Welcome to the SenzaGen AB Audio Cast for Teleconference Q2 2021. For the first part of the call, all participants will be in a listen-only mode, and afterwards there will be a question and answer session. Today, I'm pleased to present Peter Nählstedt. Please begin your meeting. Thank you very much. My name is Peter Nählstedt. I'm the Incoming CEO of SenzaGen. I thank you all for joining our half-year report session. We can have the next slide, please. First, shortly about me as I am the new CEO. I have a background in the life science sector primarily. I have worked in it for most of my career. I have more than or around 20 years of management experience in life sciences and the industrial sector. My educational background is a Master of Science in Chemical Engineering and a bachelor's degree in Business Administration. Previous roles I've had is, notably, I've served as CEO of Probi between 2014 and 2018 when the company was going through a rapid growth phase. I also had a number of other positions in strategy, marketing, and sales at GE HealthCare, Life Sciences, and Trelleborg here in Sweden and also in the U.S. I've been a Board Director of SenzaGen since 2018, but I also worked in operational roles in the company. Since I have worked with the team, both the management staff and the board, I know the company very well. I think the company has great potential, and I also want to thank Axel Sjöblad for doing a great job as a CEO before me, and also the collaboration I've had with him in these last years. I now very much look forward to and am very excited to drive the company's expanded growth strategy. The growth strategy of SenzaGen entails commercializing the revolutionary GARD platform, also to broaden our test portfolio and now actively seek for acquisition opportunities, which I will go into a little deeper in this webcast. Next slide, please. If we start with taking a look at our financial performance for the first half of 2021, I want to start with noting that the SenzaGen team have been able to grow the sales with more than 30% compared to the same period last year. It is clearly outperforming an industry which is growing of around 10%. SenzaGen has done it in a quite challenging time, where there has been very limited and actually close to none travel internationally, which is very important for a young company to position its product and services to be able to travel and attend conferences and so on. We've had a challenging condition and we've still been able to grow quite well. We achieved important orders from customers during and also after the period, both for GARD®skin and GARD®air, from a European customer in the chemical industry. We've received a notable order for GARD®skin Dose-Response, which is a new product from us, which is looking at risk assessment between weak and strong skin sensitizers from one of the world's leading cosmetic companies. We've had orders for both skin allergy tests and irritation tests valued at close to SEK 700,000 from a global consumer product company. We are well-financed, we continue with a strict cost control until the pandemic has further decreased. Notably, you can also see that we have slightly increased the loss in the first half. It is due to investments that we've made in additional sales resources in the first half, and also in the mix of customers in the first half where we had a quite large reference lab in the U.S. where we sold a project to, but we regard that order to be highly strategic as it is becoming a reference for many of its member companies in the U.S. Next slide, please. We see that we have several major international companies that became SenzaGen customers last year, and it is very pleasing to see that they are repeating their purchases and coming back now in 2021. Repeat business is important for us as we grow our customer portfolio, of course. We have also seen a substantial increase in inquiries from new customers during the first half and also after the end of the period. It is this increase of demand that have prompted us to also invest in our lab, both in terms of expanding our staff somewhat so that we prepare for an expansion that we think is going to happen this fall. Next slide, please. We have customers all over the world, and we have some examples here where we have a pharmaceutical company, Lundbeck, from Denmark, who have tested and are very pleased with our GARD tests. We have medical technology companies like Galderma, and we have this research institute, RIFM, in the U.S., which is identifying dosages of fragrances. We have also other examples of customers in the past. We continue to work on expanding our customer base, of course. With that, we can take the next slide and immediately transition to the next slide again. The goal for SenzaGen is to become a profitable and customer-centric company and break even. To do so, SenzaGen has six strategic initiatives, and they are to drive the GARD revenues. Second one is to broaden our portfolio. Third one is to build strategic partnerships. Fourth is to ensure regulatory acceptance. The fifth one is to ensure that we have the right capabilities and resources. The final and sixth one is to optimize and adapt internal processes, and systems and tools. This last one is, of course, that we want to be prepared for growth as we start to see an increased demand of our tests, both GARD and new ones. Can take the next slide, please. One thing which is new that we've worked on recently is to expand our strategy and also grow with strategic M&A activities. We see an opportunity in the marketplace to supply a full range of products and services in the in vitro testing environment. We want to focus on the high-performance end of that. We do see, as I mentioned, an opportunity in that marketplace to take that space. Therefore, we have expanded our strategy to also include M&A activities, where we are actively seeking to acquire companies that have reached profitability and that are growing in sales. The last important item that we're looking for are companies that can complement the SenzaGen portfolio and help us to become this full range supplier in in vitro testing, helping customers and the world to get rid of animal testing. Can take the next slide, please. While we have added inorganic growth to our agenda, we still have organic growth as a firm priority. We have intensified market activities to drive the GARD revenues. As I alluded to in introduction, we have important orders both from new and returning customers. After the end of the reporting period, we also noted that we had a large order for the GARD®skin Dose-Response from one of the world's leading cosmetic companies, SEK 650,000. We had another large order of another SEK 650,000 from a global consumer product company for both in vitro test skin allergy testing and irritation tests. The second part of organic growth is to broaden our CRO offering and adding more tests. This is as we have worked with customers now, we do see a need from them for SenzaGen to offer complementing tests to the GARD system. We have added the OECD-validated skin irritation and skin corrosion tests, and it is, of course, very promising that we already have orders for skin irritation and confirming that this strategy has a great promise for us. This fall, in the next few months, we will add more tests for more endpoints within skin toxicology, and also, as I alluded to on the previous slide, work with acquisitions as a growth strategy. Fourth point here is that we develop strategic partnerships to help our growth, and we have renewed and expanded the collaboration agreement with one of the world's leading CROs, Charles River. We have expanded our collaboration with the Research Institute for Fragrance Materials, or RIFM, with the GARDskin Dose-Response project. We have signed a new distributor in U.S. with the in vitro specialist Enthalpy. We have entered into new preferred supplier agreements and master service agreements with global companies. Next slide, please. We need to ensure regulatory acceptance of the GARD platform, and we are making progress on that agenda. On the new ISO standard for medical devices, we have GARD included in the round robin, and we're waiting for the ISO organization to finalize its work. Our expectation is that it will be completed before year-end. The timeline for this project has been impacted by the pandemic, but this is our expectation that it will be completed this year. We've also worked on submitting the GARD®skin medical device test to the FDA in U.S. to enable status as a Medical Device Development Tool, or MDDT. We have addressed the questions, and we have moved the matter forward with FDA in the first half of this year. Finally, we are working on getting the GARD tests adopted as official test guidelines by the OECD organization. As we have reported recently, we have a big step towards that with the positive scientific opinion from the authority's external scientific committee on GARD®skin, and I have a couple of slides which explains what that means in some more detail shortly. Next slide, please. As we are preparing and growing, we also need to ensure that our organization is prepared for the growth. We are ensuring that we have the right and that we have sufficient resources in place. We have recruited two new lab engineers in the first half to be able to meet the increased customer demand. We have continued to adapt and develop our internal processes, systems, and tools. We have a continuous focus on sustainability. SenzaGen is helping a sustainable world by developing and performing non-animal tests. Our tests contribute to both safer and more sustainable products reaching the market, a better work environment for our customers, and a reduction of animal testing in the world. Next slide, please. I want to come back to the very important and positive scientific ESAC opinion on GARD®skin, which we believe paves the way for an OECD validation and thus opens up for new commercial opportunities for the company. In July, the EU reference lab for alternatives to animal testing, EURL ECVAM, announced that their scientific advisory committee, ESAC, had finalized its GARD opinion, and this work had been ongoing for some time. We can now state that our groundbreaking GARD technology, based on both genomics and machine learning, has been validated by an objective group of international experts. Their conclusion of ESAC is that they recommend that OECD includes GARD®skin on their list of internationally agreed test methods, which is a major milestone in the regulatory approval process for the GARD technology. We will, with this opinion, be able to offer GARD®skin to a broader customer base. This paves the way for an accelerated market growth. We will, of course, refer to the positive ESAC opinion in our external communication going forward. We had a separate press conference about the ESAC opinion, which Axel Sjöblad led a couple of weeks ago. I just want to state the conclusion. Next slide, please. The ESAC group concludes that the evidence provided on GARD®skin is sufficient and adequate to support its scientific validity. They consider that GARD®skin is ready to progress to further consideration for OECD for test guideline development. They also consider that GARD®skin is ready for regulatory use. Depending on the regulatory context, positive results may be used as standalone data to source and identify sensitizers. This means that GARD®skin is the first genomic-based test that has achieved standalone status for identifying skin allergens. Negative results may not be sufficient standalone and may need to be complemented by other tests due to the limited applicability domain, mainly. ESAC does not consider one of our other tests, GARD®potency, to be ready for regulatory use, but do consider it as a valid method ready for industrial screening purposes. Next slide, please. We are pleased with the collaboration we had with the authority, and we have two quotes here from Silvia Casati, JRC scientist and working group coordinator, who states that, "This is the first time a machine learning algorithm has been independently reviewed for use in the field of regulatory toxicology. Using the code explanations and data provided by the test developer, that is SenzaGen, ESAC was able to verify the algorithm and reproduce the processing steps to convert raw data into predictions for both GARD®skin and GARD®potency." João Barroso, JRC scientist and ESAC coordinator, states that according to ESAC, GARD®skin is ready for further consideration at the OECD for possible development of a test guideline. These standard OECD test guidelines are internationally recognized test methods used by government agencies, industry, and independent labs all over the world to determine the safety of chemicals used in many different sectors, including cosmetics, pesticides, and industrial chemicals. Next slide, please. We had a lot to report on this morning. Looking ahead, we have a full agenda. We have an objective to develop the complete skin toxicology package for regulatory testing. We have gradually increased our competitiveness both as a test developer and as a GLP-certified contract research organization for cell-based toxicology tests. We have expanded our regulatory test offering with the OECD-validated skin irritation and corrosion tests that complement GARD. We have received the positive ESAC opinion, which we think will drive further customer and partner interest in GARD®skin. We see that when we finally have an OECD GARD®skin test guideline in place, we can offer GARD®skin for regulatory testing to a significantly broader customer base in cosmetics, chemicals in E.U., U.S., and Asia. We are keeping up the momentum and contact with OECD and the Swedish Chemicals Agency to keep the momentum in this test guideline process. We have set a great baseline. We continue to develop GARD. We add new tests, and now we also will drive acquisition opportunities. Thank you very much for listening, and we are ready for questions. Thank you. If you would like to ask a question, please press zero one on your telephone keypad. If you wish to withdraw that question, you may do so by pressing zero two to cancel. There'll be a brief pause while any questions are being registered. Once again, as a reminder, if you do wish to ask a question, please press zero one on your telephone keypad now. Okay, there appear to be no audio questions. I'll return the conference to the speakers for any closing remarks. Okay, Richard. I think we had a lot to report on, and we also had a recent conference call on the ESAC opinion, which it seems like have clarified a lot of the questions. I thank everybody for their attendance then, and look forward to presenting the second half or full year report in due course. Thank you very much.
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