Biovica International

Significant events during the first three quarters

• The first commercial agreements in USA were signed with MediNcrease Health Plans, Contigo Health and Occum Health.
• Results from the SWOG study (S0226) presented at ASCO.
• Biovica obtains PLA code for Medicare.
• Biovica announced the start of a prospective DivTum® TKa clinical trial in partnership with Yale Cancer Center.
• The company's CLIA Lab obtained CAP accreditation.
• Biovica signed agreement with world-renowned cancer clinic in Florida.
• Resolution by the Board to conduct a rights issue of SEK 120 million.
• Biovica signed commercial agreement with Axlab A/S in the Nordics.
• Biovica received final pricing decision on DiviTum TKa from Medicare effective 1 January 2024.
• Resolution on change to the Articles of Association and rights issue at EGM.
• Biovica published the results from the rights issue.
• Biovica signed commercial agreement with Palex Group in Spain and Portugal.

Significant events during the fourth quarter

• Biovica signed master service agreement for TKa testing with leading pharma company (value of first order, SEK1.7 million).
• Biovica signed another master service agreement with Biopharma company (value of first order, SEK 1.2 million).
• Interventional DiviTum Tka trial initiated with Washington University.
• Biovica received positive patent notification for immunotherapies.
• DiviTum TKa in observational trial at Mayo Clinic in Florida
• Biovica will save SEK 30 million/year and is investigating a new go-to-market model in the USA.

Significant events after the end of the period

• DiviTum TKa results presented at ASCO, the world’s largest cancer conference

Webcast:
When: 18 June 2024, 3 PM to 4 PM CET
Where: registration via lyyti: https://www.lyyti.in/Biovica_Q4_Earnings_call_2024__Live_Event_5908
Broadcast language: in English

CEO’s comments

Biovica made significant progress with sales during the fourth quarter 2023/2024. A positive thing to highlight is the sales trend in the USA. Our efforts to introduce DiviTum® TKa to the US market is beginning to yield results in the form of higher sales. The trend from the third quarter has persisted and further strengthened. During the fourth quarter, sales increased in the USA by more than 50% compared to the preceding quarter. It means that our sales in the fourth quarter were higher than the accumulated sales of the previous three quarters and the number of unique patients nearly doubled during the quarter. The trend continued in May, which means that our accumulated sales since the launch in 2023 have surpassed SEK 1 million in the USA. This is an important milestone for becoming cash flow positive during the second half of 2025.

There was also positive sales growth in Pharma Services during the quarter. We have established ourself as an important partner for pharmaceutical companies that are developing new, targeted treatments for cancer and our goal of signing our first agreement for a Companion Diagnostic (CDx) development project is within reach.

In total, sales during the fourth quarter amounted to SEK 1.9 (0.6) million. For the entire fiscal year, our sales were SEK 7.3 (3.4) million. This was under the goal of SEK 10 million, but we end the fiscal year with a positive trend that bodes well for the coming quarters.

In April, we implemented a cost-savings program that will reduce costs by SEK 30 million per year, with an associated restructuring cost of SEK 8 million. We are retaining most of our sales force and they continue to cultivate our customers with good results.

The feedback from our sales force, who are meeting with oncologists on a daily basis, is very positive. Oncologists who treat patients with CDK inhibitors – the standard treatment for metastatic breast cancer – see a great need for a tool that helps them monitor their patients and assess whether the treatment is effective or not. In addition, the FDA initiative called Project Optimus, aimed at reforming and improving dose optimization, generates a greater need for a biomarker such as what is offered by DiviTum TKa.

Our clinical collaborations with academia also progressed during the quarter. For example, an observational trial with DiviTum TKa at Mayo Clinic in Florida was initiated during the quarter, as well as a clinical trial, BettER that was launched at Washington University School of Medicine in St. Louis. The study at Mayo Clinic involves 100 patients to investigate the potential of DiviTum TKa as a predictive biomarker. BettER is an interventional trial aimed at using biomarker-driven insights to adapt therapies and reduce unnecessary toxicity, thereby improving patient outcomes. These studies are expected to strengthen our already strong documentation and contribute to the desired outcome of having DiviTum TKa included in clinical guidelines and payment systems.

During the quarter, we also received a positive International Preliminary Report on Patentability (IPRP) covering the use of TKa as a prognostic and monitoring marker for immunotherapies. In addition, the European Patent Office (EPO) has concluded that all our claims are novel and innovative, which paves the way for a quicker patent process in Europe. An approved patent makes it possible to create unique, protected value propositions in an area that greatly benefits patients and opens up possibilities for expanding Biovica's market potential even more.

Rapid developments are happening in the area of cancer diagnostics and treatments, all of which is positive for Biovica given the increasing focus on personalized medicine and biomarker-driven treatments. The trends are aligned with our efforts and we are well positioned thanks to DiviTum TKa. We made significant progress within the company during the year and there are many external factors impacting Biovica and DiviTum TKa in a positive way.

At the same time, there are challenging factors in the outside world that could negatively impact the company, such as regulatory changes, the competitive situation and economic factors that could impact the company’s operations, financing and strategic plans. We are still being impacted by the persistent high interest rates, which has lowered the risk appetite of investors. Focusing on sales and keeping costs down is the best way for us to meet those challenges. Thanks to the enormous dedication of our employees, we have continued to develop the business despite these challenging times.

The rights issue during the third quarter makes it possible for us to continue building on the good start for DiviTum TKa in the USA and Europe, along with expanding our cooperations in the pharmaceutical industry. We are dedicated to creating value for patients with metastatic breast cancer and for our shareholders.

Anders Rylander, CEO