Significant events during the fourth quarter

• The PROMIX breast cancer study at Karolinska University Hospital has been published in the scientific journal, ESMO Open.
• The DiviTum®TKa budget impact model shows potential for savings of three times the cost of DiviTum®TKa.
• Biovica strengthens its management team by appointing a new commercial manager and a new quality and regulatory manager.

Significant events after the end of the period

• Results presented for DiviTum®TKa showing its prognostic and predictive capabilities for patients with metastatic skin cancer who are undergoing immunotherapy.

Audiocast:
When: 18 June 2021 at 10.00 CET
Where: https://tv.streamfabriken.com/biovica-international-q4-2020-2021
Phone numbers: SE: +46850558359, DK: +4578150109, UK: +443333009263, US: +16467224904
Broadcast language: in English

CEO’s comments

For Biovica, the fourth quarter has been focused on activities to prepare for the upcoming launch of DiviTum®TKa in the US market. We are following our schedule for being able to launch DiviTum®TKa in the USA during the third quarter 2021 and utilizing the time prior to approval in the best way possible.

As part of that, we have grown the organization in both Sweden and the USA. The management team was strengthened with the addition of Helle Fisker as the new commercial manager and Joakim Arwidson as the new quality and regulatory manager. Their contribution and extensive experience will be a key factor for ensuring the success of our upcoming launch. Besides their recruitment, the addition of our new Scientific Director, Amy Williams, working from our office in Boston, was also very important.

One of the most essential cornerstones of a successful commercialization of DiviTum®TKa in the USA is reimbursement from payers. And for that to happen, we need to ensure that both oncologists and payers are informed about its value. With that in mind, we have created economic models based on the excellent clinical results of DiviTum®TKa, thereby generating data on the social benefits through cost savings of using the assay.

Subsequent to the end of the quarter, we presented the results from one such budget impact model at the leading health economics and outcomes research conference, ISPOR. The benefits from including DiviTum®TKa when monitoring hormone receptor positive metastatic breast cancer would primarily come from a reduction in futile therapy costs and other monitoring costs. The model shows that there are potential savings of up to three times the cost of DiviTum®TKa. These are very strong results, particularly since new healthcare interventions tend to add to the total cost of care.

One of Biovica’s strengths is the amount of positive results from clinical trials using the assay. At the ASCO annual meeting during 4-8 June 2021, results from a new study at Karolinska University Hospital were presented. They show the prognostic and predictive capabilities of DiviTum®TKa for metastatic cutaneous melanoma patients undergoing immunotherapy. Metastatic skin cancer (malignant melanoma) is an aggressive form of cancer. Patients are treated with expensive immunotherapy, in the order of around USD 30,000 per patient/month, and they may experience serious side effects. For patients who respond well however, the treatment can make an enormous difference. There is a great need for better biomarkers in this area, which is why the results are so promising.

The results provide another strong indication that DiviTum®TKa has great potential beyond our initial area of metastatic breast cancer.

Our application is one of the few that the FDA resumed its review of, already back in January. Because of that, we are sticking to our goal and remain confident that we will obtain 510(k) approval for DiviTum®TKa during the third quarter of 2021, even though the FDA 510 (k) reviews for IVD products in general have been significantly delayed.

Major cancer institutes are already important partners in our study collaborations and they could later become important commercial partners to us as well. In preparation for the launch in the USA, we have been having discussions with several oncology labs. Each of them has a sales force that could offer DiviTum®TKa as a service to their customers. Our intention is to enter into an agreement with a commercial partner after we obtain 510(k) approval during the third quarter.

Fourth quarter sales of SEK 318 thousand are derived from two new customers. It is both encouraging and satisfying that we are adding new pharmaceutical companies as customers and that they are using DiviTum®TKa when developing new, promising cancer drugs.

All of this activity during the quarter brings us one step closer to realizing our vision of helping doctors arrive at treatment decisions with greater certainty. It means that we can make a difference in giving cancer patients a longer life with better life quality. We are looking forward to the upcoming commercialization and soon being able to make a meaningful difference for patients with metastatic breast cancer. A successful launch in the USA for use of DiviTum®TKa in treating metastatic breast cancer is the first step towards realizing the product’s full potential. In summary, it has been an intensive quarter and year for Biovica. I’m excited and optimistic about the remainder of 2021 and all it holds.

Anders Rylander, CEO