Q4 2021 Aveo Pharmaceuticals Inc Earnings Call
[music].
Hello, and welcome to the Aveo oncology fourth quarter and full year 2021 financial results and 2022 guidance conference call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. Please.
Star Zero on your telephone keypad as a reminder, this conference is being recorded.
Now my pleasure to turn the call over to Hans with whom of lifestyle advisers. Hans Please go ahead.
Thank you operator, good morning, and thank you all for joining us on today's call to discuss <unk> fourth quarter and full year 2021 financial results and 2022 guidance I am joined today by Michael Bailey, Chief Executive Officer, Mike Fair RSO, Chief Commercial officer.
<unk> <unk>, Chief Financial Officer, and javelin Dallas, Chief operating officer.
Where we begin today's call. Let me remind you that during this discussion we will be making forward looking statements within the meaning of the private Securities Litigation Reform Act of $19 95.
These forward looking statements are subject to important risks and uncertainties, including those that are detailed in today's press release and in the risk factors section of our most recent annual report on Form 10-K , which is on file with the SEC that may cause actual results to differ materially from those results expressed.
And such statements.
Furthermore, we caution you that these forward looking statements represent our views only as of today and we do not assume any obligation to update these statements whether as a result of new information future events or otherwise except as required by law.
With that I will now turn the call over to <unk>, President and Chief Executive Officer, Michael Bayley Michael.
Thank you Hans and thank you to everyone for joining us on today's call.
Excited to share with you. The continued progress we made across our portfolio during the fourth quarter of 2021.
This past quarter cap, what we believe was a successful and especially important year for our bank with the launch of our first commercial product the tender or to those in it for patients with relapsed refractory advanced RCC.
The fourth quarter of 2021 marks our third full quarter of it did the sale.
On March 20, <unk> 2021 the paas.
Last few quarters had been busy as we focus on successfully executing our U S commercial strategy, which included hiring and training field teams and building commercial infrastructure, including distribution patient access and reimbursement.
As a result of the team's execution on this strategic launch plan, we have experienced a steady increase in commercial uptake for Ted.
This positive momentum continuing in the fourth quarter as we saw a 26% increase in prescriptions filled in this quarter compared to the third quarter.
Once again, achieving our quarter over quarter revenue growth goal.
We are pleased with these early results and believe the Tildes commercial performance to date validates its potential to serve as a standard of care for relapsed refractory advanced RCC patients.
As we previously indicated the restrictions related to the ongoing COVID-19 pandemic have impeded our ability to gain in person access to customers prescribers and other health care professionals. We believe these access challenges that caused a protracted launch curve to date compared to the pre COVID-19 .
Open access environment.
However, we expect continued quarter over quarter growth and remain confident that the tis that has the potential to become the third and fourth line RCC standard of care.
I'd like to conclude my comments on the <unk> commercial launch by announcing that starting in December 2021 and continuing through January 2022. So it's tipped it took a leadership position in the share of third and fourth line RCC new patient start according to Guy Cubie is brand impact.
Port.
As Mike Fair Russell will discuss in detail. This move for Tinder to earlier line patients is an important part of our long term strategy as it signals that the tip is being more broadly adopted by oncologist for third line patients, which May also result in an expansion in the average treatment duration over time.
As we look towards 2022, we're now in a more informed position to provide U S revenue guidance. Specifically, we currently expect to achieve 2022 net sales revenue of between $100 million to $110 million.
Turning to our product development pipeline, we've issued several exciting clinical announcements recently, including positive clinical data updates for Tuesday at both ask a G. U in February 22, and <unk> Gi in January of 'twenty two.
I'd ask Oh Gee, you, we presented five year follow up data for progression free survival and overall survival from our Tivo three trial.
These data show over five times, the PFS rate, the tivo as an adverse or often at the three and four year landmarks.
Importantly, this prolonged progression free survival benefit has resulted in the continued improvement in the OS hazard ratio, which now stands at 0.89.
I'd ask a G. I, we presented top line efficacy and safety data from our phase III deducted trial.
This cohort consisted of 20 patients with advanced Unresectable previously untreated liver cancer or HCC, who have not previously received treatments.
Patients in this cohort were treated with a combination of 0.89 milligrams of Tivo isn't it plus their balloon map.
These topline results demonstrated that the combination of the 0.89 milligram of Tivo and <unk> was well tolerated and demonstrated a 28% partial response rate with a medium progression free survival of 7.3 months and one year overall survival of right of <unk>.
76%, which we believe positioned the combination well relative to other bad yet.
Immune checkpoint.
EBITA combinations in this setting.
In conclusion, we believe these new data further support the future development of closing their bags and attractive bedroom all of Teekay I for use in combination with their loopnet in first line advanced Unresectable HCC patients as well as provide further evidence that the.
Tim there's activity and selective profile that conveys the potential to reduce off target toxicities.
The deductive trial is currently enrolling a second cohort of patients that have previously received treatment with bevacizumab and it has a lose or that we expect this cohort will enroll another 20 subjects. We believe these data presented opportunity to generate the first clinical trial data and emerging population.
[noise] of advanced Unresectable HCC patients, who have previously been treated with bevacizumab and tend to lose a map.
We recently amended the dosing in the Geneva to trial to now use the 0.89 milligram to those in a dose in the combination.
This change is based in part on the promising H C. C. I O combination results I just covered using the 0.89 milligram dose of exposing it to optimize the potential risk benefit profile for Geneva, which we believe is also consistent with the Fda's recent guidance for companies to invest.
The gate optimal combination dose dosing.
In addition, we recently entered into a clinical trial collaboration and supply agreement to evaluate to those in it in combination with NK T 215 to <unk>.
<unk> novel <unk>, two alpha inhibitor, which is an emerging target of the interest in RCC.
We believe that this new collaborative initiatives with Nike has the potential to further establish the timna as the combination veg F. R. T. K I have choice and importantly will only slightly increase our 2022 to those in our R&D spend.
Eric will provide additional color on the 2022 opex guidance in a moment.
Turning to FICO tiers are bad we believe this asset is well positioned to potentially address a significant unmet medical need that exists for patients with HPV negative recurrent or metastatic head and neck cancer pain.
Our patient population is prognosis is very challenging.
After being granted fast track designation by the FDA in the fourth quarter of 2020 , One we announced in January that we had entered into a clinical trial collaboration and supply agreement with Merck K G. A darmstadt, Germany to evaluate pickled Susan that in combination with urban tox or she talks a mab in EG.
If our targeted antibody in patients with recurrent or metastatic head and neck squamous cell carcinoma.
We also recently announced that we have started scaling up the manufacturing for FICO to emad and expect to be expect to complete manufacturing of drug substance, where the clinical supply in the second quarter of 2022.
This initiative will be followed by standard drugs stability studies and drug preparation of the final clinical trial materials, which we expect will enable the initiation of the potential registration clinical trial in the first half of 'twenty three.
In the meantime, the company expects to finalize the potential pivotal clinical trial design and consultation with the SBA as well as to continue ongoing partnership discussions.
We're 80 380, our anti G. D. F 15 antibody, we completed the enrollment of the healthy subject study in the fourth quarter of 2021.
Initial data observed satisfactory drug safety and a reduction in the G. D F 15, and subjects and there were no drug related adverse events identified.
So operational errors at the trial site cause data integrity concerns that are being discussed with the FDA to confirm the suitability of the data for regulatory purposes, and our ability to publish the data from this trial we.
We do not expect the data quality issues in the phase one clinical trial the impact our plan to initiate a phase one b clinical trial in cancer patients during the second half of this year.
Finally, we recently announced a preclinical collaboration with actinium, two potentially expand our portfolio of buying power G assets by creating a new <unk> three antibody radio conjugate or a R. C.
We believe in addition to the progress with the tip of the launch we continue to successfully advance our pipeline efforts to support future growth.
In order to help manage the development of our pipeline in December we appointed Jetblue Dal as Chief operating officer.
Jeff is responsible for overseeing operational functions key to maxing out mouthing, our organizational efficiency and advancing our pipeline and then escalating our strategic partnering initiatives in support of our three wholly owned antibody clinical stage product candidates.
I am pleased to report that we believe that he has already made a positive impact on the company over the past few months by leveraging his experience leading organization for changes in scale and that he is a valuable new member of the executive team.
I like to now turn the call over to Mike The Russell to walk us through more detailed commercial update including fourth quarter 2021 metrics Mike.
Thank you Michael.
As Michael mentioned, we continue to be encouraged by the commercial launch of her ticked up and I'm excited.
Lighted to share with you results from our third full quarter of sales for.
For the fourth quarter of 2021 U S. Net product revenue was $16 8 million, which reflects a 17% increase in U S. Net product revenue from the third quarter.
For calendar year, 2021 U S. Net product revenue was $38 9 million.
Finally during the fourth quarter, we recorded a total of 780 commercial prescriptions, representing a 26% increase in commercial prescriptions compared to the third quarter.
During the fourth quarter, we added approximately 73, new accounts, bringing the total number of accounts to 333, an increase of 28% compared to September 30th 2021 .
These folks have their prescribing accounts represent over one third of the RCC market potential.
As Michael indicated from the end of the fourth quarter and in early 2022 we see a notable increase in the photo of the share of third line new patient starts as recorded by our COO via brand impact from 10% in November to 25% in December and continuing to grow in January .
This increase has put us in a leadership position for new patient starts in our target population representing positive progress in our goal of becoming the third line standard of care in relapsed refractory RCC.
In terms of outreach, we believe our teams are executing well and we're seeing steady progress towards reaching all of our key customers in person, we're using technology to engage them remotely.
In addition, we have supplemented the field sales teams efforts with extensive marketing outreach peer to peer influence opportunities and social media initiatives in order to increase awareness and areas facing access restrictions.
Looking ahead, we expect to continue to invest in these strategies as well as emerging opportunities to enhance our awareness and utilization.
We have already achieved our leading share of voice in the relapsed refractory RCC setting as reported by our QBR, which we believe is a positive reflection of the effectiveness of our efforts.
In closing we continue to be pleased with the significant progress that our commercial team has made since launch and the encouraging reception for Tivo has received from oncologists patients and the broader medical community.
We look forward to updating you on our continued progress over the coming quarters.
I'll now turn the call over to Eric with Sarah to discuss fourth quarter and full year 2021 financial results.
Eric.
Thank you Mike.
Total net revenue for the fourth quarter of 2021 was $17 $6 million with U S. Net product revenue of $16 8 million selling general and administrative expense for the fourth quarter of 2021 was $15 $7 million a level consistent with the prior three quarters and compared with nine.
$10 million in the fourth quarter of 2020.
Research and development expense for the fourth quarter of 2021 was $6 $1 million compared with $4 6 million in the fourth quarter of 2020.
Total revenue for the year ended December 31, 2021 was $42 3 million and.
In U S. Net product revenue was $38 9 million selling general and administrative expense for 2020 , one was $60 8 million compared with $22 2 million in 2020.
Research and development expense for 2021 was $26 3 million compared with $22 7 million in 2020.
Looking into the new year, we expect our commercial spending levels outside of R&D costs to remain relatively constant for 2022.
Specifically, we expect commercial spend for 2022 to increase slightly over 2021 to approximately $50 million, reflecting the full year expenses of the commercial launch as compared to only three quarters of 2021.
Gross margins are expected to remain in the mid to high 80 percentile.
In addition, we expect general and administrative expense to remain flat at approximately $20 million for the year.
In terms of our R and D expense for the year, we expect that to be in the range of $60 million to $70 million for 2022 as this increase reflects increased clinical trial activity for the year.
As Michael mentioned earlier, we currently expect to report in $100 million to $110 million of U S. <unk> net revenue in 2022 more than double of what we've achieved in the three quarters of our 2021 launch.
With the achievement of the sales milestone in December for the Hercules debt facility more than a quarter before the April <unk> 2022 deadline, we drew down the additional $5 million tranche on the facility, resulting in a total debt of $40 million.
We are pleased to share that we ended the fourth quarter of 2021 with cash cash equivalents and marketable securities of $87.3 million compared with $61 8 million at December 31, 2020.
We believe our existing cash cash equivalents and marketable securities as of December 31st 2021, along with our expected U S. Net product revenues from the sales of the tempter will enable us to maintain our current operations for a period of at least 12 months. Following the filing of our annual report on Form 10-K .
Ended December 31, 2020 , one a full overview of the results for the fourth quarter of 2021 is available.
Our annual report on Form 10-K .
I will now turn the call back over to Michael Bayley Michael.
Thank you Eric to close we believe we are well positioned for continued success with the commercial launch of the tip day here in the U S as well as the clinical advancement of devotion of combinations and our pipeline products.
Look forward to providing updates on our progress in the coming quarters as we continue on our mission of improving the lives of patients with cancer.
Well now open the line to Q&A operator.
Thank you and I'll be conducting a question and answer session if you'd like to replace in the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if he'd like to remove your question from the queue for participants using speaker equipment may be necessary to pick.
You're up your handset before pressing star one one moment, please while we poll for questions.
First question is coming from Stephen Willey from Stifel. Your line is now live.
Yeah. Good morning, guys. Thanks for taking the questions and congrats on the quarter.
Hmm.
Maybe just a quick one on guidance first so.
I know you did 17% sequential.
Fourth quarter.
It appears like the midpoint of the range is implying somewhere around 20% sequential growth throughout 2022. So.
Not sure what you can tell us with respect to just what's assumed in there with respect to account growth.
Covid restrictions in terms of how that impacts access.
I guess.
Just any commentary you can provide there would be helpful.
Hey, Steve Thanks for the question I'm going to I'm going to turn it over to the guidance question to Eric and Mike can talk a little bit about.
Any access or not follow up Eric.
Yeah, I think with respect to the the guidance assumptions most of the commercial assumptions can be handled.
By my first, though but I think you're sort of generally correct and sort of thinking about how it should build over the.
Or the year.
Mike.
Yeah, Thanks, Eric and thanks for the question, Steve and so we now have three full quarters of launch trajectory behind us So that really helps us to see how we can project forward.
As was mentioned earlier on the call. We also have some leading indicators.
I think really encourage us and the progress going forward and in particular, our areas of focus have been increasing our prescriber base and we continue to make good progress there over a third of the RCC market is now covered by our prescribers and moving into the third line setting as we had guided previously a lot of our early patient trial.
Within a very late line setting and we don't think the performance of those patients is indicative as far as their duration on the drug of where we can go and we're very pleased to see that we have on our leadership position in new patient starts in the third line setting and again, that's very much a leading indicator our total patient share in the third line setting is still modest.
But we are now leading the new patient starts and so if we can maintain that over time, which we believe we can we will become the share leader there. So again, it's a combination of the great.
Amount of history, we have now to project forward as well as the leading indicators that give us confidence in these numbers.
Okay, that's actually very helpful.
And then just a clarification question I know you spoke about the 0.89 milligram dose being optimal.
So you said that's being now included into the Tivo to protocol.
Yes, Steve that's correct, we've modified or amended the protocol to go to the 0.89 and as I mentioned in the previous.
Previous statements.
Based on a couple of things one is the data we've seen in the deductive trial at that 0.89 in combination with.
They are really bad.
As shown activity that on par if not better than the other bedroom that Jeff combinations and full dose with a better tolerability profile I'll also add just as a point of reference if you look at the Cabo Levo Checkmate Checkmate 90, our study.
In the first line they were using a reduced this also they had very positive results for those established them to share later in the first line of RCC. So.
A couple of data points that I think are important to consider overall, we believe this will optimize the risk benefit profile for the combination in second line and will further establish tivo is the best tolerated agent are think about this relative to the full dose Cabo at Tesla in the contact of a three which will likely happen.
Lots of dose reductions and interruptions.
Related to that the FDA has recently announced project Optimus, which.
Which is their effort to improve the risk benefit the combinations by optimizing dose. We believe this change is very consistent with that importantly, though the the thing I want to make sure. We all recognize that the control arm will remain at the 1.3 more in the higher dose of Tivo isn't it and overall just from an operational perspective. This change should have.
Minimal impact on the enrollment time and since we are just at the beginning of the study and we're initiating sites.
Okay. So.
Have you had to pause enrollment to push the amendments through each trial site or has this been a pretty seamless integration about alternative dose.
No. We we have paused enrollment importantly, we had two patients enrolled to date both were on the single agent arm. So there's certainly no safety signal here. This is just really what we believe will optimize the combination does and will be very consistent with his project.
Optimists, which the FDA just recently actually did a big symposium last week.
Understood. Thanks for taking the questions.
Yeah.
Thank you. Your next question is coming from the swamp cooler, Rob Mccarthy from H C. Wainwright. Your line is now live.
Thank you.
Folks.
Congratulations on.
On a on a strong quarter and hmm.
See the bullish sentiment going forward.
Hum.
In general I am.
I know most of your script I've been in the fourth line and you're starting to see new starts in the third line, but but to date what has been the average duration of treatment I'm seeing in the market.
Thanks for the question RK I'm going to turn that right over to him to my parents up Mike.
Yes, Thanks RK great question so as.
As we look at our history now with only three full quarters of launch the majority of our patients started so far or less than six months old or.
So in Tivo three as you recall the average duration was greater than a year with about 20% still progression free at two years, so with such a short history, it's really too early for us to calculate duration now.
That said I think we have some really important information we've shared.
And it's in our corporate deck. That's alive now is that we did see more early drop offs and we define that as patients who discontinued after just one cycle in the first two quarters of launch so in Q2 and Q3 the rates were 24 and 27%.
And in Q4, this early drop off rate improved to 14%.
And we really think this is very likely due to the late line patient trial in our initial launch and now that we're seeing these new patient starts in the third line and taking that leadership position. We expect going forward. These results in the future to be closer to the Tivo three experience.
Okay, perfect and then on the on the sales force efficiency.
Do you see.
You know at this point is it optimum and also with.
Some of the.
Some of the areas of the United States opening up.
Do you need to Oddish.
Additional sales force than what you have currently.
Hum.
You know, which I would imagine, especially with.
The encouraging adoption that had been seen recently.
Yeah. Okay again, thanks for the question I'll just start by saying, we're very comfortable with the organizational size in the field force, we have mikes point.
Pointed out some of the key metrics and I'll turn it over to Mike to just provide a little more color.
Oh, great. Thanks, Michael So yeah.
RK, we're really pleased with our oncology account manager team our field sales team, we've maintained our leading share of voice in the relapsed refractory RCC setting.
And that really tells us that we have the right.
Size team. It also tells us that.
We've got really creative and our promotional mix and continue to enhance our non personal promotional efforts in getting more tools to the field team as well for non personal engagement. So.
We're really pleased in our ability to execute where things are access restricted. We're also very excited that we do believe things are going to start opening up just recently, we had a pretty significant team at Astro gene and they're not finally engaging with the thought leaders in person ESCO and in June will be in person. So.
That really opens up a lot more opportunities for us as well. So we built this team to be right sized for when things do open back up and we also built this team to have the capabilities to <unk>.
As we have a leading share of voice when we do have access restrictions.
Okay. Thanks, Mike one last question.
Suddenly my remarks on the on the new starts and dish.
The the leadership position that.
To date, it was gaining but all but what's your commentary on the refills I'm very full status of the current patients.
Okay.
I'm sorry, our caves that AR is a duration question or.
Our like know what percentage of patients are coming back for refills.
Oh refills, Okay, Mike you want to try to tackle that.
Yeah, Okay, I think the best I can do is refer back to the early discontinuation rate that we've put out there now so.
We initially had shared and we shared in our release in January the majority of our initial patient trial was in very late line patients. So beyond fourth line many of these patients.
And so we did see a much higher portion of them discontinue after one cycle. So essentially our take is that we're probably beyond the benefit of any treatment at that point and so as we're moving into the earlier line as we're seeing from the IQ via data starting in December and continuing the latest report through January we're seeing a key.
Corresponding decrease in the drop off rate so the with a 14% early drop off rate in the fourth quarter that means the balance of those patients 86% went on to get refills, and it's going to take us a while to answer. The overall question. You asked earlier I know duration. It's is a key question for all.
But we just need more time, especially as we're having a shift in our patient population.
Gonna take a fair amount of time with a fair amount of patients on treatment to really see where the average comes out because we believe we will see as we did in our clinical trials, so pretty significant tail of the curve and patients who benefit from furtive there for a very extended periods of time.
Thank you folks thanks for taking my questions.
Thanks for the questions RK.
Thank you as a reminder, that star one to be placed in the question queue. Our next question today is coming from calling Cousy from Baird. Your line is now live.
Hi, good morning.
Thanks, so much for taking the questions and congrats on all the progress.
So looking at for Q, you had 17% revenue growth and 26% increase in script volume. So can you maybe comment on pricing in the quarter or any other pushes and pulls we should be thinking about.
Hey, Kelly and thanks for the question I'll turn that over to Mike just to talk about that increase.
Sure. Thanks for the question Colleen so the the main driver of the the difference you see in those growth rates is the inventory levels. So we added very little inventory inventory in Q4 compared to Q3.
And we expect our inventory levels to remain lean they basically fluctuate between two and four weeks supply.
On hand based on the launch ordering patterns, we've seen to date. The other thing that can have an impact quarter to quarter as the timing of.
Title transfer so as we if we get an order right at the end of the quarter. The scripts can show up in one quarter, but.
The delivery date of the title transfer it may happen in a day or two later and can fall into a subsequent quarter. So there should be minor differences, but generally.
Our gross send out was very stable between so that's really the driver is going to be inventory level.
Yeah in college and saw a little of that obviously in 2021.
Great. Thank you that's very helpful and looking to 2022 now so there's going to need and an increase in R&D. This year can you just talk about how you're prioritizing investment across the different programs in your pipeline.
Sure Eric do you want to talk about that that guidance I can fill in afterwards.
Yeah, I'd say just in terms of the Delta from last year to this year. There was about the initial $10 million for the cyclophosphamide manufacturing.
That we mentioned being pushed out.
You know from last year to this year as you're aware, we running the Geneva threep or too many of them are two trial, which we've previously disclosed there's about a $40 million to $45 million trial over a three maybe four years.
The prior year, we only had about one quarter of that so you can think about.
Annualizing into this year, we also have our incremental investments in 380 in terms of some milestone payments that we're going to make and some.
Drug supply costs for potential trials at the end of the year.
And then as we mentioned earlier, just a minor things, but that that should be able to reconcile you from last year's spend of this year's spending.
I think Mike Michael can talk about how we prioritize spending.
Yeah, Kelly and I think what one of our key initiatives here in in 2022 and beyond is really moving up in lines of treatment in kidney cancer with combinations and that's in Sydney, though to study and that's probably our biggest then but you know we'll continue to spend on it but that is again showing that.
Tivo is the best combination drug to use with immunotherapy and furthering that with the collaborations with Nikon.
Again with their head to alpha so.
Our big initiatives here this year right with regard to Tivo are continuing on that combination work, establishing us as the combination of choice.
But as Eric also pointed out Tuesday map getting ready for a potential phase III studies is a really important initiative. This year the primary cost around that it's going to be manufacturing.
We're in current dialogues with various collaboration partners are part partnerships for specifically looking for the ex U S territories.
Certainly that could play a role in the overall expense that we ended up committing to a phase III study, but as we've guided we don't expect to start that study until the first half of 'twenty three after finalizing discussions with the FDA and hopefully finalizing a partnership.
Okay, Great. Yeah. My last question was going to be on site that isn't that partnerships, where it looks like you actually touched on that in that answer. So I think that's it for me. Thanks, so much for taking our questions.
Well that's fantastic. Thank you for the questions.
Thank goodness question today is coming from Sumit Roy from a Jones research. Your line is now live.
Hi, everyone. Congratulations on the commercial development a quick question. If you can give us a little color on.
Like Dupont the prescription growth, how many were new versus how many were refills.
And what percent growth are you seeing is it primarily in the <unk>.
Community centers are more established larger academic centers that'd be great.
Super Thanks for the question I'll turn that over to Mike again.
I assume it. Thanks for the question I don't think I can break down the script growth quarter over quarter, and two new versus refill I think.
What's important for us from a forward looking trend is that we are seeing that we now lead the new patient starts in that third line setting which is again a recent development just starting in January .
Remember and continuing to the latest January report.
Again, we just don't have it broken out that way as far as where we're seeing the growth.
We're continuing to build our base I think the fact that we've got.
A little over 330 accounts onboard up about 3000 targets out there and they represent about a third of the market potential tells you that a lot of the larger centers, who often are aware of new products sooner.
A lot of the thought leaders are there.
We're a bit I guess weighted towards those clinics that have more of the patients at the moment.
But we're continuing to see growth and very excited to continue to build out our base.
As well as move into earlier lines, which is going to increase our duration of therapy, we believe.
Great. Thank you and the last question is.
On the deduct if the second line HCC trials, where patients are being enrolled.
I've asked in the Tivo when should we expect that data is it bigger in 'twenty two should we expect more like first half 'twenty three.
Yeah, Hey, Thanks again for the question our expectation is that we would complete enrollment of that second cohort at the end by the end of 'twenty, two so probably be reporting that in the first half or middle of 2023.
Perfect. Thank you for taking the questions congratulations again.
Thank you.
Thank you next question is coming from Andrew Berens from SVP Leerink. Your line is now live.
Alright, thanks, guys for taking the question.
All the color.
I guess I'm just trying to understand you said, 25% market share is where you guys are at now could you just give us some color on that I'm trying to understand what that means for the overall size of the market sounds like it's around 300 million, which I'm thinking for your original.
Got it.
For the drugs are launched and I guess since we don't have a duration question how are.
Are you seeing patients that were traditionally not addressable coming into the market now that Tivo is available I think that number was at 50% original way so are.
Are you seeing your addressable market expand alright, thanks a lot.
Yeah, Andy Great questions and thank you for that Oh, I'll just tack on one thing we haven't give the 25% share is not guidance, we've given our reported Mike who's talking about a.
New patient share and I'll turn it over to Mike to add some color to that.
Yeah, great questions, Andy So from a share perspective, and you can see this in our updated corporate deck.
Where we're leading now is in the share of new patient starts.
And so that's newly presenting third line patients and that's where in December we had a 25% share. They also report for my QB, a total patient share, which is a combination of patients who are ongoing treatment.
As well as those who are just initiating in our shared there was only 6% in December . So if we can maintain the 25% or the leading new patient share overtime. Our total patient share will catch up to that number. So we think we don't want anyone to think we have a 25% total market share right now we think.
The opportunity is very significant for our growth there.
And your question about the addressable market size. So it's going to take time to see this play out, but we can't say that decision resources, which is where we got in the 50% they updated their metrics a little bit towards the end of last year and they're now reporting 58% of the third.
Third and fourth line plus patient population is going under active treatment.
So.
We can't say, if we can fully take credit for that but we do believe especially given a lot of the patients we saw get the initial trial.
We're pushing hard here, we think we're a big part of it and we hope to continue to improve that rate in the future.
Yes.
Can you tell on that.
I'm sorry, Andy you just add a little more detail on that and link it to the $300 million.
Number you referenced previously decision resources. It said the third plus market line market was worth about $350 million the update that Mike talked about increase that to $480 million.
For 2022.
So consistent with what we've been guiding.
Right. Okay. No I appreciate that and then just on the dosing changes what what is the.
Is there any specific toxicity that led to a decrease in the dose in the combination.
No Andy there was no toxicity.
Toxicity, we saw in the kidney votes and study as I mentioned earlier to Steves question. We only had we had two patients enrolled in the study both were on the single agent 1.34 arms. So this is purely a strategic decision that based on the.
The growing body of data that shows that you really probably don't need the high dose and again as we said, it's very consistent with the Fda's current optimists program, where they're really looking for industry to really kind of balance out that risk benefit.
In considering combination doses in particular.
Okay. Thanks, a lot I appreciate it.
Sure.
Thanks for the question Dan.
Thank you we've reached end of our question and answer session I'd like to turn the floor back over to management for any further or closing comments.
Well. Thank you very much and thank you all for joining US today. We appreciate your continued support and we look forward to updating you on further progress in the coming quarters that will conclude the call.
Thank you that does conclude today's teleconference and webcast you may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.