G1 Therapeutics Inc (GTHX) 2022 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the G1 Therapeutics First Quarter 2022 Financial Results Conference Call. (Operator Instructions)

Please be advised that today's conference is being recorded. (Operator Instructions)

I would now like to hand the conference over to Will Roberts, Head of Communications. Please go ahead.

Thank you, Abigail. Good morning, everyone, and welcome to the G1 conference call to discuss our first quarter 2022 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, g1therapeutics.com. On this morning's call, the team will provide a business overview of the first quarter of 2022, including an update on our clinical programs and our commercial progress in that period with COSELA, which is approved and commercially available to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or a topotecan-containing regimen for extensive-stage small cell lung cancer, or ES-SCLS. A question-and-answer 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 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, May 4, 2022.

Joining me on the call today are Jack Bailey, our Chief Executive Officer; Andrew Perry, our Chief Commercial Officer; Raj Malik, our Chief Medical Officer; and Jen Moses, our Chief Financial Officer.

I'll now turn the call over to Jack. Jack?

Thanks, Will. Good morning, everyone, and thank you for joining us on the call today. Today's headline is that as of the beginning of March, we have successfully deployed our G1 sales team, fully transitioned out of our sales relationship with Boehringer Ingelheim, and in doing so, have entered a new phase of COSELA promotion in which we are in full control of the commercial opportunity for this important drug. COSELA is a unique and innovative drug that can fundamentally change the paradigm by which small cell lung cancers are treated. It's proactively administered and covers multiple lineages. (inaudible) practitioners have been doing for the last 30 years, namely treating hematologic events caused by chemo reactively with a variety of single lineage interventions which carry their own unintended consequences. Our goal over time is to replace these reactive treatment modalities with COSELA, a simple 30-minute infusion prior to chemo to reduce, and in some cases, eliminate the cytotoxic events that put chemo patients in the hospital and prevent them from completing their regimens. We are excited about this as are the people we hear routinely from, including patients who have been through chemotherapy with COSELA, infusion center nurses on the front line of patient care and treating oncologists. As you will hear from Andrew, our newly deployed sales team made good progress during the back half of the first quarter in improving COSELA access and uptake. Intend to use remaining time and reimbursement remains as strong as it has been since launch. Importantly, ordering by our top 100 organizations increased quarter-over-quarter, and more broadly, we continue to shift the proportion of our business towards those top 100 organizations. So not only did overall volume increase, it increased in the accounts that have the ability to maximize the future potential of COSELA.

Turning to our clinical operations. We continue to make good progress in enrollment in our ongoing Phase II and Phase III trials. And as of today, we are on plan to provide initial results on schedule. This morning, I will ask Andrew to cover our recent commercial progress, including an update on the first quarter of 2022 and month-over-month progress during the quarter. The first opportunity in which we were in full control of the commercialization effort. Raj will then provide an update on some of our medical and clinical momentum, including the real-world data we recently presented at 2022 NCCN meeting. Finally, Jen will provide the financial results for the quarter, including a reminder that our cash runway takes us into 2024. Then 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 to spend some time on a variety of commercial topics, including first quarter sales activity and leading indicators of growth. This has been a quarter of significant commercial transition, and so we're also providing a special snapshot of monthly sales growth during the first quarter to provide additional insight into this transition. We began the first quarter of 2022 with COSELA still being promoted by BI, our co-promotion partner since launch. And with the first year of our G1 Oncology Sales Account Managers, or OSAMs in the field. By mid-February, we had deployed our complete team of 34 G1 OSAMs, and by March 2, the BI arrangement had been concluded. So in March, COSELA was solely promoted by the G1 sales team for the first time. We continue to be encouraged by the market reception for COSELA across payers, providers and health care organizations. Payer coverage, brand awareness and intention to prescribe all remain strong, and we're seeing that translate into physician endorsement and account level trial and uptake with our largest customers. Coming out of the first quarter, we believe we now have a commercial platform, which will allow us to generate growth through both breadth and depth.

Starting with first quarter sales activity. We ended the quarter with $5.5 million in net sales of COSELA, representing just over 20% via volume growth period-over-period. As previously mentioned, the first quarter was one of significant transition as we moved into the next phase of COSELA commercialization. And our goal during this transition period was to maintain growth at a similar level to the growth we saw in quarter 4 of last year when BI were still promoting the brand. We were successful in doing so. The first quarter grew approximately 20% versus Q4 compared with approximately 22% growth in the prior quarter. When we look at the snapshot of Q1 growth data on a monthly basis, we can start to see the progress of this transition and the impact of our sales team. In January 2022, we saw vial volumes nationally declined 2% compared with December 2021. But in those 7 territories with the G1 OSAM, vial volumes doubled. In February, we had 13 G1 OSAMs in the field until our full deployment mid month, and we saw month-over-month volume growth of 5%. After March 2, we no longer have support from the BI team. We saw 4 consecutive weeks of all-time high vial volumes, culminating in 38% monthly volume growth over February. Just over 70% of our first quarter demand came from community hospitals or clinics with the remainder being academic institutions.

Moving to our account liable performance. As a reminder, one of the reasons for recruiting our own sales team was to bring in extensive account knowledge and provider relationships with the top 100 health care organizations, which treat around 50% of eligible patients with extensive-stage small cell lung cancer. We were pleased to see COSELA trial an uptake and 9 new top 100 organizations during the first quarter to bring the total number of top 100 organizations with COSELA utilization to 53 by end of Q1. And we see an overall reorder rate of around 80% in those 53 organizations. Since the end of the quarter, we were informed that MD Anderson Cancer Center in Houston had added COSELA to formulary, and we have seen their first order come through as well, taking us to 54 of our top 100. Uptake in endorsement from a large organization like MD Anderson has the ability to alter our sales trajectory. However, getting on formulary itself can be just a step in the process. Further physician level education and in-service programs with nursing will follow to ensure success. Several of these top 100 organizations have now only incorporated COSELA into their formularies and EMRs, they have also specified it as the standard of care within their order set for extensive-stage small cell lung cancer. And in these examples, sales growth can occur very rapidly. As a result of this focus on the large organizations with more patient potential, we have not only added breadth with more of the top 100 organizations ordering, but we've been able to shift our priorities to what driving depth of uptake across the many clinics and accounts, which form part of those larger organizations. In fact, our median vial volume in our top 100 organizations ordering has increased by 140% compared with Q4 -- comparing Q4 of 2021 with Q1.

Last year, the proportion of our total business from top 100 organizations hovered between 40% and 50%. And in the most recent months, that proportion has gone almost 60%. So not only have we been adding volume since bringing our new sales team on board, we have done so by accessing more top 100 organizations and by driving additional uptake within those organizations. As a result, we now believe we have more of a platform which can sustain our future growth ambitions. But the next phase of COSELA commercialization underway, we remain confident in the appeal of COSELA in the marketplace. Our new G1 sales team are fully deployed and are benefiting from an increase of in-person engagements as more clinics open up to appointments, programs and exhibits. Brand awareness remains over 80%, and among oncologists who are aware of COSELA, intention to use is over 85%. The half of those respondents saying, they anticipate using COSELA in the next 2 months. We also know that our COSELA messaging is resonating with customers. In Q1, our key messages outperformed the industry average for oncology brand message effectiveness, and of course, reimbursement coverage remains excellent. As a reminder, approximately 60% goes through Medicare and 30% through commercial pay. We've had terrific coverage from the word go with very few payer rejections.

Overall, I'm pleased with the progress we made during Q1 and transitioning to the next commercial phase. We retained our key customers, expanded our base of prescribers and created a platform for strong growth. We continue to see examples of rapid growth in individual accounts, and we have a number of physician advocates who are ready to champion COSELA with their colleagues. We have excellent payer coverage and a strong health economic value proposition. Yet, of course, we believe there is significant unmet need and potential remaining for COSELA. Our sales and marketing teams are focused on promoting the unique benefits of COSELA and ensuring the relevant customer systems and processes that are updated (inaudible). But in addition, recent scientific presentations using real-world data have begun to demonstrate the extent of the unmet need based by our customers and outline the benefits that are seen with COSELA. Going forward, we anticipate more of this real-world data merging with support for COSELA, and we look forward to working with health care providers to ensure that interference can be communicated.

With that, I'll now turn the call over to Raj for medical and clinical update. Raj?

Thanks, Andrew, and good morning, everyone. I want to first discuss some compelling real-world data that we recently presented at the National Comprehensive Cancer Network, or NCCN Conference, on the benefit that COSELA provides patients, and then remind listeners of our current expectations for data from our ongoing Phase II and Phase III trials of trilaciclib. The NCCN data described the substantial burden of myelosuppression and its impact on health care resource utilization and the impact that pretreatment with trilaciclib can have on patients with small cell lung cancer receiving chemotherapy. In the study, the researchers conducted an analysis of 3,277 patients who received chemotherapy alone and 21 patients who received trilaciclib prior to chemotherapy. Including 17, we received commercial trilaciclib in the real-world setting. Utilizing data from the Integra Connect database, the researchers quantify the frequency of Grade 3 or greater myelosuppression hematological adverse events, or HAEs, including neutropenia, anemia or thrombocytopenia and associated health care resource utilization, including supportive care and all-cause hospitalizations. The results were consistent with those from our clinical trials, showing that the use of trilaciclib prior to chemotherapy was associated with an approximately 50% reduction in patients with 1 Grade 3 or greater HAE, and a 74% reduction in the percent of all-cause hospitalizations up to 21 days after treatment compared to patients who received chemotherapy alone.

Among patients with Grade 3 or greater HAEs in 1 blood cell lineage, the use of trilaciclib prior to chemotherapy was associated with an 86% reduction in thrombocytopenia, a 58% reduction in anemia and a 57% reduction in neutropenia compared to patients who did not receive trilaciclib. Regarding patients with Grade 3 or greater HAEs in 2 blood cell lineages, the use of trilaciclib was associated with a 100% reduction from 20% to 0 in patients experiencing anemia and thrombocytopenia, a 76% reduction in both neutropenia and anemia and a 79% reduction in both neutropenia and thrombocytopenia compared to patients receiving chemo alone. The use of trilaciclib prior to chemotherapy eliminated Grade 3 or greater HAEs in all 3 lineages in this evaluation. No patient receiving trilaciclib experienced cytopenia in all 3 lineages compared to 15% of patients who did not receive trilaciclib. Importantly, use of trilaciclib also had a remarkable impact on all-cause hospitalization. No patient receiving trilaciclib prior to chemo was hospitalized between days 8 and 16 after initiation of chemotherapy compared to just over 7% of patients receiving chemo alone. And only 1 patient, or 4.8%, who received trilaciclib was hospitalized between days 1 and 21 compared to 19% of patients who received chemo only. These data are very compelling, and we look forward to presenting more real-world data as they become available.

Regarding our clinical program, I can report that as of today, we remain on track to provide initial results from our ongoing clinical trials in the timelines we have previously disclosed. First, we currently expect initial data from our 3 ongoing Phase II trials in the fourth quarter of this year. These include the following: Overall response rate and mono protection endpoints from PRESERVE 3, our study of trilaciclib with chemotherapy and the immune checkpoint inhibitor, avelumab in patients with bladder cancer receiving first-line treatment. Overall response rate and mono protection endpoints from our trial in 45 triple-negative breast cancer patients designed to evaluate the additive combination potential of trilaciclib with Trodelvy, an antibody drug conjugate, or ADC. An initial data evaluating immune changes in the tumor microenvironment across the cancer immunity cycle from our mechanism of action study designed to confirm our understanding of the immune-based mechanism of action of trilaciclib and its ability to modulate the tumor immune microenvironment. Regarding our ongoing Phase III trials, this has been a challenging time for all companies, including ours, who conduct clinical trials in Ukraine. Our mitigation efforts have included working closely with our CRO partners on business continuity and assistance in relocating some Ukrainian trial patients, thereby allowing them to remain on schedule with these trials.

First, we expect to release initial data, including results from mono protection and overall response rate endpoints from PRESERVE 1, our ongoing line extension trial of trilaciclib in first-line colorectal cancer in the first quarter of next year. We experienced significant acceleration in patient enrollment in this trial during the first quarter, allowing us to complete enrollment of the protocol specified number of patients. However, we are now enrolling additional patients to make up for those from whom we may not be able to collect follow-up data due to the geopolitical situation in Ukraine. Second, we expect initial data, including interim results for overall survival from PRESERVE 3, our first-line triple-negative breast cancer pivotal trial in 170 patients with PD-L1 positive and negative tumors in the second half of next year. This trial is designed to follow up on the exciting statistically significant improvements in survival we observed in our Phase II triple-negative breast cancer trial.

With that, I'll turn the call over to Jen for a review of the financial results for the first quarter of 2022. Jen?

Thanks, Raj, and good morning, everyone. As Will mentioned, full financial results for the first quarter of 2022 are available in this morning's press release and will be in the 10-Q, which we intend to file today after market close. Our total revenue for the first quarter of 2022 was $6.9 million, comprised of net COSELA revenue of $5.5 million and license revenue of $1.4 million. Our license revenue for the quarter was primarily related to clinical trial reimbursement from EQRx and Simcere. Cost of goods sold for the 3 months ended March 31, 2022, was $0.7 million. As a reminder, the majority of the manufacturing costs related to COSELA sales were incurred prior to FDA approval and, therefore, were recorded as R&D expense in prior periods. These costs will continue to impact the presentation of cost of goods sold in future periods until initial pre-launch inventory is depleted.

Our research and development expenses for the first quarter of 2022 were $26.3 million compared to $16.5 million for the first quarter of 2021. The increase in R&D expense was primarily due to an increase in clinical trial spend. Accelerated enrollment in our CRC trial and ramping enrollment in our other Phase III and Phase II trials drives a large increase in R&D costs this quarter. This ramp in the related costs were anticipated. And because of ongoing supply chain issues due to COVID and the mounting concerns in Ukraine in the first quarter, we made the decision to accelerate shipments of supplies (inaudible) to our European sites during this period. As a result, our R&D line for the 2022 year is front-loaded, and the first quarter should be the highest quarter of R&D expense in 2022. We expect R&D to remain above 2021 levels, but decrease as the year goes on.

Our selling, general and administrative expenses for the first quarter of 2022 were $26.7 million compared to $23 million for the first quarter of 2021. Increase in SG&A expenses quarter-over-quarter was largely due to an increase in personnel costs related to the completion of the hiring and deployment of our OSAMs. We expect our quarterly SG&A expenses to vary somewhat quarter-to-quarter, but stay in a range similar to that of Q1 for the rest of 2022. Regarding our cash position, as described in the press release this morning, we ended the first quarter with cash and cash equivalents of $183 million compared to $221.2 million as of December 31, 2021. We expect this to be sufficient to fund our operations and capital expenditures into 2024. This projection of cash runway includes a future drop of an additional $25 million on our debt facility with Hercules, which is currently available to us at our discretion, but has not yet been drawn down. While we may receive a $30 million milestone payment from our partner since the year later this year, conditional upon approval of trilaciclib in China, that payment, along with any future royalties, has not been considered in our current cash guidance.

With that, I'll turn the call back over to Jack for some closing comments. Jack?

Thank you, Jen, Raj, Andrew and Will. And as always, I want to thank people living with cancer for their inspiration. Caring for people living with cancer is at the core of what we do and who we are at G1. We remain driven and focused to ensure that we reach our goals for you and your family.

Before I close the call, I have 2 final topics to cover. First, regarding rintodestrant. As you saw in this morning's press release, after completing our evaluation of partner -- partnering options and data from recent clinical trials in the highly competitive oral SERD space, G1 has made a strategic decision to discontinue the program, including all clinical and partnering efforts in order to focus our full attention on the development and commercialization of trilaciclib. G1 will responsibly wind down all remaining clinical efforts for rintodestrant by the end of this year and revert the rights back to the originator, the University of Illinois. Importantly, for modeling purposes, there are no additional financial obligations due to the originator resulting from the reversion, and there will be no more spend of significance on this program. Second, in terms of guidance. As we have previously communicated, we intend to provide formal guidance as soon as we have enough data on the performance and impact of our G1 sales team to do so. Given that our G1 sales team has only been fully deployed since mid-February, we do not yet have the required data to do so at this point while we intend to provide formal guidance on our August call for the second quarter of the year. As of today, we remain comfortable with analyst consensus for COSELA net sales in 2022, currently sitting just under $42 million.

Before we move on to Q&A, let me just recap some key points that you have heard today. As of the beginning of March, our sales team is in the field in driving usage and our partnership with BI has ceased. We are already seeing evidence of the impact of the sales team on driving growth in their first full month in the field, March volume grew by 38% over February after 2 roughly flat months. We have seen that once an institution tries COSELA, they tend to adopt it. Our reorder rate among the 53 top 100 organizations using the drug remains over 80%, and we continue to successfully shift the proportion of our business towards those top 100 organizations. Our medical team continues to present and publish important new data on trilaciclib, including the first real-world data presented last month at NCCN. These data show that the use of trilaciclib prior to chemotherapy was associated with a variety of measures of improved outcome, including a 74% reduction in the percent of all-cause hospitalizations up to 21 days after treatment compared to patients who received chemotherapy alone. We expect to provide initial results from 3 Phase II trials later this year, the ADC combination, MOA and bladder combination studies and data from our 2 ongoing pivotal trials in CRC and TNBC next year, starting with CRC data in the first quarter of 2023. This means that as of today, over the next 10 months, we expect to announce the results of 4 clinical trials, including 1 pivotal Phase III line extension trial. We are excited about the potential for trilaciclib in all of these settings and are also well along in developing important preclinical data on the potential synergistic effect of trilaciclib on a variety of other novel anticancer modalities.

We look forward to hosting an R&D Day with you later this year to discuss these data ahead of the data readouts from these trials. Thank you for taking the time this morning. We will speak again in this format in August on the second quarter 2022 call.

With that, I will close the call and turn it over to Q&A. Operator, would you please remind our listeners how to ask the question.

(Operator Instructions)

Our first question comes from Gil Blum with Needham & Company.

First of all, congratulations on rolling out your sales force. So maybe a question relating to that. It looks like that you had a pretty big bump in March month-over-month. Do you think this is a bolus? Or should we continue to expect acceleration throughout the year? Is there any way to think about this?

Yes. Thanks, Gil. It's Andrew here. We were very pleased to see that bump in March, and I think it's a product of our sales team being able to access those top 100 organizations being able to bring them on board and also being able to access more (inaudible) there. We have continued to see growth in April, and we'll comment more on second quarter growth as we move through the year. But we do believe, as I said on the call that we've created a platform to generate, Gil, this type of growth going forward.

Okay. Okay. And maybe considering your recent NCCN guideline updates and the data you presented, can you tell us a little bit about the feedback you've been getting from prescribing physicians on this information?

Yes. Raj, you want to take that one?

Yes. So these data were just a real-world data. They were not -- did not result in an update on the guidelines. It was presented at the conference. And the feedback we've gotten has been very positive because really it's the first real-world evidence showing that COSELA works as we expected it to work and similar to what we saw in our clinical trials. And particularly, we were pleased to show the multi-lineage benefits.

All right. And maybe a last one, considering we're getting closer to pivotal readout for the colorectal cancer study, and that is a much larger indication. How do you think about a potential launch there? Do you expect synergies with small cell? Or would there be required a big expansion of the sales force? How should we think of that?

Thanks, Gil. At this point, we're still evaluating what that go-to-market strategy would be. I do think that our existing sales team has room in the bag to be able to incorporate certainly several of our future indications into their capability today, but we'll evaluate that as we get closer to a potential registration.

Right. And maybe a last one. Now with the discontinuation of rinto, how should we think from a cost-saving perspective on OpEx looking forward?

Yes. Gil, it's Jen. I think -- as I described, I think you -- we're really expecting this R&D level to be the highest of the year for this quarter, though I think you should see a decrease of that over the year. And yes, really, the bulk of activity we're in the middle of it right now. So we're seeing a very high level currently.

And I think specifically to rinto, Gil, we really look at that as de minimis. What small amount was being spent on it will stop by the end of this year, just so we can conclude the normal things that you have to do to wind up the studies that were existing on this, but it's de minimis overall.

Our next question comes from the line of Kaveri Pohlman with BTIG.

My first question is for colorectal cancer. I believe you'll gather myeloprotection benefit data faster than the survival data. Does it make sense to submit an NDA based on that data and file later for anti-tumor activity?

Kaveri, this is Raj. I can answer that. Yes, that's exactly our intention. So when the myeloprotection data are available in the first quarter of next year, assuming they are positive, we will have discussions with the agency about filing.

Great. And then about -- regarding bladder cancer study. So yes, I understand the readout this year will mostly focus on ORR. But any thoughts on durability or survival? Perhaps, you could just help us understand what duration of response and/or survival, which is the primary endpoint here is clinically meaningful?

Yes, Raj here again. I think since the trial is currently ongoing, as you know, the durability and PFS data, particularly PFS as the primary readout, will require a longer follow-up. So we reported the early data that we have, but expect more meaningful data on PFS and durability next year.

Our next question comes from the line of Ed White with H.C. Wainwright.

So the first one is just on gross to net, if you could let us know what that number is. And how -- you mentioned reimbursement. I'm just wondering more about reimbursement at these top 100 accounts, the one's that you haven't penetrated yet, has reimbursement been an issue? Or are there any issues with those other accounts that you haven't been able to penetrate yet?

It's Jen. On gross to net, we're in the range I've given previously, mid- to high teens. We're continuing to believe that, that will hold going forward. So I'd just reiterate that guidance that we gave on a previous call.

Yes. And I think on the reimbursement, so far the payer reimbursement for COSELA has really been excellent right from launch, as I said on the call. In terms of whether it constitutes a barrier of top 100 that have adopted, I would say that, that is not a barrier. I think there's an opportunity with many of those top 100 to actually educate them on the health economic, value propositions that our payers that gravitate to early in the adoption cycle, and that argument has only got more compelling. And I think with these real-world data continues to be compelling. So we anticipate more of those top 100s coming on board as we went forward. And in fact, we do continue to see top 100 accounts come on board regularly, as I just outlined early on.

Great. And one last question for you, I'm just curious, is the 34 sales reps that you currently have, are you rightsized now? Or will you be adding more later in the...

Yes. Right now, we are fully deployed with the 34. We don't have an intention to expand that based on the kind of potential that we have. And I got to say, those 34 individuals are very, very capable people, and I think they have a lot of potential to deliver for the business.

Our next question comes from the line of Anupam Rama with JPMorgan.

What portion of COSELA detailing is in-person versus virtual? And how is this dynamic sort of trended over the first 4 months of the year with the sales force expansion? And have you seen any difference in uptake, if the primary detailing is in-person versus virtual?

Yes, we now see pretty much 50% of our details are in-person, which is great, and that has progressed in Q1 over previous quarters. Now obviously, there's the background trend of COVID there.We've got the changeover of our sales team going on as well. So -- but we do see account access opening up as well. Many of our top accounts that were really closed down to everyone, including, in many cases, caregivers of patients or family members of patients, they are -- they have set a calendar for when they are opening up to those in-person interactions as well. So I do think this will continue to get better. And as I outlined on the call, it's not just those in-person face-to-face contacts, it's also programs and (inaudible) opportunities to make sure that folks are educated on how to administer the product as well as exhibits that customers are now attending as well.

And difference between the two. Between live or virtual obviously.

Okay. Yes. In terms of -- we haven't really analyzed the difference and impact between live and virtual. So I don't really have data to back that up. But I would say that the efficiency of the live interaction is certainly much higher because when you're in the office, you do get the opportunity just to see multiple stakeholders at the exact same time and potentially have them in the room together. So although I don't have data to back up the effectiveness, I'm pretty sure it's a much more efficient method.

Our next question comes from the line of Tony Butler with ROTH Capital.

This is (inaudible) on for Tony. My question is on small cell lung cancer patients. I wonder if you can shed some light on the proportion of patients completing all of the chemo doses. And then perhaps, it would be also great to know if you could tell us the average number of COSELA doses that each patient get it front line, second line, third line settings?

Yes, thanks for the question. I can give you some of the information I have, which is that over 90% of our patients are first line. So the vast majority are first line. And on average, we anticipate that they probably go through about 20 vials of COSELA. So [24] would be the full labeled dosing for first-line patients. And on average, I would estimate that we probably see about 20. So hopefully, that helps there. I think in terms of the more detailed information that you're looking for, I don't have that ready to hand. I do think that as we collect more real-world information and we see the real-world information start to reflect what we saw in the clinical trials, it will be interesting to form more of a picture of them.

(Operator Instructions)

Our next question comes from the line of Troy Langford with Cowen.

Congrats on all the progress. This is Troy on for Joe. I just have a couple of quick questions around the COSELA launch. So first of all, you all mentioned a couple of metrics to measure depth of uptake among the several key accounts on the call. So do you have a target number that you hope to achieve in this regard? And I guess how much more room do you think you will have to grow these numbers? And then I have a follow-up.

Yes. So right now in our top 100 organizations, I would estimate -- and this is really an estimate because it relies on a lot of kind of calculation. The estimate is about 15%. And so there's clearly a significant growth there. Now why is it only 15%? Well, in some of those top 100 organizations where we have been put in an advantageous place in the order sets, we're actually seeing sets of utilization that has to be 2/3 to almost 100%, I would guess. It would really be the exception that a patient would not be given COSELA in those organizations. And when that happens, we see very, very rapid adoption. But in other circumstances, obviously, we have just started to come on board. So I just talked about MD Anderson, we received their first order. We're on formulary. And obviously, their (inaudible) right now is low because they're right at the beginning of the curve uptake. So the -- that kind of average (inaudible) of 15% really represents kind of skewed distribution. But clearly, there is potential when an organization uses COSELA, sees the benefits of COSELA for them to put us in a position where it is the expectation that it is used with every eligible extensive-stage small cell lung cancer patients. So our goal there would be to make it the exception for COSELA was not used.

Okay. Great. That's really helpful. And then just on the COSELA sales force. So now its launched, what additional levers do you all think you have to -- that you can pull to increase COSELA adoption?

Yes. So right now, what I'm really excited about actually is the potential for peer-to-peer exchange because as we've developed more COSELA (inaudible) and I thought to say, physicians actually call me through the switch board to campaign for more COSELA uptake in their accounts. And I've to tell them that we're doing everything we can and that we appreciate their support in doing it. But as our representatives, as our OSAMs get out there, we see that they develop those physician champions and those physicians decide to communicate their experience to the other physicians in the account and as we see nurses have the same experience, the (inaudible) have the same experience, making sure that, that peer-to-peer exchanges happening becomes really a critical lever for us to fill going forward.

Our next question comes from the line of Tony Butler with ROTH Capital.

This is (inaudible) again, and this one is for Jennifer. It's possible I missed your point about the 2022 R&D expenses being front- loaded. Could you please clarify?

Sure. So our number for first quarter, this is our highest level of activity in our trials. As Raj mentioned, our CRC trial, we were fully enrolled for our initial number of patients that happened earlier in the quarter than we anticipated. We're also adding additional patients for Ukraine. But on top of that, we did anticipate supply chain issues. Just from COVID and then also anticipating the Ukraine conflict, we wanted to go ahead and move supplies into the European sites. So we did front-load a lot of those costs in the first quarter as well. So because of those 2 things, we really anticipate the first quarter to be the heaviest spend in R&D. We would still be above 2021 levels, obviously, for R&D because we have all of these trials ongoing, but we should see a decrease throughout the year. Hope that's helpful.

I'm showing no further questions at this time. I'd like to turn the conference back to Jack Bailey, CEO.

Thank you, Abigail. As always, we look forward to keeping you all updated on our progress as we go forward. Certainly, thank you for joining us today, and we just hope you all stay well. We look forward to being in touch soon. Thank you.

This concludes today's conference. Thank you for participating. You may now disconnect.