Significant events during the first three quarters

• Biovica received FDA approval for DiviTum® TKa in July.

• Resolution on rights issue at EGM in November.

• DiviTum TKa results from MA38 study presented at SABCS.

• Biovica established an experienced sales team in the USA in December.

• Clinical validation data on DiviTum TKa published in Biomarkers.

 
Significant events during the fourth quarter

• Biovica obtained CLIA Certification for its laboratory in San Diego.

• Biovica signed a commercial partnership agreement for the use of DiviTum TKa in the Netherlands and Poland.

• Biovica signed a commercial partnership agreement for the use of DiviTum TKa in Italy.

 
Significant events after the end of the period

• Extraordinary General Meeting in May 2023. Decision to issue new stock options (for a maximum amount of 168,000 stock options) and performance share program (for a maximum amount of 56,000 performance shares) for employees in the USA.

• A commercial agreement has been signed with MediNcrease Health Plans – 15 million policyholders gain access to DiviTum TKa.

• A commercial agreement has been signed with Contigo Health ConfigureNet – Biovica’s largest commercial agreement to date.

Webcast:
When: 21 June 2023, 3 PM to 4 PM CET
Where: registration via lyyti: https://www.lyyti.in/Q4_Earnings_Call
Broadcast language: in English

CEO’s comments

We are continuing our efforts to ensure that DiviTum TKa is commercially successful and a benefit to patients who are being treated for cancer.
 
In the USA, those efforts are focused on signing agreements with payers and caregivers. This is how we are laying the foundation for a successful market introduction and achieving our ambitious sales targets.
 
These agreements will ensure that we reach many patients and establish an attractive price level that is on a par with, or higher than, what we have previously communicated. The agreements also ensure that there is a process in place for quickly getting paid, with a minimal amount of administration.
 
Thus far, our sales team has succeeded in getting two agreements signed, which are with MedINcrease and Contigo Health. They are both Preferred Provider Organizations (PPOs), which are health plans that supplement ordinary health insurance and are something that many employers offer their employees as a benefit. We anticipate that we will soon be signing more agreements in the USA.
 
Together, these agreements ensure cost reimbursement of DiviTum TKa to millions of policyholders in the USA, particularly via the agreement with Contigo Health, which is by far the largest.
 
Another area that is important to a successful launch is getting DiviTum TKa included for reimbursement by Medicare, which is the federal health insurance program in the USA. We’ve made progress with this as well. Our Medicare Enrollment application has been approved, which means that we will be able to submit claims for reimbursement to Medicare. 
 
Thus far, we are being referred to a general code, which involves a more cumbersome administration process and challenging discussions around the price when we seek cost reimbursement from Medicare.
 
All of this will be solved by obtaining a unique PLA code for DiviTum TKa. We made progress on that front prior to the end of the financial year by submitting our application to obtain such a code. We are expecting to receive feedback on that sometime during the fall of 2023.
 
In Europe, we have made some significant progress too. We signed commercial partnership agreements with both the Italian company, IT Health Fusion and TOROMEDICAL Group, covering the Netherlands and Poland. These agreements cover price levels that are on a par with, or slightly above, what we have previously communicated.
 
The Italian market is one of the largest in Europe and we have strong support there among Key Opinion Leaders (KOLs). We also have high ambitions for the Netherlands, where we have a nationwide study underway, as well as the strong support we have from KOLs there.
 
We are looking forward to the 2023-2024 financial year and introducing DiviTum TKa in these markets, along with signing more agreements in Europe.
 
There is much interest from pharmaceutical companies and robust growth in this area, albeit from low levels thus far. We are striving for exponential growth in our sales to pharmaceutical companies in the years ahead. There is enormous potential in being able to sell the assay as a companion diagnostic to one of the cancer drugs that is currently under development. And, the more collaborations we are involved in, the greater our likelihood of succeeding with that.

Right now, we are facing a difficult environment in the financial market where risk appetite is low. It is a drastic change compared to a year ago. The rights issue we executed during fall 2022 reflects this and it means that we must be cost conscious and careful with our commercial and clinical investments.

Despite these challenges, our outlook for the future is positive because we are certain that DiviTum TKa can make a difference in the lives of patients with cancer. Our full focus is thus on quickly making the assay available to as many patients as possible so that it can improve their lives and benefit both caregivers and payers. We are excited and optimistic as we look forward to an interesting FY2023-2024.

Anders Rylander, CEO