Bioventix plc

("Bioventix" or "the Company")

Results for the year ended 30 June 2025

Bioventix plc (BVXP), a UK company specialising in the development and commercial supply of high-affinity monoclonal antibodies for applications in clinical diagnostics, announces its audited results for the year ended 30 June 2025.

Highlights:

• Revenue down 4% to £13.1 million (2024: £13.6 million)

• Profit before tax down 5% to £10.1 million (2024: £10.6 million)

• Cash at year end of £5.1 million (30 June 2024: £6.0 million)

• Second interim dividend of 80p per share (2024: 87p)

• Total dividends 150p per share (2024: 155p)

Introduction and Technology

Bioventix creates, manufactures and supplies high affinity sheep monoclonal antibodies (SMAs) for use in diagnostic applications.  Bioventix antibodies are preferred for use when they confer an improved test performance compared to other available antibodies. 

Most of our antibodies are used on blood-testing machines installed in hospitals and other laboratories around the world.  Bioventix makes antibodies using our SMA technology for supply to diagnostic companies for subsequent manufacture into reagent packs used on blood-testing machines.  These blood-testing machines are supplied by large multinational in vitro diagnostics (IVD) companies such as Roche Diagnostics, Siemens Healthineers, Abbott Diagnostics & Beckman Coulter.  Antibody-based blood tests are used to help diagnose many different conditions including, amongst others, heart disease, thyroid function, fertility, infectious disease and cancer. 

Testosterone is an example of a blood test where a Bioventix SMA has facilitated an improved test.  In 2003, it became clear that testosterone tests performed on automated IVD platforms were deficient.  Whilst the higher levels of testosterone in healthy adult males were accurately reported, the lower levels of testosterone in pre-pubescent boys and women were inaccurately reported.  In 2005, Bioventix created an antibody called testo3.6A3 which was evaluated by customers during 2006.  Evaluations were successful and following the necessary regulatory approvals, the first testosterone assays based on testo3.6A3 were launched in 2009.  A number of IVD companies still use this antibody for revised tests that more accurately measure lower levels of testosterone. 

Over the past 20 years, we have created and supplied approximately 30 different SMAs that are used by IVD companies around the world.  We currently sell a total of 15-20 grams of purified physical antibody per year which accounts for 25-30% of our annual revenue.  In addition to revenues from these physical antibody supplies, the sale by our customers of diagnostic products (based on our antibodies) to their downstream end-users attracts a modest percentage royalty payable to Bioventix.  These downstream royalties currently account for the remaining 70-75% of our annual revenue. 

Bioventix adopts different commercial and scientific approaches when creating new antibodies.  The first is own-risk antibody creation projects which gives Bioventix the complete freedom to commercialise the antibodies produced.  The second is contract antibody creation projects in partnership with customers who supply materials, know-how and funding and to create antibodies that can only be commercialised with the partner company.  More recently, a third route of product development through collaborative research has become important and is exemplified by our work on the diagnosis of Alzheimer's through tau blood tests with the University of Gothenburg.  In all cases, after initiation of a new project, it takes around a year for our scientists to create a panel of purified antibodies for evaluation by our customers.  The evaluation process at customers' or academic collaborator's laboratories generally requires the fabrication of prototype tests which can be compared to other tests, for example the customer's existing commercial test or perhaps another "gold standard" method, on the assay machine platform being considered.  The process of subsequent development thereafter by our customers can take many years before registration or approval from the relevant authority, for example the US Food and Drug Administration (FDA) or EU authorities, is obtained and products can be sold to the benefit of the customers, and of course Bioventix, through the agreed sales royalty.  This does mean that there is a lead time of 4-10 years between our own research work and the receipt by Bioventix of royalty revenue from product sales.  However, because of the resource required to gain such approvals, after having achieved approval for an accurate diagnostic test using a Bioventix antibody, there is a natural incentive for continued antibody use.  This results in a barrier to entry for potential replacement antibodies which would require at least partial repetition of the approval process arising on a change from one antibody to another.  This barrier to antibody replacement arises from a combination of factors driven by the clinical criticality of the test and the potential consequences of making such a change which include the time and cost to register any changes required to validate the performance of the replacement antibody. 

Another consequence of the lengthy approval process is that the revenue for the current accounting period is derived largely from antibodies created many years ago.  It is noteworthy that in the new field of neurological assays, this dynamic has evolved with the relatively rapid launch of "research use only" (RuO) products by our customers. 

2024/2025 Financial Results

Bioventix is evolving from the generation of value from our historical product set of core antibodies into a business with increasing expertise and reach in the creation of antibodies for application in the diagnosis of a range of neurological conditions and diseases.  Our results for the financial year ended 30 June 2025 reflect this evolution with revenues for the year decreasing by 3.6% to £13.1 million (2023/24: £13.6 million).  Profits before tax for the year decreased by 4.8% to £10.1 million (2023/24: £10.6 million).  Cash balances at the year-end were £5.1 million (30 June 2024 £6.0 million). 

Our most significant revenue stream continues to come from the vitamin D antibody called vitD3.5H10.  This antibody is used by a significant number of diagnostic companies around the world for use in vitamin D deficiency testing.  Sales of vitD3.5H10 increased by 12% to £6.6 million which was slightly ahead of expectation considering conditions in the downstream market, in particular in China. 

We have reported previously that we have achieved consistent material growth in the sales that we make directly to Chinese IVD companies.  In the year 2024/25 such sales totalled £2.4 million representing 18% of our total revenues (a reduction of approximately 7% of our total revenues compared with the previous year). 

As noted in previous results, important aspects of the Chinese commercial landscape are going through a process of change.  As well as the China First policy in promoting local manufacturing, another major driving force for change is the Chinese Central Government procurement policy that aims to continually reduce all costs, including those of healthcare. 

This has led to continued price pressure on final IVD assay sales prices in the local Chinese downstream market and consequently there are two trends that adversely affect Bioventix.  Firstly, we believe that our longstanding Western IVD customers are suffering both a loss in volume, as Chinese IVD companies secure market share, and price erosion, because of the policy of cost reduction.  Both factors reduce the royalties we earn for assays used in China that are based on our antibodies.  It is difficult to quantify the precise effect of these lost sales as our customer royalty reports do not contain either the geographic detail or the detail of the volume and prices of their product sales.  Secondly, local Chinese IVD companies who have used Bioventix antibodies are being motivated to seek cheaper, royalty-free local alternatives to sustain their own businesses.  Changing the antibodies used in assays consumes precious resource and is generally undesirable but might be prompted by a product's economic viability.  We believe that the pressure to switch to cheaper antibodies will continue in both the short and medium terms with perhaps 2% of our annual revenue at risk in the short term and potentially an additional 3%-4% also at risk in the medium term.

The recent impact of these market factors has resulted in the following increase/decrease (+/-) in our sales compared to the previous year 2023/24:

- T3 (tri-iodothyronine): £.1.46 million (+6%)

- biotins and biotin blockers: £0.69 million (-40%)

-  progesterone: £0.53 million (-16%)

-  estradiol: £0.42 million (-19%)

-  testosterone: £0.33 million (+1%)

-  drug-testing antibodies: £0.18 million (-43%)

In addition to the impact of external factors such as dynamics in the Chinese market there will also be changes reflecting our historic commercial structure and success built on supply and royalty contracts with lifetimes of between 10 and 15 years from the first use of our antibodies by our customers and approximately £200k of annual progesterone sales will be lost in the next financial year.

Disappointingly, troponin sales have remained flat year on year.  We had anticipated that our royalties would grow in line with increased sales of our customers' troponin assays stimulated by a new application for troponin testing outside the historic acute chest pain application (i.e. suspected heart attack) in A&E centres.  It has been shown that testing in patients with existing medical conditions, known to elevate the risk of a future adverse cardiac event, can benefit from troponin testing to help quantify such risk.  For example, the American Diabetes Association recommended regular cardiac testing of diabetes patients in 2022 (ADA/ACC Consensus report, Pop-Busui et al. Diabetes Care 2022:45:1670).  These positive advancements have not yet led to increased troponin royalties and we believe that this is due to the lead time taken for such initiatives to translate into changes in clinical practice.  Whilst we are unable to predict when we will see the resulting increased volumes, we remain positive that troponin royalties will start to deliver growth in 2026 and beyond.  As previously disclosed, Siemens troponin revenues will terminate for contractual reasons in June 2032. 

Over the course of the financial year 2024/25 our activities in the increasingly important field of neurology diagnostics have advanced, not only in our work with academic partners on the underlying science, but also on the development of key products and commercial relationships with our IVD customers.  We now have three Tau antibodies being made at scale in our manufacturing facility.  In addition to this, three newer antibodies are currently moving into large scale production.  We have been delighted with the response to evaluation samples of antibodies supplied to our customers and our SMAs now feature in several Research use Only ("RuO") assays.  These RuO assays are being commercialised by specialist high sensitivity platform companies, such as Quanterix and Alamar, as well as being provided by IVD companies for evaluation on a global scale. (Details of our Neurology pipeline are included in the Company's slide presentation and in the Annual Report.)

The volume of such RuO assays is much higher than we had previously expected and reflects the growing interest in and importance of new neurology assays.  In particular, RuO assays are being used as part of pharmaceutical clinical trials and by key opinion leaders on Alzheimer's disease for live population studies and for analysing frozen samples from human biobank resources. 

Total Tau/neuro SMA sales during the year increased fourfold from £155k in 2023/24 to £605k, comprising £530k of physical antibody sales and £75k of product royalties. 

The use of our antibodies in such RuO assays is very encouraging and bodes well for future IVD use.  However, we are fully aware that approved clinical use of IVD assays in future will be a key milestone and would represent a significant increase in the realisation of value.  

We estimate that 50-60% of our total sales are directly linked to US Dollars via physical product pricing in US Dollars or indirectly linked to US Dollars via royalties based on downstream US Dollar sales.  The remainder of the currency split is dominated by Euros and important Asian currencies.  Currency effects in the financial year reduced turnover, on a constant currency basis turnover would have been c£250k higher at c£13.4m.  In addition, there was also a loss of approximately £170k due to adverse currency movements.  Our view continues to be that hedging mechanisms would not, in the longer term, add value and may have the potential to add risk to our business.  Consequently, future movements in exchange rates may therefore affect our Sterling revenues. 

Cash Flows and Dividends

As reported above, the performance of the business during the year generated cash balances at the year-end of £5.1 million and royalties received during quarter 3 of 2025 have added to this balance. 

In consideration of our established dividend policy and the available cashflows, the Board is pleased to announce a second interim dividend of 80 pence per share which, when added to the first interim dividend of 70 pence per share makes a total of 150 pence per share for the current year. 

Accordingly, a dividend of 80 pence per share will be paid in November 2025.  The shares will be marked ex-dividend on 6 November 2025 and the dividend will be paid on 21 November 2025 to shareholders on the register at close of business on 7 November 2025.

Research and Future Developments

In addition to the Tau/neuro commercial developments above, our research continues and we are making new antibodies that could feature in additional blood tests to better assess the level of Tau pathology, a critical parameter of interest to neurologists in the field of Alzheimer's disease.  Additional areas of neurology diagnostics also feature in our pipeline developments.  Peripheral neuropathy (i.e. non-brain related neuropathy) and cerebral amyloid angiopathy (amyloid build-up in brain blood vessels) are two such research activities currently being undertaken by our team in our laboratories. 

Bioventix has been working with the University of Gothenburg since early 2020 to create new antibodies to Tau and to develop prototype assays for use in Alzheimer's disease.  This collaboration has been a key to our growing success in this field, and we plan to continue our work with this world-leading research facility into the future.  The view of many neurological opinion leaders, shared by our IVD customers, is that blood-testing machines will soon offer a panel of new neurological tests that will reveal information about patient brain health which will be useful for screening and therapy monitoring purposes. 

Whilst not of the same potential value as our activities in neurology diagnostics, we have continued our work on sewage contamination of rivers and lakes.  We now have sensitive lab-based ELISA assays for paracetamol and caffeine that can detect levels of drugs equating to 0.1-1.0% of raw sewage contamination in "fresh" waters.  We are currently working with volunteer groups to conduct field trials aimed at better understanding the link between drug levels and Escherichia coli ("E.coli"), a significant concern for sewage contamination in waterways.  Lateral flow systems are progressing well, and we plan to incorporate such user-friendly devices into further field trials in 2026.  Lateral flow tests, made from biodegradable materials, will allow for much greater intensity and geographical coverage of analysis that will be available to all the many interested parties. 

Pre-Diagnostics (in Oslo) and their clinical collaborators have two amyloid beta assays based on Bioventix antibodies available for research use.  A current focus for Pre-Diagnostics is ARIA (amyloid related imaging abnormality) which is an important side-effect of new anti-amyloid drugs for Alzheimer's.  Pre-Diagnostics assays relate to amyloid metabolism and could help screen for ARIA vulnerable patients, before or during treatment. 

Our pyrene lateral flow system for industrial pollution biomonitoring is proceeding steadily as planned.  We have now completed a second manufacturing batch of lateral flow cassettes and intend to conduct further field trials with firefighters during 2026.  The follow-on project for benzene exposure has not progressed so well and we are concerned that the test detects other pollutants in addition to benzene.  This does compromise the merit of this project. 

The industrial biomonitoring and water pollution projects have required significant external expenditure during the year of approximately £340k.  As we develop the projects, we expect expenditure to continue and grow modestly into the future.  Using our cash resources to support the steady internal organic growth of our business has been a consistent feature of our strategy. 

Future Strategy

We have previously identified diagnostic biomarkers that we believe suit our antibody technology and have found academic collaborators who have seen merit in working with Bioventix.  The Tau project and our collaboration with the University of Gothenburg is an excellent example of this strategy and we will seek additional such opportunities in the future. 

We will continue to rely on our core SMA antibody creation technology which consistently helps us to create superior antibodies for our research projects.  We are also incorporating additional newer technologies where such technologies are helpful to us. 

The Bioventix Team and Facility

The composition of the Bioventix team remains at 12 full-time equivalents (14 staff in total) with one member of staff having retired during the year and one new graduate recruited from the local community.  This level of stability has formed an excellent base upon which we have been able to build our new products moving into the exciting new areas described above.  We are very fortunate to have such a dedicated and loyal team and we are grateful to them for their continued enthusiastic input and support. 

The Board has conducted a series of interviews seeking to appoint a further independent non-Executive Director.  We have made progress and expect to report further on this in due course. 

Conclusion and Outlook

This year has been particularly noteworthy as our historic core business has faced some challenges in downstream markets, particularly in China.  Meanwhile, our research and commercialisation of antibodies in the field of neurology has experienced significant progress.  The vision of our customers for growth in this exciting field together with the performance of our antibodies at many of our customers points to future success in this area. 

We expect the year to 30 June 2026 will follow a similar pattern to this year with a number of headwinds remaining within the historic core business.  As a result, we anticipate a modest decline in revenues in 2025/6 with future growth driven by the substantial opportunities in neurology and greater use of troponin testing outside the historic acute chest pain application.

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This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018 ("MAR"), and is disclosed in accordance with the company's obligations under Article 17 of MAR.

STATEMENT OF COMPREHENSIVE INCOME

FOR THE YEAR ENDED 30 JUNE 2025