DiviTum®TKa approaching FDA approval
|SEK 000s||Q1 21/22||Q1 20/21||May-April 20/21|
|Operating profit (loss)||-12,238||-8,665||-40,181|
|Profit (loss) for the period||-12,225||-8,374||-39,482|
|Earnings per share, after dilution||-0.43||-0.36||-1.39|
Significant events during the first 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.
- Biovica has strengthened its management team with the addition of Warren Cresswell, President Americas, with responsibility for the launch of DiviTum®TKa in the USA.
When: 2 September 2021 at 10:00 AM CET
Phone numbers: SE: +46850558365, DK: +4578150108, UK: +443333009262, US: +16467224902
Broadcast language: in English
During the first quarter, our focus has been on concluding the 510(k) process with the FDA. We had several meetings with the FDA and completed a SIR process (Submission Issue Request), which provided us with valuable feedback on how we should supplement our application with additional information.
Based on that, we were able to address all the areas where the FDA has requested additional information. We will be submitting that supplemental documentation at the beginning of September and, with normal processing time from the FDA, we should receive a response from them also during the month of September. The possible outcomes of that are, either approval (clearance), or a request to submit more information.
In preparation for our launch in the USA, we have grown the commercial part of the organization in both Sweden and the USA. Our latest recruitment is Warren Cresswell as President Americas. He has 25 years of experience in the diagnostics industry, bringing with him an extensive network and experience for building up and leading successful commercial organizations.
One of the most essential cornerstones of a successful commercialization of DiviTum®TKa in the USA is reimbursement from payers. Warren’s experience in this area is an important puzzle piece for this effort. With Warren at the helm in the USA, I am convinced that we will succeed with our launch and inclusion in the reimbursement system. Please read more about Warren’s background on page 3.
One of Biovica’s strengths is all of the positive results from clinical trials using the assay. At the ASCO annual meeting during 4-8 June 2021, results from a new study in a new area were presented. The study was carried out by Karolinska University Hospital and it is significant to us in that it serves as Proof of Concept in a new, important area. They show the prognostic and predictive capabilities of DiviTum®TKa for metastatic cutaneous melanoma patients undergoing immunotherapy. There is a large need in this area for better biomarkers, which is why the results are so promising, providing an additional strong indication that DiviTum®TKa has great potential beyond our first indication of metastatic breast cancer as well as immunotherapy.
Simultaneous with commercialization of DiviTum®TKa for metastatic breast cancer, Biovica will be working with additional regulatory approval for use of the assay with other indications than metastatic breast cancer, which is called intended use extension. Our belief is that, in the future, wide clinical use of DiviTum®TKa will be possible for a number of commonly occurring types of cancer.
At the company’s capital market day in May, we presented our plan for the areas where we intend to expand beyond that of breast cancer. The three areas we will first focus on are metastatic cancer in the areas of malignant melanoma, prostate cancer and lung cancer. These three areas more than double the already large market potential for our product.
We are looking forward to the upcoming commercialization and soon being able to make a meaningful difference for patients with metastatic breast cancer. We are excited and optimistic about the remainder of 2021 and all it holds.
Anders Rylander, CEO