Q1 Interim report May-July 2022/2023 – DiviTum®TKa approved for launch in the US

2022-08-31 08:00

SEK t Q1 22/23 Q1 21/22 May-April 21/22
Net sales 545 381 2,045
Operating profit (loss) -20,662 -12,238 -60,101
Profit (loss) for the period -21,004 -12,225 -60,003
Earnings per share, after dilution -0.74 -0.43 -2.11

 Significant events during the first quarter
·       Results with DiviTum®TKa at ASCO
·       DiviTum®TKa highlighted at ASCO in an oral presentation
·       Biovica’s CFO will terminate employment 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’s comments

During the quarter, we reached one of the most important milestones in Biovica’s history when the US Food and Drug Administration (FDA) granted market approval for our assay, DiviTum®TKa, as a tool for monitoring disease progression in post-menopausal women with hormone receptor positive metastatic breast cancer.
DiviTum®TKa is the first FDA approved biomarker in this area. The approval allows us to market the assay in the USA and it is thus crucial to realizing its commercial potential. Our focus now is on making the assay available to breast cancer patients in the USA before the end of the year, which will be hugely beneficial to both patients and caregivers.
Clearance was based on a number of factors, such as data showing that DiviTum®TKa has excellent capabilities to identify non progressors with high negative predictive values, NPV. For progression within 30 days, the NPV is 96.7%. This means that 96.7% of patients with DiviTum®TKa measurements below the assay clinical cut-off, did not experience disease progression within the next 30 days.
It is certainly valuable for both patients and the treating physicians to obtain this information on a monthly basis and be able to then act upon it appropriately. This has also been confirmed by the advisory boards of patient groups and oncologists that we have interacted with.
We are preparing for the upcoming launch in many ways, part of which is the comprehensive effort of obtaining CLIA certification for our wholly owned laboratory in San Diego. It will serve all of the USA and our aim is to obtain the certification for the lab sometime during this quarter. Having our own laboratory offers us greater opportunities for being able to establish a price for DiviTum®TKa that reflects the significant benefits it can offer to both payers and patients.
It also means that we can have direct contact with both customers and payers, which will provide us with valuable feedback and facilitate a smoother commercialization of the assay.  Additionally, with our own CLIA lab, we will be able to efficiently manage the reimbursement process, which is a significant advantage. We will be actively working with payers to ensure that the test gets included in guidelines.
We are also building up our organization and processes in preparation for the launch so that we can get sales up and running as soon as possible. We have set up several important commercial functions and will be hiring sales staff who are specialized in oncology diagnostics. They will both train and inform healthcare professionals so that they understand the substantial benefits associated with DiviTum®TKa, which will then generate 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 develop these collaborations further and the 510(k) clearance will help pave the way for achieving that goal.
FDA approval is an extremely important milestone for making the assay available to the US market. I would like to extend a huge thanks to our competent team that has worked so hard to reach this milestone. 
I am very much looking forward to the launch of DiviTum®TKa so that it can benefit patients, caregivers and also  create value for our shareholders!
Anders Rylander, CEO


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