Jerrell Shelton
Analyst · Janney Montgomery
Thank you, Todd. Good afternoon, ladies and gentlemen and thank you for joining us today. With me this afternoon is our Chief Commercial Officer, Dr. Mark Sawicki; and our Chief Financial Officer, Mr. Robert Stefanovich. Later, during this call, Dr. Sawicki will provide you with his comments on our sales and marketing activities; and Mr. Stefanovich will detail our financial results for the first quarter of 2018. This was another strong quarter for our company which included the continued ramp of reported revenue from our commercial agreements to support Gilead's Yescarta and Novartis Kymriah When fully rolled out, these therapy will represent significant sources of revenue growth for Cryoport as patient numbers expand and they gain traction in the medical community. I will touch on these programs in a moment but first a quick recap for the quarter. Our top line revenue for the first quarter was $4 million representing a 48% increase over the first quarter of 2017 and a 21% increase over the fourth quarter of 2017. This increase was primarily driven by biopharma revenue which rose 62% year-over-year. Revenue from our commercial agreements Yescarta and Kymriah accounting for approximately $218,000 of our biopharma revenue with the remainder fueled by a new client wins and expanded relationships that provide our advanced temperate control logistics solutions to support ground breaking clinical trials in the regenerative medicine space. It is important to remember that we are in our infancy with respect to these first two commercial CAR-T cell therapies. But make no mistake, the pace of our expansion will accelerate this year as both Gilead and Novartis’s commercial activities ramp over the remainder of 2018 and beyond. As a reminder, Novartis’s Kymriah became the first CAR-T cell therapy to receive regulatory approval when it was approved by the FDA in August last year for the treatment of patients up to 25-years of age when B-cell precursor ALL that is refractory in second or later relapse. Kymriah sales are still in their early stages generating $12 million in revenue to Novartis last quarter to prepare for increased patient adoption, Novartis has been focused on establishing its points of care sites. It recently stated that it now has 35 qualified points of care centers running, over 500 employees dedicating to Kymriah and has shipped Kymriah into 11 countries to-date. It is indeed inspiring to see Novartis comprehensively planning for large scale patient adoption. Cryoport has a global role in supporting the distribution of Kymriah and is building out new state-of-the-art logistic centers in Livingston, New Jersey and Amsterdam, Netherlands to meet the coming demand. Novartis is also working closely with the FDA and the EMA to make Kymriah available to a wider patient audience with critical unmet needs. Earlier this week, Novartis has announced that the FDA has approved Kymriah for its second indication, the treatment of adult patients with relapsed or refractory large B cell lymphoma that are ineligible for or relapsed after autologous stem cell transplant. This makes Kymriah the only CAR-T cell therapy that is FDA approved for two distinct indications. Our current agreement with Novartis covers this expansion and services for Kymriah as well as any other future additional indications. In the EU, the European Medicine Agency has granted an accelerated access to Novartis application for approval of the therapy to treat children and young adults with relapse or refractory B cell acute lymphoblastic leukemia. This approval will also further expand our support under our existing commercial agreement. Gilead's Yescarta is the first CAR-T therapy for adults living with certain types of non-Hodgkin lymphoma who have failed at least two other kinds of treatment. Its FDA approval was granted in October of last year. In the first quarter of this year, we continued the early stages supporting the commercial launch of Yescarta. Gilead recently reported $40 million of sales from Yescarta for its first quarter. It has certified 40 points of care centers and by midyear, expects to have enough of these qualified centers to treat approximately 80% of eligible Yescarta patients. Cryoport has a global role in supporting the distribution of Yescarta and will employ its global logistics center network especially in Irwin, California and Amsterdam, Netherlands to this end [ph]. Both Kymriah and Yescarta are in early rollout stages and represent substantial embedded revenue growth opportunities for Cryoport as each company works toward it respective stated patient targets and these revolutionary therapies gain traction. In addition, based on the success of these therapies both Novartis and Gilead are increasing the number of clinical trials as well as targeted indication supported by their CAR-T programs. As you know, Novartis and Gilead Kite are the big news in the biopharma market. However, Cryoport’s embedded revenue growth extends far beyond that to include many clinical trials we support in a regenerative medicine space. Our recognition of commercial revenue continue to increase during this first quarter, we also continue to grow the foundation of Cryoport’s additional future commercial revenue. In the first quarter, we secured continued solid growth in the number of clinical trials we support by adding a net total of 22 new trials bringing the total number of clinical trial supported to a record 236 up from 214 at the end of the fourth quarter and up from 139 in the first quarter of 2017. Significantly, 31 of these trials are currently supported by Cryoport are now in Phase 3. Furthermore, we anticipate supporting a further 5 or 6 additional BLA or EMA filings in 2018 based on internal information and a forecast from the alliance of regenerative medicine in addition to Kymriah’s second indication approval which I mentioned earlier on this call. Now turning to animal health and reproductive medicine which are also important markets for us, our animal health revenue declined 12% year-over-year or 32% sequentially. This relative decline was attributable to a large one-time transaction in the prior years spanning previous quarters as well as a temporary pause in a clinical trial that will restart in the current fiscal quarter. Given our current base in animal health, revenue recognition can be uneven. However, animal health has considerable upside and we view this market as an important part of our business. In reproductive medicine, we reported 20% year-over-year revenue growth or 11% growth over the previous quarter. Regarding investor relations, we consider getting our story out and a central part of keeping the financial markets informed and building shareholder value through recognition and familiarization. We have an intensified effort with our investment bankers to further develop institutional investors who regularly conducted non-deal roadshows. We are participants at investor conferences sponsored by Janney Montgomery, Needham, Cowen, ROTH and for the first time, we will be presenting at the 2018 Jefferies and Deutsche Bank healthcare conferences. Now, for more detailed information on our sales and marketing activities, initiatives, successes and outlook, I am going to turn the call over to Dr. Mark Sawicki; our Chief Financial Officer. Mark?