Cryoport, Inc.
Q2 2018 Earnings Call Transcript

Published: 13 Aug 2018

[Operator:]

Greetings and welcome to the Cryoport's Second Quarter 2018 Results Conference Call. At this time, all participants are on a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Todd Fromer of KCSA Strategic Communications. Thank you, you may begin.

[Todd Fromer:]

Good afternoon. Before we begin today, I would like to remind everyone that this conference call contains certain forward-looking statements. All statements that address our operating performance, events, or developments that we expect or anticipate occurring in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and not on information currently available to our management team. Our management team believes these forward-looking statements are reasonable, as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements whether as a result of new information, future events, or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events, and developments to differ materially from our historical experiences and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in Item 1A Risk Factors and elsewhere in our Annual Report on Form 10-K filed with the Securities and Exchange Commission and those described from time-to-time in other reports, which we file with the Securities and Exchange Commission. I would now like to turn the call over to Mr. Jerrell Shelton, Chief Executive Officer of Cryoport. Jerry, the floor is yours.

[Jerrell Shelton:]

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 quarter. Our performance continues to be strong as of June [ph] that the second quarter of 2018 Cryoport is responsible for 258 clinical trials and the first two FDA approved commercial CAR-T therapies from Novartis and Gilead/Kite. The ongoing ramp of new clinical trials and reported revenue from our commercial agreements drove 59% revenue increase in the second quarter for our company compared to the same period in the prior year and 54% increase over the first six months of 2017. Novartis' and Gilead's commercial ramps are progressing and increasing with measured phase. Both companies are supremely focused on certifying points of care centers to ensure that these noble and critical therapies are administered properly and that all 30,000 procedures are understood and adhered to. Additionally, both companies mentioned in their recent and respected second quarter earnings calls that they're expecting European approval this current quarter. We're working diligently with both of these companies as they make ready for their respective European commercial launches. I'll provide more detail on our progress on the biopharma market as well as on the regenerative medicine, which is a core driver of our growth and our focus is undergoing rapid advancements as the ongoing research, development, investment and more recently global expansion and transformational treatments and cure has gained space. This year alone, global financings in regenerative medicine totaled over $7.9 billion, up over 79% year-over-year. Cryoport's advanced temperature controlled logistics solutions are critical to ensure these delicate therapies maintain their efficacy and reach patients safely. By entrusting Cryoport with their invaluable commodities, our clients are demonstrating an extremely high level of confidence in the effectiveness and reliability of our industry leading logistics solutions, which as you might expect results in high royal client relationships and a very hard client retention rate. As Cryoport becomes more integrated into its clients drug development and delivery processes, we're no longer viewed by many of our clients as simply a logistics company, but instead as an integrated piece of the manufacturing commercialization process and a value distribution partner. Sometimes as our client's position us in their businesses workflow and is creating new and different expectations for the type of partner they expect us to be. Now, more than ever we have a clear visibility of Cryoport's exciting near and long-term growth pathway and it is therefore becoming increasingly important for us to invest in building out the company's infrastructure to support the integrated role and anticipated growth. This has been a major focus for us during the first half of 2018 and I'm pleased to report that we're significant progress in expanding and improving our competencies along our business, including our quality assurance system, sourcing, engineering, cost accounting, logistics solutions and information technology to name a few. We're also bolstering our personnel not just in our headquarters in Irvine California, but also in our two newly opened logistics centers in anticipation of a higher level of global logistics demand. We moved quickly to open these two new state of the art global logistics centers, one of which is located in Livingston, New Jersey and the other in Amsterdam, Netherlands. Both facilities are operational in supporting customers with official opening scheduled for the month of October. The processes for opening new facilities is not trivial, besides the build out, staffing, training and permitting, very rigorous file certifications and audits have been passed and completed. This additional infrastructure is the beginnings of further plan development that will drive our global expansion and position us to ramp our client agreements as additional anticipated therapy approval in the European Union and the United States take place. It should also be noted that the demand we're experiencing from existing customers reaches beyond the United States and Europe to the Asia Pacific region, where we also are currently in various stages of planning to further expand our global footprint. We're always focusing on improving our technology and expertise in every opportunity and ensuring that Cryoport proper maintains its competitive edge and reputation for best in class service whether that is through the quality, experience, technology or the dedicated customer service that Cryoport delivers. Although we distinguish our services primarily through our trade secrets and [indiscernible] we've four patents pending on new products that will be launched later this year or next year. As our credentials grow so are our partnerships with other industry leading companies. As an example World Courier which is AmerisourceBergen has partnered with Cryoport to integrate our first fleet of temperature controlled solutions into its global network. This integrated platform includes Cryoport's complete chain of compliance solutions to biopharmaceutical companies ensuring full traceability of equipment, processes and handling of trails and gene therapies while intrinsic. While we've been working with World Courier for several years now, this expansion of our relationships is another indication of the need for the quality systems and solutions that only Cryoport can provide for commercialized therapies. The partnership means that Cryoport's complete suite of temperature controlled logistics solutions will now be offered through World Courier's global network of 140 company owned offices operating across 50 countries. Partnering with World Courier will enable a greater number of pharmaceutical companies to easily access our logistics solutions plus the must have information we provide through our advanced information technology. Now we'll go into detail about our specific achievements in the biopharma market during the second quarter of 2018 and we're positioning for longer term growth. Biopharma revenue rose 73% year-of-year and contributed 83% of our total revenue for the second quarter, which was over $3.8 million. Revenue from our commercial agreements with Yescarta and Kymriah accounted for approximately $446,000 of this. When of these products are truly available and patient numbers have reached capacity, we expect to generate significantly higher revenue from these therapies. As stated by the companies this ramp will be ongoing for the next several years as they continue to expand their indications and geographic availability. We are already seeing possible updates from both Novartis and Gilead as to their progress. We're also pleased with the continued growth of the number of clinical trials we support driven by new clients and expanded relationships with our existing client base. In the second quarter of 2018, we increased the total number of clinical trials we support and by more than 22 , bringing the total number of clinical trials supported to 258 up from 172 we from in last year and from 236 at the end of the first quarter of this year. Of the trials we currently support 34 are in Phase III. In addition, by BLA or EMA balance that we incurred thus par in 2018 and we expect another four BLA or EMA filings to occur before year's end based on internal formation and the forecast from the Alliance for Regenerative Medicine. This is complimented by 20 Regenerative Medicine Advanced Therapy Designation known as RMAT that have been granted so far this year with Cryoport supporting the majority of them. An RMAT designation is a special delegation given to sponsors who're selling gene therapies if their product is intended to treat s serious or life threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs as defined in the 21st Century Cures Act and RMAT is an award by the United States through the Drug Administration that allows for faster more streamlined approvals of regenerative medicine products within the United States. Now, turning to Animal Health, our revenue increased 7% year-over –year. Animal Health is a good market for Cryoport, but our focus has been primarily on the biopharma market where there is a transformational growth with unanimous opportunity. We know that the Animal Health market will continue to benefit from our solutions and we will more vigorously pursue growth in that market as our priorities permit. Similarly we see substantial upside in the reproductive medicine market. In the second quarter of 2018 we reported 17% revenue growth year-over-year as demand for assisted reproductive technology within the United States continues to drive demand for our solutions. We're continually on the lookout for a ways in which to innovate and expand our markets and grow revenue. As announced earlier, this week we are planning to launch our new CryoStork Insurance program shortly. We believe that this is a great complement to our industry leading logistics solution, which provide express transportation across the United States for the for the full spectrum of reproductive for commodities such as embryos, sperm, eggs and reproductive tissue. With many couples struggling with infertility and approximately 6.7 million women in the United States are unable to bear a child, but the American Society of Reproductive Medicine were proud to expand our range of solutions to the reproductive health market. We're expecting increase in clinic adoption of our services which will drive further growth. Now, for more detail and information on our sales and marketing activities, initiatives, successes and outlook, I'll turn the call over to Dr. Mark Sawicki our Chief Commercial Officer. Mark?

[Mark Sawicki:]

Thank you, Jerry. It's a pleasure to have the opportunity to speak with you today. Cryoport operates at the cutting edge of the life sciences industry and in many cases facilitates future directionality of systems, processes and regulatory requirements in support of regenerative medicine distribution on a global scale. The emergence of regenerative medicine as a viable therapy class, as amplified the focus on current clinical product distribution standards and the need to enhance requirements. To that end therapy Alliance for Regenerative Medicine and the Foundation for the Accreditation of Cellular Therapy cell have instituted review bodies reviewing all aspects of the collection, manufacture transportation and administration of regenerative medicines. Cryoport has played an instrumental role in the development and implementation of safer, more controlled systems, which are currently being adopted as standard practice in the industry. The latest of these is our emerging Chain of Compliance process requirements regenerative medicine distribution, which are rapidly becoming a standard for ensuring product integrity. Chain of Compliance provides complete traceability of the equipment, processes and logistics handling used in managing the environmental control of the therapy while it is in transit. Enhanced compliance standards are now being employed by an increasing number of Cryoport clients and we anticipate this trend to accelerate in the coming months. Given the rapid development of the regenerative therapy market, as discussed on the last earnings call, we have been preparing for a substantial increase in the number of clinical trials as well as commercial products we can support within our infrastructure. As Jerry mentioned earlier in support of this increase in demand from developers of the next era in medicine, we're launching two new state of the art logistics centers, one in Livingston, New Jersey in the United States and the other one in Amsterdam, Netherlands. Moreover, our entire service portfolio will be offered out of these facilities including our Cryogenic and Cryoport Express C3 or a Cryoport certified cooler platform for two to eight degree Celsius. For several years now, one of our key biopharma strategies has been focused on securing agreements to support clinical stage therapies. So that when these products move through the clinical phases towards commercialization and the logistics requirements rise, we are the first choice logistics provider. Of the trials we currently the net number [indiscernible] jumped to 34 in the most recent quarter On their recent second quarter 2018 earnings call, Novartis reported $16 million of sales for Kymriah, compared with 12 million in the first quarter. And stated that while it is early the launch for children and young adults B-cell ALL is going well. Furthermore, as we already mentioned on our last earnings call, Kymriah has been approved by the FDA for its second indication. The treatment of adult patients with relapsed or refractory large B-cell lymphoma that are ineligible for or relapsed after a target stem cell transplant. On June 29, Novartis announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use, also known as CHMP in Europe for both indications of Kymriah that already have US approval. The CHMP is the European Medicines Agency committee responsible for human medicines and this marks the first CHMP opinion for CAR-T cell therapy in two distinct indications, DLBCL in adults and B-cell ALL in children, Bringing Novartis closer to making Kymriah available to the EU to patients who are in critical need of the new treatment options. Additionally, Novartis has filed for Kymriah commercial approval in Japan, Australia and Canada. As a reminder our current agreement with Novartis covers any expansion services for Kymriah as well as any other future additional indications including global approvals. Now moving on Gilead, Gilead reported second quarter sales of Yescarta of $68 million compared to 40 million in the first quarter 2018. It also reported that it has completed the authorization of more than 60 cancer centers, which cover approximately 80% of the Yescarta available eligible patients in the United States and is continuing to work on authorizing additional centers while also working with centers to enhance patient flows and educating community oncologists about cell therapy and helping them to connect their patients to cancer centers for appropriate treatment. Last month, Gilead also announced that the CHMP adopted a positive opinion for Yescarta approval in the EU for relapsed or refractory DLBCL. Gilead expects the European Commission to grant marketing authorization in the current quarter and it's already preparing for the European lunch. It plans to complete the authorization of more than 20 centers in the EU by the end of 2018. Additionally, Gilead is opening 117,000 square foot manufacturing facility in Amsterdam that is proximate to our new Amsterdam facility. As with Novartis our current commercial agreement covers this potential expansion of services. And you can see we're still in the very early stages of the ramp of these first two commercial CAR-T cell therapies and are in a very clear path to accelerated revenue growth ahead of us. We're very proud of our role of supporting Gilead and Novartis as they bring their cell therapies to wider range of patients around the world and we are encouraged by their early progress with the roll outs. Beyond Gilead and Novartis, bluebird bio announced on July 26 that their LentiGlobin gene therapy was granted accelerated status by the European Medicines Agency for the treatment of Transfusion-Dependent Beta-Thalassemia or TDT. The EMA previously granted Priority Medicines or PRIME eligibility and Orphan Medicinal Product designation to LentiGlobin for the treatment of TDT. LentiGlobin is also part of the EMA's Adaptive Pathways Pilot program, which is part of the EMA's effort to improve timely access for patients to new medicines. The US Food and Drug Administration also granted LentiGlobin orphan drug status and breakthrough therapy designation for the treatment of TDT. Bluebird bio announced that they intend to file and NAA for LentiGlobin in TDT with EMA later in 2018. Turning to Animal Health, as mentioned previously we have recently on boarded a number of new companion animal clinical trials that tend to have lumpy [ph] revenues earlier in their clinical development as well as a number of larger laboratory groups supporting another large animal health entity. We anticipate that a number of these will start to ramp in the coming two quarters which will positively impact the revenues in these areas. Finally, within our reproductive medicine market we are excited to announce the launch of our CryoStork Insurance product. CryoStork Insurance will enable expected parents to insure their reproductive materials against the risk of damage or loss when being moved between clinics. Our sales strategy for this insurance product will be aimed at both the intended parents and the fertility clinics. We currently have relationships with approximately 400 clinics. These clinics will recommend and in some cases require expected parents to utilize our solutions as part of the IDF process. For clinics CryoStork Insurance product helps them to minimize risks. For expectant parents they can manage financial security during the IDF treatment and for Cryoport this represents an additional revenue stream that we can bring to market relatively quickly. We anticipate rapid adoption of the service throughout our clinic network and client base as it is a unique to the marketplace. Thank you. Now I'll turn the call back over to Jerry. Jerry?

[Jerrell Shelton:]

Thank you, Mark. Now, for a detailed financial report on our second quarter, I'll turn the call over to our Chief Financial Officer, Mr. Robert Stefanovich. Robert the floor is yours.

[Robert Stefanovich:]

Thank you, Jerry. Good afternoon everyone. I'll review the financial results for the three and six months periods ended June 30, 2018, provide some additional comments and then turn the call back to Jerry. For the six months period, net revenues increased by 3 million or 54% to 8.7 million, compared to 5.6 million for the same period in the prior year. Biopharma, our largest market increased by 68% over the prior year period to 7/1 million from 4.3 million in the first half of 2017. As a result of the continuing increase in the number of biopharma clients utilizing our services, increasing clinical trials supported for these clients and the commencement of commercial launches of Yescarta and Kymriah. Our revenue from Animal Health decreased 3% to 5484,000 for the first half of 2018 compared with the same period of 2017, primarily result of the temporary trials and the trial conducted by one of our Animal Health customers in the first quarter which has since resumed. Revenue in the reproductive medicine market increased 19% over the prior year period to 1 million. This increase was driven the 26% increase in revenues in the US market and partially offset by 1% decrease in revenues in the international market. We continue to see growing demand for comprehensive reliable solutions in this market and intend to build out our leadership position. Gross margin for the six months period ended June 30, 2018 was 54% or 4.7 million, compared to 37% or 2.6 million for the prior year. This increase in gross margin by over seven percentage points is primarily due to the occurrence of scale from the increase of business volume allowing us to leverage our technology based business model. Operating expenses increased 2.7 million for the six months period ended June 30, 2018 or 33% as compared to the prior year. This increase is primarily a result of building out on organizational support of the expected increase in business volume, liquidities, non-cash stock passed compensation expense and startup cost for the new logistics centers in Livingston, New Jersey and Amsterdam Netherlands. We reported net interest expense for the six months ended June 30, 2018 compared interest expense in the prior year quarter of 16,000. Net loss for the six months ended June 30, 2018 was 5.2 million or $0.19 per share, compared to a net loss of 2.6 million or $0.18 per share for the same period of 2017. The net loss for the six months period ended June 30, 2018 includes a onetime non-cash charge of 0.9 million as a result of the World Courier [ph] completed in February of this year. Adjusted earnings before interest, tax, depreciation and amortization, EBITDA for the six months period ended June 30, 2018 continued to improve by approximately 400,000 to a level of 1.4 million compared to the same six months period in the prior year. Even with the ongoing investments we're making to build our organization and enhance our global footprint through our new logistics centers. Now, moving to our quarterly results, for the second quarter net revenue increased by 1.7 million or 59% to 4.6 million compared to 2.9 million for the prior year second quarter. This quarter was driven by our success in the biopharma market where revenues increased by 73% over the prior quarter from 2.2 million to over 3.8 million. The increase in the number of clinical trials and ramping revenues from the two commercial therapies were probably supporting and the growth drivers for this quarter and I expect to drive future revenue acceleration as closer trials advance and are commercialized and commercial therapies ramp and are launched in geographies offered additional indications. Our revenue from Animal Health increased 7% to 279,000 for the quarter compared to the same period of 2017. Gilead continues to be our largest client in this market and we're currently in the process of renewing our agreement with them. Revenue in the reproductive medicine market increased by 17% over the prior year second to 499,000, this increase was primarily due to an increase in the US market of 23% driven by our continued success of our marketing campaigns and roll out the expansion of our suite of logistics solutions such as CryoStork. Revenues in the international market increased by 2%. Gross margin from the second quarter of 2018 was 54% or 2.5 million compared to 38% or 1.4 million for the prior year quarter. This increase in gross margin by over six percentage points is primarily due to the economies of scale from the increase of our business volume. As we've mentioned in previous calls, our target margin is 60%. Having said that bringing new logistics centers on line such as our logistics centers in Livingston, New Jersey and Amsterdam, Netherlands may impact margins temporarily as logistics operations fully ramp. Operating expenses increased by 1.7 million for the three months period ended June 30, 2018 or 53% as compared to the prior year. This is primarily due to the result of building out our organization in support of the expected increase in business volume, startup costs for new logistics centers in New Jersey and the Netherlands and non-cash stock based compensation expense. We continue to invest in building out our organization and expertise to meet the growing demand of our solutions and expected ramp in business. Net loss for the second quarter of 2018 was 2.5 million or $0.09 per share compared to a net loss of 1.9 million or $0.08 per share for the second of 2017. Adjusted EBITDA for the three months period ended June 30, 2018 continued to improve to negative 0.8 million compared to a negative 0.9 million for the same three months period in the prior year. We ended our quarter with a strong cash position and debt free reporting 20 million in cash and cash equivalents as of June 30, 2018 compared to 15 million as in December 31, 2017. The increase in cash and cash equivalents was primarily a result of the aforementioned long tender offer with net proceeds of 4.6 million and regular exercises further bolstering our cash flow and allowing us to execute on our plans for 2018 and beyond. Overall, we are well positioned and funded to continue to execute our strategy and drive organic growth. Lastly we filed our quarterly report on Form 10-Q with the SEC today. With that I'll turn the call back to Jerry. Jerry?

[Jerrell Shelton:]

Thank you for your financial report, Robert. We appreciate the support of loyal and long-term shareholders. At all times our priority is to build a successful sustainable business that will bring value to all our stakeholders. In June we were pleased that Cryoport was added to the Russell Indexes. We consider that recognition and acknowledgment of the progress we have made executing on our mission and the strong support we have received from the investment community some of whom are on the call today. Being included in the Russian Indexes provides additional liquidity for our stock and a broadened shareholder base. Approximately $9 trillion in assets under management are benchmarked as invested in products based on the Russell Indexes, which underscores the importance of these indexes to the financial markets. We also continue to work to further increase our exposure to institutional investors, to that end we'll be attending investment conferences held by Cowen and Janney during the third quarter, in addition to regularly conducting non-deal road shows. We have an excellent investment story to tell. Cryoport's solutions are mission critical to our biopharma customer's. Our demand is stronger than it's ever been. We have multiple new a commercial agreements on the near term rise and the opportunities to expand existing relationships globally. We've also established a pipeline of clinical trials in various stages that will fuel our long-term growth for many years to come. The Cryoport team has established on industry leading brand, erected hard barriers to entry in terms of infrastructure, technology and knowhow and built a strong balance sheet upon which to continue growing our company organically and through acquisitions impossible. It's an honor to lead our capable team of people and it is an exciting time to be an investor in Cryoport. Operator, please open the floor for questions.

[Operator:]

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from Paul Knight with Janney. Please go ahead. Mr. Knight, your line is live.

[Paul Knight:]

Okay. Can you hear me now?

[Unidentified Company Speaker:]

We can hear you now, Paul.

[Paul Knight:]

You can hear me now, okay.

[Jerrell Shelton:]

We can.

[Paul Knight:]

Okay. Thanks very much. Hey, Jerry, congratulations on the gross in the quarter. Is this coming from incremental customers or is it multiple trials from the same customers?

[Jerrell Shelton:]

I will let answer that question.

[Mark Sawicki:]

It's a combination of both. So we do have strong new client acquisition, which are contributing new trials to that total portfolio volume, as well as existing clients contributing to that 258 trials.

[Paul Knight:]

Great. And then on the - if I think about the operating loss, I guess it was really attributable to the facility expansions in New Jersey and Amsterdam. Would that be the right way to think about it?

[Jerrell Shelton:]

Yeah, I'm going to turn that one to Robert Stefanovich.

[Robert Stefanovich:]

Yeah, Paul, you are absolutely right. It's a combination if you look at the operating expenses that we have and part of that is the startup costs for the Netherlands and to some extent for Livingston, New Jersey and then we also had additional stock-based compensation expense that's outlined in the Q that is embedded into the operating expenses. That's a non-cash item.

[Paul Knight:]

Okay. And then last, Jerry, if you can talk about where do you think you are in the competitive position in the marketplace? Are you increasing your 120,000 data points? Is that like building a bigger mode? Where do you think you are with potential competition that might be out there?

[Jerrell Shelton:]

Well, Paul, I think we are in the strongest position ever. As I mentioned, for example, in terms of momentum we filed our five new patents and one of those is a new product demand. Two of them are affectedness and two of them are revolutionary to the industry. So in terms of competitive positioning in the marketplace, we are reconfirmed every day and we work very, very hard to maintain that. We never have an arrogance about our competitive advantage. We are always working to make sure that we are sensitive to the market and especially sensitive to our individual clients and their needs and that we are moving ahead on every front. So if you look at our packaging, our information technology, and our logistics expertise, we do nothing but improve that on a daily basis, certainly on a quarterly basis. And so I think we are in an excellent position. We don't see any new competition on the front. We don't see any strengthening competition. And as you saw recently, we signed a strategic agreement with World Courier where World Courier took on all the Cryoport solutions giving them the strength of our chain of compliance story, our chain of compliance methodology that then wouldn't be available to them otherwise. So that's an AmerisourceBergen company. That's a company that has infinite assets that they could put toward, but they chose Cryoport as opposed to trying to build up themselves and they chose it for a reason because of the competitive advantages we have.

[Paul Knight:]

Okay. Thank you very much.

[Operator:]

Our next question comes from Richard Baldry with Roth Capital. Please go ahead.

[Richard Baldry:]

Thanks.

[Jerrell Shelton:]

Hi, Rich.

[Richard Baldry:]

How are you?

[Jerrell Shelton:]

Good.

[Richard Baldry:]

Good, so the two new facilities that are up and launched, so I assume the European one is kind of not through putting because we haven't had approvals there. But is the New Jersey facility actually through putting actual services as we talk right now?

[Jerrell Shelton:]

Actually the New Jersey facility was improved officially today. Both facilities are through putting and we will have a measured ramp-up making sure that everything is working where we know this designed work and that we confirm that everything is working the right way. So they both are working. They both are approved by our clients and by our quality assurance team here at California.

[Richard Baldry:]

So in terms of the cost to get those launched, are they filled into the COGS line, I guess, maybe some more in the G&A as well? Are there any one-time things that got them up and launched in the quarter that would kind of fall away or is it more of a sort of steady state now that they are up and running this is the new level for those?

[Jerrell Shelton:]

I'll turn that to Robert Stefanovich.

[Robert Stefanovich:]

Yeah, just a few comments on that, Rich. Well, in terms of the facilities being up and running, this is really just now happening. So it's really not reflected in the second quarter. We did have obviously startup costs associated with that and one hide cost just $300,000 that are embedded in our operating expense of start-up costs, as well as capitalized assets in the range of $200,000, $250,000, plus bringing in now the additional shippers Cryoport Express shippers that include our Smartpak condition monitoring system. But if you really look at those two operating centers, it's really now starting and we'll see around, so it's not included in the second quarter.

[Richard Baldry:]

And maybe could you talk about any sort of intermediate term plans for additional facilities, maybe in Asia or somewhere else to support the clinical trials that you are working with now or the future approvals being sought by clients you've got commercially?

[Jerrell Shelton:]

Yeah, Rich. That's a very good question and certainly that's in our planning purview, but our answer is right now it has to be on getting these two new logistic centers up and running appropriately and satisfactorily, but your question is absolutely in our purview and in our planning horizon.

[Richard Baldry:]

I heard you talked a little bit about the fact that your partners are viewing you differently as things evolve; maybe as you move into the commercialization phase, maybe talk about like what specifically that means. Is that they are understanding how important it is to the process or is it something about the volumes as you retire volumes that's changing that makes them sort of come back to you and have some different needs over time? Thanks.

[Jerrell Shelton:]

Yeah, Rich. That's a very good question and it's certainly in the evolving arena and I'm going to turn that to Dr. Sawicki who is right on the front line with these people all the time.

[Mark Sawicki:]

Yeah, hi, so what we are seeing is our clients are increasingly coming to us for guidance from a regulatory standpoint. So the chain of compliance competency that we've been working on is a perfect example of that and what it is, it's us starting to dictate within the marketplace what that standard should be and this is largely predicated on client request and observations in conjunction with their clinical activity and their commercial launches and feedback from both the FDA and the European Medicines Agencies. And it all comes back to a higher threshold from a quality standpoint for commercial products versus clinical products in the space and there is a much lower tolerance for the traditional status quo logistics distribution competencies that have been in the market for this period of time. So, yes, we are absolutely becoming an indispensable aspect when it comes to helping them from a guidance standpoint and dealing with the FDA and European Medicines Agencies in conjunction with commercial activity.

[Richard Baldry:]

Thanks. Just last check question on the stock-based comp startup, was there any sort of one-time milestone type things in there or is this sort of a new level we should think about as a steady state forward? Thanks.

[Jerrell Shelton:]

Yeah, now for your planning purposes and modeling purposes, yeah, I assume kind of a steady state with the amounts that we have. So there weren't any milestone type of investing features in Q1. Generally our stock options are pretty [indiscernible] in term of the investing schedule.

[Richard Baldry:]

Great and congrats on the great quarter.

[Jerrell Shelton:]

Thank you.

[Operator:]

Our next question comes from Jason Seidl with Cowen & Company. Please go ahead.

[Jason Seidl:]

Thank you, operator, and Jerry and team. I want to go back to the facilities and maybe ask a question it a different way. In terms of a revenue standpoint, Jerry, what scalability of these facilities are for the Cryoport network?

[Jerrell Shelton:]

Jason, are you saying what's the potential scalability of these facilities?

[Jason Seidl:]

Yes, in terms of a revenue basis, ballpark.

[Jerrell Shelton:]

Okay. So we build these facilities on a modular basis and we build them on a scalable basis I should say, on a scalable basis and that we build them out at approximately 7500 out of a - footprint of about 7500 square feet, give-or-take, a couple of hundred square feet and then we also negotiate for leases of the - they first write a refusal and leases of the adjacent property so that we have the room to expand as we need to expand. So, well, we don't give out specifics for each individual in terms of the actual revenue because, of course, part of that depends on what we are supporting in the mix. We are scalable and we did build them out for supporting these to begin with, these first two commercial therapies, both in Europe and United States, Yescarta and Kymriah and other indications that those therapies might be approved for. So they are scalable and we feel that they can support, for example, the Kite is building a 100,000 square foot plan within a mile of our Amsterdam operation. That's why we placed it in the position that is placed in. And they are scalable and - but we don't give out specific numbers for you. I think you would probably mistake for each of our district centers.

[Jason Seidl:]

Now, well, it's clear that there is some room to grow and, yeah, I didn't think your placement of the Amsterdam facility was a happy accident. But it sounds like there is some good growth to come. I want to touch a little bit on the chain-of-command product because that intrigues me because somebody else brought up sort of where you are in the competitive landscape - even more of an advantage out there. But does anybody else have anything that's close to this product?

[Jerrell Shelton:]

Well, actually, Jason, we have that phrase trademarked and, no, they don't - Mark will go into more detail about what is included in our chain of compliance, because it's an extremely important concept and one that the industry is very - is warming too very, very quickly.

[Mark Sawicki:]

Yeah, so as we started taking a look at this based on the feedback that was coming back from the regulatory authorities in particular in conjunction with both the Novartis and the Gilead and Kite launches, one of the - there is some commonality in regards to theme related to an enhanced regulatory footprint around this compliance competency and what the compliance competency is it's an enhanced traceability of all the equipment and processes which are related to distribution of these therapies. And so what we are doing in essence is we are putting the same regulatory scrutiny on our equipment and processes as you would see in a GMP biologics manufacturing footprint. And this has never been done in a logistics space and the reason that we have the ability to do it is we have a unique informatics platform, our Cryoportal, which we have been able to collect and cross-reference all of the data that's coming into that system into a single unified database that is fully integrated. Most other parties have their track and trace from a scan code basis and database, their data captured from their data loggers and database B, their incoming order management process may even be in the third database and they have no way to cross-reference them and they don't have any traceability competency down to the serial level on any equipment in their infrastructure. While we do all of those things and we can integrate them together and so that's something very, very favorable from the FDA and European Medicines Agencies and things. So they are the ones who are really honestly starting to drive this competency and it does put us in a very unique position.

[Jason Seidl:]

It does very much. So it sounds like it's a big advantage for you guys. I'll turn over to somebody else. I appreciate the time as always, gentlemen.

[Jerrell Shelton:]

Thank you, Jason.

[Operator:]

Next question comes from Sean Hannan with Needham & Company. Please go ahead.

[Sean Hannan:]

Yeah. Thanks. Good afternoon. Thanks for taking the questions here. So I want to see if I can start in the top line with some variables you had mentioned a little bit earlier. So you folks observed the revenue ramps at the two really improved biopharma clients of yours with Kymriah and Yescarta. As you observe those ramps and as you observe then the trends specialized facilities and hospitals, can you give us an update here that might be a little more specific in terms of how you are modifying your expectations of timeline, say, for Gilead or Novartis with those specific therapies to hit those targeted $8 million to $10 million in revenues, because it seems like they are at a little bit of a different space, albeit, with different price points, but I think that an updated perspective would be useful, particularly given that we are on the edge of EMA approval?

[Jerrell Shelton:]

Yeah. Sean, I'm going to make a few comments and I'm going to turn it over to Mark Sawicki to give you a more detailed answer to your questions. But I'm going to start off saying first of all, we are dealing with revolutionary therapies. These therapies had never before been done and these companies are taking great care to make sure that those points of care are qualified and that the inoculation takes place and that the therapies are exactly right. They don't want any setbacks. They don't want any problems and they are being very responsible. So we are highly respective of that. Is the ramp a little bit off where we expected? Yes, it is, but that's to be expected. This is biology that we are working with and it's data-driven and data is being collected and care is being taken and a responsible approach is being taken as well. So with that, I'll turn it to Mark for more finite answer.

[Mark Sawicki:]

Thanks, Jerry. So as we take a look at this and we look at the activity ongoing within our two commercial clients, they continue to take a very, very aggressive stance in the marketplace and I think publicly they disclosed enhanced manufacturing competencies. Jerry talked about the Kite facility in Amsterdam and Novartis has announced additional manufacturing capacity coming online in Europe as well. Very aggressive expansion plans, both of them have publicly acknowledged their launch profiles in Europe. And so I don't think that we are going to see a material difference in that ramp. It's just going to - I would still feel very confident that that top line in is an appropriate number. It's just - as these things come online, we are going to see that ramp just aggressively modify maybe geographically more so than anything on a significant delay or anything along those lines, so.

[Sean Hannan:]

Okay. Well, let me ask totally different way because I just feel I need a little bit more information, because we are a few quarters into the experience and I think yes, it's a new one and it's a new process for everybody, but do we see from a Cryoport standpoint as you guys are making your internal investments, hard capital in facilities in this quarter whether it be Livingston or Amsterdam or also then, say, in personnel and other records. We clearly, within Cryoport, are going to have some views around and adjustments around when do we think we can hit this types of numbers because that's going to support your investment path as well. So at this point are we talking about the ability that we should be able to get into the range in concept in year 2020 or 2021 or is it possible that's a little further out than that?

[Jerrell Shelton:]

Yeah, I think that, first of all, there is a lot of data available on both the Kite and the Gilead Kite website and through their calls, as well as through Novartis. As for our planning, we feel that our planning is on target. We didn't build facilities for them to be vacant or hire people for them to be idle and there is some orchestration to take place and there is load to place on these facilities and ramp up times and so forth as I mentioned earlier. But we feel that we are on schedule and we are coordinated with the manufactures and we talk - we have dedicated program managers and we have fluid conversation lines going all of the time. So we feel confident that we are on the right pathway and we made the right decisions in terms of building out our capacity and our planning. Mark, would you like to add anything to that?

[Mark Sawicki:]

No, I think that's accurate. Well, we can't provide specific guidance on what the ramp schedules look like, because its proprietary in nature. What Jerry had mentioned is true. I mean we are working very, very closely with both parties ensuring that we have the right assets in place at the right time and we haven't gone through an aggressive build out of two new facilities with the expectation that that volume is distant in timeframe.

[Sean Hannan:]

Understood. Okay, alright. Let me switch gears for a moment into talking a little bit around the OpEx, it sounds like what was addressed for an earlier questions dot com level should be a new dollar point relatively static. Even as I pull that out and I looked at the level of OpEx spend, should we continue to see an incremental ramp-up from here as just in the general nature you continue to grow your business as well as expand your efforts to bring in clients, to what degree should we be seeing that or is there some element of the dollar spent you are able to maintain here? If you can help us to understand the past of this OpEx through the ends of the year at least, I think that would be really helpful.

[Jerrell Shelton:]

Sean, I'm going to turn this to Robert in just a moment, but again I'm going to make a general comment or two. You can expect some lumpiness in our OpEx now and in the future because we build facilities and they don't instantly have volume coming through them, revenue associated with them, so we have to build in advance and so there will be some lumpiness there. Well, I forecasted the margins we talked about in the past or absolutely the margins that we believe will, what we know, our insight, that 60% gross margin and 30% operating profit. But on the volume s of that you will see some lumpiness as we build out the infrastructure, the network, the logistics network, not only in the Unites States but around the world. Robert, would you like to add to that?

[Robert Stefanovich:]

Yeah, just a few comments and then like you said, we already mentioned some of it. If you look at the operating expense excluding stock-based compensation expense and also including the startup costs that we had during the second quarter, which were about $300,000 including the operating expense, then you start really looking at the two quarterly operating expenses that we had outside of those two items. So when you look at that, you compare that for instance to even the second quarter of last year. It's only increased about $420,000 or $430,000 and that's really the increase in organizational structure that we have. And so if you go and look at the second half of this year, we did already allow the build out of the organizational structure and so we have the sales team in place. We have the quality organizational employees and the other supportive staff. So where you may see additional increases is really more strategic to support the growth and logistics management and the logistics centers. And so if you look at operating expenses going forward, I wouldn't expect a significant increase in operating expenses compared to the second quarter of this year.

[Sean Hannan:]

Okay. Thanks very much. Thanks for addressing the questions, folks.

[Jerrell Shelton:]

Thanks, John.

[Operator:]

Our next question comes from Brian Marckx with Zacks Investment Research. Please go ahead.

[Brian Marckx:]

Hi, guys. Congrats on the quarter. One on biopharma revenue. It looks like the dollar amount increased from Q1 and excluding the commercial revenue, it looks like it was the greatest increase on a quarter-over-quarter basis that you've ever had. Is there anything particularly unique in the Q2 biopharma number?

[Jerrell Shelton:]

I think there is and I think it has to do with our business development team. So I'll let Mark answer that in more depth.

[Mark Sawicki:]

Yeah, Brian, so our team has worked really, really hard on capturing as much market share as possible and we have been targeting acquisition with many clinical trials as possible. We have a bonus of new programs that have been brought on and new clients that have brought new trials in that are now starting a second and third trial. So we think very strongly that that's not a one-time event, but that's going to help contribute moving forward to obviously our revenue growth.

[Brian Marckx:]

And then in terms of pricing, just general pricing, have you been able to take some pricing increases as well.

[Jerrell Shelton:]

Mark, why don't you answer that?

[Mark Sawicki:]

Yeah, so what we are doing is, yeah, obviously we are always driving towards improving margins through accretion in base pricing but we are also significantly diversifying our revenue stream beyond just our traditional core assets. We put a large program management organization in place now, which drives direct revenue on a headcount basis. We've instituted our consulting business which is now starting to contribute notable revenue as well. And those are just the beginning. So we do believe that that will also contribute to an average enterprise value of a given client in the coming quarters.

[Brian Marckx:]

Relative to the World Courier arrangement, is your Cryoportal integrated with their system similar to the way it was with FedEx and UPS?

[Jerrell Shelton:]

It will be, it will be. There is an integrative aspect to that and all of that's outlined in the announcement, so there is no new news there, but that is a part of it, yes. We made our entire suite of solutions available to World Courier and we think that's going to build well for both World Courier and certainly for Cryoportal.

[Brian Marckx:]

And, Jerry, in terms of timelines for full integration, do you have an idea of when you think that may be completed?

[Jerrell Shelton:]

Full integration with World Courier?

[Brian Marckx:]

Yeah.

[Jerrell Shelton:]

We work with World Courier for a number of years. We formalized and extended our relationship and that's what this is all about. So that integration should be finished in this quarter.

[Brian Marckx:]

Okay, great. Thank you.

[Operator:]

Our next question comes from the line of Len Yaffe with StockDoc Partners. Please go ahead.

[Len Yaffe:]

Thank you very much. I would like to add I think another validation what you are undertaking is the fact that Regeneron just announced this past week they were investing significantly endower bio including the purchase of $100 million in the stock way above the current market price that's starting developing six targets with them. So I think that they recognize that this is a long way to go. And what I was wondering was two things. One is as the Kymriah, Yescarta sales grow sequentially, what type of proportionate increase until other products get approved? Should we expect in your revenue base given that it could depend on sales in the US versus not the US? And then the second question for Rob would be could you give us some sense given the scaling out in anticipation of years/decades of significant products coming to market, what this means to roughly, not exactly at all, would be in breakeven quarterly revenue level for Cryoport? Thank you.

[Jerrell Shelton:]

First of all, Len, thank you for your comments there in the beginning and I want to turn it to Mark to answer your - the first question and then the Robert for the second.

[Mark Sawicki:]

Yeah. As much as I would love to give you guidance in regards to what that looks like for both products, I'm going to have to steer you back to both the Novartis and the Gilead announcements for their earnings and projected ramps. It's not in our place to speculate and put that data out. I'm just going to reiterate that we build out two new facilities to support these and we still feel very bullish on their prospects, but I'm not going to go beyond that at this point in time. Robert, you want to comment the second?

[Robert Stefanovich:]

Yeah, Len, yeah, just recall as Jerry mentioned early, we are building out our organizational structure to support and really to leverage our positioning in the market space. With that said, if you look at our cash flow breakeven range, now we are looking at currently now $24 million to $28 million annualized revenue and as we further build the organization and we see the ramps from these commercial launches, we'll probably have a more accurately picture as to when to expect breakeven and at some point we'll also start giving forecast to the market space, but given the dynamics in the market space right now in our positioning, that's a little bit too early for us to do so.

[Len Yaffe:]

Great, thanks so much.

[Robert Stefanovich:]

Thank you.

[Operator:]

Thank you. This concludes today's teleconference. You may disconnect your lines at this time and thank you for your participation.