Steve Williamson
Analyst · Stifel. Your line is open
Thanks, Laine. Good afternoon, everyone, and welcome to our first quarter 2025 earnings call. Here with me is Mehul Joshi, our Chief Financial Officer. I am pleased to report that Pulmonx delivered worldwide sales of $22.5 million in the first quarter of 2025, representing 20% growth over the same period last year and 21% on a constant currency basis. We're encouraged by our team's continued execution of our commercial initiatives, and we remain confident in our ability to deliver on our previously communicated revenue guidance of $96 million to $98 million for the full year 2025. Throughout the first quarter, we made steady progress executing our acquired test and treat strategy, setting the stage for sustained growth and long-term success. This strategy is focused on helping our customers more efficiently acquire the right patients, test them for eligibility and ultimately treat more patients suffering from COPD. We expect the strong foundation we are building will help accelerate penetration into our estimated $12 billion market opportunity, and support growth at/or above 20% over the long-term. As part of the first step of our strategy to acquire the right patients, we're increasing both clinician and patient awareness and engagement, while at the same time, rolling out tools like LungTraX Detect to help our customers identify patients with severe emphysema who are already under their care. Our market research indicates that the vast majority of pulmonologists are aware of endobronchial valves, but less than a third have referred a patient for evaluation. Our data indicate this is primarily related to a lack of familiarity with patient eligibility criteria. To address this gap in awareness, in Q1, we hosted over 40 peer to peer events, engaging and educating providers in the community who manage COPD patients about the selection criteria and benefits of Zephyr Valves. In addition, following the success of our previous Medscape CME courses, which engaged over 37,000 clinicians, in early April, we were excited to launch two new CME modules through Medscape that build on the prior programs. While virtual education is a cost effective means of reaching a large audience, often in person education of the highest potential clinicians can help drive engagement and action. As our sales team has successfully established a footprint of treating centers across the globe, we’re now beginning to pilot cost efficient programs to engage larger numbers of high potential COPD clinicians in our most developed markets. This year we’re expanding our field presence by hiring therapy awareness specialists dedicated to community physician education who we expect to increase referrals for valve treatment. We’ve hired and trained our first seven target geographies in the US We anticipate they will begin to make an impact starting in the second half of the year. One of the dynamics we’ve also identified through our research is that clinicians less familiar with valves may be reluctant to refer unless prompted by the patient for fear the patient may not qualify and be disappointed. For that reason, we’ve seen benefits to educating patients to be their own advocates and encourage their physicians to explain their full range of options. In Q1, we continued to refine our direct to patient targeting and education and we saw a record number of unique patient engagements driven by these DTP initiatives. As a result of these efforts, we’re confident we are on track to meet the patient education goals communicated on our last call. In addition to our work on education and engagement of providers, we are increasingly encouraged by our customers’ progress in identifying patients who may qualify for valves who are already under management in their facilities for other medical conditions. Our LungTraX Detect system prospectively analyzes CT scans and hospital PAC systems to identify patients with radiographic emphysema and seamlessly integrates them into a simple workflow for further evaluation. We are encouraged by the early results of our first handful of active centers where LungTraX detect customers are seeing an average rate of emphysema detection of approximately 15% consistent with previously published data. We’re also seeing a significant increase in the number of patients entering workup in our pilot sites. Most importantly, clinicians seem to grasp the benefits of shifting from lung cancer screening to a more comprehensive lung health screening approach. I’m pleased with the number of customers entering the contracting phase and we expect to see more hospitals activating LungTrax detect throughout the year. Now shifting to the second leg of our strategy, the test phase focuses on relieving what can be a bottleneck to care, the coordination of patient workflow and helping scale high volume treatment centers. One key element to this is gaining hospital administrative support. The concept that is increasingly resonating with hospital executives is the value of building and scaling comprehensive lung health programs, which offer broad benefits compared to silo disease specific programs for lung cancer, lung transplantation or COPD. For example, many hospitals today offer cancer screening, but these programs are often not set up to trigger action on other serious conditions found by the screening, such as emphysema. Leading hospitals are now establishing lung health programs that have care coordination and clinical pathways designed to support holistic patient care. These hospitals recognize that by investing in pulmonary patient care, they can attract many new patients into their health care system and optimize the care of patients they already see. By being proactive, these hospitals are improving the health of communities they serve, increasing reimbursement for their system and reducing mortality from lung disease. We have found that the most successful centers have dedicated support staff, including clinical navigators, who enhance workflow efficiency by guiding patients through the testing process. However, some institutions hesitate to add additional headcount. To address this, we're marketing a new program that offers our hospitals a third-party technology-enabled solution to virtually manage patients through the hospital's workflow process. Early feedback from the first customer has been that the service efficiently streamlines the process of qualifying patients from LungTrax detect and scheduling them for work. We believe this third-party service is an efficient solution for hospitals to scale work up without adding internal headcount. Although, we are in an early phase, we're encouraged by our results thus far and have begun targeted marketing of this program to LungTrax the tech customers and customers with internal resource constraints. Another way to expand test capacity is to expand the number of center screening patients. In Q1, we also added 10 new U.S. accounts, ending the quarter with 285 active accounts. We define active accounts as centers that have placed a revenue-generating order in the quarter. Looking ahead, we'll continue to add new high potential accounts opportunistically. Turning to the third and final leg of our strategy focused on treat. We are increasing our global footprint and seeking to expand indications to fuel our long-term growth potential. In Q1, we delivered strong international year-over-year revenue growth of 39% and marking a material acceleration as we anticipated. Results were driven by continued strength in China and growth in select international markets. In Europe, we continue to deploy proven sales tools we utilize in the U.S. for use in local geographies. And this includes operational best practice sharing, community physician engagement, virtual case discussions with experts and peer-to-peer education programs. Furthermore, we're exploring a variety of targeted approaches to increase severe emphysema screening and existing accounts looking to develop their case volumes further, such as review of pulmonary function test results and lung cancer screening test results for patients with high levels of trapped air or emphysema disruption. We anticipate the impact of our international efforts to continue to drive revenue growth in the near term, particularly through the first half of 2020. Outside of Europe, we're making progress in our Japanese post-market surveillance study, which supports our plans for broader commercialization in approximately 2026, as one of the largest medical device markets in the world, Japan represents a significant opportunity where an estimated 100,000 patients stand to benefit from Zephyr valves. To build awareness of our technology in Japan, we hosted several medical education events during Q1, engaging over 500 COPD focused physicians as we continue to enroll in our post-approval study and begin to seed the market ahead of commercial launch. On expanding indications, we continue to increase enrollment in activated centers around the world in our AeriSeal CONVERT II trial. Once we receive PMA approval, AeriSeal will allow us to treat emphysema patients with collateral ventilation, which we expect to expand our immediately addressable market of eligible patients by an estimated 20% globally. We continue to anticipate the commercial launch for AeriSeal outside of the U.S. and approximately 2026 and in the U.S. in approximately 2027. Overall, I am pleased with the progress of our ongoing programs, which have positioned us as a strong partner to our accounts by offering comprehensive solutions across the entire patient care journey. We believe our combined efforts to grow patient volume, increased test efficiency and expand the ability to treat patients will accelerate penetration of the market opportunity for Zephyr valves. That said, it will take time to implement these programs across our account base, and it will also take time for new patients to work through the system to treatment. While U.S. growth has moderated over the past four quarters, it has sharpened our view of key pressure points in the patient funnel. And we're taking decisive action to unlock the next phase of expansion. Early results from targeted initiatives are encouraging, and we believe they will set the foundation for accelerated U.S. growth in the back half of the year. The question we consistently pressure test when assessing the U.S. opportunity is the Total Addressable Market, or TAM. Are there truly 500,000 patients with severe emphysema who can benefit from Valves. Based on the engagement and volume we see through our direct-to-patient programs, we believe the answer is unequivocally yes. Every day, physicians hear from patients across the country, who are severely debilitated out of options and unaware that treatment is available. The unmet need is large and it is urgent. Today, we have hundreds of customer sites covering major metropolitan areas. The infrastructure is in place. The challenge lies in better connecting these patients to the physicians who can treat them. As I mentioned before, our data shows that fewer than a third of community pulmonologists are actively referring patients for BLDR and typically only after all other options have failed. This gap in awareness is something we are actively addressing. As I highlighted, we've launched a multi-pronged strategy incorporating therapy awareness specialists, expanded peer-to-peer education efforts and launched a national CME program through Medscape to drive best practices more broadly. In parallel, LungTraX Detect is enabling hospitals to proactively identify valve candidates directly from hospital pack systems, bypassing traditional referral bottlenecks and accelerating patient access to care. Further, we're working to enable greater efficiency, particularly with regard to the speed at which patients move through the workup and treatment process. LungTraX Connect addresses this directly. Streamlining everything from CT scan uploads, to patient tracking and workflow management. It is becoming a critical tool for patient care coordinators to improve throughput, reduce delays and enhance the overall patient experience. The patients are there, the programs to treat them exist, and now the focus is connecting them two. We anticipated this plateau, we've acted decisively, and we've taken actions to stem what we believe is a temporary slowdown and expect Q1, to represent a low point of U.S. growth as we anniversary a first half of tough comps and expect to see the impact of these initiatives in the second half of the year, positioning us to return to consistent, sustainable, long-term U.S. growth. Finally, I'd like to provide an update on the civil investigative demand we received from the U.S. Department of Justice in December of 2022. As a reminder, the original action was filed in connection with the request for information under the False Claims Act and the Anti-Kickback Statute. I am pleased to report that on March 31st, 2025, we received notice that the DOJ formally declined to intervene in the case. We remain committed to operating with the highest standards of integrity and compliance, and we're pleased to put the CID behind us, as we continue to focus on delivering value to patients, providers and shareholders. In conclusion, our Q1 performance reinforces our belief that Pulmonx is well positioned for sustainable growth in the long-term, and we are laying the foundation for continued success as we execute on our strategic initiatives. Now, I'll turn the call over to Mehul, to provide a more detailed review of our first quarter results.