Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) - Positive development in the USA continues
SEK t | Q4 | Q4 | May-April 24/25 | May-April 23/24 |
Net sales | 2,332 | 1,899 | 8,619 | 7,290 |
Operating profit (loss) | -20,341 | -41,490 | -85,839 | -126,845 |
Profit (loss) for the period | -20,766 | -39,532 | -87,624 | -124,823 |
Earnings per share after dilution | -0.21 | -0.47 | -0.95 | -2.14 |
Number of shares at the end of the period | 97,786,384 | 84,055,560 | 92,569,248 | 84,055,560 |
Cash and cash equivalents at the end of the period | 24,415 | 79,407 | 24,415 | 79,407 |
Cash flow from operating activities | -17,826 | -25,251 | -85,367 | -114,575 |
Average number of employees | 26 | 35 | 27 | 37 |
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: 18 June 2025, 3 PM to 4 PM CET
Where: register via: https://www.eventbrite.com/e/biovica-q4-earnings-call-2024-25-tickets-1392516366939
Broadcast language: in English
Significant events during the fourth quarter
Biovica signed an agreement with Eurobio Scientific covering 60% of the European market
Biovica has secured a new work order worth SEK 2.5 million for TKa testing services in the Pharma Services part of the business
Biovica and Outcomes4Me have embarked on a new collaboration to empower patients with metastatic breast cancer to better understand how well their treatment is working
DiviTum TKa data in combination with inflammation proteins presented at the AACR meeting enhance precision to predict efficacy of immunotherapy
Significant events during the third quarter
DiviTum TKa results presented at ASCO, the world's largest cancer conference
Biovica signed new drug development agreement
Extraordinary general meeting of Biovica International AB
Biovica carried out a directed new issue of units for approximately SEK 16.4 million
Biovica signed an agreement with US Biotech company in clinical phase
Biovica secured a significant order for TKa testing services
Biovica published the outcome of exercise of warrants from series TO3B.
Biovica signed a master service agreement (MSA) with UK biotech company
NewDivitum TKa data that significantly increases the market potential presented at SABCS
Biovica signed an agreement with US healthcare and insurance giant
Biovica's CLIA lab obtained a permit from the state of New York, which opens up the entire US market
Biovica secured yet another significant order for TKa testing services
Significant events after the end of the period
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 under that agreement for SEK 4 million
New data on DiviTum TKa 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 subsequent to important partnership and commercial success
Biovica resolved on a fully guaranteed rights issue of approximately SEK 80 million at SEK 0.63 per share
Notice issued of extraordinary general meeting of Biovica International AB
Biovica signed an agreement with its fifth Tier 1 biopharma company in the USA
CEO's comments
Important steps were made during the 2024/2025 financial year to establish DiviTum TKa as a standard approach to treatment monitoring in breast cancer. Strong clinical evidence, commercial success and new strategic partnerships have played a key role in solidifying our position in the US and European markets.
Compared to the previous quarter, our sales in the USA increased by more than 25% in the fourth quarter and the positive trend has extended into the new fiscal year, following the recent close of our books.
We have continued generating new clinical evidence for DiviTum TKa. The results from three cancer studies were presented at the 2025 ASCO Annual Meeting, which is the largest oncology conference in the world. The most impactful results, however, were those presented at the San Antonio Breast Cancer Symposium (SABCS) in December, where seven breast cancer studies - including two focused on early-stage disease - were shared. It opens up a new, very large market for us, with estimated market potential of up to USD 3 billion. There is a significant need within the healthcare industry to optimize and streamline the use of costly treatments - such as CDK4/6 inhibitors. This is where DiviTum TKa makes a real difference - providing evidence-based, cost-effective decision support.
Further confirmation came in the form of a new agreement with a leading US healthcare and insurance giant with more than 10 million policyholders and annual revenue in excess of USD 100 billion. This organization - which serves as both a healthcare provider and health insurer - has observed that policyholders are at times prescribed costly treatments that are not always effective. The use of DiviTum TKa can enhance patient outcomes - while dramatically lowering costs for the organization. The agreement makes it possible to establish DiviTum TKa as one of their standard routines for breast cancer treatment.
In May 2025, we also began a collaboration with the US-based diagnostics company Tempus AI, which will offer DiviTum TKa nationwide through its network of hundreds of sales representatives in the oncology field. Tempus AI has an impressive track record, with annual revenue growth exceeding 30%. Biovica's CLIA-certified laboratory will serve as a reference lab to Tempus AI, which will enable them to include DiviTum TKa in their collection of precision medicine solutions currently offered to more than 6,500 oncologists.
Within our Pharma Services business, we continued to strengthen our relationships with the pharmaceutical industry throughout the year. Subsequent to the end of the period, we signed two new MSAs with Tier 1 (annual revenue exceeding USD 10 billion) pharmaceutical companies. An initial order of approximately SEK 5 million has already been received, with call-offs expected to take place over the next 2 to 3 years. This means that we now have 18 MSAs in place, including 5 with Tier 1 companies, representing a contract volume of approximately SEK 25 million in revenue to be recognized over the next 2 to 3 years as the services are delivered. This will be a key factor in achieving the financial targets that we have announced and an important step towards more comprehensive collaborations that could lead to new, customer-financed Companion Diagnostic (CDx) products.
An additional key milestone this year was our new collaboration with Eurobio Scientific - a leading in vitro diagnostics company - which expands our commercial reach across Europe. It opens the door to eight key European markets, which together account for 60% of our priority EU markets. The combination of Eurobio's extensive hospital and laboratory network with our technology lays a strong foundation for increased test adoption across Europe.
We are entering the new fiscal year with renewed confidence and increased market penetration - driven in part by the recent approval for our CLIA laboratory to offer DiviTum TKa to residents of New York State, as well as the growing interest we are seeing from both commercial partners and the clinical community. Our robust network of partners and growing presence in the clinical space position us well for continued growth, which is also reflected in the financial targets that we recently announced. The goal is to increase sales to SEK 50 million during the 2025/2026 fiscal year, derived primarily from the USA and Pharma Services.
At the beginning of the financial year, we completed a targeted new share issue of SEK 16.4 million to support the continued commercialization and development of our operations. Participation came from both existing shareholders and new institutional investors. Subsequent to the end of the period there is also a rights issue underway and we are hoping for a high level of participation. Our assessment is that the guaranteed amount of SEK 80 million, based on the current business plan and in line with our previously communicated financial target, will sufficiently cover our needs until the point when the company is cash flow positive around the turn of the year 2026/2027.
I would like to sincerely thank our employees, investors, clinical partners and everyone else who has contributed to our success during the year. Together, we will take the next steps toward improving treatment outcomes and quality of life for cancer patients throughout the world.
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 2025-06-18 08:00 CEST.
Attachments
Q4 2024 2025 Biovica Kommuniké 2025 04 30 Eng Final For Publikation
SOURCE: Biovica International
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/year-end-report-2024%2f2025-1040824
