Biovica Q3 Interim report Nov 2024 - Jan 2025

Significant events during the third quarter

• New DiviTum® TKa data that significantly increases the market potential was presented at SABCS
• Biovica signed an agreement with US healthcare and insurance giant
• Biovica’s CLIA lab has obtained a permit from the state of New York, which opens up the entire US market
• Biovica signed a significant order with UK-based pharma/biotech company for TKa testing services

Significant events after the end of the period

• Biovica signed an agreement with EuroBio Scientific covering 60% of the European market
• Biovica signed a new work order for SEK 2.5 million with US biotech company for TKa testing services
• Biovica has begun collaborating with Outcomes4Me – a patient app with more than 250.000 users

Webcast:
When: 13/3 2025 kl. 15.00 CET
Where: registration via: Biovica Q3 Report FY 2024/2025
Broadcast language: in English

CEO’s comments

In the third quarter, I note a positive sales trend, with sales doubling compared to the same period last year, while we have also grown our backlog of orders from pharmaceutical companies.

But the most significant event of the quarter was when we signed the most important agreement thus far in Biovica’s history. It is with a US Insurance giant that is one of the largest Integrated Delivery Networks (IDNs) in the USA. The agreement is significant not only because of its enormous commercial potential, but also because it confirms the substantial savings DiviTum TKa can offer insurers and caregivers, while benefiting patients.

This covers more than 10 million US policyholders and opens up a new, important distribution channel for us. Furthermore, conditions within the organization are favorable for DiviTum TKa to become a standard for monitoring breast cancer treatment, which would significantly boost sales.

Now that Biovica’s CLIA lab has obtained a permit from the state of New York, we have full coverage in the USA for offering DiviTum TKa to all patients and caregivers.

Subsequent to the end of the period, we signed two additional significant orders for TKa analyses and expertise in interpreting the results to pharmaceutical companies that are developing new drugs in cancer treatment. One is with a UK-based pharma/biotech company and the other is with a company based on the east coast of the U.S. Both are developing promising next generation CDK inhibitors.

These orders, together with those we are expecting during the last quarter of the financial year, give us a pipeline of services ordered but not yet delivered of SEK 25 million. It is a doubling of what we had at the beginning of the financial year. It is a clear indication of the positive trend in this area and our enormous future potential here.

We are working to sign agreements with more major caregivers and distributors in the USA and Europe. One of the agreements already in place is with EuroBio Scientific, which will be selling and providing DiviTum TKa in Austria, Benelux, France, Germany, Switzerland and the UK. EuroBio Scientific is dedicated to building a strong presence in oncology across Europe. An important milestone for them was the acquisition of two products and a sales organization from Myriad in fall 2024. Now, they are further expanding their oncology portfolio with DiviTum TKa. Together with the prior signed agreements, we now have coverage of all the important markets in Europe.

It is also noteworthy that a total of 7 abstracts of studies where DiviTum TKa has been used were presented at the San Antonio Breast Cancer Symposium (SABCS), which is the world's largest breast cancer conference. The results reinforce that our assay is an important indicator and predictor for patients with both metastatic and early breast cancer. The new results, especially regarding DiviTum TKa's use in adjuvant treatment, support the assay’s use also in earlier stages and not just for patients with metastatic breast cancer. This multiplies the market potential of DiviTum TKa by a factor of six.

Interest in the assay has surged since DiviTum TKa data for adjuvant treatment was presented at SABCS and diagnostic companies seeking to cut healthcare costs while maximizing patient benefit are increasingly drawn to Biovica and DiviTum TKa.

The results from using DiviTum TKa to guide the use of CDK inhibitors are convincing. According to a study presented at ASCO 2024, the world’s largest cancer conference, the cost increases by SEK 132,500 (USD 12,212) per patient each month when CDK4/6 inhibitors are used in addition to endocrine treatment. The authors of the study emphasize the importance of only using these expensive treatments on the patients who can benefit from them the most[1]. This is where DiviTum TKa has an important role to play.

To accelerate acceptance and use of DiviTum TKa, we also embarked on a new collaboration with Outcomes4Me. It is a professional organization focused on helping and empowering cancer patients in the USA. The company has developed a cancer navigation platform that supports more than 250,000 patients, which offers us a direct channel for creating awareness of what DiviTum TKa can offer them.

We are putting a great deal of effort into developing our business model and strengthening our financial position while maximizing our long-term growth. In 2025, an improvement of our cash flow will continue to be the key priority. To support this, it is particularly important that we can demonstrate the significant progress we've made — including new partners, stronger clinical evidence, positive order growth, and a much larger total addressable market for our test. We are optimistic about the steps we will make in the next quarters and the long-term potential of DiviTum TKa.

Anders Rylander, CEO

For more information, please contact:
Anders Rylander, CEO Anders Morén, CFO
Phone: +46 (0)18-44 44 835 Phone +46 (0)73 125 92 46
E-mail: anders.rylander@biovica.com E-mail: anders.moren@biovica.com

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752 37 Uppsala
+46 (0)18-44 44 830

Biovica – Treatment decisions with greater certainty
Biovica develops and commercializes blood-based biomarker assays that help oncologists monitor cancer progression. Biovica’s assay, DiviTum Tka, measures cell proliferation by detecting the TKa biomarker in the bloodstream. The first application for the DiviTum® TKa test is treatment monitoring of patients with metastatic breast cancer. Biovica’s vision is: “Improved care for cancer patients.” Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum® TKa has obtained FDA 510(k) clearance in the USA and has CE marking in the EU. Biovica’s shares are traded on the Nasdaq First North Premier Growth Market (BIOVIC B). FNCA Sweden AB is the company’s Certified Adviser. For more information, please visit: www.biovica.com