Stephen D. Griffin
Thank you, Cheryl. Before we dive into the financial results, I want to begin with an update on the production challenges we encountered earlier this quarter. Since April, our teams have successfully resolved the lower production yields and restored output to historic levels. While we experienced reduced shipments in April and May, I want to emphasize that this did not result in any delayed deliveries to patients. Toward the end of the quarter, we were modestly behind on certain international OA Pain shipments, which impacted commercial revenue slightly. However, we expect to fully recover and deliver product for these purchase orders in the third quarter. I'm proud of the cross-functional collaboration that enabled us to resolve this issue within the quarter. and we've implemented new procedures to help ensure that this disrupt type of disruption does not recur. With that, I'll now provide financial updates on the quarter. Please refer to Slide 4 of the presentation. In the second quarter, Anika generated $28.2 million in total revenue, an 8% decline compared to the same period in 2024. Revenue in our commercial channel which includes our globally distributed, highly differentiated products was flat year-over-year at $11.9 million. However, within this channel, regenerative solutions delivered standout performance, growing 41% year-over-year driven by continued momentum in the Integrity Implant System. Importantly, Integrity has now achieved sequential growth for 5 consecutive quarters and as of June, we've already exceeded full year 2024 revenue for the product on track to more than double in 2025. This underscores the strength of the platform and the growing demand we are seeing in the market. Offsetting this growth was a 10% decline in international OA pain sales, primarily due to approximately $900,000 in unfilled orders stemming from previously mentioned lower yields as well as a difficult year-over-year comparison due to the timing of shipments in Q2 2024. Absent the lower yields, we would have expected international OA Pain to be flat in the commercial channel to be up approximately 8%. With yields now fully restored, our teams are working diligently to fulfill backlog distributor orders and expect to recover these orders in the third quarter. Revenue in the OEM channel, which includes our domestic OA Pain and nonorthopedic products sold under long-term agreements, declined 13% in the second quarter to $16.3 million. This performance was in line with our expectations, reflecting continued pressure on demand and pricing for Orthovisc as well as lower pricing for Monovisc, offset partially by higher end-user volume. Monovisc pricing was stronger this quarter due to the timing of contractually obligated payer rebates from J&J, which, as with others in this market can vary significantly from quarter-to-quarter. We anticipate a pricing decline in Q3, followed by a modest rebound in the fourth quarter, with no change to our full year pricing outlook. While we do not directly control this channel, we remain actively engaged with our partner to drive for greater price stability and market expansion. Despite ongoing headwinds, Monovisc and Orthovisc continue to lead the U.S. market and remain profitable contributors to our business. The remainder of our OEM business, our nonorthopedic sales grew in the quarter due to the timing of customer orders. Second quarter gross margin was 51%, down 16 percentage points from the same period last year. The primary driver was a onetime $3 million charge related to the lower yields of Monovisc and Cingal in April and May. This charge, largely noncash represents the full extent of the lower yields and falls within the previously communicated range for the full year impact. Excluding this onetime item, gross margin would have been above 60% for the quarter. In addition, gross margins were impacted by a $3 million year-over- year decline in Monovisc and Orthovisc sales to J&J, primarily driven by lower pricing that impacts both transfer units and royalties and directly reduces gross profit. With the lower yields now resolved, we expect gross margins to improve in the second half of the year to the 58% to 59% range as we communicated on our first quarter call. That said, the combination of reduced high-margin J&J revenue and the first half manufacturing challenges will result in a lower overall gross margin for 2025. These dynamics were anticipated and are already reflected in our full year guidance. Turning to operating expenses. Total second quarter OpEx was $18.5 million, down $3.8 million or 17% compared to the same period last year. Selling, general and administrative expenses declined 22%, while research and development expenses were down 6%. The $3 million reduction in SG&A was primarily driven by a onetime nonrecurring $1.6 million expense in 2024 and $1.4 million in headcount-related cost savings actions. As we've pivoted the strategic focus of the company, we continue to streamline and optimize our organizational structure to align with our future direction. These actions reflect our commitment to disciplined cost management and mitigating the impact of revenue pressures while continuing to invest in areas that support long-term growth. Adjusted EBITDA from continuing operations was negative $200,000 in the second quarter, a decline of $4.9 million compared to the same period in 2024. The decrease was primarily driven by the onetime scrap costs for our recent manufacturing challenges in addition to lower high-margin revenue from J&J, partially offset by the meaningful reductions in operating expenses. Without the onetime scrap costs, the company would have generated positive EBITDA in the quarter. Now turning to cash and liquidity. In the second quarter, we used $200,000 in operating cash flow an improvement compared to the $1.1 million of cash used in the same period last year. This was driven by stronger working capital management and disciplined cost controls in response to revenue pressures. We invested $1.4 million in capital expenditures during the quarter, down $2 million year-over-year due to timing. These investments are focused on expanding capacity at our Massachusetts manufacturing facility to support anticipated volume growth across Monovisc, Cingal, Integrity and Hyalofast. This will position us well to meet future demand and scale efficiently. We ended the second quarter with $53 million in cash and no debt. Now on Slide 5, I'll review our full year financial outlook for 2025. We are maintaining our 2025 full year guidance. For the full year, we continue to expect our commercial channel to generate between $47 million and $49.5 million in revenue, representing 12% to 18% growth in 2025. Our OEM channel remains on track to deliver between $62 million and $65 million, a range of 16% to 20% decline versus 2024. At the midpoint of down 18%, this range is reflective of higher volumes but lower pricing for J&J. As a reminder, J&J has full control of sales, marketing and pricing activities for these products in the United States, and Anika receives transfer unit revenue and royalties based on J&J's end user pricing. Now turning to profitability. We are maintaining our 2025 adjusted EBITDA guidance range of negative 3% to positive 3%. As a reminder, this range is reflective of 3 primary impacts all of which we shared at the end of the first quarter. First, the impacts from lower manufacturing yields and scrap for Monovisc and Cingal experienced in the first half of 2025. Second, lower pricing from J&J for Monovisc and Orthovisc. And lastly, the 2025 costs associated with the Cingal bioequivalent study required for our NDA filing. As a result of the Hyalofast clinical trial outcomes, we are revising our long-term revenue guidance for the commercial channel to reflect a possible extension of the FDA review process. While we still plan to file the PMA in the second half of 2025, we are now modeling for a 12-month delay in launch timing. As a result, we are updating our commercial channel growth outlook to 10% to 20% in both 2026 and 2027 compared to our prior range of 20% to 30% growth. We currently anticipate a $3 million revenue contribution from Hyalofast in 2027 with full market release in 2028. These revised projections reflect growth from our already approved products, particularly Integrity and continued strength in our international OA Pain portfolio, both of which have demonstrated strong momentum. Despite this adjustment, our liquidity remains strong with no need to raise capital, and we remain confident in our ability to execute on our long-term strategy. With that, I will now turn the call back over to Cheryl.