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Cerus Corporation (CERS 0.84%)
Q2Â 2020 Earnings Call
Aug 4, 2020, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Ladies and gentlemen, thank you for standing by, and welcome to the CERUS Corp. Q2 2020 Earnings Conference Call. [Operator Instructions]
I'd now like to turn the conference over to Tim Lee, Investor Relations Director. Please go ahead.
Tim Lee -- Investor Relations Director
Thank you, operator, and good afternoon. I'd like to thank everyone for joining us today. As part of today's webcast, we are simultaneously displaying slides that you can follow. You can access the slides from the Investor Relations website at www.cerus.com/ir. With me on the call are Obi Greenman, Cerus' President and Chief Executive Officer; Dr. Nina Mufti, Cerus' Vice President, Development and Red Blood Cell Program leader; Kevin Green, Cerus' Chief Financial Officer; Vivek Jayaraman, Cerus' Chief Operating Officer; Dr. Laurence Corash, Cerus' Chief Scientific Officer; and Carol Moore, our Senior Vice President of Regulatory Affairs and Quality.
We issued a press release today announcing our financial results for the second quarter ended June 30, 2020, and also describing the company's recent business highlights. You can access a copy of this announcement on the company website at www.cerus.com. I'd like to remind you that some of the statements we will make on this call relate to future events and performance rather than historical facts and are forward-looking statements. Examples of forward-looking statements include those related to our future financial and operating results, including our 2020 financial guidance and goals, operating expenses and gross margins.
Commercial development efforts, future growth and growth strategy, future product sales, product launches, the impact of current and future products on blood center operations. Ongoing and future clinical trials, ongoing and future product development and other regulatory activities as well as the timing of these events and activities. These forward-looking statements involve risks and uncertainty that can cause actual events, performance and results to differ materially.
They are identified and described in today's press release and under Risk Factors in our Form 10-K for the year ended December 31, 2019, and our Form 10-Q for the quarter ended June 30, 2020, for which we will file shortly. We undertake no duty or obligation to update our forward-looking statements. On today's call, we'll begin with opening remarks from Obi agreement, followed by Dr. Nina Mufti, who will provide an update on our red blood cell program. Kevin Green will then review our financial results, and finally, Obi will provide closing remarks.
And now it's my pleasure to turn the call over to Obi Greenman, Cerus' President and Chief Executive Officer.
William 'Obi' M. Greenman -- President, Chief Executive Officer
Thank you, Tim, and good afternoon. I'm pleased to report our highest quarterly product revenue performance to date at $21.5 million despite the Q2 challenges posed by the COVID-19 pandemic. These results are evidence of the resilience of our business during this time and the essential and growing role that pathogen and activation plays in helping secure the supply chains for blood safety and availability. Dedicated team at Cerus has also shown a great ability to adapt. I am grateful for their foresight in the crisis management planning that has allowed us to support our blood center customers throughout this period and also to help them initiate multiple COVID-19 convalescent plasma programs at the same time.
The record product revenues in the quarter were driven by robust year-over-year platelet kit sales growth in the U.S., coupled with strong plasma and alumina sales increases in our EMEA region. In the U.S., with the March 31, 2021 deadline for compliance with FDA guidance on platelet safety now less than eight months away, the U.S. commercial organization continues to focus its efforts on helping our blood center customers and their hospital clients to meet the deadline. The American Red Cross, the largest blood provider in the U.S., continues to lead the transfusion medicine field forward with approximately 25% of their platelets now being INTERCEPT-treated.
20 of the 23 red cross production sites are producing INTERCEPT platelets. Finalizing their strategies for bacterial safety guidance compliance remains a priority for U.S. blood centers, despite the recent challenges of the COVID pandemic. Just recently, the Red Cross officially notified all of its hospital customers of its goal to convert to 100% pathogen-reduced platelets. In preparation, the American Red Cross is directing all customers to begin updating their IT systems now to accommodate INTERCEPT-treated platelets. With this step, alongside offering an interim bacterial testing option, the Red Cross is positioned to provide platelets compliant with the FDA guidance requirements to all customers by the deadline of March 2021.
The four other large blood center customers in the U.S., that in combination with the Red Cross, collectively represent 70% to 75% of the overall U.S. blood supply are all currently producing INTERCEPT platelets and have acknowledged that INTERCEPT is the preferred method to comply with the FDA guidance document. As a reminder, the overall market opportunity in the U.S. for Intercept platelets is approximately $150 million per year. Our goal is that INTERCEPT becomes the standard of care for platelets in the U.S., and we aim to capture as much of this opportunity as possible during the next few years.
One of the key factors that could drive even faster INTERCEPT uptake is the extension of the shelf life for INTERCEPT platelets from five days to seven days. This label claim already exists in other countries, including France and Switzerland, where the operational benefits and ease of use have been solidly documented and INTERCEPT is used for 100% of the platelet supply. We continue to make progress on the recovery and survival study necessary for our planned FDA submission for a day seven shelf life on INTERCEPT platelets. The submission is targeted by the end of this year, early next, and we anticipate possible FDA approval for this seven day claim in mid-2021.
In the context of the FDA guidance for platelet safety, the potential for a day seven claim, combined with the pandemic preparedness facilitated by pathogen reduction, strongly favors the choice of INTERCEPT for both blood centers and hospitals. The security afforded by treating platelet units versus just testing them is a simple concept that resonates well during the COVID crisis. The need for coronavirus convalescent plasma and the desire to pathogen and activate it, help drive plasma kit sales and new customer illuminator placement in EMEA, which helped fuel a solid Q2 performance in the region. We think the illuminator placement in the quarter bode well for additional kit sales downstream.
While uncertainty about the COVID-19 impact on the global healthcare systems and economy persist in the second half of 2020, we are confident in our ability to deliver on our guidance of $89 million to $93 million in product revenue this year. Looking beyond EMEA, we're excited about our recently announced five year contract with the Hong Kong Red Cross for INTERCEPT platelets. The Hong Kong Red Cross is a member of the influential Asia Pacific Blood Network and a key opinion leader globally. This is a very strategic account and represents an important beachhead for Cerus to expand its presence in Asia Pacific.
In the coming quarters, we look forward to sharing with you our expanding initiatives in APAC. In parallel with our commercial activities, our product pipeline continues to advance and positions us well to sustain our revenue growth going forward. As previously announced, the PMA supplement application for a pathogen-reduced cryoprecipitated fibrinogen complex was submitted to the FDA at the end of May. Given the 180-day review clock on PMA supplements, we believe pathogen-reduced cryoprecipitated fibrinogen complex or a pathogen-reduced cryo could receive FDA approval as early as the end of this calendar year.
With the potential approval now less than five months away, we have expanded our prelaunch preparation, including incremental hires to the therapeutics team that will lead our commercialization efforts. We continue to be excited about the launch because of the potential clinical benefit for bleeding patients and the size of the overall market opportunity in the U.S. We are also on track to submit for a new technology add-on payment, or NTAP, with CMS in October to further support the economic utility of our pathogen-reduced cryo product at the hospital.
A possible receipt of the NTAP in 2021 could expand access of pathogen-reduced cryo to bleeding patients subsequent to the launch and thereby accelerate overall product adoption. Let me now turn it over to Dr. Nina Mufti to provide a clinical and regulatory update on our red blood cell program, which remains our single largest opportunity given the volume of red cells transfused globally. Red cells are the most frequently transfused blood component, and we are the only company in the world developing a pathogen activation system for red cells.
And correspondingly, the only company with a full pathogen activation portfolio. Dr. Mufti has been with Cerus for 13 years and has been our Vice President of Development since 2012. During her tenure, she oversaw the program development for the PMA submission and subsequent FDA approvals for both INTERCEPT platelets and plasma. With the increasing importance of the red cell launch, we appointed Nina to lead the INTERCEPT red cell team with two main goals: progress the CE Mark approval and product launch, and advance to a PMA submission for the red cell product in the U.S.
Nina Mufti -- Vice President of Development and Red Blood Cell Program Leader
Thank you, Obi. I am pleased to provide an update on our red blood cell program. As many of you are aware, the development pathway for the program has not been easy or straightforward, but we've made solid progress on the development pathway to bring the product to market. Recent achievements have been the combined work on various chemistry, manufacturing and control activities, including the qualification of new glutathione suppliers and establishing clarity around the clinical approval pathway. Recent discussions with European and U.S. regulatory agencies have provided clarity on pathways to registration.
Let's start with Europe, where our CE Mark application will be reviewed under the new medical device regulation, or MDR pathway. We are transitioning our submission made under the Medical Device Directive, or MDD, to the MDR this year. Although there has been a recent one year extension for submissions under the MDR, moving to May 2021 due to COVID-19, the duration of our review process under the MDD would exceed the May 2021 date. As a result, we submitted our MDR pre-application to TUV or notified body in June 2020 and gained agreement on a modular submission process consisting of four separate modules.
We plan to submit modules one and two of our CE Mark application under the MDR pathway by the end of Q3 2020. The first two modules consist of both the clinical and nonclinical safety data as well as the data for in vitro RBC quality and pathogen inactivation efficacy. Module 3, which includes the chemistry and manufacturing control data for the active substance, amustaline, and the clincher used in the inactivation process glutathione, is targeted for submission in Q2 2021. This module will include the qualification data from our new glutathione supplier.
In addition to TUV, module three will also need to be reviewed by the Irish Health Products Regulatory Authority or HPRA, our competent authority for this submission. HPRA's review process is a minimum of 210 days and will define the time line for approval. The fourth and final module, which contains information on the manufacturing of the processing and filter sets and final packaging, is planned for submission at the end of Q2 2021. Based on the anticipated review time lines by both TUV and HPRA, we expect CE Mark approval for INTERCEPT red blood cells in 2022.
Switching to our U.S. red blood cell program, we recently met with the FDA to discuss the chronic transfusion study requirements for a PMA submission. During that discussion, we proposed expanding our current RedeS study to include patients who receive multiple RBC transfusions to support a chronic anemia indication for the product rather than conducting an additional stand-alone Phase III study, as previously planned. The agency agreed to this approach, thereby shortening the time line to obtain data in patients that receive multiple RBC transfusions.
As a result, we submitted our revised protocol for the RedeS study to the FDA and are in discussions with BARDA to fund this protocol expansion. Despite the impact of COVID-19 on the red cell U.S. clinical trial program, we are working with our clinical trial sites to reestablish enrollment plans through the remainder of 2020 and into 2021.
We will share updates on the overall PMA submission schedule later this year. In summary, with a clear CE Mark road map and alignment with the FDA on the clinical trial requirements for chronically transfused patients required for a PMA submission, our efforts to commercialize the INTERCEPT red blood cell system in the European and U.S. markets remain on track. With the renewed focus on pandemic preparedness by government officials, we look forward to offering the full INTERCEPT portfolio to our blood center customers. Let me now turn it over to Kevin for an update on the second quarter financials.
Kevin D. Green -- Vice President of Finance and Chief Financial Officer
Thank you, Nina, and good afternoon, everyone. As Obi mentioned earlier, we posted record product revenue during the second quarter, totaling $21.5 million. This represents an 18% increase compared to the $18.2 million reported during Q2 of 2019. Foreign currency exchange rates negatively impacted reported Q2 sales by approximately 1%. On a year-to-date basis, reported product revenue totaled $40.1 million, up 12% compared to the $35.7 million reported during the first half of 2019. Foreign currency exchange rates negatively impacted reported year-to-date sales by approximately 1.5%.
While all of us continue to grapple with the dynamic impact of the COVID-19 pandemic, the INTERCEPT business has remained resilient. We certainly saw some unusual inventory management and demand from blood centers during Q2, with certain customers choosing to bring down their existing platelet inventory while accelerating their use of plasma sets, in part for SARS-CoV-2 convalescent plasma. As such, the total number of kit sales was up on a global basis, while the calculated number of treatable platelet doses shipped was essentially flat during the quarter.
Looking ahead, we expect that the platelet business will be the primary growth driver for the balance of the year, although we may see continued interest on our plasma kits compared to our previous expectations. For the year, the calculated number of treatable platelet doses and the number of kits sold have increased 6%. To illustrate the Q2 dynamic, platelet kits accounted for approximately 82% of total kit sales, while plasma sales accounted for approximately 18%. In recent quarters, the mix was closer to 90-10. Government contract revenue in support of our BARDA collaboration is reported separately from our product revenue and totaled $5.3 million during the second quarter compared to $4.3 million during the prior year period.
On a year-to-date basis, government contract revenue was $11.4 million compared to $8.7 million during the 2019 period. Now let's move to our reported gross margins. Gross margins on product sales for the quarter were consistent for both Q2 2020 and 2019 at 55%. On a year-to-date basis, gross margins were 55% compared to 54% during the first half of 2019. We saw offsetting factors in our gross margin composite during both Q2 and for the year-to-date basis, with volumes and foreign exchange rates providing an improvement, offset by product mix, namely increased plasma and illuminator sales. Turning now to operating expenses. Operating expenses totaled $31.7 million for the quarter compared to $31.2 million for Q2 of 2019.
On a year-to-date basis, operating expenses totaled $63.5 million compared to $60.8 million for the first half of 2019. Specifically, SG&A expenses during the quarter accounted for $16.1 million compared to $16.7 million for Q2 of 2019, a key driver of which was a slowdown in travel and conference attendance during Q2 as a result of the shelter in place experienced during the quarter. We are also seeing continued leverage with our commercial teams, driving revenue growth without incurrence of additional cost. Similarly, on a year-to-date basis, SG&A spending totaled $32 million compared to $32.9 million during the first half of 2019.
Research and development expenses for the quarter totaled $15.6 million compared to $14.4 million during the prior year. The higher R&D expenses were driven by increased activity for the U.S. red blood cell program supported by BARDA, work on our triple set configuration and extended shelf life for our U.S. platelet product as well as development efforts on a next-generation illuminator. Year-to-date, R&D expenses totaled $31.4 million compared to $27.9 million for the prior year period.
Net loss for the second quarter totaled $14.9 million or $0.09 per diluted share compared to a net loss of $17.6 million or $0.13 per diluted share for the prior year period. Year-to-date, net loss was $31.3 million or $0.19 per diluted share compared to a net loss of $36.4 million or $0.26 per diluted share during the first half of 2019. In terms of our balance sheet, we ended the second quarter with approximately $136.5 million of cash, cash equivalents and short-term investments on hand. Given our current expectations and guidance, we continue to believe 2020 cash used from operations will be in the $50 million to $60 million range, with $27.6 million already recorded during the first half of the year. With that, let me turn the call back over to Obi.
William 'Obi' M. Greenman -- President, Chief Executive Officer
Thank you, Kevin. As you can tell from our comments today, our top line, pipeline and bottom line results are progressing in the right direction despite the ongoing pandemic. We are increasingly excited with how we are positioned for continued revenue growth as a function of the required compliance with the FDA guidance on platelet safety. From a global perspective, the inherent value of a proactive approach to blood safety over the historically reactive testing strategy has taken on new significance with our customers.
The challenges of rapidly developing assays for SARS-CoV-2 that are sufficiently sensitive and specific has illustrated the fundamental weakness of the current blood testing paradigm to secure blood safety against emerging infectious disease threats. It is the same testing paradigm that requires three different assays to ensure blood safety against just hepatitis B alone, plus another two different assays each that are required for both HIV and hepatitis C. And even with this strategy of multiple redundant tests, there remains a concern about window period transfusion-transmitted infections when blood donors are still infectious, but the tests cannot detect the viral pathogen in their blood.
A July publication in the American Society of Hematology's Journal of Blood raises some new concerns about the sensitivity of current blood screening assays for HIV during the era of rapidly growing use of HIV pre-exposure prophylaxis or prep and anti retroviral therapies. The possibility that these blood donors are not identified by current tests to prevent HIV-contaminated blood products from entering the blood supply highlights the critical role that INTERCEPT can and already does play in creating a proactive blood safety paradigm.
Whether it is protecting against emerging infectious disease threats like chikungunya, Zika and now SARS-CoV-2, or addressing the gaps in the current testing and donor deferral paradigm, INTERCEPT provides a global solution for a global unmet need. During the coming months, with this pandemic appearing to increase in the U.S. and globally, Cerus will continue to focus on ensuring that we are able to support the current and future growth of our business, while at the same time readying ourselves for two key product launches. Operator, please open the call for questions.
Questions and Answers:
Operator
[Operator Instructions] And our first question comes from Mathew Blackman from Stifel. Your line is now open.
Mathew Blackman -- Stifel -- Analyst
Good afternoon, everyone. Thanks for taking the questions. Maybe Obi, to start, appreciate the color on U.S. adoption at the Red Cross. Now I think you said 25% INTERCEPT platelet mix. Can you just remind us where the Red Cross was, say, at the end of 2019, just to get a sense of the ramp? And any color on where the other big four blood banks are today?
William 'Obi' M. Greenman -- President, Chief Executive Officer
Yes. I think, Vivek has joined us on the call today. So given his area of responsibility of the commercial operations in the U.S., I'll let him answer that question.
Vivek K. Jayaraman -- Chief Operating Officer
Sure. Matt, thanks for the question. Hope all is well on your end. We the ARC has been climbing pretty steadily, really since even before the guidance was finalized. If you recall, they made the decision to go to 100% PR independent of guidance. So they're out ahead relative to the other 4, what we'd like the big five customers needs to call big five blood center families in the U.S. account for about 70% of nationwide distributions.
And so we're in a position where we've made good progress with all of them, which is encouraging. I think the thing that we're most excited about is the fact that they are seeing now has 20 sites manufacturing INTERCEPT platelets. And so we saw a pretty significant ramp-up in Q1 with respect to their actual platelet penetration, but I think even more encouragingly, we saw a pretty big step-up in terms of their production volumes and percentages, which will bode well for future quarters.
Mathew Blackman -- Stifel -- Analyst
All right. Great. I got a couple of follow-ups. Just curious on the seven day U.S. platelet label. I assume that's just literally a label change rather than customers you need to do something differently from a process standpoint. Is that first of all, is that a fair characterization? And so the follow-up to that is, is it also fair to say that beyond also improving productivity and efficiency and the relative value versus the other one step options that this would also help augment so the argument for a premium price, the premium price you guys are asking for on INTERCEPT. And I've got one more question after this.
William 'Obi' M. Greenman -- President, Chief Executive Officer
Yes. So you're right, Matt, this would be a label change. It's still, we believe it will be a 180-day review after we get the submission in. So there's a lot of data that will go along with that submission, both from the recovery and survival study that I mentioned, but also data from Europe.
What we've seen in Europe is the earlier release that's available with INTERCEPT, earlier release of the platelet component allows for an effective shelf life that's six or close to seven days at times, and that really does increase the overall operational efficiency at blood centers, allows them to collect blood during the week as opposed to on weekends, and it really bridges sort of supply gaps that you would otherwise see. And so at least from our perspective, it does provide a value-added benefit that ultimately should be reflected in pricing. We already see that with pathogen-reduced platelets in the United States. Yes, I think that addresses your question.
Mathew Blackman -- Stifel -- Analyst
Yes. And then the last question, Kevin, as you said, impressive SG&A leverage in the quarter. Sorry if I missed this, but is this sort of roughly $16 million per quarter runway run rate the way we should be thinking about the back half of the year on the SG&A line specifically?
Kevin D. Green -- Vice President of Finance and Chief Financial Officer
Yes. I think thanks, Matt. I do think it will pick up slightly, but we are certainly seeing a continued slowdown in travel and conference attendance, and most of those are marketing related. We are also, as Obi mentioned in the prepared remarks, starting to staff up for the cryo launch. So I think there'll be a slight step up, but it's not going to be at accelerated levels.
Mathew Blackman -- Stifel -- Analyst
Thanks so much guys. Congratulations on a very good quarter.
Kevin D. Green -- Vice President of Finance and Chief Financial Officer
Thank you.
Operator
[Operator Instructions] Thank you. And our next question comes from Josh Jennings from Cowen. Your line is now open.
Eric -- Cowen -- Analyst
Hi, This is Eric [Phonetic] on for Josh. Congrats on another strong quarter. I was hoping to discuss your recent announcement out of Hong Kong with the tender offer there. What sort of opportunity do you guys see out of that market? But more broadly, how do you see the opportunity in Asia Pac evolving now that INTERCEPT has an initial presence in the region?
William 'Obi' M. Greenman -- President, Chief Executive Officer
Thanks, Eric. Yes, again, I'll let Vivek handle that. This is an effort that we have under way for a long time in Hong Kong, and we conducted an important clinical study there over the last several years that ultimately led to the outcome, but Vivek can provide more perspective on sort of the tender, but also the larger strategy in APAC.
Vivek K. Jayaraman -- Chief Operating Officer
Yes. No. Thanks, Obi. And I think the way the question was asked actually frames how you want to think about it perfectly. The overall size of the market is about 3,000 units and the tender is over the course of five years with initial tranche of about 20%. But more importantly, if you think about the influence of the Hong Kong Red Cross and their involvement with the Asia Pacific Blood Network, they're an incredibly influential customer.
And so as we think about whether it's further progress into mainland China or other key geographies in the Asia Pacific region, this is without a data, very critical and strategically important beachhead. There's a lot of untapped opportunities for us in that part of the world. And so having sort of a premium anchor tenant is a key step forward in terms of executing against our strategy.
Eric -- Cowen -- Analyst
Great. And then separately, the FDA guidance window on platelet safety, as you highlighted, that's only eight months away now. So with that deadline approaching, has the pace of INTERCEPT adoption changed in the past few weeks? Or should we continue to expect incremental adoption through that March 2021 time line?
William 'Obi' M. Greenman -- President, Chief Executive Officer
Yes, again, I'll turn that over to Vivek just to cover sort of the growth in the U.S. through the remainder of the year and through the compliance period.
Vivek K. Jayaraman -- Chief Operating Officer
Yes, certainly. As I think Kevin indicated previously, and Obi certainly touched on this as well, we think in the future periods, the U.S., and particularly the U.S. platelet business, is going to be probably the single most significant driver of growth and what we've been experiencing year-to-date, I think, supports that contention. There have been obviously, we didn't come into the year anticipating the pandemic. And as you know, the hospitals here in the U.S. have had focused on COVID triage and really a lot of elective procedures and so forth were canceled so that you could marshal resources to address the COVID surg that rolled through the country.
And so that invariably had an impact on platelet utilization and guidance compliance. Having said that, I think everyone is sort of waking up to the fact that, that deadline is there. There's been a methodical move in terms of platelet adoption independent of the COVID pandemic. But I think you're going to see a continued push forward. I think the guidance compliance period is coming to an end here. Certainly, it serves a bit of a wake up call, but there are still going to be the immediate pressures relative to COVID that are going to distract hospitals to some extent. But I think net-net, you'll see really solid and compelling growth out of our U.S. platelet business.
Eric -- Cowen -- Analyst
Understood, thank you guys for the questions.
Vivek K. Jayaraman -- Chief Operating Officer
Thanks so much.
Operator
[Operator Instructions] Thank you. And I'm showing no further questions at this time. I'd like to turn the conference back over to Obi Greenman for any closing remarks.
William 'Obi' M. Greenman -- President, Chief Executive Officer
Well, thank you all again for joining us today. We will be participating in the Canada Virtual Health Care Conference next month and look forward to seeing virtually many of you then. Thanks again for joining us today.
Operator
[Operator Closing Remarks]
Duration: 33 minutes
Call participants:
Tim Lee -- Investor Relations Director
William 'Obi' M. Greenman -- President, Chief Executive Officer
Nina Mufti -- Vice President of Development and Red Blood Cell Program Leader
Kevin D. Green -- Vice President of Finance and Chief Financial Officer
Vivek K. Jayaraman -- Chief Operating Officer
Mathew Blackman -- Stifel -- Analyst
Eric -- Cowen -- Analyst
