Keith Murphy
Analyst · Jefferies
Thanks Steve and good afternoon everyone. I'm going to jump right in by highlighting that based on what we see with the month already behind us in the fourth quarter, we’ve updated our fiscal 2016 outlook for net cash utilization and revenue recognition from our previously disclosed liver contract booking. We are making steady progress on the topline. Total revenue gained 112% versus last year’s comparable period with the primary contribution coming from service work related to our exVive3D Human Liver Tissue. Barry will cover his financial updates and trends later on in his remarks. I'll spend my time today on recent developments in the preclinical safety market, progress we're making with our collaborators and partners, the development of our kidney program, and the steps we are talking in the therapeutic tissue space. Before I dive in, it’s worth revisiting the key fundamental element that formed the foundation for our excellent long term growth prospect. First, we are serving critical unmet needs in markets with very attractive profiles. There is a clear demand for more productive preclinical tissue models, given the 100s of late stage trial clinical trial failures and drug withdrawals that have occurred over the last two decade. Of these failures and overwhelming percentage were for either toxicity, or lack of efficacy, resulting in billions of dollars in wasted drug discovery and development costs. Similarly, for our therapeutic tissue opportunities, when you consider more than 75% gap in transplant medicine between patients on a waiting list and transplants that are completed in an average year, it’s evident that we may have a long term answer by creating tissue replacement products for surgical implantation. Second, we lead the industry with the innovation in cutting-edge services that come with the first mover advantage. In short, no one else has achieved what we do building 100% cellular tissue that is demonstrated to reproduce native tissue function. There are others marketing or attempting to develop improvement to traditional models, but none of them have demonstrated the ability to recreate the key aspect of in vivo form and function in the same way as Organovo bioprinted tissue. Third, we are fortifying a competitive advantage with the world class IP portfolio. Our team really does a great job here extending the influence and reach of our innovation, while also putting us in a strong position to defend our products and services. It starts with the NovoGen bioprinting process where our engineering team continues to make significant enhancements to further develop that platform. Our IP portfolio now includes more than 25 exclusive patents globally and more than 80 patent applications pending. These patent filings don't just relate to our bioprinting technology, but also cover uses in drug discovery and tissue constructs. To name just one recent success year, we recently had our first liver tissue patent issued in the United States. Taking all this together, we have a flexible platform that allows us to target multiple revenue streams across the preclinical safety, efficacy modeling, and therapeutic markets. When you take a step back, we really have great operating leverage, as a portfolio company, with valuable assets. Turing to discussion of our progress in key areas. In the preclinical safety segment, we continue to grow customer adoption of the exVive 3D Human Liver tissue. Although this product was launched in late 2014, it’s worth reinforcing that given the long revenue recognition cycle, we have less than one year of true commercial result. That's a short period of time for any new product or business. These are multi-dimensional, high-content projects that often spread over many months with different milestones. Fiscal 2017 will be an important period as we’ll have year-over-year comparisons to point to as we evaluate our ongoing performance. Those benchmarks don’t exist today as we are still breaking new ground. We remain encouraged with our early customer profile in the liver business. Our customers span the globe including the United States, Europe, and Asia, and we continue to penetrate the top 25 global pharmaceutical companies. Repeat contract continue to commend at a solid pace. We had another top 25 global pharmaceutical customer win in the last few weeks, bringing our total to four with this important group. While we can't always refer to these customers by name due to confidentiality and business reason, over time we’ll describe as much as we can about the customers and the work we are doing for them. Two of our top 25 global pharmaceutical customers have had their two new posters accepted for the Society of Toxicology annual meeting in March. They will be discussing the results they've seen in preclinical studies that are using our technology. We’ll also be presenting two posters ourselves at this influential conference, highlighting the strong data we’ve recently achieved internally with exVive 3D evaluation studies. As I’ve shared before, these types of collaborations with key customers, as well as our continuing to build the data set that validates our product and services will be vital to customer penetration in all of our business lines. It's all about credibility with our customers and we continue invest to do more. Moving now to kidney tissue development. As you may remember, we hit the functional validation milestone for our kidney tissue back in October. We are working diligently to publish this great work by our researchers in conference presentations and pre reviewed journals are also taking the necessary steps in manufacturing quality and other functional areas to ready this product for commercial use. We are still on track to commence data testing for the kidney tissue in the second calendar quarter of 2016 and for the initiation of contracting later in the year. With an addressable market of over $2 billion and roughly 6,500 annual programs that required toxicity testing, we are well-positioned to capitalize on this potential $100 million plus annual revenue opportunity. The lack of existing alternatives, particularly effective 2D cell models is even more acute in kidney than in the liver business, and we forecast pricing to be superior to the liver tissue. Ongoing discussions with our toxicology customers suggest there is a strong demand for our kidney tissue and we'll also take our learnings from the liver commercial launch to drive early success. Before I wrap up with a quick update on our partnerships and therapeutic segment, let's spend some time on how we've recalibrated our sales and marketing approach. Now that we've had dedicated business development resources in place across the United States and in Europe for a full quarter, the focus has shifted to refining and segmenting how we sell to our customers. Some customers may just need a quick report on one compound with basic data on tissue health and tissue histology, while others undertake multi-compounds and require a full redoubt including several functional biomarkers and metabolism. The adaptability of our platform lets us address diverse customer needs while looking at key aspects of liver biology to tell a complete story. To that end, we now offer a structured menu to access or service offerings allowing our customers to tailor the framework of their preclinical testing programs. Moving now to a quick update on our partnerships and therapeutics business. Our partnership with L'Oreal continues to move ahead and I'm excited to report today that we expect to complete Phase1 of our agreement ahead of schedule with this leader in the beauty and cosmetics market. We also expect to recognize revenue in a few months for the completion of this first part of our contract and have already begun work on the next set of deliverables. As a reminder, our collaboration with L'Oreal's United States based technology incubator contemplates a few primary sources of revenue, including being a commercial supplier for our bioprinted skin tissue, co-marketing our skin model to other beauty and cosmetics company, and royalty and licensing payments from cosmetic products tested and marketed using our product. As for our Maersk relationship, we continue to work on both the toxicology and custom tissue disease modeling parts of that agreement and are also pleased to announce that we have completed our earliest deliverables and recognized revenue from multiple stages of this contract. We'll expect you to do the same with additional stages overtime. This is a multifaceted long-term agreement and we hope to provide more detailed information as the deal progresses. Finally, we continue to see great promise for our tissue replacement products where the potential exists to revolutionize therapeutic applications and materially improve patient outcomes. We're still in the early days and are seeing solid result in animal models in the multiple tissue types that we're evaluating. Our timelines are on course as we continue to aim for an investigational new drug or IND submission with the FDA in the next three to five years depending on the tissue type and expect to share preliminary data from the animal models in the next 12 months to 18 months. In wrapping up my thoughts, we continue to achieve the scientific and operating targets we've set for ourselves and are seeing steady progress across our business line. We are poised to penetrate the next set of customers and are refining our sales in marketing effort to maximize the breadth of our revenue profile. The liver business is growing, the skin model is advancing and the kidney product is on schedule. Our investment thesis and our long-term profile are intact and we're prudently deploying capital to change the shape of medical research and practice. We look forward to updating you on our progress again after the 2016 fiscal year-ends. With that, I'll turn it over to Barry for a more detailed financial review.