Clinical validation completed, work with the FDA submission in the final phase
SEK thousands | Q1 20/21 | Q1 19/20 | May-April 19/20 | |
Net sales | 340 | 367 | 1,671 | |
Operating profit (loss) | -8,665 | -6,147 | -29,816 | |
Profit (loss) for the period | -8,374 | -6,118 | -30,318 | |
Earnings per share, after dilution | -0.36 | -0.33 | -1.24 |
Significant events during the fourth quarter
Biovica announced its goal to achieve 15 percent share of the total market potential in each market within three years of the launch.- Importance of DiviTum® and TK activity acknowledged in two scientific journals.
- ASCO Educational Book 2020 highlights DiviTum® results and TK activity.
Significant events after the end of the period
- Clinical validation, which is the last step required for the FDA validation, has been completed with positive results and the stated criteria have been met.
- Directed share issue for
SEK 148 million a number of Swedish and international investors, including Andra AP-fonden, Coeli Asset Management and Lancelot Asset Management.
CEO’s comments
During the quarter, we took important steps towards achieving our goals. Preparations for the market launch of DiviTum® have intensified and we are working in accordance with our timetable to submit the application for market approval to the
After having submitted the 510(k) application to the FDA, we expect to receive market approval at the start of 2021, which will give us access to the substantial US market for patient monitoring. Efforts to document the assay prior to approval have been extensive and during the quarter, we took several important steps in this process. One important part of the application is the extensive clinical validation study on American patients, which we are carrying out in collaboration with SWOG Cancer Research Network.
The clinical validation was completed during the summer, where we analyzed more than 1,700 samples with good results. Just as with the analytical validation, we met the criteria we had defined. The clinical validation has thus been completed with positive results. What now remains is to compile and submit the application, which we are planning to do during the month of September.
Also during the summer, we submitted the results from the SWOG study for publication and presentation. We expect that they will be presented at a conference just prior to year-end, along with publication of the results during the first quarter of next year.
Our important collaboration with SWOG also lays the foundation for
During the quarter, results from a study with DiviTum® were published in Scientific Reports, a prestigious journal from the publishers of Nature. Furthermore, the ASCO Educational Book 2020 highlighted DiviTum® and the unique, strong results achieved when using it for monitoring the treatment effect of CDK4/6 inhibitors. This type of recognition is extremely important because it gives us extensive coverage and thereby creates excellent channels for reaching future customers. Wide knowledge of DiviTum® at the time when it obtains market approval will facilitate quicker progress in the test reaching its full commercial potential.
Besides that, we have made progress in creating a plan for reimbursement. Specifically, our efforts during the quarter have resulted in a clear plan for coding, coverage and payment of DiviTum®. We also initiated studies on the social benefits via cost savings of using the DiviTum® assay to treat metastatic breast cancer and thereby convince payers in USA of its value.
The market potential in the initial markets for DiviTum® is substantial, at
In May, we held a Capital Market Day, where we presented our strategy and announced our goal of achieving a 15 percent market share in each market within three years of the launch of DiviTum®. Long term, our goal is to claim 50 percent of the market share in each market. We also explained our plan for companion diagnostics (CDx) at the event.
To finance the commercialization plan, we carried out a directed share issue for a total of
In recent years,
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