Ken Reali
Analyst · Craig-Hallum Capital Group. Please go ahead
Thanks, Dave. Good morning, everyone, and thank you for your interest in Bioventus. As we move into the second half of the year, we look to build on the meaningful progress the Bioventus team has made towards accomplishing the goals we laid out in January. A few of our successes to date include closing the financing and acquisition of CartiHeal, completing the integration of Bioness and materially progressing on the integration of Misonix and positioning ourselves to achieve double-digit organic growth for the year by leveraging our technology-leading medical devices, our significant commercial organization and improving market access with expanded reimbursement and preferred coverage agreements across our verticals. We are extremely proud of the way that our entire organization continues to drive toward achieving our goals and strengthening our long-term outlook and we are looking forward to continuing to build on our momentum in the second half of the year. We are pleased to report that throughout the second quarter, we saw a steady recovery across our surgical solutions vertical, which was impacted by the more acute hospital staffing shortages and Omicron related challenges we faced in the prior quarter. Mark will discuss our guidance shortly, but we believe hospital volumes will continue to trend towards a normal environment in the second half of the year. We believe the foundation and diversification of our business and end markets will remain strong despite the increased potential for economic challenges in the coming months. Over half of our product portfolio is sourced to enable fixed gross margins, allowing us to have a strong and consistent gross margin despite the inflationary headwinds impacting the global economy. In addition, in past recessionary environments, we have not experienced significant business interruptions. Still, we are prepared to take the necessary actions to control costs in order to ensure we deliver on our EBITDA and earnings commitments while continuing to support the long-term needs of our business. Moving to our results, revenue increased 28% during the second quarter to $140 million, including organic growth of 8%, which positions us well to achieve double-digit growth for the year. Constant currency growth was 9%, a good performance compared to a solid comp versus 2021. Additionally, we generated strong sequential revenue and adjusted EBITDA growth. While growth was robust across our portfolio, supply chain and regulatory disruptions in our advanced rehabilitation portfolio limited our second quarter growth. Going forward, we expect this revenue to be recognized in the second half and thus do not expect this shift in timing to have an impact on our full year results. Across pain treatments, we saw double-digit revenue growth, driven by continued market share gains by our single-injection Durolane HA therapy and our three injection Gelsyn HA therapy as we highlighted on previous earnings calls reimbursement for HA shifted from wholesale acquisition cost to average selling price at the end of June. Given the sales mix of our HA portfolio, this new pricing dynamic has not fundamentally impacted our overall growth opportunity. As expected, we have been able to lower our reimbursement rebate rates on all of our preferred contracts with private payers, which has offset lower pricing for other areas of our HA business. The modifications to these agreements are consistent with our modeling exercises done over the past several months as we prepared for this new environment. Additionally, we are seeing some potential opportunities to increase our market share where a few competitors are no longer able to utilize pricing as an incentive for physicians to receive a higher reimbursement. As the only company with a portfolio of HA products across single three and five injection therapies, we have held the number two share position in the HA market and continue driving towards becoming the market leader over the coming years. Turning to surgical solutions as I mentioned, our business rebounded from last quarter's macro headwinds with organic growth returning to double-digits. We are encouraged by the sequential improvement that we generated throughout the quarter and continue to experience strong momentum thus far in the third quarter. We also saw a similar recovery in our Misonix BoneScalpel during the quarter. Restorative therapy revenue generated double-digit growth, bolstered by the inclusion of our Misonix wound business. As I mentioned earlier, growth was limited in our advanced rehabilitation business due to supply chain issues impacting our domestic business as well as back orders for our international customers as we await regulatory certifications related to the new European medical device regulation or MDR process. The domestic supply chain issues have been resolved early in the third quarter, and we are back to fulfilling orders and eliminating our back orders. We expect to receive MDR certification in the third quarter so that international revenue will be back online in the fourth quarter. Finally, our International segment grew 26% on a reported basis, driven by our Misonix acquisition and constant currency growth was 1%, primarily driven by continued strength in Durolane. The regulatory challenges related to our advanced rehabilitation portfolio are expected to continue into the third quarter, but we anticipate recapturing most of this revenue in the fourth quarter. As a result, we expect to see organic growth trend below normal in the third quarter, but then trend above normal in the fourth quarter for our international business. Finally, given the current geographic mix of our business, we do not anticipate the recent movement in foreign exchange rates to have a material impact on our revenue. Our international business continues to be a low double-digit percentage of our total revenue. Now I'd like to update you on our 2022 priorities. As highlighted earlier, we are off to a great start to the year and remain focused on our execution across our key priorities for 2022. Our first priority is to achieve double-digit organic growth for the year through our technology-leading medical devices and the continued strong execution of our commercial organization. While we fell just short of that for the quarter, we made significant progress across some of our key growth areas. In pain treatments, we solidified market access for our HA business by reaching a three-year extension on our United Health contract, where Durolane remains the exclusive single-injection product, and Gelsyn continues to be one of two products for three injection therapy. In addition, our 2-year contract with Cigna, which we announced in May for Durolane and Gelsyn also became effective at the start of the third quarter. Within surgical solutions, OSTEOAMP Flowable, our injectable allograft bone graft substitute solution continues growing rapidly since its introduction last year. As a great example of the innovation being infused into our portfolio, over the past three years, we have launched several new products, including OSTEOAMP Flowable, which now represents close to 60% of our bone graft substitutes revenue, enabling us to grow our market share. Also in surgical solutions, we received 510(k) clearance for SonaStar Elite in late July. SonaStar Elite represents the newest hand piece for our neXus Ultrasonic Surgical platform, and it will deliver best-in-class and significantly more power, versatility and control and the removal of hard and soft tissue in multiple surgical specialties, including specifically neurosurgery. This creates a large market expansion opportunity for Bioventus. We plan to commence a limited market release in the fourth quarter. Our second priority is to complete the integrations of our recent acquisitions while delivering on our cost synergy commitments and leveraging our enhanced scale to accelerate revenue growth. We continue to drive progress on that front, and we remain on track for the integration of Misonix that could be completed next year and to deliver at least $20 million in cost synergies by the end of 2023. Besides the realization of cost synergies, our combined commercial teams continue to leverage our enhanced scale and customer relationships to accelerate sales growth and cross-selling opportunities. Additionally last week, we gathered all our U.S. direct sales representatives, over 500 reps in total together for the first time since the acquisitions of Bioness and Misonix for a summer sales conference. The conference enabled us to further cross-train our sales representatives on the new products in their verticals and hear firsthand from their colleagues on effective sales techniques. We expect this meeting to be a significant springboard to further increase momentum in the second half of the year as we unleash broader cross-selling efforts within our entire sales force after piloting multiple initiatives earlier this year. Our third and final priority for the year was recently completed with the closing of the acquisition of CartiHeal, which we believe is a revolutionary and game-changing device for multitudes of patients suffering from knee osteoarthritis and osteochondral defects. As a reminder, it received FDA breakthrough device designation in December of 2020 and FDA PMA approval in late March of this year. CartiHeal has significant potential with a $1.3 billion total addressable market. It is also supported by significant clinical data used for PMA approval as evidenced by the robust data generated from its pivotal clinical trial demonstrating superiority to micro-fracture and debridement procedures. The completed clinical trial is the largest cartilage repair trial undertaken to-date, and we expect it will be published in a peer-reviewed medical journal by next year. The addition of CartiHeal complements our joint preservation technologies and specifically our HA business and customer base, further supporting our growth drivers and helping us deliver on our goal of sustained double-digit revenue growth. Our restructured agreement not only enabled us to finance the acquisition, but also aligns future milestone payments with value creation that unlocks the full potential of CartiHeal. We will continue to compile clinical evidence and expect multiple articles to be submitted for publication and medical journals over the next few years to support reimbursement coverage and coding. In the coming months, as we launch CartiHeal, we will work with our surging customers to ensure that each case is preauthorized to build its reimbursement profile. As we progress on the market development plan, we will update you as we achieve the key value-driving milestones for CartiHeal. Lastly, given the increase in debt to finance the CartiHeal transaction, including future milestone payments, we intend to pause on future M&A activity until we return to our targeted range of net debt to adjusted EBITDA of three to four times. We expect to achieve this goal by the end of 2023, primarily through EBITDA growth, driven by double-digit revenue growth and margin expansion as well as free cash flow generation. In conclusion, we continue to build momentum as we execute on our growth strategy, and we have further bolstered our growth potential with the acquisition of CartiHeal. With the acquisition behind us, our second half focus will be on achieving our other priorities and financial commitments for the year. I remain confident we will deliver on cost synergies from our acquisitions and enhance our growth profile by leveraging our technology-leading medical devices, scale and commercial infrastructure to deliver consistent double-digit growth. Now I'll turn the call over to Mark.