Dan Orlando
Analyst · Needham & Company. Your line is now open
Thank you, Nick. As mentioned earlier in the call, MACI revenue for the fourth quarter increased 26% over Carticel revenue in the fourth quarter of 2016 representing the third consecutive quarter of strong MACI growth following the launch. We also saw strong results across several key large performance indicators for MACI biopsies, which are by far the most important leading indicator for near-term MACI growth increased 48% in the fourth quarter and 33% for full year 2017 compared to the same periods in 2016. Overall, surgeon interest and demand for MACI continues to expand as we saw 22% expansion in the number of unique surgeons sending biopsies in 2017 compared to 2016 and about a 10% increase in the average number of biopsies per surgeon. This significant increase in MACI biopsies and the rapid expansion of our MACI surgeon customer base is very encouraging for MACI’s growth prospects, especially since the rate at which biopsies convert to implants has been very consistent over the last 5 years and we have not seen a material change from previous conversion rates since the launch of MACI. While we cannot be certain that conversion rates will remain confident in the future given this growth and biopsies, we are confident that implant volume will continue to grow. To help drive this growth, we have been very active in both marketing activities and medical education. To-date, we have trained approximately 600 surgeons on the MACI surgical procedure. And with sustained emphasis and investment, we expect to continue to grow our trained surgeon base this year. Given both the increased interest in MACI from surgeons who have not previously used Carticel or have yet to do a MACI implant and the expanding surgeon, MACI surgeon base, we announced last quarter that we are expanding the sales force from 28 representatives in 4 regions to 40 representatives in 5 regions. The expansion will allow us to take advantage of the growing interest in MACI, which is based on the MACI’s demonstrated clinical benefit and improved payer access resulting from updated medical policies. In addition as the number of MACI implants surgeon increases, the required support from the sales force of course also expands. We have hired representatives for vast majority of our new territories and are on track to have these representatives trained and in the field on April 1. In addition to increase support for our surgeons, we are also providing an expanding set of support services to potential and actual MACI patients. Sporting patient starts with access to MACI, we are pleased that with only 9 months following the launch of all of the top 20 plans have medical policies, which provide access to MACI. We estimate that this represents approximately 85% of commercial covered lives in the United States. There will always be smaller plans that do not have specific MACI medical policy, but for these, we generally are able to gain approvals on a case-by-case basis. In addition to MACI access, we have in place a highly integrated pharmacy provider case management and patient support and education program called My Cartilage Care to support patients from biopsy through rehabilitation. By directly managing customer-facing portion of the medical authorization and benefit review, we are able to ensure a high-quality experience for both surgeons and patients. With the patient and surgeon support foundation in place and having achieved broad payer access, the timing is perfect for watching the MACI It’s Your Move campaign with world champion swimmer 5-time Olympian best-selling author and MACI patient Dara Torres. Dara’s story is compelling for all potential MACI patients. After competing in five Olympic Games following the 2009 World Championships, Dara began experiencing chronic pain in her left knee. She was diagnosed with a cartilage defect and after research and treatment options and consulting with several top U.S. sports medicine surgeons, she chose to be treated with Carticel. In 2016, Dara was diagnosed with a similar cartilage injury in her right knee. Based on the positive outcome, she had earlier treatment with Carticel, she chose to be treated with MACI, the campaign which was aimed at active individuals who are sidelined from their favorite activities due to knee pain possibly caused by cartilage injury will highlight Dara’s patient journey and will seek to help other patients understand the medical condition and seek treatment. The campaign tagline, It’s Your Move is a compelling call to action for patients seeking to return to their favorite activities. Dara, her personal story and her motivating messages will become a core component of all online MACI promotions from maci.com to Facebook, YouTube, banner ads and search engine initiatives. I encourage you to visit the maci.com website to experience for yourself the compelling imagery and messaging of this powerful call to action per patients. In summary, there is clear demand for MACI from an expanding set of surgeons when we have put in place the core components necessary to ensure that we can translate this demand into MACI implants. This is the right time to invest in both an expanded sales force and patient focused promotional initiatives such as It’s Your Move campaign and it is the right time for us. Turning to Epicel, revenue in the fourth quarter was $6.1 million, up 62% over the fourth quarter of 2016 as we saw a significant increase in the number of orders and institutions ordering to Epicel compared to the same period in 2016. While Epicel revenues are inherently volatile, the number of burn centers taking biopsies and treating patients has increased and we expect that episode volume should continue to grow on an annual basis. In total, Epicel was utilized by 40 burn centers in 2017, which is double the number of centers utilizing this potentially life-saving therapy when the business was acquired in 2014. As we have previously discussed, the first phase of Epicel growth was reengaging surgeons who have previously used Epicel and we are trained on the optimal use of this product. We believe that the recent growth is the result of our investment and related Epicel peer-to-peer training intended to establish a standard of care to help surgeons identify Epicel patients. We are focusing our message on patients’ revival to reinforce the powerful lifesaving potential benefits of Epicel. Along with our increased promotional efforts with surgeons, we have improved our patients and burn association meetings, including speaker programs targeted to major regional and national burn conferences and presented held educational symposia and exhibited at more than half a dozen important conferences and programs over the second half of 2017 alone. Finally, we have also created a reimbursement hotline, staffed with billing experts to 8 hospitals with questions about coding and reimbursement for Epicel. Epicel can be an important life-saving therapy for severe burn patients and we are so pleased that our investments to-date have expanded its utilization and we are confident that through our continued support, we will reach more patients in need. I will now turn the call back to Nick.