Glen French
Analyst · Morgan Stanley
Thanks, Laine. Good afternoon, everyone, and welcome to our second quarter 2022 earnings call. Here with me is Derrick Sung, our Chief Financial Officer. In the second quarter, we generated worldwide sales of $14 million, representing our highest quarterly revenue to date. We're pleased with our second quarter performance as we continue to see strong patient demand for our Zephyr Valves improving end market dynamics and the ability of our team to execute and manage our business in a fluid environment. Our performance was driven by particularly strong results in the United States, where we achieved sales 18% higher than our previous record in the fourth quarter of last year as procedure volumes recovered from the winter COVID surge despite continued pressures from hospital staffing shortages. The momentum exiting the quarter leaves us confident in our ability to deliver on our full year 2022 revenue guidance of $55 million to $60 million even in the face of ongoing macro uncertainties and incremental foreign exchange headwinds. Throughout the second quarter, we continued to execute on our initiatives to expand our global commercial footprint. In the United States, we added 18 new treating centers, bringing our total number to 248 and keeping us on track to meet our objective of establishing at least 280 trained Zephyr Valve centers in the U.S. by year-end. We also added on additional sales territory in the U.S. and 2 additional international sales territories, bringing our total U.S. and international sales territories to 55 and 36, respectively. One of our primary goals is to educate both health care providers and patients about endobronchial valves being part of the standard of care for severe emphysema. In the second quarter, we launched joint education campaigns with 2 leading lung advocacy organizations, The American Lung Association and the COPD Foundation. These collaborations will extend through 2022 and include educational materials for patients, physicians, nurses and respiratory therapists including accredited courses, videos, webinars, podcasts and articles. We have also expanded our health care provider education outreach at the local level with a focus on a selection of community physicians who manage large populations of COPD patients. Together with our physician collaborators, we continue to build on the clinical evidence for Zephyr Valves. In June, the first prospective study to assess cardiac function following bronchoscopic lung volume reduction with Zephyr Valves was published in the American Journal of Respiratory and Critical Care Medicine. This study found that a reduction in lung hyperinflation using Zephyr Valves resulted in improvements in cardiac function, such as preload, cardiac output and heart muscle contractility, thus suggesting a role for Zephyr Valves in modifying the risk for heart failure in severe emphysema patients. Innovative clinical work such as this continues to advance the scientific evidence demonstrating the clinical value of endobronchial valves. Turning to our longer-term growth initiatives to expand our addressable market. We are excited about 2 upcoming data readouts associated with our AeriSeal clinical development program. As a reminder, we are developing AeriSeal to provide a solution for severe emphysema patients not currently eligible for Zephyr Valves due to the presence of a gap in the fissure separating lobes of the lungs, which results in collateral ventilation or air flow between the lobes. This collateral ventilation prevents a target lobe from deflating when Zephyr Valves are inserted. AeriSeal is a polymeric foam that is delivered via a bronchoscope to seal the airways leading to the fissure gaps between the lobes of the lung, potentially enabling treatment of patients who were previously ineligible for valves due to collateral ventilation. Thus, we see AeriSeal as a potential way to increase the number of patients who are candidates for Zephyr Valve therapy. We are looking forward to seeing the publication of data from a single center proof-of-concept, investigator-led feasibility study from Australia that evaluated AeriSeal to eliminate collateral ventilation in the target lobe, and if successful, then followed up treatment of that lobe with Zephyr Valves. This manuscript was recently accepted and is expected to publish in the coming months. AeriSeal is also currently being studied in our CONVERT trial, a multicenter, multinational study, which we are conducting in Europe. We are also pleased that interim data from this trial has been accepted for a podium presentation at the upcoming European Respiratory Society International Congress in Barcelona, Spain on September 4. At this presentation, we expect to share data on an initial subset of CONVERT patients that will shed light on the preliminary conversion with AeriSeal of targeted patients with collateral ventilation. This information should provide additional insight and proof-of-concept around the use of AeriSeal to expand Zephyr Valves to severe emphysema patients with collateral ventilation in a larger multicenter study. Learning from the CONVERT trial continues to inform the design of our U.S. IDE study, which we are discussing with FDA and expect to initiate sometime next year. Lastly, our initiative to expand geographically into the Japanese market remains on track. We recently hired an experienced leader in Japan to drive our commercial efforts and we are engaged in a constructive dialogue with the Japanese authorities following the submission of our regulatory application late last year. We continue to expect regulatory approval in Japan by the end of this year, followed by the establishment of reimbursement and subsequent commercial launch in the back half of 2023. Again, we estimate Japan to be a $1 billion opportunity with approximately 100,000 patients in need of our Zephyr Valve treatment. In summary, I believe the record sales that we achieved in the second quarter along with the continued progress on our commercial and strategic initiatives positions us well for continued growth through the remainder of the year and well into the future. With that, I'll now turn the call over to Derrick to provide a more detailed review of our second quarter results.