Q1 2024 G1 Therapeutics Inc Earnings Call
Okay.
Operator: Good day, and thank you for standing by. Welcome to the G1 Therapeutics First Quarter 2024 Financial Results.
Speaker Change: Good day, and thank you for standing by and welcome to the G. One therapeutics first quarter 2024 financial results. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During this session you will need to press star one on your telephone.
Operator: At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Will Roberts. Please go ahead.
Speaker Change: Here, an automated message advising and as race to withdraw your question. Please press star. One again, please be advised that today's conference is being recorded I would now like to hand.
William C. Roberts: Conference over to your speaker today, well Roberts. Please go ahead.
William C. Roberts: Thank you, Victor. Good morning, everyone, and welcome to the G1 conference call to discuss our first quarter 2024 financial results and business updates. 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 for the 2024 first quarter, including an update on our commercial progress and clinical programs for that period with Cosella, 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 topatechin-containing regimen for extensive-stage small-cell lung cancer.
William C. Roberts: Thank you Victor good morning, everyone and welcome to the G. One conference call to discuss our first quarter 2024 financial results and business update.
William C. Roberts: The press release on these financial results was issued this morning and can be found in our news section of our corporate website, you want therapeutics Dot com.
On this morning's call the team will provide a business overview of the 'twenty 'twenty four first quarter, including an update on our commercial progress and clinical programs in that period with the seller.
William C. Roberts: Which is approved and commercially available to decrease the incidence of chemotherapy induced mouse depression in adult patients who are administered prior to our platinum it took us I containing regimen or cup of tea can containing regimen for extensive stage small cell lung cancer.
William C. Roberts: Q&A session will follow the prepared remarks.
William C. Roberts: A Q&A session will follow. 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 risk and uncertainty that could cause actual results to differ materially from those expressed in and replied to 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 1st, 2024.
William C. Roberts: 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.
William C. Roberts: Such statements represent managements judgment as of today enable of risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements.
William C. Roberts: 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 web site.
William C. Roberts: Any forward looking statements represent our views as of today May <unk> 2024.
William C. Roberts: Joining me on the call today are Jack Bailey, our Chief Executive Officer, Andrew Perry, our Chief Commercial Officer, Dr. Raj Malik, our Chief Medical Officer, and John Umstead, our Chief Financial Officer. I'll now turn the call over to Jack. Okay?
Speaker Change: Joining me on the call today are Jack Bailey, our Chief Executive Officer, Andrew Perry, Our Chief Commercial Officer, Dr. Raj Malik Chief Medical Officer and.
Speaker Change: John <unk>, our Chief Financial Officer.
I'll now turn the call over to Jack <unk>.
John E. Bailey: Thanks, Will. Good morning, everyone, and thank you for joining us on the call today. From a commercial perspective, we continue to identify and execute on growth opportunities for Cosella. However, as you will hear from Andrew, our biofueling growth in the quarter was 4% over the fourth quarter of 2023 due to some challenges that he will speak to shortly. But as a result of the impact of the actions we've taken and the more recent sales trend, we remain confident in our 2024 net sales guidance of $60 to $70 million.
John E. Bailey: Well good morning, everyone and thank you for joining us on the call today.
Andrew Perry: Commercial perspective, we continue to identify and execute on growth opportunities for cross sell as you will hear from Andrew our bio volume growth in the quarter was 4% over the fourth quarter of 2023 due to some challenges that he will speak to shortly.
Andrew Perry: As a result of the impact of the actions we've taken.
Speaker Change: Recent sales trends, we remain confident in our 2024 net sales guidance of $60 million to $70 million.
John E. Bailey: We are committed to expanding usage of Casella in its first syndication in extensive stage small cell lung cancer and, assuming we continue to achieve our internal forecast, expect to drive G1 to profitability and cash flow positivity later next year. Now, as you'll hear from Raj, we also remain focused on the opportunity for category leadership across the spectrum of triple-negative breast cancer. And in that regard, we look forward to two important data readouts over the coming months.
We are committed to expanding usage of <unk> in its first indication in extensive stage small cell lung cancer and assuming we continue to achieve our internal forecast expect to drive <unk> to profitability and cash flow positivity later next year.
Speaker Change: And also you'll hear from Raj. We also remain focused on the opportunity for category leadership across the spectrum of triple negative breast cancer and in that regard look forward to two important upcoming data readouts over the coming months.
John E. Bailey: First, we've shown promising results thus far in our ongoing phase 2 trial when Trilocyclib is combined with ADC-Sasatuzumab-Covitecin, including meaningful improvements in median overall and 12-month survival. As you saw this morning, we are excited to provide updated results in a poster at ASCO 2024 in early June. Next, if the final results from our ongoing Phase 3, Preserve 2 trial of trialocyclibra are positive, they would be amongst the most significant data generated in the first line metastatic setting across PD-L1 status and a compelling data set for people living with this extremely aggressive disease.
Speaker Change: First we've shown promising results, thus far and are on.
Speaker Change: Ongoing phase II trial, when trial of <unk> combined with the ADC substitution back over to Jim <unk>.
Speaker Change: <unk> meaningful improvement in median overall.
Speaker Change: 12 months survival.
Speaker Change: As you saw this morning, we are excited to provide the updated results in a poster at Astro 2024 in early June.
Speaker Change: Next if the final results from our ongoing phase III <unk> preserved to trial a trial in <unk> positive they would be amongst the most significant data generated in the first line metastatic setting across PDL one status.
Speaker Change: Compelling data set for people living with this extremely aggressive disease.
John E. Bailey: As Raj will discuss, based upon recent interactions with the FDA regarding the inclusion of events from patients enrolled in Ukraine, these results are now expected late in the second quarter of this year. Finally, as you saw in a press release earlier today, we've out-licensed the global rights to liracyclib, excluding the Asia-Pac region, to an early-stage transomics company called PepperBio. Through this transaction, Pepper Bio gains exclusive rights to develop, manufacture, and commercialize Liracyclib in those areas for all indications except for certain radio-protected uses.
Speaker Change: As Raj will discuss based upon recent interactions with the FDA regarding the inclusion of events from patients enrolled in Ukraine. These results are now expected late in the second quarter of this year.
Speaker Change: Finally, as you saw in our press release earlier today, we've out licensed the global rights to literal cycling, excluding the Asia Pac region. Two in early stage trend Zomax company called Pepper buyout.
Speaker Change: Through this transaction pepper biogas exclusive rights to develop manufacture and commercialize little cyclic in those areas for all indications except for certain radio protectant UCITS.
Speaker Change: <unk> identified CDK four six as a key pathway for hepatic cellular carcinoma through their proprietary data platform.
Speaker Change: Mineral cyclic will now be their lead clinical stage asset to complement our early stage discovery pipeline.
John E. Bailey: They've identified CDK4-6 as a key pathway for hepatocellular carcinoma through their proprietary data platform. Lerocyclib will now be their lead clinical stage asset to complement their early stage discovery pipeline. On today's call, Andrew will provide an update on our recent commercial efforts, and Raj will provide the status of our ongoing TNDC trials and remind you of the timing of the data from each. John will then provide the financial results for the quarter, including our revenue, expense, and cash expectations, along with a review of the financials associated with the PepperBio transaction. Finally, I'll be back for some concluding comments. With that, I'll turn the call over to Andrew. Thank you, Josh. I'm glad to take this opportunity.
Speaker Change: On today's call Andrew will provide an update on our recent commercial efforts Raj will provide the status of our ongoing CNBC trials and reminds me of the timing of the data from each.
Ron will then provide the financial results for the quarter, including our revenue expense and cash expectations, along with a review of financials associated with the pepper buyout transaction finally, I'll be back for some concluding comments with that I will turn the call over to Andrew.
Andrew Perry: Thank you, Jack. I'm glad to take this opportunity to update you on our first quarter 2024 performance, which was a quarter where we made significant headway in parts of our commercial business, although in other areas, we also faced some short-term challenges. Our goal in Q1 was to build on the strong double-digit quarter-over-quarter growth which we delivered in Q4 of 2023 and to set up growth opportunities which will help us deliver our full year goal.
Andrew Perry: Thank you Jonathan I'm going to take this opportunity to update you.
Andrew Perry: On our first quarter 2020, or performance, which was a quarter, where we made significant headway in parts of our commercial business.
Andrew Perry: Other areas. We also faced some short term challenges.
Andrew Perry: Our goal in Q1 was to build on the strong double digits quarter over quarter vital growth, which we delivered in Q4 of 2003 and.
Andrew Perry: And that's helped growth opportunities, which will help us deliver our affiliate your goals.
Andrew Perry: We were largely successful in these objectives, with some regional and segment variants, driven by some executional headwinds, which we took actions to address within the quarter. And while our vial volume grew, it should have been closer to double digits this quarter if we had executed better in several areas. As a reminder, in first-line extensive stage small cell lung cancer, the maximum duration of chemotherapy is less than 90 days.
Andrew Perry: We were largely successful in these objectives with some regional and segment driven.
Andrew Perry: Driven by some execution headwinds, which we took actions to address within the quarter.
Andrew Perry: And finally, our final volume growth it should have been closer to double digits. This quarter, if we have executed better in several areas.
Andrew Perry: As a reminder, in first line extensive stage small cell lung cancer, a maximum duration of chemotherapy is less than 90 days.
Andrew Perry: So our quarterly growth relies on building a new patient base every quarter and then creating additional breadth and depth with newer existing accounts in order to grow. Beginning with sales volume, we ended Q1 with 4% overall volume growth compared with Q4 2023. The low growth was attributable to three factors. First, we added too few new patients over the holiday period of December into January, which then impacted the number of continuing patients through the course.
Andrew Perry: Quarterly growth relies on building a new patient mix every quarter, and then creating additional pad and pattern with new or existing accounts in order to grow.
Andrew Perry: Beginning with sales volume, we ended Q1 with 4% overall, while volume growth compared with Q4 2023.
Andrew Perry: Loan growth was attributable to three factors first we added two new patients over the holiday period in December and to January <unk>.
Andrew Perry: A number of continuing patients through the park.
Andrew Perry: Secondly, we had a slow start with several large customers, primarily in the South East. These customers typically comprised a fifth of our volume, and their orders were below the levels we would expect in the first part of the quarter. Thirdly, three of our contracted customer networks performed below expectations. In each case, I will outline the actions we took to address the executional gap.
Andrew Perry: Secondly, we have a slow start with several large customers primarily in the southeast.
Andrew Perry: Customers typically comprise of our volume and then orders were below the levels. We would expect in the first part of the quarter.
Andrew Perry: Currently three of our contracted customer networks performed below expectations in each case.
Andrew Perry: Actions, we took to address the execution gaps.
Andrew Perry: Firstly, we deployed three new sales representatives at the beginning of January. Secondly, we invested in a significant digital advertising push with increased display ads in high-potential geographies, including the South East, as well as a digital and field campaign focused on driving depth with existing Cosella prescribers and customers affiliated with contracted accounts. Thirdly, we met with senior management at our large customers in the southeast to address any educational or operational gaps which could be slowing sales growth.
Andrew Perry: Firstly, we deployed three new sales representatives at the beginning of January.
Andrew Perry: Secondly, we invested in a significant digital advertising push with increased display ads and high potential geographies, including the southeast as well as the digital infield campaign focused on driving pads with existing prescribers and customers affiliated with contract with the clients.
Andrew Perry: Currently we met with senior management at our large customers on the southeast to address any educational our operational gaps, which could be slowing sales growth.
Andrew Perry: Finally, we enhanced several of our existing contracts and executed two new community network contracts, including one in February which has been immediately successful and is significantly growing volume. The slow start to the year in the South East was offset by almost 30% growth in our West region, which comprises around a quarter of our volume. Three of six territories in the West region grew more than 50% in the quarter.
Andrew Perry: Finally, we enhanced several of our existing contracts and execute the two new community network contracts, putting one in February which has been immediately successful in significantly growing volume.
Andrew Perry: The slow start to the year in the southeast was offset by almost 30% growth in our west region, which comprises.
Andrew Perry: Prizes around a quarter of our volume.
Andrew Perry: Ex territories in the West region grew more than 50% of Macquarie.
Andrew Perry: As a result of this success, we added an additional headcount in our West region, focused on the Texas market, which continues to represent an enormous opportunity. We also saw double-digit growth in the customers covered by our expanded strategic accounts function, which combines specialist knowledge of oncology pharmacy with extensive health systems experience. Those customers grew over 20% during the quarter and now comprise roughly 20% of our overall volume. Going into Q2, we added an additional set of customers to their mix where we believe this team can accelerate systematic adoption.
As a result of the success, we added an additional head count in our West region focused on the Texas market, which continues to represent an enormous opportunities.
Andrew Perry: We also saw double digit growth in our customers covered by our expanded strategic perhaps function, which combines specialist knowledge of oncology pharmacy with extensive health systems experience.
Andrew Perry: Most customers grew over 20% during the quarter and now comprise roughly 20% of our overall volume.
Andrew Perry: Going into Q2, we added an additional set of customers severe mix, where we believe athene can accelerate system.
Andrew Perry: Focusing on the top 100 customer organizations, which represent around half the volume opportunity in the market, we added two new top 100 customers during Q1 and another one in April, meaning 78 of the top 100 have ordered Coacella launch today. 63 customers ordered during Q1, which jumped up from 56 in Q4, the highest number of top 100 customers to order in a quarter since launch. Our proportion of business in the Top 100 stayed similar to Q4 at 57%.
Andrew Perry: <unk>.
Andrew Perry: Focusing on the top 100 customer organizations, which represent around half the volume opportunity in the market.
Andrew Perry: The two new top 100 customers during Q1 and another one in April meaning 78 of the top 100 of <unk> cel launch to date.
Andrew Perry: 63 top 100 customers ordered during Q1, which jumped up from 56 in Q4, our highest number of top 100 customers to order in a quarter since launch.
Andrew Perry: Our proportional business in top 100 stay similar to Q4 at 57%.
Andrew Perry: Across our business, we added over 50 new accounts in total, which is similar to the last few quarters. Our estimate of CoStella patient share remains around 13% in the first-line market, demonstrating that there remains significant opportunity for growth. Moving into Q2, we saw a return to stronger growth in March, and April has been our highest month for both volume and X-Factory sales launched to date. The large customers in the South East, who started slow in Q1, are back to growth at over 30% quarter to date.
Andrew Perry: Across our business, we added over 50, new accounts in total which is similar to the last few quarters.
Our estimate of cross sell of patient share remains around 13% in the frontline market demonstrating that there remains significant opportunity for growth.
Andrew Perry: Moving into Q2, we saw a return to stronger growth in March and April has been our highest month for both volume and ex factory sales launch to date.
Andrew Perry: Large customers in the southeast who started slow in Q1 are back to growth of over 50% quarter to date on our contracted business is also growing in double digits quarter to date.
Andrew Perry: And our contracted business is also growing double digits quarter to date. With the actions we have taken with three new top 100s and, for the first time, more than 60 top 100s using Coacella during the quarter, we're confident in continued growth and our guided product revenue target. I'll now pass the call to Raj.
Andrew Perry: With the actions we have taken with three new top 100 and for the first time more than 60 top 100, Skus you can sell it during the quarter were confident in continued growth and our guided product revenue target.
Rajesh K. Malik: Thanks Andrew and good morning everyone. Today I will provide the status of our ongoing clinical trials and our expectations for the timing of results. For our Phase III-Preserve II trial in combination with gemcitabine and carboplatinum... As we mentioned on our last call, the boundary hazard ratio for a positive result at the final analysis is 0.67. As a reminder, the hazard ratio for the pembrolizumab arm of Keynote 355, the Intent-to-Treat or ITT population was 0.89, and the FDA-approved PD-L So a positive result in PRESERVE-2 would mark the biggest improvement in overall survival to date in first-line metastatic triple negative breast cancer.
Andrew Perry: Now pass the call to Raj, Thanks, Andrew and good morning, everyone. Today, I will provide the status of our ongoing clinical trials and our expectations for the timing of results.
Raj: Our phase III preserve two trial in combination with Gemcitabine and Carboplatin as.
As we mentioned on our last call the boundary hazard ratio for a positive result at the final analysis of 0.67.
Raj: As a reminder, the hazard ratio for the parallelism at our keynote <unk> five and the intent to treat or ITT population was <unk> 89.
And the FDA approved PD Lone positive population was <unk> 73.
Raj: So a positive result, and preserve to what Mark the biggest improvement in overall survival to date in first line metastatic triple negative breast cancer.
Rajesh K. Malik: Regarding this trial, we recently received feedback from the FDA recommending that the final analysis should be conducted in the ITT population, which includes the survival events from patients that were enrolled in the Ukraine, rather than the modified IQT population that would have excluded them. Subsequent to our February financial results call, we reached agreement with the FDA on the statistical methodology for the overall survival analysis incorporating these events. As a result, we have amended the protocol to account for these changes, and we now expect that the final overall survival analysis will be conducted at the end of the second quarter of 2024.
Raj: Regarding this trial, we recently received feedback from the FDA recommending that the final analysis will be conducted in the ITT population.
Raj: Which includes the survival events from patients that were enrolled in the Ukraine.
Raj: Rather than the modified ITT population that would have excluded them.
Raj: Subsequent to our February financial results call, we reached agreement with the FDA.
Raj: On the statistical methodology for the overall survival analysis, incorporating these events.
As a result, we have amended the protocol to account for these changes and we now expect that the final overall survival analysis will be conducted at the end of the second quarter of 2024.
Rajesh K. Malik: We will announce the top-line results via press release and, if positive, look forward to a more robust presentation of results at a medical meeting later in 2024. Assuming we achieve the overall survival endpoint, we will meet with the FDA to discuss the results and our plans for a supplemental NDA filing as soon as possible thereafter. Next, regarding our Phase 2 trial of trialocycline in combination with the TROP2 antibody drug conjugate sasitizumab, we're happy to announce this morning that the updated results have been accepted for a poster presentation at ASCO in early June.
Raj: We will announce the topline results via press release, and a positive look forward to a more robust presentation of our results at a medical meeting later in 2024.
Raj: Assuming we achieved the overall survival endpoint, we will meet with the FDA to discuss the results and our plans for a supplemental NDA filing.
Raj: As soon as possible thereafter.
Raj: Next regarding our phase II trial of <unk> in combination with the trop two antibody drug conjugates substance use and that are.
We're happy to announce this morning that the updated results have been accepted for a poster presentation at <unk> in early June.
Rajesh K. Malik: As a reminder, in January, we described promising initial data, including meaningful improvements in median overall survival and 12-month survival, among patients receiving trialocyclib in combination with sasituzumab compared to historical results for the ADC alone, and we are excited to update these initial results at ASCA. Our measure of a successful trial would be an approximately three months or more improvement in median overall survival over historical results with sasatu We believe that such a result would be of interest to companies developing Trope 2 ADC, who are pursuing development partnerships with us to move this combination into pivotal trials for triple negative breast cancer and beyond.
Raj: As a reminder, in January we described promising initial data, including meaningful improvements in median overall survival and 12 month survival.
Raj: Among patients receiving <unk> in combination with <unk> compared to historical results of the ADC alone.
Raj: And we are excited to update these initial results at <unk>.
Raj: Our measure of a successful trial will be in approximately three months or more improvement in median overall survival over historical results for <unk> on that.
Raj: We believe that such a result would be of interest to companies developing trop two adcs.
Raj: Pursuing development partnerships with us to Mount this combination into pivotal trials.
Raj: In triple negative breast cancer and beyond.
Rajesh K. Malik: We are also very interested in exploring efficacy in various subsets of patients, such as those treated with prior checkpoint inhibitors or CDK4-6 inhibitors. These types of exploratory analyses, which will be included in the ASCO results, could be helpful in designing future clinical trials of tralocycline plus trope 2 ADC combination. We look forward to both readouts as positive results from these trials would enable us to build category leadership in triple negative breast cancer. With that, I'll turn the call over to John for an update on our financial results. John? Thanks, Raj. Good morning, everyone.
Raj: We're also very interested in exploring efficacy in various subsets of patients such as those treated with prior checkpoint inhibitors or CDK four six inhibitors.
Raj: These types of exploratory analyses, which will be included in the actual results could be helpful. In designing future clinical trials of <unk> plus trop two ADC combinations.
Raj: We look forward to both Readouts as positive results from these trials will enable us to build category leadership in triple negative breast cancer.
Raj: With that I'll turn the call over to John for an update on our financial results John.
John W. Umstead: Thanks, Raj, and good morning, everyone. As Will mentioned, full financial results for the first quarter of 2024 are available in this morning's press release, and we'll be in the 10Q, which we expect to file after market close. Net sales of Cosella were $14.1 million for the first quarter of 2024. This compares favorably to $10.5 million in net sales of Cosella in the first quarter of 2023, representing an increase of 34%. Our total revenue for the first quarter of 2024 was $14.5 million, which compares favorably to $12.9 million in the first quarter of 2023.
John: Thanks, Raj and good morning, everyone as will mentioned full financial results for the first quarter of 2024 are available in this morning's press release and will be in the 10-Q, which we expect to file after market close.
John: Net sales kassala were $14 $1 million for the first quarter of 2024.
John: This compares favorably to $10 $5 million net sales or to sell it in the first quarter of 2023, representing an increase of 34%.
John: Our total revenue for the first quarter of 2024 was $14 5 million, which compares favorably to $12 9 million in the first quarter of 2023.
John W. Umstead: Our total operating expenses were $23.5 million in the first quarter of 2024 compared to $38.7 million for the same period in 2023, comprised of the following: $1.1 million in cost of goods sold compared to $1.5 million for the same period in 2023. $7.3 million in research and development expenses compared to $15.5 million for the same period in 2003. This change was primarily due to continued wind-down of previously completed studies. Lastly, $15.1 million in selling, general, and administrative expenses compared to $21.8 million for the same period in 2023. The decrease in SG&A expenses was primarily due to decreases in personnel costs and medical affairs and continued optimization of our commercialization activities.
John: Our total operating expenses were $23 $5 million in the first quarter of 2024 compared to $38 7 million for the same period in 2020 comprised of the following.
John: $1 $1 million and cost of goods sold compared to $1 $5 million from the same period in 2023.
John: Seven $3 million in research and development expenses compared to $15 $5 million from the same period.
John: This change was primarily due to continued wind down of previously completed studies.
John: And lastly, $15 $1 million and selling general and administrative expenses compared to $21 8 million for the same period in 2023.
John: The decrease in SG&A expense was primarily due to decreases in personnel costs and medical affairs and continued optimization of our commercialization activities.
John W. Umstead: Regarding our cash position, we ended the first quarter with cash, cash equivalents, and marketable securities of $65.2 million, compared to $82.2 million as of December 31, 2023. It is important to note that this current cash balance of $65.2 million reflects an $8.7 million pay-down of our debt facilities during the quarter due to the borrowing-based limit tied to our trailing three-month revenue. However, by reducing our principal, we will realize cash interest savings of almost $1 million this year.
John: Regarding our cash position, we ended the first quarter with cash cash equivalents in marketable securities of $65 2 million compared to $82 $2 million as of December 31, 2023.
John: It is important to note that this current cash balance of $65 2 million reflects an $8 $7 million paydown of our debt facilities during the quarter due to the borrowing base lending tied to our trailing three months revenue.
John: However by reducing our principal we will realized cash interest savings this year of almost $1 million.
John W. Umstead: Based on our current revenue projections, we do not anticipate having any further pay-downs until required principal payments begin in December of this year. Absent this pay-down, our operational cash burn totaled approximately $8 million for the quarter.
John: Based on our current revenue projections, we do not anticipate having any further paydowns until required principal payments began in December of this year.
John: Absent this paydown, our operational cash burn totaled approximately $8 million for the quarter.
John W. Umstead: Next, regarding our revenue, expense, and cash runway guidance for 2024. As previously stated, we remain confident in our net sales revenue guidance of between $60 million and $70 million for 2024. There was no change to our 2024 Gross to Net Expense Percentage Estimates. Additionally, we anticipate receiving a $5 million milestone payment from Junor in the back half of 2024 following their commercial approval of Leracyclib in China. If approved, we would begin receiving royalties on sales of larycyclops in the territory.
John: Next regarding our revenue expense and cash runway guidance for 2024.
John: As previously stated we remain confident in our net sales revenue guidance of between $60 million and $70 million for 2024 there.
John: And there is no change to our 2020 for gross to net expense percentage estimates.
John: We anticipate receiving a $5 million milestone payment from <unk> in the back half of 2024 following their commercial approval of <unk> in China.
John: If approved we would began receiving royalties on sales of <unk> cycled in the territory.
John W. Umstead: Regarding expenses for 2024, we currently expect operating expenses to be 15 to 20 percent lower than those of 2023. This is driven by reduced R&D spend in addition to continued optimization of our cost structure following previously targeted headcount reductions while continuing to invest in the commercial organization.
John: Regarding expenses for 2024, we currently expect operating expenses to be 15% to 20% lower than that of 2023.
John: This was driven by reduced R&D spend in addition to continued optimization of our cost structure. Following previously targeted headcount reductions while continuing to invest in the commercial organization.
John W. Umstead: We continue to expect a 2024 year-end cash, cash equivalents, and marketable securities balance in the range of $50 to $60 million. And based on the foregoing, we expect that our cash runway will take us into the third quarter of 2025. This cash runway includes anticipated TNBC filing and launch-related costs but does not include any TNBC-associated revenue. Finally, Jack mentioned earlier in the call that we have out-licensed Leracyclib to PepperBio, excluding the Asia-Pac countries which were previously out-licensed to Genore.
John: We continue to expect a 2020 for year end cash cash equivalents in marketable securities balance in the range of $50 million to $60 million.
John: And based on the foregoing, we expect that our cash runway will take us into the third quarter of 2025.
John: This cash runway includes anticipated CNBC filing and launch related costs or does that include any knbc associated revenue.
John: Finally, Jack mentioned earlier in the call that we have out licensed layer cycling to pepper buyer, excluding the Asia Pac countries, which previously out licensed two gene or <unk>.
John W. Umstead: G1 expects to receive up-front payments of mid-single-digit millions within 12 months, and we are eligible to receive up to $135 million upon achievement of certain development and commercial milestones. In addition, we will receive a double-digit royalty on aggregate annual net sales of Lericycle. With that, I'll turn the call back over to Jack for some closing comments.
John: <unk> expects to receive upfront payments of mid single digit millions within 12 months and we are eligible to receive up to $135 million upon achievement of certain development and commercial milestones.
John: In addition, we will receive a double digit royalty on aggregate annual net sales cycle.
John: With that I'll turn the call back over to Jack for some closing comments. Thank.
John E. Bailey: Thank you, John, Raj, Andrew, and Will. And, as always, I also want to recognize the cancer community. We are thankful for the opportunity to be a part of your journey.
John E. Bailey: Thank you John Raj, Andrew and well it is always I also want to recognize the cancer community. We are thankful for the opportunity to be a part of your journey.
John E. Bailey: Now, as you heard from Andrew, we are encouraged by the continued growth and acceptance of Coacella in our Top 100 accounts, the return to expected ordering patterns in April by some large customers in the Southeast after a slower than expected first quarter, and the immediate impact of our strategic accounts function. But while our commercial team continues to execute on growing the product in its first indication, our corporate focus must stay on the upcoming clinical results from our ongoing TMDC trials that, if positive, could build category leadership in triple negative breast cancer. To that end, we look forward to presenting the mature survival results from our Phase 2 trial of trilocyclib in combination with the Trope 2 ADC Sousatusamab at ASCO in June.
John E. Bailey: Now as you heard from Andrew we are encouraged by the continued growth and acceptance of consolidate our top 100 accounts. The return to expected ordering patterns in April by some large customers in the southeast after a slower than expected first quarter and the immediate impact of our strategic accounts functions.
John E. Bailey: But while our commercial team continues to execute on growing the product in its first indication our corporate focus must state on the upcoming clinical results from our ongoing TWC trials that are positive to build category leadership in triple negative breast cancer.
John E. Bailey: And we look forward to presenting the mature survival results from our phase II trial of <unk> in combination with the trop two ADC substitutes a map at <unk> in June we believe that an improvement in overall survival of approximately three months or more due to the addition of <unk> to that ADC would be.
John E. Bailey: We believe that an improvement in overall survival of approximately three months or more due to the addition of trilocyclib to that ADC would be a striking success and would allow us to pursue development partnerships to move the combination of trilocyclib and Trope 2 into pivotal trials. Furthermore, we expect final results from our ongoing Phase 3, Preserve 2 trial in first-line triple negative breast cancer late in the second quarter of this year. If positive, we would move quickly toward the filing of an SNDA.
John E. Bailey: Striking success and would allow us to pursue development partnerships to move to combination of triglyceride glib in trop, two adcs into pivotal trials.
John E. Bailey: Furthermore, we expect final results from our ongoing phase III preserved two trial in first line triple negative breast cancer late in the second quarter of this year.
John E. Bailey: If positive we would move quickly towards filing of an SBA.
Operator: Thank you for your time this morning. We will speak again in this format on the second quarter 2024 call in August, and we'll see many of you at ASCO or on our upcoming non-deal road shows. 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?
Speaker Change: Thank you for your time. This morning, we will speak again in this format on our second quarter 2024 call in August and we'll see many of you at <unk> or on our upcoming non deal roadshows 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.
Operator: Thank you, and as a reminder to ask a question, you need to press star 1 1 on your telephone and wait for a name to be announced. To withdraw your question, please press star 1 1 again. Please stand by while we compile the Q&A roster for our first question. First question, I'm answering on behalf of Gil Blum from Needham. Your line is open.
Speaker Change: Thank you and as a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please standby we compile the Q&A roster.
Speaker Change: For first question.
Speaker Change: Our first question comes from the line of Gil Blum from Needham Your line is open.
Gil Joseph Blum: Good morning, everyone, and thanks for taking our questions. Maybe maybe a quick one on the commercial aspect here. Would you say that we're starting to see some level of seasonality? Well, I'm kind of focusing on the remarks regarding the holidays and how that affected the patient at all.
Gil Joseph Blum: Good morning, everyone and thanks for taking our questions.
Gil Joseph Blum: Maybe maybe a quick one on the commercial aspect here would you say that we're starting to see some level of seasonality.
Gil Joseph Blum: Im kind of focusing on our remarks regarding the holidays and how would that affect.
Gil Joseph Blum: Affected patient pickup.
Andrew Perry: the claims data to diagnose when we see a drop in new patients. We diagnosed that issue around February, and we're able to, obviously, immediately act on it. I don't think that there's any reason to think that, in any way, this is a seasonality issue. This is about our ability to execute, which we have to continue to improve every quarter. What we have seen, of course, though during Q1 was some great enhancements in our execution in some parts of the country and in some segments of our business, including in our West business and our strategic accounts business and actually in our academic sector as well, which also grew during the quarter. So yeah, I hope that answers your question.
Speaker Change: Thanks, Bill no I would not say that.
Bill: It takes a couple of months in the claims data to diagnose when we see a drop in new patients we diagnose issues around February and we're able to obviously immediately on it I don't think there's any reason to think that in any way. The seasonality issue. This is about our ability to execute which we hope to continue to improve every quarter.
Bill: What we have seen of course, so during Q1 was with some great enhancements in our execution and some parts of the country and in some segments of our business, including at our West and our strategic accounts business.
Speaker Change: And actually in our academic sector as well, which also grew during the quarter. So.
Speaker Change: So, yes, I hope that answers your question.
Speaker Change: It does come back that was very helpful.
Rajesh K. Malik: It does, that was very helpful. And as to the readout for the triple negative breast cancer study... What details do you think you're going to include in that readout, and will those details and the level of disclosure depend on whether the study is successful? Thank you.
Speaker Change: And as to the.
Speaker Change: Readout for the Triple negative breast cancer study.
Speaker Change: What details that you think youre going to include in that readout.
Speaker Change: Well those detailed in the level of disclosure depend on whether the study is successful.
Gil Joseph Blum: Yeah, hey Gil, Raj here. Yeah, so we plan to include enough in the press release really for the investment community to get a sense of what the results were. We always have to balance this with presenting the full set of data at a medical conference, so obviously the degree of improvement in overall survival, some important subsets, some comments on safety, obviously, those types of comments. But it should be a full disclosure.
Speaker Change: Sure.
Speaker Change: Yeah, Hey, Gale Raj here.
Rajesh K. Malik: So we plan to include enough in the press release.
Rajesh K. Malik: Really for the investment community to get a sense of what the results, where we always have to balance this with presenting the full set of data at a medical conference. So obviously the degree of improvement in overall survival some important sub steps.
Rajesh K. Malik: Some comments on safety, obviously those types of comments.
Rajesh K. Malik: But it should be a fulsome disclosure.
Gil Joseph Blum: Okay, excellent. That's all from us today. Thank you.
Speaker Change: Okay excellent that's all.
Speaker Change: From us today. Thank you.
Operator: Thank you. One moment for our next question. Our next question will come from Joseph Thome from TD Callen. Your line is open.
Speaker Change: Thank you one moment for our next question.
Joseph John: Hi there, good morning. Thank you for taking the time to answer my questions.
Rajesh K. Malik: Our next question will come from the line of Joseph Thome from TD Cowen Your line is open.
Joseph John: Maybe one around the inclusion of Ukrainian patients in the TMBC study. Maybe can you just give us an idea of what proportion of patients were from Ukrainian sites? And whether the company was advocating kind of one way or the other to do the ITT or the MITT population? You know, were there any issues with getting patients to take the drug or data quality or anything like that?
Joseph John: Hi, there good morning, Thank you for taking my questions maybe.
Joseph John: Maybe one around the <unk>.
Joseph John: Inclusion of the Ukrainian patients in the <unk> study, maybe can you just give us an idea of what proportion of patients were from Ukrainian sake.
Joseph John: And whether the company with advocating one way or the other to do the ITT or the M. ITT population.
Joseph John: Are there any issues with getting patients for aggregate of quality or anything like that thanks.
Rajesh K. Malik: Yeah, hey, Joe. So we had, you know, initially proposed the modified ITT population, which sort of excluded these patients and, obviously, the events from these patients. But the agency recommended that we include the events from these patients. And so it was really a discussion back and forth on how to do that, because there are a variety of approaches to do that.
Speaker Change: Yeah, Hey, Joe So there were 13 patients that were enrolled in Ukraine.
Speaker Change: So we had.
Joe: Initially proposed the modified ITT population.
Speaker Change: We sort of excluded these patients and obviously the events.
Speaker Change: From these patients.
Joe: The agency recommended that we include the events from these patients.
Joe: And so it was really the discussion back and forth on how to do that because there are a variety of approaches to do that.
Rajesh K. Malik: And that's kind of what resulted in our timeline. But in terms of, you know, we're obviously blinded to the data. We remain confident in the results. So it was a relatively small number of patients, 13 out of 187. So, so, yeah, we feel we feel confident.
Joe: And thats kind of what resulted in our timeline, but in terms of.
Speaker Change: We're obviously blinded to the data we remain confident in the results.
Speaker Change: So it was a relatively small number of patients 13 out of a 187.
Speaker Change: So yes, we feel that we feel confident in the data.
Joseph John: And then maybe just one on the combination with Tridelby and sort of the path forward there. I know you indicated some potential partnership interests if the data were positive and, you know, kind of hit that three-month benchmark. Maybe, where are you in terms of potential partnership discussions? And is there a path forward for a combination without a partner? Or would you need a partner to move toward phase three?
Speaker Change: Great and then maybe just one on the combination with <unk> and sort of the path forward. There I know you indicated some potential partnership interest of the data are positive and kind of hit that three month benchmark maybe.
Speaker Change: Maybe where are you in terms of potential partnership discussions and is there a path forward for a combination without a partner or would you need a partner to move towards a phase III. How are you thinking about that.
John E. Bailey: Yeah, thanks Joe. This is Jack.
Joseph John: How are you thinking about that? Yeah, thanks, Joe. This is Jack.
Speaker Change: Yeah. Thanks, Joe This is Jack I really think we're prioritizing partnership on this <unk>.
John E. Bailey: Yeah, I really think we're prioritizing partnership on this. I mean, A, there are just a lot of ABC companies out there, multiple Trope 2 companies. So we've had discussions ongoing. A lot of folks are anticipating or waiting for that data to come out. So that is our preferred path at this point to look for.
John E. Bailey: A lot of ADC companies out there multiple trop two company you so.
John E. Bailey: We've had discussions ongoing a lot of folks are anticipating you are waiting for that data to come out. So that is our preferred path at this point to look for partnership box development capital vehicle to do that.
Joseph John: Awesome. Great. We look forward to the update. Thank you.
Speaker Change: Awesome, Great. We look forward to the update thank you.
Operator: One moment for our next question. Our next question comes from Anupam Rama from J.P. Morgan. Your line is open.
Speaker Change: One moment for our next question.
Anupam Rama: Hi guys, this is Priyanka on behalf of Anupam. I just have one quick question. I think it was mentioned in the call that 60 of the top 100 accounts are using Cocella. How would you tackle those who are not using Cocella, and are there any commonalities between those that you can target?
Speaker Change: Our next.
Speaker Change: Comes from the line of.
Speaker Change: <unk> Rama from Jpmorgan Your line is open.
Andrew Perry: Thanks, Priyanka.
Rama: Hi, guys. This is <unk> on for Tom.
Rama: I just have one quick question I think I have mentioned in the call that 60 of the top 100 accounts are using cross seller. How would you tackle those who are not using can tailor and are there any commonalities between dose that you could target.
Speaker Change: Thanks, Bianca so actually 78 of the top 100 trial Costello launched today.
Speaker Change: We added three since our last call. So actually we've continued to add to the number of our filing.
Andrew Perry: So actually, we've continued to add to the number that are trialing. In Q4, 56 of the top 100 had actually ordered during the quarter. That jumped up significantly to 63 in Q1. So that's actually the biggest jump up that we've seen in quite a few quarters.
Speaker Change: In Q4 56 of the top 100 have actually ordered during the quarter, but that jump up significantly to 63 in Q1, so essentially.
Speaker Change: Really the biggest jump up that we've seen in quite a few quarters.
Andrew Perry: So, you know, the secret to growth obviously in those top 100s is continuing to build depth and moving from trial utilisation to systematic adoption. We do continue to add new top 100s over time, and things like, you know, the guideline improvements we saw in ASCO last year are obviously helpful, as are the real-world evidence that we've been able to compile on a medical front. So we continue to make headway in the top 100, and we continue to see them as a growth driver going forward, and we look forward to reaching them.
Speaker Change: The secret to growth obviously in those top 100 is continuing to build best in moving from trial Utilizations of system adoption.
Priyanka Arun Grover: Thank you so much.
Speaker Change: Do continue to add top one hundreds overtime and things like that guideline improvements we saw in hospital last year are obviously helpful as always.
Speaker Change: The real world evidence that we've been able to compile on the medical front. So we continued to make headway in the top 100 as we continue to assume that the growth driver going forward and we look forward to reporting success.
Speaker Change: Sure.
Speaker Change: Gotcha, Thank you for months.
Speaker Change: Okay.
Operator: Thank you. One moment for our next question. Our next question comes from Laura Prendergast from Raymond James. Your line is open.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Our next question comes from the line of Laura.
Laura: <unk> <unk> from Raymond James Your line is open.
Laura Anne Prendergast: Hey guys, thanks for taking the questions. Just two quick ones for me. First, as far as first-line triple negative breast cancer is concerned, what is the expected time on the chemotherapy treatment for a patient versus what you guys have been seeing in lung cancer? And then if the PRESERVE-2 trial does hit on overall survival, do you expect to be able to get approval beyond first line based on the PRESERVE-2 study? You know, just how you guys are thinking about this. Thank you. Hey Laura, yeah.
Laura: Hey, guys. Thanks for taking the questions just two quick ones for me first as far as in first line Triple negative breast cancer. What is the expected time on the chemotherapy treatment for patient versus.
Laura: You guys have been seeing in lung cancer.
Raymond James: And then if the <unk> trial does hit.
Raymond James: On overall survival do you expect to be able to get approval beyond first line based off of the preserve two study just how are you guys are thinking about this.
Rajesh K. Malik: Hey Laura, yeah so in terms of the first line, TMBC obviously can't comment on our phase 3 just because it's still ongoing. However, if you refer back to the phase 2 study, the number of cycles on the median number of cycles is around 8, but if you look at the total cumulative dose of chemo is about 50 to 60 percent greater when patients receive trila compared to chemotherapy alone.
Speaker Change: Hey, Laura yes, so in terms of the first line TWC, obviously kind of comment on our phase three just because.
Laura: Still ongoing however, if you refer back to the phase II study.
Speaker Change: The number of cycles.
Laura: The median number of cycles around eight.
Laura: But if you look at the total cumulative dose of chemo is about 50% to 60% greater when patients receive trial compared to chemotherapy.
Rajesh K. Malik: So in terms of your second question, could we potentially get approval beyond the first line indication? You know, this is always going to be a matter of discussion once we have the data and related to the indication statement. You know, and obviously, our approach will be to try and get as broad an approval as possible with regard to gemcitabine-carboplatin combinations, which could, of course, span first line and beyond, but that'll be a matter of discussion. Thanks, guys.
Laura: Alone.
Laura: So in terms of your second question was could we potentially get approval beyond the first line indication.
Laura: There's always going to.
Laura: Be a matter of discussion once we have the data and related to the indication statement.
Laura: Tom.
Laura: Obviously, our approach will be to <unk>.
Laura: And get as broad an approval as possible with regards to Gemcitabine and carboplatin combinations, which could of course span.
Laura: First line and beyond but that would be a matter of discussion with the agency.
Speaker Change: Great. Thanks, guys.
Laura Anne Prendergast: Thank you. One moment for our next question. Our next question comes from David Nierengarten from Wedbush. Your line is open.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Our next question comes from the line of David Nearing Garden from Wedbush. Your line is open.
Operator: Thanks for taking the question. Maybe a follow-up on the Ukrainian patients. I guess I'm wondering if the agencies preferred to include them because it would aid in statistical analysis or, you know, provide a more robust answer. And I ask this because it would seem, from moving up in the timeline, that events have occurred among that population. So, you know, they would contribute, unless I'm wrong. So that's the question. Thanks. Yeah
Speaker Change: Hey, Thanks for taking the question.
Speaker Change: On the Ukrainian patients.
Speaker Change: I guess the.
Speaker Change: I'm wondering if the agencies pre.
Speaker Change: Preferred to include them because it would aid in statistical analysis or provide a more robust answer and I ask this because it would seem from moving up with the timeline that.
Speaker Change: Events have occurred from that population so.
Speaker Change: Yes, they would contribute unless I'm wrong. So that's the question.
David Matthew Nierengarten: Yeah, David, uh... Yes, so events have occurred in those patients, and that is the reason why when you count those events, the timeline moved up a little bit to the end of the second quarter. We're obviously blinded. We don't know which, you know, which arm those events actually occurred on.
Speaker Change: Yes, David.
David: Yes so.
David: Events have occurred in those patients and that is the reason why when you count those events the timeline moved up a little bit and that the second quarter.
Speaker Change: We're obviously blinded, we don't know, which which arm those events actually got burned in.
Rajesh K. Malik: And I think, you know, this is an open question, really, in terms of how to deal with patients who are enrolled in Ukraine. And there is really no good guidance out there. In fact, the FDA or the European agencies are starting to put something out, so I think it's been sort of all over the board. So we've put our proposal forward. The agency clearly wants to include all the data, which is what we're doing. Yeah, that's where we landed. Okay, bye.
Speaker Change: And I think this is an open question really in terms of how to deal with patients who are enrolled in Ukraine and there is really no. Good guidance out there in fact from the FDA are.
Speaker Change: The European agencies are starting to put something out.
Speaker Change: So I think it's been sort of all over the board. So we put our proposal forward.
Speaker Change: And the agency clearly wants to include all of the data, which is what we are doing so.
Speaker Change: Yes, that's where we landed.
David Matthew Nierengarten: Okay, thanks.
Speaker Change: Okay.
Speaker Change: <unk>.
Operator: Thank you. One moment for our next question. Our next question will come from the line of Stephen Berzy from H.C. Wainwright. Your line is open.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Okay.
Speaker Change: Our next question comes from the line of Steven <unk> from H C. Wainwright. Your line is open.
Edward Patrick White: Hey, this is Steve on behalf of Edward White. Congratulations on the LyraCycle deal. So we're just wondering whether the payments are per indication, and are they going to be one-time payments? And then also what triggers the milestone payments and then the timing on those.
Steven: Hello. This is Steve on for Ed Y Congratulations on the Alere cycle of deal.
Steven: Just wondering whether the payments are per indication and are they going to be one time payments and then also what triggers the milestone payments and then the timing on those.
John E. Bailey: Yeah, thanks, Steve. And so we're certainly excited about the deal, too. It gives Leroy Cycler the opportunity to obviously benefit patients. So I didn't catch your first part. In terms of the milestones, they're a combination of both development and regulatory, so those will unfold over time. The first part of your question was
Steven: Yes, hi, it's Steven So we're certainly excited about the deal two it gives a little cycle of the opportunities you obviously benefit patients.
Steven: So I.
Steven: You can take your first part in terms of the milestone there a combination of both.
Steven: Regulatory so those will unfold over time your first part of your question was.
Edward Patrick White: So are the payments going to be per indication, different indications they could go into? Yeah, they're, they're, they're.
Steven: So are the or the payment is going to be per indications different indications that could go into.
John E. Bailey: Yeah, there can be multiple payments based on multiple invitations.
Steven: Yes.
Steven: There can be multiple payments based upon multiple limitations.
Speaker Change: Okay. Thank you.
Speaker Change: Yes. Thank you.
Operator: Thank you. And as a reminder, that's star 11 for questions, star 11. One moment for our next question. For the next question, we'll come from the line of Tash Hassan from Rodman and Red Shaw. Your line is open.
Steven: Yeah.
Steven: Thank you.
Steven: And as a reminder, that star one for question start 111.
Steven: Moment for next question.
Steven: Our next question comes from the line of Tosh Hassan from Rodman and Renshaw. Your line is open.
Tash Hassan: Good morning, this is Tash Sanna on behalf of Tony Butler. If I heard correctly, um... I think Andrew spoke about the addition of three new headcounts in the sales force. I wonder if you could share your thoughts about how this is expected to help with the commercial efforts in the current setting. And then I have another question.
Tosh Hassan: Good morning, this is Josh.
Tosh Hassan: One for Tony Butler.
Tosh Hassan: If I heard correctly.
Josh: I think Andrew spoke about the addition of three new head count.
Speaker Change: Salesforce I wonder if you could.
Speaker Change: So your thoughts about how this is.
Speaker Change: Got it too with the commercial efforts in the current study.
Speaker Change: And then I have another question.
Salesforce: Sure Yes. Thank you for the question.
Speaker Change: We always are looking at our sales force size and structure to be able to identify new opportunities and capitalize on them.
Andrew Perry: structure to be able to identify new opportunities and capitalize on them, and these changes were our effort to do that. I also mentioned that we added a headcount in the West, for example, to do exactly that, to take advantage of some of the opportunities we've identified. In many situations, the success of Cosella relies on sales representatives gaining access to key decision makers, key prescribers, as well as nursing and pharmacy staff, and so our sales team plays an invaluable role in doing that, in combination with our market access team, including our strategic accounts team, and then answering any questions that arise through our medical affairs team. So, in many respects, the continued evolution of our sales force is absolutely critical to our success, and we'
Speaker Change: These changes were our effort to do that I also mentioned that we added the headcount in the last for example to do exactly that to take advantage of some of the opportunities we've identified.
Speaker Change: In many situations with the success of Costello relies on sales representatives, gaining access to key decision makers key prescribers as well as nursing and pharmacy staff and so our sales team fulfillment of Hollywood Bowl with doing that in combination with our market access team, including our strategic accounts team and then answering any.
Speaker Change: Is that right through our medical affairs team. So in many respects. The continued evolution of our Salesforce is absolutely critical to our success and where we're at and delighted to welcome those new folks into our organization.
Speaker Change: That's helpful. Thank you.
Andrew Perry: That's helpful. Thank you. The other question is about small-cell lung cancer patients beyond the front-line setting. For example, can you share with us your data, and, assuming that there is any, the share of the second-line and third-line markets, and also whether you see a significant number of patients being dosed with Cocella in the second and third line after having received it in the front-line setting? Sure, yeah, I think
Speaker Change: The other question is about.
Speaker Change: Small cell lung cancer patients beyond from beyond the frontline setting for.
Speaker Change: For example.
Speaker Change: Can you share with.
Speaker Change: Your day.
Speaker Change: Data and assuming that there is any.
Speaker Change: Share of second line Thats sort of end market and also whether you see a significant number of patients being.
Speaker Change: Being dose we could sell out in the second and third line after having received at the frontline setting.
Andrew Perry: Sure, yeah, I can give you an outline of that. So, about 90% of our use today is in the first-line setting; about 10% is in second-line plus. Within that 10%, there's a... There are top of TCAN patients, which is part of our indication, as well as patients who are re-challenged with copacide platinum. Our overall market share, or our first-line market share, is around 13%. Our overall market share is not too different from that, and our share in the second-line setting is not too different from that either. Certainly double digits of eligible patients in the second-line setting, so there's not a huge difference in our market share across first- and second-line use.
Speaker Change: Sure, Yes, I can give you an outline of that so about 90% of our used today is on the first line is bad thing about 10% is in second line plus.
Tash Hassan: Very helpful. Thank you.
Speaker Change: Not.
Speaker Change: 10%.
Speaker Change: Let's start with pecan patients, which is part of our indications as well as patients are re challenged with the pulp site platform.
Speaker Change: Our overall market share or a first line market share was around 13%. Our overall market share is not too different from that and our share in the second line setting is not too different either.
Speaker Change: Double digits.
Speaker Change: Of eligible patients in the second line setting so theres not huge difference.
Speaker Change: Our market share across the first and second line use our focus is mainly first language because that represents the majority of patients.
Speaker Change: Very helpful. Thank you.
Operator: And with no further questions in the queue, I'd like to turn it back over to Jack Bailey, CEO, for any closing remarks. Thank you, operator.
Speaker Change: Thank you and with no further questions in the queue I'd like to turn it back over to Jack Bailey CEO for any closing remarks.
John E. Bailey: Thank you, Operator. As always, we look forward to keeping everybody updated on our progress. Thank you, too, for joining us today. We'll be in touch.
John E. Bailey: Thank you operator.
John E. Bailey: As always we look forward to keeping everybody updated on our progress certainly thank you for joining us today will be in touch.
Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.
Speaker Change: Thank you for your participation in today's conference. This does conclude the program you may now disconnect everyone have a great day.
John E. Bailey: Okay.
John E. Bailey: [music].
John E. Bailey: Okay.
John E. Bailey: Okay.
John E. Bailey: Yes.
John E. Bailey: [music].