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Transcript
OP
Operator
Operator
Good morning, ladies and gentlemen, and thank you for standing by. Welcome to ImmunoPrecise Antibodies Fiscal Year 2022 Third Quarter Earnings Results and Business Highlights Call. Currently, all participants are in a listen-only mode. Following the presentation, we will answer pre-submitted questions. I would like to remind everyone that this conference call is being recorded today, March 16th at 10:30 AM Eastern Time. I’ll now turn the call over to John Mullaly. Mr. Mullaly, please go ahead.
JM
John Mullaly
Operator
Thank you and welcome. Dr. Jennifer Bath, President and Chief Executive Officer of ImmunoPrecise Antibodies; and Ms. Lisa Helbling, Chief Financial Officer will be the speakers on today’s call. A Q&A period answering pre-submitted questions will follow their summary of the quarter followed by closing remarks. Before Dr. Bath begins, I have been asked by ImmunoPrecise Antibodies to read the following Safe Harbor regarding forward-looking statements. I would like to remind everyone that ImmunoPrecise remarks today contain forward-looking statements about its current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements or other future events or developments. In preparing these forward-looking statements, several assumptions were made by ImmunoPrecise and there are risks that results may actually obtained by the company will differ materially from those statements. As a consequence, the company cannot guarantee that any forward-looking statements will materialize and you are cautioned not to place undue reliance on them. ImmunoPrecise refers to current and potential investors to the forward-looking statements and information section of its Management Discussion and Analysis issued today at www.sedar.com and on EDGAR at www.sec.gov. Forward-looking statements represent ImmunoPrecise's expectations as of March 16, 2022. Except as maybe required by securities laws, ImmunoPrecise does not undertake any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise. I would now like to turn the conference over to Dr. Bath.
JB
Jennifer Bath
Analyst
Thank you, John. Good morning and thank you for joining IPA’s investor call today. We have a lot to update you on from this reporting period across both the CRO business and also from Talem Therapeutics. We're pleased with the progress and the continued execution of IPA’s strategic operating plan. We've continued to fill key roles within the organization sales and marketing teams, helping to ramp growth and bring global awareness to our business. We remain confident in our ability to grow revenues through existing clients’, new business wins, tackle emerging sectors and our development of next generation services. Additionally, our Talem pipeline continues to gain merit and worth as several assets advance toward key value inflection points. Lastly, we are moving the development of our PolyTope TATX-03 forward on multiple fronts, both in-house and through external partnering, which we will discuss in some detail on this call. We'll start with a performance review of our CRO business. We're pleased to report that the company's project revenue is up 22.6% this quarter, as compared to the same period last year. As we actively and tactically grow our CRO business, we continue to see steady upward expansion in both the number and size of projects under contract. The increased growth is partially attributable to the growing addition or the ongoing addition and enhancement of what we call function first discovery options, capabilities that are catching the interest and attention of top pharma and biotech companies. IPA's function first platforms particularly with respect to its B Cell Select technology significantly elevate the value of each lead candidate sequence that is delivered. These functions focused workflows decrease timelines and cost by efficiently identifying clinically relevant candidates and eliminating time spent on functionally irrelevant antibodies. Thus 100 function first sequences from IPA are worth…
LH
Lisa Helbling
Analyst
Thank you, Jennifer, and good morning, everyone. I'm Lisa Helbling. IPA's, CFO, unless otherwise noted, all numbers are referred to in Canadian dollars. The company's total revenues of 4.8 million during the three months ended January 31, 2022, compared to 4.5 million in 2021, 300,000, or 6.6% increase. Most notably, the company's project revenue was 4.1 million, compared to 3.3 million the same period last year a 22.6% increase. As Jennifer mentioned, the growth is driven primarily by the company's B cell select platform, with expansion in both the number of projects and the size of projects under contract leading to revenue increases of 750,000 for the quarter. Total product sales during the three months ended January 31, 2022 totaled 466,000, a decrease of 724,000 or 60.9%, compared to the same period last year. The higher product sales during the three months ended January 31, 2021, related to the company's first sale of its internally generated therapeutic antibody asset. During the three months ended January 31, 2022, the company achieved growth of catalog product sales of 400,000. Catalog product sales include, for example, antibodies, enzymes, and proteins and as Jennifer mentioned, the increase in sales is attributed to the launch of our new website and addition of new distributors. The company's gross profit was 2.6 million, with a 54% gross profit margin compared to 3.6 million and a 79% gross profit in 2021. This quarter's gross profit margin of 54% is within our expectations. During the fiscal year ended January 31, 2021, the company sold that first internally developed therapeutic antibody, the cost had already been expensed as research in a prior year as required by IFRS. In addition, as previously reported, during the past two years, the company improved its Accounting and Financial Reporting System culminating in the full…
-M
A - John Mullaly
Analyst
Thank you, Lisa. Before Jennifer adds any closing remarks, I'd like to spend a little time asking some of the questions that we received from analysts and investors. The first question reads as follows. The State of the Union by President Biden disgusts cancer being the new direction of focus for his administration hasn't been a precise seen an increase in interest in the cancer antibodies recently. And has this caused any shift of interest from the companies for the PolyTope antibody?
JB
Jennifer Bath
Analyst
Great. Thank you, John. We really appreciated the question. I will just start, first, the majority of therapeutic programs contracted to IPA have actually always been in the area of oncology and immuno-oncology. And at the present day, that's definitely no exception. Most companies just to kind of give a lay of the land, either have a mandate to work on a specific disease or a cluster of diseases, and either way, a mandate that governs all of their programs. Some of them have flexible mandates that may at times add discovery programs for infectious diseases, for instance, such as COVID. Specifically, we have not seen any notable increases in request for oncology work in the past few weeks as compared to prior weeks or months. Although, I would anticipate that there would be a lag between the target collection and validation, and the time at which they would bring those programs forward to us. So in other words, we wouldn't necessarily see that trend, if it was impacted by the State of the Union. We anticipate that those that are already in oncology will stay there with their expertise. And those without such expertise will not likely switch gears. And the same likely goes with infectious diseases such as COVID. We also have not seen any negative impact on TATX-03 conversations since the State of the Union.
JM
John Mullaly
Operator
Thanks, Jennifer. I'll read the next question. Would ImmunoPrecise consider a monthly shareholder update letter, I find there are so many things going on, it would be helpful to hear on a more regular basis, the less discussed projects?
JB
Jennifer Bath
Analyst
So thank you, first of all for the suggestion. So we are interested in doing something very similar to this as well. So we have been, we currently are discussing several options, including monthly newsletters, monthly updates on the Talem website, recordings of some of our investor presentations, whether it's from investor conferences, or large group presentations, which are averaging right now about once a month as well, developing very IPA specific blog updates, or even combinations of these options. So we plan to implement a sustainable option along these lines in the next one to two months.
JM
John Mullaly
Operator
I will read the next question. Where's the company at on commercializing any of the Talem pipeline?
JB
Jennifer Bath
Analyst
So, our business development team and I'm going to give you a little background here on how these communications work first with our former partners. Our business development team is actively targeting potential partners for several of Talem's programs. So while we regularly attend to major partnering conferences in our industry, such as bio and JPMorgan, we also directly reach out to selected groups. This is a continuous process that's typically initiated during the development of a program prior to candidate selection. The process can take several months and includes confidential in-depth scientific discussions, prior to or in parallel with the business discussions. During those business relations, we're sometimes asked to generate specific supportive data to validate the fit of the candidates for a particular pharmaceutical company. As an example, we've just successfully completed additional experiments from our TATX-22 program to generate supporting data with for further discussions with a potential partner. While partnering our out licensing at each stage of the asset development is possible and is sometimes explored by the business development team. Moving the program forward to at least in vitro proof of concept adds value to the asset and facilitates both conversations. As stated previously, and even larger value add is typically had at the point of receiving in vivo functional data. And you've heard in our updates today, in vitro functional data oftentimes includes many different tests looking at various activities of antibodies, sometimes even numerous mechanisms of action, as well as the possibility of using certain antibodies in more than one therapeutic format. These many assays also guide us towards the best route for IP protection and enable the possibility of multiple out license things per asset, or additional value for the purchase of an asset that we've been able to demonstrate possesses more than one potential commercial use. Given the amount of know-how and energy that goes into each asset and the value gained by seeing it through to its final characterization, we believe that in the long run, maximizing the value of each asset, as opposed to making a faster sell is definitely in the best interest of the company and its shareholders. We will continue to keep you updated on the progress of those discussions and relationships with those pharma partners.
JM
John Mullaly
Operator
Thanks, Jennifer. Next question. Does PolyTope have a partner, will the company still proceed to clinical trials without a partner?
JB
Jennifer Bath
Analyst
Okay. So as mentioned earlier, IPA is partnered with Elektrofi and that partnership, as discussed is currently being supported by the DoD funding through IND enabling studies. With good IND study outcomes, it is possible that the DoD would extend that funding to cover IPA's clinical trials, as well as additional clinical manufacturing. However, if required, yes, IPA has budgeted for and has prepared a clinical study design for Phases 1 and 2a for TATX-03.
JM
John Mullaly
Operator
Great. Next question. Recent slide decks are not showing Pierre Fabre partnership pipeline, nine targets, start being allocated to this opportunity?
JB
Jennifer Bath
Analyst
So the partnership Pierre Fabre, as many of you know, it's a co-development of up to nine targets selected by Pierre Fabre over a three-year period. At this point, the Joint Research Committee has met and work has started but we did not receive permission of Pierre Fabre to share any specific status updates on their programs.
JM
John Mullaly
Operator
Next question. From Dr. Bath’s point of view, has the company missed the COVID window of opportunity?
JB
Jennifer Bath
Analyst
Right, so great question and a question we've heard a couple times over this quarter. So first of all, from the start of our efforts to develop an antibody-based solution for SARS-CoV-2 and for future variants, we were aware that such a product would require this level of scientific rigor and extensive characterization. Thereby, accepting that other products would enter the clinic quicker. So I do want to discuss this aspect first before addressing a little bit more about that market. So in most of the immunotherapies, which are not the same as active vaccines with which we’re vaccinated and boosted for almost one and a half years now. They've been introduced relatively recently. Notably, the application of the first two of the five immunotherapies, which are authorized for emergency use in the U.S. are now restricted, and they've lost their efficacy against the Omicron variant. Another remarkable note here is that only one of the EUA antibody treatments is actually allowed for pre-exposure prophylactic use, and even then only after the FDA recommended to double the dose due to the lack of or the reduced efficacy in treating Omicron. In contrast, IPA, although later than these five also deliberately targeted this market segment of prophylaxis, as this market includes a large group of immune impaired persons on which we elaborated earlier. Our product was developed with a focus on the enduring efficacy and is to our knowledge, the only first-generation antibody-based product that has not been escaped by any of the current virus variants. Thus, we believe the investment and thorough R&D and validation of TATX-03 will ultimately pay off. While the lower very variants of Omicron led people to believe that SARS-CoV-2 hospitalization rates caused by emerging Omicron sub-variants -- while the lower virulence of Omicron led people to believe that SARS-CoV-2 will just be a mild flu, current increases in infection and also hospitalization rates caused by emerging Omicron sub-variants are telling us differently, not to mention that the number of COVID-19 related deaths are significant. And this number did not return to baseline after infection levels peaked. The so-called “baseline level” of COVID-related mortalities is in fact increasing. So going back to this question, no, we absolutely don't believe that we've missed the COVID window of opportunity. We believe that our product within sustainability is actually sliding into a place where in a time -- where there's an urgent need for an effective therapy that can work both prophylactically and also in the treatment of COVID-19.
JM
John Mullaly
Operator
Thank you, Jennifer. I'll read the next question. You now have a number of assets ready for partnering? What is the most likely use of any proceeds in case of a deal? PolyTope trials, acquisition of research share buybacks or general corporate ifs?
JB
Jennifer Bath
Analyst
So great question and definitely obviously someone who's paying really close attention to everything that we say. So the short answer is really all of the above are possible. So we're continuing to move TATX-03 forward as mentioned. Now with the potential backing of DoD, so whether or not funding from any source out licensing deal would be required to support that is unsure at this time, but that would be one possibility if required. As stated previously, we do continuously monitor potential acquisitions, especially those companies with disruptive technologies, and those that are value add to our existing services. We have also reviewed a normal course issuer bid. However, since the time that the share price has dropped considerably, the company has been in a blackout which is making that often unfeasible. So should the share price remain lower for a longer period of time extending into a non-blackout period and should other specific parameters also be aligned, we would reconsider this absolutely. Moreover, we have been ramping our next generation sequencing platform for our clients and also for ourselves. As the company is building a strong foothold in the synthetic biology, space, NGS and omics are at the foundation of in silico development and discovery. IPA will also be articulating his broader strategy in that respect shortly. Lastly, we're still actively working toward enhanced levels of manufacturing quality, so this may be another area of viable and strategic investment for the company.
JM
John Mullaly
Operator
Thank you, Jennifer, for addressing those questions. 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 us on to Jennifer's closing remarks with some insight into this current fiscal year strategic planning, Jennifer?
JB
Jennifer Bath
Analyst
Great. Thank you, John. So to wrap up this conference call, we want to thank, of course IPA’s employees, clients, partners, and our shareholders for being a part of this exciting journey of accelerated transformative antibody discovery and innovation with us. We're proud to say that we are driving the development of Talem’s PolyTope TATX-03 our lead pipeline asset forward on multiple fronts both in-house and through external partnering as noted during the call today, and in recent electrified press releases. Internally we believe that our PolyTope TATX-03 program is progressing well. And we've taken a conservative development approach after prudently serving the shifting regulatory landscape around the development of COVID vaccines and therapies and avoided the pitfalls all to which some development programs have to come to. With this in mind, we expect IND submission to the FDA for TATX-03 to be somewhere in the timeframe of Q2 or Q3 on the 2022 calendar year, and we will post again those relevant timelines and updates shared with you today on the Talem Therapeutics website. Our CRO project revenue business continues to grow as evidenced by the reported 22.6% top-line growth. Moving forward, we will continue to actively and tactically grow our CRO business as we continue to see steady upward expansion in both the number and size of projects under contract. We're also expanding partnerships in this arena as evidenced by the announcement of our joint project with Pierre Farber, the second largest private French pharmaceutical group, which is expected to be the first partner program of many multiple target multiple year collaborations. Additionally, we've implemented the right leadership and infrastructure and expanding our marketing and sales programs to expand the reach and awareness of our capabilities. Lastly, I do want to emphasize that as a management team, it's…
OP
Operator
Operator
This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.