Time has come. We will now begin the FY 2022 financial results briefing of the Sosei Group. Thank you very much for taking time out of your busy schedule to join us today. My name is Nomura, CFO, and I will be the moderator for this session. We have around 20 participants and around 150 online watching this earnings call. Thank you very much for your attendance. Today, we have Chris Cargill, CEO, and Matt Barnes, President of Heptares and Head of U.K. R&D. We will start. I will first explain the FY 2022 financial results, followed by Chris, CEO, on our business strategy and progress, and Matt Barnes, President and Head of R&D, on the progress of R&D. Finally, Chris Cargill will again explain our goals and growth strategy for the future. Please turn to page five of the presentation.
Page five shows the financial highlights for FY 2022. Revenue for FY 2022 totaled JPY 15.5 billion, down from JPY 17.7 billion in FY 2021, mainly due to an upfront fee of $100 million for the licensing of the muscarinic agonist series to Neurocrine in FY 2021. Operating profit was JPY 3.4 billion, a slight decrease from JPY 3.7 billion in FY 2021 due to lower sales and increased investment in R&D. Net profit for FY 2022 was JPY 380 million, also a decrease, mainly due to the impairment loss of MiNA, in which we have a certain stake. Cash and cash equivalents increased by JPY 6.5 billion from JPY 60.1 billion in FY 2021 to JPY 66.6 billion, sufficient for continued strategic investments.
I will elaborate on this on the next page. Moving on to slide six. The upper left graph shows revenue by segment, and the lower left graph shows operating profit and core operating profit, respectively, with comments corresponding to each graph on the right. If you look at the green box for FY 2022, the top graph shows revenue by segment, which consisted of JPY 4.6 billion in upfront fee income from new contracts, JPY 7.3 billion in milestone payments, and JPY 3.5 billion in royalties, other FTEs, et cetera. Regarding upfront fee income in gray, we received a large upfront fee from Neurocrine in FY 2021, as I mentioned earlier, so FY 2022 was smaller than that. We did receive JPY 4.6 billion in upfront payments from two new drug discovery partnership with AbbVie and Eli Lilly.
These are both very exciting new alliances with multiple targets, which will be explained later. Regarding milestone income in light blue, we recorded JPY 7.3 billion, a significant increase over last year, thanks to significant progress, including $30 million for the start of phase II trials for an M4 agonist licensed out to Neurocrine and $10 million for the start of phase II trials for GLP-1 agonist being developed by Pfizer. Milestone revenues depend on the progress of the pipeline, so as with the upfront fee, there will naturally be fluctuations from year to year. However, given that the number of partners is expanding and development products with existing partners are generally progressing well, we expect milestone income to be more stable than before in the medium to long term.
Royalties and others in dark blue were generally unchanged at JPY 3.5 billion, although they were affected by foreign exchange rates and other factors. Regarding the operating profit and core operating profit on the bottom half. Operating profit for FY 2022 slightly decreased from FY 2021 to JPY 3.4 billion. In addition to the decrease in revenue, which I explained earlier, the increase in costs, mainly due to the enhanced investment in R&D, had a negative effect in FY 2022. The impairment loss of JPY 3 billion on M1 agonist in FY 2021 was a factor pushing down operating profit.
Core operating profit basically follows the same trend. The difference between FY 2021 and FY 2022 is larger than that of the operating profit because FY 2021 core operating profit does not include the impact of the impairment loss on M1 agonist. On slide seven, let me touch a little more on R&D investment and SG&A expenses. The graph on the left shows R&D expenses at the top and SG&A at the bottom, with actual results and the forecast for FY 2023. While we basically aim to balance our income and expenditures, we are expanding our R&D investment, in particular, in preparation for significant future growth.
Mainly, as written on the right side, we are strengthening our platform and translational research functions and are steering our strategy to increase the value of licensing agreement by conducting clinical trials up to phase I-B, II-A in-house. In particular, as will be explained later, we plan to move at least two development products into clinical trials in FY 2023, and we expect R&D expenses to range from JPY 8 billion-JPY 10 billion. In contrast, G&A expenses will not change that much compared to FY 2022, although we will continue to strengthen our R&D support system and corporate governance. These are the highlights of our business performance. Chris will now update you on our business strategy and business progress. Chris, the floor is yours.
Thank you, Nomura-san, good afternoon, everyone. We are very pleased with our financial management and performance, with another fiscal year profit achieved. Please turn to slide nine. It's wonderful to be back in Tokyo again and to see everyone face to face. My name is Chris Cargill, CEO of Sosei Group. I'll now discuss the vision for Sosei Group, and that vision is that we invest in world-leading science to deliver life-changing medicines. Over the years, we have acquired and invested in technologies and capabilities to enable world-leading GPCR-focused drug discovery. As a result, we now have over 40 programs in various stages of discovery and early development. Looking ahead, as a Japanese company, we have an obligation to make a difference to the lives of patients living with unmet need, especially in Japan.
Therefore, over the medium term, you will see us take steps to develop medicines in Japan for Japanese patients. Longer term, we want to establish a Japan pharma business unit that can deliver the best innovations from our pipeline, as well as in-licensed innovations from international pharma partners. Please turn to slide 10. We have a clear strategy to drive our business forward, and there are four pillars of strategic focus. one, we will continue to invest in our world-leading GPCR drug discovery and SBDD platform capabilities. We will execute new and progress existing major cash flow-generating partnerships with global pharma partners. three, we will continuously transform our in-house R&D capabilities and operations. four, we will commence steps to develop products for Japanese patients and to build a Japan pharma business unit. Please turn to slide 11.
The first pillar of our strategy involves extending and enhancing our world-leading GPCR drug discovery platform advantage. GPCRs are one of the most important drug target classes, with almost 30% of all marketed medicines targeting GPCR-associated pathways. Despite historic success in drugging GPCRs, there remain hundreds of undrugged GPCR targets with broad therapeutic potential. GPCRs remain as important as ever. Advances in technology have brought renewed excitement to this target class, with the pharma trade press heralding the second golden age of GPCR drug discovery is now here. In the past 18 months, there's been a lot of supportive activity. We've seen new private biotechs emerge with hundreds of millions of dollars of venture funding. We've seen AbbVie recently acquire a GPCR-focused biotech for over $200 million. Just last week, we saw a new GPCR-focused biotech publicly IPO on the Nasdaq.
All of this activity bodes very well for us. As importantly, we have proprietary technology, a platform with over 170 scientists, and over 15 years of know-how. We will continue to invest in our world-leading GPCR drug discovery and SBDD platform capabilities to exploit this second golden age of GPCR drug discovery. Please turn to slide 12. The second pillar of our strategy involves major milestone and cash flow-generating partnerships, ensuring that we continue to execute new collaborations and progress existing programs with global pharma partners. The income that we generate from strategic licensing provides non-dilutive finance to support investment and growth. The left-hand side chart summarizes our activity over the past decade and how these many existing partnerships will underwrite value creation potential into the future. The right-hand side chart details that we are one of the most prolific licensors of innovation globally.
This business model ensures we have the diversification of a big pharma whilst maintaining the catalyst-rich upside of a biotech, which is what makes our business unique. Please turn to slide 13. The third pillar of our strategy involves transforming our in-house R&D operations. Now, much of this realignment was completed last year. However, it will remain an important continuous improvement process. There are four initiatives that we have applied to ensure the efficiency of R&D operations going forward. Firstly, target biology is to be entrenched at the forefront of our pipeline planning so that we are investing in programs with a robust and testable hypothesis. Secondly, we now operate with a program-centric model. This is because we believe traditional linear ways of working in pharma R&D organizations can be inefficient and unproductive.
Our scientific functions now exist to support program teams. It is the program leaders, not the scientific functional leaders, who are empowered to make program-related decisions. Thirdly, we opened a second facility at our Cambridge research campus. This houses our newly formed translational medicine team of professionals. This brings together all preclinical and early clinical development talent into a single team in the same facility to support faster progression of programs into the clinic. Lastly, we embrace a quick-win, fast-fail approach to investing in our programs. When our translational medicine or drug discovery teams generate data that indicates a program is unlikely to meet the thresholds for ongoing investment, we will terminate that program as soon as possible. By terminating programs during this earlier, cheaper phase of the drug development process, we don't waste investment capital.
This means we only invest in programs that have a better chance of success to make a difference for patients who are waiting. The key purpose of these initiatives is to ensure our world-leading science is supported by operational best practices to drive efficiency, focus, and superior long-term value creation potential. Please turn to slide 14. The fourth pillar of our strategy involves the opportunity to build a disruptive pharma business unit based in Japan. Now on this slide, we have listed several reasons why we believe Japan is an attractive market for investment. With the future potential of our world-leading science and broad pipeline, we will begin to take steps to build a business unit in Japan that can help us deliver innovative medicines to patients.
Initially, we believe our focus will be on underserved specialty therapeutic areas, we will take a U.S.-style approach when going to market with a lean development and commercial model. If ultimately successful, we will use the Japan Pharma Business unit as the linchpin unit to expand across the Asia-Pacific region. Now moving on, please turn to slide 16. This slide details a simplified snapshot of our partnered and in-house pipelines. The green ticks represent all the areas where progress was achieved in FY 2022, and I'll speak in more detail about this on the next 2 slides. We are uniquely positioned as a company moving forward over the next three years. This pipeline exhibits the diversification of a big pharma as well as the catalyst-rich upside of a biotech company.
We expect to see a number of these programs move into and through clinical development over the medium term, with selected partnered programs potentially generating significant milestone income to support our continued growth. Please turn to slide 17. In FY 2022, we made excellent progress against the objectives set across our strategic pillars. Beginning with the first strategic pillar, where we focus on world-leading GPCR drug discovery. In FY 2022, we further enhanced our GPCR and SBDD platform value. We executed a new collaboration with Alphabet's Verily and leveraged their AI and datasets to already identify multiple new GPCR targets of interest for future drug discovery. We executed a new platform collaboration with US company Kallyope to again identify novel first-in-class GPCRs for future drug discovery. We achieved five milestone events across programs as part of our multi-target collaboration with Genentech.
Importantly, we executed two major new multi-target collaborations with global pharma partners, an up to $1.2 billion agreement with AbbVie in the neurology space and a $700 million agreement with Eli Lilly and Company in the diabetics, diabetes and metabolic space. As a result of these collaborations and continued progress with existing drug discovery partners, the long-term future of our GPCR pipeline is secure. Please turn to slide 18. Moving to the second and third strategic pillars. In the area of major cash flow-generating partnerships, we witnessed strong progress. Pfizer committed to invest in its GLP-1 agonist program for type two diabetes and obesity, commencing a large Phase II-B clinical trial in the U.S.
This generated a $10 million milestone income event to Sosei. Our partner, Neurocrine, rapidly advanced its M4 agonist program for schizophrenia, commencing a Phase II clinical trial in the U.S. This generated a $30 million milestone income event to Sosei upon the IND acceptance. Lastly, our co-owned investment company, Tempero Bio, received FDA clearance to commence clinical trials in the U.S. and received a $5.3 million grant from NIDA. This program targets substance use disorders, an area of huge unmet medical need in the U.S. Together with the team at Tempero Bio, we hope to see this program advance further in 2023. In the area of transforming in-house R&D, the realignment of talent and the new program-centric focus saw us advance selected programs in preparation for first-in-human clinical trials over the next three years.
With the support of new strategic collaboration partner, Verily, we advanced multiple clinical and pre-clinical programs such as both EP4 programs and the GPR52 program to a position where we expect at least two new first-in-human clinical trials to begin in 2023. Thank you for listening, and I'll now hand over to Dr. Matt Barnes, Head of UK R&D, to talk in more detail about the GPCR platform and selected clinical programs. Thank you, Matt.
Thank you, Chris. Good afternoon, everyone. My name is Matt Barnes. I'm the President of Heptares and Head of R&D in the U.K. I will present our progress in the R&D area. Please turn to slide 20. I would like to start by emphasizing that we remain committed to strengthening our world-leading GPCR platform capabilities, and that world leaders in the pharmaceutical industry continue to choose our platform to prosecute complex GPCRs. Significant progress has been made in this area over the last year or so to support our pre-discovery and discovery areas and build on our core star and structure-based drug design technologies. Our latest additions include cryo-EM and a protein binder toolkit, which will allow us to reach a structural position for more difficult targets more quickly.
The addition of DNA-encoded library, or DEL screening and GPCR chemogenomic library screening ensure that we continue to identify and deliver better hit compounds more quickly. It is important we continue to strengthen our platform capabilities, as this is one reason that the companies listed on the right-hand side, including new multi-target discovery collaborations with AbbVie and Lilly in 2022. They continue to make us the go-to partner of choice in this area. Please go to slide 21. In addition to strengthening our platform area, we have been extremely successful in prosecuting more strategic collaborations on choosing the right target. Following our first collaboration with Inveny AI in this area in 2021, we have also established two key partnerships in 2022.
In January 2022, we signed a deal with Verily to identify new GPCR drug targets and subsequently generate novel drug candidates in immune-mediated diseases. The research collaboration combines Verily's immune profile capabilities and Sosei Heptares' STAR platform and SBDD capabilities to identify GPCRs expressed in immune cells, enhance our understanding of their functional relevance, and prosecute as potential drug targets in immune-mediated diseases. In May 2022, we entered into a collaboration with Kallyope to identify and validate novel gastrointestinal GPCR targets for drug discovery. The agreement leverages Sosei Heptares' GPCR diversified compound library and GPCR expertise with Kallyope's gut-brain axis platform, which includes sorry, an organoid phenotypic screening approach. Novel GPCR drug targets emerging from this collaboration will provide new opportunities for potential therapeutic intervention in gastrointestinal diseases.
Identifying and validating new GPCR drug targets combined with our core technologies and new molecule identification through internal methods or via collaborations provides huge potential for maintaining a full, healthy, and sustainable early pipeline of projects. Please go to slide 22. Next, I would like to turn our attention to the progress on some of our clinical stage partnerships. This slide summarizes our highly successful collaboration with Neurocrine Biosciences on the novel muscarinic receptor agonists for schizophrenia and other neuropsychiatric disorders. As Chris mentioned earlier, Neurocrine initiated a placebo-controlled phase II clinical study in the second half of 2022 to investigate NBI-1117568, formerly HTL 878, the selective M4 agonist as a potential new treatment for schizophrenia. This clinical development milestone triggered a payment of $30 million to Sosei Heptares from Neurocrine.
NBI-568 represents the most advanced candidate under this multi-program collaboration, but also of note is the intention to initiate phase I clinical studies on both the dual M1/M4 agonist, now known as NBI-570, and an M1 selective agonist, both in 2023. Sosei Heptares is working extremely closely and effectively with Neurocrine on this collaboration. Of note is that Sosei Heptares retains rights to develop all M1 agonists in Japan in all indications. Please turn to slide 23. Further progress on our other clinical stage partnerships is captured in this next slide, which provides an update on PF 532, now known as lotiglipron, and that's from the Pfizer Q4 2022 results.
This is a GLP-1 agonist which Pfizer presented at the EASD meeting in September last year. They initiated a large phase II clinical study in type 2 diabetes and obesity towards the end of 2022, resulting in a clinical development milestone payment of $10 million to Sosei Heptares from Pfizer. Please note this asset was discovered by Pfizer scientists during a research collaboration in which Pfizer accessed Sosei Heptares' proprietary technology to develop and enable structure-based drug discovery for GPCRs. We remain very encouraged by the data released by Pfizer thus far, highlighting the half-life of the molecule is supportive of once a daily administration and robust dose-dependent declines in mean daily glucose and body weight were observed with once daily 532, consistent with a potential best-in-class small molecule profile against an already well-validated drug target, GLP-1.
We believe this asset has huge potential in indications such as type two diabetes and obesity, which has recently been underpinned by Some market opportunity assessments by Pfizer, suggesting that a preference for oral versus injectables, with a view that orals might capture up to 30% of the GLP-1 market by 2032. A market that is projected to reach $90 billion by 2030 based on current market growth. Please turn to slide 24. In addition to our highly successful collaborations, we have a rich internal portfolio of programs with three wholly owned assets to begin clinical studies within the next 12 months. On the left is our EP4 antagonist for immunosuppression in solid tumors, which is a collaboration with Cancer Research UK that Chris mentioned earlier, and I will go into more detail on the next slide.
In the middle is our GPR52 agonist program, which is a novel GPCR target, which presents opportunities in schizophrenia and psychosis. Both of these programs are due for clinical start in the first half of this year. Lastly, on the right-hand side is our EP4 agonist program for inflammatory bowel disease. This asset is highly potent and selective molecule with an oral but GI-restricted profile, which will be due for clinical start towards the end of 2023. We're really excited about these three internal programs as they offer opportunities across our key therapeutic areas of focus. They represent a mix of novel and validated targets, which allows some mitigation of risk and provides a great opportunity for our translational medicine team to demonstrate the best practice approach we strive for. Advancing these internal programs into the clinic will ultimately provide Sosei Heptares with higher value creation.
Moving to slide 25. On my final slide represents some more detail of our EP4 antagonist program for immunosuppression in solid tumors with Cancer Research U.K. We signed this new collaboration with CRUK in August 2022 to advance clinical trials for this promising cancer therapeutic EP4 antagonist. Why did we do this? Well, as you know, cancer is an extremely complex area and expensive area of clinical development. CRUK has the best access to an unrivaled network of world-leading scientists and clinicians in this area, with a world-class infrastructure across 20 clinical centers in the U.K. Has a proven track record, having delivered 6 agents as registered medicines alongside world-leading corporate partners to date.
In addition, we will share the costs and risks associated with this clinical program, which will be coordinated and managed by CRUK, with Sosei Heptares retaining the license to clinical trial results and collaboration IP. CRUK will receive a share of future revenue if the drug is successfully developed, which we believe is a real win-win for cancer drug development and cancer patients. That concludes my section highlighting our significant progress in the R&D area in 2022. I will now pass back to Chris, who will highlight our objectives for 2023.
Thank you, Matt. Please turn to slide 27. As mentioned in my slides earlier, and as summarized on this slide, we executed strongly against the objectives that we set ourselves at the beginning of FY 2022. Regarding strategic growth initiatives, we continue to search and evaluate for opportunities to acquire revenue-generating products and or companies, as well as for late-stage products to in-license for clinical development and future commercialization in Japan and APAC. Regarding acquisitions, we remain cautious for specific reasons, namely that quality overseas pharma and biotech company valuations remain high, while the Japanese yen remains weak. As such, we will remain disciplined and not be tempted to do an ill-timed transaction. Regarding in-licensing of late-stage products, this will remain an ongoing process for several years as we seek to rapidly build a pipeline for Japan and APAC.
I can confirm that from FY 2022 and into this year, FY 2023, we are involved in multiple conversations with counterparties under confidentiality. Please turn to slide 28. Turning now to our priority objectives for FY 2023. Across our four strategic growth pillars, we as a team commit to do the following. We will invest to enhance our world-leading technology and GPCR structure-based drug design capability. We will execute at least one new high-value cash flow-generating collaboration, as well as supporting our partners to advance existing partnered programs. We will advance at least two new in-house programs into first in-human clinical trials. Lastly, we will take clear steps to build a Japan pharma unit by in-licensed or in-house products. Please turn to slide 29.
Here are our four strategic pillars for growth over the next three years, which, if executed well, will position the company strongly for the latter half of this decade. Please turn to slide 20. sorry, slide 30, our 2030 vision. I began this presentation with the vision for Sosei Group, which can be neatly summarized as we invest in world-leading science to deliver life-changing medicine. To do this, we need a strong, sustainable business. On this final slide, I want to explain what the 2030 vision looks like for Sosei Group. We will have novel medicines that we help to discover on the market globally via our partners. We will have a disruptive, lean commercial business in Japan delivering in-licensed and ultimately, our in-house discovered products. We'll have a growing pipeline of innovative programs serving areas of unmet medical need.
We will have rapidly growing sales, cash flows and profits. We'll be the leading biotech in Japan, driving innovative medicines to patients. This completes the presentation today. Thank you for your time. We will now take Q&A.
Chris and Matt, thank you very much. Those of you at this venue and on the web, thank you very much for your attention. Now, we would like to move on to Q&A session. The institutional investors, analysts and the media people, please raise your hand or press the Zoom raise hand function. The moderator will appoint you. When we would like to raise questions from the Zoom, please unmute yourself and speak up. We will have the simultaneous interpretation, so when you would like to ask question, we hope that you would speak moderately and to be as succinct as possible. Please raise your hand. The person at the front seat, please.
Hashiguchi of Daiwa Securities. Thank you. I have a question on the M&A strategy. Sosei, historically speaking, has had a few large-scale M&A, which has driven your growth over the years. Last year, you were actively looking for M&A target. I think you said that repeatedly. This time you showed us this year's target and your medium to long-term vision. You did not mention M&A in your vision. Is this a change of your corporate strategy? If so, what is the background to that? What is the impact on Sosei's growth story? Thank you very much.
Thank you for the question. This is a question to you, Chris. Chris, please.
Thank you very much. I did mention acquisitions on the last couple of slides. The way I would describe it is, no real change to the strategy. It's just that M&A will potentially support us execute the strategy faster. As you rightly pointed out, Sosei is a company that has grown traditionally via acquisition. It will continue to be the case going forward. As I mentioned last year, and as I mentioned in my speech just now, over the last few years, the conditions, and by that, I mean valuations of companies in this sector, combined with the fact that we finance ourselves with yen, has made the transaction, the aspects we don't control of a transaction difficult.
What I said in my speech just now is we remain focused on using M&A as a path to execute our strategy faster, but that now we don't wanna get dragged into a transaction at a poor time. Hopefully that answers your question. In summary, M&A is still very much part of how we will achieve our vision faster.
Thank you very much. If I may elaborate, basically this is to recap, what Chris said, and our strategy remains unchanged. When we prepared our goal that we're showing on the slide, of course, we have internal discussion. M&A, as Mr. Hashiguchi mentioned, it has been functioning as a growth driver. If you take a look at the situation, we were able to have good acquisitions in the past. If we need to limit within this year, and if we need to look at whether we are achieving our KPIs, we are not quite sure whether that is correct or not. We were always including that, within our goal, but we are now daring down our goals from six to four.
As you can see, we thought that this would not be appropriate as a part of our goals. Our strategy remains unchanged. This is just a supplementary comment. If you have any questions or comments, please. The man, at the front row, please.
Jefferies Securities. My name is Miura. I have several questions. The first question is related to TSE Prime transition, I think you are making efforts to do that. If you can move on to page seven of the slide, in terms of the expenses, TSE Prime listing, you are including that. By taking a look at this, it seems like there is a higher probability that you would shift to TSE Prime. Am I correct in my understanding? If you are to transition, what will be the timing that you're going to transition?
Sure. Miura-san, I'll answer that. We are working on a TSE Prime transfer project. We can't confirm whether or not it will be successful. However, we do think that based on our management of the business for a number of years and our financial performance, that we have put ourselves in a good place to potentially transfer. As I'm sure you will understand, it's not up to us. It's up to the Tokyo Stock Exchange. We remain confident, and we are hopeful. We can't sort of, you know, we can't say definitely that it will happen.
My second question, also on page seven, you talked about the R&D cost, the expenses. There are three bullet points. The bottom one, you said that you will progress the phase, the prioritized program to phase Ib. On page 24, you talk about in-house, three key products. Those are the ones that will start phase Ib. Is that what is meant by the third bullet point? How can I understand the start of phase Ib? Could you elaborate? Thank you very much.
Matt will answer, and I will talk about the financial aspect after that. Matt, please.
Yeah. Thanks for the question. of course, phase Ib, to get to phase I-B, you need to do phase Ia. Those will be the clinical starts that the costs are referring to. of course, you need to gear up to enable the start of clinical studies. You need to scale up material. You need to do toxicology if you're committed to taking those programs into early clinical studies yourself. That's what the cost is associated with. It's not a cost for phase Ib, it's for preparation for phase Ib. Yeah. Does that make sense? Yeah. Okay. Thank you. Thanks for the question.
Thank you very much. Any other questions?
The third question. I'm sorry I'm asking you many questions. On page 14 of the slide, you have the future direction of the Japan business. Especially what I noted was the one on the right-hand side, to be attractive market for disruptors, it says. In what kind of respect are you trying to establish Japan business as the disruptor, compared with the traditional pharmaceutical companies? How are you going to differentiate yourself? Can you talk about the idea behind this? Thank you very much. I would like to ask Chris to respond to the question.
Sure. Thank you, Miro-san. Thank you, Nomura-san. I think the best way to describe this is traditional pharmaceutical companies, both Japanese and international, have been built on the premise that you need a very, very large commercial infrastructure to be successful. We don't have a very, very large commercial infrastructure in place. What we do have is a business that can be built from the ground up. When I mentioned in my speech, we want to build a business that is lean, that does not have a very, very large fixed cost base or very, very large commercial infrastructure, but one which makes best use of partners, contract sales forces, et cetera.
We have the opportunity to build the right-sized business to be profitable and disruptive and agile for the future. We believe that existing competition will find it very difficult to restructure themselves back into that sort of a sized organization. We have an opportunity to build a much better model going forward. I said in my speech that the model that we are looking for would be best described as the model that a U.S. biotech would use in its go-to-market approach, as opposed to large-cap pharma. Hopefully, that makes sense. Thank you.
Great. Thank you very much.
Thank you.
Thank you very much. Any other questions? Yes, gentleman in the front row.
Toyo Keizai. My name is Onishi. My first question is, for the Japanese market, so late stage product will be brought in to the Japanese market. I think you've said this from last year or before that. Why could you not bring this in last year or the year before that? This is the same as the M&A. What is the bottleneck, if any? This year, can you realize this without fail? That's my first question. Thank you.
Thank you. Chris, could you answer this question?
Yeah, sure. Thank you for the question. I'll start with the end of your question. No, I cannot guarantee that a transaction will happen this year. What I can say is the bottleneck is not from our side. You know, when we assess potential products to in-license, we go through a very rigorous process. Both scientific, commercial, legal, financial diligence must be done. We have done this on a number of products over the last 18 months. The reason we haven't transacted is because those products have not met our minimum investment criteria. We have an investment committee that assesses these opportunities when we diligence them. To date, we have not found a product despite significant diligence, that we think meets the minimum criteria to be successful, profitable, and actually meet an unmet medical need in Japan.
I guess in summary, we're quite strict in the criteria that we apply. We will not in-license anything. We will only focus on products that definitely meet, are going to meet an unmet medical need for patients, but equally that those products make commercial sense as well. That completes my question. Response, sorry.
I have additional follow-up question on that. For example, the ones that will be licensed in Japan, you mentioned unmet medical needs are the target disease are decided and on that basis, it is difficult to negotiate and agree with the counterpart or it's not the developed product or products in development, but the products that are very close to completion. Is there an option to license in of something that is very close to completion? Is that an option you can consider?
Yeah. Thank you. Our focus is very much on products that are clinically de-risked. That generally means they're already approved in another, in another market. In order to get that product on the market in Japan, local, ethnic bridging studies would be required, plus some sort of a phase III or pivotal clinical trial is usually required. That is our area of focus. That is what we see as the fastest path forward, but not every product is the same. We do have to take all that into account, but we are much more interested in products that have already passed phase III overseas and therefore, the clinical risk is lower. Not to say we wouldn't do something else, but that's where we start. From a therapeutic area perspective, we think the most opportunity lies in CNS, rare and orphan diseases, and immunology.
That's a starting point for our search. Again, it's not definitive because actually what we're more interested in is finding a product that we can develop well and deliver well, and that may fall outside those therapeutic areas. That completes my response.
Moving on to my second question. R&D expenses. I understand the forecast for this fiscal year, your mid to long-term platform, or to strengthen, the development and in order to enhance, your added values after phase Ib and, if necessary, to phase II, to raise to phase II. From that perspective, over 2-3-year period, would you expect to see the increase in the R&D expenses in the upcoming 2-3 years? I think this is a finance-related question. I would like to respond quickly. Of course, the possibility for the increase of R&D expenses is not zero.
From the company, which is not pharmaceutical or company like us, whether the project is going to be successful and even if we succeed in the project, we need to validate every time we work on project. The more favorable the clinical trial becomes, there will be more expenditure. The situation really it does depend on how it progresses. If I may elaborate, the graph on page seven is based on Japanese yen as an expenditure. As you know, from FY 2021 to FY 2023 to our forecast, the exchange rate is quite volatile. I want to talk about the details there in the first report, they are well controlled. I hope you would understand in that manner. That concludes my response. Now moving on to the next question.
If you have any question, please raise your hand. The person in the back, please.
Can I just ask maybe, and I'm not sure if this is for Chris or for Matt, but if you could comment on the recent acquisition of rather not acquisition, the IPO of Structure Therapeutics, I think last week or the week before? I think there's a lot of similarities with Sosei, scientifically, but perhaps also what they are doing with AI and what you are doing with Verily. Their IPO was highly successful. I wonder if you can comment on what you think of that?
Yeah. Perhaps. Thank you for the question. I'll start, and then I'll let Matt speak more to the approach and the science. As I mentioned in my speech, we are really excited about all of the activity in the GPCR drug discovery space. As I said in my speech, it's like the second coming of GPCR drug discovery. It's in vogue again. Structure Therapeutics achieving a successful IPO in a difficult market is a fantastic result. It's great. You know, quite frankly, you're right, there are a lot of similarities between the two companies, not only from the way they go about drug discovery and how they are using specific tools to support their structure-based drug design approach. Also the programs that are in their pipeline, you know?
From that perspective, you know, we're really pleased to see more activity in the space. I'll let Matt comment on his, on his thoughts on Structure.
Yeah. Thanks, Chris. Yeah. I think I share Chris's enthusiasm. I think it's great for the GPCR field to have that investment, that endorsement, and we very much welcome that. Structure-based drug design using GPCRs. As the slide 11 highlighted, you know, our feeling is that you can have, you can have a platform which is based around structure-based drug design, but it takes many years to build everything else that you need to utilize that platform in the best possible way. You need the right computational chemist, the right medicinal chemist, the right molecular pharmacologist. You know, you need a lot of people with a lot of expertise to make best use of that platform.
That's what we've been doing for 15 years, and that's why we say we have a 15-year head start, is how we believe. That's the first part. The second part is actually relates to one of my slides. Maybe I can just highlight this, which is our chemogenomic library, which is on slide 21, in the middle, kind of in halfway down. This chemogenomic library, this is a GPCR-focused screening library that we have built. It's about 50,000 compounds. We've used that 15 years of knowledge to build that library of compounds, and we use that to screen to find new hits. If you're working on novel GPCRs, you can obtain a structure. You still need to find a hit compound to start with.
Because we've been working more in novel GPCRs, we knew that this would become a problem for us, and that's why we invested on this chemogenomic library, which exploits all that 15 years of knowledge to build, design and build that screening set. We've been using that to find new hit chemistry, and we've been doing that successfully. That is very much the other hand of the structure-based platform. You need the hit chemistry as well as the structure. I think there are some differences there just in the maturity of the company and the knowledge that we have built. Yeah. Thank you.
Thank you very much. We have 1 apology. 6:00 P.M. is the scheduled time for concluding this session, we haven't been able to take any questions from the web. We would like to take 2 more questions by extending the time to end this session. The video for this Q&A session will be streamed on our website. If you need to leave due to time constraint, we hope you will check through the video screening. We have many comments on the web as well. At the end of this session, we will not have any screen. If you have anything that you missed, please make sure to jot down in the Q&A box.
As usual, we would like to respond to all questions through our official blog. Please make sure to include your comments in the Q&A box. We just have a little more time to continue, but we would like to take two questions from the web. The first one is from Citigroup Securities. Yamaguchi-san from Citigroup Securities, please unmute yourself and speak up your question. Yes. Can you hear me? Yes, we can hear you. Thank you. This is Yamaguchi speaking. For the financial results, I would like to ask one question. Q4 results were quite a high performance, and the drivers for Lilly and Tempo have contributed in Q4. Are those the right factors? Yes. Since this is related to finance, I would like to respond. Yes.
In Q4, Lilly was included. Lilly's upfront payment, it was up $7 million, part of $37 million. Tempo, we don't have any milestones, so in principle it's not included in Q4. The others include Pfizer's GLP-1, phase IIb initiation and AbbVie, 2020, pipeline progress based on the past agreement. There was a $10 million revenue. Those are the major factors. Thank you very much. I have one simple question. Verily and, like, Verily and Carioci. GPCR, you bought three. Are you still in the process? Or are you still trying to discover or find? Have you found the 3 with Verily and Carioci?
Okay. I will take that. I can take the question. Thank you for the question. I think the question was about the output, the productivity of Verily and Kallyope in terms of producing new GPCR drug targets. This work is progressing very well. We hope later this year that we will be able to include some of these targets into our pre-discovery and discovery portfolio. Thank you for the question.
Thank you.
Thank you very much. Thank you, Yamaguchi-san. To the last question, Tsuzuki-san from Mizuho Securities. Please unmute yourself and state your question.
Thank you very much. My name is Tsuzuki from Mizuho Securities. Can you hear me? Yes, we can hear you. Thank you. I have two simple questions. The first one is about M&A. It's an additional question. Currently, you are trying to convert your structure and you also have the deal for diabetes with Lilly. The priorities, what are you expecting for as the priorities of the company? That's what I would like to know. Another question is, if you have any POC, like data this year, we would like to have any information related to that. Those are two of my questions.
Thank you very much. The first question is related to M&A. What could be the possible targets, the types of the companies? The second one is, what will be the pipeline that can obtain POC this year? The first question will be responded by Chris, and the second will be answered by Matt.
Thank you for your question. With regard to M&A, I can't really disclose what potential targets might be except to say that what I said earlier was that we would be open to using M&A to accelerate our strategy. Our strategy and four strategic pillars that I outlined, around investing in discovery, growing partnerships, transforming R&D, and building a Japanese business are sort of the core areas of our company. I think everybody knows that most of the revenue-generating opportunities in the pharma and biotech sphere are in the United States, located in the United States. We would be open to that. Of course, that would accelerate our geographic expansion. Most likely, M&A will be focused on the four strategic pillars that I mentioned earlier. Thank you.
Yeah. In answer to your question about clinical proof of concept. Normally, you would associate a clinical proof of concept with phase II. If you look at the programs we have in phase II with our partners. The first one, Neurocrine. That's not due to finish phase II until the end of 2024. The Pfizer GLP-1 molecule 532 is due to finish phase II in January, I think, 2024. Unless those timelines change, we won't see a clinical POC in 2023. But it all depends on the rate of recruitment of patients and the will and the speed of our partners to reach the end. Thank you for the question.
Thank you very much. Thank you for the question. As I mentioned, we have more questions, but my apologies, because of time, we would like to conclude now. Amongst some of the questions we received in text, I think they are covered from the questions that are responded. For the ones which have not been answered, we would like to respond by using the official blog. What we have discussed and entertained as questions will be disclosed on the website later on. We would like to conclude the earnings result for year ending December 2022. Thank you very much for your attendance.