Sonny Bal
Analyst · Needham & Company. Your line is open
Thanks, Mike, and good afternoon everyone. Welcome to our third quarter 2015 earnings results conference call. I will begin by giving an update of Amedica’s recent operational highlights and afterwards, Ty Lombardi will provide us details on the financial results for the quarter and then we’ll open up for questions. I’d like to begin today’s call by sharing how pleased I am with the progress we’ve made throughout the company from our financial and operational standpoint. Despite, what we’ve experienced in the market in the last two trading days, I was assure our listeners that there is nothing wrong with the company. We are in a strong financial position, we are compliant with all debt covenants and we’ve made substantial progress in our goals and we’re executing on our vision all of which Ty Lombardi and I will outline later on in this call as Ty will outline also. We’re able to reduce year-to-date operational cash burn levels by 38% from last year, while also reducing our debt principal balance. This is a significant positive impact from the restructuring we completed at the beginning of this year. Result for these actions are beginning to show and these vital to our continued success going forward. I strongly believe that we have turned the corner as a company as we continued toward an increasingly positive trajectory. I am very optimistic in our ability to increase market share for silicon nitride materials, launch new and exciting products, engage more surgeons and expand our research and development, while increasing value for our shareholders. We have made excellent progress in all levels of our business this past quarter with the release of new products and expansion into new geographic market, much of which I’ll touch on later. We recently finalized definitive agreements to raise up to $15 million, which will be used to strengthen our balance sheet and help to get us out of some toxic previous debt and will provide stability to our balance sheet and cap table. With this table and improved balance sheet, we are better positioned to develop innovative products and renderings and compositions of our materials and ongoing effort. Amedica has a strong infrastructure in place with top level manufacturing, good management, business development and research and development teams. Our silicon nitrate materials are truly unique and differentiated and we believe they are better than anything on the market. As my team and I are out in the field on a regular basis, it’s very good to see a renewed excitement about Amedica and silicon nitrate biomaterial again. I’ve talked to many surgeons, doctors, investors, distributors, potential primate label and OEM partners all across the world and they are excited by the quality and potential of our ceramics. Another big move we undertook during the quarter was to appoint Dr. Giuseppe Pezzotti to our Scientific Advisory Board. Professor Pezzotti is a world-renowned materials scientist that will help us further develop our silicon nitrate technology platform, it feel that is very close to him. Dr. Pezzotti holds three doctoral degrees in material science engineering, solid state physics and medical sciences. With that excellent background, he will be pivotal to provide further validation of the uniqueness of our proprietary silicon nitrate composition and advance the science even more. Since joining us this quarter, Professor Pezzotti has provided a webcast on the physics, chemistry and mechanical behavior silicon nitrate and how it compares to biomaterials. He will be a part of future webcast in the coming months regarding the team’s research findings which have the potential to yet further improve clinical outcomes of our proprietary biomaterial. In regards to products, we announced the addition of our articulating inserter for minimally invasive Transforaminal Lumbar Interbody Fusion or TLIF procedures and the relive of a silicon nitrate Lateral Lumbar Interbody Fusion Device. Starting with the articulating inserter, we are getting very positive feedback that this minimally invasive and surgery approves visibility and provides another access option for surgeons. And we are already beginning to see a positive impact on the business during this beta testing. The scorpion articulating inserter will be made available to a field of surgeons and distributors as early as next week. Moving on now to Valeo II Lateral Lumbar Interbody Fusion Device; we underwent an initial launch in September to make the device commercial available, which includes a second generation instrumentation to improve patient safety and surgeon ease of use. With the first phase of the Lateral Lumbar System complete, our product development team is now undertaking the task of creating additional sizes and footprints of the Interbody device to make the system more widely available for a myriad of procedure and patient anatomy types. In addition to these two products, our product development team is also deepened the process of updating a Preference 2 Metals System. I am proud to announce that the first phase of this project was completed during the quarter, which has greatly improved an update of the instrumentation within the system. And again, we’re seeing some early positive impact on our financial results as more systems will be coming online during Q4 and into Q1 next year. These actions which are critical to offset recent declines in our metals revenue are also paramount where our ability to fully update our Preference Metal Systems. Speaking of which a Preference Elite System, the new and much improved metal system remains on track to be launched into the field during the second half of next year. This is very significant for us because this new metal system will not only have a pull through effect on a silicon nitrate sales which we’re already seeing with recent instrument updates but this system will also arrival much of what’s out there in terms of state-of-the-art products in the market today, allowing surgeons to have just one rep in the operation room during the procedure. In addition to a further updated instrumented system, Preference Elite will also future a cannulated screw and design amenable to minimally invasive procedures. Looking forward to 2016, we’ll continue to keep our product development teams busy because we’re considering several new projects such as a standalone fusion device, additional versions of our Composite Interbody Fusion Device and also a second generation formulation of our core silicon nitrate technology platform. All of which we can details at future date. These are very exciting times that Amedica all made possible by improved financial and cash position. Continuing with similar success we’ve experienced in the product development side, discussions with both private label and OEM partners continue to be strengthened throughout the year and quarter. We continue to draw interest and navigate opportunities that present the best option for our company. We have been working diligently to secure and finalize agreements on that front. Some agreements take longer than other to finalize but I remain confident and optimistic for the future of a hybrid OEM and private label strategy. Our business development strategy also remains very strong as we educate, share and present data to our peers about the benefits of silicon nitrate and why it’s the perfect biomaterial. We strongly feel the strategy is that an infection point and this was obvious during the recent North America Spine Society Conference in Chicago last month. There were several discussions and presentations during the week, not by us, by others, which furthered our claim that silicon nitrate is the ideal biomaterial. These presentations and discussions range from explaining why PEEK or plastic cannot fuse its own to how ceramics just as silicon nitrate play a critical role in the spinal fusion process. As several surgeons, manufacturers and others from the industry came to our booth. The overwhelming conversational theme was which biomaterial they should more to or away from PEEK. Needless to say we had a busy time at NAS this year meeting with influential context about the retail and OEM private label side of the strategy. Those conversations were both educational and encouraging and they are continuing. While there are other materials in the market today which provide increase surface topography to stimulate bone in growth, keep in mind silicon nitrate is the only material in the world that offers the world first natural nano-surface biotechnology. This natural technology includes increased surface area for osteoblasts and proteins, but also contains a unique surface chemistry which lends to the materials anti-infective and osteopromotive properties claims that no other material out there today can make. And might I add, we can engineer that surface topography to suite particular needs. Our business development team has been very active and getting in front of the influences and building interest. These discussions have been limited to spine for a larger spectrum of the potential medial applications, the silicon nitrate will be ideal for. The science behind our material is concrete and strong and getting the word out of conferences NAS is paramount. We are actively accessing these partnerships here domestically as well as in Europe, Latin America and Asia, the medical application that includes spine, hip, knee, dental and others. As you may have noticed recently, we secured our first joint development agreement for dental application this quarter and we’re moving closer to hip and knee, which we will touch on later. Our increased efforts to expand the use of silicon nitrate through our existing sales and distribution channels are paying off. Our improved financial situation is exciting and offers the Amedica grade upside potential moving forward. I am convinced that there are many opportunities to help strengthen the existing distributor of surgeon base and build future on it. Progress with peer reviewed publication is also going very well and we are ahead of schedule on that font. We plan to announce two more accepted publications later this month, one of which includes a future publication in The Journal of the European Ceramics Society. It is a solid body of work with over 600 references that outlines a key role ceramics namely silicon nitrate play an orthopedic applications. We are very proud of this key publication and it has already turned more than a few heads in the orthopedics and ceramics research communities and gotten us invitations to conferences. I am also proud to note that our presents and discussions at this year’s International Society of Technology in Arthroplasty or ISTA abbreviated was a success, our presentations all of which were accepted at the conference. We’re well received and one of our submitted abstracts regarding surface modulation of silicon nitrate ceramic secured the Transatlantic Orthopaedic Congress Abstract Award. Our R&D team continues to validate our unique material claims through in Vivo and in Vitro studies which have yielded several whitepapers and peer viewed publication this year. This approach has provided additional fire power for our sales and business development teams to make new contacts and solidify new deals. Each new peer reviewed article makes it easier to show the medical community and potential OEM and private label partners, the validity of our unique silicon nitrate clinically benefits. This strategy has been very effective and our conversation with other in the field have become more responsive allowing for a large market penetration which increasing potential sales. Feedback we continue to receive as that silicon nitrate is a super material that offers excellent results and unique benefits. Please stand behind our evidenced based outcomes and we will continue to bring these findings to the public. We are committed to our data expansion efforts and we will continue to push those. There is much to do on this front and our scientific team continues to build on the portfolio of peer reviewed publications related to the basic material properties of silicon nitrate throughout the year. We are the leaders in nano-technology surfaces for medical applications and these scientific papers will continue to provide the knowledge base to further improve up on an innovative technology platforms. Moving on to recent international endeavors, we noted in our previous call that we had clearance for our first generation silicon nitrate into body fusion devices and instrument sets in Brazil. I am pleased to announce that our first shipment of product has cleared customs and we anticipate further developments and announcements from the region in the coming months. And Brazil is a sizable market with a population of more than 200 million people and we look forward to experiencing incremental growth as that region comes fully online. Our business development efforts both internationally and domestically have been vital for finding us key new markets and opening additional sale channels. We look forward to further cultivating this opportunity in Brazil and other markets while accelerating the adoption of silicon nitrate for use in biomedical applications. Now clinical outcomes and peer reviewed scientific data are vital to our success going forward in the unique biomaterial. It’s a data drive world out there. our customer need data to add scientific credibility and to validate the use of silicon nitrate over other materials that have been used in medical applications. Together, our studies will continue to provide us with a solid clinical foundation that our sales and marketing team can build on and there are surgeon and hospital customers that our OEM and private label partners need in order to adopt our technology more widely. In regards to regulatory efforts, FDA has request for 24 month clinical performance data was fulfilled early this week. The FDA is now able to consider further clearance of our Cervical Composite Silicon Nitrate Interbody Device, that’s already been used in Europe. This submission is important to us. We spend the necessary time during the data gathering and analysis process to ensure that we had everything right before submitting it to the FDA for further review. And we feel confident in our submission as we’re able to work with the FDA and other key partners as efficiently as possible. And we look forward to a favorable outcome, the anticipated timeline being first quarter of 2016. With the FDA decision on the horizon, we continue to be diligent in discovery of additional innovative solutions. Our Femoral Head Testing has progress nicely and we received very constructive feedback on our proposed where a testing protocol from the FDA. We now have a clear understanding of the pathway to market for our silicon nitrate Femoral Head in the United States. These FDA comments will ensure that the testing of our material has compared with the ceramic predicate devices on the market will meet or exceed every existing testing standard. We anticipate being able to provide additional details on this testing soon and look forward to the results of a direct comparison with all other Femoral Head materials out there. Interest in our silicon nitrate continues to grow and we recently announced a joint development agreement for dental applications. This agreement marks a first step into a market outside of spine. But this is only the beginning. Worthington is our first dental OEM customer and we will work closely with them to develop prototype and manufacture. They have patterned it in very creative dental implant system. This new alliance into a new market allows for further acceptance of silicon nitrate for medical applications and validates the advantages of our proprietary biomaterial and as compared to anything else out there. From a manufacturing standpoint, our team continued to exceed expectations this quarter as production yields increased beyond 97%, which is a sizable increase from the same period last year and a strong continuation from the previous quarter. This high yields speaks to the tight control process that in place despite the many complicated steps is takes to manufacturer our silicon nitrate devices. Additional opportunities, we increased yield and reduced production throughout. Throughput time this year have been identified and will be implemented throughout the year. And before I turn the call over to Ty Lombardi to review the financials, I like to remind our listeners why we’re so thrilled about Amedica’s bright future. We are truly a unique highly differentiated company one of its kind in the world. We’re the only company that develops and commercializes silicon nitrate ceramic as a biomaterial platform for use in spine and potentially many, many other medical applications. We have the only FDA and CE cleared silicon nitrate manufacturing facility anywhere in the world. We are unique for four reasons; one, we sell branded products directly to hospitals through a sales force and distribution structure. Two, we can private label these innovative silicon nitrate products to other companies, looking to broaden their product portfolio. Three, we’re able to develop OEM partnership where we take a company’s existing design or devise made out a legacy inferior material like plastic or metal and we can ceramasize it so to speak into silicon nitrate very effectively thereby increasing a strength biocompatibility, making it anti-infective and we can customize it. And four, potential, we already make Superior Interbody Spinal Devices that are sold in the U.S., Europe and South America and look to add other medical applications. There are numerous peer reviewed publications that speak to the many benefits of silicon nitrate in healthcare and we’re just beginning to scratch the surface of what this fantastic biomaterial can do in the current healthcare market. This multi-pronged strategy will allow us to capture additional market share, while achieving profitability on accelerated timeline as compared to our peers given the superior benefits of our biomaterial technology platform. The restructuring changes we made at the beginning of this year have truly positioned Amedica for success over long haul. We are now on pace to reduce manufacturing cost 20% year-over-year through a combination of lean and continuous improvement initiatives. Driving down manufacturing cost has been a priority for us and we continue to execute one cost per piece or our cost per piece is very competitive with other materials that are now commercially available. We are continuing to growth our existing private label in OEM business within upcoming metals launch system in 2016, some metal updates in fourth quarter. We are in great shape going forward. This unique hybrid sales strategy is made possible by the hard work and dedication of our finance team. The recent equity financing and strong improvements we made to operational expenses now given us the necessary runway to fully execute on the strategy. With that I’ll now turn the call over to Ty Lombardi, who will discuss our financial results. Ty?