G1 Therapeutics, Inc.

Good day. Thank you for standing by and welcome to the G1 Therapeutics Second Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. I would now like to turn the conference over to your host, Mr. Will Roberts, please go ahead, sir.

Thank you, Les. Good afternoon, everyone, and welcome to the G1 conference call to discuss our second quarter of 2021 financial results and business update. The press release on these financial results was issued after market closed this afternoon and can be found in the news section of our corporate website, g1therapeutics.com. On this call, the team will provide a business overview of the second quarter of 2021 and including an update on our launch progress in that period with COSELLA, which was approved by the U.S. Food and Drug Administration on February 12th, 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 ESSCLC, and became available in the channel in early March of 2021. The question and answer session will follow the prepared remarks. 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 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, August 4, 2021. Joining me on the call today are Jack Bailey, our Chief Executive Officer, Jen Moses, our Chief Financial Officer, and Raj Malik, our Chief Medical Officer. With that, I'll turn the call over to Jack. Jack?

Thanks, Will. Good afternoon, everyone, and thank you for joining us on the call today. Today's headline from the second quarter is one of a continued focus on execution, both as it relates to our early readout of our ongoing commercial launch of COSELLA and as it relates to our clinical programs. Now, I joined G1 because of our shared commitment to improve the lives of people impacted by cancer. This core mission is tangible at G1, and I am confident in the G1 team as we seek to help as many people with cancer as we can and drive long-term value for our shareholders. We believe 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 small cell lung cancer patients with certain chemotherapy regimens. It allows oncologists treating small cell lung cancer patients to move away from treating significant myelosuppressive side effects individually with different drugs after the damage has been done, to instead enabling them to help decrease or prevent the occurrence of these side effects altogether with the proactive use of a single therapy. And during the second quarter, we continued to lay the groundwork for broad commercial access to COSELLA as we made progress toward our long-term goal of ensuring the availability of this important drug. But we also remain equally focused on COSELLA's next indications. During the second quarter, we initiated three new clinical trials with COSELLA, including a registrational trial in metastatic triple negative breast cancer and two phase two trials in patients with non-small cell lung and bladder cancer. This is in addition to the pivotal trial in colorectal cancer, dosing four, which was initiated in the first quarter. So in total, we now have two phase three registrational trials and three phase two trials ongoing with multiple readouts starting in the second half of 2022. Now we have a lot of important content to cover today. I will cover our commercial efforts for the second quarter of 2021, the first full quarter of COSELLA sales, and also provide an update on the leading and lagging indicators of COSELLA access and uptake that we introduced on the last call. Raj will then provide an update on some of our medical efforts and clinical milestones during the second quarter. He will also touch on the upcoming trial that we expect to initiate in the fourth quarter of this year. designed to further define the immune-based anti-tumor mechanism of action of COSELLA. Finally, Jen will provide the financial results for the quarter. Then I'll be back for some concluding comments. Now, before we discuss our results for the quarter, you likely saw that on Monday we announced that Soma Gupta left the organization for personal and professional reasons. We appreciate her contributions to the planning and the launch of COSELLA and certainly wish her the best going forward. We also announced at the same time that we have hired a new chief commercial officer, Andrew Perry, the former vice president of U.S. marketing at Beef Healthcare North America, a joint venture majority owned by GlaxoSmithKline. He is a proven leader and strategist with a history of driving consistent performance and commercial success and has tremendous commercial experience across a wide variety of specialties, including oncology. especially in areas including commercial launch strategy, execution, and co-promotion management. Andrew starts on August 16th, and I really look forward to having all of you meet him on our next business update. Now, turning our attention first to the commercial update, the launch efforts of the combined G1 and Beringer-Egelheim commercial team during the quarter resulted in us booking $2.5 million in net sales of Cosella for the quarter ending June 30th. Much of the last three months was spent with various community practices and hospital systems to gain inclusion on formulary and order sets. And this will remain a key focus for the coming months as well. For those not familiar with the process of formulary inclusion, it's multi-step requiring doctor advocacy in a practice or institution, having a successful P&T scheduled and decision taken, and then where they exist, incorporation into EHR order sets. It's worth noting that this year, primarily due to the slow open of the country, we have seen a number of these planned P&T meetings postponed, which can affect the speed of uptake. On our last call, we set up a variety of leading and lagging indicators to help you follow our progress quarter over quarter, which I will now cover. I'll focus in on four key areas, awareness, coverage and reimbursement, engagement, and utilization. Now, for awareness, both aided and unaided are solid. As of the end of June, our unaided awareness, or awareness of COSELLA without specific prompts, was at 56%. And aided awareness, based upon questions on familiarity with COSELLA and its indication, was at 77%. These are both above benchmark for this point in an oncology product law. Now regarding coverage and reimbursement, all of the payers have been covering COSELLA when written to label. Approximately 60% is Medicare Part B, 30% is commercial, and the remaining 10% is government and other forms of coverage. And we now have payer policies in place or pending that provide coverage for approximately 80% of unlabeled patient lives. Three of the top five U.S. payers have made positive formal coverage decisions within the first four months of product availability. Most importantly, we are not seeing any pushback in terms of reimbursement of filed claims. We have had formulary approval at 18 of our top 100 organizations, and 21 organizations have proceeded with inclusion of COSELLA into their order sets. Now, not all of our top 100 organizations have a P&T process for use, and some are still determining how to incorporate COSELLA into their order set. We expect additional approvals over the coming months. Now, as you may recall, we filed for our C code and permanent J code in March, and we recently received both. Our C code for pass-through hospital outpatient system use became effective on July 1, and our permanent J-code for all sites of care across all channels will become effective October 1. And as you saw this morning, we were just issued a new technology add-on payment, or NTAP, for COSELLA. It will also become effective for provider billing on October 1, 2021. The NTAP is an important tool that provides additional payment to hospitals above the standard DRG payment amount. Moving on to engagement perspective, as of the end of June, the team has achieved approximately 53% reach to our 2,500 targeted HCPs and made an additional nearly 4,000 targeted calls to other prescription-enabling functions, such as nurses and pharmacists, who are critical stakeholders in the supportive care space. At the end of Q2, almost 60% of these calls were still virtual. And while we believe the ratio of in-person to virtual calls will improve over time, we don't yet know how quickly or how many institutions will remain virtual in a post-COVID environment. As some of our oncology peer companies have recently stated, the oncology category is lagging most other therapeutic areas, many of which we're approaching pre-COVID levels. This is a macro issue which we are closely monitoring as we head into the next few months. This also underscores that continued maturation of our virtual capabilities will continue to be vital, as this will be an increasingly important and expected way to reach many in our target audience. From a utilization perspective, in the second quarter, 70% of our demand came from community hospitals or clinics, with the remaining 30% coming from academic hospitals. We received orders from 68 unique organizations up from 20 at the end of March. 28 of those are from our top 100 priority organizations, again, up from seven that had worked at the end of March. These priority organizations are essential to not only driving the breadth or trial of COSELLA into the community and hospital accounts across the US, but also the death or number of physicians in any given practice using a drug and encouraging others to do so. At this point, The breadth of adoption to date of COSELLA is directionally correct. However, we are increasing our efforts to drive depth across these accounts. Now before I close, I want to comment on some things we are seeing in the channel in the third quarter. We have seen some recent softness in orders, which we believe is addressable. As you've just heard, the performance metrics for the second quarter are solid, despite a slower than ideal opening of the country. We have good awareness The product is performing clinically as expected. Physician experience with the drug is excellent, and we have encouraging data that shows accounts that trial the drug are embracing it, so strong depth can be achieved. Our breadth, as I said, is directionally correct, but driving depth is the next challenge. We have some regions of the country that are outperforming on this dimension. However, others are underperforming. We will look to address this and drive more consistent and stronger execution across the country in all regions. So to summarize, our net sales for the second quarter were just over $2.5 million. Both aided and unaided awareness are above baseline for a product like this. We have moved through several operational hurdles, for example, the NCCN guidelines and payer reviews, while still having many P&T processes yet to complete. We have seen no issues in coverage and reimbursement, and we have received our C code, permanent J code, and NTAP, with the latter two being effective on October 1st of this year. We will continue to monitor the impact of COVID-19 variants on the opening of our target community practices and hospital systems and their willingness to receive reps into their offices. And while in-person selling is important, and also likely more critical for a buy-and-bill cell like Priscilla. We intend to remain as effective as possible, even in a virtual sales environment, and will continue to evolve and improve our virtual capabilities going forward. Now, with that, I'll turn it over to Raj for an update on our medical and clinical efforts during the second quarter. Raj?