Good day, and thank you for standing by. Welcome to Roivant's update regarding initiation of patent litigation against Moderna conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Paul Davis. Please go ahead.
Great. Good morning, and thank you for joining today's call to discuss the initiation of patent litigation against Moderna by Genevant and its licensor, Arbutus. I'm Paul Davis, the head of communications at Roivant. On the call today, we have Roivant's CEO, Matt Gline, and Dr. Pete Lutwyche, CEO of Genevant. For those dialing in via conference call, you can find the slides being presented today on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as we present to help you follow along. We will end the call with a Q&A session. I'd like to remind you that we will be making certain forward-looking statements during today's presentation that reflect our current views and expectations.
We encourage you to review the information on slide 2, as well as other materials we've filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. With that, I'll turn it over to Matt Gline.
Thanks, Paul, and good morning, everyone. Before I start, I want to acknowledge it's a difficult moment in the world, and while we're here today to provide an update on a corporate matter, we're also watching the situation in Ukraine closely and hoping dearly for peace. With that, I'll begin my presentation this morning on slide 4. This morning, Genevant and Arbutus jointly filed a complaint against Moderna in the U.S. District Court for the District of Delaware, asserting infringement of 6 patents licensed by Genevant. Now, before we get into the rest of today's call, I just wanna start by saying very clearly that we're not seeking an injunction and that we do not wish to impede in any way Moderna's COVID-19 vaccine from reaching as many people as possible. We felt it was very important to make it clear up front.
We want to recognize the important work that Moderna has done to develop a vaccine with record speed, and we are also proud of the significant contributions of Genevant's LNP technology to the vaccine's success. Before we go into details on today's filing, we want to provide some background on Genevant and its technology, and for that, I'll hand it over to Pete.
Thank you, Matt, and good morning, everybody. If we move to slide 5, Genevant is a leading nucleic acid delivery solutions company with world-class technology platforms, a robust patent portfolio, including key patents licensed broadly from Arbutus and decades of expertise and experience in nucleic acid drug delivery and development. Now, vaccines and other medicines using RNA or other nucleic acid technologies are an emerging frontier that has enormous potential. Historically, though, these medicines have been challenging to develop. Firstly, nucleic acids need to get into target cells to exert their effect, but being large hydrophilic molecules, they do not readily cross most cell membranes. Secondly, they're highly sensitive to nucleases, and without adequate protection, are susceptible to being degraded in the human body.
For decades, the need for a delivery technology capable of delivering RNA cargo intact to its intended target has been 1 of the most significant challenges in the development of RNA-based medicines. The solution to this long-standing problem is now commonly referred to as lipid nanoparticles or LNP, and this was developed by scientists at Arbutus and predecessor company, and several of these scientists are now at Genevant. LNP generally consists of a carefully selected mixture of specialized lipids, a conjugated lipid, which is commonly a polyethylene glycol or PEG conjugate, an ionizable or cationic lipid, a phospholipid, and cholesterol or other amphipathic lipid. These lipids form a particle that encapsulates the nucleic acid payload to protect it from degradation and facilitate its uptake into the target cell, then enabling endosomal release of nucleic acid into the cytosol, where it can exert its effect.
Genevant's technology became the first LNP to be part of an FDA-approved RNA product, this being Alnylam's ONPATTRO in 2018. Today, LNP has become the primary means of delivering messenger RNA and an emerging approach for gene editing applications as well. The Genevant team is committed to advancing the technology still further to enable novel approaches to addressing unmet medical needs. We have several active collaborations, and some of these are shown on slide 6. If we go to slide 6, I won't read through all of these, but the slide reflects, I think, our approach to selective partnering with leading pharma and biotech companies who have innovative technologies that can benefit from our delivery technology and expertise.
We're working in very broad and diverse areas from our efforts to deliver gene editing constructs to muscle with Sarepta, to stellate cell-targeted LNPs for fibrosis with Takeda, hepatocyte delivery for rare diseases, again, with Takeda, also with 2seventy bio , and then oncology applications with Gritstone bio and BioNTech. We are, of course, working in the area of mRNA vaccines, including for COVID, where we've partnered several times with some of our collaborations focused on bringing a solution for low and middle-income countries. In at least 1 case where we've worked to transfer our efficient and scalable manufacturing process to enable local production of the vaccine. With that short introduction, I'll turn it back over to Matt.
Thanks, Pete. Moving on to slide 7, I'll start by talking a little bit about the sort of backdrop IP portfolio. As you may know, Genevant has a robust intellectual property portfolio with approximately 700 LNP-related patents and pending patent applications. Today, we're focusing on 6 specific patents shown on the table on the slide. The first 5 are particle composition patents, which describe the compositions and ratios or relative amounts of various types of specific lipids included in each LNP. At the bottom of the table, we also reference the '651 patent, which describes certain LNP compositions in which mRNA is encapsulated. We'll talk more about each of these on the slides to come. I'll note that some of these patents refer to lipid vesicles or nucleic acid lipid particles.
For simplicity's sake and for the purpose of today's presentation, we're going to generally refer to them as lipid nanoparticles or LNPs. On slide 8, I'm going to now talk about some of the particle composition patents and in particular, some of the public disclosures that support Moderna's infringement of the Genevant and Arbutus's patents. As you'll see here, and on slide 8, Moderna has made statements regarding their vaccine in multiple contexts, including a 2020 preprint of an academic publication that described the molar ratios of the LNP of their vaccine candidate used in preclinical work. A separate preclinical study of their vaccine, published in the New England Journal, confirmed that the mRNA was encapsulated in an LNP, quote, as described previously, citing an earlier Moderna publication describing the same molar ratio as the preprint that I mentioned.
Moderna also filed a patent application describing that same molar ratio as "used in the phase I trial of mRNA-1273," and in a sworn affidavit from their Deputy GC, declared that the lipid carrier particle used in their phase I study is the same as the 1 that was ultimately approved for use in their product. The table on the slide shows the molar ratios disclosed by Moderna, as well as certain quantitative aspects of the patents asserted in today's complaint. The overlap is evident. I also want to highlight specifically the '378 patent all the way to the right, which has no quantitative limit for the cationic lipid, meaning that it covers certain LNPs with cationic lipid molar concentration below 50%.
I'll also note that while Moderna has denied infringement, they have refused multiple requests to provide information on their vaccine formulation to Genevant, even under a confidentiality agreement, and Moderna has specifically obscured details of the LNP composition of their commercial product in regulatory filings. Moving on to slide 9, I just want to take a minute to talk a little bit more about the 651 patent. 651 has a different subject matter from particle composition patents. As shown on the slide, it covers, 1, lipid vesicles comprising a cationic, amphipathic, and PEG lipid, and 2, mRNA, at least 70% of which is fully encapsulated in the lipid vesicles. We know that Moderna's vaccine includes these lipids, and from Genevant's experience, we believe at least 70% of the mRNA is fully encapsulated in the lipid vesicles.
Most notably, this patent has no quantitative constraints on the molar ratios of these types of lipids. On slide ten, I want to highlight that Moderna has long been aware of Genevant's patent portfolio, going back at least to 2016. Moderna's CEO has dismissed the LNP technology at issue and the need for rights under these patents while claiming that Moderna has developed their own LNPs. Despite these assertions, beginning in 2018, Moderna sought to invalidate some of the U.S. patents through the IPR, or Inter Partes Review process with the Patent Trial and Appeal Board. Moderna was largely unsuccessful as the PTAB upheld key claims of the '435 patent as patentable in 2019, and all claims of the '069 patent as patentable in 2020.
In 2021, and this received some recent attention, the Federal Circuit rejected and dismissed Moderna's respective appeals of these PTAB decisions. Finally, on slide 11, I'll wrap up by saying a few words on next steps. As is the case with any litigation, it's difficult for us to comment on specifics. That said, we do expect that Moderna will respond to this complaint within the next several months, and that pending Moderna's response, the court will set a schedule for further proceedings in the case. We expect that litigation with Moderna could take at least 2 years, but again, there are many factors that could affect that timeline.
Before I go to Q&A, I want to remind everyone that we're really excited about the breadth and strength of Genevant's LNP technology platforms, both in the context of the mRNA COVID vaccines as well as in other therapeutic areas and modalities. Genevant's scientific team has worked very hard on this over many years, and it's great to see that work come to fruition. I'd now like to turn to Q&A, noting there will likely be some things that we won't be able to address here, but we're happy to take whatever questions that we can. Thank you very much. With that, I'll ask the operator to please open the line for questions.
Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question is from Dennis Ding with Jefferies. Your line is open.
Hi. Good morning. Thanks for taking my question. I have 2 questions, if I may. Number 1, can you just comment on your confidence level around a positive outcome with this case, and, you know, more specifically, what a positive outcome would look like? Number 2, can you please provide your thoughts on some of the technologies used by other mRNA players in the space and, you know, would those technologies also potentially infringe upon some of these patents? Thank you.
Yeah, thanks. Thanks, Dennis. Thank you very much for listening, and obviously, thanks for following this situation. On your first question about confidence and about what an outcome might look like, I guess I'll say, first of all, I think the complaint speaks for itself in terms of our level of confidence in the evidence that we have. In terms of what a positive outcome might look like, you know, I think it's difficult to sort of speculate on damages, but in patent infringement cases, damages, I think you know, are calculated on the basis of a reasonable royalty, which is a legal term of art that requires consideration of various factors.
I can't comment super specifically on our litigation strategy outside of what's in the complaint, but we think the circumstances here are unique, and these factors support significant damages, potentially, frankly, well beyond what we have seen speculated in certain places publicly. Genevant is a willing collaborator, and as we show on slide 6 of the presentation, we've done a lot of deals, including several early preclinical COVID vaccine deals, which were entered into under very difficult circumstances than those that apply to Moderna and which may or may not prove relevant here.
I'd also like to remind everyone that Moderna has repeatedly acknowledged the importance of LNP technology to their vaccine, that without the technology, our technology, Moderna's vaccine wouldn't work and Moderna wouldn't have received their profits from sale. On your other question about other mRNA vaccine manufacturers, I can't comment today on our litigation strategy aside from what's in the complaint, other than to say we're committed to defending our technology against parties that infringe or induce infringement of our patents broadly. I think that covers kind of the various avenues that we might pursue.
Got it. Thank you.
Thank you.
Thank you. Our next question comes from Yaron Werber with Truist Securities. Your line is open.
Hi. Thanks for taking the question. All right, I'll be quick on 2 points. I know people have asked about if patent infringing under EUA versus non-EUA, and I know there's precedent for, you know, filing a patent infringement lawsuit even though drug's approved under EUA. What are the different options for how this court case could go, if in fact they decide that there is a difference between products sold under those terms? That's the first question. Second, I know they failed their IPR, but just curious, you know, if Moderna does claim they have a different cationic lipid, which they've said in various points, like, when would we learn that? Would we learn that in the filing that their next filing when they argue what their rebuttal might be to this?
Given I'm not a chemist, do you think 1 skilled in the art would feel like that different cationic would still fall under the 069 patent? Thanks.
Thanks, Yaron Werber. Those are all good questions. You know, on the first 1, in terms of sort of possible ways this could go from a sort of litigation perspective, you know, it's hard to predict exactly what the paths are, but I don't know that we think, for example, the fact that it's under EUA affects our strategy particularly much. I don't know that that makes a big difference to us. You know, on the chemistry question, I guess what I would say is so Moderna has a proprietary cationic lipid that they disclose. They call it SM-102. We believe it to be in the category of lipids covered by our patent claims, ionizable cationic lipids.
In short, I think all of the claims of our patents that refer to ionizable cationic lipids ought to cover that lipid.
Okay, great. Thank you.
Thanks, Yaron Werber.
Thank you. Our next question comes from Neena Bitritto-Garg with Citi. Your line is open.
Hey, guys. Thanks for taking my question. I was just wondering if you could talk a little bit about any interactions that you've actually had with Moderna since the December appeals decisions came through. I know in the complaint it does say that you have tried to negotiate with them, you know, privately in the past. I'm just curious if you have had any discussions since then. Thanks.
Yes. We haven't commented on the specific sort of character or timeline of our interactions with Moderna over time, other than to say that we've had some discussion with them. I think it's probably best not to go into the details of that timeline right now. We have consistently communicated with them and with other parties who might be interested in licensing our technology.
Got it. Thank you.
Thanks, Nina.
Thank you. Our next question comes from Yaron Werber with Cowen. Your line is open.
Great. Thanks for taking my question. Maybe Matt, first of all, can you discuss a little bit your patent portfolio in Europe, or at least your thoughts about Europe? Secondly, at this point, is your expectation that they're still going to try to invalidate the 651 and some of the other patent portfolio, or do you think that's mostly off the table following the Federal Circuit decision? Thank you.
Yeah. Thanks, Yaron, for the question, and thanks for joining. As far as Europe is concerned, you know, some of our patents, especially some of the particle composition patents, have European analogs. We haven't said anything about our litigation strategy as pertains outside the U.S. or otherwise, but as I said to an earlier question, you know, we do intend to pursue any possible avenue to defend our intellectual property rights. I think that sort of covers the Europe question. Then, sorry, the other question was. Sorry, could you just repeat the second question? I didn't quite get that.
Yeah. I mean, obviously after the Federal Circuit, most of the patents cannot be invalidated. Do you think there's a few patents they're still going to try to argue are obvious and invalidate? Or do you think this is gonna ultimately be on composition and merits of the patents versus their composition?
Yeah. Thanks, Yaron. It's a great question. Sorry, I couldn't remember it. You know, I think the first answer to the question of what Moderna will try to do is you should probably ask Moderna what they'll try to do. I don't know for sure. You know, I think we feel like we have a broad patent estate. We think it's robust. We think it has already withstood the challenges that they've made, and you know, we're prepared for whatever else they want to try.
Maybe just finally from you. Our understanding from Pfizer and BioNTech is that they're using the Acuitas LNP technology. Is that your understanding as well? Thank you.
Yeah, we're not commenting today on other manufacturers of mRNA vaccines. What I'll say is I think we have a broad IP estate, including our particle composition patents, and that patent estate is independent of what other technology anyone may have licensed. You know, we'll comment more on that when we have an opportunity to do so.
Okay. Thank you.
Thank you. Our next question comes from Corinne Jenkins with Goldman Sachs. Your line is open.
Hey, thanks. Can you just help us understand some of the key assumptions that are built into that estimate of a 2-year litigation process here? What are some of the things that can either pull that timeline forward or push it further out?
Yeah. Thanks, Corinne. Yeah, it's a great question. Obviously something that's on our minds and other people's minds as well. You know, I think it's hard to comment on the specifics. We said at least 2 years in the materials. You know, I think we, as you might imagine, have a very strong team working with us on this, and they've worked on many cases like this 1 before. I think some of that's based on the judgment of our experts, and then some of it's just based on the mechanical time that it takes for responses and, you know, time it takes people to come back, et cetera. Obviously, there's lots of factors that can affect the timeline of a litigation.
Obviously, if there were any kind of agreement or license or settlement reached, it would completely change the timeline. It's hard to speculate specifically, but we're gonna work to get this resolved as quickly as we can.
Okay. Maybe can you just help us understand some of the legal expenses you expect to incur and where we expect to see them show up, both in timing and then where on the filing, given, you know, with Arbutus, Shimervax, and Roivant are all kind of participating here.
Yeah. Thanks, Corinne. First of all, I'll just make a comment that I hope everyone understands, which is that Roivant is well resourced to cover a complaint like this 1, that the expenses aren't gonna be particularly highly material to Roivant as a whole, and that we expect to make sure that we're spending the money we need to support our intellectual property. You know, I think the total amount and the timing obviously depends on the course that the litigation takes. It depends on how long it takes. It depends on what various things Moderna attempts per the previous questions. It's hard to speculate on the exact numbers. You know, maybe when Roivant gives future guidance on total burn, you can rest assured that that guidance will include litigation cost estimates.
As I said, I don't think they're gonna be highly material. You know, I would expect them to accrue sort of over the course of the process, so I don't think it's gonna be particularly chunky. There's work to do kind of throughout the 2+ years of the case.
Helpful. Thank you.
No problem. Thank you.
Our next question comes from Douglas Tsao with H.C. Wainwright. Your line is open.
Hi. Good morning. Thanks for taking the questions. Just, Matt, I'm just curious how broadly do you expect sort of this type of litigation to be potentially applied, meaning obviously it's very relevant for the mRNA vaccines, but you know, this is a broadly used technology. Do you think that we should expect to see you pursue litigation on other fronts as well?
Yeah. Thanks. Thanks, Doug, for listening, and thanks for the question. You know, I think the complaint we filed this morning pertains to specifically to Moderna's mRNA COVID vaccine, and that's really what we're talking about today. You know, I think beyond that, both the patents themselves as well as the nature of the arguments made in the complaint speak for themselves. I think we would seek to watch for other situations in which we could support and defend our intellectual property as well. Right now we're focused on the matter at hand.
Okay, great. Thank you.
Thanks, Doug.
Thank you. Our next question, David Risinger with SVB. Your line is open.
Thanks very much. Good morning, Matt. I have a couple questions on the ex-US patent situation. Obviously that could be a significant financial opportunity for the company as well. Could you go into some more detail than you provided on page 7 of the slide deck? I guess specifically, page 7 highlights that patents have issued in a number of countries and the EU patent, so that's a singular patent, was validated in certain major European countries. But you have many particle composition patents, so could you provide a little bit more clarity on those ex-US and what we might expect from, you know, a litigation standpoint ex-US? Then, if you could also comment on the 651 patent specifically and whether there is a similar patent that's been granted ex-US. Thank you.
Yeah. Thanks, David. Thanks for joining the call, and thank you for the good questions. Obviously, the ex-U.S. situation is important to us, and we're sort of considering that possibility as well. The complaint we filed this morning is just a U.S. complaint, and doesn't go beyond the U.S. You know, first, I'll just say even in this complaint, we're seeking the full extent of damages permitted by U.S. law, which includes damages for any infringing act that would be committed by Moderna in the U.S. That would cover any doses that Moderna made here in addition to doses that Moderna sold or offered for sale here, imported into the country or otherwise administered or used in the U.S. That's the first thing I'll say.
The second thing I'll say is, you sort of highlighted the comment on page 7, you know, we have an ex-U.S. patent portfolio that is broad. It overlaps in many ways with the U.S. patent portfolio, but not in every way with the U.S. patent portfolio. There are foreign analogs to a number of our particle composition patents. They don't cover exactly the same territory, but they're interesting and patents that we are obviously sort of thinking about. As far as the 651 patent specifically, I'll say that there is not a foreign analog to that patent specifically.
Thank you.
Thank you, David.
Thank you. I'm currently showing no other questions at this time. I'd like to turn the call back over to Matt Gline for closing remarks.
Great. Well, thank you again everyone for joining this morning. It's a technical subject, and so we want to make sure we give people a chance to ask questions as best we can answer them. We really appreciate your time and look forward to talking again soon in the near future. Have a great day.
This concludes today's conference call. Thank you for participating. You may now disconnect.