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spk06: Good day and thank you for standing by. Welcome to the G1 Therapeutics 3rd Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require assistance during the conference, please press star 0. I would now like to turn the conference over to your speaker today, Will Roberts. Thank you. Please go ahead.
spk00: Thank you, Gail. Good morning, everyone, and welcome to the G1 conference call to discuss our third quarter 2021 financial results and business update. The press release on these financial results was issued this morning and can be found in the news section of our corporate website, g1therapeutics.com. On this morning's call, the team will provide a business overview of the third quarter of 2021, including an update on our commercial progress in that period with COSELLA, which was approved by the U.S. Food and Drug Administration on February 12, 2021, to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum and toposide-containing regimen or topotecan-containing regimen for extensive stage small cell lung cancer, or ES-SCLC. and which became available on the channel in early March of 2021. A Q&A session will follow these 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 risk 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, November 3, 2021. Joining me on the call today are Jack Bailey, our Chief Executive Officer, Jen Moses, our Chief Financial Officer, Andrew Perry, our Chief Commercial Officer, and Raj Malek, our Chief Medical Officer. And with that, I'll turn the call over to Jack. Thanks, Will.
spk03: Good morning, everyone, and thank you for joining us on the call today. We hope that you and your families are well. Today's headline from the third quarter is one of action and rapid execution to maximize the value of COSELLA for patients, healthcare professionals, and investors alike. COSELLA is a paradigm-changing drug. It is the first and only multi-lineage myeloprotection therapy to offer proactive protection against the dangerous impacts of myelosuppression when treating people living with small cell lung cancer. And we are experiencing a variety of important drivers, excuse me, a little bit of a head cold, or tailwinds, such as an exceptional reimbursement environment with no pushback on reimbursement or filed claims, along with a new permanent J-code that went inactive only one month ago high awareness and intention to treat, and excellent user experience and strong reordering. However, as most of you know from IQVF and other data sources, the softness that we discussed on the last call continued throughout this quarter, driven by variable geographic performance and a lack of access to the largest accounts. We believe that this is imminently addressable, and as you will hear, we are well along in the process. Actions we've taken include hiring our new Chief Commercial Officer, Andrew Perry, who I will introduce shortly, and we are in the process of hiring with urgency a new supplemental G1 sales force to access these top accounts. As our co-promotion partner, Barrier Ingleheim continues to be aware of the need to strengthen the sales line in the near term. Excuse me, so far we have good continuity in strategy, but we are also taking bold and immediate action to rectify this near-term performance gap. Turning to the clinical side of the business, we also remain focused on the long game via our tumor agnostic clinical programs to ensure that we continuously develop new data with tricyclic and a variety of tumors, chemotherapeutic backbones, and in combination with other therapeutic agents to maximize the applicability of the drug to future treatment paradigm. For example, as you will hear from Raj, we expect to initiate two new studies later this quarter designed to do just that, one of which will assess tricyclic in combination with an ADC. Now, we have a lot to update you on this morning. I will first introduce Andrew Perry and ask him to cover our commercial efforts for the third quarter of 2021 with a focus on our tailwinds and how we are addressing our headwinds, including a review of where we are in hiring our new sales Raj will then provide an update on some of our medical and clinical momentum during the third quarter. Finally, Jen will provide the financial results for the quarter, including that our cash runway now takes us into 2024. Then I'll be back for some clues and comments. With that, I am very excited to introduce our new Chief Commercial Officer, Andrew Perry. Andrew has 25 years of strategic product leadership experience with specific expertise in launching new innovative products in the U.S. market across a variety of therapeutic areas, including oncology, of growing brands throughout the product lifecycle, and managing co-promotion relationships. He's already fully integrated into the team, and I'm excited for all of you to get to know him. Andrew?
spk02: Thank you, Jack. I'm glad to be with you today to talk a bit about a number of topics, including our tailwinds and headwinds, the softness many of you already noted in data sources like IQVIA, and the aggressive steps we're taking to correct it and alter the sales trajectory, including an update on our progress with the new supplemental G1 Salesforce, which I'll cover in depth. We booked $3.6 million in net sales of Cosella for the quarter ending September 30th, representing a 60% growth in vial demand over the entire quarter. And this was driven by successes in new accounts, but also accounts where Cosella has been embraced at multiple sites across their organization. So we're seeing evidence of not only increased breadth, but also depth. However, as we mentioned last quarter, we did see gaps in uptake in many of the top 100 largest organizations, which collectively treat over half of patients with extensive stage small cell lung cancer. Our G1 supplementary sales team will focus on driving adoption in these top 100 organizations. In my first 10 weeks, I've been focused on improving commercial execution. For example, we just recently had our first in-person national sales training meeting with BI. This was the first opportunity for the sales team to practice in person and receive training on new resources and tools Now, as Jack mentioned, we've got meaningful tailwinds that are in our favor, including an excellent reimbursement environment with no pushback on reimbursement of filed claims, a permanent J-code, strong awareness and intention to use, and excellent provider and patient experience, all of which I will cover separately. But physicians need to understand the clinical value of the product and what it will offer their practice when they use it for their patients with extensive stage small cell lung cancer. And this process relies on sales representative access to key prescribers, which, as you'll hear, is a core requirement of our new sales team. Now, we don't have some of the traditional barriers like payer challenges that usually plague new products. However, despite the lack of these barriers, we need focused execution to move our largest prescribers from general awareness to product adoption. Now, many clinics have limited ability to directly engage customers during Q2 and Q3 because they close down to both in-person rep visits and to any external engagement outside of the office, even in some cases actually to digital engagement. And while COVID doesn't help, great sales execution always benefits from sales representative access to key customers and high-quality trusted relationships. And so we are moving rapidly to build that at G1. So let's discuss the important tailwinds that I described a moment ago, starting with reimbursement. And the reimbursement landscape continues to go remarkably well. Through August, approximately 55% has been Medicare Part B. Around 40% is commercial, and the remaining is Medicaid. Pair coverage remains very strong, with pair policies in place or pending that provide coverage for approximately 80% of on-label patient lives. Four of the top five U.S. payers have made positive formal coverage decisions since product availability. We have not seen any pushback in terms of reimbursement of filed claims. And you likely saw that our permanent J codes was effective on October 1st, just about a month ago. And this code provides important reimbursement reassurance, particularly for those community clinic practices that wait for a permanent J code before adopting a new product. billing process. And this is important because some of the top 100 organizations have referenced the need for a permanent J-code before they can consider Cosella. And we have communicated this new permanent code to all of our customers. In the third quarter, over 75% of our demand came from community hospitals or clinics. And as of the end of the quarter, we'd received orders from over 100 unique organizations 35 of those are from our top 100 priority organizations, up from 28 of the top 100 that have ordered as of the end of June. And we've made good progress since the end of the quarter, with more of the top 100 priority organizations ordering for the first time in October. Based on our experience with those 35 priority organizations using Cosella as of the end of the quarter, when things are done correctly with the right account access and the right setup of order sets, debt is driven across accounts affiliated with that parent organization. And we know several examples, including one mid-sized system in the mid-Atlantic area, where our teams have been able to create access to key stakeholders across the organization, engaged with them to place CoSela into their process, helped them identify appropriate patients, and then seen very rapid growth. Awareness has remained high since launch, currently at 55% for unaided awareness and 75% for aided awareness. Intention to use the product is also high, with approximately 70% of surveyed oncologists saying that they intend to use Coachella in their institutions within six months, with another 19% intending to use it in the next seven to 12 months. Now, we believe this is a result of more than two dozen publications focused on COSELLA and a solid digital campaign. But moving a doctor from intention to use to actual usage requires sales representative access and engagement with multiple customer stakeholders, including the pharmacist, the nursing team, and, of course, the prescriber to get the product on formulary and into the right order set so that it's available for use with appropriate patients. And even once that has been done, Identifying that first patient who could benefit from Cosella and having that conversation with a customer when they're considering using the product for the first time is something that benefits from personal engagement. And briefly on that topic, engagement has been mostly virtual today. As of the end of September, the BI team had achieved around 65% reach by all methods, whether personal, virtual, or digital, with our 2,500 target HCPs. And that said, reach on its own is not really a sufficient indicator of engagement moving forward, and the new G1 sales team will prioritize engagement through high-quality and ideally in-person customer discussions. Regarding experience with COSELLA, we continue to hear overwhelming positivity from doctors who have begun to use it with their patients. They tell us that COSELLA is as highly effective at proactive multilineage myeloprotection in real-world use as it was in clinical trials. It fits smoothly in the clinic workflow. No additional trips to the office or significant time and share required. And in general, once a doctor tries COSELLA, he or she becomes an advocate, and we see this manifest as a high reorder rate of at least 75%, with some accounts achieving 80% total share, and that can happen in as little as 30 days. Finally, from a patient perspective, Our advocacy team is actively engaged with patient advocacy groups, and we've begun to get remarkable feedback from cancer survivors who have been prescribed Coachella. One recent example came from a woman who went through chemotherapy for small cell lung cancer twice, the second time after the availability of Coachella. She commented that she never felt worse than she did while on chemo the first time. It was so awful. that she said she would never get chemo again. And when circumstances did require chemo again, fortunately, her doctor was ready to add Crocella. And this time, in her words, I feel like I don't even have cancer, and I don't look like I'm sick. I can do anything. Now, for us at G1, we are highly motivated by patient experiences such as this, but we are also convinced more than ever of the potential of Crocella. So there's strong support for Cosella in accounts where we have rep access and physician and patient experience. But thus far, we have lacked the required demand creation firepower in many of the largest accounts. So I'll now cover our progress with the new G1 Cosella-focused sales force. We believe that a novel and innovative launch product like Cosella will benefit from a sales team 100% dedicated, to accessing and driving debt in those 100 organizations which provide care for more than half of patients who could benefit from COSELLA. We are hiring professionals with extensive tenure and experience in oncology sales and with demonstrated ability to gain access to and be successful in the accounts we're focused on. So to provide a sense of interest in these positions, we've received hundreds of applicants for the field's positions and have several highly skilled priority candidates with the desired track record in each region. And these candidates want to join G1 at this time, primarily because of innovation and opportunity. They've done their research. They know that Costella is a novel breakthrough therapy and priority review drug. They know it has a novel mechanism of action, dual commissioning. and no competition. They know all of that, and they want to share in driving the growth and success of CoSella. So as of today, we have already hired the vice president of sales. We have an offer accepted for a regional sales director. We also have offers out or accepted for four sales representatives, one of whom started earlier this week. Just in these six individuals, we have nearly 100 years of collective selling experience in oncology. Overall, we expect to have a majority hired by year-end and in the field quickly. And to ensure that we can have them activated quickly, we are challenging the traditional launch model. Companies typically hire a sales team, train them up as a group, launch them into the field together. But that's a protracted process that can take significant time. So our model is different in that we're hiring, training, and deploying these highly effective individuals into the field as they arrive. which should save time and allow us to start seeing the impact of this new sales team more quickly. Cocella is a paradigm-changing product that provides a unique benefit to patients with extensive stage small cell lung cancer undergoing chemotherapy. We know what caused the recent softness in sales, and as you've heard, we are directly and rapidly addressing it. I'm confident that these efforts will convincingly change the trajectory of uptake and enable Cocella to impact the lives of many more patients with small cell lung cancer. So with that, I'll now turn the call over to Raj for an update on our medical and clinical efforts during the third quarter. Raj.
spk01: Thanks, Andrew, and good morning, everyone. I'm going to cover two topics. First, I will provide a brief update on two of our medical affairs efforts that directly support the commercial efforts, including ensuring that our new supplementary sales team is fully trained and ready for the field. I'll then provide an update on our clinical programs including an update on a couple of new upcoming clinical trials that we have added to our pipeline. As Andrew mentioned, our data suggests that 70% of treating physicians intend to use Casella within the next six months. So what about the other 30%? In many cases, these physicians underestimate both the clinical and economic impact of multilineage chemotherapy-induced myelosuppression, and the toxicity of standard small cell lung cancer chemotherapy. As such, our medical team has developed a provider model, which we internally call Project Mirror, to help practices understand their own data on the clinical impact of multi-lineage model suppression in their clinic, and the medical and economic value of appropriate use of Casella. Through this program, G1 is engaging with key accounts to conduct real-world evidence analyses to hold up the mirror, if you will, and quantify the costs and burdens associated with multilineage myelosuppression. And to be clear, it's not just neutropenia we are talking about, but also anemia and thrombocytopenia, the amount of growth factor use, blood transfusions, dose delays, et cetera. Further, the medical affairs team will play an integral role in the training of the new G1 sales team. to ensure our G1 Oncology sales professionals are ready to make an immediate impact. The training of our sales colleagues will be conducted with a two-fold purpose of increasing their medical and scientific product knowledge and enabling compliant collaboration. And as always, our MSLs are actively available for HCP clinical discussions. Let's shift now to a clinical program update. Overall, our approach to designing our clinical program is to monitor the evolution of future standards of care and develop trial-a-cyclic with these in mind. We must always anticipate the future landscape and conduct trials that will generate important data to maximize future usage in those settings. As the company evolves, this will include trials with a variety of additional chemotherapy backbones, but also potential combinations with agents with a variety of novel antitumor mechanisms. like ADCs and anti-tigets, TIM3s, and LAG3s. In that regard, you saw in this morning's press release, we will initiate two new G1-sponsored trials later this quarter. The first study that we expect to initiate is a Phase II single-arm trial study of trilocycline in combination with sasituzumab govitecan and ADC in patients with locally advanced or metastatic triple-negative breast cancer. This is an area where Trialocyclib and our Phase II trial and this ADC have both shown survival benefits and could act synergistically to improve patient outcomes along with reduced myelosuppressive side effects common with some ADCs. We will provide more detail on the trial design once it is underway, but at this point we expect initial myeloprotection data and tumor response data in the second half of next year. The second is a Phase II single-arm study, which we discussed on the last call, to further support the anti-tumor mechanism of action of Trialocycline. We also expect to initiate this Phase II trial soon. In addition to providing further insights into the mechanism of action, these data should also provide support for novel combination approaches, e.g., with anti-TIGIT or LAG-3 antibodies, and investigating additional tumor types. More information on the trial design will be provided once initiated, and we expect data from this trial in the second half of next year. I mentioned earlier that we must always anticipate the future landscape and conduct trials to maximize the future applicability of Trilocycline. This is relevant to how we evaluate our ongoing studies. The treatment landscape is changing rapidly in second- and third-line non-small-cell lung cancer, away from docetaxel. the chemotherapy being used in our Phase II trial, thereby decreasing the market opportunity for this combination. With that in mind, we've made the strategic decision to discontinue the second third-line non-small-cell lung cancer Phase II trial and reallocate those funds to support the two new Phase II trials I just described. First-line non-small-cell lung cancer, on the other hand, continues to be a significant unmet market opportunity. where chemo checkpoint combinations are standard of care. Based on its mechanism of action, we believe there could be an improvement in outcomes by adding trial-aside lips to this combination. G1 has a robust investigator-initiated study program. We've indicated a variety of areas that are of scientific importance to G1 in the medical professional section of our corporate website, and we welcome the incoming interest today. For those new to this topic, an ISS is a study that is developed and conducted by an independent investigator who serves as a sponsor of the study and assumes full responsibility for its conduct with oversight by an IRB. The first ISS we have accepted to support is one in first-line non-small cell lung cancer, a study in tralocyclic in combination with chemo and a checkpoint inhibitor. We are coming up on a remarkable period for our clinical programs, as we expect trials to start reading out around this time next year, and then throughout the next several years, as we conduct important new trials to generate data to help ensure broad future usage of Trialocycline in a variety of current and future treatment paradigms. With that, I'll turn the call over to Jen for a review of the financial results for the third quarter of 2021. Jen?
spk04: Thanks, Raj, and good morning, everyone. As Will mentioned, full financial results for the third quarter of 2021 are available in this morning's press release and will be in the 10Q, which will be filed after market close. Today, I will focus on a few key points from our disclosures. Our total revenue for the third quarter of 2021 was $4.9 million, comprised of net product revenue of $3.6 million and license revenue of $1.3 million. For net product revenue, consistent with our last set of guidance, we realized a gross-to-net percentage in the high teens and expect to realize a gross-to-net percentage in the mid-to-high teens going forward. Our license revenue was primarily related to clinical trial reimbursements from EQRX and Simsear and delivery of clinical drug supply and manufacturing services to Simsear, EQRX, and Genor. Cost of goods sold for the three months ended September 30th, 2021 was 0.6 million. And as a reminder, the majority of the manufacturing costs related to Cosella sales were incurred prior to FDA approval and therefore were recorded as R&D expense in prior periods. These previously expensed costs will continue to impact the presentation of cost of goods sold in future periods until initial prelaunch inventory is depleted and additional inventory is manufactured and sold. G1's research and development expenses for the third quarter of 2021 were $21.1 million, compared to $17.9 million for the third quarter of 2020. The increase in R&D expenses was primarily due to an increase in clinical trial spend, which is offset by a decrease in expense recognized for the manufacturing of active pharmaceutical ingredients and drug products to support clinical trials. Our selling, general, and administrative expenses for the third quarter of 2021 were $24.3 million, compared to $18.4 million for the third quarter of 2020. The increase in SG&A expense was largely due to an increase in commercialization activities, an increase in personnel costs due to increased headcount, and increased medical affairs costs, information technology spend, professional services, and other administrative costs. Regarding our cash position and runway, As described in the press release this morning, we ended the third quarter with cash and cash equivalents of $212 million, and we recently amended the loan terms and outsized our debt facility with Hercules Capital, which now provides total commitments of $150 million, of which $100 million was fully available as of amendment closing. The company has drawn down $75 million from this facility in total. This includes the $30 million that had been drawn as of September 30, 2021, and an additional $45 million, which was drawn on November 1st at the close of the amendment. Including both our cash position as of September 30th and the impact of our amendment agreement with Hercules, we've extended our cash runway and now expect our current financial position to be sufficient to fund operations into 2024. With that, I'll turn the call back over to Jack for some closing comments.
spk03: Jack? Thank you, Jen, Raj, Andrew, and Will. Before we close the call, I want, as always, to thank those people living with cancer for their inspiration. November is Lung Cancer Awareness Month, and I'd like to specifically acknowledge those living with lung cancer and those we have lost to it. We take our obligation to you seriously and are moving quickly with COSELLA to dramatically improve your chemotherapy experience. And at the same time, we are a nimble company and must move decisively to make changes, additions, and improvements to build short and long-term value. Before we move to Q&A, let me just recap what you've heard today. We have a variety of important commercial tailwinds with none of the traditional barriers that play new product launches. We have a permanent J code as of October 1 and no issues with reimbursement. Awareness and intention to use remain high. That said, we need to improve execution to move positions from awareness and intention to use to actual usage. Experience with the drug, as measured by physician and patient commentary, in addition to account reordering, has been excellent to date. We are making quick progress on hiring our new sales team to provide access to the largest accounts. We have two new trial cycle of Phase II trials starting this quarter, one in combination with an ADC and one to further elucidate its mechanism of action. Both are part of our overall program to maximize the future value and applicability of Trilocycline. While the landscape in second- and third-line non-small-cell lung cancer has changed, causing us to make the strategic decision to revisit our second- and third-line study, we expect to support an ISS in first-line non-small-cell lung cancer. And as a result of our strong CAHPS position at the end of the third quarter and the restructuring of our Hercules zone, Our cash runway now takes us into 2024. Thank you for your time this afternoon. We will speak again in this format in February on the full 2021 call, though I'm sure I'll see many of you during the late fall and winter roadshows and conferences, and hopefully soon in person. 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?
spk05: As a reminder, to ask questions, you will need to press start your phone. To withdraw your question, press the pound key. Please stand by while compiled the QA roster. Your first question comes from the line of the very post from BPIG. Your line is open.
spk07: Yeah, good morning. Thanks for taking my question and thanks for the update. For the mechanism of action, Are there any biomarkers you plan to study in relatively more cold tumors like colorectal cancer? And my second question is also regarding the CRC study. You're testing Costella as both supportive and anti-tumor drug. Can you tell us your strategy there, how you plan to move forward from the primary endpoint of myeloprotection to secondary endpoint of efficacy?
spk03: Yeah, thanks, Maria. I appreciate the question. You're correct on the CRC. I'm going to take the second one and flip the first one over to Raj. On CRC, we are measuring our primary is indeed myelosuppression, but we have allocated 20% of the alpha to antitumor efficacy. So both of those will be studied in that trial. In terms of the first point, in terms of biomarkers in the MOA study, I'll flip that over to Raj.
spk01: Thanks, Jack. Hi, Kaveri. So the MOA study that I just described is looking specifically for changes within the tumor microenvironment, things like we've discussed before, like Tregs and CD8 levels. I think your question was, are we also looking at biomarkers across our other programs? And the answer is yes. These will be in the peripheral blood. and we'll be looking at very similar markers of immune activation. And I think having the tumor data in the TMBC will really, and peripheral blood data in the TMBC, will allow us to then make correlations of what we see in the peripheral blood versus the tumor.
spk07: Got it. Thank you. And maybe one question, maybe a little more remedial question. Can you run like a solid tumor study for myeloprotection to determine the myeloprotection benefit in other tumor type in late-line patients? Because these are really sick patients. They have beaten up immune system. And, you know, like having the expansion of besides the small cell lung cancer would be really helpful for those patients. Just your thoughts there.
spk01: Yeah, so in all of our studies, we're evaluating myeloprotection as well. So, for example, the TMBC study, the bladder study, the ADC study. So we will have a broad set of myeloprotection data, even beyond the colorectal study, which is where we're focusing on myeloprotection. One of the important outcomes in addition to antitumor efficacy, as Jack mentioned. So as these studies read out, we will have a sense of model protection across a variety of tumors and a variety of chemotherapeutic agents.
spk07: Makes sense. Thank you.
spk00: Operator? Well, we seem to be having some logistical issues on the part of our provider. So it would appear that the best choice right now is to close the call. We'll follow up with everybody after the call. I apologize for the technical issues on their end.
spk03: Okay, well, thank you all. Sorry for the technical difficulties. Just to conclude, we're actively bringing COSELLA to people living with extensive stage small cell lung cancer and, as you've heard, conducting intelligently designed clinical trials to maximize the future value and applicability of this drug in a variety of cancers. As always, we look forward to keeping you updated as we move forward, and we will continue to be as transparent and proactive as possible in this regard. Thank you for joining us today. Please stay well.
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