G1 Therapeutics Inc (GTHX) 2021 Q3 法說會逐字稿

Good day, and thank you for standing by. Welcome to the G1 Therapeutics Third Quarter 2021 Financial Results Conference Call. (Operator Instructions)

I would now like to turn the conference over to your speaker today, Will Roberts. Thank you. Please go ahead.

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 COSELA, 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/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer or ES-SCLC. And which became available in the channel in early March of 2021. A question-and-answer session will follow the prepared remarks.

Before we begin, I'd like to remind you that today's webcast contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements represent management's judgment as of today and may involve risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements. For more information on such risks and uncertainties, please refer to our filings with the Securities and Exchange Commission, which are available from the SEC or on our corporate website. Any forward-looking statements represent our views as of today, 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 Malik, our Chief Medical Officer.

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

Thanks, Will. 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 for COSELA per patients, health care professionals and investors alike.

COSELA 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 or tailwinds, such as an exceptional reimbursement environment with no real pushback on reimbursement or filed claims, along with a new permanent J-code that went to active only 1 month ago, high awareness and intention to treat and excellent user experience and strong reordering. However, as most of you know from IQVIA and other data sources, the softness that we discussed on the last call continued throughout the 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 supplemental G1 sales force to access these type of accounts.

As our co-promotion partner, Boehringer Ingelheim continues to be aware of the need to strengthen the sales line in the near term. So far, we have good continuity in strategy but we are also taking bold and immediate actions 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 trilaciclib in a variety of tumors, chemotherapeutic backbones. And in combination with other therapeutic agents to maximize the applicability of the drug to future treatment paradigms. For example, as you will hear from Raj, we expect to initiate 2 new studies later this quarter designed to do just that, one of which will assess trilaciclib 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 force. 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 concluding 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 life cycle; 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?

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 sales force, which I'll cover in depth.

We booked $3.6 million in net sales of COSELA for the quarter ending September 30, representing a 60% growth in vial demand over the prior quarter. And this was driven by successes in new accounts. But also, accounts for COSELA 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 pull-through of the new permanent J-code.

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. Now physicians need to understand the clinical value of the product and what it will offer to their practice when they use it for their patients with extensive-stage small cell lung cancer. And this process relies on sales representatives 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 closed 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. Payer coverage remains very strong with payer policies in place or pending that provide coverage for approximately 80% of on-label patient lives. Four of the top 5 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-code was effective on October 1, 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. It's a product-specific reimbursement code assigned to outpatient and physician-administered buy-and-bill products, like COSELA to enable a more efficient and a more predictable 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 COSELA. 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've received orders from over 100 unique organizations, up from 68 at the end of June. 35 of those are from our top 100 priority organizations, up from 28 of the top 100 that had 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 COSELA as of the end of the quarter, when things are done correctly with the right account access and the right setup of order sets, depth is driven across accounts affiliated with that parent organizations. And there are several examples, including one midsized system in the Mid-Atlantic area where our teams have been able to create access to key stakeholders across the organization, engage with them to place COSELA into their process, help them identify appropriate patients and they have 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 78% of surveyed oncologists saying that they intend to use COSELA in their institutions within 6 months, with another 19% intending to use it in the next 7 to 12 months. Now we believe this is a result of more than 2 dozen publications focused on COSELA and a solid digital campaign.

But moving a doctor from intention to use to actual usage require 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 COSELA 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 has achieved around 65% reached 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 COSELA, we continue to hear overwhelming positivity from doctors who have begun to use it with their patients. They tell us that COSELA 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 COSELA, 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 COSELA. One recent example came from a woman who went through chemotherapy for small cell lung cancer twice, the second time after the availability of COSELA. 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 COSELA. 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 COSELA. So we've with strong support for COSELA in accounts where we have rep access and physician and patient experience. But thus far, we have lacked the required demand creation fire power in many of the largest accounts. So I'll now cover our progress with the new G1 COSELA-focused sales force.

We believe that a novel and innovative launch product, like COSELA, will benefit from a sales team 100% dedicated to accessing and driving depth in those 100 organizations, which provide care for more than half of patients who could benefit from COSELA. We are hiring professionals with extensive tenure and experience in oncology sales and with demonstrated the ability to gain access to and to be successful in the accounts we're focused on.

So to provide a sense of interest in these physicians, we've received hundreds of applicants for the field physicians and have identified 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 COSELA is a novel breakthrough therapy and priority review drug. They know it has a novel mechanism of action, dual committee endorsement from NCCN, strong reimbursement coverage and no competition. They know all of that, and they want to share in driving the growth and success of COSELA.

So as of today, we have already hired a Vice President of Sales. We have an offer accepted for our Regional Sales Director. We also have offers out or accepted for 4 sales representatives. One of them started earlier this week. Just in these 6 individuals, we have nearly 100 years of collective selling experience in oncology. Overall, we expect to have the 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 protractive 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.

COSELA 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 COSELA 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?

Thanks, Andrew, and good morning, everyone. I'm going to cover 2 topics. First, I will provide a brief update on 2 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 COSELA within the next 6 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 multilineage myelosuppression in their clinic, and the medical and economic value of appropriate use of COSELA. 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 multi-lineage 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 twofold 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 trilaciclib 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-TIGITs, TIM-3s and LAG-3s.

In that regard, you saw in this morning's press release, we will initiate 2 new G1-sponsored trials later this quarter. The first study that we expect to initiate is a Phase II, single-arm trial study of trilaciclib in combination with sacituzumab govitecan, an ADC in patients with locally advanced or metastatic triple-negative breast cancer. This is an area where trilaciclib in our Phase II trial and this ADC have both shown survival benefits and could act synergistically to improve patient outcomes, along with reduced mylosuppressive 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 antitumor mechanism of action of trilaciclib. 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, [edging] 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 trilaciclib. 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 2 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 this mechanism of action, we believe there could be an improvement in outcomes by adding trilaciclib to this combination.

G1 has a robust investigator-initiated study program. We have 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 trilaciclib 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 trilaciclib 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?

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 10-Q, 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 Simcere, and delivery of clinical drug supply and manufacturing services to Simcere, EQRx and Genor.

Cost of goods sold for the 3 months ended September 30, 2021, was $0.6 million. And as a reminder, the majority of the manufacturing costs related to COSELA sales were incurred prior to FDA approval and, therefore, were recorded as R&D expense in prior periods. These 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 product 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 upsized 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 1 at the close of the amendment. Including both our cash position as of September 30 and the impact of our amendment agreement with Hercules, we have 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. 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 COSELA 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.

Now before I 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 plague 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 physicians 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 2 new trilaciclib 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 trilaciclib. 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 third-line study, we expect to support an ISS in first-line non-small cell lung cancer.

And as a result of our strong cash position at the end of the third quarter and the restructuring of our Hercules loan, our cash runway now takes us into 2024.

Thank you for your time this afternoon, and we'll speak again in this format in February on the full 2021 call. So 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?

(Operator Instructions) Your first question comes from the line of Kaveri Pohlman from BTIG.

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 COSELA as both supportive and antitumor drug. Can you tell us your strategy there, how you plan to move forward from the primary end point of myeloprotection to secondary end points of efficacy?

Yes. Thanks, Kaveri. I appreciate the question. You're correct. On the CRC, we are -- 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.

Thanks, Jack. Thanks, 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. The -- 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 TNBC will really -- and peripheral blood data in the TNBC will allow us to then make correlations of what we see in the peripheral blood versus the tumor.

Got it. And maybe one question, maybe a little bit of a remedial question. Is there -- 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 having extension of -- besides the small cell lung cancer would be really helpful for those patients. So just your thoughts there.

Yes. So in all of our studies, we're evaluating myeloprotection as well. So for example, the TNBC 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 myeloprotection across a variety of tumors and a variety of chemotherapeutic agents.

Operator? Gail? 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 with everybody after the call. I apologize for the technical issues on their end.

Okay. Well, thank you, Will. Sorry for the technical difficulties. Just to conclude, we are actively bringing COSELA 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.