SenzaGen AB (STO:SENZA)
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Earnings Call: Q2 2021

Aug 19, 2021

Speaker 1

Welcome to the Sensogen AB Audiocasts 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 Neilsberg. Please begin your meeting. Thank you very much.

My name is Per den Halsbeth. I'm the incoming CEO of Sensogen, and I thank you all for joining our half year report session. We can have the next slide, please. So 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 of the year, I have 2 years of management experience in life sciences and the industrial sector. My educational background is a Master of Science is in chemical engineering and bachelor's degree in business administration. Previous roles I've had is notably, I've served as CEO of ProBe between 2014 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 the Board Director of Sensogen since 2018, but I also worked in operational roles in the company. So 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 Forblad 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 I'm very excited to drive the company's expanded growth strategy.

The growth strategy of Sensagen entails commercializing the revolutionary Guard platform, But also to broaden our test portfolio and now see 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 twenty twenty one, I want to start with noting that we have been able The Sensogen 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%. And Sensorgen has done it In a quite challenging time where there has been very limited and actually none close to none travel internationally, Which is very important for a young company to position its products and services to be able to travel and attend conferences and so on.

So 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 of the period, both from for GodSkin and God Air from a European customer in the chemical industry, we've received a notable order for Guard Skin Dose Response, which is a new product from us, which is looking at risk assessment between weak and strong skin sanitizers from 1 of the world's leading cosmetic companies. And we've had orders for both skin allergy tests and irritation tests valued at close to SEK 700,000 from Global Consumer Products Company. We are well financed, but 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 is the quiet large reference lab in the U. S. Where we sold a project to, but we 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.

So We see that we have several major international companies that became Sensing customers last year. And It is very pleasing to see that they are repeating the purchases and coming back now in 2021. So repeat business is important for us as we grow our customer portfolio, of course. And we have also seen of the year. Substantially increasing inquiries from new customers during the first half and also after the end of the period.

So it is this increase of demand that have prompted us to also invest in our lab, of the year, 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 Guard tests, we have medical technology companies like Galderma And we have this research institute, Rifim, in U. S, which is identifying dosages of fragrances. And we have also other examples of customers in the past.

So And we continue to work on expanding our customer base, of course. So with that, we can take the next slide And immediately transition to the next slide again. So The goal for Sensagen is to become a profitable and customer centric company and breakeven. And to do so, Stencilion has 6 strategic initiatives, and they are to drive the Guard revenues 2nd one is to broaden our portfolio. 3rd one is to build strategic partnerships.

4th is to ensure regulatory acceptance. The first one is to ensure that we have the right capabilities and resources. And then the final and fixed one is to optimize and adapt internal processes and systems and tools. And then 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 card and new ones. You can take the next slide, please.

One thing which is new that we've worked on in recently is to expand our strategy and also grow with is strategic M and A activities. So we see an opportunity in the marketplace to become to supply a full range of products and services in the in vitro testing environment. And we want to focus on the high performance end of that. And we see we do see, as I mentioned, an opportunity in that marketplace to take that space. Therefore, we have expanded our strategy to also include Q and A activities where we are actively seeking to acquire companies that are that have reached profitability And that are growing in sales.

And then the last important item that we're looking for are companies that can complement of the Sensogen portfolio and help us to become this full range supplier in in vitro testing, helping is the first part of the question. We'll take the next slide please. So while we have added inorganic growth to our agenda, we still have organic growth as a firm priority. So we have intensified market activities to drive the Guard revenues. And as I alluded to in the introduction, we have important orders both from new and returning customers.

And after the end of the reporting period, we also noted that we had a large order for the Skarskin dose response from 1 of the world's leading cosmetic companies, SEK 650,000. And we had another large order of another SEK 650,000 from a global consumer product company for both in vitro of the Q2, skin allergy testing and irritation tests. The second part of organic growth is to broaden our CRO offering And adding more tests. And this is as we have worked with customers now, we do see a need from them So Sensigen to offer complementary tests to the Guard system. So we have added the OCD validated skin irritation and skin corrosion tests.

And it is, of course, very promising that we already have orders for skimming rotation and confirming that this strategy is has a great promise for us. This fall, in the next few months, we will add more tests or more endpoints within skin toxicology and also as I alluded to on the previous slide, work with acquisitions as a growth strategy. 4th point here is that we develop strategic partnerships to help our growth. And then 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 American Research is for fragrance materials or written with the card skinders response project.

We have signed a new distributor in U. S. With the VITROS Specialist, Entopy. And 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 Guard platform and we are making progress on that agenda. So on the new ISO standard for medical devices, we have Guard included in the round robin and we're waiting for the ISO organization to finalize its work. Our expectation is that of the presentation to finalize its work, our expectation is that it will be completed before year end. It has 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 Guard Skin medical device test to the FDA in U.

S. Is to enable status as a medical device development tool or MDDT. And we have Address the questions, and we have moved the matter forward with FDA in the first half of this year. And then finally, We are working on getting the Guard tests adopted as official test guidelines by the OCD organization. And as we have reported recently, we have a big step towards that with a positive scientific opinion from is the external scientific committee on GARDSCIN.

And I have a couple of slides which explains what that means in some more detail shortly. Next slide please. So as we are preparing and growing, we also need to ensure that our organization is prepared for the growth. So 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.

And then we have continued to adapt and develop our internal processes, systems and tools. And we have continuous focus on sustainability. So Sensagen is helping just a sustainable world was by developing and performing non animal tests. So our tests contribute to both safer and more sustainable products reaching the market, of the business, a better work environment for our customers and a reduction of animal testing in the world. Next slide please.

So I want to come back to the very important and positive scientific ISAC opinion on Guard Skin, Which we believe that paves the wave for an OECD adaptation and thus opens up the new commercial opportunities for the company. So in July, the EU Reference Lab for alternatives to animal testing, EURL of the Q1 announced that their Scientific Advisory Committee, ESAC, had finalized its Guard opinion, and this work has been ongoing for some time. We can now state that our groundbreaking Guard technology based on both genomics and machine learning has been validated by an objective group of international experts. And their conclusion of the SAC is that they recommend that OECD includes Godskin on their list of internationally agreed test methods, which is a major milestone in the regulatory approval process for the Guard technology. We will, with this opinion, be able to offer Godskin to a broader customer base and this paves the way for an accelerated market growth.

And we will, of course, refer to the positive EASA opinion in our external communication going forward. So We had a separate press conference about the EASA opinion, which Axel Hoeghorst led a couple of weeks ago. I just want to state the conclusion. So next slide please. So the EASAAC group concludes that the evidence provided on Godskin is sufficient and adequate to support its scientific validity.

They consider that Godskin is ready to progress to further consideration for OECD for test guideline development. They also consider that Gottskin is ready for regulatory use. Depending on where regulatory context, positive results may be used as stand alone data is to source and identify sensitizers, meaning that this means that GodSkin is the 1st genomic based Test that have achieved stand alone 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. And EASA does not consider our other test to be ready for regulatory use, but do consider it as a is ready a valid method ready for industrial screening purposes.

Next slide please. We are pleased with the collaboration we had with the F40 and we have 2 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 of the data provided by the test developer that is Sensagen, GESAC was able to verify the algorithm and reproduce the processing steps to convert raw data into predictions for both GuardSkin and Guard Focus. And then Joao Araujo, GOC scientist and ESSEC coordinator states that according to ESSEC, the Guard Skin is ready for further consideration at the OCD for possible development of a test guideline. These standard OECD test guidelines are internationally recognized test methods used by government agencies in that 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. So next slide, please.

So We had a lot to report on this morning. Looking ahead, we have a full agenda. We have an objective to 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 OCD validated skin irritation and corrosion tests that complement Guard, we have received the positive ASAC opinion, which we think will drive further customer and partner interest in GodSkin. And we see that when we find we have an of the OSV Guard Skin Test guideline in place, we can offer Guard Skin for regulatory testing to a significantly broader customer base in cosmetics, chemicals in EU, U.

S. And Asia. And we are keeping up the momentum and contact with OECD and the Swedish Chemical Agency to keep the momentum in this test guideline process. So we have set a great baseline. We continue to develop Guard.

We add new tests and now we also will drive acquisition opportunities. Thank you very much for listening and we are ready for questions. Okay. There appear to be no audio questions. I return the conference speakers for any closing remarks.

Okay. Okay, Richard. I think we had a lot to report on and we also had a recent conference call on the EASA opinion, which of the question, it seems like I have clarified a lot of the questions. And 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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