Significant events during the first quarter

• Extraordinary general meeting of Biovica International AB.
• Biovica signs its first commercial agreement in the USA with MediNcrease Health Plans.
• Results from the SWOG study (S0226) presented at ASCO.
• Biovica signs its second commercial agreement in the USA with the supplier network, Contigo Health ConfigureNet™.
• Biovica obtains PLA code for Medicare.
• Biovica signs its third commercial agreement in the USA with Occum Health for DiviTum® TKa.

Significant events after the end of the period

• Biovica announces start of DiviTum TKa clinical trial

Webcast:
When: 21 June 2023, 3 PM to 4 PM CET
Where: registration via lyyti: https://www.lyyti.in/Biovica_Q1_Earnings_call_2023__Live_Event_3956
Broadcast language: in English

CEO’s comments

During the quarter, we continued to keep our focus on commercial activities in order to, as quickly as possible, make DiviTum® TKa available to patients, healthcare providers, payers and pharmaceutical companies that are developing new cancer treatment drugs. We are proud that DiviTum TKa is providing benefits in so many ways.

It is worth noting that we signed our first agreements with payers in the USA. The agreements are with MedINcrease and Contigo Health. They are Preferred Provider Organizations (PPOs) which offer employees supplements to ordinary health insurance via their employers. Together, these agreements ensure that millions of policyholders in the USA will be reimbursed for DiviTum TKa, particularly via the agreement with Contigo Health, which is by far the largest.

We also signed a commercial agreement with Occum Health, a company that offers healthcare solutions for self-insured employers. The agreement makes our assay available to more than 500 employers (primarily large companies with thousands of employees) that have decided to shoulder much of the responsibility for their employees’ healthcare costs and are using Occum Health for that process.

These commercial agreements enable us to reach many patients and simultaneously establish an attractive price level that is also cost-effective for the customer. They also reduce the amount of administration and ensure that we are paid quickly. It is extremely satisfying to see the interest that private payers have in DiviTum TKa and that they are willing to pay for the major benefits that the product offers, in fact, at price levels higher than what we have previously communicated to the market.

We have also made good progress with getting DiviTum TKa included for reimbursement by Medicare (the federal health insurance program in the USA). In July, we achieved an important milestone when we obtained a unique PLA code for DiviTum TKa tests analyzed at our CLIA laboratory in San Diego. As of 1 October, we will thus be able to start using the code for payments from both Medicare and private payers. The next step is to assign a price to the PLA code and we expect that to happen by the end of the year. This will make the process even smoother and ensure that we are paid at the agreed level.

Besides our interaction with private and public payers, we are also engaging with hospital organizations and oncologists in an effort to fuel demand and promote sales. We are having success with this, too. Our strategy is to focus on the organizations with the largest patient flows for metastatic breast cancer, since they can derive the greatest benefits from DiviTum TKa. They typically have several hospitals situated in one or more states, which means that a single agreement would cover a significant number of patients who are undergoing cancer treatment. As a first step, we want to sign agreements pertaining to the logistics and pricing. After that, our focus can be on starting up a flow of tests. We are in the latter stages of negotiation with several hospital chains and expect to soon be announcing our first agreement in that area.

The agreements we have signed thus far, together with the PLA code, put the important prerequisites in place for starting to scale up the flow of tests and generating sales, which will be evident in the figures we report during the second half of the year and particularly in the last quarter of the current financial year.

We are also making strides with the launch effort in Europe. Several activities are underway for launching DiviTum TKa in the three markets where we have agreements in place. For example, we held training for our partners’ sales teams and have met with Key Opinion Leaders (KOLs), who have informed their oncologists about the benefits associated with DiviTum TKa, thereby raising awareness and generating demand for our product. Simultaneous to that, we are working to get agreements signed in additional markets. During the second half of the year, I also expect to see a major contribution to our sales from Europe.

And, yet another area where we are making headway is our collaboration with, and sales of DiviTum® TKa to, pharmaceutical companies that are developing new cancer drugs. During the summer, we signed yet another agreement with a new customer and started up several new projects. We are anticipating higher revenue from that already during this financial year.

One of the cornerstones for successful commercialization of DiviTum TKa is strong scientific support. It was thus very positive that a poster with DiviTum TKa results from the SWOG study S0226 was presented at the world’s largest cancer conference, the annual ASCO meeting, in June.

The study compares the results from DiviTum TKa and CA 15-3, which is a biomarker that is currently being routinely used in the treatment of metastatic breast cancer. The results confirm DiviTum TKa’s ability to monitor and predict outcome in hormone receptor-positive metastatic breast cancer, enabling more informed treatment decisions. It is very gratifying that DiviTum TKa is able to complement and improve today's standard methods of breast cancer monitoring.

In times like these, one area that is important for many companies, including Biovica, is securing good funding for the organization until reaching positive cashflow from operations. A great deal of work has gone into this over the summer, and we have several alternatives that we are in the process of finalizing. The significant progress we have made in the various commercial areas in recent months is certainly a positive contributor to this process.

Encouraged by the success we have had thus far with the launch of DiviTum TKa, we are working tirelessly to quickly make the assay available to as many people as possible, thereby generating benefits for patients, payers and shareholders alike.

Anders Rylander, CEO