Glen French
Analyst · Bank of America. Your line is now open
Thanks, Brian. Good afternoon, everyone and welcome to our second quarter 2021 earnings call. Here with me today is Derrick Sung, our Chief Financial Officer. I'm very pleased to report that our business was quite resilient through the second quarter as we drove adoption of our life changing Zephyr Valve treatment. In Q2, we achieved worldwide sales of $12.2 million, which represents our highest level of quarterly revenue ever. In the United States, we experienced a recovery in procedure volume as hospital restrictions eased following the increase in vaccinations and decrease in COVID cases across the country. After working through some backlog in the first month of the quarter, we were encouraged by the sustained recovery in activity at our U.S. treating centers and the clear resumption of underlying demand for our Zephyr Valve treatment. Outside the U.S., our business faced continued pressure in the first part of the quarter because of the spring COVID surge that led to a new wave of lockdowns across a number of our markets in Europe. However, we saw a marked recovery in sales in June as COVID cases waned and hospitals began to reopen to procedures, and we remain optimistic that the recovery of our international business will be sustained in the back half of the year. Through the second quarter, we also made steady progress in other key objectives, building on our success in Q1. We’ve further augmented our commercial team, expanding our base of treatment centers, and we were successful in securing incremental commercial payer coverage in the U.S. Thus, we are updating our outlook for the rest of the year and now expect full year 2021 revenue to be in the range of $49 million to $51 million, up from our prior guidance of $48 million to $50 million. As we build a foundation to deliver on these expectations and sustain future growth, we continue to expand our commercial infrastructure. In the U.S., we have nearly completed our targeted sales territory expansion for the year with a total of 53 active territories, and we expect to add just 1 or 2 more through the remainder of the year. Outside the U.S., we've added 2 additional territories in Europe, bringing our total of international sales territories to 30. We have also continued our success in adding new Zephyr treatment centers and building interest among physicians for our life-changing therapy. In the U.S., we added 20 new treating centers during the second quarter, bringing our total U.S. treating centers to 180. We have -- we are well on track to meet our year-end objective to offer Zephyr Valve in at least 200 treating centers in the U.S. As we continue expanding our commercial footprint in the second quarter, we also launched a software upgrade to our Chartis system to new and existing customers that makes it simpler, faster, and more effective to definitively identify the patients most likely to benefit from our Zephyr Valve treatment. The upgrade enables highly accurate prediction of the absence of collateral ventilation at lower flow rates and in less time while also allowing physicians to easily record, export, and share video assessments. This upgrade is a testament to our dedication to innovation and further enhances the value of Chartis, which remains a key platform differentiator. Turning now to reimbursement. We have secured further positive policy wins across the Blue Cross Blue Shield plans. On our last call, we mentioned that we had received positive coverage policy from Blue Cross Blue Shield of Massachusetts, which took effect in June. Since our last call, we have also received a positive coverage policy decisions from Blue Cross Blue Shield of North Carolina, the largest payer in the state with over 2 million covered lives and Regent's Blue Cross Blue Shield, which covers nearly 2 million lives across Oregon, Washington, Idaho, and Utah. As we've discussed in the past, our policy wins with commercial payers in the U.S. validate the clinical acceptance of our technology and reduce the prior authorization time for patients waiting to receive Zephyr Valve treatment, but we no longer see reimbursement as a major barrier to adoption of our treatment. At Pulmonx, we take great pride in our scientific leadership in the field of interventional pulmonology. We are the first and only company to have demonstrated across four randomized controlled clinical trials that patients selected with our Chartis system and successfully treated with Zephyr Valves, show clinically meaningful and statistically significant improvements in lung function, exercise capacity, and quality of life compared to medical management alone. Zephyr Valve have been included in treatment guidelines for COPD worldwide, and the quality of evidence for treatment with endobronchial valves has been graded A by the global initiative for chronic obstructive pulmonary disease, widely known as GOLD. As part of our continued efforts to lead the science in our field, we were pleased to see the presentation and publication of long-term follow-up data from two of our key studies demonstrated the durability of the benefits associated with our Zephyr Valve treatment. Long-term follow-up data from the TRANSFORM study was presented at the American Thoracic Society Virtual Conference in May. TRANSFORM is the first multicenter randomized controlled trial to evaluate effectiveness and safety of Zephyr Valves in patients with heterogeneous emphysema selected for the absence of collateral ventilation in the target lobe. The original publication reported results out to 6 months, and we were pleased that the long-term follow-up data showed sustained quality of life improvement out to 24 months post treatment, lasting lung function improvement out to 24 months treatment -- post treatment, increased exercise capacity out to at least 18 months post treatment, and long-term reduction in hyperinflation, resulting in reduced breathlessness. In late July, long-term follow-up data from the IMPACT study was published in respiration, the International Journal of Thoracic Medicine. IMPACT was a multicenter randomized clinical trial that showed that Zephyr Valves deliver benefits to a group of patients who have very few treatment options because of wide spread and consistent destruction of lung tissue, also known as homogeneous distribution of emphysema. Zephyr is the only endobronchial valve to receive approval from FDA for the treatment of patients with homogeneous distribution of emphysema and is the only minimally invasive option available to help these patients breathe easier. We estimate that patients with homogeneous emphysema make up approximately half of the severe emphysema patients who are candidates for our treatment, and we believe our unique indication for treatment of this group of patients is a key differentiator that sets us apart from other competing technologies. Data from the July IMPACT publication demonstrated that improvements from baseline to 6 months seen in the Zephyr Valve group were maintained out to 12 months with clinically and statistically significant improvements in lung function, exercise capacity, quality of life, and reduced breathlessness. That is the -- this is the first report of a multicenter study, showing benefit out to at least 1-year of this homogeneous emphysema patient population. Together, the long-term data from both TRANSFORM and IMPACT demonstrate that our Zephyr Valve is a safe and effective treatment option with long-term benefits for patients with severe emphysema, including those with homogeneous disease who have few other alternatives. To summarize, we've continued to make strong progress across all of our key commercial objectives, have made progress in advancing both science and technology around our offering and continue to receive validation from our clinical and economic stakeholders that Zephyr Valve offer lasting and life-changing benefits to our patients. As we look ahead, we are optimistic in our long-term growth trajectory given our performance to date. With that said, I will now turn the call over to Derrick to provide a more detailed review of our second quarter results.