Michael D. Dale
Thank you, operator, and welcome to everyone joining us this morning as we discuss our 2025 second quarter financial results. I'll begin today's call with a financial and corporate overview, highlighting our progress through the second quarter and year-to-date implementing our strategic plan, followed by an update on the Biologics License Application, or BLA, for our Avance Nerve Graft. I will then pass the call to Lindsey to review second quarter's financials and outlook for the remainder of 2025, and then we will open the lines for a question-and-answer session. As remarked in this morning's earnings release, we are delighted with our second quarter performance and progress year-to-date for the business. We believe our strong revenue growth and related business milestone achievements reflects the soundness of both our market development strategies and commercial execution capabilities. I have mentioned publicly on various occasions that I felt our performance through midyear would be an important measure of our progress optimizing our business model. While there will always be opportunity for further optimization, as a leadership team, we believe based on the measures we use for our customer creation business models, we are managing our market opportunities the way we had planned and have high confidence in our ability to grow the business consistent with the guidance we have previously provided for our strategic plan. Regarding the quarter, Q2 sales increased to $56.7 million, growing 18.3% compared to the same period last year. This performance reflects double-digit growth across all of our nerve repair target markets, including extremities, oral maxillofacial and head and neck and breast. Consistent with prior quarters, our growth is driven by expanding adoption of nerve care using Axogen's nerve algorithm for the treatment of all types of peripheral nerve injuries, including traumatic, iatrogenic and chronic nerve injuries. The Avance Nerve Graft is the primary growth driver, often complemented based on the clinical situation by one or more of our nerve repair connection, protection or termination products. In extremities, we continue to execute our high potential account strategy with solid growth in both traumatic and chronic nerve injury procedures in the quarter. In oral maxillofacial and head and neck, surgeon adoption of the Axogen algorithm during the quarter was strong across all procedures, but particularly in mandible reconstruction procedures. And likewise, in breast, we continue to see strong adoption of our breast resensation techniques, supported by new surgeon activation, increased procedure volume and implant-based reconstruction cases and the expansion of our commercial infrastructure. In summary, we are encouraged by the broad-based adoption of our nerve care portfolio and momentum across each of our 3 target markets. To assess our progress, we continue to monitor key metrics tied to our plan and 2025 strategic priorities, including high potential accounts, commercial expansion, professional education, new product development, clinical research and prostate market development. I'll begin with an update on our performance and growth in high potential accounts. We continue to focus on expanding our presence in these accounts to drive more consistent customer creation, algorithm adoption and improvements in sales force productivity. Our goal for 2025 is to generate at least 66% of revenue from high potential accounts. Through the first half of the year, we continue to exceed our target with approximately 70% of revenue growth driven by high potential accounts. Furthermore, through the first half of the year, average high potential account productivity is up 21% year-over-year, tracking in line with our full year target. These results reinforce our belief that our focus on high potential accounts is enabling broader and more enduring adoption of nerve care, and as such, more predictable growth. During the first half of 2025, there were 641 active high potential accounts, all of the approximately –- of the approximately 780 accounts that meet our high potential criteria, which represents an increase of 19 accounts or 3% as compared to the first half of 2024. Regarding our 2025 commercial infrastructure expansion goals, as of end of second quarter, we are now at or ahead of our hiring plan for each target market. In breast, we ended the quarter with 19 breast resensation sales specialists and 1 regional sales director. We are on track to double the breast sales force in 2025 by the end of the year, targeting 22 reps and 2 regional sales directors. To support broader adoption in non-breast markets, we added 5 additional sales representatives in high potential territories in the second quarter, ending with 124 sales professionals, including 12 regional sales directors. In oral maxillofacial and head and neck, consistent with our plan, we added 5 field-based market development managers year-to-date. Surgeon training remains a core component of our customer creation and nerve repair algorithm adoption. Execution of our 2025 professional education programs are on track and we fully expect to meet our 2025 surgeon training targets. In breast, we have trained 35 surgeon pairs year-to-date, and with 3 programs planned in the second half of the year, we are confident we will meet our 2025 target of 75 surgeon pairs trained. Active breast resensation programs increased 9% from the second quarter of 2024 from 116 to 126. We estimate 280 surgeons performed a breast resensation procedure in the second quarter, which represents a 17% increase versus the second quarter of 2024. In extremities, we have trained 67 surgeons year-to-date, up 37 from first quarter 2025, with 6 additional programs planned in the second half of the year. We expect to meet our 2025 target of 105 surgeons trained. In oral maxillofacial and head and neck, we have trained 41 surgeons year-to-date, up 15 from first quarter 2025. We are on track to meet our 2025 target of 45 surgeons trained. Next, I will provide an update on our clinical research priorities. We continue to advance our 2025 initiatives and are on track to complete a level 1 study protocol for implant-based neurotization, a level 1 clinical evidence plan for Avance versus autograft in mixed and motor nerves and a clinical evidence plan for oral maxillofacial and head and neck. Regarding research and development, as we have outlined in our strategic plan, innovation is critical to our long-term growth. Through midyear, we continue to progress and advance our innovation platform across 3 core pillars: therapeutic reconstruction, ease of coaptation and protection expansion. Regarding coverage and payment, during the quarter, multiple noncoverage policies were removed within the Blue Cross Blue Shield network for nerve care, adding an estimated 10 million additional covered lives. Year-to-date, we estimate 17 million additional lives are now covered for nerve repair for peripheral nerve injuries using synthetic conduits or allografts, which brings coverage amongst commercial payers to more than 55%. Adding to our progress during the second quarter, we enjoyed significant external validation of Axogen's differentiated technologies and leadership in peripheral nerve repair, with 17 new peer-reviewed publications citing clinical use or discussion of our products. For those interested, these peer-reviewed studies are available on our website. And finally, I will provide an update on our prostate clinical and market development plan. We are excited about the opportunity to improve nerve function outcomes in robotic-assisted radical prostatectomy and continue to work closely with key opinion leaders to advance surgical technique development. During the second quarter, we completed the hiring of our clinical development team, which will provide field-based support to surgeons and pilot sites incorporating nerve repair into their robotic-assisted prostatectomy cases. We added 3 additional clinical pilot sites and now have 6 active sites. We expect to meet the goal of having 10 pilot sites running by year-end. Procedures are ongoing, and we aim to complete 100 cases by year-end. Before I hand it over to Lindsey, I would like to address the status of the Biologics License Application, or BLA, for Avance Nerve Graft. The BLA remains on track and continues to progress as planned. During the second quarter, we completed several key regulatory milestones to support our anticipated approval in September of 2025, the late cycle meeting with the FDA, pre-licensing inspection and sponsor inspection under the FDA's Bioresearch Monitoring Program. These milestones follow the successful clinical trial inspections we spoke about on our last call, further reinforcing our confidence in the strength and completeness of our Biological (sic) [ Biologics ] License Application submission for Avance Nerve Graft. We reiterate prior guidance that we expect BLA approval in September. The BLA approval will secure 12 years of market exclusivity from biosimilar nerve allografts and establish Avance Nerve Graft as the only implantable biologic indicated for the repair of functional deficits in peripheral nerves. With that, I will turn it over to Lindsey, who is off to a great start as Chief Financial Officer and is adding a great deal of clarity to our operating performance.