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Adam Karlsson ... (+3)
  • Adam Karlsson
  • Erik Cassel
  • Jakob Lembke

Biovica International AB - Terminating coverage

ABGSC ceases coverage of Biovica …due to the end of the contractual period Last published estimates are shown in this report

Adam Karlsson ... (+3)
  • Adam Karlsson
  • Erik Cassel
  • Jakob Lembke

Biovica International AB - Achieves 510(k) clearance for DiviTum

The long-awaited FDA decision announced on 30 July Management looks to have the test available by year end Opens up USD 200-350m annual market opportunity

Adam Karlsson ... (+3)
  • Adam Karlsson
  • Erik Cassel
  • Jakob Lembke

Biovica International AB - Updated timeline for sales start

FDA decision expected in Q3, potential sales start in Q4 DiviTum shown complimentary to ctDNA Q4’21/22 EBIT of SEK -19m, cash position of SEK 90m

Adam Karlsson ... (+3)
  • Adam Karlsson
  • Erik Cassel
  • Jakob Lembke

Biovica International AB - Takeaways from Capital Markets Day

Demand generation important for CLIA lab strategy Multiple angles to market the product US launch will follow after 510(k) decision

Adam Karlsson ... (+3)
  • Adam Karlsson
  • Erik Cassel
  • Jakob Lembke

Biovica International AB - Evolved commercial strategy

Adding its own CLIA lab to US go-to-market FDA process resumes – potential approval in June-July Q3’21/’22 EBIT of SEK -14.4m and cash of SEK 108m

Adam Karlsson ... (+3)
  • Adam Karlsson
  • Erik Cassel
  • Jakob Lembke

Biovica International AB - Prolonged FDA review times

Abnormal FDA review times impacting 510(k) clearance Prospective trial TK IMPACT initiated Q2’/21/22 EBIT of SEK -14.3m and cash of SEK 118m

Adam Karlsson ... (+3)
  • Adam Karlsson
  • Erik Cassel
  • Jakob Lembke

Biovica International AB - Closing in on the finish line

510(k) clearance feedback could be one month away Appointment of President of the Americas Q1’21/22 EBIT of SEK -12.2m and cash of SEK 130.9m

Jakob Lembke ... (+3)
  • Jakob Lembke
  • Rickard Anderkrans
  • Viktor Sundberg

Biovica International AB - US commercialisation around the corner

Expects commercial partner after 510(k) clearance in Q3 Adding to the organisation and health economic data Strong cash position and good cost control in Q4’20/21

Jakob Lembke ... (+3)
  • Jakob Lembke
  • Rickard Anderkrans
  • Viktor Sundberg

Biovica International AB - Take-aways from Capital Markets Day

Paving the road towards commercialisation US lab partner expected within 12 months Looking at the potential beyond breast cancer

Rickard Anderkrans ... (+2)
  • Rickard Anderkrans
  • Viktor Sundberg

Biovica International AB - High activity preparing for US launch

FDA 510(k) clearance expected before end of Q3’21 Solid progress in commercial activities RUO orders from pharma companies a positive surprise

Rickard Anderkrans ... (+2)
  • Rickard Anderkrans
  • Viktor Sundberg

Biovica International AB - Ticking the boxes for a 2021 launch

Successful clinical validation and 510(k) submitted Fully funded for DiviTumTKa launch in 2021 Next up: Commercial partnership and FDA clearance

Rickard Anderkrans ... (+2)
  • Rickard Anderkrans
  • Viktor Sundberg

Biovica International AB - A flurry of clinical data ahead of the SABC...

Four abstracts showing promising data for DiviTum Encouraging signals beyond patient monitoring FDA submission to proceed to substantive review Q1’21e

Biovica International AB: 1 director bought

A director at Biovica International AB bought 70,000 shares at 32.125SEK and the significance rating of the trade was 54/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two ye...

Rickard Anderkrans ... (+2)
  • Rickard Anderkrans
  • Viktor Sundberg

Biovica International AB - Clinical validation and directed share issu...

Clinical validation of DiviTum TKa has been completed Raising ~SEK 148m in a directed share issue The last step before 510(k) FDA filing in September

Rickard Anderkrans ... (+2)
  • Rickard Anderkrans
  • Viktor Sundberg

Biovica International AB - Approaching FDA submission

Analytical validation for the 510(k) expected in June Solid clinical and KOL collaboration progress Financial update and reiterated financial targets

Rickard Anderkrans ... (+2)
  • Rickard Anderkrans
  • Viktor Sundberg

Biovica International AB - Highlights from Capital Markets Day

Sets ambitious 15% market share target for ‘24e Additional flavour on launch strategy and assumptions FDA 510(k) application on track for submission in Q3’20e

Rickard Anderkrans ... (+2)
  • Rickard Anderkrans
  • Viktor Sundberg

Biovica International AB - Q2 ’19/’20: FDA application in the work...

510(k) application set for mid-2020 Clinical data Financial update and key milestones ahead

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