UPPSALA, SWEDEN/ACCESSWIRE/August 31, 2022/ Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II)
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SEK t
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Q1 22/23 | Q1 21/22 | May-April 21/22 | |||||||||
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Net sales
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545 | 381 | 2,045 | |||||||||
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Operating profit (loss)
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-20,662 | -12,238 | -60 101 | |||||||||
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Profit (loss) for the period
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-21,004 | -12,225 | -60,003 | |||||||||
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Earnings per share, diluted
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-0.74 | -0.43 | -2.11 | |||||||||
First Quarter Highlights
Results with DiviTum®TKa at ASCO
DiviTum®TKa highlighted at ASCO in an oral presentation
Biovica’s CFO will leave his job in December 2022
FDA clearance for DiviTum®TKa
Significant events after the end of the period
· No events after the end of the period
CEO Comments
During the quarter, we achieved one of the most significant milestones in Biovica’s history when the U.S. Food and Drug Administration (FDA) granted marketing authorization for our test, DiviTum ®TKa, as a tool for monitoring disease progression in postmenopausal women with hormone receptor positive metastatic breast cancer.
DiviTum®TKa is the first FDA-approved biomarker in this area. Approval allows us to market the test in the United States and is therefore crucial to realizing its commercial potential. Our goal now is to make the test available to breast cancer patients in the United States before the end of the year, which will be extremely beneficial for patients and caregivers.
Clearance was based on a number of factors, such as data showing that DiviTum®TKa has excellent abilities to identify non-progressors with high negative predictive values, VPN. For progress within 30 days, the NPV is 96.7%. This means that 96.7% of patients whose DiviTum®TKa measurements are below the clinical threshold of the test did not experience disease progression within 30 days.
It is certainly valuable for patients and treating physicians to get this information on a monthly basis and then be able to act accordingly. This has also been confirmed by the advisory boards of patient groups and oncologists with whom we have interacted.
We are preparing for the upcoming launch in several ways, part of which is the overall effort to achieve CLIA certification for our wholly-owned lab in San Diego. It will serve all of the United States and our goal is to achieve laboratory certification during this quarter. Having our own laboratory provides us with greater opportunities to be able to price DiviTum®TKa that reflects the significant benefits it can provide to both payers and patients.
It also means we can have direct contact with customers and payers, which will provide us with valuable insights and facilitate smoother marketing of the test. Additionally, with our own CLIA lab, we will be able to efficiently manage the reimbursement process, which is a significant advantage. We will actively work with payers to ensure testing is included in the guidelines.
We are also developing our organization and our processes in preparation for the launch in order to be able to market as quickly as possible. We have put in place several important commercial functions and will be recruiting commercial specialists in oncology diagnostics. They will train and educate healthcare professionals to understand the substantial benefits associated with DiviTum®TKa, which will then drive sales of the product.
Biovica has several collaboration agreements in place with pharmaceutical companies that use DiviTum®TKa in the development of new drugs. Our goal is to further develop these collaborations and 510(k) clearance will help pave the way to achieving this goal.
FDA approval is an extremely important step in making the test available on the US market. I would like to extend my heartfelt thanks to our capable team who have worked so hard to achieve this milestone.
I look forward to the launch of DiviTum®TKa so that it can benefit patients, caregivers and also create value for our shareholders!
Anders Rylander, CEO
Contact
Anders Rylander, CEO
Phone: +46-18-444 48 35
Email: anders.rylander@biovica.com
Cecilia Driving, Executive Vice President and Chief Financial Officer
Phone +46-73-125 92 47
Email: cecilia.driving@biovica.com
Biovica – Treatment decisions with more confidence
Biovica develops and markets blood biomarker tests to assess the effectiveness of cancer treatments. Biovica’s DiviTum® test measures cell proliferation by detecting a biomarker in the bloodstream. The test has successfully demonstrated its ability to assess therapy efficacy early in several clinical trials. The first application of DiviTum is monitoring the treatment of patients with metastatic breast cancer. Biovica’s vision is that all cancer patients will receive optimal treatment from day one. Biovica collaborates with world-renowned cancer institutes and pharmaceutical companies. DiviTum is CE marked and registered with the Swedish Medical Products Agency. Shares of Biovica are traded on the Nasdaq First North Growth Market (BIOVIC B). FNCA Sweden AB is the company’s certified advisor, info@fnca.se, +46 8 528 00 399. For more information, please visit: www.biovica.com.
This information is information that Biovica International is required to make public in accordance with the EU Market Abuse Regulation. The information was submitted for publication, through the contact persons listed above, on 2022-08-31 08:00 CEST.
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Q1 2022 2023 Biovica EN
THE SOURCE: Biovica International
See the source version on accesswire.com:
https://www.accesswire.com/714131/Q1-Interim-Report-May-July-20222023–DiviTumRTKa-Approved-for-Launch-in-the-US
