G1 Therapeutics, Inc.
Q3 2021 Earnings Call Transcript

Published: 3 Nov 2021

[Operator:]

Good day, and thank you for standing by. Welcome to the G1 Therapeutics Third 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. I would now like to turn the conference over to your speaker today Will Roberts. Thank you. Please go ahead.

[Will Roberts:]

Thank you, Gail. Good afternoon, 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 launch 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 became available in the channel in early March of 2021. A Q&A 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; and Andrew Perry, Chief Commercial Officer; and Raj Malik, our Chief Medical Officer. With that, I’ll turn the call over to Jack. Jack?

[Jack Bailey:]

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 of COSELA for patients, healthcare professionals and investors. COSELA is a paradigm changing drug, excuse me. 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 file claims. Along with a new permanent J Code that went on active only one month ago, high awareness and attention to treat an 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 into supplemental G1 sales force to access these top accounts. As our co-promotion partner Boehringer Ingelheim 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, we are also taking hold 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 in a variety of tumors, chemotherapeutic backbones, and a 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 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 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 results for the quarter, including that our cash runway now takes us into 2024. Then I’ll be back for some 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 the 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?

[Andrew Perry:]

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 (0

[Raj Malik:]

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 COSELA 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 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 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 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 a company evolves, this will include trials with a variety of additional chemotherapy backbones, but also potential combinations with agents with a variety of novel anti-tumor mechanisms like ADCs and anti-TIGITs, 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 2 single arm trial study of trilaciclib in combination with sacituzumab govitecan and ADC in patients with locally advanced or metastatic triple negative breast cancer. This is an area where trilaciclib in our Phase 2 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 2 single arm study, which we discussed on the last call to further support, the anti-tumor mechanism of action of trilaciclib. We also expect to initiate this Phase 2 trial soon. In addition to providing further insights into the mechanism of action, these data should also provide support for novel combination approaches, aging with anti-TIGIT or LAG3 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 2 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 2 trial and reallocate those funds to support the two new Phase 2 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 and outcomes by adding trilaciclib to this combination. G1 has a robust investigator initiated study program. We’ve indicated a variety of areas that are our 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, but 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?

[Jen Moses:]

Thanks, Raj. And good morning, everyone. As Will mentioned, full financial results for the third quarter 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 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 three 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 expense 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 in 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 with 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 then 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?

[Jack Bailey:]

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. Before we move to Q&A, let me just recap what you 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 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 two new trilaciclib Phase 2 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, 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 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. We will speak again in this format in February on the full 2021 call, though I’m sure I’ll see many of you in during the late fall and winter road shows 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:]

Your first question comes from the line of Kaveri Pohlman from BTIG. Your line is open.

[Kaveri Pohlman:]

Yes. 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 core tumors like colorectal cancer? And my second question is also regarding the CRC study. You’re testing COSELA as both supportive and anti-tumor drug. Can you tell us your strategy there, how you plan to move forward from the primary end point of myeloprotection through secondary endpoint of efficacy?

[Jack Bailey:]

Yes. Thanks, Kaveri. I appreciate the question. You’re correct. On the CRC, we are – I’m going to take the second one and then put the first one over to Raj. On CRC, we are measuring our primary is indeed myelosuppression, but we have allocated 20% of the alpha2 anti-tumor 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.

[Raj Malik:]

Thanks, Jack. Hi, Kaveri. So the MOA study that I just described is looking specifically for changes within the tumor micro environment. 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 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.

[Kaveri Pohlman:]

Got it. Thank you. And maybe one question, maybe a little of 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 off, they have beaten up immune system and like having expansion of besides the small cell lung cancer, it would be really helpful for those patients. So just your thought there.

[Raj Malik:]

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 are focusing on myeloprotection. One of the important outcomes in addition to antitumor efficacy as Jack mentioned. So as these studies readout, we will have a sense of myeloprotection across a variety of tumors and a variety of chemotherapeutic agents.

[Kaveri Pohlman:]

Makes sense. Thank you.

[Will Roberts:]

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

[Jack Bailey:]

Okay. Well, thank you, all. Sorry for the technical difficulties. Just to conclude, we’re 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.