SEK 000s | Q1 21/22 | Q1 20/21 | May-April 20/21 |
Net sales | 381 | 340 | 2,077 |
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 ofWarren Cresswell , President Americas, with responsibility for the launch of DiviTum®TKa in theUSA .
Audiocast:
When:
Where: https://tv.streamfabriken.com/biovica-international-q1-2021-2022
Phone numbers: SE: +46850558365, DK: +4578150108,
Broadcast language: in English
CEO’s comments
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
One of the most essential cornerstones of a successful commercialization of DiviTum®TKa in the
One of Biovica’s strengths is all of the positive results from clinical trials using the assay. At the ASCO annual meeting during
Simultaneous with commercialization of DiviTum®TKa for metastatic breast 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.
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