Interim Report January-September 2024

Comments from Fredrik Olsson, Chief Executive Officer

In the third quarter, we implemented several of our growth strategies and achieved robust growth in our enzyme business. Even with the sale of our antibody business, finalized mid-quarter, we grew sales organically by 13% year-over-year.

When adjusted for the antibody business revenue, this strong growth can be attributed to the solid sales performance in the enzyme segment. Sales growth in enzymes was fueled by large orders in our ADC technology and we saw growth across all major geographic markets. Enzyme sales in analytics totaled SEK 31.6 million, setting a new record for a single quarter and representing growth of 24%. Growth in the enzyme business was 28% when adjusted for currency effects, and 13% when further adjusted for a significant ADC order

In the third quarter, we implemented several of our growth initiatives. In July, we invested in Sequrna and their unique technology platform for RNAase inhibitors, which will pave the way for our expansion into new application areas. Market-preparation activities are underway as part of the partnership, where we now own 25% of Sequrna, gearing up for product sales and distribution, including through our own sales organization. In the middle of the third quarter, we completed a strategic sale of our antibody business to Leinco Technologies to focus our operations on our enzyme business and the growth opportunities we foresee moving forward

Our operating profit in the third quarter demonstrates a strong improvement over last year. The sale of the antibody business contributed to the improvement, but even adjusted for this we show a strong improvement in earnings. Operating profit adjusted for the antibody business almost doubled compared to the third quarter last year. This solid performance has further strengthened our cash position, providing flexibility and the capacity to pursue continued investments in future growth initiatives.

We are experiencing growing interest in our technologies in antibody conjugation and ADC. These technologies are a key component of our strategic growth initiatives, where we are working to broaden and improve our offerings to customers in a market with strong underlying drivers. We intend to continue our efforts in ADC to position ourselves as a clear partner to our customers who want to apply our technologies also in the manufacturing of ADC and related products.

We launched a new enzyme for the analysis of new antibody formats, which occupy an increasing share of biopharma companies’ pipelines. The product has initially been well received by our customers and we see continued opportunities to add new enzymes as our customers develop new and improved antibody-based drugs.

Toward the end of the quarter, we filed patents for no less than four newly developed enzymes with potential therapeutic applications. We have thereby expanded our offering, which together with Xork, creates a differentiated portfolio of enzymes to address challenges in gene therapy and other autoimmune diseases.

I am highly satisfied with both our growth and performance in the third quarter. Genovis remains strong amid challenging geopolitical factors and macroeconomic uncertainty that have impacted our end markets throughout the year. The long-term underlying growth in new and improved pharmaceuticals remains the foundation of Genovis’ business. Our strategic decision to sell the antibody business allows us to focus our resources on our core business and new growth initiatives, such as genomics and ADC.

In closing, I would like to extend my warmest thanks to the employees at Genovis who made several advances during the quarter and continue to do a fantastic job for our customers in their efforts to develop drugs and new treatment methods for patients around the world.

Genovis Interim Report January-September 2024

Half-Yearly Report January – June 2024

Comments from Fredrik Olsson, Chief Executive Officer

In the second quarter, we maintained sales both sequentially and year-on-year. Excluding currency effects and inventory adjustments of approximately SEK -2.9 million compared to the previous year, our operating profit at the EBITDA level improved by 6%. This EBITDA level, at nearly 28%, reflects the stability of our business, where we sustain margins and earnings even in a challenging market.

We have performed well operationally despite challenging market conditions, with restrictions on venture capital for biotech companies temporarily affecting a large part of our customer base and their ability to invest in their development programs. Our sales to the major global biopharmaceutical companies continued to grow in the quarter compared to the previous year, reflecting the value of our broad customer base which, along with our strategic growth initiatives in ADC and new antibody formats, continues to deliver value in a challenging market. In recent years, we have expanded both our customer base and product portfolio through our technologies in these areas and we see growing interest in our technology platforms in ADC. I expect continued robust growth in business opportunities within this area moving forward.

In the course of our strategic review of the antibody business, which we initiated last quarter, we noted interest in the operation, which has resulted in our decision to sell the business to Leinco Technologies. After careful consideration and analysis, we concluded that the sale of the antibody business not only offers an attractive financial outcome, but also frees up resources and capacity that we will now be able to invest in exciting new initiatives that we strongly believe in, and that are in line with our long-term growth strategies. The divestment will enable us to focus even more on innovation and expansion in our most promising business areas. I am confident that this restructuring will lead to increased efficiency and better offers for our customers, while strengthening our competitiveness in the market.

At the beginning of the third quarter, we made a strategic investment in Sequrna. The investment enables Genovis to offer new products to both current and new customers, while opening up opportunities for expansion into new application areas. Collaboration with Sequrna and their unique RNAse inhibitor opens up opportunities for us to expand into new markets in genomics. RNA sequencing is expected to become an increasingly useful tool in both basic research and diagnostics. Moreover, the emerging clinical RNA-based technologies, such as mRNA, represent a major opportunity to contribute to improved human health, which inevitably requires reliable methods to protect RNA in multiple application areas. 

Our pipeline of new products continues to develop strongly. Our new infrastructure, combined with AI and a skilled team, generates completely new opportunities for developing enzyme products. We have launched three new products so far this year and I expect the pace of launches to remain high for the rest of the year. We have developed several new enzymes for both analytical and gene therapy applications, which will give us a broader offering when we regain the rights to our Xork enzyme later this year.

Even though our markets have generally seen reduced demand due to the limited availability of venture capital for biotech companies, I am optimistic when I see how our products are appreciated by customers and how our pipeline is steadily expanding – a result of the strong dedication our employees to our customers and to our strategic growth initiatives.

I would like to extend my warmest thanks to all my colleagues who, every day, with great dedication, help our customers in their quest to develop the medicines of the future to improve people’s lives.

Genovis Half Year Report January-June 2024

Interim Report January – March 2024

Comments from Fredrik Olsson, Chief Executive Officer

We begin 2024 with a strong operating profit and very good cash flow. Even adjusted for license revenue, we improved our performance, both compared to the first quarter of 2023 and the previous quarter. Through continuous improvements and increased capacity, we have maintained good margins despite our expanding product offering, demonstrating the scalability of our business. We have strengthened our already strong cash position, which provides both stability and freedom of movement for continued aggressive investments in growth.

First quarter sales represent the single best quarter to date for our enzyme business in analytics. Sales increased 8% organically compared to the same period last year and by 12% sequentially in relation to the fourth quarter of 2023. This sales growth should be viewed in light of the continued challenging market conditions in China, as well as the ongoing restructuring among both smaller and larger biopharma companies.

In the antibody business, sales decreased by around 30%. Underlying sales to the research market continue to grow, while customers in diagnostics are reducing their inventory levels following the pandemic, which has affected sales for the quarter. Sales to the diagnostics market are expected to recover during the year as customer inventories normalize. We have initiated programs to focus our resources on the most profitable parts of the antibody business to improve performance while adapting the business to the volatile nature of customers in diagnostics.

For enzymes aimed at potential therapeutic applications in gene therapy and other autoimmune diseases, we have initiated more business development activities ahead of formally regaining the rights to Xork™ in the second half of this year. Our development of new enzymes in this application area has also made significant progress recently and we have several new and unique product candidates in development.

Launching new products and enzymes in analytics is an important component of our growth strategy. I am extremely encouraged to see how our pipeline has continued to evolve in recent months, with our team taking advantage of the improved opportunities in our new lab and production facilities. We have already launched two new products and I expect that we will reach our full-year targets in the second quarter and that the launch rate will remain high for the rest of the year.

We see encouraging signs that access to venture capital for biotech companies has improved in early 2024. Even if we, as a supplier to these companies, are somewhat further down the chain of events, it bodes well for the future. The increasing diversification of antibody drugs continues to provide good growth opportunities for Genovis. With our constantly expanding product portfolio and the underlying growth drivers for biologics, I look forward with confidence to Genovis’ continued growth journey.

I would like to extend my warmest thanks to my colleagues at Genovis who, with great dedication, work tirelessly to help our customers in their crucial work of developing new important drugs.

Genovis Interim Report January-March 2024

Genovis Annual Report 2023 published

To read or download the annual report in Swedish, go to:

https://investor.genovis.com/wp-content/uploads/Genovis_AR_2023_Sv.pdf

To read or download the annual report in English, go to:

https://investor.genovis.com/wp-content/uploads/Genovis_AR_2023_En.pdf

For more information, please contact:

Fredrik Olsson, CEO, Genovis AB

T+46 (0)70 276 46 56

E:  fredrik.olsson@genovis.com

Press Release _annual report_2023

Genovis_AR_2023_En

Year-end report January-December 2023

Comments from Fredrik Olsson, Chief Executive Officer

Looking back at 2023, I can say that we have once again achieved our best performance to date. We increased our sales by 55% and our operating profit more than sixfold compared with the previous year. For the full year, the core business grew by 31%. Enzymes in analytics grew by 35% and the antibody business by 13%. At the same time that we moved the entire enzyme operation to new custom-built premises in Kävlinge, we have maintained our operational capacity, ensured the functionality of our new production facility, and launched 4 new products. Our 2023 launches have garnered considerable interest and have been well received by our customers. With the new products, we have expanded our offering of enzymes targeting key components of the immune system, thereby opening opportunities for new applications in analytics and potentially for diagnostic and therapeutic use in the future.

In the fourth quarter, sales rose by 6% compared with the corresponding quarter last year. For Enzymes in analytics, sales grew by 12% and the antibody business declined by 18%. The dampened pace of growth in the quarter is mainly attributable to sluggish customer activity in December. As we enter 2024, however, we note a resurgence in customer activity in line with our expectations.

Enzyme sales continued to be strongly driven by the North American and European markets, which together achieved over 20% growth in the quarter. Market conditions in China remained challenging, especially when compared with the same quarter last year. Sales of our antibody conjugation technologies continue to grow strongly as customers pursue ADC-related projects, where our products have multiple applications. The antibody business continues to be affected by volatility related to production orders for diagnostic applications, but we expect a recovery in 2024.

The development project of the Xork enzyme as a potential pre-treatment in gene therapy is making progress. Recently a development milestone was achieved that triggered a 1 million USD compensation to Genovis.

I am not satisfied with the results in the fourth quarter due to lower growth rates than in previous quarters of the year. In addition, the rapid appreciation of the SEK toward the end of the year, as well as costs related to the relocation of premises and activities related to our business development, had a negative impact on earnings of approximately SEK 3 million. Despite a weak operating profit, we show a strong cash flow for the quarter, mainly linked to improved working capital. As a result of the cash flow, we have further strengthened our cash position, affording us operational leeway to implement our strategic growth initiatives.

In December, we launched another unique enzyme for a specific type of antibodies, expanding our coverage to encompass most of the key antibodies in the immune system. Our pipeline of product development projects continues to expand in line with our long-term strategic growth initiatives. At present, it is significantly broader than previously, including several projects within existing markets for enzyme and antibody conjugation, as well as completely new markets such as Genomics. In addition, we continue to develop enzymes for potential therapeutic applications such as gene therapy, where we see a continued strong interest in new enzymes, and we now have several new enzymes under development.

Because of the growing opportunities in product development, we have implemented changes in our organization to better meet the needs of our customers and our lofty ambitions for new products in 2024. We also remain deeply committed to pursuing our strategies for inorganic growth avenues, including licensing, commercial partnerships, and acquisitions.

I would like to thank all my colleagues at Genovis for their fabulous efforts in 2023. Despite a challenging business landscape and the relocation of our operations, we achieved our best year to date. With a strong 2023 behind us and a promising start to the new year, I eagerly anticipate what lies ahead with confidence. With an expanding pipeline of innovative solutions for our growing customer base, my colleagues and I look forward to continuing to develop business at Genovis in the coming year.

Genovis Interim Report January-December 2023

Interim Report January-September 2023

Comments from Fredrik Olsson, Chief Executive Officer

We continue to show strong growth during the third quarter. Sales rose by 31% compared with the corresponding quarter last year. Growth in the core business was 41% after adjusting for license revenue. Adjusted for currency fluctuations, growth in the third quarter was 35%. Enzymes in analytics grew by 38% and the antibody business by 4%.

We saw continued strong demand for our enzyme products, mainly in the North American market, but also in Europe. Compared with the second quarter, we see some improvement in the Chinese market but sales in Asia remained sluggish due to lower customer activity in China. Other markets in Asia continued to show good growth. The subdued growth for antibodies is related to some volatility between individual quarters for production orders for diagnostic applications, but the underlying business continues to show solid growth. 

In general, we experience robust activity in our business and demand is mainly driven by major global pharmaceutical companies focusing on antibody drugs – especially new formats such as bispecific antibodies, fusion proteins and antibody conjugates, known as ADCs. Interest in our enzyme-based technologies for antibody conjugation is rising and we see good growth for our technologies, particularly in connection with a general increase in interest in the development of ADCs as a therapeutic modality. These drugs are also more complicated to analyze, which drives enzyme sales for biochemical analysis of ADCs.

With a clear commercial focus, coupled with our investment in our sales and marketing organization, we continue to drive growth. In a challenging market landscape, we leverage our increasingly diverse range of offerings to recognize and seize business opportunities. Through a collective effort and strong support from every facet of the organization, we have kept our momentum robust and ensured our operational effectiveness during this period, all while relocating laboratories to new premises. Our product development is following our activity plan, where we have launched three products so far this year. I expect additional product launches toward the end of the year and our pipeline for 2024 includes several strategic projects to support our future growth ambitions.

The third quarter was characterized by our move to new, specially designed premises that offer improved opportunities for scaling up and continued growth. The new facilities and related investments have therefore impacted our cost base. In addition, we had non-recurring costs of just over SEK 1 million during the quarter related to the move and double rent expenses, which will gradually diminish as the year comes to an end.

I am pleased with our robust growth and earnings for the quarter, especially in light of the investments and temporary costs related to our growth aspirations. Adjusted for non-recurring costs, our operating profit has improved year-on-year. Our ability to maintain strong growth in a challenging market landscape with industry-specific and macroeconomic challenges shows that our continuously expanding offering creates value for our customers. As we continue to invest in future growth prospects, our strong cash flow enhances our liquidity, empowering us to proactively seize opportunities as they emerge.

I would like to convey my heartfelt thanks to all my colleagues at Genovis who work tirelessly to assist our customers in their efforts to develop and manufacture the medicines of the future. I would also like to extend a particularly warm thank you to all employees who have done a fantastic job over a long period of time, enabling our move to brand new premises – another milestone in the growth journey at Genovis.

Genovis Interim Report January-September 2023

Half-Yearly Report January-June 2023

Comments from Fredrik Olsson, Chief Executive Officer

In the second quarter, we continue to show strong growth in the business. We grew revenue by 40% compared with the corresponding quarter last year and show growth in both the enzyme and the antibody business. Our strong growth in the core business, where enzymes in analytics grew by 43% and the antibody business by 24%, reflects our increasingly broad range of products that continue to be developed in close dialogue with our customers and our investment in the commercial organization.

We see a continuation of the strong development in the US and Europe, while Asia remains weaker due to generally subdued customer activity in China. In general, we have good activity in our business and demand is widely distributed across our growing product portfolio. We perceive a gradual increase in the focus on inflammation and immunological diseases in the pharmaceutical industry, where several technologies in our offering are relevant. Moreover, we see an increase in investments in next-generation mRNA technologies and note that our products are being used and evaluated in several mRNA projects.

During the quarter we launched two new enzymes and licensed our first enzyme for the genomics market. IgMBRAZOR™ is a proprietary enzyme that cleaves IgM antibodies with high efficiency and precision, and ImpARATOR™ broadens our offering in glycan analysis. The first orders for both products were delivered to customers in June and initial feedback has been positive. For our genomics enzyme, we have initiated the transfer of technology from the inventors and started work on developing the production process. Our plan is to start the commercialization of the enzyme in early 2024. In May, encouraging preclinical data on ASCGT were presented within the framework of our collaboration with Selecta.

The strategic strengthening of our commercial organization, which was carried out last year, along with good momentum in our product development, have positioned us well for the future. Sales growth is strong despite a general weakening of the macroeconomy, which has also affected parts of our industry, where access to venture capital for biotech companies is currently challenging.

The second quarter was characterized by a flurry of activity ahead of our move to new, specially designed premises that offer improved opportunities for scaling up and continued growth in the business. We continued to invest in infrastructure and in the beginning of the third quarter we initiated our relocation. We have protected the operational capability of certain parts of the business to ensure our ability to deliver during the relocation period. The move is expected to be completed by the beginning of the fourth quarter.

I am of course extremely pleased with our performance for both the second quarter and the first half of the year. We have almost doubled our revenue compared with the previous year, while increasing our operating profit fivefold. At the same time that we are investing for our future growth with new premises, and while continuing to pursue a highly active product development strategy, we are also maintaining a strong cash position that provides opportunities for further aggressive investments.

The start of the third quarter continues to show good customer activity and I look forward to further developing and growing our business in new premises together with my colleagues at Genovis – who continue to do a fantastic job of helping our customers in their quest to develop the medicines of the future.

Genovis Half Year Report January-June 2023

Interim Report January-March 2023

Comments from Fredrik Olsson, Chief Executive Officer

We started the first quarter of the year with record-breaking sales, making it our single best quarter ever. Revenue increased by 119%, driven by gene therapy license revenue, and at the same time we delivered our best quarter ever for the core business.

Growth in our core business was 41%, where enzymes in analytics grew by 38% and the antibody business by 60%, which is the single best quarter for each segment respectively to date. We mainly saw strong development in both the US and Europe, while Asia was slightly weaker due to sluggish customer activity in China. In general, we see continued robust activity in our business.

During the quarter, we launched a further developed product based on our GlySERIAS enzyme, which continued to show solid sales growth at the beginning of the year. Our product development continues to have good momentum with additional product launches planned during the year. Our collaboration with Selecta Biosciences in gene therapy is following the established development plan and preclinical data will be presented at ASCGT in May. Our sales and marketing team continued to create good activity in our markets, aided by strong support from development and production, as well as application and support.

In April, we acquired the patent rights to a new enzyme for analyzing DNA. This is our first enzyme in genomics with applications in research, diagnostics and forensics. During the year, we will work on developing applications with the enzyme together with partners for future commercialization.

To further strengthen our local presence and commercial capability in China, we have initiated a collaboration with ArcticZymes Technologies. Both companies have unique enzymes with high customer value for the global Life Science industry and together they open up opportunities for a stronger commercial organization and development in the Chinese market.

In the second half of the year, we will move the business to new, specially designed premises that offer improved opportunities for continued growth and scaling up of the business. At the beginning of the year, we started investing in equipment and furnishings, which will continue in the second quarter with the move planned for the third quarter.

I am of course extremely pleased with our performance at the beginning of the year. It is particularly satisfying that all parts of the core business show strong growth and that we have maintained a good gross margin despite increased raw material costs. Much of the increase in the total cost base compared with the previous year is linked to the licensing deal with Astellas, with respect to both incentives and royalty to inventors.

With an outstanding performance, a strong start to the year and good customer activity, I look forward to Genovis’ continued growth journey. I would like to thank my colleagues at Genovis who work hard every day to find the optimal solution to the challenges that our customers face.

Genovis Interim Report January-March 2023

Genovis Annual Report 2022 published

To read or download the annual report in Swedish, go to:

Årsredovisning 2022

To read or download the annual report in English, go to:

Annual Report 2022

Press Release _annual report_2022

Genovis_AR_2022_En

Year-end Report January-December 2022

Comments from Fredrik Olsson, Chief Executive Officer

In the fourth quarter we continued to have strong sales growth of 38% in the core business. For enzymes in analytics, sales increased 30% and in the antibody business growth was 80% year over year. We also see continued high customer activity in all geographic markets at the start of the year.

We experienced continued good customer activity in our markets during the quarter. New products continue to expand our business toward multiple applications and future medicines in a very satisfying manner. Over the course of the year we added a total of four new products that have been very well received by our customers. Products developed and launched in recent years are showing strong growth and taking an increasing share of our overall business. This is very gratifying and validates our ability to execute our strategy of customer-driven innovation.

Our collaboration with Selecta Biosciences for the Xork enzyme in gene therapy is being developed with several potential customers who are interested in our joint offering. At the beginning of the new year, Selecta sublicensed the enzyme to Astellas Pharma for use together with their gene therapy candidate for treatment of Pompe Disease. In addition to the early revenue of approximately SEK 42 million, this is an important reference deal that opens up further business opportunities for Xork in other gene therapy indications.

The expansion of our sales and marketing organization initiated during the year was fully implemented by the end of 2022, completely on track. We have consistently seen results from our efforts in different geographies and segments. Excluding license revenue from Selecta, our enzyme business grew by 29% during the year and antibody sales increased by 38%.

I am of course not satisfied with the operating profit and cash flow in the fourth quarter 2022. However, they were weighed down by a one-time cost after we decided to refund parts of an insurance claim related to a patent dispute in 2014, therefore disconnected from our business, which continues to develop well. Our liquidity remains robust and together with license revenue from Xork we will have over SEK 100 million in cash and cash equivalents in the first quarter 2023, providing us with both strength and opportunities for continued aggressive investment.

I would like to thank all of my colleagues at Genovis for their fabulous efforts in 2022. Our growing team has, despite a challenging environment and economic turbulence, done an outstanding job of navigating through the year.

I look forward with confidence to developing Genovis’ business together with our growing team in 2023 and continuing our growth journey based on innovative solutions for our expanding customer base in the biopharma industry and their aspiration to develop medicines for the future.

Genovis Year End Report Jan-Dec 2022 EN