Q4 2020 Puma Biotechnology Inc Earnings Call
Good afternoon, My name is Donna and I'll be your conference operator today.
On to the Puma Biotechnology conference call.
At this time, all participants on a listen only mode. After the Speakers' formal remarks, there will be a question and answer session. If you would like to ask a question during that time simply press. The Star then the number one on your telephone keypad. If you would like to withdraw your question. Please press star two.
If you require operator assistance during the conference. Please press Star Zero and as a reminder, this conference is being recorded I would now like to turn the conference over to Ms. Marianne.
Oh, Hannesson senior director of IR for Puma Biotechnology is thank you. Please go ahead.
Thank you Donna and good afternoon, and welcome to put on this conference call to discuss our financial and adults for the fourth.
Reported for 2020, joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board and Super Biotechnology next and loans against Chief Financial Officer, and Jeff <unk>, Chief Commercial officer.
After market closed today and initiative.
News release detailing the fourth quarter of 2020 financial results.
And he was really the slides for Jeff what we referred to and a webcast for this call are accessible via the home page and investors sections of our website and Puma biotechnology Dot com the webcast and presentation slides will be archived on our website and available for replay for the next 90 days.
Today's conference call will include statements about the company's future expectations plans and prospects that constitute forward looking statements for purposes of federal Securities laws.
Such statements are subject to risks and uncertainties and actual events or results may differ from those expressed and each forward looking statement.
For a full discussion of these risks.
Certainty for each week.
And our periodic and current reports filed with the SEC for time to time, including once filed for Angela.
Reported on form 10-K for the year ended December 31 2020.
You are cautioned not to place undue reliance on forward looking statements, which speak only as of the date of this live conference call February 25th 2021.
The company undertakes no obligation to revise or update any forward looking statements to reflect exactly the circumstances. After the date of this conference call, except as required by law.
During today's call. We may also refer to certain non-GAAP financial measures didn't fall adjustments to our GAAP figures.
These non-GAAP metrics may be useful to investors and stuff on that too, but not as substitute for our GAAP financial measures.
Please refer to our fourth quarter 2020, and news release for reconciliation for GAAP to non-GAAP results I will now turn the call over to Alan.
Thank you Mary Anne and thank you all for joining our call today.
Good day for your reported total revenue for the fourth quarter of 2020.
For $2 6 million.
Total revenue includes net U S sales as well as royalty fees from our sub license fees.
Net sales for $50 million and the fourth quarter of 2000 and Troy.
Presenting for slight decrease from the $49 3 billion and net sales reported in the third quarter of 2020, and a decrease from the $58 7 million reported and Q4 of 2019.
Our fourth quarter results also included royalty revenue of $2 6 million versus 200000 in Q4 for 2019.
During the fourth quarter of 2020, we continued to experience challenges brought on as a result for the COVID-19 pandemic.
I'll begin with a review of the highlights of the quarter and then Jeff Ludwig will provide more details on <unk> commercial activities Maximo and <unk> will follow with highlights of the key components of our financial statements for the fourth quarter of 2020.
During the fourth quarter of 2020, there were several clinical updates for the company and where are we.
For the full for investors.
Early October we announced the efficacy results up direct and heard you positive HR positive early stage breast cancer from our phase III extra day after that and clinical trial were published in the journal of clinical breast cancer. We believe that this publication will also increase awareness and your legs and its benefit and.
This patient population. We also presented updated data from the extra net trial and from our ongoing controlled trial, which is investigating ways to reduce the side effects and improve the tolerability of the drug at the San Antonio breast cancer Symposium in December.
And investors are also aware Puma has an ongoing basket trial up and you're at.
And hurts your mutated cancers referred to as the summit trial.
And the trial was modified in early 2020, such that ER positive <unk> negative breast cancer patients who have a hurts your mutation were randomized to receive either for western alone for that.
For the plus trastuzumab or the combination of neuropathy and thoughtful investments plus trastuzumab.
Under the initial Simon's two stage design each on the amended study will enroll seven patients during stage one and.
And if no patient in a given on response that all will be closed for further enrollment.
And the first stage, one or more patients respond the arm will be expanded up to 18 patients.
Washington and for patients in the expanded arm respond that arm will be closed to further enrollment.
More than for patients respond the arm will be expanded and additional patients will be enrolled.
Enrollment in this trial is continuing in 2021, and our current estimate and that we will reach the initial enrollment of 21 patients, which would be seven patients per arm and early Q2 of 2021.
The timing of this enrollment may be impacted by COVID-19, or the recent weather conditions and certain parts of the us.
And once enrollment in this trial is complete we look forward to being able to perform a topline analysis of the response data, which would determine whether or not and should expand their respective arms under the Simons two stage design that was previously described.
The timing of this is obviously dependent on enrollment and whether or not patients and a given arm response, we would expect to have the topline analysis completed somewhere between mid 2021 and late 2021 and.
And we have noted previously we will further anticipate that this topline analysis, which formed the basis for a pre NDA meeting with the FDA to discuss the potential for accelerated approval.
As investors are also aware and November we announced interim data from another cohort from the summer trial and more specifically the cohort of patients with metastatic non small cell lung cancer with epidermal growth factor for Egfr.
Excellent and a T mutations.
And previously treated with and Egfr tyrosine kinase inhibitor.
And late January 2021, we presented additional data from this cohort of patients and an oral discussion at the World Conference on lung cancer presented by the International Association and for the study of lung cancer. We are continuing to enroll this cohort of patients and.
Anticipate and we will have additional data from this cohort you report and the second half for 2021.
Moving on to other developments in the fourth quarter, we were pleased to announce that Puma prevailed and us.
And I it'll appeal proceedings brought against its license European patent and E. P patents one eight for eight for one for which covers the use of irreversible Egfr inhibitors, and treating just sitting on it and or a lot of resistant cancer and cancer with the T 790 M Egfr mutation.
The European Board of appeal announced its decision and a final hearing on December 1st concluding that the opposition on the patent initiated by a bearish on ingelheim entity was inadmissible and reversing the European and opposition decision issued in 2014, thereby upholding the patent as originally granted.
In addition to day after the close Puma announced that Puma and PR February have agreed to extend the terms of their existing licensing agreement for <unk>.
Clued granting a peer for break.
Commercialization rights for near links to greatest trader, China, US, which includes mainland, China, Taiwan, and Hong Kong and Macau on.
Under the terms of the agreements for mobile received an upfront payment of $50 million as well as additional regulatory and sales based milestone payments that could add up to an additional $240 million vs.
And milestones will be based solely on our regulatory and sales achievements in greater China.
In addition, Puma will receive significant double digit tiered royalties on the sales of near links in greater China.
In addition, Puma and Cambridge Pharmaceuticals have mutually agreed to terminate their license agreement to commercialize near links in greater China.
<unk> has agreed to pay and Cambridge, a onetime fee of $20 million and return to return all rights to <unk> and even greater China back to Cuba.
We are pleased to extend our relationship with Pierre if I break into the greater China region for you.
For a break currently markets the drug Navelbine also known as its been are all being which is one of the common chemotherapy drugs used in the treatment for breast cancer in China and is therefore, well equipped with an existing commercial infrastructure in China to make near links and success and mainland China, we anticipate that Pierre for break.
Plans to make drillings available for breast cancer patients in mainland China, and the second quarter of this year.
I will now turn the call over to Jeff Ludwig Puma as Chief Commercial officer for a review of our commercial performance during the quarter.
Thanks, Alan I appreciate it and thanks for everyone for joining our fourth quarter earnings call. The.
Our commercial organization continues to work very hard to reposition their links with the goal of strengthening the risk benefit perception, increasing our promotional interactions with customers and deploying resources and an innovative and efficient manner.
We believe that <unk> can play an important role and the treatment of metastatic breast cancer, but our focus is on extended adjuvant with a goal of preventing patients from becoming metastatic <unk>.
And this market is significantly underpenetrated and more and must be done to help patients and their families and this battle with early stage breast cancer.
I am pleased with the foundational work that has been put in place and we are increasing our emphasis around focus and execution moving forward.
Before I move into the commercial review just to remind you that I will be making forward looking statements.
As you May recall, we have two channels that provide <unk> links to patients we refer to these as our specialty pharmacy channel and our specialty distributor channel for in office dispensing channel.
The majority of our business flows through the specialty pharmacy channel more specifically in Q4, approximately 79% of our business went through this channel with the remaining 21% flowing through the specialty distributor channel.
This is in line with what we reported during our Q3 earnings call as well.
Now later on our call Maximo will review the full financial results, but I will now provide you with the current U S sales results.
Slide four shows us quarterly net sales of neuro links since FDA approval.
And as Alan noted, our net U S product sales were $50 million and our fourth quarter of 2020. This is a slight increase over the $49 $3 million, we reported in Q3 of 'twenty and 'twenty.
As mentioned on prior Q4 earnings calls, we tend to see a decline and new patient starts and the fourth quarter each year as some patients decided not to initiate new therapies around the Thanksgiving Christmas and new year's holidays.
In addition, these results continued to be impacted by the COVID-19 pandemic and.
As you are likely aware COVID-19 infection rates and deaths increased significantly and the fourth quarter to levels not seen previously and we have only recently begun to see these decline.
These spikes have caused continued challenges with live face to face interactions with customers and virtual interactions remain the norm the.
And the field team is working very hard to adapt to this new environment and we have increased our non personal promotional efforts.
With that said overall promotional interactions remain below our pre COVID-19 baseline.
In addition, these spikes can cause a disruption and overall patient flow and this is more likely to occur in the early stage breast cancer setting.
Combining the Q for holidays, along with the significant increase and COVID-19 infections, we did see some softening in both and specialty pharmacy channel and the specialty distributor channel in Q4.
Now on slide five shows the bottles of narrowing sold by quarter. Since launch we sold 3585 bottles of <unk> and Q4, 2020, which is a very slight decrease from our Q3 2020 bottle sales of 3000 and 611.
The focus of the commercial organization is to grow neuro linked quarter over quarter, which did not happen in Q4.
With that said I have mentioned previously that I am happy with some of the foundational work that has been put in place to change the risk benefit perception of <unk>.
Key elements of this and of this strategy include the following for.
First the publication of the interim results for the control study and the September additional of Annals of oncology.
This was important because it highlighted that anti diarrheal strategies, including dose escalation can significantly reduce the incidence of grade three diarrhea, and improve overall tolerability of neuro links.
The second key element was the publication of the final efficacy results excuse me from the extra net trial in the October edition of clinical breast cancer.
This was important because it highlighted the benefits seen in a descriptive analysis of patients at heightened risk of disease recurrence.
These patients were her two positive HR positive with residual disease, receiving their links with within one year following their trastuzumab based therapy.
This descriptive analysis demonstrated day consistent benefit in invasive disease free survival overall survival and CNS events, we believe that <unk> can play an expanded role in the broader extended adjuvant setting, but it's important to note that there remains significant opportunity even in this high risk group.
<unk>.
And finally, good representation of neuro links during December San Antonio's breast cancer Symposium with 10 accepted posters, including spotlight poster on the extra net OS data and.
And a poster highlighting the benefits of dose escalation from the control study.
We believe that this information combined with additional supporting initiatives can play an important role in changing the perception of the risk benefit profile of <unk> going forward.
And early indicator of the impact of the Controle publication can be seen on slide six which shows that in Q4, approximately 38% of all new patient starts were initiated at a reduced dose.
This is an increase over the 33% we reported and Q3.
As a reminder, this is very important since we have control data showed that utilizing a dose escalation strategy in the extended adjuvant setting coupled with PR and loperamide showed a greater than 60% reduction and grade three diarrhea.
60% reduction and median cumulative days of grade three diarrhea, and an approximate 80% reduction and discontinuation.
We believe that the increasing adoption of dose escalation will improve the overall tolerability of neuro links and increase the average length of therapy with the end result, benefiting more patients battling breast cancer.
Slide seven highlights the strategic collaborations we have formed across the globe with the goal of making <unk> available to more patients around the world.
Key highlights and Q4 include the launch of neuro links in Finland, and Switzerland, as well as the most recent metastatic approval and Argentina that incurred in January of 'twenty and 'twenty one and.
In addition, as Alan highlighted in his opening remarks, we have extended our partnership with Pierre Fabre rate to greater and greater China, which will now include mainland, China, Taiwan, and Hong Kong and Macau.
We are continuing to work closely with our partners and look forward to the potential for <unk> to be approved in additional countries in Europe, Latin America Asia, and the Middle East.
In summary, I'm proud of the foundational work that has been done by the team and believe that we are well positioned to increase the impact we're having on patients battling her two positive breast cancer.
I will now turn the call over to Maximo for a review of our financial results maxima.
Thanks, Jeff.
I will begin with a brief summary of our financial results for the fourth quarter of 'twenty and 'twenty.
Please note and I will make comparisons to Q3, Q2, 'twenty and 'twenty.
Which we believe are better indications of our progress us a commercial company and year over year comparisons.
For more information I recommend that you reported dollars 10-K, which will be filed in early March and includes our consolidated financial statements.
For the fourth quarter of 'twenty and 'twenty, we reported a net loss based on GAAP for $15 million or so.
38 cents per share.
Our GAAP net loss for Q3, 'twenty and 'twenty was $31 5 million and our GAAP net income for Q2, 'twenty and 'twenty was $3 4 million.
On a non-GAAP basis, which is adjusted to remove the impact on stock based compensation.
We reported a net loss of $5 5 million or <unk> 14 per share for the fourth quarter of 2020.
Gross revenue from Nellix sales was $60 1 million and Q4 'twenty and 'twenty.
Versus $58 6 million and Q3.
As Alan mentioned it net revenue from Nellix sales was 15 million.
That increase for net sales for $49 3 million and the third quarter of 2020.
And Q4, 'twenty and 'twenty, we also recognized $2 6 million and royalty revenue for them always lower partners versus $1 5 million and Q3.
Our gross to net adjustment in Q4 was about 16, 8%.
And the increase from the 15, 8% gross to net adjustment in Q3.
The increase was driven mostly on higher rebates to flow a price increase and holds.
Cost of sales for the fourth quarter was $10 9 million.
Which included the amortization of intangible assets related to our license of neuropathy net of approximately.
And then $2 million.
Going forward and will continue to recognize and amortization of the milestone payments to the license for about 2 million per quarter as cost of sales.
For fiscal year, 'twenty, 'twenty, one Puma anticipates and Nellix net sales will be and the range of $205 million to $210 million.
We also anticipate that our gross to net adjustment in 'twenty and 'twenty, one will be between 18, 5% and 19, 5%.
Furthermore for fiscal year 'twenty, one we anticipate receiving royalties from our partners around the world and the range of $16 million to $17 million and potential license revenue in the range of 30 to 32 million.
We recognize there's a great deal of uncertainty regarding the impact of COVID-19.
And this may continue to negatively impact our sales royalties and license revenue.
Historically, the first quarter represent the lowest net product sales quarter of the year.
Due to a number of factors, including a decline and new patients starting mailings during the call.
Holidays, and the fourth quarter of the prior year.
Which carries over to bottle sold in Q1.
Also the recent weather conditions and certain parts of the US created some disruptions to our shipment and enrollment.
We are tracking the recovery closely.
We anticipate our Q1 'twenty 'twenty, one and earnings net sales will be and the range of $42 million to $43 million.
Royalty revenues will be on the range of $2 3 million and lie.
And our license revenue will be $30 million.
Also we anticipate for the gross to net and Q1 'twenty 'twenty, one will be approximately 20% to 21%.
SG&A expenses were $28 8 million and the fourth quarter of 'twenty and 'twenty.
Compared to $29 6 million and $29 4 million for Q3, and Q2, 'twenty and 'twenty respectively.
SG&A expenses included non cash charges for stock based compensation of $4 3 million for the fourth quarter of 'twenty and 'twenty.
Compared to $4 1 million for Q3, and four for 7 million for Q2.
Research and development expenses.
For $24 2 million and the fourth quarter compared to $23 3 million and $24 7 million for Q3, and Q2, 'twenty and 'twenty respectively.
R&D expenses included non cash charges for stock based compensation and $5 3 million for Q4.
Compared to $3 5 million and $5 9 million for Q3 on Q2, 'twenty and 'twenty respectively.
In the fourth quarter of 'twenty and 'twenty.
Whom our reported cash burn of $15 6 million, which included a $10 1 million milestone payment for Pfizer compared to cash and a one 8 million and Q3 and $6 2 million and Q2 'twenty and 'twenty.
For the full fiscal year our cash.
Burnt and was $19 3 million, which included 26 million for payments to the license on their optimism.
We ended the fourth quarter of 'twenty, and 'twenty with $93 4 million and cash cash equivalents and marketable securities.
And our accounts receivables balance at December 31 was $25 5 million.
Our accounts receivable terms range between 10 and 68 days.
Our day sales Outstandings are about 46 days we.
Estimate and as of year end 2020, our distribution network maintain and approximately three weeks of inventory.
Overall, we continue to deploy our financial resources to focus on their boxes on mid afternoon through ongoing clinical trials and the commercialization on Netflix.
Thanks Maximo.
We continue to recognize that we need to improve yearly sales growth and that the COVID-19 pandemic is presenting challenges to us with respect to achieving metrics Puma senior management and cooperation with the board of directors continues to remain focused on New Orleans revenue and sales growth and 2021 and beyond we are.
Moving to adapt to the virtual environment that we have needed to pivot toward due to the COVID-19 pandemic and we are hopeful that changes for our commercial infrastructure will make a positive contribution to new airlink sales growth, we look forward to updating investors on this and the future.
And there continues to be a significant unmet need for women battling breast cancer, we have puma are committed and passionate about finding more effective ways and helping these patients during their journey and we will continue to strive to achieve that goal.
This concludes today's presentation, we will now turn the floor back to the operator for Q&A operator.
Ladies and gentlemen, the floor is now open for questions. If he would like to ask a question. Please press star one on your telephone keypad at this time.
For confirmation tone will indicate your line is for the question queue.
True move your question you May press Star two.
Our first question today is coming from Keenan Mckay of RBC capital markets. Please go ahead.
Alright, Thanks for all took and the question.
And two fold question.
Wondering first off for the next steps on the ongoing litigation on Pizza and none.
On your IP and and.
And you and.
And then b.
Beyond that.
As it relates to sales of Maryland.
And there lies just wondering in the metastatic setting what the feedback has been from from reps around our competition with a true.
For Kaiser and her two positive space again, and metastatic setting. Thank you.
Yeah.
Thank you for the question Shannon.
With regard to our T 790, and patents and I'm sure you can imagine that topic is one that's a V.
Very sensitive legal matter and.
And so therefore theres not theres not much comment on we can provide on it.
On your second question with regard to the metastatic on Jeff's, if you'd like to take that sure happy to so Ken and as I mentioned and opening remarks. We are excited that neuro links was approved and the metastatic setting in February as you mentioned <unk> was approved soon thereafter and April and we feel very good and and quite honestly on another.
<unk> was approved in late December so that's very good for patients and a metastatic setting where there's many more options. We're still watching to see how that sequencing plays out but I can tell you that our focus is really in extended adjuvant trying to do everything we can to prevent patients from becoming metastatic intermedics met us.
Static setting we expect to see some sequencing of agents as unfortunately patients progressed, but in the extended adjuvant setting we do not seen the same type of competitive environment and we believe that market is significantly underpenetrated. So our focus is really in the earlier lines of therapy and.
And Ken and I can add to that.
And look in the metastatic setting and especially kind of that third line and beyond.
It's been for drugs approved within within 2020 timeframe.
And you had and hurt you guys are near links and then our agenda and as Jeff said from a commercial standpoint, that's an extremely competitive area. So it's much wiser for us to maintain our focus on the extended adjuvant, where you know there is no competition for us for the only drug approved and so that tends to be where we have the very large majority of our focus.
Okay.
So does that answer your question.
Yes. It does thank you very much.
Thank you. Our next question is coming from Kenneth Atkins of Cowen. Please go ahead.
Hi, guys. Thanks for taking my question.
As we look forward to the update and the second half could you remind us what you think the bar for successes and Egfr exon 18 mutant lung cancer, what profile do you think you need to achieve there to to be successful.
Hi, Thanks for that question that is a good question.
I don't know the answer to quote what the bar is to be successful US you will we are focusing on patients who have.
And Egfr exon 18 mutations.
And specifically those who have already been treated with and Egfr T. K I. The only data that's out there in that space would be the data with fat NAV.
Which showed a roughly 10 ish percent response rate.
And using that as a bar.
And that as kind of a comp if you will.
That's where I think the bar is.
Obviously, I can't answer that from a regulatory standpoint, it until we've actually had a discussion with them.
But from our perspective on.
Our interim data showed a 40% response rate, we think that compares very very favorably.
And the data with the fat nib.
Thank you know the best comp I can get and the only one that's out there for that niche. If you will is the fact that data that's the best barometer I can give you.
Got it Okay and then just one question on the guidance what kind of assumptions are built into the guidance for new airlink sales in 2021 in terms of.
What happens with the pandemic and and how should we think about true.
And through the year.
Okay.
And I can take that.
In terms of.
Guidance for <unk>, especially focused on the us.
We are thinking about the Covid pandemic, obviously, you're aware of what's happening here. We believe a lot of folks are beginning to get vaccinated and ultimately we believe the second half of 2021 will be very different than the first half of 2021 from a commercial promotional perspective as we start to see.
Hopefully knock on wood offices begin to open up travel resume and a little bit more normal fashion and ultimately from from neuro <unk> commercial standpoint. This is a very promotional <unk> sensitive product and we we obviously have some very good data that came out and the latter half of 'twenty and 'twenty and so having those channels open up for more promotion.
Activity should allow us to build growth quarter over quarter moving forward.
Okay. Thank you that's helpful.
Yeah.
Once again Thats Star one to register a question at this time.
Thank you. Our next question is coming from Cory <unk> with Jpmorgan. Please go ahead.
Hey, this is Turner on for Cory. Thanks for taking my question. So it sounds like the pre NDA meeting to discuss and celebrated approval of the.
Hershey and he told me and hormone receptor positive breast cancer.
Cohort a and some of the trial will occur later this year and you just talk about the pushes and pulls on getting accelerated approval and perhaps just what do you think you need to show on the data to achieve it.
Yes, just to clarify you are talking about the hurts your mute and breast correct.
Yes, correct, yes, yes, okay.
So if you don't mind I'll go into kind of a long winded explanation here. When we started the summit trial, we were first treating with the rat and the balance of single agent and that study and so these were patients who were hurt you negative E on.
Our positive and had a hurts you mutation, we treated with and are at NAV, we were getting responses, but the duration of them was very short and.
And what we found was looking at pre and post treatment biopsies.
And we're finding that when you gave your attitude to inhibit the mutation the estrogen receptor transcription was up regulated.
Quite high so it was.
It's clear that the mechanism and escape there with the estrogen receptor so it and move forward with combining the radnet with for restaurants. So that we are hitting the hertz and mutation and hitting the estrogen receptor and youre getting a higher response rate we are getting a longer duration of response, but it wasn't kind of that now.
910 month types of Earth day.
And as we were looking for we again did pre and post treatment biopsies and we found was although we were hitting the estrogen receptor and where you're heading and mutation and the tumor was hurts you negative the mechanism of escape weighted with up regulating and the her two receptor. So it's flipping for being her two negative her two positive. So we then gave you were at net to hit the mutation we gave.
For that strength to hit the estrogen receptor and then we're getting herceptin trastuzumab to prevent the tumor for trying to go to become her two positive. That's when we started getting much higher response rate longer durations and we wanted.
For the FDA, and weird and meeting with them and discuss the path forward.
And they acknowledged that the science was very well thought out and they even acknowledged to us that they had had a lot of meetings with companies where with some.
And evolving kind of smaller.
Targeted populations, where you need it more than one drug to try to treat effectively treat the tumor.
What they asked us to do was to try to isolate the contribution up and are at nib choose.
<unk> that triplet choose and you're at NAV.
Herceptin for restaurants, triplets, and Thats, where the Simon two stage came in which was the triplet and one arm.
Herceptin for restaurant and the other for vesting and alone and the other.
It's going to really depend on what we see and that data I mean, if you see what you would hope to see which is the clear advantage of the triple over the others.
I'm hopeful that will be with the FDA was looking for now we obviously have a.
Very large body of data.
On the triplet out in Iraq, and the Herceptin for investment and that would obviously for them a very significant basis of and accelerated approval filing, but we're hopeful if you see that clean separation, that's exactly that question and the FDA would like answered. So I can't give you any metrics or numbers all I can say is that.
That appears to be what they have asked us to do that's what we are doing and so we will know more after we've seen the data and had a discussion with the FDA.
Got it that's helpful. Thanks.
Okay.
Thank you. Our next question is coming from Geoff Meacham of Bank of America. Please go ahead.
Hey, guys. This is alec on for Geoff Thanks for taking my questions.
I think Jeff touched on this a little bit but on your new partnership with Pierre Fabre and in Asia, and how do you view the market for Niraparib and these geographies versus what you've seen in the us and I guess, what is your sense as to peer fab Ray's commitment pushing niraparib and these markets versus your prior partner and <unk>.
I guess related to that what will be your go to market strategy and additional geographies, whether we could expect additional partnerships announced over the course of 'twenty one.
Okay.
Talk about share far.
Pierre for Gray has been a great partner to us and Europe we.
We expanded the partnership wants to include some other countries.
In addition to Europe and and this is the second expansion of it their execution has been excellent and Europe and they've been a wonderful partner to US one of the things that's very attractive about them is the fact that they had been selling the drug navelbine, which has been around <unk>, which is one of the main chemotherapy drugs used in breast cancer. So there is an existing channel that.
And place to breast cancer physicians in their territories.
In terms of in China.
They're trained and they've already been training their people and we're scheduled to launch the drug in China.
And the second quarter, so and a few months.
Very.
Large commercial and infrastructure there it's on par with the other companies in the area.
We have a very odd.
Optimistic view of it in terms of the actual dollar amounts are I would say that the us is probably the biggest market for the drug.
Europe is probably second and I would say China is.
Close behind and in that second place and it may actually be a tie between Europe and China. So I think it's going to be a very significant opportunity for us and we're looking forward to their launch there.
Now in terms of your question on other territories as Jeff went over in his slide.
Got pretty much partnerships across the board I think there's a few more countries out there, but the main ones.
Which is obviously now.
Europe, the Middle East North West Africa, South Africa.
Latin America, Canada, Israel, Australia that we hope we partnered dose. So we've got I think the main large country that we still have and partnered is Japan.
And then I think there's a few smaller ones as well.
Alright, great. Thanks.
Thank you. Our next question is coming from Paul Choi of Goldman Sachs. Please go ahead.
Hi, everyone. Thank you for the updates this is Charlie on for Paul. So I've just got a quick question and it's great to see the uptake of the dose titration increase with the cue for patients that you showed there.
And I'm, just wondering or we're just wondering what is being done in terms of expanding on making sure that patients continue that uptake of dose titration regimen from the control study. In addition to no publication of the control study results, what's being done to promote this sort of regimen to increase garlic and uptake. Thank you so much.
Yes, no I appreciate it very good question. We believe that is a very important foundational part of our strategy is as we believe the embedding are operationalized a dose.
On a dose escalation can change the profile of risk benefit and Tolerability. So clearly a significant message for the field force commercially both directly as well as non commercial non.
Personal promotion is to highlight the benefits of the control study.
We have also submitted the control study to the FDA for a label update on potential label update coming forward.
And we are working with many of the pathways and guidelines committees as well to ensure that this becomes embedded as part of the standard of care for extended adjuvant patients and air as well.
Okay.
One other piece that we're moving forward with is we have actually received approval for a new bottle size that is a 133 count bottle size that supports the adoption of dose escalation for the first month and therapy that bottle size. Obviously supports the three pills for a week four pills per week and then six pill.
<unk> for the remaining two weeks so that it will also be launched in the foreseeable future as well to further and bad dose escalation.
Okay.
Alright, great that's excellent color. Thank you so much.
Thank you. Our next question is coming from Gena Wang with Barclays. Please go ahead.
I guess and Sheldon Albertina, Thanks for taking all my questions are for.
So could you comment on your current revenue breakdown from the extended adjuvant setting and Bruce is metastatic and also your expectation about this breakdown for evolution of this breakdown going forward can we assume that that's majority will still come from extended adjuvant.
And secondly is on the X and <unk>.
F. R E T E mutated non small cell lung cancer.
And do you have any idea about the current penetration of genetic testing for these Nick Smith of mutation is it bundled and the Egfr testing already.
Okay on your first question, Jeff if you'd like to Alan and I.
And I believe are asking us to breakdown and metastatic vs extended adjuvant.
And we estimate currently as seen in the fourth quarter about 6% of our new patient starts are in the metastatic setting.
And I would suggest that that expectation or breakout will be consistent for at least the next several quarters and as I mentioned before our focus is really heavily on the extended adjuvant and early stage breast cancer, where there is an awful lot of patients that are not being treated there and we think we can make a bigger impact on patient.
Lives and with the goal of preventing them or hopefully and helping them prevent recurrence and day metastatic setting.
And then on your second question, which is on the Egfr exon 18 in lung cancer. There very good about doing mutation screening I would venture to guess that it's pretty much done for every patient and the Egfr exon 18 mutations and already on the lung cancer panels, and everybody runs and so theres no.
Special test that anyone has to run its being picked up on the existing panels.
That's very helpful. Thank you so much.
Thank you at this time I would like to turn the floor back over to Mary Anne for closing comments.
Thank you for you and Puma biotechnology.
As a reminder, this call may be a replay.
A replay of the webcast.
I'm, a biotechnology dot com beginning later today have a good evening.
Ladies and gentlemen, thank you for your participation and interest and Puma Biotechnology you may disconnect. Your lines at this time and have a wonderful day.
Okay.
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