Good morning, everyone, and thank you for standing by and Welcome to the VBI Vaccines conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. As a reminder, this conference call will be recorded. I'd now like to turn the conference over to Nicole. Nicole Anderson, Director of Corporate Communications and Investor Relations. Please go ahead. Good morning. Thank you all for joining us on the call today as we announce the U.S. FDA approval of PreHevbrio, our three-antigen hepatitis B vaccine, now approved for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults aged 18 years and older. We issued a press release sharing this news earlier this morning. Joining me on the call from VBI is Jeff Baxter, President and CEO. Before we begin, I would like to remind you that this call will contain certain forward-looking statements. Specifically, I would like to remind everyone that all statements other than statements of historical fact included in this presentation are forward-looking statements. Although we believe that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Given these risks, uncertainties, and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement and are made only as of the date of this presentation. For additional information and detail, I refer you to our SEC and Canadian filings. I would now like to turn the call over to Jeff Baxter, President and CEO of VBI Vaccines. Thanks, Nicole, and good morning, everyone. Thank you for joining us. This is a very exciting day for VBI, and we are very proud to share the FDA approval of PreHevbrio. A prophylactic hepatitis B vaccine expresses pre-S1, pre-S2, and S antigens for the hepatitis B virus, and it is the only three-antigen adult Hep B vaccine in the U.S. This approval is the result of intense dedication and hard work from the entire VBI team and our partners over the last several years. It is really the first step in our mission to provide broad access to our vaccine and to help strengthen the public health effort to prevent the spread of Hep B. Though universal vaccination recommendations have been in place for nearly three decades, Hep B remains a persistent health problem in the U.S. Notably, suboptimal surveillance results in under-representation of the true disease burden. Acute HBV disease rates have increased in recent years, with more than 50% of cases being reported among adults aged 30-49. Low awareness of infection status leads to the increased risk of transmission, with 68% of chronically infected adults unaware of their infection status. Adult vaccination rates remain persistently low, with a low vaccination rate for adults aged 19 and older of only 25%. This leaves approximately 200 million adults unprotected against a disease that is 100 times more infectious than HIV. Though global attention has been rightly so focused upon ending the COVID-19 pandemic over the last 20 months, it is clear that the public health bodies recognize the continued threat Hep B poses. The CDC's ACIP recently unanimously voted to move from a risk-based Hep B adult vaccination recommendation to a universal recommendation for adults aged 18-59. Additionally, both the Healthy People 2030 and the Viral Hepatitis B Strategic Plan 2021 to 2025 initiatives include notable targets to reduce the rate of acute Hep B, increase infection awareness, and reduce the rate of Hep B-related deaths. The WHO has adopted the goal of eliminating Hep B globally by 2030. These measures reflect renewed and intensified commitment to the fight against Hep B, and we believe PreHevbrio has the potential to be a meaningful new tool in that fight. The approval of PreHevbrio was based on safety and immunogenicity data from our global phase III clinical program, consisting of two concurrently run pivotal studies, PROTECT and CONSTANT, which combined enrolled approximately 4,400 participants. This program initiated in late 2017 and was completed in 2020 and was a head-to-head comparison of PreHevbrio versus Engerix-B, the most widely used single antigen hepatitis B vaccine. The PROTECT study achieved the primary endpoint of non-inferiority of seroprotection rates in all adults, with seroprotection rates of 91.4% versus 76.5%, and statistically significantly higher seroprotection rates in adults aged 45 and older, 89.4% for PreHevbrio versus 73.1% for Engerix-B. The integrated safety analysis of both studies demonstrated good tolerability with no unexpected reactogenicity. The most common adverse events in all age groups were injection site pain and tenderness, myalgia, and fatigue, all of which were resolved without intervention in one-two days. There was no increase in reactogenicity over the full vaccination schedule and no concerning clusters of severe adverse events. Through discussions with the FDA, we were able to include further age delineation in our package insert, including seroprotection rates for adults aged 18 to 44, 45 to 64, and 65 and older. With the ACIP's recent shift to universal Hep B vaccination recommendation for adults aged 18 to 59, this data may be of notable importance to support those broader vaccination guidelines. To that point, discussions with the ACIP are ongoing, and we are working with the committee through a very busy time, given the evolution of COVID-19 vaccine recommendations, to have PreHevbrio included in their recommendations as quickly as possible. To prepare for this approval and for the commercial launch of PreHevbrio, as we announced in December 2020, we have been working with Syneos Health now for more than two years to build a comprehensive and strategic framework for product launch and market entry. I said many times in the past, an effective product launch does not begin at approval, but in the one and a half to two years prior to that approval. Our partnership with Syneos has enabled an innovative, flexible, and integrated approach to vaccine commercialization. Our strengths, illustrated by this approval, are in discovery, development, and regulatory strategy. Collaborating with Syneos as a full end-to-end commercialization partner allows us to leverage their significant network and their extensive vaccine launch expertise. As part of that collaboration, we have a fully dedicated leadership team led by John Dillman, who has previously spent 17 years at Sanofi Pasteur vaccines in a variety of senior commercial sales and marketing leadership roles. We have also built up field teams across medical with 14 medical science liaisons in the U.S., Europe, and Canada, market access with about 10 national government and regional account managers. Those people are already in place and talking to healthcare professionals. Sales, with a sales leadership team already on board and a team of about 50 field vaccine specialists expected to be fully onboarded by the end of January 2022. The market access team is already in discussions to ensure broad access to PreHevbrio, as well as to identify and engage key distribution and channel partners across wholesalers, specialty distributors, integrated delivery networks, or IDNs, group purchasing organizations, vaccine buying groups, and retail, to name but a few. We expect our full field sales force to be deployed by March 2022, at which point they will use the already compiled and prioritized targeted list of about 5,000 accounts across hospitals and clinics to drive pull-through. To support field team efforts, we also plan to launch an engagement call center as well as additional digital resources to build brand awareness. The last two years working with Syneos has laid important groundwork, and we look forward to the continued successful relationship as we work to get our vaccine in the hands of healthcare providers. Briefly, other notable milestones in the lead-up to this approval include the publication of the PROTECT and CONSTANT data in high-caliber peer-reviewed journals, The Lancet Infectious Diseases and JAMA Network Open, respectively, and the American Medical Association establishment of a new and unique current procedural terminology, or more commonly known CPT code, for the three-antigen Hep B vaccine PreHevbrio. This will streamline the reimbursement process and differentiate PreHevbrio from the single-antigen Hepatitis B vaccines. Importantly, looking to the market opportunity for PreHevbrio, the 2019 pre-pan-pandemic U.S. adult market for Hep B vaccines was approximately $320 million and growing strongly. By far the vast majority of which was attributed to the single-antigen Engerix-B from GSK. This market has not yet recovered to pre-pandemic levels, but it is getting there. Recent estimates vary on the potential impact of the universal adult ACIP recommendations, but general consensus is that it could increase the adult market to more than $500 million over the next several years in the U.S. alone. We do not anticipate providing revenue guidance in our first year of launch. We believe it's too early to make accurate predictions, especially given the evolving recommendations and landscape from the impact of COVID-19. We will instead focus on execution and demonstrating product adoption in the field through market share. We do expect PreHevbrio to be a meaningful new tool for healthcare providers, the sentiment reiterated to us in many of our discussions over the past two years. We intend to provide color commentary as we progress through the first quarter for launch, including net revenue and other notable market penetration metrics. We will announce the price of PreHevbrio upon product availability, expected to be Q1 2022. That being said, we wanna provide healthcare providers with a highly cost-effective new intervention, so we expect that price to be highly competitive with the market leader Engerix-B. We are enthusiastic about developing and growing meaningful partnerships with healthcare providers and public health groups, such that we can drive awareness around the unmet needs in Hep B, increase adult vaccination rates, and provide a differentiated tool for HCPs to combat the spread of Hep B infection. This approval is absolutely transformational for VBI, not only because we are able to meaningfully join the fight against Hep B, but it also demonstrates our ability to progress a candidate through clinical development, navigate the regulatory environment, and ultimately commercialize a product. This process has laid critical groundwork for the rest of our pipeline, better supporting our ability to execute on our commercial objectives and vision. Over the next six months, there are a number of milestones anticipated across our portfolio. In addition to those highlighted in our third quarter earnings release, David Anderson, VBI's Chief Scientific Officer, will present an update from the ongoing study of VBI-1901 in recurrent glioblastoma patients later today at the World Vaccine Congress. Additionally, COVID-19 in particular remains top of our minds due to the recent emergence of the Omicron variant. I've said in the past that chasing variants will not be an effective strategy to combat COVID-19, so our focus is on creating vaccines that provide long-term breadth of protection with good safety and tolerability profiles. This effort includes both boosters with different variants, including the VBI-2905, as well as the development of pan-corona vaccine candidate VBI-2901. By the end of the year, we expect to have pre-clinical data that should signal the extent to which our coronavirus candidates are able to address the widening variant pool. We have already ordered and are accessing Omicron's genetic sequence against which we will plan to test our different candidates. This will further build upon the panel of variants we've already tested against, including strong immunogenicity against Beta, Delta, and the ancestral strain. We look forward to providing updates and sharing data as we continue to work hard to address significant and relevant unmet medical and public health needs. With that, I'll pause here and hand over to the operator to open up the line for questions. Thank you. Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for your questions. Our first questions come from the line of Steven Seedhouse with Raymond James. Please proceed with your questions. Thanks very much. Good morning. Congratulations to everyone at VBI. I wanted to ask about the ACIP recommendations, just in their current form, sort of how they accommodate for PreHevbrio. You mentioned sort of some potentially anticipated changes given it's approved now. What would you be hoping for or looking for in those eventual updated recommendations that would sort of be favorable for PreHevbrio? Hey, good morning, Steve. Yeah, it's a great question actually. Sort of the broader point is that a lot of people, you know, focus often, rightly so, on what the package insert says about a product. In the world of vaccinology and vaccine recommendations, the ACIP recommendations are very, very important alongside the FDA's package insert, and the two really do go hand in hand. In terms of key opinion leaders and protocols and various formularies, the ACIP recommendations are critical, particularly for universal reimbursement in both the private and the public sectors. We are in discussion with the ACIP. We have, we believe, a very strong working relationship with the Hep B advocacy groups, as could be seen by the inclusion of the Hep B's incoming chairperson quote in our press release today. The addition of a third vaccine, particularly one that has, you know, phenomenal safety profile, very high immunogenicity, particularly in older individuals aged 45 and over, is seen as a really important addition to the main two vaccines, Hep B vaccines that are approved in the U.S. What we've been looking for in discussion with the ACIP over the next several months is, first and foremost, the full ACIP endorsement of the universal adult recommendation 18-59. Then within that, PreHevbrio being a recommended vaccine. At this stage, I don't think it goes beyond that, Steve, but just getting that recommendation alongside, obviously Engerix-B, HEPLISAV-B from Dynavax, and what still remains RECOMBIVAX HB from Merck, still out in the market, is a very important first step. That creates a level playing field for PreHevbrio to essentially compete against those vaccines. That was a very long answer to your question, Steve, and not that specific, but that's the broad landscape as we see it today. It's helpful. I mean, if I could just follow up. I mean, based on your experience and knowledge, how long would you anticipate a change to take here to sort of specifically name PreHevbrio in the recommendations? I think, you know, the caveat would be, of course, what happens with, you know, emerging and further divergent variants of COVID-19. Assuming that that doesn't hijack the work of the ACIP, you know, more than it is so already, we would expect to get an ACIP recommendation, probably before the end of the first quarter of next year. And, you know, that would really work very nicely with our field force and supply chains and everything else being fully onboarded, stock supplied with our newly recruited market access team, really sort of hitting the road. I think our ambition would be, Steve, the end of the first quarter. Great. Okay. Just with respect to the point you make on COVID clearly not being, you know, an independent consideration here, there's only so much bandwidth there, but also at VBI, I'd be curious to get your thoughts on, given this approval now, and with your programs in the clinic and with Omicron, you know, emerging, is there an opportunity for you to sort of enhance the focus and the bandwidth you're devoting to the COVID programs? And maybe we'll just ask for an update on sort of when the next clinical data would be forthcoming from your program. Yeah. I mean, first thing I'd say, Steve, in the sort of macro COVID-19, you know, I would first of all like to thank and recognize the work of the FDA to meet this PDUFA deadline. Against everything else that's going on with COVID-19, the FDA, you know, has been a great sort of collaborator in reviewing this file. You know, really delighted to say that our manufacturing facility in Israel was actually one of the first to actually collaborate with the FDA on their remote interactive evaluation process, essentially virtual GMP site audits. You know, first of all, you know, sort of hats off to the FDA in working with us to move this forward and meet the PDUFA commitment. Now, we've met that PDUFA commitment, Steve. As you say, the work is now focused in our manufacturing facility in Israel, to, you know, build the supply chain ready for the first quarter of next year and essentially this product availability early in 2022. In terms of our internal bandwidth, largely, the EVLP programs, mainly at this point in time, GBM, the COVID programs, and actually our CMV candidate is focused at our research facility in Ottawa, Canada. We have been recruiting hard. We have been working with our collaborators, in particular Resilience, our manufacturing partner, and the NRC to increase our bandwidth. With regards to the COVID-19 program, you know, no change to the current public guidance, but we are working really hard to try and be creative, in particular to get 2901 into the clinic as early as possible. It's all hands to the pump to get twenty-nine oh one into the clinic as soon as possible, recognizing the potential for twenty-nine oh one as a pan-coronavirus vaccine candidate to protect against emerging and unforeseen COVID-19 variants, which is why preclinically testing twenty-nine oh one against Omicron, which, you know, we should have data in the next several weeks, will be important. Having said that, Steve, the clinical data, the next clinical data we're expecting is from the booster study of twenty-nine oh five in Canada, which is a single dose of twenty-nine oh five, a Beta variant, which up until Omicron had been the most divergent variant. We will be testing against all known variants, including Omicron, in those individuals who have previously been vaccinated with two doses of messenger RNA. We will have that data in early 2022. That's the next clinical data, Steve. I think, you know, we would hope to have preclinical data against Omicron over the next several weeks. We have heard the feedback loud and clear from the WHO, you know, exactly the public health bodies around the world, that really the goal is to stop chasing variants and to try and, you know, develop a more longer-term pan-coronavirus candidate. We have heard loud and clear that people wanna see 2901 in the clinic sooner rather than later, and that's absolutely our goal. Yep. Great. Okay. Just last question from me. I appreciate your comment about price, so we'll look forward to that around the time of commercial launch. Just regarding the economics of the Syneos collaboration, could you remind us sort of how that breaks down and, you know, for every dollar sold here, how much of it, you know, will find its way to VBI's top line? Sure. Well, 100% of the revenue of sales from PreHevbrio will be reported against VBI's top line. At the moment, we are paying Syneos on a fee for service basis in the preparation for launch and launch. That may change as we launch the product, obviously to incentivize sort of market access performance. We may move to a risk sharing basis. At the moment, it's strictly a fee for service. People will have to wait and see our financial filings to see how much we're spending. What I can tell you economically, this is a very, very efficient relationship for our shareholders. We're probably getting at least a one-two, you know, say, kind of half the price, essentially, if we had tried to do this ourselves. That's just through the synergies and the vast experience and quality of people that we can access in Syneos. At the moment, Steve, fee for service, we may change that as we go into launch service. You know, otherwise we wouldn't anticipate necessarily a royalty type arrangement or anything else. It is more likely to be a fee for service with some kind of financial milestones against sales target to drive performance. Great. Well, thanks so much for taking all the questions. Congratulations, Jeff. Thanks, Steve. Have a good one. Thank you. Our next question has come from the line of Kelechi Chikere with Jefferies. Please proceed with your questions. Yes. Thank you for taking my questions, and congrats on the approval. I guess, first, can you speak to where you think physician awareness is on your vaccine and the benefits it provides over what's currently available? Any color there would be extremely helpful. I guess, can you also talk to some of the work that you're doing to broaden awareness of your vaccine? Yeah. Yeah. Good morning, Kelechi. Thanks for getting up at 5:30 AM in San Francisco. I think, you know, first and foremost, you know, our medical sales liaison staff through Syneos, it's fantastic actually to see them, you know, carrying two-sided cards and, you know, LinkedIn profiles saying, you know, VBI Vaccines. So they really do feel part of the team, very committed to the product. They've been meeting with key opinion leaders and key physicians and the key clinics. So there is that broader awareness. Of course, the really important thing here is, again, you know, people focus on, you know, the package inserts, but the really important thing here is that we were able to establish PROTECT and CONSTANT in two extremely high quality, you know, peer-reviewed journals. The MSLs are able to use that data, given it's in the public domain and peer-reviewed, to actually discuss the benefits of PreHevbrio. I think the feedback we're getting is that this is clearly a highly effective vaccine, which is safe and well-tolerated, and particularly statistically significantly SPR better in adults age 45 and over. Of course, that is the age group, as I mentioned earlier, where we're seeing some significant increase in breakthrough HBV infection. Given the fact that this is differentiated as a three-antigen vaccine, given that it doesn't use a next generation, it uses alum, which has been in hundreds of millions of individuals around the world safely. Given the sort of rapid kinetics of protection, you know, kind of 90% plus after two doses, then, you know, people are saying, "This is, you know, this is a very important addition to our armamentarium." Of course, physicians and key opinion leaders are somewhat, you know, restricted by what is on formularies and what is on, that's Medicare and Medicaid formularies, the public pay formularies, and what's on the private payer formularies. That is where, you know, vaccines is perhaps one of the most price-intensive, and price-competitive kind of, sectors of, you know, the pharmaceutical world. As I've said, we will make sure that we price highly competitively with GSK's Engerix-B. Given that, you know, we have very, very important advantages over Engerix-B, but you need to be still price competitive. I think if you look at the slower adoption of other Hep B vaccines, you know, a lot of the sort of market access research says that, you know, the price, the WAC price, the wholesale acquisition cost, is one of the key determinants. The other thing is, if you price competitively within kinda circa 5% of the current standard of care, it avoids a prolonged contracting process, allowing you to essentially supply your product on a much quicker basis than you might do, say, if you went with a 30% or 40% premium to the current standard of care. Thank you. That's really helpful color there. I guess just adding to that, can you speak to the cadence in which you anticipate your vaccine being added to these formularies? Is it something that you anticipate taking all of 2022 and going into 2023? Or is this something where you expect it to occur relatively quickly given that, hey, you are pricing competitively, you have been in discussions with the various, payers, talking about your vaccine? Any color there would be helpful. Yeah, I mean, I think, you know, who knows in this pandemic world. I think, you know, normally, we certainly have very ambitious targets in terms of getting on those formularies and having those contracting discussions. The important thing is that we, you know, actually, I met with the senior market access and commercialization people in Philadelphia, you know, many months ago. Back in the summer, we already had our sort of target list of 5,000 accounts that we wanna go to. You know, Syneos have really been able to recruit a first-class team, Kelechi. You know, many of them are rolling off of significant product launches for GSK and Sanofi. They come with this amazing kind of Rolodex and knowledge of, you know, where you can access accounts quickly and often have personal contact. I can't make any promises at this point in time, with the caveat of COVID-19. We would expect a pretty rapid sort of access. I don't think it's gonna take all of 2022, but what you can certainly do, our market folks call it filling the pie. You can certainly access the first quarter of that pie very quickly within the first three months. Thank you. Congrats again. Thanks, Kelechi. Thank you. Our next question has come from the line of Leland Gershell with Oppenheimer. Please proceed with your questions. Thank you. Good morning, and my congratulations on this approval. Couple questions, Jeff. First, on the insurance side, just wondering, you know, as we think about kind of the timing of people's individual healthcare plans, you know, resetting at the beginning of the year with this approval coming toward the end and then your launch early in 2022, is there any, you know, relevance to kind of how those, you know, timings line up, you know, potentially either in your favor or not? Also have a question with respect to the strategic side, which is, you know, obviously a lot's going on at VBI and there's, you know, a number of assets you're focused on beyond this one. I'm wondering, you know, if there's sort of a level of sales at which, you know, you may see this being an attractive asset for a suitor who's, you know, already entrenched in the vaccine space and maybe look to monetize so as to benefit your R&D funding for the pipeline. Thanks. Yeah. Good morning, Leland. They're all great questions. I mean, I think in terms of your first question, you know, the really important axis here is the discussions and the outcome of those discussions with the ACIP. Because if the ACIP recommends PreHevbrio as part of, you know, the prophylactic Hep B vaccine world, then as I said earlier, that creates a level playing field and also means that with that universal recommendation, that private healthcare plans must essentially reimburse adult vaccination of Hep B, which is not currently the case. Secondarily, you know, again, it would be covered by Medicare and Medicaid. You know, that's the first and most important step in the discussion with the ACIP. It is all based and premised upon the strength of your clinical data. We believe, you know, with PROTECT and CONSTANT, we have very strong clinical data. I don't wanna tempt fate, but, you know, we should have a positive sort of discussion and interaction with the ACIP about including PreHevbrio in the recommendations. Where, you know, our stars obviously align is, you know, launching into a market with that universal adult recommendation. As I mentioned, you know, all things being equal, you know, some estimates say that the market will grow from $320 million in the U.S. a year to in excess of $500 million a year, and that will be the case for several years as adult vaccination sort of catches up with that universal recommendation. I mean, given the sort of U.S. and WHO objective of eliminating hepatitis B chronic breakthrough infections by 2030, you know, that kind of implies, you know, pretty rapid uptake of universal adult vaccine recommendation, certainly in the U.S., and presumably will have, you know, a positive impact on hepatitis B vaccination recommendations in Europe as well and other major markets. We see private markets in China and various other places, you know, often following the U.S. and European recommendations. That, that's the first point, you know. Our stars could align there, and we could be launching into a very hot market for the next several years. That's the first thing. The second thing, around the sort of broader kind of resources and where we go with, you know, COVID-19 versus our pipeline and sales. The most important thing for us is, and where I and our board of directors believe we can add most value, first of all, public health value for unmet medical needs, but also for our investors. You know, it's clear that if you do good things, you know, for the public health environment and, significant unmet medical needs, then, you know, shareholder returns follow that. We believe we can really add the most value in the sort of discovery pre-discovery, development, and regulatory progression of the candidates that would come out of our platforms where we develop our vaccines. That is why we've clearly partnered with Syneos in terms of, really was one of the first end-to-end partnerships, 'cause we didn't want the distraction of having to hire, you know, 50 medical access people to fill the sales force. We wanted to concentrate on progressing our pipeline and bringing more candidates forward for regulatory approval. You know, to your point, I think it also kind of makes it easier to think about, you know, once we're, you know, supporting the clinical development of PreHevbrio and the manufacturing, then, you know, commercial partnerships and perhaps more than that, are easier to envisage. Because it's not like we're gonna have 120 commercialization people in VBI on our payroll. So it does make it easier to perhaps envisage what a commercial partnership or perhaps something bigger in business development terms could look like. But I think to be very clear at this point in time, Leland, we are entirely focused with Syneos on the successful commercialization. As I mentioned earlier, we're really looking forward to actually being a biotech company that has a top-line revenue line, and you know, receiving 100% of that revenue, and using it to invest in our pipeline development. Great. Those are all very helpful answers. Then just a couple of CMC questions, if you could just, Jeff, comment on the manufacturing capacity for PreHevbrio and perhaps what the current stability is and shelf life and if that may be extended with further study. Thank you. Yeah. You know, as I mentioned earlier, we were, you know, really delighted to be able to collaborate with the FDA on their first remote interactive evaluation. It was also important because, you know, the Israeli Ministry of Health had given us, or renewed the GMP certificate essentially in January 2020. To have, you know, the Israeli Ministry of Health approve our factory in terms of ICH guidelines, and ICH guidelines basically determine GMP acceptability in the rest of the world apart from the U.S. The FDA has some slightly more stringent requirements on top of ICH. To then get the FDA GMP approval was very important to us. The reason it was important for us, 'cause a couple of years ago, after we acquired SciVac Therapeutics in 2016, we actually kind of renewed and refreshed the leadership team. And also we shut the factory for over a year. And after, you know, a reasonably significant investment, completely renovated, refurbished the factory and increased capacity through the bottlenecks, which typically in our world are in the fill finish, the downstream processes rather than the upstream. You know, both the Israeli Ministry of Health GMP certification after that refurbishment was completed and the FDA was important. To answer your question, Leland, we certainly believe we have more than enough capacity to support a North America launch and a European launch of this, for this foreseeable future. Great. Thank you very much, again. Again, my congratulations on the approval of PreHevbrio. Great. Thanks for the questions and following up. Thank you. Thank you. This concludes our question and answer session. I would like to turn the conference call back over to CEO Jeff Baxter for any closing remarks. Thank you. Well, once again, thank you to everyone who joined this call. Thank you for your interest in what we are doing. We believe we are a really important part of the fight against hepatitis B, and we're really excited to be working with Syneos Health and to get this product out there for healthcare providers and their patients. More broadly, you know, today is a transformational day, as we've said a number of times. We in the company have never been more excited, more energized, more motivated with the approval now of PreHevbrio to continue to progress our pipeline. I mentioned earlier, you know, we're gonna devote a lot more resources to our coronavirus programs. We're gonna try and do everything we can to get VBI-2901 in the clinic as soon as possible. You know, we look forward to the clinical data coming out of VBI-2905. Dave Anson later will be, you know, present some data at World Vaccine Congress. We're excited, you know, to see our GBM candidates progress, and also, you know, to introduce some new candidates to our pipeline over the coming months. Once again, this is a huge day for VBI, and all of our partners, collaborators, our principal investigators, everyone in the field. I think it's also a very important day for our investors and shareholders as we begin this kind of next phase of our journey. The approval is just the start, and we're really looking forward to getting PreHevbrio out there in the hands of healthcare providers and their patients. With that, I'll conclude and say again, thank you for your continued interest and support of VBI. I will speak to people shortly again. Thanks. Bye. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.