Jeffrey S. Farrow
Thanks, Aziz, and good afternoon, everyone. Echoing Bobby's and Aziz's comments, we had a remarkable quarter. In the second quarter, XDEMVY generated $102.7 million in net product sales, marking our strongest quarter to date. The response to XDEMVY has reinforced our conviction in its blockbuster plus potential, and we see substantial long-term opportunity to expand its role in eye care and reach more patients around the world. In the second quarter, we shipped approximately 94,000 bottles to distributors and dispensed approximately 91,000 bottles to patients, slightly above the top end of our Q2 guidance of 90,000 bottles dispensed. Inventory levels at the distributors were consistent with the prior quarter at approximately 2.5 weeks. As a reminder, we recognize revenue when XDEMVY is shipped from our warehouse to the distributors, not on bottles dispensed to patients. Gross-to-net discount for the second quarter was in line with our guidance at approximately 45%, and the sequential improvement in the discount was primarily driven by a reduction in patient copays as many patients work through their annual deductibles. Gross margins were flat at 93%. Continuing through the P&L, increases in SG&A expenses of approximately $44 million in the second quarter of 2025 as compared to the prior year were primarily driven by sales and marketing costs to support the XDEMVY launch. Specifically, direct-to-consumer advertising costs, increases in employee-related costs due to the larger sales force as well as variable costs associated with growing prescription numbers and sales. These variable costs include pharmacy fees, prior authorization, support at ECP offices and patient support programs. R&D expenses increased by $3.3 million in Q2 2025 from the prior year, primarily due to expenses related to the TP-04 program and other research and development programs as well as higher employee-related expenses. Cash and cash equivalents at quarter end were approximately $381 million. All other financial details are outlined in the earnings release we issued earlier this afternoon. Looking ahead, we remain confident in the strong near- and long-term growth potential of XDEMVY with our sales force gaining even more momentum among ECPs, our direct-to-consumer campaign driving more patients to proactively request XDEMVY and physicians increasingly shifting from monthly to weekly and even daily prescribing, we are well positioned for continued success. For the third quarter, we expect inventory levels to remain in line with Q2 2025 at approximately 2.5 weeks. Gross-to-net discount to improve and be in the range of approximately 43% to 45% with continued improvement into the low 40s by year-end 2025. And SG&A to remain relatively consistent with Q2 as we plan to maintain annual DTC costs in the range of $70 million to $80 million. Since the launch of XDEMVY, we have demonstrated consistent quarter-over-quarter growth of bottles dispensed. And in terms of demand, we expect to build on the tremendous success we generated in the second quarter with even stronger performance in Q3 despite the typical seasonal headwinds like summer vacations and holidays. For the third quarter, we expect bottles dispensed in the range of 95,000 to 100,000. Consistent with our previous statement in the fourth quarter and beyond, we expect the accelerating impact of our direct-to-consumer campaign, motivated sales force and positive reimbursement dynamics to continue to fuel the launch of XDEMVY. Turning to our pipeline of future growth drivers. We remain on track to initiate the Phase II study for OR later this year and have already begun key preparations and validation efforts, including clinical site selection and the development of objective and replicable scales. Correspondingly, we expect R&D expenses to increase with the planned initiation of this study in the second half of 2025 and anticipate total costs between $7 million and $10 million split between 2025 and 2026. As we look at the potential for XDEMVY's global expansion, meetings with regulatory authorities in Japan remain on track for the second half of this year and potential European regulatory approval for a preservative-free formulation of XDEMVY is expected in 2027. In closing, we are entering the third quarter in a position of strength. With strong tailwinds from our investments in DTC and our exceptional sales force, we are poised to continue building on our growth trajectory, and we look forward to sharing more updates with you in the coming quarters. I will now turn the call back to Bobby for final remarks.