly and good morning, everyone and welcome to the Clovis oncology first quarter 2021 conference call.
Thank you for joining us you've likely seen this morning's news release, if not it's available on our website at Clovis oncology dotcom.
As a reminder, this conference call is being recorded and webcast on <unk>.
<unk> may be accessed live on our website during the call and will be available on our archive.
<unk>.
Today's agenda includes the following Patrick Mahaffy, our President and CEO, who will review the highlights of today's corporate update and her book of commercial progress and Doctor Thomas Harding, Our Chief Scientific Officer will review, the FEP situating stubborn and targeted radionuclide therapy development Okay.
Thank you Ross, our Chief Medical Officer, who will discuss the interest to human clinical milestones, but on the fitness during 2021.
Okay.
And then Daniel actually financial officer from covered the quarters financial results in greater detail Pat will make a few closing remarks, and then we'll open the call for Q&A during which time asking on Thomas I think it'll be a bell.
To answer your questions.
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.
Any statements concerning our financial outlook.
That's a business plans all of these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward looking statements our.
Our actual results could differ materially due to a number of factors, including the effects on duration.
That's 19 pandemic and the timing and extent of recovery from the COVID-19 pandemic.
Please refer to our recent filings with SEC for a full review of the risks and uncertainties associated with their 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, please note that we'll be discussing cash burn on non-GAAP financial measure during todays conference call.
Gaucher for Linzess are on todays news release, which can be found on the line.
Now I'd like to turn the call over to Patrick Mahaffy.
Thanks, Andrew Good morning, welcome everybody.
Taking the time today.
While the continuing headwinds from COVID-19 impacted Rebecca sales in the U S and in Europe. This quarter, we believe the effects of the pandemic on patient diagnoses patient visits and access to oncology practices, which began in late March last year will lessen over the course of 2021.
Sales in Q1, 2021 were $38 $1 billion, which were lower than both Q1 2020, our last pre pandemic quarter on our best U S sales quarter ever.
And also lower than Q4 'twenty 'twenty.
It is extremely important to note that the sequential decline that we experienced from Q1 2021 in the U S is consistent with the minimal growth or decline for other approved PARP inhibitor indicated for ovarian cancer in the U S.
Which is a result per appears to be a result of the ongoing impact of COVID-19.
We were hoping that Q2 2021 represents the beginning of a return to a more normal post pandemic environment.
While it is encouraging that office visits at the end of 2020 had returned to pre pandemic levels.
Office visits are only leading indicator.
The number of ovarian cancer diagnoses and Diebold can surgeries declined 15% on what we're going to fall and winter.
The reduced number of ovarian cancer day, Bocchini surgeries and reduced administration with platinum based chemotherapy.
I had a continuing impact on the on the maintenance use of PARP inhibitors broadly.
And as a consequence, Rebecca specifically.
We do anticipate that as patient visits begin to rise as.
As diagnoses increase and the urgent need to more actively manage this often fatal disease grows for the maintenance treatment of ovarian cancer patients will increase including the use of Rebecca for women with advanced disease.
In terms of advancing our pipeline I'm extremely pleased to announce that we achieved an important milestone in our commitment to targeted radionuclide therapies with the FDA clearance of our I N D for F 'twenty 26 per treatment and imaging, which.
Which enables us to open for enrollment the lumi are phase one two trial this quarter.
In addition, we anticipate announcing top line the Athena data for the rack of monotherapy versus placebo arms in the first line ovarian cancer maintenance treatment setting in the second half of this year.
Interim efficacy data from the non clear cell ovarian cancer phase two court of the Lille is sitting there, but it'll vivo combination will be presented a poster at <unk> on June.
While evidence of clinical activity has been observed we do not believe that the efficacy data support further development in non clear cell ovarian cancer enrolment continues in the other three expansion cohorts and gynecological cancers, and we plan to provide an update on the endometrial cohort later this year at a medical meeting.
Let me turn now to Rebecca commercial update.
Our global net revenue for the first quarter of 'twenty, one 2021 was $38 1 million down 11% over the comparable prior year period.
Dan will describe these results in greater detail.
As we've discussed previously an additional effect of COVID-19 is the substantial acceleration on what was already a trend towards reduced inputs on access to academic and community based clinics by sales rep.
We believe this reduced access to oncology practices will continue.
Even once the pandemic is ultimately under control.
Practices increasingly preferred digital programming and communication that can be accessed on their own time.
We believe the commercial strategy, we introduced last fall will enable us to meet these preferences as the effects of COVID-19 lessen over time.
This strategy embraces a hybrid approach that elevates easily accessible digital programming virtual communication and peer to peer interactions.
In person promotion is reduced and those remaining in person activities are much more targeted.
We remain energized about our strategy and believe that we are an early adopter of a trend that will be increasingly common for oncology marketers.
In fact, several companies across the industry have announced similar changes in recent months.
We adopted this hybrid strategy to better reach physicians the way they wanna be reach.
Utilizing resources customized to their practices with the goal of accelerating growth as the ongoing impact of the virus resolves over time.
Despite our lower sales in Q1 compared to Q4, we believe we maintained our U S market share given that our competitors also appeared to experience COVID-19 related impact on U S sales.
Well this is not yet proof of the potential for our hybrid commercial model.
We maintained our share in a difficult environment with a hybrid model and with the 30 per cent reduction in SG&A compared to Q1 2020.
Not all of this reduction was specific to selling costs, but we clearly believe we have found more cost effective commercial model to address our physician customers in the U S.
Obviously as we come out of COVID-19, we hope our model will also accelerate growth.
With regard to the U S prostate indication will still a modest contributor to U S revenues.
Sales of per bracket in the prostate indication that were consistent with our sales in Q4 2020.
Turning to Europe, we were very pleased with our progress to date. Despite the COVID-19, Lockdowns remain in place in most countries.
Sales of <unk> were up significantly you can go to the first quarter of 2020.
As in the U S. We believe that a more normal oncology practice will reemerge as Europe reopens.
We have a smaller commercial organization in Europe and had been utilizing virtual communication in each of our primary territories as regulations allow.
While national regulations vary among European countries, and as compared to the U S. We are tailoring, our hybrid digital strategy for each country to better reach our finish on prescribers.
As we explained previously.
December 19th 2020 was the earliest peak at an index could've been filed for Rebecca.
Since that time generic entities had been permitted to file an NDA for <unk> with a paragraph four certification.
Asserting that one or more patents listed in the Orange book for Rebecca Alright, Theyre, not infringed invalid or not enforceable.
We have not received any paragraph four certification notice letters.
And to our knowledge no NDA filings for Cracker GAAP peppered have been made to date.
Because we kept room cancellate is considered a cytotoxic drug.
Published FDA guidance requires any parties seeking approval for a generic form of recap or to file a bio I N D and recommend showing bioequivalence in I'm quoting here.
Male patients with the deleterious BRCA mutations associated with advanced cancer, who had been treated with two or more chemotherapies and are receiving a regimen of recap route Kim fleet.
The guidance set forth additional criteria, including the demonstration of bioequivalence to a 90% confidence interval.
Demonstrating bioequivalence with Rebecca would only be an initial step in the NDA approval process.
And a potential Ando litigation a generic challenger would also need to successfully challenged or design around Orange book listed patents, some of which do not expire until 2035.
Now, let me turn the call over to Dr. Thomas Hurting our Chief Scientific officer to briefly discuss the F. 'twenty 'twenty six and targeted nuclear targeted nucleotide therapeutic programs.
Topics of growing interest as we are now moving into clinical development with F 22 86.
Yeah.
Hello, It's a pleasure to speak with you today.
Mentioned on Tuesdays and continues to grow from toxic weighted.
<unk> therapeutic programs, including our lead asset <unk> two to eight six which we expect to enter into clinical development in this quarter with a phase one two lumia study.
Talk to me like the NUPLAZID therapy uses kept to toxic molecules to deliver on radiation missing isotope specific achievements.
He's talking molecules peptides and people do with small molecules.
When injected into a patient's bloodstream targeting molecule that purchased accounts yourselves delivering high doses of radiation to the tumor while sparing normal tissue.
Our lead compound FAP two to eight six license as part of our ongoing collaboration with <unk> Pharmaceuticals is an investigational peptide targeted radionuclide therapy, which targets fibroblast activation protein S. H P.
I think he is highly expressed on cancer associated fibroblasts forecast, which represent one of the most abundant cell components in humans.
And 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.
Cancer, such as fiber box play a critical role in tumor initiation and progression and metastasis and therapeutic resistance.
For example, recent studies have demonstrated the F. A P expression cash is a potent immunosuppressive activity.
Tumor progression and control resistance to immune based therapies, such as PD, one PDL one blockade.
And sitting tumor types, such as sarcoma mesothelioma I think Pete May also be expressed on the tumor cells themselves. In addition to the cancer associated fibroblasts.
S. A P to tweak six consists of two function elements first targeting peptide that binds to a P. P expressing pass on tumor cells.
On second site that can be used to attached radioactive isotopes.
Depending on the specific radioactive isotope attached S. A P. Two to eight six can be use of patient imaging and selection both therapeutic applications.
You know if things went to lumi yesterday, if a P to tweak fix will be attached to the isotope gallium 68, two and I'll pass it on that mission positron emission tomography or pet imaging inflection of patients from fusion study.
From a therapeutic agent P. Two to eight six will be attached to the August lutetium, one 7%.
Dmitry, we took popsicle ionizing radiation it causes DNA damage and cell death.
Non clinical studies, including animal models presented at ESMO last year showed a S. A P T to wait six completely from selectively bind to S. E T.
In addition, antitumor efficacy that's a P. Two.
To tweak six linked to be kitchen is observed in <unk> expressing tumor models.
We look forward to sharing additional preclinical and clinical data.
On your meeting.
We submitted to ANZ applications F. A P to 'twenty six pieces in imaging and therapeutic agents at the end of 2020 to support on Loopnet study.
With expansion cohorts planned in multiple tumor types as part of a global development program.
We are pleased to announce beyond these create following acceptance by the FDA CMC data from the first about clinical sites each of which was effectively soon as real time manufacturers. The imaging agent give them extremely short almost like from gallium 68.
With FDA clearance of the Ind's the lineage W is expected on future enrollment by the end of this quarter.
The phase one portion of Illumina study will evaluate the safety of U S. H P. Tau investigational therapeutic agents and identify the recommended phase two dose and schedule of lutetium on 707 labeled two to eight six.
Once the recommended phase two dose is determined phase two expansion cohorts planned in multiple different tumor types.
It's a P to tweak sixth label with gallium 68 will be utilized as an investigation on imaging agent to identify patients with a hey people stick tumors appropriate for treatment with a therapeutic agent.
In addition studies or let's say P to tweak things linked to an alpha particle emitting radionuclides in combination studies with other oncology compounds are also being planned.
Given the role of S&P expressing cash in mediating immuno suppression combination with PD, one and PD lone blockade will be a priority.
In addition to our own program a separate investigator sponsored imaging study with a P to train six is underway at UCSF true.
F. A P expression in multiple tumor types and is currently enrolling patients.
Results from this study along with preclinical data we are generating are expected to help inform selection of tumor types for a phase two expansion cohorts.
In addition, we and <unk> pharmaceuticals are collaborating on a discovery program directed at three additional targets for targeted radionuclide therapeutic development to which we have global rights.
With our achievements to date, we believe we have the opportunity to be a leave it in the bedroom chilled to talk to you probably get therapy for the treatment of solid tumors tend to be the first to clinically develop a peptide targeted radionuclide therapy talked against a P.
We are also enthusiastic about the topic on the subject of on discovery collaboration on look forward to providing additional data without appropriate.
One last thing.
Exciting new data will be entire targeted radionuclide therapy. So it will be reported in a plenary session on <unk> in June.
In March Novartis from that Phase III vision trial on PSM 8617.
Me 1000, metastatic castrate resistant prostate cancer patients that achieved both co primary endpoints, including overall survival.
We look forward to seeing the details from the study on bleach It will offer a new treatment option for amendment advanced prostate cancer.
And further validate talking to radio therapy, as an important new therapeutic class.
Now I'll turn the call over to Lindsey Rolfe to discuss the pipeline from a bracket and resubmit Kinsey.
Kinsey.
Good morning index with each day to discuss key clinical milestones expected flow Rebecca.
In 2020 from.
Do you book, we expect to announce top line clinical data from the Athena trial monotherapy arm in the second half of 2021.
Is that timing is contingent upon the occurrence.
Hi.
Yes.
As a reminder, this evening thanks, Jade agitation study from.
Client newly diagnosed advanced ovarian cancer maintenance.
What you see now we believe we are uniquely positioned to evaluate in terms of true independent.
Monotherapy.
Christine on in the first line maintenance.
Actual depopulation.
Increases of BRCA and.
And in the all comers or intent to treat book.
One is evaluating any potential.
The combination.
Uh huh.
Hum.
We believe this study also.
Opportunity to truly differentiate them in the first line.
As I mentioned on here he Athena readouts on pending on the true based on the Cherokee.
Yes.
One is top line is not true.
We would time from Indiana.
P value.
Continuing with me 10 percentage points.
The load stuff.
Tom Safety punchy.
Evaluate Inc.
Homologous recombination repair genes, including back on Christine's times continues to emerge from patients.
This study evaluates.
In patients with recurrent solid tumors associated with identity theory homologous recombination.
The issue with that gene mutation.
Based on our interactions with FDA. This study may be registration, enabling true hockey team on tumor agnostic label.
Pending data, we could potentially file for approval in the U S. For this indication in the first half from 'twenty to 'twenty two.
I mean, you could see clinical trials.
The study being sponsored by the alliance and accounts in oncology, which is part of the National Cancer Institute.
Cash is a phase three study comparing it.
To extend them to see them as a novel therapy.
Line N T L. P C. All comers population.
The approximately 1000 patient study will begin enrollment shortly following.
It's true that Romney pharmacokinetics substance, which is no longer necessary. Following the successful completion. The closest sponsored phase one study is on making the same combination.
Now I'll discuss each segment.
This isn't it is on investigational engine.
Which inhibit vascular endothelial growth, we said two months free free.
Platelet derived growth since 2000 feature on five rupees.
That's one true true.
The Clovis sponsored study phase one day, two studies evaluating the sickness in combination with Opdivo in gynecologic cancers, which is currently enrolling patients.
Expansion cohorts.
Engine from.
On the non piece.
Thanks, Angie cohort have been accepted for poster presentation at <unk>.
Well evidence of clinical activity have been obsessed we believe it's pretty day did not support percentage then.
On pace on a very intensive.
On the street.
Non kissel endometrial cervical and T cells.
On such endometrial cancer.
Continue to enroll patients and we plan to submit an abstract describing the engine and dmitry.
So the medical meeting later this year.
Lastly on peace Triple net on the defense and the effects of COVID-19 on our clinical trial enrollment remains minimal.
And with that chemical assets.
We discussed last quarter net financial results.
Thanks, Lindsay and Hello, everyone. We reported net product revenues from a bracket of $38 1 million for Q1, 2021, which included U S. Net product revenues of $31 7 million and ex U S. Net product revenues of $6 4 million.
This includes comparable net revenues from our prostate indication in the U S. In Q1, 2020 one as seen in Q4 2020.
First quarter 2021, net revenues represent an 11% decrease compared to Q1 2020.
In which we reported net revenues of $42 6 million, including net product revenues in the U S of $39 3 million and ex U S. A $3 3 million.
As Pat mentioned, we believe we maintain U S market share during the quarter. Despite the decrease in revenues as each of the marketers of PARP inhibitors with ovarian cancer indications based on COVID-19 related impact in the U S. Inc. Q1, 2021 compared to Q4 2020.
Gross to net adjustments totaled 25, 6% globally in Q1, 2021 compared to 25, 6% from Q4 2020, the same as last quarter.
This metric fluctuates quarter to quarter, and it's difficult to estimate our future revenues, but a range on that mid to high 20 per cent seems likely depending on the revenue distribution mix for the U S and Europe.
European revenues increase in proportion to the U S Global G T N will increase correspondingly.
Research and development expenses totaled $52 8 million for Q1, 2021 down 23% compared to $68 2 million for the comparable period in 2020, primarily due to lower spending on Rebecca clinical trials, we expect research and development expenses to be lower than the full year of 2021.
Compared to the full year 2020.
Selling general and administrative expenses totaled $29 9 million for Q1, 2021 down 30% compared to $42 6 million for the comparable periods in 2020 with savings due to the COVID-19 situation globally and overall cost reduction efforts further we expect SG&A expenses.
The decrease from 2021 compared to 2020.
We reported a net loss for Q1 of $66 3 million or <unk> 64 per share compared to a net loss for the first quarter of 2020 of $99 3 million or $1 39 per share.
Net loss for Q1 included share based compensation expense of $4 million compared to $13 million for the comparable periods in 2020.
Turning now to a discussion of cash as of March 31, we had $199 million on cash and equivalents.
And as of March 31, we had drawn approximately $113 6 million under the sixth Street partners LLC Athena clinical trial financing and had up to 61 $4 million available to draw under the agreement to fund expenses of the Athena trial base.
Based on the company's anticipated revenues spending available financing sources and existing cash on cash equivalents. We believe we have sufficient cash and cash equivalents to fund our operations into early 2023, including any cash repayment unless refinanced earlier of the remaining $64 4 million aggregate principal amount of the two and a half.
Percent convertible notes at maturity in September 2021.
Net cash used in operating activities was $61 9 million for Q1 2021 down from $82 5 million reported in Q1 2020 cash burn in Q1, 2021 was $48 1 million down 28% from $66 9 million in Q1 2020, we have rich.
<unk>, our RNA, R&D and SG&A expenses considerably compared to prior years.
Recently, we reduced R&D and SG&A expense by $28 1 million and reduced net cash used in operating activities by 25 per cent compared to Q1 2020, we expect this trend of lower cash burn to continue through 2021.
Now I'll turn it back to Pat.
Thanks, Dan.
In summary, we're very enthusiastic about F 'twenty 'twenty, six and our targeted radionuclide therapeutic development program overall.
And look forward to providing updates as lumia opens for enrollment in our programs continue to advance.
We believe the targeted radionuclide therapy will become an extremely important component of anti cancer therapy and believe that our early commitment to this field has been validated by the recent phase III vision trial for <unk> 617.
On metastatic castration resistant prostate cancer.
Which as Tom noted, we will report will be reported at <unk> in June.
If anything we believe F. P may be an even more important target given its presence in multiple solid tumors and we are pleased to be the first company to enter clinical development with an F targeted peptide targeted radionuclide therapeutic.
Well the last 12 months of COVID-19 headwinds have been challenging we believe that we're well positioned as the effects of the pandemic lessens over time for several reasons.
The day later this year.
Which we anticipate may ultimately support Rebecca as us and what will likely be its most important indication. The first line maintenance ovarian cancer setting, which includes the largest patient population of women with advanced ovarian cancer following successful treatment with platinum based chemotherapy.
We believe that the hybrid approach incorporated into our U S commercial strategy last fall.
Best enables us to reach clinicians in the way they want to be reached and positions us well as the impact of COVID-19 on oncology practices lessens over time.
We remain focused on disciplined cost control as Dan discussed and our cash burn will be lower in 2021 and 2020.
Finally based on current revenue and expense forecast, we believe we have sufficient resources to fund our operations into early 2023.
With that we'll be happy to answer any questions you may have.
As a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound key please standby, while we compile the Q&A roster.
Your first question comes from the line of Cory <unk> with J P. Morgan.
Hey, this is gavin on for Cory Thanks for taking our question.
Quickly on the S&P program.
Clearly, there's some interest there I'm curious what your expectations are for patient accrual there.
Do you expect physicians to do you know.
On the receptive of enrolling patients in the study and just any color you can provide on your expectations. Thank you.
You know, it's a standard phase one, but Lindsay maybe I'll, let you answer that question with a little more detail.
So.
Thanks, Catherine just pass it is standard.
And with.
With cohort by cohort enrolled.
Enrolment, so timeline wise, we would expected to proceed in that fashion.
In terms of.
<unk>, yes.
At each of the discussion on site. So we're working with a neutral net.
And one more from colleges.
Your line is the engagement on the appropriate expertise, we're not expecting.
I'm conscious just to manage this whole new therapeutic modality that day at hand in hand.
Within every case, a very enthusiastic nutrient medicine.
Okay next question please.
Yeah.
Hello, Andrew on your next question comes from and widen with H C. Wainwright.
Good morning, Thanks for taking my questions just to as a follow up on the <unk> piece.
To be more clear could we see some phase one data this year.
And what we've said is that the phase one we'll be continuing this year on it it's more likely to be presented formally.
At a medical meeting next year on.
That being said, we've committed to providing updates on the program on these quarterly calls.
Including if and when and as we see them on.
Initial evidence of.
Clinical benefit.
These calls will be a forum for an update on progress, but the formal presentation on scientific data.
Will be it will be.
Probably sometime in the first half of next year.
Okay. Thanks, Pat and I, just wanted to get a little bit of clarity on.
The expenses I know that you had said that costs will be down are expected to be down on 2021 versus 2020.
But I'm looking at the first quarter and thinking on a going forward on a sequential basis quarterly.
Are we looking at a new base now or could we expect to see additional cuts going forward on a quarter to quarter basis.
Dan.
Yeah. Thanks for the question.
As we've talked about in the past we've had a a.
A declining slope of R&D spend primarily around the Rebecca trials, which are.
For the most part awfully enrolled and going down the other side of the slope. So there'll be continued reductions really driven by that.
And on the SG&A side, where.
We clearly expect to have lower SG&A for the year.
And.
The rate of.
How that will proceed for the rest of this year.
We haven't specifically disclosed, but but part of that will.
Get back to.
Activities that we may or may not contemplate in the second half of the year related to the sales and marketing group.
But clearly we're.
At a much lower level of spend than we were.
Spread last year.
Okay. Thanks, Dan and my last question if I may.
Pat you had mentioned that you maintained.
Share in the U S Park market.
Can you give us a little bit more color on what's going on in the U S Park market.
<unk> talked in the past about penetration being 40% to 45% in the second line maintenance.
Area and just wanted to get your thoughts on where it is now and what if anything can be done to get the.
The penetration of the market to grow the overall market I know you've worked on in the past or is it just getting through the pandemic.
Yeah. So so in terms of sort of Q4.
Versus Q1.
You heard our numbers today.
July was down 5% per.
From Q4 to Q1 and actually that included a 5% price hike on January 1st So they were effectively down 10%.
<unk> sales were effectively flat.
And they noted that any growth that the primary growth driver for them.
In the U S was in the prostate indication.
On.
S T O.
There was a presentation on kind of what's happening in real world real World experience.
And utilization of PARP inhibitors on the maintenance setting and it remains at around 50%.
So while many physicians.
Have adopted.
Maintenance treatment in the second line setting and to some extent on the first line setting on.
On either they're limiting it to a subset of populations, who they think would benefit most maybe a tracker and maybe its HRD.
It's related to the patients experience on.
On platinum.
We still see a number of physicians, who are a percentage of the physician population that limit their use.
Two of of PARP inhibitors.
Due to a very small number of patients and that's why we're at that 50% number that we as a community have not cracked for whatever its been now three years.
In addition.
A driver of.
Of.
Of the market's performance in Q1.
It was just the continuing effect of COVID-19, and the cumulative effect of COVID-19 on ovarian cancer day booking surgeries.
On primary diagnosis.
And on on.
A more limited use because of that.
Of platinum based chemotherapy, which which are on a precedent therapy for use of PARP maintenance.
Office visits are back to normal.
I think that this is going to correct itself.
Tragically, many patients are going to be diagnosed with more advanced disease.
Which is going to create an urgency around care and so that's why I referenced in my prepared remarks that we think is COVID-19 lessons.
That things will improve over the course of this year, but.
But we did see that cumulative effect.
On the PARP market in Q1.
Okay. Thanks, Pat for taking my questions you bet. Thank you.
And your next question comes from the line the line of Paul Choi with Goldman Sachs.
Hi, Thanks, Good morning, and thank you for taking our questions Kim.
Two pipeline questions Portland, Lindsay if I may 1st.
Just with regards to your commentary on Lone Star could you. Please elaborate just on what.
FDA feedback has been that gives you confidence that the trial could be registration, enabling us is talking about patent minutes post.
Recent FDA update on meetings.
And then second on the Leo one update and the decision to not proceed in an.
Non ferrous Hello value can you comment whether <unk>.
On the MTBE dose was reached for that particular cohort and Thats. Some particular reason or was it just underwhelming efficacy. Thank you very much.
Okay.
<unk>.
So net.
As you know there's plenty of precedent now true approvals in hand.
Non ciena.
<unk> defined indications.
We have discussed it.
Development time.
<unk> EBITDA.
And behind the nine city, taking that feedback into accounts so that gives us.
Okay.
On the right track there.
For.
Mir one into the non peso as net income.
We.
Okay.
Yes.
This was underwhelming efficacy, but those things.
Was just as we had expected you will recall that we had.
<unk>.
On possibility build teams of patients to escalate.
Does it they could see the first Michael was on.
Significant adverse effects and we saw the proportion of patients those pesky just as we anticipated.
On that the adverse event profile was also just as we got anticipated zone.
Right.
On slide 14.
<unk> per player.
Yeah.
And then of course, the other three independent cohorts and connected phenotypes.
Continuing on.
Thanks for the questions.
Thank you.
And your next question comes from the line of Andrew Burns with SBB Leerink.
Hi, Thanks, I was wondering if you guys could give some more color on the lodestar program.
How much do you think the tumor agnostic indication would expand the addressable market.
On what's the status of the other PARP inhibitors in this indication and then I have a question about your cash runway after that.
The.
The largest population.
Of BRCA mutated patients.
Is.
In ovarian cancer.
In breast cancer and prostate cancer.
So I think it will have an effect if approved.
On <unk>.
And obviously, we think the opportunity to bring targeted therapies to other indications where they may be effective as what is.
That's what we're here to do.
I would actually focus everybody's attention. However on two trials that are going to be markedly larger and an opportunity for us that Athena, which we'll read out prior to any data from lodestar.
And Triton three.
Which will at the latest fully enrolled in the first quarter early second quarter of next year, and we'll definitely have data next year.
And those are far bigger indications for us from Lone Star, we're enthusiastic about lodestar.
Obviously directing the trial consistent with.
F D a interactions.
I'm pleased to be doing it but the two big drivers for us over the next year 18 months.
Our Athena and Triton free.
And you had another question.
Yes, just on award on.
On that what what is the status of the other PARP inhibitors.
In a tumor agnostic indication before free cash flow my question.
They're not as forthcoming on those programs as we are or as tesoro used to be.
So it's hard to know exactly what their status or others are running either monotherapy trials I believe Pfizer is running a combo trial with an I O agent as well so.
As ever in the PARP class or is likely to be competition.
Okay.
Thanks, and then.
Just on the cash runway I'd, just like to get some more clarity.
Because I don't see how it stretches from 2023.
Did you guys say that includes repaying the 2021 note.
Based on our numbers I, just don't see even if you back in our range.
<unk> expenses further and back out on screen, you could stretch a $190 million per 'twenty three.
Yeah, Andy this is Dan so.
So there's a few components that obviously so from a revenue point of view, we have a range of outcomes that we planned for and we're effectively in those ranges.
Although we are having some struggles in the U S. At the moment the European sales continue to do well in and we're feeling pretty good about that and we do hope for improvement as the year goes on with the COVID-19 situation.
And on the expense line as you can see we're pretty dramatically reduced expenses and we've continued to do that over the last year or so.
And so that is a large contributor to that as well. It does include repaying the 2021% to $64 million.
But we also keep in mind have the $61 million less coming in on the Athena financing. So it's really a $190 million plus 61 is the way to look at it over.
Over that timeframe, so it's more like $250 million.
And we do have.
Spence levers that we have.
Help us to get there so.
<unk>, obviously looked at it pretty carefully at some important disclosures so were.
That's where we are.
Okay, great. Thank you very much from a color I appreciate it.
Yes.
On <unk>.
Your next question comes from the line of Joe Catanzaro with Piper Sandler.
Hey, guys. Thanks for taking my questions, maybe one first on Leo and Lindsay I think you've kind of alluded to this but does this signal you've seen in non clear cell ovarian provide any read through to the other cohorts and then Relatedly I know we've seen data for Limbach net plus <unk> in ovarian cancer, but don't specifically recall if they.
Broken out clear cell versus non clear cell just wondering if.
Do you have any insight into that.
Thanks, John for the question.
I think.
Cohorts really independent.
Moving on a piece of that Chinas net six women.
Moving on.
Kimberly really non T cell line is is not similar to the types of Chinas simplicity.
I think on the 15th.
The second question what was it again, sorry, it's whether labatt net plus Pembroke has broken out their ovarian cancer data based on non clear cell versus clear though.
So I'm pretty sure. They didn't include cash constipation.
Cancer patients in the cohort.
It was 90 of high grade series per connection.
Okay got it and then if I could just ask a follow up I'm wondering if you could elaborate a little bit on what you saw on <unk> of last year round <unk> dynamics that contribute to a relatively strong quarter, then that you didn't see this quarter.
Yeah I'll take that.
We've tried to figure that out and I think the primary thing we saw is that.
From Q4 on.
New patient starts.
Combined with continuing therapy.
From patients enrolled as early as the end of the prior year on in Q1.
Allowed us to kind of continue with.
A good sales performance and in fact, we didn't see a number of patients fall out of out of.
Therapy, and our average duration of use actually continued to go up some.
In Q1.
Some of those patients fell off and were not adequately.
I'll say replaced with newly diagnosed patients eligible for second line.
Maintenance for the reasons I described the falloff in the reduction and the bulking surgery platinum based chemo and overall diagnosis.
We believe that dynamic will change over the remainder of this year, particularly as in patient visits office visits have gone back to normal.
And obviously this is a tragically difficult disease to treat.
When it's not treated because of concerns about COVID-19 or other things it doesn't stop growing and.
And it doesn't stop occurring.
And so patients are going to be diagnosed they're going to be requiring therapies and they're going to get back into the maintenance use of PARP inhibitors, including grew bracket so as as diagnoses increased.
Patient starts will increase.
And that will be the driver of sales over the remainder of this year for the class not just for us.
Okay. Thanks for taking my questions you bet.
And your final question comes from the line of chasing them.
Mod with bank of America.
Hi, Good morning, Thanks for taking my question Pat I, just wanted to get some color on your thoughts about what kind of off target Tox might you expect to see with 22 a day effects.
And then as it relates to it to the Athena study.
Assuming that you do have the positive data come in what would be the next step to filing for the F. N B, a and when would you expect that to actually have that new label at thank you.
Yep.
So with regard to F 'twenty 'twenty six.
We have a limited amount of data.
As you may recall from the 10 or 11 patients that were image.
And treated on compassionate use in Germany.
And we did not see on.
Off target accumulation.
And any tumor type I'm, sorry on any tissue type.
And we're pleased that we didn't we also.
Didn't see anything in animal models that caused us any concern.
Obviously with any new drug it can be hard to predict what a side effect might be.
And if there would be off target accumulation.
The two areas I think we would be most focused on would be the potential for myeloma depression.
True of any DNA damaging agent.
And the second is because of the way.
Each of the.
Each of P. S on May 617, allude, a thorough and and our agent all peptides.
Are eliminated we will see some accumulation in the kidney.
And the question is whether that has any acute or chronic impact. It has not promoted thorough or <unk> $6 seven at least to our knowledge will get an update on the entirety of P. S. On may six seven months or so.
But theres nothing in our data.
Caused us to be thinking Oh man.
We're really worried about something.
When we did see the original scans from.
The 10 or 11 patients in Germany.
Because of the known off target accumulation in the salivary glands have <unk> 617.
All of US looked at the salivary glands on of course, we didn't see any accumulation there that's very specific to us it makes 617.
So we're we're optimistic.
Optimistic.
Obviously, it's a phase one study that will start at a low dose and so what it's a signal emerges we'll we'll see at Lindsay anything you would add to that.
No that was excellent.
Great.
Then on.
What was the timing.
So the timing of the Athena data as Lindsay noted will be driven by.
When we achieve it.
A specified number of PFS events.
I would I would suggest that when we see those data.
And announce those data we'd be about three months from filing an S. N D E. And then the FDA would have up to six months to review it. So so think of.
Think of an approval on or around a potential approval on or around nine months from when we announced top line data.
Okay. So hopefully.
Will it be when I went to COVID-19 recovery by that cars com.
I believe strongly I think all of US do that we will be in hope so permanently for all sorts of reasons.
Okay. Thank you Pat.
Thanks, Susan.
Anna.
Okay. Thanks, everyone.
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