Market

G1 Therapeutics, Inc. (GTHX) Q1 2021 Earnings Call Transcript | The Motley Fool

Image source: The Motley Fool.

G1 Therapeutics, Inc. (NASDAQ:GTHX)
Q1 2021 Earnings Call
May 5, 2021, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by and welcome to the G1 Therapeutics 2021 First Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session [Operator Instructions]

I would now like to hand the conference over to your speaker today, Mr. Will Roberts. Please go ahead.

Will RobertsHead of Investor Relations

Thank you Jilian. Good afternoon everyone and welcome to the G1 conference call to discuss our first quarter 2021 financial results and business update. The press release on these financial results was issued after market close this afternoon and can be found in the News section of our corporate website G1therapeutics.com.

On this afternoon’s call, the team will provide a business overview of the first quarter, including an update on our launch progress with COSELA, which was approved by the US Food and Drug Administration on February 12, 2021, to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer, or ES-SCLC and it became available in the channel in early March. A question-and-answer session will follow the prepared comments.

Before we begin, I want to remind you that today’s webcast contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements represent management’s 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. For 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, March 5, 2021.

Joining me on the call today is Jack Bailey, our Chief Executive Officer; Soma Gupta, our Chief Commercial Officer; Jen Moses, our Chief Financial Officer and Raj Malik, our Chief Medical Officer.

And with that, I’ll turn the call over to Jack. Jack?

Jack BaileyChief Executive Officer

Thanks Will. Good afternoon everyone and thank you for joining us on the call today. We certainly hope that you and your families are healthy and well.

Today’s headline is one progress toward our mission via continued execution by the G1 team on both our launch efforts for COSELA in extensive-stage small cell lung cancer and in our clinical efforts as we execute on our robust development plan. As many of you know, G1 was founded in 2008 by Dr. Norman Ned Sharpless, the current Director of the National Cancer Institute to discover novel therapeutics that target protein kinases that help mediate cell division.

His mission even then was to improve the experience of chemotherapy and to improve and extend the lives of people living with cancer. And I’m happy to say that our mission has not changed as the company has evolved. The development, approval and launch of COSELA in extensive-stage small cell lung cancer isa one example of how we were actively advancing that mission. Another is our tumor-agnostic clinical program with the late stage clinical trials ongoing or soon to be initiated in multiple tumor types. Soma will share that the early indicators are suggestive of a drug that is being well received by oncologists in oncology nurses and is well covered by payers.

COSELA is already being administered to patients. It fits well into the oncologists workflow. Oncology nurses are being actively educated on its benefits. It’s reasonably priced and supported by strong budget impact data. It was quickly added to two NCCN guidelines and it represents the start of a true paradigm shift in chemotherapy patient support from reactive single lineage treatment with multiple drugs, depending on the side effect to that of proactive multi-lineage myleo protection.

Equally good progress has been made in our clinical efforts with COSELA. Since the beginning of the first quarter, we started dosing patients in our pivotal colorectal cancer trial. We’ve initiated our pivotal TNBC trial. We also opened an investigator-initiated trial portal, which is generating a number of interesting potential opportunities and we expect to initiate two more Phase II trials later this quarter in non-small cell lung cancer and bladder cancer. So by the end of the current quarter, we expect to have two Phase III registrational trials and three Phase II trials under way.

Now today’s call will cover an important amount of information. I’ll let Soma to discuss our commercial efforts through the end of March, our first four weeks of being a commercial organization and provide some leading and lagging indicators of COSELA’s access and uptake. Raj will then provide an update on our medical efforts and also our recent clinical milestones in the first quarter. Finally, Jen will provide the financial update for the first quarter of 2021. Then I’ll be back for some concluding comments.

I’ll now turn the call over to Soma for her update on our commercial efforts and results over the first four weeks of sales. Soma?

Soma GuptaChief Commercial Officer

Thanks, Jack, and good afternoon everyone and thanks for joining us on the call. These are exciting and very busy times as we are launching COSELA. And though, we are very early in the launch cycle, the indicators to date have been positive and suggest a high-level interest in adopting COSELA and the potential for strong coverage from payers. I’m very proud of the great work we have seen from this combined G1 and VI team. Thanks to their efforts, we booked approximately $600,000 in net sales as of March 31st in COSELA’s first four weeks of availability. We’re off to a solid start and I’m optimistic that we can sustain this early momentum moving forward.

Launching a drug during a pandemic is new territory for all of us and the team has performed well. As we discussed in our last call, our sales training was completed in the week of February 26 and the team was in field the following week to coincide with availability of drug on on March 2nd. G1 and BI made good early progress even though drug was available for only the last four weeks of the quarter. So a few highlights.

First thus far our targeted priority payers have been covered for approximately 60% of it has been Medicare Part B, about 30% is commercial and then 10% is government and other forms of coverage as we had expected. We are seeing good initial traction with prescribing docs and nurses with vials being ordered by 20 unique organizations in the month of March alone. We have nearly doubled that number since.

From an engagement perspective, as of the last week of March, again only four weeks in, the team had already achieved a nearly 30% reach to our 2,500 target HCPs and more generally made an additional 3,000 calls to other prescription-enabling functions in the accounts. Almost a third of the calls were live. In what every really the country continues to open back up, we expect that trend to continue. That said, the team has proven itself to be entirely capable of virtual calls. And while not of indicator of usage, it’s also good to see the sales force share of voice among targeted physicians is already in the same range as that of other products used by treating oncologists like Neulasta, TECENTRIQ and Imfinzi.

And of course we are leveraging our learnings from G1’s initial national broadcast as well as other region-specific sneaker programs that have been scheduled. We’re very happy with a robust interest in these educational programs and also the strong interest and scheduling live programs versus virtual ones, which we will likely have an even greater impact. Let’s now go into a little more detail on sales performance adoption and market access.

Sales performance for the first four weeks of product availability exceeded our internal demand target. As would be expected, approximately 60% of the demand came from community hospitals and clinics with 40% coming from academic hospitals. Regarding adoption, again, we are seeing promising early metrics. 20 unique organizations, what we call parent accounts, to which multiple accounts roll up ordered COSELA in March and most of them have reordered as would be expected given patients typically get six doses per cycle and four cycles per patient.

60% of these unique organizations did not participate in a clinical trial for COSELA, suggesting that we are focusing on the right targets and are generating good interest and awareness outside of the already-aware and experienced and cohort.

I’m also enthusiastic of seven of our 100 priority calls, those that we can put are critical to driving both depth and breadth of COSELA adoption had already ordered as of March 31st. Our best estimates indicate that approximately 30 small cell lung cancer patients were helped with a decision to start COSELA in the first month of launch, which given the infrequency of these patients presenting, is a good strong start

The process to be made available for use in large institutions or community practices are individualized and very institution-specific and as such will take time to work through all of them, but we are happy to report that we made some very important early progress in March. For example, one of the largest GPO account in the Southeast is a big and very influential account that drives volume. They’re highly controlled account so the key unlocking account like this is through the key decision makers at the top. Our team immediately got to work on the key drivers from top down, P&T review, EHR systems update and formulary inclusion; from bottoms up nurse programs and see any interaction, physician awareness advocacy and pull-through demand. That process was completed in late March and since then demand from them has been strong and we are seeing orders nearly every day.

This is a process that we will repeat with all of the large community practices and when we are through this large GPO came on board with COSELA so quickly after launch we know each large community practices has its own process and it will take some time to move through each one. Some of you like this one, where there is a high degree of institutional control and acceptance can be determined by a few key decision makers, while others will stick to their system dictated pathways, maybe something like clear value and are awaiting that decision as part of their overall assessment. And will continue to work through all of them on the account by account basis, but the approach will be the same.

Support P&T reviews and inclusion in EHR systems to open the account from the top, while driving HCP awareness, scheduling nurse and pharmacy programs and activation patient advocacy so demand is being generated from the bottom. Many are also influenced by NCCN and as Raj will discuss further in his remarks, COSELA was added to two NCCN guidelines during the last week of the quarter, so we are leveraging that where appropriate. These steps are critical to selling a buy-and-bill product that requires a total office call. By doing this critical upfront work, COSELA will be made more easily available to interested prescribers.

Those seven of our top priority orders were already ordered, have also added to their formularies and their EHR order sets for small cell lung cancer. So, we see things more generally going in the right direction. So, every large community practices the same which you believe these are the right general steps to succeed? To do this success, it takes work and some time and will be our focus for the next two quarters or so. We have a great experienced team that has done this before with over 20 different oncology products and we will get there.

Switching to market access, we made good early progress with payers, including completion of COSELA presentations to priority payers, representing over 80% of covered lives. These split into approximately 70% Medicare Part B plans and 30% commercial plans. Anthem, a priority national payer published our first formal policy on March 31st with a prior authorization to label as expected. All payers will issue policies based on these presentations over the coming months. Thus far, our priority payers are approving prescriptions that are written to label. We’ve filed for our permanent JNC codes in March and they should be approved by September. For those in the inpatient setting, we filed for what’s called a new technology add-on payment. We should — so that started by September as well.

However, even prior to the permanent codes, we are seeing very little push back in terms of reimbursement above payments. Of course some practices, typically those of small size, will hold off until the permanent J code is issued, but overall we are not seeing payer and reimbursement issues, thanks to strong interest in the product, endorsement by NCCN and of course what we feel is a fairly priced offering. We also discuss the importance of aided and unaided awareness up to some of the past and we are enthusiastic about the progress we have seen in that regard through the end of March. Both awareness measures are well above baseline, but it’s a little early in the launch to attach significance to it. We will provide update in that regard on the next call.

So that was a long information. To summarize, we are seeing good early metrics of the engagement and ordering from priority orders. Our demand sales came in line with our expectations for the first month of availability. We are seeing good progress with key large community GPO account though the process to progress each one will take some time. And then from a market access perspective, we have seen no issues in coverage and expect our permanent codes to issue in the second half of the year. So we are off to a solid start and we believe we are well positioned to build up in momentum we’ve generated in these first four weeks [indecipherable] of our teams, we’ve been able to meet every class for product and support. It is a very exciting time for the commercial team at G1 and FDI. And I’ll now turn the call over to Raj Malik. Raj?

Raj MalikChief Medical Officer

Thanks Soma and good afternoon everyone. I’m going to cover three topics. First, I’ll highlight some of our medical efforts during the quarter, including COSELA’s addition to the NCCN guidelines and how our interactions with HCPs are progressing. Second, I will describe some compelling budget impact model data that were recently presented at the Academy of Managed Care Pharmacy or AMCP meeting in April. Finally, I’ll provide an overview of our recently initiated pivotal trial in triple-negative breast cancer or TNBC.

Our medical science team has held over 350 medical-to-medical engagements since FDA approval. In addition to interactions with academic opinion leaders, our MSL team is actively engaging with community cancer clinics, where the majority of small-cell lung cancer patients actually present and are treated. The team is taking a total clinical approach with engagements with the oncologists and other allied healthcare professionals, especially nursing, pharmacy, and other clinic staff in the community cancer clinics and integrated delivery network key accounts.

Some of the insights we’ve heard from community oncologists are around the importance of education on the novel mechanism of action of COSELA. It’s a proactive, multi-lineage approach to protecting the bone marrow, which is new and different from what they were used to. Most oncologists immediately think of neutropenia when it comes to myelosuppression. But when we discuss the other lineages, red blood cells and platelets, they begin to understand the novel mechanism.

They’re also used to thinking about oral CDK4/6 inhibitors that are administered chronically. However, what makes COSELA unique is that it’s administered IV, cleared rapidly, and only administered on days that chemo is given in order to provide a transient G1 arrest or myelo protection. The nursing community is on the front lines of dealing with patients and managing chemo-related side effects and the feedback from them has been resoundingly positive regarding the reduction of myelosuppressive chemo consequences by COSELA.

Many of the questions from nurses so far have been very practical and pragmatic in nature. Mostly around choice of IV infusion sets, like which tubing and filters are compatible with IV administration of COSELA. This is important since this indicates that they are interested and preparing to use COSELA in their practice. The field medical team has also received a lot of practical questions from pharmacists in addition to a request for pharmacoeconomic information to inform their P&T and formulary decisions, like the data we presented at the AMCP meeting.

Our MSLs have also seen a strong uptick and interest in the G1 scientific platform. And this not only helps to drive interest from additional investigators for our life cycle management clinical trials, but also translates into new proposals for investigator-sponsored studies.

Our medical team was instrumental in having COSELA added to two updated National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology in late March. The treatment guidelines for small cell lung cancer and a supportive care guidelines for hematopoietic growth factors. This type of simultaneous update of two NCCN guidelines is not only rare, but also a testament to the multi-disciplinary importance of this breakthrough therapy. Ganing inclusion into relevant guidelines also drives inclusion into oncology care pathways, which is a vital part of our strategy to ensuring appropriate patient access as these recommendations facilitate payer reimbursement and patient access.

We have submitted data packages to the oncology care pathway committees via their formal submission processes. G1 has a very robust publications plan on which we are executing. For example, 18 trilaciclib peer-reviewed manuscripts have been published to-date, eight of which were in 2020 or 2021 and several others have been submitted and are under review. In addition, we have submitted abstracts for presentation at eight different medical meetings in 2021. At the AMCP meeting, we presented the budget impact of prescribing COSELA to decrease the incidence of chemotherapy-induced myelosuppression in adult patients with extensive-stage small-cell lung cancer from the perspective of a third-party payer.

The model created and compared two scenarios for this analysis over a five-year time horizon and a hypothetical plan with 1 million members in total. The first, which was a pre-launch scenario, outlined the economics and outcomes associated with standard extensive-stage small-cell lung cancer treatment before COSELA was available. The second, which was the post-launch scenario, displayed the economics and outcomes projected to evolve when those same standard treatments are needed with COSELA being given.

The results are compelling. Chemotherapy-induced adverse events in patients treated with extensive-stage small-cell lung cancer are estimated to be fewer over five years in the scenario where COSELA is available, resulting in a net financial impact of COSELA, which is estimated to be a budgetary cost saving. The presentation is available on the Publications page of our corporate website.

Next, regarding our clinical development progress, our first line colorectal Phase III trial is continuing to enroll patients. In late April, we initiated PRESERVE 2, our second pivotal Phase III trial, which is a randomized double-blind placebo-controlled study of COSELA in patients receiving first or second line gemcitabine and carboplatin chemotherapy for locally advanced unresectable or metastatic triple-negative breast cancer.

This cancer comprises up to 20% of all breast cancers and is an aggressive disease with poor outcomes. Because the tumor is negative for estrogen, progesterone and HER2 receptors, thus the term triple-negative, patients do not respond well to common medications that block hormone or HER2 receptors. Instead treating TNBC typically consists of using chemotherapy combinations, in addition to radiation and surgery.

Therefore, there is a significant medical need for well-tolerated and efficacious therapies with novel mechanisms of action. The study is enrolling two cohorts of patients. Cohort one will enroll 170 patients receiving first-line therapy regardless of tumor PD-L1 status who have not been previously treated with a PD-1 or PD-L1 inhibitor. Cohort two will enroll 80 patients with a PD-L1 positive tumor, receiving second-line therapy, following prior PD-1 or PD-L1 inhibitor therapy.

These two cohorts are adequately powered and considered independent of each other. Within each cohort, enrolled patients will be randomized 1:1 to receive either COSELA or placebo, prior to gemcitabine and carboplatin therapy, administered intravenously on days one and eight in 21 day cycles, which is the same dosing regimen used in group two of our positive Phase II study. Treatment will continue until progressive disease, unacceptable toxicity, withdrawal of consent, investigator decision or the end of the study, whichever occurs first.

The primary endpoint in both cohorts is to evaluate the effect of COSELA on overall survival compared with placebo. Secondary objectives in cohort one include assessments of COSELA’s has impact on overall survival in PD-L1 positive and PD-L1 negative groups and on progression-free survival compared to placebo and for cohort two on progression-free survival compared to placebo.

The key secondary objective in both arms includes assessment of the effect of COSELA on patients’ quality of life as measured by time to first deterioration of the fatigue compared with placebo. Other secondary endpoints in both arms will evaluate the effect of COSELA on measures of anti-tumor activity, including overall response rate, clinical benefit rate and duration of response. And the myeloprotection effect of COSELA on multiple measures of multi-lineage myelosuppression, including neutrophils, red blood cells and platelets. We expect these pivotal data to readout in the second half of 2023. We also remain on track to initiate two additional Phase 2 trials of COSELA this quarter. One in second and third line treatment of non-small cell lung cancer and the other in first-line treatment of locally advanced or metastatic bladder cancer or metastatic urothelial carcinoma.

Finally, turning to rintodestrant our oral SERD. We will present Phase II data from our combination of rintodestrant with palbociclib in 40 patients with ER positive HER2-negative breast cancer at ASCO later this quarter and a press release will coincide. We will provide the details of the presentation as soon as embargo policy allows.

With that, I’ll turn the call over to Jen for her to review the results of the first quarter. Jen?

Jennifer MosesChief Financial Officer

Thanks Raj and good afternoon everyone. As Will mentioned, full financial results for the first quarter of 2020 are available in our press release and 10-Q. Today, I’d like to focus on a few key points from our disclosures. Our total revenue for the first quarter of 2021 was $14.2 million comprised of net product revenue of $0.6 million and license revenue of $13.6 million. We recognized product revenue upon delivery of COSELA to our specialty distributors.

First quarter product revenue includes net product sales from our first shipments in March, following FDA approval. Our license revenue was primarily related to development milestone payments from our license agreement with Simcere, which provides them with development and commercialization rights for trilaciclib across all indications in Greater China and revenue from EQRX with whom we have a license agreement for lerociclib. The revenue from EQRX relates to delivery of clinical drug supply and manufacturing services and reimbursement of clinical trial costs.

In addition, we recognized revenue related to achievement of the development milestone by Genor. It’s worth noting that while we do expect to continue to receive modest expense reimbursements and payments under our supply agreements from our partners, we do not expect to receive this amount of license revenue in any one quarter for the remainder of this year.

Cost of goods sold for the three months ended March 31st, 2021 was minimal as the majority of the manufacturing costs related to the first quarter of COSELA sales were incurred prior to FDA approval and therefore were recorded as R&D expense in prior periods. The prior expensing of these costs will continue to impact presentation of cost of goods sold in future periods until the initial pre-launch inventory is depleted and additional inventory is manufactured as a result. G1’s research and development expenses for the first quarter of 2021 was $16.5 million compared to $20.4 million for the first quarter of 2020. The decrease was primarily due to a decrease in costs for manufacture of active pharmaceutical ingredient drug product to support clinical trials as well as decrease in external costs related to discovery and preclinical development.

Our selling, general and administrative expenses for the first quarter of 2021 were $23 million compared to $11.4 million for the first quarter of 2020. The increase was largely due to an increase in compensation costs due to increased head count and increased commercialization activity. We ended the first quarter with cash and cash equivalents of $279 million, which included the $86.4 million in net proceeds from our at-the-market offering with Cowen. As a reminder, this activity utilized all remaining capacity under the sales agreement, so this ATM offering is now closed.

We also drew an additional $10 million under debt financing facility with Hercules Capital and entered into an amendment to the agreement, which provided slightly lower interest charges and additional covenant relief on a future tranche of debt. There is currently $70 million of capacity remaining on the Hercules facility. We expect our current financial position to be sufficient to fund operations into 2023.

With that, I’ll turn the call back over to Jack. Jack?

Jack BaileyChief Executive Officer

Thank you, Jen, Raj, Soma and Will. Before we conclude this portion of the call and go to Q&A, I want to thank the people living with cancer and their healthcare professionals for their inspiration. In particular given that May is oncology nurse month, I’d like to personally thank these nursing professionals for their incredible work they do. You are truly the front line of care for people living with cancer and walk with them every step of the way from diagnosis onward.

We appreciate the opportunity to be part of and help support your community. I would also like to thank the G1 team for your continued dedication to improving the lives of cancer patients as we execute on our clinical and commercial programs we will have the opportunity to impact a lot of lives, your dedication and drive matters.

Now as I mentioned on the last call, the first quarter of 2021 was transformational for G1 and I’m happy to report that we are well along in turning the corner on becoming a commercial organization without losing focus on our clinical endeavors. We will keep you up to date as possible on our commercial rollout of COSELA through these leading of the way indicators of both interest and uptake, which we intend to provide every quarter, along with our revenue results.

However, on this call we described some patient numbers to help you understand our early trajectory. We do not intend to provide them every quarter as we start to get into our revenue generation. Again before we move to Q&A, let me just recap what you heard today. The combined sales team is executing on its launch program and achieving good early metrics of engagement and adoption of COSELA.

We see no issues in coverage and expect to hear about our permanent J C and NTAP codes in the second half of this year. Our medical affairs team has held over 350 medical-to-medical engagements across the MSL team since FDA approval, driving education on Cosela and interest in the G1 scientific platform. We have a strong publications program on which the medical team is executing, including the recent presentation of data showing that the net financial impact of COSELA is estimated to be cost savings from a budget standpoint.

COSELA was added to two different NCCN guidelines in late March, which we expect to facilitate timely payer reimbursement and ongoing patient access. We recently initiated our pivotal trial in TNBC with data expected in 2023. We also expect to initiate our Phase II programs in non-small cell lung cancer and bladder cancer later this quarter giving us five ongoing late stage trials and numerous readouts coming over the next 24 months. And finally, we have cash runway that takes us into 2023 with options to extend that further.

Thank you for your time this afternoon. We will speak again in this format in the August call for Q2 earnings, but between now and then, we look forward to connecting with many of you at the upcoming virtual healthcare conferences and roadshows in the weeks ahead.

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?

Questions and Answers:

Operator

[Operator Instructions] Our first question comes from the line of Mr. Tom Shrader from BTIG. Please go ahead.

Unidentified Participant

Hi, this is [indecipherable] for Tom. Thanks for taking our question. I just have one on the oral SERD. With all the updates from the other SERD programs like the Sanofi’s and Genentech’s, has the bar for what has to be seen for rintodestrant changed?

Jack BaileyChief Executive Officer

Yes, thanks for the question. Really appreciate it. I would say our internal measure that we communicated of CBR24 for between 60% and 65% really remains. To your point, as more data comes out in the SERD class, both on the efficacy and the tolerability and side effect standpoint, we’ll continue to monitor that. But we believe that we can match the safety profile and strong tolerability and hit a CBR in that range we’ll consider this a good result.

Unidentified Participant

Great, thank you and congrats on the progress.

Jack BaileyChief Executive Officer

Thank you very much, I appreciate it.

Operator

Our next question comes from the line of Anthony Butler from ROTH Capital. Please go ahead.

Anthony ButlerROTH Capital — Analyst

Thanks very much. Soma, I appreciate the presentation and the color. But I have to ask, can you describe any payers that had a push back, but importantly how did — how are the field agents able to actually deal with that push back? I think it’s important as a lesson to be learned. And then the second question involves around in discussions that you’ve been having with payers, who has yet to sign contracts or incorporate COSELA within their reimbursement, again can you discuss where are the — any rate-limiting steps that may be occurring at least to date? Thanks very much.

Soma GuptaChief Commercial Officer

Yes, sure Tony. Nice to hear from you. So on both points, so as I said in my comments, we have had very little pushback from payers at this stage. And so at this point, what’s happening is physicians are choosing to write it. They’re putting it in and they’re not having issues. In fact, as you know, we have this, one-to-one service. So, the cases that have come through there, same thing, no problems. I think at this stage, it’s PA to label.

And so, to answer your second question — the second question around the policies is that the processes, those presentations that are given, we’ve done those presentations that cover about 80% of lives at this stage. They are well under way and then they all take their time to review the data, understand the data understand the benefit, and then incorp and then write the policy. And so as I said, we got the first policy from Anthem at the end of March. So we were very happy about that.

I think different insurance company basically handle about in different ways and take time on different timelines. So we feel that might take anywhere between — it could take six months for all of them to come on board write their individual policies. Some of them came on, Anthem came on very early in the — on the progress. But I would say overall, this is not an area with the payers, where we’re seeing a lot of pushback on an issue. And so even to answer your question about how the reps are handling it, the reps aren’t really having to handle it, because it hasn’t really present much of an issue to-date. Again, we think we’re fairly priced fit. We think people understand multi-lineage that they’re getting, the benefit of not just what they got with others, but they’re cutting the other pieces and I think that goes a long way in terms of the value proposition on COSELA, but we’ve very encouraged by the progress on the payer front today.

Anthony ButlerROTH Capital — Analyst

Thank you very much.

Operator

Our next question comes from the line of Mr. Chad Messer Junior from Needham. Please go ahead.

Chad MesserNeedham & Company — Analyst

Great, thanks for taking my question and thanks to the whole team for all the added color today and like my predecessor analyst, a special thanks to Soma for all of her color. Soma, I may need to replay parts of your prepared remarks today at two-third speed so I can absorb it all. And our ability to process information clearly slower in years, but if we could just dive into a couple of things, I’m trying to get a hold on. So — and I get it so we’re talking about the very earliest days. It’s a very flash time point than the launch. Things do sound like they’re going well, but $600,000 in sales through that very end of March. I believe if I have my notes down correct, you guys are estimating that’s about 30 patients that you’ve treated maybe some context on that number. I know it’s a month’s of early data but like are we 2%, 20%, 40%.

And then you also, I believe, again, I’ve got to read my own piece of written notes, but 60-40 on the community academic breakdown and 60-30-10 on the net D the commercial and government breakdown like, can you give us some context on where those are and where we think they need to be, like I mean again, right. So, it’s just the first few weeks, we’re all going to over analyze it. That’s what we do, but sort of where are we on those, if you could give us some?

Soma GuptaChief Commercial Officer

Yes, absolutely. So yes, I tend to be a fast talking orator as you may now. So, appreciate that, so — but interestingly you’ve got all the numbers correct. So that’s the first thing. So on the 30-patient so what I can tell you about the 30 patient is it is an estimate. It has the way that the data comes into us as we see different accounts. We first of all, we see accounts and so accounts will order and will be able to see. Okay that person, they ordered five vials, that’s probably a second line patients; that person may they ordered 6 vials, that’s probably as our first line patients.

So we’re doing a little bit of math to get it our best estimate around the patient, but we just think it was important to be able to get a perspective on how many patients we think went on drug and we think it’s about 30. Of that 30, we think about half of those are definitely first line patients. We think about 25% of those might be second line and then about 25% of them we’re just not sure based on the way the order and came in.

So that’s a little bit of coloring, at least on the patient piece and in terms of where we think that is we think that’s very positive. We think directionally 30 patients was great for four weeks. This is a disease when you think about it, there is only 30,000 patients are present in a given year. Out of those 17,000 to 18,000 are first line, about 10,000 are second line and the kind of the remainder are thereby decisions don’t really make it through multiple lines of therapy.

So, when you think about that on a — so you take that number and you kind of do it on a monthly basis, the number of patients walking in every month is not that big. And so for us we thought 30 patients with a good number for the first month of launch. That’s the first thing. The other number that you mentioned the 60-40 can be in any split, we actually think that’s going to move closer to 70-30 over time.

We think that what might have happened in this instance, is that the community — sometimes the community institutions are larger practices. They have longer processes to kind of pull it through and the whole process I talked through about cutting TNT and opening it up from the top, sometimes that talks us a little bit longer and some [indecipherable]. And then, some of the academic accounts that just goes faster, because they can get access to the things they need to, that might be why it weights little bit heavier on academic than what we’ve– I think what we expect to see in steady state, which in my mind would be more or less 70-30.

But on the payer mix of 60-30-10, that’s actually what we expect to see. So that was actually right in line with our — exactly how we expected to come in. Again these patients the average age is 65. So, we know that the heavily Medicare population. So, it would seem to us about 60% is reasonable, 30% commercial and then 10% kind of VA, DoD and others. So in general, we think this is actually the patient count again it’s an estimate, but we feel very good about the patient count is and where we we’re able to get to in the first month. And as I said, the other two metrics I deal are very in line with what we thought we would start.

Chad MesserNeedham & Company — Analyst

All right, well, really — color and please accept my permission to take a breath. Thank you.

Operator

Our next question comes from the line of Mr. Joe Thome from Cowen and Company. Please go ahead.

Joe ThomeCowen & Company — Analyst

Hi there. Thank you for taking my questions. First one, just on the P&T approval process given kind of the COVID pandemic time frame, what’s the average time from sort of initial presentation to the hospital for it to get through the P&T committee?

And then second, is it possible to use COSELA concomitantly with other GM-CSF products in clinical practice? I know in clinical study, we saw obviously reduced need, but is it still reimbursable after launch? Thank you.

Jack BaileyChief Executive Officer

Thanks. Thanks, Joe. I’ll quickly address the first one and then I’ll put the second one over to Raj. In terms of what your typical P&T timeline. To Soma’s point, this is really very individualized that’s on an account by account basis depending on either the institutional or top-co institution versus a large community practice. So, a team is monitoring this. We’ve got a good sense for a lot of them when they will occur. But to be honest the duration of when they start and how long take really does vary account by account. But the team is heads down executing on this and making sure they have the information they need to be able to, hope we move to their processes as quickly as possible. Raj, you want to take the second question?

Raj MalikChief Medical Officer

Yes, happy to. So in our trials we allowed the use of G-CSF and what we actually found was a substantial decrease in the need for G-CSF when when COSELA, but there were no safety issues with giving both COSELA and G CSF. So we think in practice because of the proactive approach with COSELA, prescribers will initially use COSELA and also having the multi-lineage benefit and could have the option of using G-CSF if needed down the road.

Joe ThomeCowen & Company — Analyst

Okay, perfect. Thank you very much.

Jack BaileyChief Executive Officer

Thanks, Joe.

Operator

Our last question comes from the line of Mr. Ed White from HC Wainwright. Please go ahead.

Ed WhiteH.C. Wainwright — Analyst

Good evening. Thanks for taking my questions. Thanks for the update on rinto. Just wondering if you can briefly review your strategy there again? And has there been interest from partners for that product? And then a quick question for Jen, just that the cash runway into 2023, does that include the 70 million left from the Hercules deal? Thanks.

Jack BaileyChief Executive Officer

Good to hear from you Ed. I’ll answer the first one and flip it over to Jen to hit your second question.

In terms of rintodestrant, we are still on the same path that we communicated last year, we believe, given the competitive nature of the class, the cost of the Phase III development programs, let alone the significant investment to commercialize, we think the best use of shareholder capital is to partner that. To your point, we have had interest in it and have had discussions, obviously as we released the data at ASCO that will be the next in the logical milestone here will follow-up, a lot of those discussions, but we’re still on path to be able to partner there and really fully deploy our capital behind trying to development plan. Jen you want to take the second one?

Jennifer MosesChief Financial Officer

Sure. So how — when we’re giving guidance we run it a number of different ways that’s for early stages of revenue looking at a bunch of different options, but we are not utilizing the full $70 million to get to 2023. So, hope that answers your question.

Ed WhiteH.C. Wainwright — Analyst

That does. Yes. Thank you.

Jack BaileyChief Executive Officer

Thanks Ed. Okay that’s looks like it’s the last question, so let me just conclude by saying we are very excited to be bringing COSELA to patients with extensive-stage small cell lung cancer and through our clinical teams to many more patients with a variety of different cancers as always I look forward to keeping you all updated as we move forward and certainly we will continue to be as transparent and proactive as possible in this regard. So to everyone listening, thank you for joining us today to please stay healthy, and well, we look forward to talking soon. Thank you.

Operator

[Operator Closing Remarks]

Duration: 48 minutes

Call participants:

Will RobertsHead of Investor Relations

Jack BaileyChief Executive Officer

Soma GuptaChief Commercial Officer

Raj MalikChief Medical Officer

Jennifer MosesChief Financial Officer

Unidentified Participant

Anthony ButlerROTH Capital — Analyst

Chad MesserNeedham & Company — Analyst

Joe ThomeCowen & Company — Analyst

Ed WhiteH.C. Wainwright — Analyst

More GTHX analysis

All earnings call transcripts


AlphaStreet Logo

This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. We’re motley! Questioning an investing thesis — even one of our own — helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.



Most Related Links :
usnewsmail Governmental News Finance News

Source link

Back to top button