Charles Sherwood
Analyst · Northland Capital. Your line is now open
Thank you, Sylvia, and good morning, everyone. Please now turn to slide number three. 2015 was a successful year for Anika commercially, clinically, operationally and financially. End user momentum contributed to drive strong top line results. We are making progress in key pipeline programs and we achieved record product revenue for both the fourth quarter and full year which Sylvia will discuss in more detail. But what we are most enthusiastic about today are the substantial opportunities to further expand and disrupt the current clinical regiment and marketplace for orthopedics medicines. Opportunities that can drive growth to the next level and put Anika in a more central, dominant position among the competition. I want to use today's call to emphasize the four pillars of our long term strategy to position in a couple of superior sustained growth. They are international expansion, a promising pipeline, infrastructure enhancements to support future growth and strategic M&A to compliment organic growth. Now please turn to slider number 4. The first pillar in our growing international presence - I am sorry. The first pillar is our growing international presence. Concurrently, we have active commercialization relationships in over 55 countries and we are constantly pursuing new avenues for expansion globally including the world's major markets. As an example, we recently signed an agreement with a new partner for the commercialization of MONOVISC and CINGAL in China, the world's third largest viscosupplementation market. We continue to diligently pursue with new relationships that will give us the access to markets like Japan, the world's second largest viscosupplementation market. Moving on, our next pillar for growth is our clinical pipeline. For over two decades, we have been developing, manufacturing and successfully commercializing therapeutics based on our proprietary hyaluronic acid technology. That experience has translated into the core viscosupplementation franchise that we have today. ORTHOVISC is a leading multiple-injection therapy while MONOVISC is number two single-injection therapy. This business is growing and is poised to be the U.S. market leader in 2017. From an investor standpoint, we provide the opportunity for a stable cash-producing business that represents solid downside protection. In addition, unlike many companies in our space, we also bring a vibrant and near-term opportunity to further disrupt the market with new products. We are more than just our current viscosupplementation business. Our vision is to develop a portfolio of Orthobiologic products to serve the needs of orthopedic surgeons and their patients. We will have a significant presence in both the office and surgical settings driven by our powerful HA technology platform. This proprietary platform allows us to modify HA to bring to market differentiated and innovative products to address a wide range appellative, restored and regenerative indications. First, CINGAL expands the use of viscosupplements beyond the current osteoarthritis or OA therapeutic paradigm. While addressing OA there is a spectrum of treatment. Physicians initially recommend diet and exercise followed by NSAIDS and analgesics and then eventually steroids. In more advanced stages of the disease, HA injections are utilized and these are eventually followed by as a last resort total knee replacement. With CINGAL, we can expand these HA, targeting patients starting to use steroids, as well as those suffering the later stages of OA with the aim of pushing out the timeframe for total knee replacement. During the fourth quarter, CINGAL was approved in Canada and we expect the commercial launch shortly. We expect European approval within the next two months. As we announced last September, we received guidance from the FDA to advance the review of CINGAL through the drug pathway, not the medical device pathway. Since then we have been in discussions with the agency to understand the full scope of the clinical requirements related to our filing of a new drug application. Preliminary feedback from the FDA indicates that our generation of additional clinical data will likely be acquired before filing that NDA. The extent cost and specific details of this additional clinical work have not been finally determined at this juncture. However, if the FDA requires substantial additional clinical work, it may have a significant impact on our commercialization timeline or the product in the United States. As a result, we requested in our schedule to begin collaborative discussions with the FDA early next month and we hope to quickly reach a reasonable, expeditious and mutually acceptable path towards completing any necessary clinical work and submitting our NDA for the product. We remain confident in the merits of the already completed and highly successful CINGAL clinical program and the product's potential value to patients, both of which are underscored by our recently announced approval in Canada and our expected approval in Europe. Beyond CINGAL another pipeline opportunity is expanding the indications for our viscosupplementation products. Currently, our viscosupplements in the United States are only approved for use in [MI] [ph]. We are currently collaborating with our U.S. commercial partner to grow the applications for viscosupplement, including MONOVISC for use in the hip. Our aim is to be the first to market with this expanded indication within initial goal of achieving approval by 2020. The third major pipeline opportunity for Anika is solidifying our position in regenerative medicine with HYALOFAST. This product is a biodegradable scaffold that is used to enable cognitive degeneration in patients suffering from cartilage defects caused by trauma. We have demonstrated that HYALOFAST can generate high-aligned like cartilage in a single step arthroscopic procedure. As a result, it is non-invasive and will be less costly than those treatments available today. We are making progress towards eventual marketing approval in the U.S. During the fourth quarter, we commenced patient enrollment in our FastTRACK Phase 3 study. We believe this study will give us the pivotal clinical data necessary to support marketing approval for an indication for the repair of cartilage defects in the United States. Internationally, HYALOFAST and CE Mark in Europe and is available commercially in 18 countries with more than 6,000 users today. In addition to the development programs I have just reviewed, we have several innovative products in the pipeline which are designed to round out our product portfolio in both office and surgical settings. I look forward to further discussing our development pipeline during the next investor call in April after certain internal development progress is achieved. Please now move on to Slide number 5. The third pillar of our growth strategy is the strengthening of our corporate infrastructure. Most notably, we are developing our own direct commercial capability in the United States. While discussion of this topic has been associated with CINGAL, I want to emphasize that the advantage of having a direct capability will reach far beyond any one product. The ability to go direct empowers Anika to own its end-user relationships, gives us access to key data and provides us a larger share of the end-user revenue which in the long run would increase profitability. Most importantly, it allows us to flexibility to pair future product - future pipeline products with the commercial route that is most advantageous for Anika and for our shareholders. To this end, we have begun carrying out this initiative by engaging a contract sales organization. We see the development of our direct capability incurring in three stages. The first is setting up a medical affairs infrastructure to introduce pipeline products to the academic community, key opinion leaders and payers. The next is building commercial operations to prepare for the transactional aspect of any product launch. This would include coordinating distribution channels to ensure availability of products for decisions in patients. And then finally, there is the build out of a commercial sales force to represent product pipeline products to the end users. Our next infrastructure enhancement is the integration of our outsource manufacturing operations under one roof in our Bedford headquarter. These operations include those currently in Italy where our HA products are currently produced. Fully integrating our global manufacturing operations will allow us to accelerate product development, gain full control of our supply chain, and positively impact our margins. The fourth pillar of our growth strategy is to strategic M&A. While we have a strong foundation in our current products boasted by a robust pipeline, we believe the right acquisition can complement and enhance our organic growth trajectory. To this end, we have engaged a consulting firm to assist us in identifying opportunities. We will pursue strategic acquisitions to augment our technology, add to our product pipeline or provide enhanced commercialization capabilities. We will be deliberate in our evaluation. Looking for companies that have are in appropriate size can be easily integrated into our culture and operations and our accretive. Most importantly, any acquisition we make must accelerate our growth. Before I turn the call back over to Sylvia, I want to emphasize Anika's significant prospects. We have a proprietary and strong platform technology in hyaluronic acid. We have a market-dominant viscosupplementation franchise as well as major pipeline developments. We are strengthening our infrastructure to support our growth with a direct commercialization capability and integrated manufacturing to accelerate R&D. Furthermore, we look to augment our business through strategic M&A to enhance our capabilities and further drive our performance. Enclosing, we are well positioned with a clear strategy to deliver value for years to come. And with that, I'll turn it back to you, Sylvia.