Glen French
Analyst · Morgan Stanley. Cecilia, your line is open. Please go ahead
Thanks, Laine. Good afternoon, everyone and welcome to our first quarter 2023 earnings call. Here with me is Derrick Sung, our Chief Financial Officer. I am delighted we are off to a strong start in 2023 with our focused commercial strategy on track to enable us to deliver on our near-term revenue commitments while we continue to make consistent progress on our longer-term geographic growth and clinical indication expansion initiatives. We achieved $14.5 million in worldwide sales, benefiting particularly from relative strength in the U.S. where we achieved 55% year-over-year sales growth. We expanded our base of treatment centers and saw relative stability and account activity despite typical first quarter seasonality. These trends, along with our commercial momentum exiting the first quarter, leave us confident that our 3-pronged strategy designed to build a strong foundation for long-term sustainable growth will enable us to achieve our previously communicated full year 2023 revenue guidance of $63 million to $65 million. As a reminder, our focused commercial strategy is as follows: first, training hospitals that we believe, based on our comprehensive assessment criteria, have the potential to be high-performing Zephyr Valve centers; second, providing information and education on Zephyr Valve program best practices to our physician and administrative champions, which facilitate increased efficiency and procedural capacity; and finally, increasing commercial activity by building local education and awareness of the substantial benefits of Zephyr Valves for emphysema patients and the COPD physicians who manage them. While we continue to make progress on all 3 initiatives, our primary focus this year remains on educating existing U.S. treating centers about best practices for Zephyr Valve programs to encourage greater efficiency, and therefore, procedural capacity and improve the patient experience. We are seeing an increasing number of our existing accounts investing in their Zephyr Valve programs as a key component of their growing pulmonology service lines. As our accounts seek to scale their programs, we are sharing best practices from our high volume accounts, both on the clinical front through expert case reviews and on the administrative side through clinical coordinator best practice training sessions. We are also taking the opportunity with sites trained virtually during the pandemic to provide in-person training and peer-to-peer education to accelerate their learning curves. As a result of these efforts, we are seeing a growing number of more efficient and more clinically experienced hospitals offering Zephyr Valves. We continue to expect to see the results of these and similar activities translate to sales and increased productivity in the back half of this year. As a reminder, we measure account productivity based on the average number of cases conducted in a given quarter by our active established Zephyr Valve treating hospitals, which are those that have been performing Zephyr Valve procedures for at least 12 months and have placed a revenue generating order in the quarter. Average account productivity for the first quarter of 2023 was approximately 4.1 cases in the U.S. remaining in the range of 4 to 5 cases per account that we have experienced since exiting the pandemic. As expected, the lower account productivity in the first quarter compared to the fourth quarter of 2022 largely reflected typical seasonal dynamics. Encouragingly, we saw the total number of active established accounts grow nicely, which thereby increased the denominator in our productivity calculation. We continue to expect a meaningful ramp in account productivity in the back half of the year, exiting 2023 above 5 cases per active established account. Meanwhile, U.S. account activity in the first quarter of 2023 was 74%, slightly higher than what we saw in the fourth quarter of 2022. As a reminder, we define account activity as the percentage of treating centers that place a revenue generating order in a given quarter. We continue to expect account activity to remain in the 75% range as we benefit from a more normalized operating environment and grow our denominator of treating centers. To that end, in the U.S., we added 15 new treating centers in the first quarter of 2023, bringing our total number of U.S. centers to 293. We continue to expect to identify and establish a total of 40 to 50 new accounts throughout the year. Beyond our near-term commercial strategy, we are also looking to further tap into the more than 1 million patients around the world who suffer from severe emphysema and are profoundly short of breath despite high dose medications. Following regulatory approval of our Zephyr Valve in Japan last year, we continue to expect the establishment of reimbursement and the initiation of sales through our post-market study in late 2023. As a reminder, we estimate Japan to have approximately 100,000 patients who stand to benefit from our treatment. In our clinical development pipeline, we remain on track with our AeriSeal program to meaningfully expand the addressable market for our Zephyr Valve solution. We continue to expect to complete enrollment this year of our CONVERT 1 trial with final data presented next year. We are also taking final steps to enable the launch of our next multinational clinical trial, which we call CONVERT 2, in the back half of this year. Results from CONVERT 2 will form the basis for our AeriSeal PMA submission. In summary, we are very pleased with our progress in increasing engagement with top centers and expanding best practices with our emerging centers. We have been delighted to see strong early traction and receptivity across our team and with our customers. As awareness around the unmatched benefits of Zephyr Valve procedure build, we believe we are well positioned to address the substantial unmet needs of the largely untapped global population of patients with severe emphysema. Again, we expect to build on this early commercial momentum to drive continued growth in the back half of the year. With that, I now turn the call over to Derrick to provide a more detailed review of our first quarter results.