Significant events during the second quarter

• Resolution by the Board to conduct a rights issue of SEK 148 million
• Summons to extraordinary general meeting on 7 November
• CLIA laboratory application submitted
• Anders Morén appointed CFO, starting 1 January 2023

Significant events after the end of the period

• Resolution on rights issue passed at the extraordinary general meeting on 7 November 2022
• Abstract and poster at SABCS on TK IMPACT study
• Abstract and poster at SABCS on results from MA38 study
• Sales team in place for launch in the USA from December.
• Successful outcome for the rights issue. SEK 148 million in capital raised, prior to issue costs.
• CLIA certification expected during the first quarter 2023

Webcast:
When: 15 December 2022 at 15.00 CET
Where: registration via lyyti
Broadcast language: in English

CEO’s comments
A defining characteristic of Biovica’s second quarter was market approval for our assay, DiviTum® TKa from the FDA, which we received just prior to the start of the second quarter. Obtaining FDA approval is one of the most important milestones in the company’s history and it is crucial to realizing the commercial potential of the assay. We are now able to market and sell it in the US market as a tool for monitoring disease progression in post-menopausal women with hormone receptor positive metastatic breast cancer. In the USA, there are around 168,000 women who have metastatic breast cancer, for whom DiviTum® Tka could be used to monitor their treatment. The market potential of the US market is estimated at USD 200-350 million per year and our goal is to have claimed 15% of that market three years after the launch.

In the USA, the test will be offered via the laboratory that we have set up in San Diego. It must first become CLIA-certified however before we can offer our customers DiviTum® Tka-analyses from the lab. The application was submitted in October and we have received feedback that the regulatory agency, California Department of Public Health (CDPH), will conduct an inspection in January 2023, which is why we now anticipate that the laboratory will be granted CLIA certification during the first quarter of 2023.

In order to be able to launch the assay on the US market, we are now building up our organization in the USA. We have had 5 very experienced individuals working for us in the US for some time. Now, since 1 December, we have fortified the team with eight new hires, each of whom has an established track record of successfully launching and selling this type of test. The team also has individuals with extensive experience in the US reimbursement system and insight into how we can ensure that the reimbursement level for DiviTum® TKa reflects the enormous value and benefits that it offers.

It consists of four sales representatives (each responsible for a region), two centrally located sales representatives and two specialists on the US reimbursement system. The sales team has vast experience of sales in the area of diagnostics and they will focus on training and informing healthcare professionals on the major advantages associated with DiviTum® TKa. I am very excited to see what this team in the USA will be able to achieve!

It has already started working and they will soon be meeting with Key Opinion Leaders, oncologists, hospitals, etc. to generate demand for the product. In parallel, our Market Access team has been interacting with payers in the USA. All of it is aimed at ensuring a successful launch. None of these activities will be affected by the CDPH laboratory inspection for CLIA certification in January.

We are also developing the processes that need to be in place so that we can start selling as soon as possible, creating our marketing material and pursuing a wide range of other activities necessary for launch and sales. We will be actively working with payers to ensure that the assay receives the right reimbursement level.

Our collaborations with pharmaceutical companies in the cancer area are progressing well also. We have noticed an increase in demand since obtaining 510(k) approval from the FDA.  It has resulted in DiviTum® Tka being included in several new projects with both existing and new customers. And these projects will generate revenue over the next 12-36 months in this area.

These collaborations strengthen DiviTum® Tka’s position in the area and result in DiviTum® TKa being included in an increasing number of clinical studies run by pharmaceutical companies. That, in turn, increases the likelihood of signing agreements on joint development of new products together with new drugs, i.e. Companion Diagnostic (CDx).

To finance the initial launch, the Board of Directors for Biovica resolved in October to conduct a fully guaranteed rights issue which, if fully subscribed, would generate approximately SEK 148 million in capital for the company, prior to issue costs. The rights issue has now been completed and the capital it has generated will primarily be used for launch in the USA, selected markets in Europe and scaling up our production processes.

We are very much looking forward to the launch of DiviTum® TKa so that it can benefit patients and caregivers, while simultaneously generating value for our shareholders.