Karen Zaderej
Analyst · JMP Securities. Please proceed with your questions
Thank you Bob, and good morning everyone. I’d like to welcome everyone especially our new and existing shareholders to our fourth quarter and full year 2014 conference call. Joining me on the call today is Bob Johnston, our Chief Financial Officer to discuss our financial highlights of the fourth quarter and the full year. Bob will also review our financial position following our refinancing and capital raise. 2014 was a very successful year for AxoGen in terms of growth, strengthening our financial base and it has positioned us well for 2015. AxoGen demonstrated considerable year-over-year revenue growth in each quarter in 2014. Our efforts throughout increased awareness and usage of our portfolio of nerve repair products. We heard and acted on feedbacks from many shareholders with concerns that the PDL minimum royalty and footright [ph] along with the company’s cash position was an overhang on the stock. We took action by refinancing the PDL royalty contract with a new agreement with Oberland Capital and completing the recent $15 million capital raise. We expanded our surgeon education program to direct sales team and we continue to see acceptance of our growing body of clinical data. Our goals for 2015 are to build on the success of this prior year and we remained focused on increasing awareness of our products, driving changes in clinical algorithms through surgeon education and clinical studies and improving utilization of our products by expanding our sales footprint and providing strong sales execution. So let’s start with an overview of our growth. We reported record quarterly revenue of $4.8 million which represents a 61% increase over last year’s fourth quarter. In addition to delivering record quarterly revenue, our gross margin reached 80% as we delivered improved performance across our key metrics. Our fourth quarter results were the culmination of the year long momentum in our growth and market advancement. For 2014, our full year revenue was $16.8 million representing a 54% growth over full year 2013. As I’ve said on previous calls we have kept our execution very focused which has led to our high growth. The market for peripheral nerve repair is very large. The area in which we are currently focussing is estimated to be $1.6 billion in the U.S. So our 2014 full year revenue of $16.8 million would suggest that we have penetrated approximately 1% of the market and we have significant upsides. AxoGen is uniquely positioned to provide the best solution to this large and untapped market. One of AxoGen’s greatest strengths is our broad portfolio. We believe that our comprehensive product portfolio is a barrier to competitive entry. The portfolio addresses the key issues facing nerve surgeons today. How they provide off the shelf treatment options for patients in a phased and cost effective manner and avoid the potential complications and costs associated with an additional surgery to harvest autograft tissue. Our three brands address the full spectrum of surgical repair needs for the typical nerve repair surgeon. The first of these products is Avance Nerve Graft. It is donated human nerve tissue processed through our proprietary cleansing and de-sterilization method and intended for the surgical repair of peripheral nerve gaps. Next is AxoGuard Nerve Connector, the only extracellular matrix coaptation aid for tensionless repair of severed peripheral nerves. And finally, AxoGuard Nerve Protector is the only extracellular matrix implant used to protect injured nerves and to reinforce the nerve reconstruction while preventing soft tissue attachments. Our products eliminate the need for the additional surgery associated with the harvest of nerve autograft tissue repairs and offer new options to treat the more than 900,000 nerve injuries that will be surgically repaired this year in the United States alone. In today’s healthcare environment, medical products need to provide both clinical and economic values to drive adoption. Our off the shelf nerve repair products offer the hospital and the surgeon advantages in terms of time and economics. First and most importantly, the harvest of the autograft is not separately reimbursed and there is no financial driver for this procedure. Elimination of a procedure to harvest the patient’s own nerve tissue will save 30 to 60 minutes or more in the total procedure time. That in turn reduces costs of both the OR and anaesthesia. Using a national average for OR cost this time savings equals about $4000 in cost savings for the hospital. Not only does the reduction in time save OR and anaesthesia cost, it presents the facility with the opportunity to perform more surgical procedures. A typical large hospital could gain the equivalent of 6 to 9 days of additional available OR time in a year by adopting these off the shelf technology. In addition, OR may eliminate the need to harvest the patients on tissue may allow the use of local or regional anaesthesia instead of general anaesthesia which reduces even additional cost. Off the shelf nerve repair products may also prevent cost associated with complications from nerve autograft harvest procedures. Surgical site infection is one of the most common complications of any surgical procedure and the cost to a facility to treat a surgical site infection can be more than $20,000. Hospitals are increasingly aware of this cost as they are being held more financially accountable for avoidable complications that readmit in 30 days. Hospitals are investing in reducing the hospital acquired infections but the only way they can completely eliminate the opportunity for a hospital acquired surgical site infection is to not do the surgery. AxoGen’s products offer the benefit of eliminating the additional surgery to harvest the autograft nerve tissue. Off the shelf nerve repair products such as Avance Nerve Graft offer a compelling value message to surgeons, facilities and patients alike and we believe our value proposition is driving steady surgeon migration to our product portfolio. Now I’ll update you on AxoGen’s marketing and sales approach. What I like to refer to is the four pillars of growth. We are achieving the desired results for each initiative so let me highlight how the team is successfully executing this plan. First, we’re building a higher level of market awareness. To introduce more surgeons to the benefits to new treatment options we engage with them at hospitals, clinical conferences, promotional events and surgeon education courses. At the joint annual meetings of the American Association for Hand Surgery, American Society for Peripheral Nerve and American Society for Reconstructive Microsurgery. We sponsored a surgeon panel, titled, "The Value of Nerve Repair Technologies in Your Practice". The response of this session was outstanding with more than a 100 surgeons in attendance, a virtual who’s who in the nerve surgeon community demonstrating the growing interest in Avances and nerve repair treatment and the effectiveness of our awareness programs. More importantly, the tone of the conversation in these meetings has shifted over the last year. The questions asked by the surgeons in the past were on the basic science of our products and the questions asked today are related to the practical aspects of using our products, things such as what sizes to order, and when to use one product versus another. Patient stories are also a part of the dialogue and at the end of the day are the real validation of the impact of our products. One such story comes from the Chicago area; surely it’s a patient who had suffered for years with debilitating pain from a very old nerve entry that had not been properly diagnosed. Shirley spent more than five years going from doctor to doctor seeking a solution for her pain. She was prescribed narcotics to help manage her pain and even underwent several surgical procedures including one in which several of her toes were amputated. However, nothing brought her relief and she was forced to give up the many things she enjoyed in her life such as hiking, spending time with family and friends as well as day to day activities like shopping and eating out. Finally after doing some online research for surgeon who specialize in nerve repair, Shirley found a team of physicians who were able to conduct nerve testing to identify the source of her pain. The neurologist identified damage in different areas of peripheral nerves in Shirley’s extremity which turned out to be three undiagnosed neuromas The surgeon was able to remove the painful neuromas leaving gaps in the peripheral nerve which he bridged with Avance Nerve Graft. Today, Shirley has reported a significant reduction in pain as a result of the neuroma removal. She is still recovering, and importantly is returning to her normal activities. To help promote awareness of nerve injuries and the treatment options, we were honoured to have Shirley represent nerve tissue recipient in the recent 2015 New Years Day Rose Parade as a rider on the Donate Life float. The benefit of growing awareness of our products generates interest and drives greater market awareness and future revenues. So our second pillar of growth is focussed on surgeon education and the development of surgeon advocates. As you will recall, in 2013 we initiated two day hands on education events led by leading nerve surgeons where we showcased the latest science and best practise in surgical nerve repair. We held four of these events in 2014. In 2014, we also piloted a separate event focussed on educating Surgical Fellows. Fellows are the surgeons in their last year of training before taking their board exams and entering their own practise. All in all, more than 110 surgeons have completed these intensive events focussed on nerve repair. The results have shown that these events are very successful in terms of both feedback from the surgeon attendees and their impact on revenue. The opportunity to learn from experts faculty, focus exclusively on nerve repair techniques and gain hands on experience leads to attendees changing their treatment approaches immediately following completion of a course. In fact, we have observed a greater than 60% increase in revenue from the surgeons who attend our prior courses. Given this impact, we have increased the number of events in 2015 to 9. We have already conducted our first events for 2015 held just two weeks ago at the Buncke Clinic in San Francisco and that event was oversubscribed. Our next event were named specifically at Extremity Fellows will be held later this month and we’ll follow these up with additional surgeon event in April and May. We expect over 225 surgeons will attend these courses in 2015 in addition to the other education events that we hold at major clinical conferences and in local territories. The third pillar of our growth strategy is to grow the body of clinical data to support the use of our product. We continued to make excellent progress building data to assist surgeons in the decision making process. At the end of January, the RANGER Study, an ongoing multi centered study focussed on the repair gaps and peripheral nerves included over 600 nerve repairs with Avance Nerve Graft. And results from this study have already been published in two peer reviewed journals and presented at more than 35 times at clinical conferences in the U.S. and in Europe. Not only has RANGER become the largest clinical study in the treatment of severed peripheral nerves, its increasing size and diversification allows for analysis of the many different factors that impact outcome. And it is become an important source of nerve outcome comparative data. So it’s the publication of the first data milestone and reconstructive microsurgery and a journal of hand surgery in 2012. The RANGER Study has been citied more than 120 times in the other scientific journal. The last by no means least of our growth pillars is sales execution. Our growth comes from both driving penetration in existing accounts and the addition of new accounts. New accounts are essential for driving growth and generate lower revenues initially as they come on board. In existing accounts, the opportunities for growth comes from our installed base in terms of expanding to other surgeons in the accounts and driving usage of our full portfolio of products A part of that focus is on ensuring that an account is using all three of our brands. As the data reflects, an account that orders all three of our brands generates at least five times more revenue than an account ordering just one brand. So we continue to drive usage of their portfolio and see good results. During the fourth quarter revenues from accounts using two or more AxoGen brands increased 80% over last year’s fourth quarter. For the full year revenue provided by these accounts increased 72% over 2013. During the year we continued to expand our sales force and at the end of the fourth quarter we had 29 direct reps up from 23 at the end of the third quarter. We are planning to add an additional 6 to 10 direct reps before year end as we seek to increase our presence in key markets. Successful sales execution starts for hiring the right people and then ensuring that they are properly trained to drive awareness and usage of our products. We have developed a solid understanding of the science of nerve repair and compelling information about the value our products offer. We were proud to educate our sales team so that they are able to deliver these messages in an effective compelling way. Our sales team is also maturing. At the end of December, 16 of our direct reps in the U.S. had been with us for more than 12 months and are showing good growth in their respective territories. In addition to our direct sales team, we had 23 independent agencies in the field at the end of fourth quarter representing our products and more of these reps are taking notice of the increased awareness and surgeon interest in our products. As I said before, with the success and continuing momentum of our current focus in upper extremity, we also saw the opportunity for additional growth in Oral Maxillofacial Surgery. Following a pilot to learn this market, we successfully launched it to our entire sales team in mid 2014. Nerve repair and Oral Maxillofacial applications is a market with about 129 million and has strong unmet clinical needs that we are able to address with our current product portfolio. Our focus in this area is on Oral Maxillofacial Surgeons who are micro surgically trained and currently addressing injuries to oral nerves, most often caused by prior oral surgery. Following the official launch of the program in mid 2014, Oral Maxillofacial targeted accounts grew more than 80% compared to the last six months of 2013. Our efforts were supported with the recent publication, Sensory Outcomes after Reconstruction of Lingual and Inferior Alveolar Nerve Discontinuities using processed nerve allograft. In the Journal of Oral and Maxillofacial Surgery like prominent OMS Surgeon and educator Dr. John Zuniga, who is Chairman of the Department of Oral and Maxillofacial Surgery University of Texas Southwest and Medical Center. This study was released in December and Fellows 21 patients with 23 separate nerve injuries in which Avance Nerve Graft links up to 70 millimetres we use to make the repair. Dr. Zuniga's findings were that 87% of the patients experienced improved neurosensory scores. What is particular noteworthy in this study that Dr. Zuniga's results mirrored those that we've seen previously and reported for Avance Nerve Graft in the broader population of the RANGER study. We are also exploring opportunities for our products to repair nerve separate during prostate cancer surgery. The cavernous nerves that control erectile function and continence line on either side of the prostate capsule, and are sometimes removed when cancer has spread beyond the prostate. In this situation high rates of impotence and incontinence are reported, and there's a need to evaluate options to repair the nerve at the time of the surgery. A study of the use of Avance Nerve Graft for this type of repair was initiated several years ago. We are now through enrolment and the 24 month follow-up period on this subject. And following completion of the data analysis, anticipate that we will be able to share the results from this study in the first half of this year. With that, Bob will provide you with some additional details on our financial results and our strength and financial resources to support our growth plan. Bob?