Puma Biotechnology Inc. Q1 2023 Earnings Call
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Good afternoon, My name is Rob and I'll be your conference call operator today.
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I would now like to turn the conference call over to Maryann Johannesson Senior director of Investor Relations for Puma Biotechnology, you May now begin your conference.
Thank you Ron Good afternoon, and welcome Chip Hummus conference call to discuss our financial results for the first quarter 2023 joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board Biotechnology, Massimo <unk> Chief Financial Officer.
Jeff Ludwig Chief commercial officer.
After market close today Puma issued a news release detailing first quarter 2023 financial each L. J.
That news release, the slides that Jeff referred to and a webcast of this call are accessible via the home page and investors sections of our website at Puma Biotechnology Dot com.
<unk> 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 results.
May differ from those expressed in these forward looking statements.
So discussion of these risks and uncertainties. Please speak to our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10-K for the year ended December 31 2022.
You are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date of this live conference call May four 2023.
The company undertakes no obligation to revise or update any forward looking statements to reflect events or 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.
Adjustments to our GAAP figures.
We believe these non-GAAP metrics may be useful to investors as a supplement to but not as substitute for our GAAP financial measures.
Please refer to our first quarter 2023 news release for a reconciliation of our GAAP to non-GAAP results.
I will now turn the call over to al.
Yeah.
Thank you Mary Anne and thank you all for joining our call today.
Today Puma reported total revenue for the first quarter of 2023, $52 8 million.
Total revenue includes product revenue net which consists entirely of near link sales as well as royalties from our sub licensees.
Product revenue net was $46 8 million in the first quarter of 2023.
This represents a decline as expected and $53 7 million reported in Q4 2022.
And it represents a 15% increase from $40 7 million reported in Q1 of 'twenty two.
Product revenue for the first quarter of 2023 was impacted by approximately $3 8 million of inventory drawdown in our specialty pharmacies and specialty distributors.
LT revenue was $6 million in the first quarter of 2023 compared to $12 million in 2000, Q4 of 2022 and $5 million in Q1 of 2022.
Yeah.
Okay.
We have 42849 bottles of neuro links so although the first quarter of 2023 compared to 3323 bottles sold in Q4 of 2022.
As we noted on last quarter's call. We estimate that Q4 that Q4 inventory build amounted to approximately 164 bottles in Q1 2023, new prescriptions or interacts were up approximately 11% compared to Q4 'twenty two.
And total prescriptions were down approximately 4% compared to Q4 'twenty to Jeff will provide further details in his comments and slides.
I will now provide a clinical review of the quarter and then Jeff Ludwig well add additional color on the early commercial activities.
And actually when the gas will then follow with highlights of the key components of our financial statements for the fourth quarter of 2022.
As investors are aware in September 2022.
I was pleased to announce that we had in licensed anti cancer drug Alistair from Takeda.
Nickel trial dates Alistair has shown single agent activity and activity in combination with other anti cancer drugs in the treatment of various cancers, including a whole receptor positive breast cancer triple negative breast cancer small cell lung cancer and head and neck cancer.
The drug has also shown activity in previous clinical trials and peripheral T cell lymphoma, and non Hodgkin's lymphoma.
Takeda is previous clinical development program with ulcerative was extensive and due to this there's a large well characterized clinical safety database with over 1300 patients who were treated across 22 company sponsored trials.
We are currently anticipating that we will be meeting with the FDA late in the second quarter of 2023 to discuss the registration pathway for al asserted in small cell lung cancer, and we're substantially I'm sorry subsequently.
Dissipate initiating clinical trials of Alastair and small cell lung cancer in the fourth quarter of 2023.
In March we are pleased to announce the publication of clinical trial results from T. V. C. R. C 41 in Jama oncology.
This was a randomized trial that tested al asserted monotherapy versus Alistair to possible investments in patients with hormone receptor positive hurts you negative breast cancer we.
We are pleased to see the activity of al assertive in this patient population as well as a resulting biomarker analysis in the publication.
As investors are also aware in April 2021 data was published in Jama Network open.
From a randomized phase two trial of <unk>.
<unk> plus <unk> versus paclitaxel in patients with metastatic breast cancer.
In patients with hormone receptor positive her two negative breast cancer. The data showed a statistically significant benefit in progression free survival for patients who received alistair to plus paclitaxel compared to patients who received paclitaxel alone.
We anticipate that the biomarker data from this trial will be presented as a poster at the American society of clinical oncology or <unk> annual meeting in June .
We further anticipate meeting with the FDA in the second half of 2023.
Can you discuss the registration pathway for <unk> in hormone receptor positive hurts you negative breast cancer and subsequently initiating clinical trials of Alastair does it hold receptor positive hurt your negative breast cancer in the first half of 2024.
We continue to anticipate that there will be several clinical milestones for the Alex sort of program in the coming months. This includes the previously mentioned biomarker data from the randomized trial of a shelf are all start up plus paclitaxel versus paclitaxel alone in hormone receptor positive her two negative breast cancer, which as I mentioned, we presented at Astro in June .
Also data from an ongoing investigator sponsored phase one two trial of <unk> plus number there's a map in the treatment of patients with RV deficient head and neck squamous cell cancer, which as anticipated sometime in 2023.
A meeting with the FDA to discuss the registration pathway for al assertive in small cell lung cancer, which we anticipate in late Q2 of 2023 and conducting the meeting with the FDA to discuss the registration pathway for Alistair did it hold receptor positive her two negative breast cancer, which we anticipate in the second half of 2023.
As mentioned on prior earnings calls and in response to Investor questions. Kumba continues to evaluate several drugs to potentially in license that would allow the company to diversify itself and leverage prove as existing R&D regulatory and commercial infrastructure.
We will keep investors updated on this as it progresses.
I will now turn the call over to Jeff Ludwig Puma, Chief Commercial officer for a review of our commercial performance during the quarter.
Hey, Thanks, Alan I appreciate it and thanks to everyone for joining our first quarter earnings call.
Before I move into the commercial review just a reminder, that I will be making forward looking statements.
Our commercial strategy continues to be largely focused on the extended adjuvant indication with a goal of helping more patients reduce their risk of recurrence. Although progress continues to be made this market is underpenetrated and more needs to be done to support patients in their battle with her two positive breast cancer.
Our commercial team is focused on increasing our reach and frequency to hcp's via personal and non personal promotion as well as extending our outreach to better educate patients around the risk of recurrence and the risk benefit profile of <unk>.
Our goal is to increase penetration in the extended adjuvant excuse me adjuvant setting and drive consistent growth.
Specifically in regards to Q1 I am pleased that we saw HCP calls increased approximately 16% quarter over quarter and those any of those calls about 81% Re-live versus virtual also in Q1, our marketing team evaluated our non personal promotion strategy and work to refine our relaunch some of these tactics.
With the goal of increasing impact in Q2 and beyond.
Lastly, the commercial team led by our clinical nurse educators continue to focus on expanding our outreach to local and regional advocacy organizations.
With that very high level updates, let me transition to some of the U S commercial slides, where I will provide some additional specifics around the business. Once that finished I'll turn the call over to Maximo for a more detailed review of our financial results.
Now moving to slide three.
Our distribution model has not changed and remains separated into two distinct channels that provide neuro links to patients. We refer to these as our specialty pharmacy channel and our specialty distributor channel or in office dispensing channel.
Most of our business continues to flow through the specialty pharmacy channel, but we did see some stronger Q1 performance and the SD channel. So the overall switch did changed slightly from Q4.
In Q1, approximately 75% of our business went through the specialty pharmacy channel with the remaining 25% of the business going through the specialty distributor channel.
As a reminder, in Q4, we reported that 78% of our business went through the specialty pharmacy channel and the remaining 22% when do the SD channel.
Now moving to slide four slide four shows U S quarterly net sales of <unk> since FDA approval.
As Alan noted our net product sales were $46 8 million in the first quarter of 2023. This.
This is a $6 $1 million increase from Q1 of 2022, and a $6 9 million dollar decrease from Q4 of 2022.
Inventory changes clearly have an impact on these numbers. So let me give you some additional insight.
In Q1, we estimate that inventory decreased by about $3 8 million.
As a comparator, we actually inventory decreased by about $4 3 million in Q1 of 2022 and increased by about $2 6 million in Q4 2022.
Moving to slide five slide five shows the bottles of narrowing sold by quarter. Since launch. Please note that this slide shows ex factory bottle sold so it represents sales into our specialty pharmacy and specialty distributor channel and not end user demand.
We sold 2000 849000, <unk> in Q1 of 2023, which.
Which is about 6% higher compared to Q1 of 2022 and about 14% lower than Q4 of 2022 now again, let me provide a little more insight around inventory changes here.
We estimate that inventory decreased by about 236 models in the first quarter of 2023.
As a comparison, we estimate that inventory decreased by about 282 bottles in Q1 of 'twenty, two and increased by about 164 bottles in Q4 of 2022.
Now the commercial team is focused on execution with the goal of driving growth both quarter over quarter and year over year gear.
Given this priority let me provide some more specifics around a few key metrics in.
In Q1, we saw quarter over quarter growth in enrollments of about two 5%.
But a decline of about 10% year over year.
In regards to commercial new patient starts or interacts we saw an 11% growth quarter over quarter, and a 1% growth year over year.
Lastly, turning to demand in Q1, we saw quarter over quarter demand decreased by about two 3%, but increased by about 4% year over year, driven by strong growth and the SD channel.
Slide six highlights the adoption of dose escalation. We continue to believe that dose escalation is an important metric as it serves to improve the tolerability of neuro links by significantly reducing grade three diarrhea, decreasing discontinuation rates and reducing the median days of grade three diarrhea.
In Q1, approximately 664% of patients who receive commercial drug started in early on a lower daily dose, which is similar to what we reported in Q4 of 2022.
I'm overall happy with the adoption of dose escalation and pleased to see dose escalation in crude included in many prominent guidelines, including N CCN.
We do have some physicians that are comfortable starting on full dose in the extended adjuvant setting and some that prefer to start at full dose in a metastatic setting with.
With that said the commercial team continues to discuss and educate around the benefits of dose escalation.
Slide seven highlights the collaborations we have formed across the globe in Q1 of 2023 neuro links received regulatory approval in the extended adjuvant setting in both Morocco, and South Africa and received regulatory approval in the metastatic setting in Colombia.
Also in Q1 2023, we're happy to announce that <unk> was officially launched in Mexico in the extended adjuvant setting.
Our global partners continue to focus on driving increased adoption and preparing for future launches I look forward to highlighting their continued progress moving forward.
I want to thank my commercial colleagues for their continued dedication to becoming more efficient and more effective as we strive to make a bigger impact on patients battling breast cancer.
I also want to thank the broader Puma organization for their support and partnership.
I know they also share our passion for making a broader impact on patients.
Now going to turn the call over to Maximo for a full review of our financial results.
Thanks, Jeff.
I will begin with a brief summary of our financial results for the first quarter 'twenty to 'twenty three.
Please note that I would make comparisons to Q4 2022 it.
We believe is a better indication of our progress as a commercial company.
Year over year comparisons.
For more information I recommend that you refer to our Q1 2023 thank you, which will be filed today and includes our consolidated financial statements.
Okay.
The first quarter of 2023.
Reported net income based on GAAP of $1 4 million or three cents per share.
This compares to a net loss in Q4 2022.
$8 6 million or <unk> 12 per share.
On a non-GAAP basis, which is adjusted to remove the impact of stock based compensation expense.
We reported net income of $4 2 million or nine cents per share.
First quarter of 2023.
Yeah.
Gross revenue from that links sales was $59 4 million in Q1, 'twenty two 'twenty three.
$65 4 million in Q4 2022.
I didn't mention it net product revenue from Nellix sales was $46 8 million compared to the $53 7 million reported in Q4 2022.
We believe that Q1 net sales were impacted by approximately $3 8 million of inventory drawdown from our distributors.
Royalty revenue totaled <unk> 6 million in the first quarter of 2023 compared to 12 million in Q4 2022.
And lower royalties versus Q4 reflects the timing of shipments to our partner in China.
Our gross to net adjustment in Q1 'twenty two 'twenty three was about 21, 2%.
Compared to the 17, 8% gross to net adjustment reported in Q4 2022.
Higher copay wasn't the main driver of increase versus Q4 2022.
Cost of sales for Q1, 2023 was $13 2 million, including $2 4 million or the amortization of intangible assets related to our and their ultimate license.
Cost of sales for Q4, 2022 was $16 8 million.
Going forward, we will continue to recognize amortization of milestones to the license or about $2 4 million per quarter as cost of sales.
For fiscal year 2023.
Month, you said page net narrow links product revenue will be in the range of $205 million to $210 million.
We also anticipate that our gross to net adjustment for the full year 2023 will be between 19% and 20%.
In addition for the fiscal year 'twenty to 'twenty, three we anticipate receiving royalties from our partners around the world in the range of 25 to 30 million.
We don't expect license revenue in 2023.
We also expect the net income for the full year will be in the range of $20 million to $24 million.
We recognize there continues to be a great deal of uncertainty regarding the impact of COVID-19, especially in countries outside of the U S.
May continue to negatively impact our sales royalties and license revenue.
We anticipate that for Q2, 2023 nellix net sales will be in the range of $47 million to $50 million.
Also we expect Q2 royalty revenue will be in the range of $2 3 million.
We further estimate that the gross to net adjustment in Q2, 2023 will be approximately 20% to 21%.
Puma anticipates, a Q2 net profit of between zero and one 5 million.
SG&A expenses were $22 5 million in the first quarter of 2023 comp.
Compared to $25 1 million for the fourth quarter.
SG&A expenses included noncash charge charges for stock based compensation of 2 million for Q1, 2023 compared to 1.8 million for Q4.
Research and development expenses were $12 7 million in the first quarter of 2023.
Compared to $13 9 million for the fourth quarter.
R&D expenses included noncash charges for stock based compensation 0.9 million in the first quarter of 2023.
<unk> for the fourth quarter.
The first quarter of 'twenty to 'twenty, three Puma reported cash burn of approximately $9 9 million compared to cash of approximately $3 1 million in Q4 2022.
In Q1, 2023, we've made a $12 5 million payment to Pfizer related to the achievement of our global revenue milestone.
An 8 million payment related to a legal settlement.
Yeah.
The expense side Puma continues to anticipate a reduction in total operating expenses in 2023 compared to 2022.
More specifically, we anticipate SG&A expenses to decline approximately 1% to 30%.
R&D expenses to increase 6% to 8% year over year.
March 31, 2023, we had approximately 71 minutes in cash cash equivalents marketable securities.
Our accounts receivables balance was $31 2 million.
Our accounts receivable terms range between 10, and 68 days, while our day sales Outstandings are about 48 days.
We estimate cut off so much 31st 2023, our distribution network maintain approximately three weeks of inventory.
Overall, we continue to deploy our financial resources to focus on the commercialization of Nellix developments of all disruptive and controlling our expenses.
Yeah.
Thanks Maximo.
We are pleased to be able to achieve positive net income during the first quarter of 2023.
Thomas Senior management in cooperation with the board of Directors continues to remain focused on improving narrowing sales in 2023 and beyond.
In the fourth quarter of 2021, we implemented a reduction in expenses with the goal of reducing expenses in order to maximize the operating cash flows. We believe that the positive net income reported in the first quarter was a direct result of these expense reductions.
Reductions were also a major contributor to the positive net income and positive cash flow that the company is guiding to for full year 2023.
<unk> remains committed to continuing to achieve these operational cash flow and positive net income and will continue to reduce expenses if needed to achieve this we look forward to updating investors on this in the future. There continues to remain a significant unmet need for patients battling breast cancer lung cancer and other solid tumors, we have puma are committed and passionate about finding.
More effective ways and helping these patients during their journey and we'll 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.
We will now begin the question and answer session.
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Thank you and your first question comes from Ed White with H C. Wainwright. Please proceed with your question.
Sorry, good afternoon, and thanks for taking my questions.
So the first question is just a clarification what was the gross to net in the quarter did I hear 22 point something.
Give me a second the gross to net was 21 point too.
'twenty, one way to do it.
Great. Thank you.
And are you seeing an increase.
In in your patient assistance programs.
Increase in participation.
Yeah.
So and we and in terms of patient assistance programs are you talking about free drug or you're talking about additional support for mentorship and things of that nature.
No free drug.
It free drug in Q4, we did not see an increase in that we we've actually been watching that very closely we had a trend going for partial last year, where we're seeing an increase in non commercial drug that did not hold true in Q1.
Yeah.
Okay, great. Thanks.
And just regarding the royalties.
Do you guys.
Provide maybe a little bit of clarity on the growth projections I know China's always been lumpy for you, but with the sort of end of COVID-19 over there or should we see it a little bit more smooth this year and also what are your partners doing.
Outside the U S sort of boost the sales numbers.
Yeah, Ed to answer the question in terms of the Lumpiness of China Youre, absolutely correct. Yeah. It is lumpy, we do get payments of various amounts a lot of that is also because of the fact that you know we manufacture the drug for our partners and then sell it to them and then they sell it to the market.
And with China, specifically, a lot of that Lumpiness has been that manufacturing of it as well so and when we can transfer things over and the time it takes and things like that so that kind of contributes to that lumpiness.
To answer your second question in terms of what our ex U S. Partners are doing you know in every country. It's different in a lot of them. There are situations, where there's countries that we still haven't gotten reimbursement for so we're waiting for that and that will provide some additional boose, but in all of them. You know we continue to see them doing the same thing we're doing in the U S which is.
They're trying to increase their share of voice and having more interactions with the physicians.
Yeah.
And are they also running their programs like you did two in an effort to increase the number of patients that start on the lower dose.
And in some countries, we do have lower dose approved in others, it's not yet on the label. So I think theres educational efforts around appropriate dosing to try to reduce any of the side effects in some countries. We do have that is promotional portion of their other mix and others, it's not there yet.
From a label perspective.
Okay. Thanks. My last question is just on the subject of starts are at the lower dose.
It seems the first quarter was down from the from the first quarter of last year.
Or are you sort of had a plateau right now how do you think this is the level that patients who will be at or is there something that you can do to increase that a bit lower just start.
Yeah, a great question I appreciate it and obviously as I keep saying we think that's very important that we continue to drive the low doses. It does change that tolerability profile I'm going to give you an estimate and I would guess that we have still some room to further penetrate but where we're not too far off of the Max that we're going to see and I'll explain that.
A little bit more theres, a couple of factors going on here number one as I mentioned there are some folks in a metastatic setting which is a small part of our business, but there are question Theres a commision clinicians in the metastatic setting that want to start on full dose for efficacy reasons in a matter of fact that urgency to treat we also have several clinicians are are a group of physicians.
<unk> in the extended adjuvant that are very comfortable starting on full dose and if a patient has challenges with side effects <unk> diarrhea, they want to dose reduce as opposed to going the other direction.
But the vast majority are starting on low dose and moving up.
The one other piece that I think it's important I want to make sure I articulate that again is as you saw in my opening that about 25% of our business now goes through DSD channel. So we've seen some growth in the in office dispensing channel.
The reason that's important in this context is that if a patient starts and the SD channel and stays in the S. D channel, we wont know what their dosing as we do not get patient specific information. We also won't get it on enrollment from those patients they don't come over to the SP side, where we collect enrollments.
What is not uncommon is that a patient will start in the S. D portion.
The adoption of dose escalation, we believe in the community setting is pretty strong if they start in the S. D session a portion of our business on a low dose and because the payer forces them to move to a specialty pharmacy. After the first or second Phil that specialty pharmacy prescription will start at 180 right.
I'll be on their second or third Phil and come in at full dose and so and we don't capture that as clearly as we would like so the numbers I quote to you are understated from what we believe the actual execution of low dose is.
Hopefully that makes some sense.
It does thanks, a lot for the clarity.
The next question comes from the line of Dubai Route with TD Cowen. Please proceed with your questions.
Hi, This is David on for Mark Thanks for taking our question. It all up on their grid snack question. It looks like for the full year to keep in line with the guidance.
The second half growth to be around 18% I guess, what do you think what are the kind of assumptions, you're making them that would lead to a significant decrease.
I have a follow up to that.
Yeah.
In terms of gross to net you're right. That's about what we expect for the back half.
What we're seeing is some of the inflation data right that that is offsetting some of the price increases that we hot so other than that we really don't don't plan for any significant changes again.
Again, you you you need to remember that Q1 is usually the highest quarter in terms of gross net or to call pay on line at halls in fall.
Okay. That's helpful. And then switching gears that altered your program I realize that you guys haven't had a conversation with the FDA, yet, but I guess internally do you guys expect to run a randomized trial or do you think you could potentially go forward with a single arm trial.
Then are there any kind of design criteria is that you think the us even require that maybe you guys would consider moving forward with Alastair in small cell lung cancer.
Davita just so I understand the last your last part can you repeat that question and clarify a little bit.
Yeah, I was just asking if there was any.
Design criteria that may be the FDA might require for you to run a trial that you move forward and I'm just based on either cashman strains or anything like that you guys might reconsider our conservation of capital.
Okay.
Yep Okay.
Okay. So first of all in terms of your the first part of your question, which is you know al sort of do we think the path to market is a single arm trial, which would allow for an accelerated approval or randomized trial.
Or a combination of both and that's the reason for having the meeting with the F. D. A M.
Looking at small cell lung cancer for example.
On one side of the Ledger you have that you know there is a.
Regulatory history.
All of them are proving drugs based on single arm trials in that indication. So you do have a regulatory precedent there.
On the other side of the Ledger, you obviously have the.
Recent guidance that's come out from the F D, a which has been leaning more toward randomized trials and away from a single arm trials.
That's the reason for having that discussion with them so whether it's a.
As a mono therapy trial, whether it's a single arm trial, I should say or randomized that's what we want to discuss with them you know whether it's in the intent in entire small cell lung cancer population or one that's a biomarker focused is another discussion we want to have with them to your last question, which is you know is there any design.
You know that due to cash reasons, we would not take forward.
As we have said in every one of our earnings calls the most important thing for this company.
Is to make sure that we are net income positive and cash flow positive. So I think at your Guys' Conference Mark had asked me the question as well, which was you know would you stagger the indications to be able to conserve cash and protect that and they didn't come line absolutely.
If it need be and we need to stagger, the breast and lung indications, especially.
As I said, we can continue to be net income positive and cash flow positive. There's no question. We will do that like I said in every one of our earnings calls we have said the most important thing for this company is to continue to be net income positive and cash flow positive and we will manage our R&D budget in order to achieve that.
Got it that's very helpful. Thank you.
Our next question comes from the line of Geoff Meacham with Bank of America. Please proceed with your question.
Hum.
Can you at least is how well they can't meet you and thank you for the question. So just a question on the.
Q2, net put out guidance.
It seems to indicate a decline year over year, while Q1 was pretty strong in terms of new patient and girls caught up I call. It and Oh, Yeah, I intend to net product revenue. So just wanted to understand a bit more on the assumptions going to that our <unk> guidance there.
Yeah.
I'm sorry can you repeat your question one more time please.
Yeah. So my question is about the the two Q second quarter net product revenue guidance of 47 to 50 million seems to be.
The year over year decline, while you had a pretty strong Q into mobile revenue growth year over year, New patient enrollment was also 11% caught up had gone up girls. So cause the money to understand the assumption goes into.
That's too cute that point, that's when you can.
Okay. So thank you for clarifying that comparing Q2 'twenty three to Q2 'twenty. Two you have to remember that there was an inventory build in Q2 of 2022 of roughly 150 to 200 bottles.
So that that's going to offset that revenue comparison that youre doing.
Okay.
Okay, well that's helpful. Thank you.
Our next question is from the line of Gena Wang with Barclays. Please proceed with your question.
Hi, Good evening. Thank you for taking our question. This is Hershey, Don French Guiana.
That's a big picture question for you.
So for Nevadan up last quarter, you announced.
Discontinuation of the summit study, so what should our focus be on.
In terms of growth opportunities outside.
I've already approved indications going forward or is the thinking now primarily on Alastair in terms of expansion opportunities.
Revenue provides floor value and you know on the heels of that if you could expand more on.
Opportunities you're exploring to like in license other products like how are you thinking about it.
Is that primarily in cancer that would complement your pipeline any additional color on that would be helpful. Thank you.
Yeah. Thank you for the question so with regard to our near links in Iraq, You're you're correct that we decided not to take the summit indications forward and the main reason for that is that you know our composition of matter patent on Niraparib expires in December 2030, So for us to go do randomized trial.
All in all these very rare mutations where if the screen the patients which can add additional time and cost. The ROI just wasn't positive to do that and again for us to go run you know a five year trials or something.
By the time I wish you a prudent for a 2028 or 29.
You're just not going to get the return on investment for that and again, it's very important for us to protect the investors and protect their ROI. So you are correct that we chose not to take that forward and foreign to write in there, but the main growth will be continued execution.
In both the extended adjuvant and metastatic breast cancer settings.
You know obviously for al sort of you know we have the two indications to go forward with which is small cell lung cancer and non small cell I'm sorry.
Small cell lung cancer, and HR positive <unk> negative metastatic breast cancer.
And then we are continuing to look at other assets to in license. We first of all as I mentioned to the prior question. The most important thing to US is continuing to maintain the company at net income positive and cash flow positive. So we obviously would look to bring anything else in and again.
Are they protection of those two things net income positive and cash flow positive cancer is what we know it's what our domain knowledge is what do we look outside of that I don't think so we just don't possess the skill set to be able to do the right assessment of it.
And to develop it and commercialize it wouldn't right now we have an existing commercial infrastructure in oncology specifically.
It doesn't really go outside of oncology I realize there's some cancers for instance, like prostate or something where you go into urology and it's a different field and things like that you don't really have that with breast cancer. It's just strictly an oncology setting so what would make the most sense from a complement perspective, there's something in the oncology space, we really wouldn't look outside that.
Yeah.
Thank you.
Our final question is from the line of my income on Pony with B Riley Securities. Please proceed with your questions.
Hi, guys congratulations again.
For taking our questions. This is actually William on for Mark.
So I realize the financials have been picked over a little bit.
Actually I'm curious about a couple of your trials with data reporting later this year I'm just curious to know if we could get a little bit more color on the biomarker data that we should be expecting upcoming and your her two negative breast cancer and then potentially also.
And then where we might be expecting that and then sort of the same idea behind the investigator sponsored phase one two trial also coming up this year.
Yes.
Thank you for the question so.
Alistair was previously tested in a trial in breast cancer and it was both a HR positive <unk> negative breast cancer and triple negative breast cancer in the patients with them and it showed efficacy in both specifically in the patients in her two negative HR positive breast cancer.
The trial with Paclitaxel plus al asserted against al against Paclitaxel alone and trial showed a progression free survival benefits.
They're doing a biomarker analysis on that and that will be presented as a poster at the <unk> annual meeting in June .
More specifically what we're interested in looking at is with a Aurora kinase inhibitor like al asserted there's a lot of pathways that one would anticipate.
It could be inhibited by and Aurora kinase inhibitor. So for example in our small cell lung cancer trial that was published there was biomarker data showing greater efficacy in the patients with C met amplifications or with our B, one that mutations or our b. One deletions. So that is what we'd be.
Very interested in seeing a would be anything that would suggest to us that by enriching the population with a certain biomarker, where we think alistair it it would be more active you would get a much greater magnitude of the benefits, which obviously it'd be better from a R&D perspective, but obviously potentially a commercial one as well so that's what.
The data we will be looking for from that trial.
On your second question that trial, which is the <unk> plus al asserted in everyone's decision head and neck cancer is still enrolling my assumption would be that we would present that probably.
Second half of this year sometime I don't think we've chosen the conference yet for that so once we do we will definitely let investors know.
Okay.
Awesome, great I appreciate that and thanks again.
Thank you. This concludes our question and answer session I would like to turn the conference back to Maryann for closing remarks.
Okay.
Thank you all for joining us today as a reminder, this call may be accessed via replay of the webcast and Puma biotechnology Dot com beginning later today have a.
Good evening.
Ladies and gentlemen, thank you for your participating in today's conference call. This concludes our program everyone have a great day you may now disconnect.