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| And while we have a strong commercial team driving COSELA penetration and demand and a clear path to profitability in this first indication, our focus is also on generating the clinical results required for TNBC category leadership |
| Our estimate of COSELA patient share continues to grow, and although claims data for Q4 are not fully available, we estimate patient share of over 13% in the first-line market, demonstrating that there remains significant opportunity for growth |
| We have shown promising benefits thus far in our ongoing Phase 2 trial when trilaciclib is combined with a TROP2 ADC, including improvements in tolerability and more recently, in initial overall survival |
| With these and other recent results, we believe that continued clinical success in these trials could position G1 for category leadership across the spectrum of TNBC, in addition to our work in extensive stage small cell lung cancer |
| We've seen that market share go up very consistently even through that platinum shortage, and our market share continues to grow |
| We were able to achieve this goal and to continue to demonstrate a broader platform of deeply adopting customer organizations |
| All 3 of our sales regions generated double-digit volume growth in the fourth quarter |
| From a commercial perspective, as you'll hear from John and Andrew, we experienced strong COSELA growth in the fourth quarter of 2023, including revenue and vial volume growth of 29% and 19%, respectively |
| We continue to pursue new contract customer opportunities, and we've already seen our highest month ever for both volume and ex-factory sales in January, giving us confidence of continued growth going forward |
| And 1 example is our new strategic accounts team that we deployed in Q4 and into Q1, and we've been delighted about the progress they've made so far |
| We experienced an increase in patient vial demand towards the end of the third quarter of 2023, which was recognized as revenue in the fourth quarter in addition to that, which we recognized due to strong quarter-over-quarter growth |
| We continue to be confident in the ability of trilaciclib to achieve a positive outcome for a variety of reasons |
| Our payer mix remains stable with the majority covered by Medicare and third-party payer reimbursement has remained strong |
| These results show that trilaciclib can provide benefits during the administration with chemotherapy in the short term, and additional benefits after trilaciclib discontinuation by improving long-term immune surveillance |
| And we're talking about an overall market here accessible to COSELA, which we estimate at over $700 million in potential gross revenue, so a very, very significant market opportunity for us |
| We are encouraged by the feedback we received daily from physicians who rely on COSELA to reduce the chemotherapy-related myelosuppressive side effects in their patients with extensive stage small cell lung cancer and by the demand trajectory in Q4 2023 and the beginning of Q1 2024 |
| And of course, second, the strength of the data that precedes this trial provides additional confidence |
| The real-world evidence we continue to generate, the most recent cut of which was presented in October at the ASCO Quality Care Symposium and a Phase 2 investigator-initiated trial at UNC Lineberger in combination with lurbinectedin, which according to the study investigator continues to look promising from the perspective of both mono protection and tumor responses |
| Focusing on the top 100 customer organizations, which represent around half the volume opportunity in the market, our growth was higher at 24% in the segment, and we added 2 new top 100 customers during Q4, meaning 75 of the top 100 of order COSELA launched today |
| In January, we described promising initial efficacy results including meaningful improvements in median overall survival among patients receiving trilaciclib compared to historical results for the ADC alone |
| And then second, on the commercial side, the 13% penetration in frontline seems really strong |
| Our total revenue for the fourth quarter of 2023 grew 45% over the fourth quarter of 2022 to $14.9 million comprised of the $13.9 million I just described in net COSELA revenue and $1 million in license revenue |
| Contracted customers grew 28% during the quarter and made up around 1/3 of our overall volume |
| So we're very ambitious for what we can continue to add and that market share going forward |
| Net sales of COSELA grew 29% in the fourth quarter of 2023 to $13.9 million compared to 19% quarterly vial volume growth |
| That said, as we discussed the milestones we have achieved during the fourth quarter, it's essential we continue to look forward to and prepare for the opportunities ahead, namely that of category leadership in triple-negative breast cancer if we are successful in our clinical programs |
| This compares favorably to the $10.3 million in total revenue, including $8.9 million in product revenue in the fourth quarter of 2022 |
| Assuming the updated results remain strong, we anticipate continued partnership interest in developing trilaciclib with TROP2 ADCs that are in various stages of clinical development in TNBC and beyond |
| We frequently described the Phase 2 trial in which we saw statistically significant improvements in median overall survival in patients receiving trilaciclib prior to gemcitabine carboplatin compared to those receiving chemotherapy alone |
| And if you recall, the - at 12 months, we had about a 20% improvement |
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| Maybe just overall, I mean, initially, the frontline TNBC data were delayed from sort of your very initial expectations, which I guess, kind of suggests that the event rate is maybe occurring a little bit slower than initially anticipated, and hopefully, some of that is due to the addition of COSELA |
| Our goal in Q4 was to restore the momentum we have built early in the year, which has been interrupted by supply disruptions of carboplatin and cisplatin during Q2 and Q3 |
| As we guided in November, our operating expenses of $122 million in 2023 were 35% lower than the $187.5 million in OpEx in 2022 |
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