UPPSALA, SE / ACCESS Newswire / September 11, 2025 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) - Partnership agreement with Tempus and continued organic growth in the USA
SEK 000s | Q1 25/26 | Q1 24/25 | May-April 24/25 |
Net sales | 2,596 | 1,714 | 8,619 |
Operating profit (loss) | -19,334 | -23,562 | -85,839 |
Earnings per share, after dilution | -0.18 | -0.27 | -0.95 |
Number of shares at the end of the period | 97,786,384 | 84,055,560 | 92,569,248 |
Cash and cash equivalents at the end of the period | 16,305 | 65,209 | 24,415 |
Cash flow from operating activities | -17,196 | -29,044 | -85,367 |
Average number of employees | 25 | 27 | 26 |
Biovica in brief - Treatment decisions with greater certainty
Biovica's vision is: "Improved care for cancer patients."
Biovica develops and commercializes the blood-based biomarker assay, DiviTum® TKa, which enables early-stage evaluation of treatment effectiveness. The initial focus is on breast cancer.
The initial focus area is metastatic breast cancer, however study results since 2024, show that DiviTum TKa can also serve as both a predictive and prognostic tool in the adjuvant treatment of early-stage breast cancer.
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
Webcast:
When: 11 September 2025, 2 PM to 3 PM CET
Where: registration via: Biovica Q1 Earnings call
Broadcast language: in English
Significant events during the first quarter
Biovica is now collaborating with Tempus to expand the commercial reach of DiviTum TKa
Biovica signed a significant Master Service Agreement (MSA) and first work order under that agreement for SEK 4 million
New data on DiviTum TKa for use in three areas of cancer presented at ASCO
Biovica secured three new assignments worth SEK 2.5 million in the Pharma Services part of the business
Biovica announced financial targets reflecting its important partnership and commercial success
Biovica resolved on a fully guaranteed rights issue of approximately SEK 80 million at SEK 0.63 per share
Biovica signed an agreement with its fifth Tier 1 biopharma company in the USA
Significant events after the end of the period
Biovica has been granted a new European patent
Biovica carried out a directed share issue for approximately SEK 42.2 million
CEO's comments
Our main focus once again in this quarter has been on increasing sales of DiviTum TKa for clinical use in the USA along with increasing our sales to pharmaceutical companies that are using it in the development of new drugs. It is thus encouraging and gratifying to see that our efforts are generating results for both new and existing customers.
Our US team has achieved sales growth for the ninth consecutive quarter. The increase in local currency, has been around 30 percent for the last two quarters and compared to the same period last year, sales have increased by more than 90 percent. Biovica has managed to achieve this growth despite having significantly reduced its staff.
We have also noticed a trend of higher awareness and recognition among patients. Several online forums now enable patients to share their stories on how they are living with their illness. Patients value DiviTum TKa for the quick feedback it offers on disease progression and treatment efficacy. Positive reports from other patients have contributed to higher levels of patient recruitment. We see this as a channel with great potential, since patients are influenced by the experiences of others and they tend to stay well informed.
Within our Pharma Services business, we have continued to strengthen our relationships with the pharmaceutical industry. Both during the period and subsequent to its end, we received additional significant work orders from both new and existing customers. We received our two largest-ever work orders in Q1, worth over SEK 7 million in total. Both of these were from a major pharmaceutical company that now has five projects underway with DiviTum TKa.
Biovica currently has a total of 18 Master Service Agreements (MSA). It corresponds to a contract value of approximately SEK 25 million that will result in recognized revenue over the next two to three years. We are seeing a trend towards both larger projects and larger pharmaceutical companies in our customer base. Five of our current customers each report annual sales in excess of SEK 100 billion. In this category, there is potential for expanded collaboration whereby DiviTum TKa could become an even more integral part of new drug development that could possibly even result in new Companion Diagnostic (CDx) products.
To sum up the quarter, what matters is not only the results we report but also the path that we are now on. Our industry is in a phase of rapid transition, where the ability to navigate change is crucial for long-term competitiveness.
For us, it comes down to three key priorities going forward to increase our sales:
Customer focus - by strengthening our understanding of how customers use the product, we are driving sales growth and expanding our ability to create new offerings tailored to customer needs.
Scalability and streamlining - we are establishing the foundation for a streamlined yet resilient company, with efficient processes that ensure growth, quality, and cost-efficiency can be achieved in parallel.
Partnership - We are collaborating with partners to develop new value propositions for customers and patients, while leveraging the broader resources, scale, and reach of our partners.
Organic growth with our existing US customers is developing in line with plan, as is progress in the Pharma Services business area. However, two of our strategic collaborations have experienced delays relative to what was previously communicated - one with Tempus AI and the other with the Integrated Delivery Network (IDN) that has started using DiviTum TKa.
The IDN has recognized how the assay contributes to improved treatment outcomes and reduced costs by identifying when treatment is ineffective. Their intent is therefore to conduct studies aimed at establishing DiviTum TKa as a standard test for their policyholders who are undergoing breast cancer treatment. It is therefore unfortunate that the first study has not commenced as planned, due to their internal decision processes being more complex than either of us had anticipated. We are working with our highest-level contacts there so that the agreement can be finalized as soon as possible.
During the summer, Tempus AI increased its ambitions for Divitum TKa, having recognized its potential to help them expand into other strategic areas. This is certainly very good news, even though it adds complexity and will result in a short-term delay in the timetable.
I recently returned from a business trip to the US, where I participated in productive meetings with both organizations to discuss these collaborations. It is gratifying to see the level of enthusiasm from both organizations for our product, and while the delays are frustrating, we are confident that the long-term value being created through these initiatives far outweighs the impact of any timetable adjustments.
We have also continued generating new, strong study results demonstrating the value of DiviTum TKa. The results from three cancer studies were presented at the American Society of Clinical Oncology (ASCO) congress in June 2025. And, at the San Antonio Breast Cancer Symposium (SABCS) in November 2024, data from seven breast cancer studies was presented, two of which confirmed use in early breast cancer. These results provide the foundation for our July 2025 launch of DiviTum TKa for patients with early-stage breast cancer who are undergoing adjuvant treatment. The launch opens up a new market that could result in a potential fivefold expansion of the addressable market for DiviTum Tka corresponding to around USD 3 billion annually in key regions such as the USA, Europe and Japan. We have started communicating this to customers and expect that it will help boost expansion in the area of early breast cancer.
The proposal to the Nomination Committee for the AGM on 23 September 2025 is for Fredrik Alpsten to be elected as Chairman of the Board. Most recently, Fredrik served as CEO of Devyser Diagnostics and he has extensive experience in the global diagnostics market. I am looking forward to welcoming him to Biovica. A fully guaranteed rights issue and a targeted new share issue were implemented during the summer to support our growth. Combined, this has generated approximately SEK 122 million for the company. The capital is expected to cover our needs until the company is cash flow positive around the turn of the year 2026/2027.
I would like to conclude by thanking our investors for their continued confidence in us. I also want to sincerely thank our employees, partners and everyone else who has contributed to our success. We also extend our sincere gratitude to our departing CEO, Lars Holmqvist, who has added valuable knowledge and leadership during his more than six years in the role.
With all the building blocks now in place, we are positioned to accelerate growth while improving treatment outcomes and quality of life for cancer patients worldwide.
Anders Rylander, CEO
Contact
Anders Rylander, CEO
Phone: +46 76 666 16 47
E-mail: anders.rylander@biovica.com
Anders Morén, CFO
Phone: +46 73 125 92 46
E-mail: anders.moren@biovica.com
Biovica - Treatment decisions with greater confidence
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 assay has demonstrated its ability to provide insight to therapy effectiveness in several clinical trials. 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 received FDA 510(k) clearance in the US and is CE-marked 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
This information is information that Biovica International is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-09-11 08:00 CEST.
Attachments
Q1 2025 2026 V3 7 2025 09 10 ENG
SOURCE: Biovica International
View the original press release on ACCESS Newswire
