Charles Sherwood
Analyst · First Analysis. Your line is open. Please go ahead
Thank you, Sylvia, and good morning, everyone. I’m pleased to report that we delivered another quarter of profitable growth, while expanding globally and advancing our substantial product pipeline and strengthening our infrastructure to support our expansion. You may recall that while we have consistently maintained tight operating controls and delivered healthy margins and profit, 2017 is a year of investment at Anika. We are making great progress toward the commercial goals that will take our growth and revenues to the next level within the coming years. Please now turn to Slide #3. I’d like to start with a few highlights from the first quarter results. Product revenue increased 5% year-over-year for the first quarter, driven primarily by MONOVISC, which achieved 24% global revenue growth as compared to 2016. During the first quarter of 2017, domestic MONOVISC end-user volume increased 48%. International MONOVISC revenue grew 15% year-over-year. We expect MONOVISC to continue gaining worldwide market share, as we expand into India and Australia in the second-half of this year and as the U.S. and international markets naturally migrate away from the multi-injection options in favor of the more convenient single injection treatments. International orthobiologics revenue increased 12% year-over-year and is expected to continue to grow with the global expansion of MONOVISC, the growth of CINGAL revenue in Canada and Europe, and the availability of ORTHOVISC-T in Germany, the UK, Poland, Hungary and Bulgaria. As a reminder, ORTHOVISC-T is indicated to relieve pain and restore function in tendons affected by chronic lateral epicondylosis or tennis elbow. Treating this condition represents an estimated $700 million global market opportunity. Excuse me, please now turn to Slide #4. We really like the balance of existing and new products as well as the migration to the single injection platform, but the more significant and exciting long-term growth opportunity that we are uniquely poised to capitalize on is the potential of CINGAL. CINGAL is a breakthrough product that is likely to expand the size of the global orthobiologics market as the first-to-market viscosupplement steroid combination product. Based on the initial positive clinician feedback, as well as early sales figures from Canada and Europe, we are confident that upon receiving FDA approval, CINGAL will set a new standard of care that transforms the viscosupplementation market. The product launch has the potential to not only grow the market, but also to significantly shift the market share balance toward Anika’s product portfolio. To that end, we continue to invest aggressively in order to accelerate that and other product development programs. Over the past few months, we made important progress towards commencing the supplemental Phase III study requested by the FDA to complete its review of the CINGAL NDA. In the last quarter, we finalized the clinical study design and commenced planning activities in Europe expeditiously. We’re excited to share that 83% of the targeted sites are now qualified. We are on track to treat the first patient in the second quarter of 2017, which will put us on target for FDA approval in early 2019. Please now turn to Slide #5. On the heels of CINGAL, we are steadily progressing our HYALOFAST and MONOVISC Hip OA clinical programs. Like CINGAL, HYALOFAST also has the capacity to expand its market. We are committed to delivering positive clinical trial progress and results as quickly as possible, enabling engagement with the regulators and launch. Last quarter, we initiated eight additional HYALOFAST trial sites in Austria, and we expect to enroll over 50% of the total patient population by year-end 2017. Turning to Slide #6. The MONOVISC Phase III trial to support the expanded Hip OA indication is being run by our U.S. Commercial partner, Mitek. Approximately 85% of the targeted 25 sites are up and running and they are progressing with patient enrollment activities. We see tremendous potential to build on the success of MONOVISC and remain committed to being first to market with this expanded indication. Before I turn the call over to Sylvia to review our first quarter financial results, I want to provide an update on certain corporate and operational infrastructure enhancements that are essential to our growth. Please turn to Slide #7 now. Last month, we officially opened our new European headquarters and training center in Padova, Italy, and we are in the process of completing quality checks and optimizing production of the solid HA manufacturing operation that we transferred from Italy to our Bedford, Massachusetts facility. We expect to be fully operational to meet the global demand for our entire product portfolio by the end of 2017. In summary, we continued to deliver profitable growth in the first quarter while progressing our long-term growth strategy. Over the next few quarters, our efforts will focus largely on advancing the CINGAL, HYALOFAST and MONOVISC Hip OA clinical programs, which hold the key to maintaining global market leadership and accelerating revenue and earnings growth. I’ll now turn the call back over to Sylvia to review our first quarter results.