Year-end ReportQ42022

CEO's comments

We are continuing our efforts to ensure that DiviTum TKa is commercially successful and a benefit to patients who are being treated for cancer.

In the USA, those efforts are focused on signing agreements with payers and caregivers. This is how we are laying the foundation for a successful market introduction and achieving our ambitious sales targets.

These agreements will ensure that we reach many patients and establish an attractive price level that is on a par with, or higher than, what we have previously communicated. The agreements also ensure that there is a process in place for quickly getting paid, with a minimal amount of administration.

Thus far, our sales team has succeeded in getting two agreements signed, which are with MedINcrease and Contigo Health. They are both Preferred Provider Organizations (PPOs), which are health plans that supplement ordinary health insurance and are something that many employers offer their employees as a benefit. We anticipate that we will soon be signing more agreements in the USA.

Together, these agreements ensure cost reimbursement of DiviTum TKa to millions of policyholders in the USA, particularly via the agreement with Contigo Health, which is by far the largest.

Another area that is important to a successful launch is geXng DiviTum TKa included for reimbursement by Medicare, which is the federal health insurance program in the USA. We've made progress with this as well. Our Medicare Enrollment applicaZon has been approved, which means that we will be able to submit claims for reimbursement to Medicare.

Thus far, we are being referred to a general code, which involves a more cumbersome

administraZon process and challenging discussions around the price when we seek cost reimbursement from Medicare.

All of this will be solved by obtaining a unique PLA code for DiviTum TKa. We made progress on that front prior to the end of the financial year by submiXng our applicaZon to obtain such a code. We are expecZng to receive feedback on that someZme during the fall of 2023.

In Europe, we have made some significant progress too. We signed commercial partnership agreements with both the Italian company, IT Health Fusion and TOROMEDICAL Group, covering the Netherlands and Poland. These agreements cover price levels that are on a par with, or slightly above, what we have previously communicated.

The Italian market is one of the largest in Europe and we have strong support there among Key Opinion Leaders (KOLs). We also have high ambitions for the Netherlands, where we have a nationwide study underway, as well as the strong support we have from KOLs there.

We are looking forward to the 2023-2024 financial year and introducing DiviTum TKa in these markets, along with signing more agreements in Europe.

There is much interest from pharmaceuZcal companies and robust growth in this area, albeit from low levels thus far. We are striving for exponenZal growth in our sales to pharmaceuZcal companies in the years ahead. There is enormous potenZal in being able to sell the assay as a companion diagnosZc to one of the cancer drugs that is currently under development. And, the more collaboraZons we are involved in, the greater our likelihood of succeeding with that.

Right now, we are facing a difficult environment in the financial market where risk appetite is low. It is a drastic change compared to a year ago. The rights issue we executed during fall 2022 reflects this and it means that we must be cost conscious and careful with our commercial and clinical investments.

Despite these challenges, our outlook for the future is positive because we are certain that DiviTum TKa can make a difference in the lives of patients with cancer. Our full focus is thus on quickly making the assay available to as many patients as possible so that it can improve their lives and benefit both caregivers and payers. We are excited and optimistic as we look forward to an interesting FY2023- 2024.

Significant events during the period

Biovica obtains CLIA certification

Biovica's laboratory in San Diego has obtained CLIA certification, which means that the company can start its commercial sales of the newly approved FDA assay, DiviTum® TKa.

The Clinical Laboratory Improvement Amendment (CLIA) is run by the Centers for Medicare & Medicaid Services (CMS), which regulates laboratories performing tests and diagnostics on human samples so ensure that they meet the requirements on accuracy, reliability, and reporting of patient test results. Biovica obtained certification for its laboratory from the California Department of Public Health.

Biovica signs a commercial partnership agreement for the use of DiviTum TKa in the Netherlands and Poland

Biovica has signed an agreement with TOROMEDICAL Group for commercialization of DiviTum TKa in both the Netherlands and Poland. TOROMEDICAL will be using its own sales force to actively market the product in those countries. Preparations for the launch are already underway.

Biovica signs a commercial partnership agreement for the use of DiviTum TKa in Italy

Biovica has signed an agreement with the Italian company, IT Health Fusion for commercialization of DiviTum TKa in Italy. IT Health Fusion, a subsidiary of BIOVIIIx, will be leading the Italian market introduction of DiviTum® Tka with its own sales team. Focus will initially be on private insurance and direct payments from customers (out-of- pocket), which together comprise approximately 40 percent of the Italian market.

Significant events after the end of the period

Extraordinary General Meeting in May 2023

Decision to issue new stock options (for a maximum amount of 168,000 stock options) and performance share program (for a maximum amount of 56,000 performance shares) for employees in the USA

Commercial agreements for clinical use in the USA

Biovica signed its first commercial agreement for clinical use in the USA. The agreement is with MediNcrease Health Plans and it offers 15 million policyholders in the USA access to DiviTum TKa via their employer-sponsored health insurance.

New commercial agreement for clinical use in the

USA

Biovica signed its second commercial agreement for clinical use in the USA. This agreement is with Contigo Health ConfigureNet. It is the company's largest commercial agreement to date and it offers many millions more policyholders in the USA access to DiviTum TKa via their employer-sponsored health insurance.

Other

2023 AGM

Biovica's Annual General Meeting will be held on 5 September 2023 in Uppsala. Notice of the AGM will be published on Biovica's website, in Post- och Inrikes Tidningar (gazette) and in SvD (newspaper). The Board of Directors proposes that no dividends should be distributed to shareholders.

Q4 - Sales and earnings

Net sales for the period amounted to SEK 587 (1,082) thousand. Sales in the fourth quarter are derived from kits sold to pharmaceutical companies, as well as analysis services that have been provided to them. The decline compared to the same period last year is attributable to one of Biovica's customer's drug candidate having failed. Over the full year, we have noticed a significant increase in interest. Please see the comments for the full year, below.

Capitalized work performed by the company for its own use amounts to SEK 369 (816) thousand. Capitalized expenditure pertains to the expenditure for development of the latest version of DiviTum TKa. In accordance with plan, final development was completed during the year. This version will initially be offered as a research product, primarily to the pharmaceutical industry.

The operating loss for the period was SEK -37,208 (- 19,132) thousand.

The cost increase compared to last year is primarily attributable to activities to prepare for commercialization of DiviTum TKa, which includes hiring a sales team in the USA and setting up the CLIA laboratory in San Diego.

Net financial items amounted to SEK 6 (59) thousand. Loss after financial items was SEK - 37,202 (-19,073) thousand. Loss for the period was SEK -37,700(-19,056) thousand.

The average number of employees for the quarter was 35 (25) employees, of which 14 (12) are women.

Group's total operating expenses.

Capitalized expenditure pertains to the expenditure for development of the latest version of DiviTum TKa. In accordance with plan, final development was completed during the year. This version will initially be offered as a research product, primarily to the pharmaceutical industry.

The operating loss for the period was SEK -110,457(-60,101) thousand. The lower earnings compared to last year are in accordance with plan and primarily attributable to activities in preparation of the commercialization of is used TKa, which includes the hiring a sales team in the USA and setting up the CLIA laboratory in San Diego.

Financial position, funding and investments

The closing amount for cash & cash equivalents on 30 April 2023 was SEK 114,327 (89,792) thousand. In December 2022, a rights issue was completed to secure capital for the company to launch DiviTum TKa. The rights issue raised capital of SEK 148 million prior to issue costs. Biovica has concluded that its cash holding of SEK 114 million are sufficient for meeting the needs of the business through March 2024. Accordingly, at the time of publishing this year-end report, the company has not secured the necessary funding for at least the next twelve months. The Board has a plan for guaranteeing the company's financing that includes various alternatives, such as a new issue. The various alternatives are being evaluated to arrive at the most attractive solution from the perspective of both the company and its shareholders. The Board and management have concluded that there are good options for obtaining the necessary capital during fall 2023.