Vijay Shreedhar
Analyst · SVB Leerink. Please go ahead
Thank you, Neil, and good afternoon, everyone. I will begin my comments with highlights of our performance in Q4, outline our commercialization strategy for the launch of the second indication for GOCOVRI for the treatment of Parkinson's patients with OFF episodes, and provide an update on the ongoing integration of OSMOLEX ER into our product portfolio. Starting with performance. Q4 total GOCOVRI paid prescriptions, or TRx, that exclude product from the free trial program were the highest in 2020 at 8,165. This represented year-over-year growth of 14% versus Q4 of last year and 5% higher versus the prior quarter. Full year TRx for 2020 were 31,070, representing a 21% increase over TRx in 2019. In Q4, patients' visits to clinics continue to be significantly impacted by the COVID-19 pandemic. We are therefore very pleased with the strong TRx numbers seen in the quarter. Further we also saw the highest number of new paid prescriptions or NRx for 2020 in the quarter, 510 NRx representing a 19% increase versus the previous quarter. The growth in numbers of new patients coming after the strong NRx results we reported in Q3 highlights continued momentum for GOCOVRI. We believe our strong performance was the result of disciplined and consistent execution to advance our strategic priorities, raising the urgency to treat, which we advanced through patient education program, featuring our patient ambassadors, effectively differentiating GOCOVRI through our sales force activity and digital campaigns, and improving access and customer satisfaction through services at GOCOVRI onboard. It is notable that in Q4, our sales force achieved a significant proportion of the pre-pandemic activity level. 50% of which was virtual, highlighting that our team has effectively adapted to drive growth. We enter 2021 with optimism, despite the complex situation with patient appointments remaining disrupted across the country. The resources we've put in place, give us confidence in our ability to navigate this environment effectively and to adapt quickly. We are also encouraged by the vaccine rollout, gaining momentum with prescribers and staff, expressing confidence in allowing sales representatives increased in-person access. Switching to the recent FDA approval of a second indication for GOCOVRI to treat OFF episodes, we are excited about the launch of this label expansion as it makes GOCOVRI the first and only product indicated for both the treatment of OFF episodes and dyskinesia, the two extremes of the motor complications spectrum. We estimate that this expanded label more than doubled our addressable patient population for which GOCOVRI is now indicated, to include those who experience OFF, dyskinesia or both. To elaborate of the 1 million patients in the U.S. diagnosed with Parkinson's disease around 700,000 are treated with levodopa. Of these patients, an estimated 200,000 experience dyskinesia with or without OFF episodes, GOCOVRI as the only product indicated for the treatment of dyskinesia has been addressing the unmet need of these patients since approval in 2017. In addition, another 200,000 to 300,000 patients experience OFF episodes only, with its second indication, GOCOVRI will now be able to address the unmet need of this new group of patients thereby significantly expanding our total addressable population to 400,000 to 500,000 patients. We believe that our opportunity for growth through this launch is significant for two reasons. First, in the absence of having an indication for OFF episodes, payers had not evaluated GOCOVRI to treat off. Many payers create criteria for utilization directly based on indication. This approval will address prescriber hesitation related to payer coverage and access barriers, allowing them to choose GOCOVRI to treat OFF episodes. Second, identification of patients for GOCOVRI in the past required documentation of dyskinesia, which may not be seen in patients struggling with OFF episodes, this approval offers the opportunity to address these additional patients and use GOCOVRI earlier in the treatment paradigm. While there are other products indicated for OFF, GOCOVRI is now the most differentiated product, a QHS bedtime medication with two indications that could potentially help prescribers avoid the compromises previously necessary in managing their patients with motor complications. Our product positioning and branded campaign are robust and even more relevant with this approval and we are intensifying outreach to rapidly inform and educate prescribers, patients and payers in the first phase of the launch. We are unlocking the significant opportunity for GOCOVRI in a highly cost-efficient manner as the additional addressable patients are treated by the same prescribers in the same clinics that we currently call on with our sales force and reach through our marketing campaigns. Early feedback from prescribers and patients have been uniformly positive with thought leaders describing this development as an opportunity to change the perception of GOCOVRI from a dyskinesia drug to one that addresses both dyskinesia and OFF, thereby having the potential to become the “adjunctive therapy of choice for patients with motor complications”. Transitioning to OSMOLEX ER, the team is integrating OSMOLEX ER into our product portfolio with current patients receiving uninterrupted care. This endeavor demonstrated our ability to integrate and commercialize new products and important indicator for us. We are currently maintaining the level of prior promotional efforts for OSMOLEX ER through a teller detailed team, with its indication for drug induced extrapyramidal reactions in adult patients. We believe OSMOLEX ER can address patient needs beyond Parkinson’s disease while amantadine IR is currently used in many of these areas, OSMOLEX ER is differentiated as an IR/ER or immediate release extended release formulation providing high doses directly upon ingestion followed by a more continuous extended release. We are conducting a comprehensive assessment of the appropriate therapeutic areas. We could efficiently target to grow the brand. Simultaneously, we’re evaluating organizational synergies as we complete the integration from distribution and patient services to digital promotion and our free trial program. We intend to provide more color on our plans for OSMOLEX ER on the first quarter call. 2020 was notable for its challenging circumstances and we are incredibly proud of our team for adapting seamlessly to this fluid environment and remaining focused on our mission to serve patients. I will now turn it over to Chris to provide an overview of our financial performance.