Cheryl Blanchard
Analyst · First Analysis
Thank you, Sylvia, and good evening, everyone. Before we discuss our financial results and outlook for the year ahead, I'd like to start by remembering Anika's President and CEO, Joe Darling, who passed away unexpectedly on January 29. When I interviewed to join Anika's Board, Joe talked about Anika and the people who make up Anika with a passion you hope every leader exhibits about his or her company. Joe was a wonderful leader and a trusted colleague who led the beginning of our transformation into a global commercial company. Over the last 2.5 years, he set Anika on its current path, reinforcing its strong foundation, leveraging its strengths and embracing innovation. Most recently, he led the development of our 5-year strategic plan, which will continue to guide our growth over the next several years. Joe was a great man with a well-deserved reputation in our industry for being a strong leader who is passionate about health care. Though certainly we'll miss his leadership, we'll miss his character, humor and friendship even more. Our thoughts and sympathies go out to his wife, Maureen; and children, Jon and Jordan. We are grateful to Joe for all that he did for Anika, and we will continue to work to honor and build on his legacy. Some of you have asked about Joe's passing. While we will continue to respect his family's wish for privacy, I can share that in early 2019, Joe informed the Board that he was experiencing some health issues. Following that communication, the Board and Joe were in regular contact regarding his health. He continued to perform his responsibilities well throughout 2019 and into 2020 and over-delivered progress against our strategic goals. Based on ongoing dialogue and Joe's exemplary performance record, the Board remained confident in his ability to lead and the Board respected Joe's wishes to keep his health condition private. The Board designed an interim Office of the President in the event Joe might need to take a short leave of absence, which he never needed. His unexpected passing was a shock to all of us here at Anika, and we are deeply saddened by his loss. Upon learning of Joe's passing, the Board activated the interim Office of the President to provide immediate ongoing leadership and oversight of Anika's day-to-day operations, while we began the search process to identify Anika's next CEO. After that time, the Board had an opportunity to consider what would be best for Anika in light of all the circumstances and, in particular, to consider the impact on the interim Office of the President structure for the time it would take to conduct the CEO search. With the support of the interim Office of the President, the Board decided to appoint an interim CEO. I am honored to assume that role and look forward to working alongside the Anika team to continue delivering for our shareholders and other stakeholders. I have a long history in the biotech and medtech world in orthopedics and specifically with joint preservation and regenerative medicine businesses. Given my experience and passion for the field, I was impressed with the company's achievements and excited by its potential. I am confident in the strength of the company's market position and growth prospects. As I step into the role of Interim CEO, I am optimistic about the future of the company. During my time on the Board, I have gained unique insight into the business, strategy and operations and have seen firsthand the growth and development of the organization. Anika is well positioned, both strategically and financially, with a talented team that has deep expertise and an innovative product pipeline. I look forward to working with the Board and the management team to capitalize upon the opportunities ahead. Please turn to Slide #3. I'd like to now discuss the significant progress that Anika continued to deliver in 2019. Last year, we took significant steps to transform Anika into a global commercial company focused on joint preservation and restoration by executing on our 5-year strategic plan. We redeployed resources and added world-class talent to our leadership team; successfully completed the build-out of our small internal hybrid commercial sales force in the U.S.; launched our first surgical orthopedic product, TACTOSET, under our hybrid commercial model and continue to expand internationally. We also recently completed the acquisitions of Parcus Medical and Arthrosurface, which expanded our joint preservation and restoration product portfolio, expanded our commercial capabilities and infrastructure, enhanced our innovative product pipeline and diversified our revenue base from our successful legacy commercial partners and distributors. These acquisitions accomplished these strategic goals, and more importantly, they strengthened Anika's unique position in the $7 billion sports and regenerative medicine market. They improved our ability to address significant unmet medical needs, which will deliver better patient outcomes and drive sustained revenue growth that will ultimately enhance value for shareholders. Please turn to Slide #4. Joe often said that our growth strategy is driven by our focus on the 3 Ps: people, products and performance. And in many ways, our 2019 results and accomplishments are a testament to that continued focus. Let's start with the people. Last year, we added several seasoned executives to our leadership team to enhance our ability to achieve our growth objectives, including Jim Loerop, Executive Vice President of Business Development and Strategic Planning; Dr. Bob Richard, Vice President of Research and Development; Steve Goldy, Vice President of U.S. Sales, and Mira Leiwant, Vice President of Regulatory, Quality and Clinical Affairs. Additionally, we successfully onboarded 4 highly-skilled regional sales directors in the U.S. under our hybrid commercial model. These sales directors are currently focused on the full launch of TACTOSET. Please turn now to Slide 5. The recent acquisitions of Parcus Medical and Arthrosurface brought a wealth of talent into our organization and further enhanced our commercial capabilities and infrastructure. Combined, they added approximately 40 sales reps and more than 150 distributors in the U.S. to our hybrid commercial model and over 70 international distributors. These acquisitions enabled us to achieve a level of commercial scale far more efficiently and quickly than greenfielding a commercial team. We are excited to fully deploy our hybrid commercial model, which will provide Anika with the direct line of sight to the market and deliver more favorable economic results. Turning to Slide 6. In December, we commenced the full-scale commercial launch of TACTOSET in the U.S. at the 2019 Orthopaedic Summit, an Evolving Techniques conference or OSET. Nearly 100 procedures have been completed to date, and we continue to receive positive feedback from the physician community regarding the therapy's ease of use and procedural efficiency. In 2019, we surpassed our initial goals of onboarding 5 distributors with product availability in 10 surgical centers. To date, we have onboarded 17 new distributors, and we plan to grow and leverage the distribution networks at Arthrosurface and Parcus. For 2020, we expect revenue from TACTOSET to be approximately $3 million. Product development for our rotator cuff repair therapy is progressing according to plan. We continue to anticipate that we will submit a 510(k) application to the FDA in the early 2021 time frame. This therapy is highly synergistic with many product offerings at Parcus Medical and Arthrosurface. Please turn to Slide #7. CINGAL, our novel third-generation viscosupplementation therapy, combining HA and steroid, continued to deliver strong performance in Canada and across Europe. International revenue from CINGAL grew close to 30% year-over-year in 2019. The continued growth of CINGAL, coupled with the strong feedback from both doctors and patients, has reinforced our confidence as we advance CINGAL towards regulatory approval in the U.S. market. We remain on track to initiate the CINGAL pilot study in the first half of 2020. We are in the process of preparing for U.S. site initiation and patient enrollment. We expect this study to confirm our trial design, increase our probability of success in a Phase III trial and generate data that ultimately will be needed to support FDA approval. There are three key differentiators in this revised protocol compared to the prior Phase III 1602 study: The first is the inclusion of a placebo arm. The second is the addition of a much larger steroid arm. And the third is the modification of the patient enrollment selection criteria for targeting our ideal patient profile. We continue to expect that the pilot study will take approximately 1 year to complete. We remain confident in CINGAL's U.S. market opportunity, which we estimate to be approximately $1 billion annually. Please turn to Slide 8. On the regenerative medicine front, we've advanced the clinical development for our cartilage repair therapy, HYALOFAST. During the fourth quarter, we continued work on adding new sites, especially internationally, and we expect to initiate 10 new sites in the first half of 2020. The trial is currently close to 70% enrolled, and we continue to expect to complete patient enrollment by the end of 2020. I am excited about Anika's momentum, confident in our market position and the opportunities ahead and look forward to the continued execution of our plan. With that, I will now turn the call over to Jim Loerop to discuss our integration plans for the Parcus Medical and Arthrosurface businesses. Jim?