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Q1 2023 Earnings Call· Wed, Sep 14, 2022

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Transcript

Operator

Operator

Good morning, and thank you for standing by. Welcome to ImmunoPrecise Antibodies First Quarter Fiscal 2022 Earnings Conference Call. Also on the call with us today are Jennifer Bath, Chief Executive Officer; Brad McConn, Chief Financial Officer; Ilse Roodink, Chief Scientific Officer; and Barry Duplantis, Vice President of Client Relations Before we get started, remember, some statements we make today, may be considered forward-looking statements for the purpose of applicable United States and Canadian securities laws. IPA cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated in the forward-looking statements. Additional information about these risks and uncertainties is included in our SEC filings. IPA undertakes no obligation to update these forward-looking statements, except as required by law. On today's conference call, non-GAAP financial measures may be used to help investors understand IPA's business performance. We refer current and potential investors to our forward-looking information section of its management discussion and analysis issued today at www.sedar.com, and on EDGAR at www.SEC.gov. Following our prepared remarks, we’ll answer analysts and investors’ submitted questions. So, with that, I'll now turn the call over to Dr. Bath.

Jennifer Bath

Management

Great. Thank you, Julianne. Good morning, everyone, and thank you for joining us today. We are pleased to offer Q1 updates on the heels of our year-end results, and as we enter this fiscal year with aggressive strategic aim, many of which we'll share with you today. We remain highly confident in our ability to grow revenues through new and existing clients, novel high revenue value - high-value revenue streams, and importantly, the commercialization of disruptive AI-driven in silico technologies, offered through our newest subsidiary, BioStrand. Additionally, four of our potential best-in-class and first-in-class therapies from our internal pipeline, are now positioned for active licensing, with the aim of commercialization this fiscal year. Lastly, we simultaneously prepare the regulatory submission of IPA’s four anti-SARS-CoV-2 antibody therapeutics, which have sailed through preclinical IND-enabling studies, and remain the only first-generation therapy to retain efficacy against all tested variants of concerns, including the most recently screened BA.2.75, with more details on that program to come on this call from Dr. Roodink. IPA employees and their directors are particularly excited about the opportunities emerging from our most recent acquisition, BioStrand. It's been exactly five months today since the closing of this transaction, and both teams have been working tirelessly at delineating what the initial outcomes of these two companies coming together could be. If what has come to fruition up to this point is indicative of the future, IPA is about to engage in a disruptive and game-changing path forward. BioStrand proposes a truly transversal and universal solution based on technologies that apply to every studied species, any sequencing format for data generation, and any application domain. As many of you know, many years ago, BioStrand made a pivotal discovery by identifying underlying universal fingerprints at the core of the biosphere’s amino acid and…

Barry Duplantis

Management

Thank you, Jennifer. We will now start with the performance review of our CRO business. When comparing this quarter to the same period last year, the company's project revenue has been quite consistent. However, we have noted several highlights that indicate growth as we look to the future. Firstly, discovery-based sales orders, which are signed commitments of future work, are up at our Canadian site by 67.5% and 18% globally. While this is a very promising metric, we do like to remind those listening that based on program timelines, IPA will be recognizing this revenue over a period of zero to 10 months. Secondly, the number of multi-phase discovery project starts, including our B cell Select phase display and hybrid DOMA platforms, are up 125% at our Canadian site, and 100% globally. The primary driver for both sales orders and project starts can be attributed to an increased demand for IPA's rabbit B cell platform. IPA began a sales and marketing push in the beginning of Q4 last year, targeting the therapeutic companion market. Therapeutic companion antibodies are critical and necessary reagents required to bring a therapeutic drug to market. The combination of IPA's function-first B cell Select workflow, and the untapped potential of the rabbits’ immune system, produces highly selective, high-affinity antibodies that provide our clients with a best-in-class solution to complete a critical piece of the therapeutic equation. Thirdly, IPA has just completed the onboarding of another major pharmaceutical company, meaning that IPA now has had a contract service-based relationship with 80% of the globe's top 20 pharmaceutical companies. Finally, IPA has begun to see an increase impact from hedge fund-backed virtual biotherapeutic companies that lack or are very limited in wet lab facilities and capabilities, and are often headed by researchers that have had previous experience with IPA's team and services while serving in past position at other IPA client companies. An example of this impact is represented by the fact that in this past quarter, two of IPA's top five revenue-generating clients operate with less than 10 employees. This contrasts with zero of our top five clients from Q1 a year ago. While IPA is always developing and expanding relationships with major pharmaceutical companies, we expect to see and will actively pursue an increase in partnerships with small, fully virtual companies. These companies can be more agile. They have substantially lower operating costs, often have significant budgets, and seek to leverage the expertise and platforms of CROs to succeed and meet their objectives within the constraints of the current global financial environment. With that final update, I'm going to turn things over to Ilse.

Ilse Roodink

Management

Thank you, Barry. We are excited to turn our attention to Talem Therapeutics, where we will be discussing our recent scientific developments and current outsizing efforts with regard to five key Talem assets, our PolyTope program, also known as TATX-03, TrkB or TATX-112, TATX-24, our companion arm for bi or multi-specifics and TATX114. For PolyTope, TATX-03, it is our Talem’s first generation for antibody combination therapy against -SARS-CoV-2. Unlike commercially available therapies, PolyTope remains effective against every variant and sub-variant of concern. This confirmed efficacy most recently includes the currently circulated BA.2.75 variant, which was shown to be neutralized by PolyTope using in vitro pseudo virus screenings. Because of PolyTope's performance in the neutralization assays and in vivo - and in vitro preclinical safety and quality assessments, Talem has received strongly positive regulatory feedback from the EMA, and is now finalizing clinical trial agreements and pushing hard to move PolyTope into the clinic. The following slide summarizes our path towards this milestone. Unfortunately, the clinical material manufacturing facility recently faced a COVID-associated lockdown, extending the completion of the manufacturing documentation for a clinical trial application by an estimated two months. Based on this revised timeline, submission of the clinical trial application to the regulatory authority is scheduled for Q4 of this year, with the first in-human trial expected to start early calendar year 2023. In addition, as previously announced, we are collaborating with Elektrofi to create subcutaneous version of our TATX-03 antibody combination therapy. We screened several formulations to identify compositions that reach a concentration approximately four to 10 times higher than standard antibody formulations, to facilitate subcutaneous administration of our PolyTope product. The prioritized formulation will be used for evaluation in IND-enabling studies. On the business front, Talem has engaged and issued a contract with a well-respected key opinion…

Jennifer Bath

Management

Thank you, Ilse. Starting with the Netherlands, our team in Utrecht is preparing for their move to the recently completed accelerator building. The laboratory and IT infrastructure are ready, and the new equipment is being received and installed to support the planned increase in capacity for automated, high throughput, small- and large-scale recombinant protein production. The team is currently planning and scheduling test runs leading up to the official moving date of mid-October. As previously announced, staff in Oss are also preparing a move to a new facility, which is currently under construction. We're fine-tuning the fit out to make sure it is in line with our expected growth and intended extension of services. Also, as recently announced, the expansion of our in-house vivarium located in Victoria, British Columbia, was completed during this first quarter, and the facility is now fully in use, with a new procedure room and higher animal capacity to support the growing demand for IT’s antibody discovery program. The team now continues its planning for the addition of new in vivo services, beginning with the PK and maximum tolerability dose preclinical studies, which are only now possible with these facility enhancements. With this, I would like to turn the call over to Brad to discuss the quarter's financial results in more detail.

Brad McConn

Operator

Thank you, Jennifer, and good morning, everyone. I'll provide an overview of our financial results for the first quarter, before touching on our financial position as of the end of the period. As a reminder, all numbers I reference are in Canadian dollars, unless otherwise noted. IPA recorded total revenue of $4.7 million during the first quarter, a 2.2% increase from $4.6 million during the first quarter of fiscal 2022. On a local level, we recorded revenue growth at all three operating sites year-over-year, with our strongest growth arising from our manufacturing sites in Utrecht. One item I do want to highlight, we generate approximately two thirds of our revenue at our sites in the Netherlands, which has caused our revenue on a consolidated basis to be negatively impacted by the weakening of the Euro, as results are translated into Canadian dollars. The negative impact of revenue during the first quarter was approximately $300,000, as compared to the first quarter of fiscal 2022. Gross profit for the quarter totaled $2.5 million, a decrease of 1.1% compared to the same period last year. Gross profit margin of 53% is likewise a slight decrease from 55% in fiscal 2022. The increased cost of sales is primarily attributable to higher cost for lab supplies, and a project mix during the quarter requiring more work to be outsourced to third party contractors Operating expenses during the first quarter totaled $12.6 million, an increase of $6.6 million compared to the same period in fiscal 2022. Research and development expense was the primary driver of the rise in cost, and totaled $5.8 million during the quarter. IPA continues to strategically invest in the PolyTope antibody combination therapy, and incurred $5.2 million in costs during the quarter for GMP manufacturing of the therapy in quantities sufficient for…

Q - Operator

Analyst

Thanks, Brad. Before Jennifer adds any closing remarks, I would like to read some of the questions we received from analysts and investors. The first two questions are from Bob Wasserman from the The Benchmark Company. The BioStrand Group recently was awarded a grant in Belgium for HYFT-based methodology. Can you explain what the grant covers and why this technology is important? And it appears that Ms. Bath’s line has disconnected. We're just in the process of reconnecting her. Please stand by. And Jennifer, you are reconnected. Would you like me to repeat the question for you?

Jennifer Bath

Management

Sure. Hello. Yes. I was dropped from the line, so I'm - yes. If you're at questions, go. Shoot away.

Operator

Operator

Certainly. Our first two questions are from Bob Wasserman from the Benchmark Company. And the first question states, the BioStrand Group recently was awarded a grant in Belgium for the HYFT-based methodology. Can you explain what the grant covers and why this technology is important?

Jennifer Bath

Management

Yes. Sure. Thank you, Bob, for your question. So, that is correct. BioStrand recently received a €460,000 grant from VLAIO, as referenced by Brad. And this is from the Flanders Innovation & Entrepreneurship, which is a research fund of the Flemish regional government in Belgium. So, this grant is actually related to a number of the things that we shared about BioStrand's updates earlier today about the structural HYFTs, and the indexing of those structural HYFTs to enable us to search with structure and ultimately function on our software. So, the grant basically builds on BioStrand's technology, which connects sequence information and structural information. So, I've mentioned previously, in biology, the structure tends to be more conserved than a sequence is, and it's very difficult typically to filter out sequences that have similar structures, but have low sequence similarity. So, as the structure is actually very closely related to the function or to the activity of a molecule, you can imagine that detecting structure similarities accurately within big data context, is very relevant and momentous task in drug with discovery. A key advantage and uniqueness of the BioStrand’s blended approach is the detection of protein sequences with similar structures, and of course then functions, but without high sequence similarities. So, in other words, on most platforms, those would never be identified. A primary application for this approach is advanced structural search capabilities and structural predictions, with a particular focus, at first on antibodies, as well as G protein-coupled receptors, better known as GPCRs. This will be extended to cover protein-protein interaction predictions at a later stage. We will be able to expand our services portfolio with HYFTs-based structural and functional modeling functionalities. By linking HYFTs with the 3D structure and function of proteins and expanding our platform capabilities for AI discovery, we support an even wider array of applications, including assay development, biomarker discovery, and computer-aided drug design.

Operator

Operator

Thank you. Our second question from Bob Wasserman is, will IPA be presenting or exhibiting at any of the upcoming fall industry conferences, such as Boston Bio Week? If so, what will be the focus?

Jennifer Bath

Management

Yep. So, we're actually really excited about this fall, because we have all these exciting case studies and new AI-driven capabilities to share. So, IPA, and also Talem, have very busy schedules, and are presenting and/or exhibiting at almost every one of these conferences. More specifically, through November, the IPA sales team is planning to attend five conferences where we anticipate our focus, not only to be our advanced wet capabilities, wet lab capabilities, of course, but a major emphasis on the new opportunities through BioStrand, as we seek to present confirmatory studies demonstrating unprecedented in silico capabilities and offerings. We will be offering access to these technologies through alternative revenue formats that combine fee-for-service with downstream revenue tails. Thus far, as indicated previously, the couple of early adopters that we have proposed advanced technology access to under these revenue formats, have been agreeable and enthusiastic. Of these conferences, for the CRO Group, three are in the US, and two are in Western Europe. As mentioned, our Talem team is also intending to attend and present and/or exhibit at seven different conferences through November as well. They will be dividing their efforts between partnering meetings with in-licensing decision-makers, as well as presenting on IPA's capabilities as a leverage for Talem collaboration, with a core focus also on our in silico capabilities through the use of recently-developed case studies. The Talem focus conferences are fairly even split between North America and Europe, and also include some specialty conferences such as the AACR or American Association for Cancer Research, a special conference on tumor immunology and immunotherapy.

Operator

Operator

These next two questions are from Sepehr from Manochehry Eight Capital. Are there any - sorry, are there additional end markets that you need to be close to? Have there been opportunities, customers you've had to turn down in the past?

Jennifer Bath

Management

So, the answers would be yes and yes. And I'll start by saying, the first end market that comes to mind, and I'll share, has been one that we have had to turn clients down on because we simply don't offer those capabilities. So, the primary end market we believe we should be closer to is that of clinical manufacturing, which is obviously closer to a clinical trial and the actual patient. After the discovery and development of a client's protein or antibody of interest at IPA, we often develop tailored manufacturing SOPs, and can conduct research-grade manufacturing, with customizable quality control for each product. However, when the client program requires a GLP product, for instance like an IND submission data, or GMP-validated product for clinical trials or for commercialization, the client needs to move to a GMP-validated third party CDML. On occasion, IPA can currently recommend the third party, or even tech-transfer the protocols for optimized expressions. However, with an extremely high client retention rate of around 95%, IPA is acutely aware of the fact that it is beneficial for both the client and IPA to complete the final workflow under one roof, and with the consistency of materials, reagents, equipment, and staff from research grade, all the way through clinical manufacturing. IPA is currently exploring options in this market. And last quarter, we were awarded a grant in the Netherlands to support a significant portion of a GMP buildout. We're currently investigating additional opportunities for funding of a potential GMP facility in the Netherlands to leverage this initial funding.

Operator

Operator

Our second question from Sepehr is, can you detail the capacity expansion plans at your facilities and the anticipated impact on financial performance?

Brad McConn

Operator

Sure. I'll take that one. So, in the near term, as Jennifer highlighted, our site in Utrecht will be completing the move to their new facility in mid-October, which will provide approximately double the lab space compared to their current location. This will help alleviate the capacity constraints that we currently have at our Utrecht site. And while there will be a little bit of a ramp-up period, we expect to see increased production begin to reflect in our financial performance beginning in Q4 of this fiscal year. We've also announced plans for our off-location to move to a new facility in the second half of calendar year 2023, in this case increasing lab capacity by approximately 30%. And as Jennifer just detailed in the previous question, additionally, in the Netherlands, we continue to explore the buildout of a GMP facility near our Oss campus.

Operator

Operator

Next, we have a few investor questions. What are the key areas of antibody research that you are able to conduct with your current capabilities at BioStrand?

Ilse Roodink

Management

All right. thanks. Julianne. So, there are several areas of antibody research already applied with our LENSai software. As outlined in the slide, that should be before you hear in blue, including analyses in the areas of target selection and validation, HYFTs discovery, lead generation, and antibody developability. So, these are offerings or things that we're using internally to continue to develop case studies and to enhance internal research, but also offerings that are available to our clients and partners as well.

Operator

Operator

And our next question is, IPA had a very big loss this quarter and is down $19 million Canadian in cash. Does IPA have enough cash to see PolyTope through phase one?

Brad McConn

Operator

Sure. I can touch on that one as well. While our spend was up this quarter, primarily due to the clinical manufacturing we previously mentioned, this was an anticipated cost. We actually came in slightly below our forecasted spend for Q1. We do feel that we have sufficient cash to see the PolyTope through Phase 1 and Phase 2a, as originally planned. As we previously stated, we've had several partners express interest in seeing the initial safety profile in human Phase 1, and we built in additional cost and time parameters to enable a smooth and relatively quick transition to any potential sponsors.

Operator

Operator

We thank you for submitting your thoughtful and concise questions today. We hope that they were answered either in our script, in the Q&A, or in the MDA. I will move on - move us on to closing remarks with some insight into this current fiscal year strategic planning.

Jennifer Bath

Management

Great. Thank you, Julianne. So, to wrap up the conference call, we'd like to thank, first of all, IPA's employees, directors, clients, partners, and of course, our shareholders, for being a part of this exciting journey of acceleration and transformation with us. We believe that some of our more recent advancements have the potential to disrupt multiple industries going forward, including market sectors such as precision medicine, therapeutic antibody generation, vaccine discovery, and development antibody humanization, and the transgenic animal industry, and lastly, the market of biosimilars. Alone, the global monoclonal antibody market is expected to surpass approximately $524 billion U/s by 2030, registering a growth at a CAGR of 12.8% from 2022 to 2030. Our aim is clearly to capture a meaningful market share by offering unparalleled technologies in a truly end-to-end fashion, on an accelerated timeline, enhancing our already clinically-validated wet lab capabilities, with state-of-the-art in silico technologies. The surging prevalence of cancer and other chronic diseases is boosting the demand for biologics, and it's expected to foster the growth of the global monoclonal antibody market for the foreseeable future. Pharmaceutical company investments in genomics are rising, coupled with the emergence of technologically-advanced genomic platforms, such as multi-species next-generation sequencing, which is expected to significantly boost the antibody market in the upcoming years. Also, according to precedence research, monoclonal antibodies are widely accepted biologics that are expected to provide lucrative growth opportunities to the market players in the foreseeable future, driven in part by rising awareness regarding the benefits and effectiveness of monoclonal antibodies. Major specific areas of increasing investment by biopharmaceutical companies are in the areas of human monoclonal antibody research, multi-omic analysis, and research on the molecular basis of disease and growing next-generation applications of antibodies. We also note the projection of significant growth rates for humanized antibodies, more effective anti-cancer antibodies with higher safety profiles and lower off-target effects, alongside a rising awareness regarding the monoclonal antibodies and their effectiveness in the treatment of cancer. We are pleased to have shared our streamlined focus on a few specific assets in Talem that have been deemed ready for out-licensing, and look forward to the active process of partnering for them this fall. We share your enthusiasm as we currently sponsor the world’s only still efficacious first-generation anti-COVID antibody as it nears the clinic. As stated previously, we’ve avoided the pitfalls which some development programs have succumbed to. Regulatory submission is rapidly approaching, with drug product delivery to clinics expected in the end of October. With that said, we hope to see you all on the next call, and thank you for joining us today.

Operator

Operator

This concludes today’s conference call. Thank you for your participation. You may now disconnect.