OABI - NASDAQ

Good afternoon, and welcome to OmniAb, Inc. Third Quarter 2024 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the call over to Kurt Gustafson, OmniAb, Inc. Chief Financial Officer. You may begin. Thank you.

Thank you, operator, and good afternoon to everyone. This is Kurt Gustafson, OmniAb's CFO. Thank you all for joining our third quarter 2024 financial results conference call. There are slides to accompany today's remarks and they are available in the Investors section of our website at www.omniab.com. Before we begin, I'd like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of federal securities laws. These forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from any anticipated results. These forward-looking statements are qualified by our cautionary statements contained in today's press release and our SEC filings. Importantly, this conference call contains time sensitive information that is accurate only as of the date of the live broadcast today, November 12, 2024. Except as required by law, OmniAb undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call. Joining me on the call today is Matt Foehr, OmniAb's President and CEO. And during today's call, Matt and I will provide highlights on the company's operations, partner and technology updates and our recent financial results. At the conclusion of the prepared remarks, we'll open the call to questions. And with that, let me turn the call over to Matt.

Thanks, Kurt. Good afternoon, everyone, and thanks for joining us today on our third quarter call. We've continued to deliver robust performance across our key metrics and are building momentum in the business. With strong execution and a leverageable business model, we're well situated to navigate a variety of industry cycles with a business that's now positioned for success. Our diversified base of partners and programs continues to grow and continued to grow during the third quarter despite a backdrop of a somewhat challenging macro environment presenting headwinds to some areas of the pharma discovery tools and technology space this year. As our partner's clinical stage programs advance, we're also gaining better insights into timing around key inflection points for preclinical and later-stage programs. These post-discovery programs represent just a subset of our growing portfolio and have over $550 million in potential milestones to OmniAb. We're committed to driving innovation to further differentiate our technologies and to bolster our pipeline and we're excited both about the potential opportunities ahead and our important place within the global pharmaceutical industry. I'll now quickly review some of our business metrics starting here on slide number 5. As shown here on the chart on the left-hand side, we ended Q3 with 86 active partners. We signed three new platform license agreements during the quarter that included new agreements with 92Bio, Memorial Sloan Kettering Cancer Center and Queen Mary University of London. Strong partnerships like these are fundamental to our success and we remain committed to expanding our partnership base, while helping partners realize their research and discovery goals. Also, I'll mention here that, we recently expanded our ion channel screening relationship with Syngenta, which began last year. And we also recently entered into a new license with Incyte Corporation. We're looking to finish the year strong in our business development and licensing efforts, and this year could potentially be our best year ever in that regard. Our growth in partner count reflects the industry's interest in our technology and our dedication to both innovation and collaboration. By fostering these relationships, we believe we're creating new opportunities for mutual success. And an added benefit is that our deep relationships with our partners help inform the intelligent expansion of our platform. Our partnerships provide a valuable vantage point on current industry trends and future opportunities and also keep OmniAb on the leading edge of in-demand technologies. The number of active programs underway by our partners remains robust and year-to-date new program additions have been strong. As shown here on slide number 6, as of September 30, active programs increased to 352 net of attrition. As you'll see on this slide, we're now providing more detail on our active programs. We're displaying both attrition and additions on the right side of the slide in the call-out bar graph shown here on the screen in the orange and the green bars. As of the end of the third quarter we had 12 terminations and 39 active program additions. We often say that terminations or attrition are a natural part of drug development. And as we've noted this year and as reported more broadly in the industry certain pharma companies continue to realign and reprioritize their therapeutic programs and pipelines. Having said that, our net growth in the number of active programs continues to validate our technology platform. We've generated growth net of attrition over multiple years now in a variety of macroeconomic and industry cycles, which I think demonstrates our ability to continuously evolve and enhance our technologies and expand our reach. As I mentioned on the previous slide, our deep relationships with our partners position us really well as we focus our innovation efforts. Now on Slide 7. As of September 30, our partners had 33 active clinical programs and approved products. During the quarter Genmab's GEN1057, an investigational proprietary bispecific antibody and Merck KGaA's M5542, which is a fusion protein both advanced into Phase I clinical trials. Genmab's GEN1053 came out of our clinical program count shown on this slide and shifted back to the preclinical stage. According to Genmab's public disclosures they are discontinuing a Phase 1/2 clinical trial in solid tumors for GEN1053, while preclinical activities in other indications remain active and ongoing. As of the end of Q3, three new OmniAb-derived programs have entered human clinical trials in 2024. Based on discussions with our partners we continue to expect that we'll see one to three additional entries into clinical development for novel OmniAb-derived antibodies by year end. Our post-discovery assets which include preclinical and later-stage programs have the potential to drive near-term and mid-term value generation. Now on slide number 8 you see the increased count in these assets. Over the past two years, we've maintained impressive growth with a 40% increase in the number of these programs reaching a total of 53 by the end of Q3. As I mentioned earlier, the programs depicted here have over $550 million in contracted potential milestones to OmniAb. The successful progression of our partners' programs showcase our collaborative efforts and our shared vision along with the value that our technologies can create. And here on slide number 9, I'll just briefly touch on some select partner updates. Immunovant has made significant progress on development of IMVT-1402. And late last week they announced IND clearance for rheumatoid arthritis where they stated that IMVT-1402 has a potential best-in-class profile for difficult-to-treat RA. They also announced that five INDs have been cleared by the FDA in a range of therapeutic applications and that they're on track to initiate potentially registrational trials of IMVT-1402 in four to five indications by the end of Q1 of next year. And they also reported positive results from the Phase 2a trial of Batoclimab in Graves' disease. In addition, they announced alignment with the FDA and IND clearance and an expectation to initiate a pivotal trial of IMVT-1402 in Graves' disease by the end of this year. Genmab highlighted both Acasunlimab and GEN-1057 on their earnings call last week as well. They described their priority in continuing to build a world-class differentiated pipeline and highlighted the Phase 3 study of Acasunlimab in second-line non-small cell lung cancer and that it is on track to start this year. They also highlighted the recently initiated Phase 1/2 trial of GEN-1057 in malignant solid tumors. At the ESMO conference, BioCity presented interim Phase 1 clinical trial results on the safety and efficacy of their first-in-class antibody drug conjugate BC-3195, which targets CDH3. They reported that 3195 demonstrated impressive antitumor activity in patients with advanced non-small cell lung cancer and that the drug is in concurrent dose optimization and dose expansion studies in China. And Teva recently disclosed Phase 1 data for TEV-53408, which is an anti-IL-15 discovered in our OmniRat technology. Teva indicated that 408 is showing a potential best-in-class profile, noting high affinity for IL-15 prolonged suppression of free IL-15 and a potential for low dosing frequency. It was well-tolerated in a first-in-human study and a proof-of-concept study in celiac disease is in progress. And last week, Teva also disclosed the initiation of a clinical study in vitiligo, which is an autoimmune disease with significant unmet medical need. And on my last slide here, slide number 10. I'd like to highlight a couple of upcoming scientific conferences by our team. We continue to increase the visibility of our differentiated technology platforms at relevant scientific conferences by showcasing innovations that we think create value for our partners. Next month we'll be at the Antibody Engineering and Therapeutics Conference town in San Diego where our team will present workflows for discovering developable binders with broad epitope coverage and affinities that serve as building blocks for multi-specifics, which is an area of significant and growing interest in the industry. In another presentation, we'll discuss the design and implementation of OmniHub, which is a new platform we're launching for bioinformatics tools that also enhances antibody discovery workflows by integrating machine learning and AI tools with our deep bioinformatics capabilities. When we kicked off the year, we mentioned that we'd be rolling out some partner experience enhancements and OmniHub is one example of this. And with that, let me now turn the call back to Kurt for a discussion of our third quarter financials. Kurt?

Thanks Matt. The income statement on slide 12 summarizes our financial performance in the third quarter of 2024. Total revenue for the quarter was $4.2 million and this compares with $5.5 million in the prior year quarter. The decrease was primarily due to lower milestone revenue and lower ion channel service revenue. We had previously guided that our revenue would be weighted towards the second half of the year. That guidance was based on statements and information from our partners and we still believe this to be true. However, it looks like most of those milestones will hit in the fourth quarter. Our R&D expense for the third quarter was $13.3 million compared to $13.9 million in the prior year quarter with the decrease primarily due to lower stock-based compensation expense. Our G&A expense was $7.1 million for the quarter compared to $8.5 million a year ago with the decrease primarily due to lower legal costs and lower stock-based compensation. Our operating expenses are in line with our expectation and we continue to anticipate total operating expenses in 2024 to be slightly less than total operating expenses in 2023. The net loss for the third quarter of 2024 was $16.4 million or $0.16 per share versus a net loss of $15.7 million or $0.16 per share in the prior year period. Turning to slide 13, you'll see our balance sheet as of September 30 2024. We ended the third quarter with $59.4 million in cash, which includes $8.5 million of capital raised through our at-the-market security offering. We raised an additional $2.9 million under the ATM program subsequent to the end of the quarter, which will be reflected in our fourth quarter financial statements. As the year progressed, we continue to observe pressure on the biopharmaceutical industry, which has led to restructurings and pipeline reprioritizations. This can drive additional volatility in our business. And given these dynamics, we believe it was prudent to add some cushion to our balance sheet through the issuance of stock of our ATM program. These new funds strengthen our cash position, enhance our financial and strategic flexibility and better prepare us for potential risks driven by macroeconomic and varying industry conditions and cycles. At this point, we believe the company is well capitalized and we enter 2025 in a better financial position. With regards to cash guidance, we expect to end 2024 with a cash balance in the range of $50 million to $60 million, which includes the proceeds from the recent ATM issuance. We anticipate that certain development milestones will be achieved in the fourth quarter. However, due to the payment terms of our agreements that typically range from 30 to 60 days, the actual cash collection for some of these milestones may not occur until the first quarter of next year, which is what drives the broad range. With regards to cash guidance for 2025, given the current expected progression of our existing partnered pipeline, we expect that cash used in 2025 will be lower than in 2024 excluding the recent ATM program proceeds. And with that, I'd like to open up the call for questions. Operator?

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. [Operator Instructions]. Your first question comes from Puneet Souda with Leerink Partners. Please go ahead.

Hi, everyone. You have Michael on for Puneet today. Congrats on the quarter. I was wondering just given the large step-up in the number of active programs this quarter, I was wondering if you could give some to how much is from maybe a macro recovery in the biopharma space versus something that you as a company are doing maybe gaining share or expanding in certain geographies?

Yeah. Michael, thanks for the question. This is Matt. Yeah. I'll just -- I'll call out one detail here that probably wasn't lost on you, but we've provided a little more detail on our active program count after kind of discussion with internal team and external stakeholders thought it would be useful. Traditionally, we've just reported numbers net of attrition, but now we're providing a little more detail on additions and attrition. And growth in program counts has been strong this year and it continues to be strong. I think it's a testament to the new technologies that we've launched. Our OmnidAb technology which is really the first and only transgenic chicken that produces single-domain antibodies, which is a novel class of antibodies found naturally in Camelids that is an area of growing interest in the industry for a variety of scientific reasons. we're getting a lot of interest in that. That's driving a lot of new starts. And then I'll say the validation of the platform is as well. We balance that with the backdrop of the industry, some of the things we mentioned in the intro around big pharma companies, realigning portfolios and pipelines and things like that. But program growth has been strong and continues to be strong.

Okay. Great. And then I had a quick question about the OmniHub. I was curious if that's another add-on as part of a standard license or if that's going to be an additional revenue stream software-wise?

Yeah, thanks. It's another tool that we use in collaborating with our partners, right? So we're going to do a full launch of that at the AATC conference in December down in San Diego. And it's really meant as a way to facilitate and streamline and accelerate discovery interactions with our partners. As we've expanded our platform, we have the benefit of a core technology of our transgenic animals that produce really strong antibody responses that creates opportunities for us to leverage machine learning and AI and big data analysis in ways that others frankly can't. And OmniHub is a way in which we can interact with our partners to kind of facilitate their efforts downstream. So it's part of our standard offering. We don't see it necessarily being a single business line item, but it's one of the ways that we continue to innovate and continue to remain on the cutting edge to meet our partners' needs not only now but in the future.

Great. Thank you very much.

Your next question comes from Matt Hewitt with Craig-Hallum. Please go ahead.

Hello, this is Tal [ph] on the call for Matt Hewitt. We've heard some rumblings that while biotech is up this year compared to last, the amount raised has declined from earlier in the year until last quarter. And as a result some companies are being a little more cautious with their investments. Are you hearing or seeing anything like that?

Yes. I think we sort of mentioned that some of these macro and industry forces that we're observing. I think it's – we're seeing the same things that you're talking about and seeing. And there certainly is pressure that's been created on the industry and that we talked a little bit about that has created some of the volatility in our business. And so we maybe have a little bit more cautious outlook, as we look ahead. All that being said, I think if you take a look at the key metrics that we have focused on in terms of signing up new deals, partners continuing to see the value of our technology and starting new programs, moving things, progressing through the clinic, we're seeing progress on all of our key metrics. So I don't discount the fact that there are some challenging industry things going on but our business continues to perform well. Matt anything to add on that?

Not really. I'd say the only thing I'd add is we talked about how some of the larger pharmas have gone through what they call "portfolio shaping initiatives, those kinds of things”. But that's balanced with – we have a lot of discussions with those in the industry. And one of the things we also hear is that at times that they are focusing their work, they also look to the best platforms and the most validated technologies to help them meet their discovery needs and that also can attract them to us. So yes, a lot going on in the industry but we feel good about our position.

Awesome. Thank you. And I do realize that it's early but how should we be thinking about the range of new clinical entries by your partners next year?

Yes. Thanks. Great question. As we look into next year and as we said, we expect one to three additional clinical entries before the end of this year, right? So just in the next six weeks or so based on our discussions with partners. And as you look at our post-discovery assets, right now we have 20 assets in preclinical. We have a pretty high bar for what we consider to be preclinical assets. So those programs are candidates to move into the clinic in 2025. I expect as we get into next year, we'll talk about that in more detail. What we often find is that the JPMorgan conference at the beginning of January is often a time when many of our partners start talking more publicly about new programs, about new trials, about new indications and their intentions for the year. And so that's often a good time around that time or post that time for us to start talking in a little more specifics about some of the programs and the count that we expect. But we feel good about the growth in the portfolio and the matriculation of the programs through the various phases.

Thank you for the color.

Next question comes from Stephen Willey with Stifel. Please go ahead.

Yes, good afternoon. Thanks for taking the question. So I guess you're talking about how growth in program counts remain strong. You mentioned that multispecifics are an area of considerable growth for the industry. Do you know what proportion of new program starts you're seeing that are multi-specific in nature? Do you have that level of insight? And then do you also have any insight into the types of targets that partners are pursuing via these new program starts? I guess I'm just wondering if you have the ability to assess kind of where each annual cohort of new program starts kind of falls on the risk spectrum?

Yes. Thanks, Steve. Great question. And the answer there is it's a range, right? But as our platform has become more widely used and more validated, the number of new modalities and approaches that partners are looking to employ downstream, leveraging our technology for discovering antibodies continues to grow. And if you look even at our visible clinical programs, a growing number of those are bispecifics, right? Multi-specifics are absolutely the next wave and we've seen an increase in multispecifics this year and interest there. And I think our OmniAb technology is also driving that as well. We're also seeing more diversification in therapy areas and areas of interest. OmniAb opens up a lot more possibilities in neuroscience, as well as in oncology where we already have a pretty broad presence. So, I'll just answer it generally and say it's absolutely increasing the interest in multispecifics. And we're pleased that partners come to us because they realize we've got technologies that are designed to meet the needs there. That's something we've been talking with them about for a long time. So they know that we're there and our technologies are designed to help meet that need.

Okay. That's helpful. And then, I think you may have given this information at some point last year, but do you have any update as to what the blended royalty rate of the post-discovery program portfolio looks like at this point? And then, is there anything that you can say about how the Immunovant 1402 asset I guess compares to that blended royalty rate? I know that that's an asset that is getting a lot of investor attention right now. Thanks.

Yes. Steve, I don't have an update for you on that blended royalty rate. We gave that number what back in September November or so of last year. But what I'll say is that rate that we provided was based on the number of active programs that we had at the time which was about 300. We obviously have grown the number of active programs, but it's kind of hard to move the needle on that number a whole lot. So, while I don't have an update to that number, I would imagine it's not that much different than the number that we provided back in November. In terms of Immunovant program, so just as a reminder, the way that that contract works is Henal was the original party that we had a contract with. So the way it works is Immunovant will pay Henal and we get a portion of whatever Henal gets. And so it's a little bit of a different structure than kind of a straight license for us. But in terms of the royalty rate, our standard sort of saying is that the royalty rate that we get is in the low to mid-single digits. And as it turns out, the percentage that we will be getting from Henal that they're getting from Immunovant is pretty consistent with that. So that's probably as far as I can go in terms of disclosure of that rate. But hopefully that's a little helpful anyway.

That’s helpful. Much appreciate it guys. Thank you.

Yes. Thanks, Steve.

Yes. Thanks, Steve.

Next question comes from Kripa Devarakonda with Truist Securities. Please go ahead.

Hi, this is Alex Xenakis on for Kripa. Question from us. We see some of your potential partners rethinking their portfolio perhaps driven by economic pressures. And are you seeing more or less partners electing to develop molecules in-house and advance to the IND stage? And maybe what are your thoughts on that? And is there any impact or can we see the seed of change that might affect your current business model going forward?

Yes. Thanks, Alex. I'll say a quick answer to your second question. No, we feel great about our business model, about the leverageability in our business and our ability to demonstrate that going forward and our place in the industry more generally. The partners come to us really for discovery technologies. We are not -- we don't intend to take programs into IND that sort of thing. They come to us to get access to our technologies that allow them to get access to broad repertoires of novel antibodies. And then to very quickly select winning antibodies that can then be taken forward. So I think we do have a unique vantage point on the industry just given that we have intimate relationships with our partners we understand the sorts of targets they're going after the ways in which they want to engage targets. And that informs how we kind of innovate around our early-stage discovery platform. So, yes, I don't see a change in our business model. We feel great about the work that we're doing and our position in the industry. And I think we have a business that's well positioned for a number of industry cycles. It's designed that way purposely. And I don't see us really strain from that.

Got it. Makes a lot of sense. Thanks for the color and congrats on the progress.

Thank you.

Thank you.

Your next question comes from Brendan Smith with TD Cowen. Please go ahead.

Hi. This is Jackie on for Brandon. Just to start off have you done any beta testing for the OmniHub offering prelaunch? And if so have you seen any feedback from your customers?

Yes. Look, Jackie, we obviously interact digitally with our partners all the time. So I guess, the short answer to that is, yes. And we -- as we've expanded our bioinformatics capabilities over the years, and then rolled out our OmniDeep platform over the last couple of years, which is a suite of in silico tools. This really became a real natural extension of the work that we're doing. So, short answer is yes, we interact with partners in this way digitally, and we'll be rolling out kind of the brand and more broadly at the ATC conference in December.

Awesome. That's great. And just to follow-up on that. Are you thinking of partnering with any cloud providers? Or are you going to kind of run things on-prem or on your own side of things?

Yes. At this point much more homegrown. Obviously, there's a lot of other IT infrastructure behind the scenes, but it's much more homegrown at this point.

Awesome. And then if I could just squeeze one more in. On the three new licenses, could you give us any color on the therapeutic interest or program size expected from these companies and then the mix regarding the platforms they're going to use?

Yes. So we announced three new deals in the quarter one with 92Bio, which is a company focused on best-in-class multi-specific antibodies, focused solely on cancer. And so they're going to be focused on cancer targets. And then the other two deals were with Memorial Sloan Kettering Cancer Center. Obviously, they have a really deep and long-standing dedication to cancer a lot of funding into translational research capabilities and a large innovation hub there. They're obviously primarily focused on novel cancer targets. And then the Queen Mary University of London, which, of course, is a top research institute in the U.K. They're really focused on cancer prevention as well as diagnostics and theranostics. And those are areas where some of our newer technologies really can be applied well. So across the board, there's a range of our technologies that these parties will be interested in much like many of our other partners. And so we're excited to add them on.

Great. Thank you so much. Appreciate it.

Thank you.

Your next question comes from Conor McNamara with RBC Capital Markets. Please go ahead.

Hi, great. Thanks for taking my question, guys. I got one for each of you. So Matt, just on a product development standpoint, what are you seeing on the development on single-domain antibodies? And what are you seeing on the adoption of OmniChicken with customers?

Yes. No. Thanks, Conor

There are no further questions. Please continue.

Great. Thanks. I'd like to thank everyone for joining today's call, and thanks for the questions. We look forward to keeping you updated on our progress, and just to updating you next quarter. Kurt and I will be at a couple of investor conferences, next week. Kurt will be in New York for the Stifel Healthcare Conference and I'll be in London, for the Jefferies Conference. And in the meantime, we appreciate your interest in OmniAb and thanks again for joining us today.