Period: May-January 2019/2020
SEK 000s Q3 Q3 May-Jan 19/20 May-Jan 18/19 May-April 18/19
19/20 18/19
Net sales 55 288 1,671 1,269 3,005
Operating profit -7,433 -5,780 -19,520 -15,346 -21,718
(loss)
Profit (loss) for -7,515 -6,045 -19,540 -15,636 -21,556
the period
Earnings per -0.31 -0.34 -0.87 -0.87 -1.18
share, after
dilution
Significant events during the third quarter
·
· Additional results validating DiviTum® as a dynamic biomarker in monitoring metastatic breast cancer were presented by Institut Curie,
· New clinical data demonstrating that DiviTum® is a strong prognostic marker in operable breast cancer were presented at the San Antonio Breast Cancer Symposium in
·
Significant events after the end of the period
· Submission of our 510(k) application for DiviTum® to the FDA is expected to occur during the third quarter of 2020, rather than in mid-2020, as earlier announced.
Audiocast
When:
Where: https://tv.streamfabriken.com/biovica-international-q3-2019-2020 or
SE: +46850558352 / DK: +4578150110 /
US: +18335268398
Broadcast language: in English
CEO's comments
During the quarter, we made significant progress in our prioritized areas: regulatory preparations, clinical studies and commercial activities.
We have a clear understanding of the
I am very proud to announce that, thus far, the results from the analytical validation meet our established requirements. Simultaneous to that, all of the patient samples from SWOG have been analyzed and the results will soon be published.
Production has been delayed due to late deliveries of one of the product's components. These problems have now been solved, which means that the analytical validations will be completed during the second quarter. Our goal is to submit the 510(k) application for market approval to the FDA during the third quarter of 2020.
Clinical results confirmed and strengthened with new studies
As for our clinical studies, we presented new results during the quarter in line with prior results, namely, that DiviTum® could be a valuable tool for ensuring that patients get the best possible results from their treatment. I would also like to highlight one of the studies that was presented at the world's largest congress on breast cancer, SABCS, San Antonio Breast Cancer Symposium, during
During the quarter, clinical data was presented demonstrating that DiviTum® is a strong prognostic marker in operable breast cancer. In particular, I would like to highlight a study that shows the prognostic effect of DiviTum®, making it possible to assess the risk of recurrence. That study was also presented at SABCS in December. It was based on more than 600 patients. Adding that to Nisman's earlier groundbreaking study, it means that we now have data on more than 800 patients Subsequent to the end of the quarter, results were also published from a study by researchers at
New additions to the senior management team
During the quarter,
We are reporting favorable results from studies and moving towards launch of the product in the US market early in 2021 and in selected European markets shortly thereafter. Wide knowledge of DiviTum® at the time when it obtains market approval will facilitate quicker progress in the test reaching its full commercial potential.
We have a unique product that meets an important need in a large, attractive market. The pieces are now in place for taking
For more information
phone: +46 (0)18 444 48 35
email: anders.rylander@biovica.com
Cecilia Driving, EVP CFO/HR/IR
phone: +46 73 125 92 47
email: cecilia.driving@biovica.com
This information is information that
In the event of contradictions or differences between the Swedish press release and this English version the Swedish text will prevail.
https://news.cision.com/biovica-international-ab/r/divitum-first-study-published-on-cdk4-6-inhibitor-against-clinical-results,c3057538
https://mb.cision.com/Main/14910/3057538/1209765.pdf
https://news.cision.com/biovica-international-ab/i/2p5a2960-color-web,c2761732
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