Q4 2022 Exelixis Inc Earnings Call
Good day, ladies and gentlemen, and they'll come through the extra like for its fourth quarter and full year 2022 financial results Conference call. My name is place Navi and I'll be your operator for today as a reminder, this call is being recorded for replay purposes.
I'd now like to turn the call Oh, what do your host for today Ms. Susan Hubbard Executive Vice President of Public Affairs and Investor Relations. Please proceed.
Thank you Bev snobby yeah. Thank you all for joining us for the <unk> fourth quarter and full year 2022 financial results Conference call.
Joining me on today's call are Mike Morrissey, our president and CEO and Chris Senner, Our Chief Financial Officer, who will review our progress for the fourth quarter and full year 2022, and at December 31, 2022 P. J Haley our executive Vice President of commercial Goodman, Our Chief Medical Officer, and Peter Lamb, Our Chief Scientific Officer.
There are also on the call today and will participate in a question and answer portion of the call.
During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website for an explanation of our results for using such non-GAAP measures as well as tables deriving these measures from our GAAP results.
During the course of this presentation, we will be making forward looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding discovery product development regulatory commercial financial and strategic matters.
Actual events or results could of course differ materially we refer you to the documents we file from time to time with the SEC, which under the heading risk factors identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today, including without limitation risks and uncertainties related to product commercial.
Market competition regulatory review and approval processes.
Clinical trial plans with applicable regulatory requirements, our dependence on collaboration partners and the level of costs associated with discovery product development business development and commercialization activities and with that I will now turn the call over night Alright. Thank you Susan and thanks to everyone for joining us on the call today.
<unk> had a strong fourth quarter and full year 2022 across all components of our business.
Pleased to see continued growth of the Cabozantinib franchise in the U S globally in the fourth quarter and full year 2022, while advancing our discovery and development priorities to build the <unk> product portfolio of the future.
And so we had a complete corporate update a few weeks ago at the Jpmorgan Health Care Conference, Chris and I will provide a summary of top corporate and financial highlights for the fourth quarter <unk>.
2023 priorities before moving into Q&A with the full team.
First we saw a strong performance of the Cabozantinib business with continued growth in demand and revenue in the U S.
<unk> maintained its status as the leading PKI for RCC in both the first line Iot C&I markets in the second line monotherapy segments fourth quarter Cabo franchise net product revenues grew 25% year over year compared to fourth quarter of 2021.
Cabo franchise net product revenues, 30% for the full year of 2022 compared to full year 2021 and have approximately doubled since 2020.
Importantly, global Cabozantinib franchise net product revenues generated by <unk> and its partners were approximately $520 million and $1 $9 billion in the fourth quarter and full year 2022, respectively.
Chris will review, our 2023 financial guidance in his prepared remarks.
Secondly, the top priority for 2023 is to advance the <unk> development pipeline.
Potential Cabo indications expedite example, internet.
Element with new pivotal trials pursuing ex vivo to myelin therapy in combination expansion cohorts with the goal of this agent into full development by year end.
Discovery organization is advancing <unk> <unk> four and <unk>.
The development towards potential andas with the range of additional projects Vectoring towards development candidates for both biologics and small molecule platforms.
Third business development activities will continue to be a critical focus for <unk> throughout 2023.
Two new option deals with <unk> seconds robot are off to a great start and we're working closely with those teams to advance their efforts to get to an option decision as quickly as possible.
Strategy to access clinical and or near our clinical stage assets that have the potential to provide differentiated benefits to patients with cancer will continue to be our primary focus in 2023. The option deal framework is the capital and we sort of resource efficient way to generate clinical proof of concept data and only pay.
For success.
Data is supportive.
And finally on January 19th the Federal District Court in Delaware issued his ruling in the first <unk> versus M. S. N case, what we referred to as M. S N. One.
In that sense validity challenge to the Cabozantinib compound patent was rejected and <unk> proposed generic product was ruled to not infringe <unk> polymorph patent.
I said did not dispute the validity of the polymorph patent. So it is also so it also remains valid and enforce no intellectual property in the <unk> Cabozantinib patent estate has been invalidated.
Our attention and resources have now shifted to MSC and two which goes to trial in October .
Turning to vigorously protect our intellectual property rights.
So with that see our press release issued an hour ago for our fourth quarter and full year 2022 financial results and an extensive list of key corporate milestones achieved in the quarter I'll now turn the call over to Chris.
Thanks, Mike for the fourth quarter 2022, the company reported total revenues of approximately $424 million, which included Cabozantinib franchise net product revenues of $377 4 million.
<unk> net product revenues were $372 6 million and included approximately $7 million in clinical trial sales.
Cabometyx traded inventory increased by approximately 750 units when compared to the third quarter of 2022 to approximately $2 seven weeks on hand.
Increase in inventory was partially latest the timing of the Christmas and new year's holiday at the end of 2022 and the beginning of 2023.
Based on what we can see in the trade. Most of this inventory has been utilized in the first few weeks of January 2023.
Total revenues also included approximately $46 million in collaboration revenues.
Which includes approximately $34 billion in royalties earned from if an indicator on their sales of Cabozantinib.
And finally clinical trials sales have historically been chopping between quarters and we expect this to continue in future quarters.
Our total operating expenses for the fourth quarter of 2022 or approximately $472 million compared to $329 billion in the third quarter of 2022.
R&D expense with the primary driver of the increase in total operating expenses, which was primarily related to higher higher licensing expenses for the three business development deals, we announced during the fourth quarter, which added approximately $130 million to earn the expenses.
Benefit from income taxes for the fourth quarter of 2022 was approximately $1.3 billion compared to a provision for income taxes, approximately $19 million for the third quarter of 2022.
The company reported GAAP net loss of approximately $30 million or nine cents per share basic and diluted for the fourth quarter of 2022. This net loss was impacted by the approximately $130 million a new business development deals, we announced in the fourth quarter of 2022.
The company also reported a non-GAAP net loss of approximately $10 million or three cents per share basic included non.
non-GAAP net income excludes the impact of approximately $20 million of stock based compensation expense that other related income tax effect.
Cash and investments for the year ended December 31, 2022 was approximately $2.1 billion.
This level of cash and investments supported by our ongoing cash flow from operations provides Netflix us.
For the flexibility to invest in internal discovery activities and also allows us to pursue external business development opportunities to expand our pipeline.
And finally, turning to our financial guidance for the full year 2023.
Announced our 2023 financial guidance at the J P. Morgan Conference in January and as detailed and slide 19th of our earnings presentation.
And with that I'll turn the call back over to Mike Alright. Thanks, Chris as you are in a call today in the X. What's his team had a great year 2022, we have even greater expectations for 2023 beyond.
Stride. This year, we're thrilled to have the momentum from our accomplished answer the franchise performance and are completely focused on the grill gross drivers across all of the business that we hope will enable X O X as to help many more cancer patients in the future.
How close by taking the entire extra like 15 for their individual and collective efforts to support our range of discovery development and commercial activities.
The team is highly motivated every day to fulfill our mission to help cancer patients recover stronger and living longer et.
Is that our expectations high and dry for results while we.
Drew considerably in 2022, we remain committed to be nimble and creative and to foster a culture of collaboration and engagement.
We look forward to updating you on our progress in the future. Thank you for your continued support and interest in X Lexis and we're now having to open the call for questions.
Mmm.
Thank you we will now begin the question and answer a question to ask a question you May press sorry, then one on you catch the phone. If you are using a speaker phone. Please pick up your handset before pressing the keys. If I can sign your question has been actress and you would like to withdraw your question. Please press star.
Two.
At this time, we will pass momentarily Goodbye <unk>.
Our first question comes from Chicago in wagon with sure Security. Please go ahead.
Hi, guys. Thanks for taking my question and apologize for the background noise Castle.
<unk> Street in New York City, right now Uhm, just on X L. O nine two I just want to get a get a read from you as to what kind of data. We can expect this year and I previously recruited at Arizona, Yeah, you'll.
To get an idea about.
The total is Brooklyn combination studies.
<unk>. Thank you.
Alright, thank vast Picard no no jaywalking please okay.
Hey, Vicki Wanna take that question.
[noise] sure happy to thanks, Mike and thanks for the question.
So in terms of X L O <unk> business now called of course, we presented the first clinical data at <unk> last year, which again.
Confirm the overall overall profile in terms of the shorter half life compared.
Compared to Cabo and you know we're pleased to see early evidence of activity tolerable safety profile were heavily focused on execution. This year in terms of the phase III that we've recently initiated an additional phase III that we plan to initiate this year as well as the expansion cohorts on our ongoing states.
One studies and so we'll be presenting additional data actually have a meaningful data to present, but I don't have any specific updates in terms of timing on that for you today.
Awesome. Thank you for letting me, taking my question and no Jay walking.
[laughter].
The next question comes from Michael Schmidt with Guggenheim. Please go ahead.
Hey, guys. Thanks for taking my questions. Just two quick ones for me I mean first on your 2023 product sales guidance.
Help us understand some of the key assumptions for.
The additional growth is coming from this year for a couple of <unk>.
And then secondly.
On the contact O. Two study, which is C. R. P. C trial, you help us understand you'll keep powering assumptions four <unk>, one is the control arm and opposed hormone therapy, setting and and prostate cancer. Thanks, So much.
Thanks, Michael So first question, Chris Boucher Star PJ, you can provide some color commentary on the on that as well and then will pivot over to Vicki on second question, Sir Michael as Chris. So as you know there are guidance is one point 75 billion.
$675 billion.
Growth in the range of 13% to 20% and.
All of that growth is coming from new indeed from current indications no new indications and we haven't assumed any compared ourselves in there I guess PJ can talk about the market dynamics around.
Thanks, Chris and thanks for the question you know with regards to the business. You know we had a strong 2022 and finish the year not only is the number one.
Mono therapy, a T K I N R. C C. But also the number one.
T K, Iowa combo as we've talked about previously you know we are seeing continued.
Growth in demand driven by market share increases from increasing duration and in particular in the last.
Four months or so at a year, we saw an increase in new patient starts with both of those together fuel growth we believe in 2023.
You know on top of that we are certainly excited to have 44 month follow up data from the 90. Our study presented at ask O G U and believed that will further support our positioning in the marketplace. So that's how we're thinking about grove in 2023.
Great. Thanks, PJ, Vicky why I handle the contact or to question at a high level.
Sure thing so in terms of contact O. Two as you mentioned that says our study of Cabozantinib catch Elisa map embedded static cashback resistant prostate cancer as weak announced we will we expect to have data for the progression free survival and point and the second half of this year and in terms of.
The power you know what I can say is it's powered for both progression free survival as well as overall survival to demonstrate a meaningful effect and that is to my appointment.
Okay. Thank you.
Alright, well thank you.
The next question comes from Puking, but.
Per Sandler. Please go ahead.
Hi, This is skylar on for <unk>. Thanks for taking my question.
Regarding the contact O. Three study I'm wondering if you can speak to what you believe the incremental opportunity is given carbon monotherapy is already leading second line or a C. C. I, just where you see the outside and added Marketshare Avenue. Thanks.
Yeah. Thanks for the question Skylar. This is P J I'm happy to address that.
So you know contact three that you mentioned, we have a strong position on the second line setting and RCC with approximately 50 per cent market market share with Cabometyx mono therapy, but certainly these patients you know they have metastatic disease and they're still greatly in need.
Of.
Of more and better options, so should contact three be positive.
And it says Elizabeth adds to Cabo in that setting.
We kind of think about that opportunity in a couple of different ways.
One is you know we believe with better data, we could expand that market share beyond 50% for a sort of a cabometyx backbone in that setting and we do believe that you know much of the 50 per cent would convert from Cabometyx mono therapy to combination therapy. So we we see market share expansion.
And then as you see a potential double with mass setting, we would expect a longer duration of therapy, they're simple.
Expanding the Cabo market and a longer duration of therapy is how we think about framing the growth from contact theory.
Alright, thanks, so much.
<unk>.
The next question comes from Jeffrey email with credit. Please. Please go ahead.
Hi, Thanks for taking my question and congrats on the progress just have one year, which is I think that Ah Gina Moto announced a deal in January and I think that was the most recent addition to your ever evolving ADC Tech snack. So just wondering if you can talk a little bit more about the specific technology got access to your.
There and how those capabilities sit with the deals and partnerships you already have thank you.
Yeah. This is Peter thanks, Thanks, a lot for the question no food right. That's that's the kind of most recent addition to kind of sweet of collaborations on the antibody drug Conjugant side.
I think as most people know, we really kind of advancing already fee pipeline, both swimming total Netflix, but also through a network of collaborators.
We haven't bandwagon makes up man I'm, just about Randy bodies, and well so it's a very nice bispecifics platform.
And then we have a couple of collaboration that give us access to some sites specific conjugation technology as well as the range of payloads.
Oh Carolyn.
M B E.
And actually the modem.
Really another access to a different site specific communication technology. So we've been using it on the research side for you know.
6789 months now and I've been very happy with the way. It was before so we went we went ahead with the deal. So we're using it to make a variety of different different AVP.
Payloads, but when they get very controlled drug antibody ratio.
Okay I'll try your next question.
Yeah. The next question comes from Jason Goopy with Bank of America. Please go ahead.
Good evening, Thanks for taking my questions.
One from in terms of the future direction of extra alone I am too I know the message here is that we'll get future updates a stellar O. Two data mature I was just wondering sort of what impact ongoing Cabo trials.
Dictate the future course of the program. So I E contact a one I assume that probably takes long off the table and curious if you'd take contact O. Two will dictate you know whether or not you'd explore 092 in the prostate setting and then just one follow up on on contact O. Three you know the ability to expand share beyond 50 per cent in the second one.
Setting is that just primarily patients who got a non carbo regimen in the frontline just given the protocol restrictions in that trial around haven't gotten Cabo frontline just wanted to clarify that thanks.
Yeah, Jason make some of the questions that he wanted to take that take that first the first question and <unk> can follow up on the second.
Sure. Thanks, So in terms of X L O nine two where Santa Linton add you know as soon as we said before we are looking at data that we we have from the Cabo program and using it to inform jan's that development and I think a prime example of that is the first phase three that we started last year stellar three.
Three which is a non M S high high colorectal cancer and that was based on data.
It was presented early last year, you know again, demonstrating the promise of the combination of a test Elisa Cabo AD with the similar kindness profile. We started this phase three with with canceling.
I think you know in terms of the comment about lung cancer.
Valuating the data from contact a wine I wouldn't necessarily say that long is off the table based on that that one trial, obviously, that's a difficult patient population in which to develop drugs and I think you know careful evaluation of data may lead us to you know consider how best to develop standards that in <unk>.
Your population.
I think go ahead pizza and Jason It's P. J, yeah with regards to your question.
Function of expanding market share and the second one with with contact three should it be positive.
The assumption there is for patients who didn't receive cabo in some form either as a combo of amount of therapy in the first place setting and there is still rude to expand that market share should that should we have a positive trial.
Okay. Thanks.
Thank you take them.
The next question comes from N D C. A redfin may I. Please go ahead.
Great. Thanks for taking my question so for <unk>.
I'm just curious if you could characterize to see Max or a U C over cause they like.
Like a 24 hour period, and maybe comment on the tissue distribution compared to cuddle just.
Just to help us.
Gage the potential for maybe like a superior efficacy profile. So that's why the first question number two really glad to see the started that non clear cell stellar three O. Four study very high in the medical need so from the modeling Stan.
<unk> could you give us a sense of what percentage of non clear cell patients are eligible for the trial, specifically I understand excluding the <unk> histology, it's really difficult to treat it.
So we're curious about how that would impact Tim Thank you very much.
And Peter I'm Gonna take the first part of the question is name yeah. Thanks, because Randy so.
Obviously with them.
Because as we were developing it was one of modulating the pharmacokinetic properties.
Take it from you.
When Cabozantinib has a half life of around 100 hours patients.
<unk> as we showed in the data that came.
Came out late last year, I believe and I have a half life around 20 hours. So.
Which is significantly shoulder, we don't see nearly as much accumulation, but it still consistent with once daily dosing.
It would be a rule go initial goal at least that which was achieved as you've gotta dig into the data in to your questions about looking at.
There are some drug level feedbacks AUC, so you've looked at that so the calculating free fractions of drug as well.
We're very confident that we're at doses that pretty similar to be approved doses of cabozantinib.
Calculations also backed up by some of the changes that we put on the poster as well with respect to various volume all because for example, you know change the bedroom for a new phone and Axel.
Which again look very similar to what we saw a historically with <unk>.
So the other day I think we're in a in a.
And a nice spot with respect to <unk>, what we expect to see from advocacy.
Because we we showed in the initial poster was suddenly encouraging.
To us pretty <unk> pretty nice Motorola clubs, but with a reduced half life again, which do you think.
Should lead to easier E E management going forward.
Okay Fantastic. Thank you Wanna take the same question.
[noise] sure happy to sign in terms of non clear cell overall about 25 per cent of renal cell carcinoma is not clear cell.
Uhm papillary actually makes up most of that so it's about 15% of the overall R. C. C population, whereas chromophobe, it's only about 5% so between papillary unclassified year alrighty almost at 20 per cent. So again that the majority of patients with non clear cell or C. C would be eligible.
For this trial and ultimately for treatment.
Got it that's very helpful. Thank you so much.
Alright, Thank you any.
Your next question comes from et cetera out with BMO capital markets. Please go ahead.
Great. Thanks for taking my question just one for me for C. B X 12, we got some data true meeting alright. The initial data there we saw some interesting signals and ovarian and breast cancer. Just wondering if we could expect a clinical update this year on that program or or any update sort of with respect to.
<unk> future plans for for development. Thank you.
Yeah, Yeah, Vicki wanted to take that one.
Yeah, So you know where where <unk>. Obviously also encouraged by the early data showing some early responses, even while we're still in Kansas escalation mm.
Still following that update late last year, you know will work with the team at Zyprexa on future clinical update.
You know I would say that again, we're stealing dose escalation at this point and you know looking forward to working with them to achieving our recommended phase two dose and moving into the next stage of development, which would be expansion in in a range of tumor types, obviously, which will be informed by ask somebody early data network.
Seeing and just escalation.
Okay. Thank you.
The next question comes from Steve already that Jeffrey Please go ahead.
Hi, This is <unk>. Thanks for taking our questions. So we have to pay may the first is about <unk>. So what's roughly the breakdown of <unk> program and your <unk> and give it some off the setback C T and the last couple of years I guess what programs do you feel most.
Confident that will show up <unk> invested capital and also like what's your appetite to do a larger two to 4 billion M&A transaction I guess my second question is cable. So just curious do you think Cabo will still be outgrowing product over the next three years just to R. C. C alone. Thank you so much.
Okay, Here's a lot there so.
We'll try to answer those questions. What are the time he may have to check back in with the area around specific some questions for Chris to take the first one sure from an R&D expense perspective, I mean, what we're seeing is receiving the costs related to the combo studies coming down and we're saying the cost related to the.
<unk> and the <unk> studies, increasing as we look at 2023 and and those will continue to grow into the future as the as the study's continue to do it at all and then from his discovery perspective, you know, we're continuing to do or discovery investments, including what's what's driven the big increase this year is it.
In 2022 with with a BB deals and will continue to look at those yeah.
And in terms of you know you're not going to give you some guidance for the ears obviously.
PKI for RCC across the first line I O T. K market is for a second line Sir trials, we have going between 313 and contact all three of those look good again.
The date of business for a good data but gets.
The opportunity to keep growing the business. So stay tuned in an airplane up question with larger deal appetite yeah, Okay, and that's what we've been we've been talking about that for awhile looking for.
The opportunity to pursue larger later stage asked us and potentially larger deals that won't qualify the size, obviously Thomas conviction in the assets and the probability of success are you on that and then the ability of those assets to generate differentiating to you that that we can then move for.
Is it a commercial setting I think we've I think it's fair to say, we've proven that way, we can generate differentiating clinical data we can use.
You said that to drive the top line growth, Wisconsin, and we're certainly proud of that and I understand that we have to do it again and again and again and doing it through both internal and external sources is the plan so stay tuned.
Thank you so much.
Thank you.
The next question comes from Jan Burger with calling please go ahead.
Great I have a couple of questions on the pipeline.
The first one on stellar O two the legs three P. D. One combos that is really interesting.
His leg, one just give us a little bit of a census, obviously approve the melanoma what is it like three with P. D. One showed in let's say R. C C and and which are which are the solid tumors are you interested in and then for none clear or see any sense is cabo, what's the leading drug in that.
Right now in first line this combo or a tivo have any share or is it really submit and if it's dominated that segment. Thank you.
Alright, great. So thanks for your own Beckie, who will take the first question and then P. J can address the second.
Yeah. So so as you noted <unk> combination with Nicole and Mab is approved in in melanoma, you know other data I would say across other tumor types right now that are in the public domain are a relatively sparse, but we're interested in the combination across a.
Range of of different solid tumors. So we've expanded that trial across you know several major tumor types. Now you know to really evaluate that combination not only in the G. U T. M are such as M. R. C C, but another major solid tumors, including you know I've had a cellular Carson.
By another so I'm really an interesting combination that we're we're looking forward to to what it will show us in terms of activity.
Yeah, Hi, your own this is P J with regards to the non clear so.
R. C C market currently characterize it as is relatively similar to what you see what we see in the overall market, including clear so.
Certainly Cabo has good utilization there's guidelines in the in the market combos get utilization.
As well, but you know I guess, how I think about it is with with a phase three there's no randomized phase III.
Studying that setting so you know should there be a positive phase III study there I think it's a significant area of unmet medical need without a high level of data available. So I think that would really provide an opportunity to drive a new standard of care of the settings, you know for for a lot of those patients.
Right and maybe if if I can just throw in a quick question on the 20th 749 gross to net can you give us any sense at all how much of that is 340 be just given how fast that program has grown over time. Thank you.
Yeah, you're on thanks for the question.
It has continued to grow throughout 2022, and I'm Gonna give you a specific number but you know as we look at 2023. We you know we think gross and that's gonna be in the range of 31 per cent or so and as we've seen in prior years, we saw that the higher in Q1 and then.
Go down as we went through the year and throughout the year in 2223.
Thanks for the question.
Thank you.
The next question comes from T. Olson with Oppenheimer. Please go ahead.
Hello. This is <unk>. Thanks for taking my question. So maybe for cable I think emotion does higher your patient started so I could have done it too and just curious whether that is due to maybe more patients in the first five setting and whether that will that will continue in 20th.
23, and separately <unk> I think the press release information you expect your initial next wave of research study so maybe some colors sound good.
X way about potentially studying sell out the.
Indication that also combination approach we should expect thank you.
Yeah. Thanks for the question T. J can take the first question and that over to Vicki for the second one yeah. Thanks. This is P. J so with regards to the the new patient starts you know I think not necessarily new patients from epidemiological setting.
Increasing that you know at first light RCC I think what we're seeing there's we've taken sure.
From competitors, particularly the second half of the year I think.
He was executing at a high level you know we have a great balance of data in terms of superior overall survival safety and Tolerability and quality of life and that's well received in a perception of that data is strong in the marketplace. So Additionally, thanks kind of opened up after the pandemic I think the opportune.
80 to really interact more with health care professionals and educate them on the data help drive increased new patient starts and give us momentum in the second half of the year.
And with that <unk>. So I'm just as a reminder of course, we initiated are pivotal program last year with a stellar three three and three O four and microsatellite.
Non M S I high collar rectal cancer and not clear simple you know cell carcinoma, respectively, and as we've mentioned we intend to initiate multiple additional <unk> typical trials of 2023, I'd say stay tuned there you know for additional details and we'll certainly be happy to provide more color <unk>.
To announce those trials.
Okay. Thank you thanks for <unk>.
The next question comes from Peter Lawson with Barclays. Please go ahead.
Thanks, So much just a <unk> kind of when we should see the the next data sets for.
The next day to fifth stellar three or four and three three and then if there's any interim PFS reached that we should be thinking about.
Okay. Thanks for your help if you want to answer that question again, yes.
Yep. So in terms of for three O three and three or four specifically of course you know these are phase three trials that we've just initiated in the last few months or.
Six months or so.
You know so we're really focused right now on you know getting countries up and running enrolling patients in terms of timing. This will all be event driven and so it's too early at this age you know to say when we expect those analyses standup will have more details forthcoming as those are available.
You know the the phase one data I would say as I said earlier, you know when we have a meaningful data set will be we will be sharing that is at a medical conference.
Perfect. Thank you then question.
Chris I missed it but the revenue contribution for clinical trials sales for 22 Q4 will be great.
Yeah. So Peter that was about it was about $7 million in the fourth quarter.
Okay and you you don't expect that to continue or just know include in that in your guidance.
We all upset as we're not including that in our in our guidance numbers.
Thank you so much.
The next question comes from seven Sir John with G. M. T Securities. Please go ahead.
Thank you for taking my question and congrats on the quarter.
Just a quick question could you. Please remind me where we are with cost make 313, so with a triplet and frontline or C. C. In terms of the next read out and I.
I saw that there may be some data ask Koji you next week by risk score what can we learn from that and and how could that inform you were thinking about you know eventually getting this maybe into you know registration. Thank you. So much. Thanks for your question Vicki one picked up.
Sure happy to so in terms of Cosmic 313, just as a reminder, we had the read out for the primary endpoint of progression free survival last year at that point. The overall survival data work and make sure. We get discussed the data with F D. A and they asked to see more mature survival data before considering.
Finally.
So we are expecting that we will have the second interim analysis of overall survival. Sometime later this year based on current projections, you know like as appropriate depending on the data we would have a conversation again with F D a about whether or not filing would be appropriate.
In terms of the <unk> G U data, they're still embargoed at this point, so I can't guarantee details, but yes, we do have a presentation by M. I N I D M C risk category and.
Really again, just looking at this study enrolled at <expletive> enter beating at risk patients.
Whether we see differences in the benefit and safety profile across this prescription.
Great. Thank you so much.
The next question comes from my King with Yes. Please go ahead.
Hey, guys. Thanks for taking the question I just want you to know that I'm sitting comfortably in my chair in my office and there's no <unk>.
Yeah, So I'm I'm I don't you actually quite safe I'm actually quite safe right now Sir So I appreciate your interest [laughter] coffee [laughter].
Just a real quick <unk> as well I'm just wondering how you guys are thinking about.
Do you have sort of like a menu of phase three trials that you'd have conceptualize and just waiting for data to confirm those or do you is it pure only going to be a data driven based on you know some of the players wanted to phase two trials that you haven't got one right now.
Yeah, My credit questions make you want to take that one.
Yeah, So first I'm glad you're safely seated in your office.
[laughter] in terms of you know as dance at development I you know, we're looking again at.
At data from a number of different sources of course, the Cabo data again coming back and referencing three O. Three uhm our study in Colorado cancer also looking at emerging data from ongoing is answer litten, a cohort in particular from stellar Ah one but will increasingly be looking all set from stellar Iowa to all of which made for.
You know future development Ah you know.
That said, we're also looking at the competitive landscape areas. Upon that need you know really to evaluate what are the best opportunities here and really places where we can make a difference for patients. So we're factoring all of that information and as we consider next indications for Santa Yeah cause I would think that there's you know there's indications.
<unk>, let's say bevacizumab has or <unk> or <unk>.
<unk>, where you know those are not indications for Cabo and perhaps those are some areas, where you can take the market share.
Yeah, that's a good way to think about it being at.
Looking at lots of different possibilities you know certainly we could think about were other T. K I have shown activity as well I would say you know Cabo is a particularly good place to look because of course, we have a similar <unk> profile.
But then also looking at novel combinations right and so I think the <unk> combination is a great example of that.
You know we see good evidence of activity then there may be unexplored areas, where we can.
You know where it might be makes sense to develop those combinations.
Right, Okay, and then just at a really high level, what what would you say to investors is the most the most important.
Milestone outside of let's say you know the M. S N litigation, but just just from the the ongoing portfolio what what's the most important data point to X Alexis holders this year.
Yeah, so it might get my <unk>.
Talking about any prepared remarks, the main the main priority for us is to advance the.
Mm noncombatant pipeline and development.
<unk> and X P O two obviously, you've been very successful with a combo.
How business and <unk>.
Even have one molecule like Cabo want more and there's certainly large on that medical need for patients across the board and we think <unk> N O two or you know first step in that direction and then we have a strong strong discovery and collaborative pipeline of modules coming up as well so.
Yeah, I'll focus is building a pipeline of molecules that we can get over the goal line from a clinical regulatory point of view and then get into a a C PS and pieces hands as quickly as possible.
Okay, Alright, thanks, Mike.
Mmm.
Alright, we do we have any more questions.
Can I assume we don't want to say, thank you very much for joining us today and certainly you're welcome to again for answering myself to call. Her she doesn't email if you have any follow up questions. Thanks again.
Goodbye.