Q4 2021 G1 Therapeutics Inc Earnings Call
[music].
Good morning, ladies and gentlemen, and welcome to <unk> Therapeutics fourth quarter 2021 financial results Conference call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time, if anyone should require assistance during the conference. Please.
Press Star then zero on your Touchtone telephone I would now like to turn the conference over to your host today will Roberts head of corporate Communications. Please go ahead.
Thank you Joanna.
Morning, everyone and welcome to the <unk> conference call to discuss our fourth quarter 2021 financial results and business update.
The press release on these financial results was issued this morning and can be found in the news section of our corporate website <unk> Therapeutics Dot com.
This morning's call the team will provide a business overview of the fourth quarter and full year of 2021, including an update on our clinical programs and our commercial progress in that period with Castilla, which is approved by the U S food and drug administration can decrease the incidence of chemotherapy induced myeloid suppression and.
Both patients when administered prior to our platinum it took me aside containing regimen.
So <unk> containing regimen for extensive stage small cell lung cancer or SCLC.
A Q&A session will follow the prepared remarks.
Before we begin I'd like to remind you that today's webcast contains forward looking statements within the meaning of the private Securities Litigation Reform Act of 1095.
Such statements represent managements judgment as of today and May involve risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements.
More information on such risks and uncertainties. Please refer to our filings with the Securities and Exchange Commission, which are available from the SEC or on our corporate website.
Any forward looking statements represent our views as of today February 23 2022.
Joining me on the call today are Jeff Bailey, our Chief Executive Officer.
Andrew <unk>, our Chief commercial Officer, Raj Malik Chief Medical Officer, and Jen Moses, our Chief Financial Officer.
I will turn the call over to Jack.
Thanks.
Good morning, everyone and thank you for joining us on the call.
Today's headline is that the fourth quarter of 2021 was an important period of commercial transition and clinical execution for <unk>, one that positions us well for a very important year for our shareholders healthcare professionals and most importantly, our patients we seek to treat.
Regarding our commercial organization consolidates, a one of a kind drug we are beginning to shift the paradigm from having to treat the dangerous consequences of Milo suppression, resulting from chemotherapy to proactively providing multi lineage Milo protection all with a single drug.
There is no other drugs on the market that provides that kind of protection.
And I am happy to say that we are almost fully transitioned away from our former co promotion partner beyond so that RG. One sales team is now in charge of executing our commercial plan and bringing this important drug to oncologists and oncology nurses across the nation.
As you will hear from Andrew we are now actively commercializing <unk> through our own <unk> sales team, who are now fully trained and recently deployed in their regions to drive access and uptake.
Be more pleased with the talent and the drive of this team and I'm very proud to have them as part of the Q1 organization.
We have seen early encouraging signs of execution, including adding 10 top 100 accounts in the first 10 weeks by the initial seven oncology sales account managers are all sams deployed in their region.
And as of the beginning of this month, we have achieved our 2021 year on call of trial of co sell 50 of the top 100 accounts.
We will continue to drive breadth, but have already begun to pivot toward driving organizational depth abuse of seller something that our new sales team is uniquely prepared to do thanks to their strong relationships and access to these key accounts.
Our goal for the current quarter just to complete the sales team onboarding nationwide and the transition away from <unk>. So that sales growth is reestablished as quickly as possible.
Turning to our clinical operations, we made excellent progress in 2021, and inspect and expect 2022 to be an exciting year for Q1.
Thanks to strong execution by our clinical team.
Happy to announce that we are on track to share. The initial data from our pivotal phase III trial of <unk> in colorectal cancer earlier than expected certainly no later than the first quarter early in the first quarter of 2023.
We also anticipate presenting the initial results from three phase II trials later this year one in combination with an ADC wanted to confirm the mechanism of action of trailer cycle and modulating anti tumor response, and one in bladder cancer with immune checkpoint inhibitor or value map.
Needless to say, we have a lot on which to update you on this call I will first ask Andrew to cover our recent commercial efforts, including the status of the sales organization and some early lead measures of success from our new <unk>.
Ross will then provide an update on some of our medical and clinical momentum, including commenting on the rationale of the two new phase III trials that we initiated in the fourth quarter and reminder of our expectations for timing of results. Finally, Jen will provide the financial results for the quarter, including that our cash.
Cash runway takes us into 2024 and I'll be back for some concluding comments with that I will turn the call over to Andrew.
Thank you Jack I'm glad to be with you today and to spend some time on a variety of commercial opex, including the fourth quarter, our sales activity and the tailwind as we've experienced an update and the strategic commercial decisions. We made at the end of the year and have successfully we've executed on those decisions. Some early impacts of those decisions on what you can expect going forward.
Starting with fourth quarter sales activity, we ended the quarter with $4 4 million and net sales of casella, representing 22% file growth period over period.
I will discuss momentarily this growth was driven largely by some very encouraging a tenant level successes by the first members of our sales team deployed at the end of last year. However, we did experience some slowdown elsewhere as we transitioned from behind Onboarding, Our new do you want <unk>.
This new patients presenting with extensive stage small cell lung cancer decreased slightly during December and January .
As we've described we exited the year with a variety of important payer wins in our favor, including continued strong awareness and intend to use with over 85% of oncologists, saying that they intend to use Costello within the next 12 months.
Positive user experience reported by oncologists, including high reorder rates and consistent feedback that <unk>.
Workflow.
A growing recognition from oncologists across seller has a unique product profile as the only product offering multi lineage Milo protection.
Excellent reimbursement coverage as a reminder, approximately 60% goes through Medicare and 50% through commercial paper and few of the traditional payer bodies, which accompany new launches.
And as you'll hear in a moment good breadth across the top 100 target organizations.
And these are all important foundational elements supporting the potential acceleration in growth.
And that we expect to drive in 2022.
As I mentioned, a moment ago, 85% of created oncologists tend to use cross sell within the next 12 months and over 50% within the next six months compared to an estimate of around 5%, who currently are highlighting the great opportunity to drive not only breath of uptake, but also that sort of share with eligible extensive stage small cell lung cancer patients.
Which today represents a total market value of over $700 million.
The reasons most frequently cited by these oncologists for delaying trial of Costello include limited engagement with sales reps today and that results in a lack of education on the label will produce mechanism of action and the clinical data as well as insurance coverage.
These observations quantify why we made the strategic decision to move forward with hiring and deploying our own sales team to promote Costello with prescribing oncologist to foster clinical efficacy at the support adoption within the office.
I said in our December call that we had set a goal to hire train and deploy four regional sales directors and all 34 of our new oncology sales account managers or <unk> by mid February and I'm happy to share that we have achieved our goal.
We deployed the first seven by the end of 2021 13 by mid January and now all 34 are in the field a month later.
In total our new sales team brings over 500 years of oncology sales experience and we couldnt be happier with the quality caliber and culture of this highly experienced group of professionals we.
We completed their training with alive and Parison sales meeting at our corporate headquarters a couple of weeks ago proactively meeting with customers to drive adoption in their territories.
Next I'll describe some of the lead measures of success that we achieved as we began deploying our sales team and making our initial investments into penetrating some of the higher volume accounts.
We ended the fourth quarter and the year was 44 of the top 100 accounts adult inco sell up from the 35, we have at the end of the third quarter.
Since the end of the year, we've made further progress as a rule of thumbs were deployed and we've now achieved adoption and 50 of these top accounts was a 2021 year end goal for us and I'm enthusiastic that while we did experience some slowdown in sales at the end of the year. We were only five weeks behind where we'd hope to be in terms of best important measure of breath.
Our <unk>, 95% of the overall eligible patient population is treated within these organizations. So there's significant potential for growth as our new sales team focused on driving uptake within these top accounts are already starting to use a wholesaler.
Around 75% of our 2021 demand came from community hospitals or clinics with the remainder being academic institutions.
Reorder rate for Costello remains high and is accelerating in the top 100 organizations overall, our reorder rate for the whole of 2021 was around 75%.
If you look only at those critical pulp 100 organizations and focus on the most of the most recent 13 weeks a reorder rate has been over 80%.
So the vast majority of accounts, who have adopted kusama continue to reorder and an even higher rate in the top 100.
Importantly, we can directly correlate the activity of the first seven Osama <unk> deployed and to priority high potential accounts to some early but important performance metrics.
First as I mentioned earlier many of these new top 100 accounts that have recently come on board are the result of <unk> have been deployed in those territories and second these first seven osama's have exceeded our expectations. They have territories, where among those at the top of the nation and performance since they have been deployed.
Comparing sales in October before these osama softness with sales in January once they've been in the field for less than two months file volumes doubled in these seven territories compared with flat volumes in the rest of the country.
Again since then we've deployed those Thompson to all sales territories and so our goal as we move through the year is to continue to drive spreads the new high volume top 100 accounts, but also driving depth of uptake across those clinics within those accounts.
We will accomplish this through our <unk> to understand the attendant dynamics in those top 100, no head to.
Has it forced our physician champions for peer to peer education, those accounts and can activate non physician influencers like nursing teams.
We're supplementing those efforts with significant marketing investment in digital tools to ensure that <unk> can take advantage of M&A opportunity.
In terms of what's possible and driving that we now have several new top 100 organizations brought onboard by horse funds, which have become some of our highest auditing nation.
<unk> nationwide in some cases has been vinyl volumes in excess of 100, or even 200 vials and just a couple of months.
Even with this rapidity of uptake we believe we are just scratching the surface there.
This is what gives us confidence in our new direction and has energized. The subsequently of the sales team as they go into the field.
<unk> is a paradigm changing product that provides a unique benefit to patients with extensive stage small cell lung cancer are undergoing chemotherapy, we believe our decision to hire and deploy our own sales team was the right decision and the early signs of success. So that this decision is already paying off.
Our goal in the first quarter is to complete the sales team onboarding nationwide. So that sales sales growth as quickly we established.
I'll now turn the call over to Raj <unk> for an update on our medical and clinical efforts during the fourth quarter and what to expect in 2022.
Thanks, Andrew and good morning, everyone.
Ill cover two topics today first I will discuss each of our clinical programs with a focus on the pivotal phase III trial in colorectal cancer and the updated timing outflows initial results that Jack mentioned.
And on the two new phase II trials, we initiated in the fourth quarter of last year.
Second I will provide an update on some of our medical efforts, including some recently published an upcoming new data.
As you read this morning in our press release based on the enrollment metrics. We are seeing we have accelerated the timing of the initial results from preserve one our ongoing line extension trial of <unk> in first line colorectal cancer.
This is a pivotal trial in approximately 300 patients with colorectal cancer.
Receiving first line charter cyclic or placebo administered prior to full Fox here and Bevacizumab.
And efficacious, but highly myelotoxic chemotherapy containing regimen given for two consecutive days of every 14 days cycle.
As a reminder.
Our initial preclinical data showing the multi lineage benefits or try to sidestep what generated with five issue, which has given us a 48 hour infusion and this regimen.
Unlike most of our other ongoing trials. The primary endpoint of this trial is Milo protection in other words protecting the bone marrow from chemotherapy induced damage, which results in less model suppressive side effects of the smaller toxic chemotherapeutic backbone.
And key secondary endpoints include progression free survival and overall survival.
Excitement at our clinical sites has been high since we initiated the study.
And thanks to that and the excellent work by our team we are projecting to announce the initial results early in the first quarter of next year earlier than previously stated.
We expect the last patient to be enrolled in the study soon and will announce additional information at that point.
Next I will discuss the two new phase III trials, we initiated last quarter.
Starting with a 45 patient trial designed to evaluate the combination potential of trauma cyclin E an antibody drug conjugate or ADC.
Patients are being treated until disease progression on days, one and eight of the 21 day cycle.
<unk> administered product with <unk>.
Adcs consist of a chemotherapeutic payload that is delivered to the tumor by the antibody to which it is conjugated.
As such Adcs can be considered targeted chemotherapy since that kill cancer cells via the cytotoxic effect off the payload.
As a result, they are highly effective but can also carry a significant risk of model suppression.
If only shown in our phase II trial that we can improve efficacy with trailer cycle, given product, which I'm sorry to beat Carboplatin.
Toxic chemotherapy and <unk>.
Therefore, there could be two potential benefits of combining <unk> with an ADC.
First is enhancing antitumor efficacy by increasing cytotoxic, killing.
And the second just by reducing viral suppression.
We expect to have initial results from this trial, including overall response rate and model protection end points in the fourth quarter of this year.
The phase III mechanism of action study is an important trial is designed to confirm our understanding of the immune based mechanism of action of trial cyclists.
And it's our belief and its ability to modulate the immune system with or without a checkpoint inhibitor.
This trial is in approximately 30 patients who are eligible to receive new adjuvant treatment for triple negative breast cancer.
We know from prior clinical and preclinical data.
<unk> has the potential to increase the ratio of CDA positive T cells.
Presser T regulatory cells preferentially, allowing proliferation of CDA positive T cells.
Pressing the T regs for a longer duration.
The primary endpoint will assess this ratio in the tumor microenvironment.
It would also be evaluating immune changes more broadly across the cancer immunity cycle.
These data should help us identify the next set of studies across multiple tumor types and treatment combinations.
Initial results from this trial are also expected in the fourth quarter of this year.
In addition, I would remind you that initial results, including overall response rate and border protection endpoints from preserved three.
Our phase two study of <unk> with chemotherapy and immune checkpoint inhibitor <unk>.
And first line patients with bladder cancer are also expected later this year.
This study is utilizing the same chemotherapy backbone used in our previous successful phase III <unk> trial.
Add the immune mechanism, we have generated suggest that concomitant <unk> could also add to the efficacy of a checkpoint inhibitor.
Finally, I'll touch on preserved to our pivotal trial in triple negative breast cancer designed.
Designed to follow up on the exciting survival signal, we saw in our phase III trial in that setting.
We have recently made two important changes to the protocol.
First we have discontinued the second line arm of this trial due to a shift in the treatment paradigm for second line metastatic triple negative breast cancer caused by the rapid uptake of <unk> in this setting.
Which has created significant barriers to enrollment in the second line cohort of this clinical study after the commercial potential in that setting.
Second we will allow enrollment of patients who have previously received a checkpoint inhibitor parallelism app for the neo adjuvant and adjuvant treatment of triple negative breast cancer into the first line arm of the trial.
To develop clinical experience in this patient population.
Initial data from this trial will be available in the second half of 2023.
Changing topics to medical affairs, among the common questions that our team gets launched regarding health economics outcomes research or <unk>.
We've recently published two important studies on that topic.
First in the December issue of the journal of medical Economics.
Describe data showing that the use of <unk> prior to first line chemotherapy.
It resulted in cost savings due to fewer miles suppressive adverse events and their associated treatment costs and patients with extensive stage small cell lung cancer.
The estimated cost savings per patient were $18840 from a year.
U S payer perspective, according to this cost effectiveness analysis.
A second recent publication in the January edition of the journal of managed care and specialty pharmacy, including the results of a study that estimated the impact of utilizing Tyler cyclists over five year periods and over 300 patients.
The use of child aside lip is estimated to reduce the number of miles suppressive adverse events, including neutropenia, febrile neutropenia anemia and thrombocytopenia.
Back to a scenario without trial assignments.
<unk> was associated with the cost savings over five years of more than $800000.
I'll conclude by mentioning that we are presenting our first real world use data for casella at the upcoming Sccm conference in March.
The abstract that was accepted described compelling integra practice data from Merck.
Suppression.
However, we have since added real world data from patients who have received cassava. Most of them are commercial patients. We look forward to sharing these data with you once they are concerned.
With that I'll turn the call over to Jen for a review of the financial results for the fourth quarter and full year of 2021 Jen. Thanks.
Thanks, Raj and good morning, everyone as will mentioned full financial results for the fourth quarter and full year of 2021 are available in this morning's press release and will be in the 10-K, which we intend to file after market close.
Today, I will focus on a few key points from our disclosures.
Our total revenue for the fourth quarter of 2021 with $5 8 million comprised of net product revenue of $4 4 million and license revenue of $1 4 million.
<unk> revenue for the quarter was primarily related to clinical trial reimbursements from detour here.
Sure.
Total revenues for the full year 2021 was $31 5 million.
Consisting of licensing revenue of $20 4 million and net product revenue of $11 1 million from sales of Capella.
Cost of goods sold for the three months ended December 31 2021.
$4 million and $2 million for the full year 2021, as a reminder, the majority of the manufacturing costs related to <unk> sales were incurred prior to FDA approval and therefore were recorded as R&D expense in prior periods.
Obviously expense costs will continue to impact the presentation of cost of goods sold.
Future periods until initial prelaunch inventory is depleted and additional inventory is manufactured and sold.
Our research and development expenses for the fourth quarter of 2021 were $19 8 million compared to $16 4 million for the fourth quarter of 2020. The increase in R&D expenses was primarily due to an increase in clinical trial, and which is partially offset by a decrease in costs associated with the manufacturing of active pharmaceutical.
Ingredients and drug product to support clinical trial.
R&D expenses for the full year 2021 was $76 2 million compared to $73 3 million for the prior year.
Our selling general and administrative expenses for the fourth quarter of 2021, or $23 2 million compared to $24 3 million for the fourth quarter of 2020.
The decrease in SG&A expenses was largely due to a decrease in spend on commercialization activities and medical affairs, when compared to our activities in preparation for launch last year and was partially offset by an increase in personnel costs due to increases in headcount.
SG&A expenses for the full year 2021 were $95 7 million compared to $68 5 million for the prior year.
Regarding our cash position and runway as described in our press release. This morning, we ended the 2021 year with cash and cash equivalents of $221 2 million compared to $273 million as of December 31, 2020.
This position to be sufficient to fund our operations and capital expenditures into 2024.
Projections of cash runway includes future draw of an additional $25 million on our debt facility with Hercules, which is currently available to us at our discretion, but have not yet been drawn down with that I'll turn the call back over to Jack for some closing comments Jeff. Thank.
Thank you Jen Raj, Andrew and well before we close the call I want to as always thank people living with cancer for their inspiration Q1 was founded to discover and commercialized drug that can inhibit progression through the sell cycle, thus improving cancer patients experience with chemotherapy and helping people live.
Longer better lives.
We remain driven and focus to ensure that we reach our goals for you and your family.
Before we move to Q&A, let me just recap some of the key points that you've heard today.
We have successfully hired trained and deployed all 34, Oh, Sam's and for Rfps and I could not be more pleased with the quality of the team.
We are already seeing evidence of the impact of the first few deployed members of the sales team on driving growth in their regions compared to regions, who did not have enough sand in place.
We remain comfortable with our analysts current expectations for <unk> net sales in 2022 with the majority of the growth happening from the second quarter of this year onward, as our team establishes themselves in their regions drives adoption breath focuses on account depth and then reestablish as <unk>.
<unk> grown our medical team continues to present and publish important new analyses showing the clinical and economic benefits of using <unk> cycle and approach appropriate patients with extensive stage small cell lung cancer.
Including budget impact that is estimated to be cost saving would used on label.
We expect to provide initial results from three phase III trials later this year, one with ADC, one an MLA and one on bladder.
And thanks to strong enrollment and execution, we now expect to announce the initial results of our ongoing pivotal trial in CRC early in the first quarter of next year and perhaps sooner.
This means that over the next 12 months, we expect to announce the results of four new clinical trials, including one pivotal phase III wind extension trial.
Thank you for your time. This morning, we will speak again in this format in May on our first quarter 2022 call with that I'll close the call and turn it over to Q&A. Operator would you. Please remind our listeners how to ask a question.
Thank you presenters, ladies and gentlemen, if you have a question at this time.
And the number one key on your Touchtone telephone.
My question has been answered or you wish to remove yourself from the queue. Please.
Your first question is from Gill of Needham <unk> Company. Your line is open.
Hi, good morning, everyone and thanks for taking our questions.
Maybe starting with the commercial angle here so.
Thoughts on potential benefits from corporate tapering in the near term I mean, we're just provide your new sales force the opportunity to meet accounts in person.
Yes, Thanks, Gil I'll flip that over to Andrew to make some comments on it yes. Thanks scale one of the things that we do look at is the proportion of even person sales calls each month and that has been improving.
During the last month or so since the turn of the year and obviously that doesn't kind of normal.
Because of the better access, but our new osama's hub or is it due to <unk>. It is hard to say, but we do know anecdotally that many customers really struggled with staffing over the last few months due to <unk>.
<unk>.
If they came down with Covid infection, obviously.
And have to quarantine and that does result in a decrease in capacity across on a kind of or any type of health care. So it is possible that there is an impact there but.
We believe we're in the we're doing the right thing with our rule of thumb is in place to be able to maximize any potential growth opportunity going forward.
Thank you.
If you have to hypothesize about.
The difficulties you've had with the.
Earlier sales.
Arrangement.
You think it might have been.
Or has something to do with the incentive basis or if you had to come up with an explanation.
Why it didn't work out originally.
Yes, the same skill.
First of all I would just underscore how excited we are about the 34 folks that we brought on board I think they bring the requisite clinical knowledge and experience improving sales performance I think looking back retrospectively.
Don't spend a lot of time doing that phase that I think the key is we've talked really since June of last year is if we can access. These top 100 accounts were approximately half of all small cell lung cancer patients are being treated.
What's going to be difficult for <unk> to reach its full potential so for us that was the real key amounts. The difference we're seeing with this new sales force that Andrew was hired as they're able to get in and they've got the relationships that got the market understanding the account understanding and are able to get trial and now really it's about driving the depth where again half.
Patients are being treated so hopefully that answers your question.
Yes, that's very helpful.
Maybe a couple of clinical questions.
First of all congratulations on that.
Accelerated timelines.
Preserve but do you have any color as to why.
Why we are seeing potentially faster enrollment or <unk>.
You have any comments.
Hey, Gil Raj here, Yes, I think as I mentioned, there's really two factors right lots of excitement in the protocol I think it's an unmet need and I think investigators see that it's an important question to test.
And second is our team our team has really done a great job. This is a big global study and running it during a pandemic is not an easy thing.
And total kudos to our team for managing all the complexities of.
Of having to do that and we're thrilled to be able to bring the timeline up.
Raj.
Have you.
I think we have a question on the MLA studying.
So we are expecting a biopsy data from this study are also going to be looking at urine biomarkers.
Things like circulating tumor DNA.
Yes, we'll be looking at both the primary outcome will be in the tumor itself. However, we are collecting peripheral blood.
And obviously as you know we can collect peripheral blood more frequently than we can tumor.
And so we will be making correlations between changes in the peripheral blood to what we find in the tumor.
Alright. Thanks.
Thank you so much for taking our questions and congratulations on a successful year.
Thanks, Joe.
Your next question is from Katherine Coleman of BP Angie Your line is open.
Yes. Good morning, Thanks for the update and thanks for taking my question.
My first question is for the bladder cancer study.
The data this year.
John .
But are there any biomarkers you plan to study here because this is a broad patient population you have cisplatin eligible ineligible PD one pathway is not unexpected.
I guess I'm just like China.
And we'll get some sense on your development strategy here.
Yes, Hi, Coverity Raj here.
So yes, you are right. We will get response rate data. This year will get progression free survival data next year, which is the primary endpoint of the study.
We will be looking at.
Archival.
Data for PD lone expression.
And also are looking at some peripheral blood markers as well.
Primary readout of courses that efficacy readout.
Got it.
And then b.
Any.
The Knbc pivotal study any feedback from the FDA.
Any sense on.
Does the discontinuation of second line Knbc equal will change anything for the first line.
Would you need to enroll additional patients or what.
You would have will be twofold.
Yes, Theres actually no impact.
Discontinuing second line on the first line I mean, you could this protocol was designed essentially as a master protocol. If you will each cohort. The first line of the second line were independently sized for those readouts.
So the first line will continue as designed so that will impact <unk>.
Discontinuing second line on that.
A portion of the study.
Thank you.
Your next question is from Edward White of H C. Wainwright Your line is open.
Good morning, Thanks for taking my questions.
So just to follow up on that.
Last question.
Sure.
Deep you enrolling patients in the second line and will we be seeing any data if you did and also.
The I spy two is also discontinued.
Just curious there too.
Sure.
<unk> were enrolled how many do you expect to release any of that data, even if it's only safety data.
Yes, Hi, Ed.
So we did enrolled a few patients I mean, not many so there will be some safety data of course.
Annualized in the second line portion then that at some point present that data.
The I spy again, just to reiterate the reason that that that was stopped and it was actually a joint decision between us and I spy.
Really a change in the landscape with the approval of <unk> added to chemotherapy in the Neo adjuvant and adjuvant study.
So yes patients again were enrolled.
At some point those data will be presented as well.
Okay. Thanks.
And just thinking about this.
Sales force now that you're fully staffed.
Uptick in expenses.
The first quarter or.
Four.
Modeling purposes.
The fourth quarter really sort of the base rate.
That we should be expecting to see in the SG&A expense line.
Hey, John .
I would expect an uptick in the first quarter just because if you recall, we're rolling out of the <unk> agreement at the end of February and we have all of the Tam.
In its first quarter that we would have only been part of that in the fourth quarter.
I would expect an increase in expenses for the first quarter and then it should taper down after that.
Arrangement.
Just on the royalty base.
Great. Thanks, Tim.
Yes.
Your next question is from Joseph Thome of Cowen <unk> Company. Your line is open.
Eric Good morning, and thank you for taking my questions. The first one on the <unk> combo study.
I think you should all be alone produces response rate around 33% within 12.
12 months it was the right comparator to use here.
Maybe what improvement on those metrics would.
Support moving forward with the TWC companies to say, which will be.
<unk>.
And then I can follow up.
Yeah, Hey, Bill Raj here.
Yes.
We are enrolling a similar population, but they enrolled in their second and third line study.
The response rate and the assent trial was around in the 30 odd percent. So what we would be looking for is an increase of let's say by about 10% or so above that as a meaningful.
Increase just to remind you from our <unk> study.
We saw a small increase in response rate of greater increase in PFS on the greatest increase in OS.
So the response rate is really just the first measure of evaluating antitumor efficacy.
The PFS is in the range of around five months, so we'd be looking at.
From an increase.
At least let's say about a month or so months are the highest in terms of media.
So those are some of the.
Sort of how we are going to be looking at the data when it's available.
Okay, Great and then maybe on the <unk>.
Performance I know historically, you had hoped to be in a place to provide revenue guidance for 2022 around now.
Kind of any updates there and I know you mentioned being comfortable with analyst consensus for the year hovers around kind of the mid forty's.
Is that correct, how you see it and maybe what's the main driver to reach reach that goal throughout the year.
Yes. So Joe this is Jack Youre right, we have not provided formal guidance at this point beyond what we've said is we're comfortable with where consensus said, we want to get through this transition quarter as you heard both.
Andrew and Jeff mentioned, so it will get a little bit better line of sight on that trajectory. So in terms of hitting 46, obviously it really is this pivot from breadth that has been the focus of the first 12 months of launch to now really driving depth or full organizational adoption.
So we assumed a breath will continue but really depth is the key.
And we think we're fully equipped with this new sales team to be able to do that so we're excited to have them out fully in the field last week was our first week and so we're looking forward going forward.
We're able to provide greater clarity to you.
The rest of the folks on this audience here.
Perfect. Thank you very much.
Your next question is from Tony Butler of Roth Capital. Your line is open.
Yes. Good morning, Thanks Raj two questions. Please.
One and preserve.
I assume that the data that you may speak about next year.
Would be just based upon myeloid suppression, what I'm trying to actually get at is.
Would it be too early to actually discuss OS and PFS with those take longer to readout and I say this because <unk> is the completion date, we primarily in November 2004, I believe.
So that's question one and number two just to.
Emphasize.
Again on preserved to.
Eliminating the second line TBC.
Again control is 250 patients.
That is the same population that existed before I just want to be clear about that and then Jack Jack and Andrew.
Particularly questions is it maybe just one I guess is it is it truly realistic to assume that you could touch a 100 out of those 100 or is it.
Is that doable. Thank you.
Hey, Tony It's Raj I'll take CF clinical ones first so yes, so just to.
Clarify that data on preserve won.
That we said would be available early in the first quarter will be milder protection and overall response rate.
The later completion date that you.
Noted in trials Dot Gov is really the PFS and OS data.
So just to clarify that so thanks for asking that.
In terms of the <unk> sample size rather than what is currently in <unk>.
Then Charles Dot Com since we just announced US today is the combined study population up to 150, which consists of 171st line <unk> second line.
So going forward, what we will be enrolling in the 170 <unk> to.
To complete that cohort.
Thank you Bob.
Sure Yeah, Thanks, Tony I'll, just add on the top 100.
Obviously, the 50 of the top 100, who are adults, but today, we're really pleased to have reached that milestone for us but of course, that's against the backdrop of hundreds of organizations nationally the our adult <unk>.
On a scale of those top 100, <unk> quite a bit between the ones who are the very largest in the country versus the ones who are in that kind of lower decile I didn't want to make clear that this is not the entirety of the number of organizations with optical cell or there was a fairly large number of organizations nationally to our adult <unk>.
And that's why you see our key.
Awards that but once we have onboard a certain proportion of organizations to allow us to accelerate sales more efficiently by generating that.
Our focus will be execution of lease so we do continue to think that.
Organizations will come on board and we do have a list of top 100 that we anticipate are likely to come onboard more rapidly than others, but I didn't want to make clear that's against the backdrop of hundreds of organization sort of up and cross sell.
Thank you Andrew.
Thank you Tony.
Your next question is from <unk> Rama of Jpmorgan. Your line is open.
Hi, guys. Thanks, so much for taking the question.
I have a broader strategic question actually there is a lot of studies, which are less liquid going on looking at <unk> <unk>.
Understanding the anti tumor benefit of kind of the cyclic is there any thought on taking on some indications that are more like say small cell, where you enhance the Milo preservation benefit thus enhancing the chemo benefit.
Like you have with the small cell label. Thanks, so much.
Yes, Thanks <unk> appreciate it.
Do think that the CRC is an important one in terms of being able to tap into a market a tumor type that is five to six times the size of a small cell. So we certainly look forward to getting that data you are correct that we have pivoted over the last 18 months to more on the anti tumor efficacy doesn't mean that we wont ever kantar.
To do model preservation studies.
The ACC combination study actually perhaps into both so I think for US we will continue to look at both we will design smart trials like the team has tried to do to date.
We will certainly follow the signs where is it where it goes as we've seen with the changing regimens and some of the new things coming out, but I would say both are on the docket as reflected in our current development plan and going forward, we'll continue to monitor both to see where we can benefit patients the most and stay on the crest of the science.
Hope that answers the question.
Thanks, so much.
Your next question is from the line of David <unk> of Wedbush Securities. Your line is open.
Thanks for taking the question, maybe it's a different flavor of auto plants question, but.
Yes.
Looking forward.
No.
Let's say that to fill or you are able to show a myeloid preservation benefit.
Triple negative breast cancer for example, but maybe.
You don't quite hit statistical significance on PFS.
They're a scenario that combined with that second with the secondary endpoint of myeloid preservation and colon cancer study that you could.
Maybe address a broader label or have a broader label for bio preservation in all tumor types is there any precedent for that I mean, I know Amgen I believe had three different tumor types to get the proper label for Neulasta.
<unk> do you think to go to the FDA with a secondary endpoint win on that you'll get a broader Milo preservation label and then.
And maybe address some other tumor types or is that.
So much speculation.
Yes, it's not an uncommon question to your point, David given how we've seen certain therapies in the oncology space.
Progress so and certainly we will keep the discussions open with the FDA as we get the Readouts on these additional studies.
I would also add that it pays and through things like competitive holistic right. You can also see payers be willing to reimburse us for data repository grows.
Either in myeloma or an antitumor efficacy. So I don't have much clear of an answer than that we do want to pursue it but we also know that it pays and sort of take this product by product indication by indication.
And then maybe a quick follow up.
Okay.
Do you feel that the competitive profile again, if that scenario were to play out the competitive profile.
Try the cycle would be sufficient to compete against.
The other agents.
You had a myeloid preservation label.
I just want to make sure I understand what we'd be able to compete on the myeloma space. We saw down in other words do you think do you think you could displace the other agents with with solely a myeloid preservation label in different tumor types, if that were to play out.
Payers and doctors.
Look for more.
I think from what we've seen both from payers to date and from the providers who have adopted early on as they appreciate the.
The fact that youre able to prevent Milo suppression.
And Youre able to do it with one one product rather than multiple so I don't envision that either payers or providers is that data grows on that but that's going to be something that they don't appreciate I'll put it that way. So I think it's really going to come down to the data, but we are pursuing both anti tumor efficacy and Milo suppression and then some.
Cases, both as I mentioned in the ADC combination study and I think that the data grows hopefully what what we have seen initially from payers is they really like this product because of the cost savings and providers like it because of what it represents in terms of patient benefits. So hopefully as the.
Data readouts contingent vessel that will be the case going forward.
Thank you.
Thanks, David.
Once again, if you would like to ask a question you May Press Star then the number one key on your Touchtone telephone. Your next question is from Bob <unk> of Raymond James Your line is open.
Good morning, guys. This is falling off again, thanks for taking my question and congrats on the quarter just ended.
Try to cycle on a higher level.
Okay.
Norfolk label.
And then on the colorectal trial, what are you guys kind of seeing or expecting to see an initial readout from presumably one thank you.
Okay I'll take the tumor agnostic question, and then I'll flip it over to Raj in terms of expectations on CRC, Yes, I think these last three questions, but when they're all similar in that.
As these data Readouts com right that goes grow the repository of evidence in terms of being able to use trial the cyclic either for more tumors on the Milo preservation front or as the data comes out antitumor efficacy certainly we would like to make sure that.
We progressed and Thats. Our vision is that this there is a tumor agnostic vision for this asset we think the benefits of either Milo preservation or antitumor efficacy or in some cases, both auto be available to the appropriate patients, but we want to make sure. We've got the data there, but that's certainly our aspiration.
And it's what we're pursuing with our development plan I think we've got to wait for the Readouts, but that's certainly why we've designed it like we have in terms of the CRC I'll flip it over to Raj yes.
Yes, so it's going to be the data early next quarter next quarter early 'twenty three I should say.
The model protection data on response rate data, so thats, how we will be available and so the endpoints are similar to what we.
Studies in small cell lung cancer.
Duration of severe neutropenia.
Current subsidiary of Neutropenia, and also we're evaluating patient reported outcomes. So those will be available as well in addition to response rate.
Great. Thank you.
Paul.
Thank you I'm showing no further questions at this time I would like to turn the conference back to Jack.
Thank you operator and as always we appreciate.
You joining today, we look forward to keeping you updated on our progress.
Again, thank you for joining us today and please stay well thank you.
Thank you presenters, ladies and gentlemen. This concludes today's conference call. Thank you all for joining you may now disconnect.
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