Joseph Darling
Analyst · First Analysis. Your line is open
Thank you, Sylvia, and good evening, everyone. Welcome to our second quarter 2019 earnings call. In the second quarter we continue to transform Anika into a global commercial company positioned to deliver innovative products across the continuum of orthopedic and regenerative medicine therapies. We also generated strong earnings and cash flow in the quarter. We're realizing the benefits from our international commercial expansion initiatives as evidence by 28% growth in our International Viscosupplement Revenue year-over-year. As a result of our strong year to-date performance we are raising our revenue and adjusted EBITDA guidance for the full year of 2019. Sylvia will discuss our updated outlook in detail following my remarks. Please turn to slide number three. Before I discuss the quarter and our other ongoing initiatives, I'd like to start with an important update on CINGAL after expense of clinical, regulatory, commercial and business analytics [Indiscernible] discussions we have decided to move forward in our efforts to bring this innovative treatment to the U.S. market. Initially we will conduct the pilot study using a newly design clinical trial protocol which we will discuss with the FDA in the coming months. We believe that this approach best balance its time, cost and risk and we tend to use this pilot program to confirm our trial design, increase our probability of success in the Phase III trial and generate data that ultimately will be needed to sort FDA approval. In the analysis we conducted to reach these decisions. One of our most important considerations was the real world evidence demonstrated by the continued strong performance and growth of CINGAL in Canada and across Europe. International revenue from CINGAL increased 125% year-over-year in the second quarter. This success with over 100,000 procedures since launch together with the overwhelmingly positive feedback we continue to receive from patients and physicians has further reinforce our confidence in CINGAL's clinical value as a safe in applications, non-opioid solution to provide fast and durable relief. Additionally, we recently conducted new primary market research with over 140 U.S. treating physicians. The results underscore the clinical need, the patient benefit and the market opportunity for this elevated treatment in the U.S. The survey outcome indicated that CINGAL is among the most likely treatment to be described out of the multiple new products evaluated in the research. All these factors have increased our confidence in CINGAL's U.S. market opportunity, which we estimate to be approximately $1 billion. The pilot study is expected to enroll approximately 240 patients across 15 sites primarily in the U.S. randomized to receive either CINGAL; the steroid triamcinolone hexacetonide or saline placebo. We expect the study to start in the first half of 2020 and take approximately one year to complete. While the pilot study will delay the potential launch of CINGAL, we believe it will improve the probability of success by confirming our belief that the new study design including modified patients and sites watching criteria will produce the pain-related outcomes the FDA is seeking for a successful NDA submission. We intent to explore with the FDA whether an adaptive trial design can be use, so that the successful outcome in the pilot study maybe levers to streamline a larger Phase III trial. Throughout this process we also intent to explore potential collaboration opportunities on terms that would be beneficial to Anika and its shareholders that can enable us to share development cost with the strategic partner. Please turn to slide number four. In addition to the CINGAL pilot study, Anika has robust product pipelines expanding beyond osteoarthritis pain management to the tissue repair and regeneration and cardiology respiration which we continue to actually advance in the second quarter, while also strengthening our executive leadership and commercial teams. As I have discussed on previous calls, our company growth prospects are driven by our focus on people, products and ultimately on enhancing our financial and operational performance. During the second quarter we continue to identify and recruit the right people to driver our transformation. It is very exciting to see the caliper of professionals joining Anika at all levels of the organization. In particular, recently we are pleased to announce that we continue to advance our U.S. Hybrid Commercial strategy and on board three highly scaled regional sales directors under the leadership of our Vice President of U.S. Sales. These sales directors have extensive enrolled industry and product knowledge and will provide feed [ph] industry to help built pre-market awareness for the upcoming launch for bone repair therapy. Additionally, they will support other orthopedic therapies currently in development which will also be launched in the U.S. utilizing our hybrid commercial model. We also continue to focus on our international sales performance under the leadership of a Vice President of International Sales. Year to-date, we've added three new international distribution partners to our global sales network now aggressively expanding the international reach for product portfolio. In the near-term, we are on track to finalize the number of agreements and product registrations in a multitude of countries within Europe, Asia and South America. We are actively increasing our focus on driving international growth through active and improved interactions with all key stakeholders across the more than 65 countries where we have a presence. Additionally, we appointed James Loerop to the newly created position of Executive Vice President of Business Development and Strategic Planning. Jim is a 30-year industry veteran who will oversee our global business development function and advance our efforts to identify and evaluate potential acquisitions, partnerships, alliances, and licensing opportunities to expand our commercial portfolio and global footprint. Please turn to slide number five. Anika is having an inflation point in its evolution. We are confident in our ability to take greater control of our future for the U.S. hybrid commercial model. As I noted previously, we expect that this hybrid commercial approach will yield significant benefits for Anika as compared to a full direct commercialization model. This approach will enable us to benefit from more rapid market penetration allow us to drive stronger revenue growth and increase profitability without the significant investment usually associated with building a large sales force internally. We believe this model will provide the most optionality and the ability to scale as we launch products across multiple categories. We will also benefit from greater visibility, control and predictability of product demand, volume and fulfillment. The upcoming launch of our first surgically delivered therapy for bone repair procedures in the U.S. in third quarter of 2019 will be our first product launch under this hybrid commercial model. Our recently hired regional sales directors are actively preparing for the soft launch in the third quarter. As we move to full scale commercial launch, we initially intend to utilize their sales directors and leverage regional and local distribution partners to drive rapid market uptake. In parallel, we will continue to evaluate potential partners with established U.S. orthopedic sales forces for this therapy. Please turn slide number six. I am very pleased to announce that we recently began showcasing the bone repair product at industry conferences including at the recent American Orthopedic Society for Sports Medicine called here in Boston and the International Society of Arthroscopy, Knee surgery and Orthopedic Sports Medicine meetings hold in Cancun, Mexico. They continue building relationships with leading physicians and gain clinical insights as we prepare for the launch. We are very encouraged by the positive feedback and constructive input we receive from these influential thought leaders and look forward to building this momentum as we approach the launch. We expect our rotator repair therapy will be the second product launched in the U.S. under our hybrid commercial model. Product development is progressing as planned and in the second quarter we continue prototype refinement for following the completion of a pilot animal study in the first quarter. In the second half of the year we will focus on the surgical instrumentation design for the rotator cuff therapy. Off note, we recently reviewed this therapy at multiple industry meetings and we conducted in-depth interviews with surgeons to gain insights on the design and optimization of the product and instrumentation. Hope the bone repair and rotator cuff repair categories represent large and attractive near term U.S. growth opportunities for Anika. We estimate the bone repair market to be 250 million to 300 million and rotator cuff market to be 150 million to 200 million. Please turn to slide seven. During the quarter we work with the FDA to amend the protocol for the HYALOFAST Phase III trial in order to accelerate enrollment and enhance our probability of success. Through the protocol amendment we expanded the number of sites from 40 to 60 and are currently adding new sites outside the U.S. and Europe which has the potential to accelerate the pace of enrollment. We also received approval to augment the inclusion criteria to target our optimal patient population. Additionally, we recently held an educational symposium for orthopedic surgeons on HYALOFAST at the International Cartilage Regeneration and Joint Preservation Society Focus Meeting. We continue to see a very high level of enthusiasm among physicians and patients for this innovative regenerative treatment. HYALOFAST represents another significant U.S. market opportunity which we conservatively estimate to be more than $0.5 billion. We believe that our future increasingly lies in regenerative medicine in other areas where we can leverage the broad utility of our proprietary solid HA or highest technology platform. We also know that the important steps that we're taking now will help pave the way for new product line. Increased control over commercial management of those products and enhance value for our physician users, patients and key shareholders. There are a number of valuable opportunities ahead and we look forward to sharing in details of our five years strategic plan at our analysts and investors day on September 18 here in Boston. We are very pleased with our second quarter results and the progress we are making across our organization as we evolve into a global company. I'll now turn the call over to Sylvia to review our second quarter results. Sylvia?