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MarketScreener Homepage  >  Equities  >  NASDAQ OMX STOCKHOLM  >  Biovica International AB (publ)    BIOVIC B   SE0008613731

BIOVICA INTERNATIONAL AB (PUBL)

(BIOVIC B)
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Biovica International : FDA resource reallocation impacts DiviTum®TKa timeline

10/30/2020 | 02:31am EST

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that it is reallocating resources to COVID-19 impacting the timeline for completion of the review of Biovica’s 510(k)-submission for DiviTum®TKa. The FDA currently estimates that the reallocation will last approximately 90 days during which time the FDA will not be able to continue reviewing Biovica’s submission.

The FDA has informed Biovica that it is handling a large number of Emergency Use Authorization (EUA) requests for in vitro diagnostics (IVDs) to address COVID‐19 and that a reallocation of resources is impacting the timeline for completion of the review of Biovica’s submission. The FDA currently estimates that the reallocation will last approximately 90 days, but states that the precise duration is not known due to the uncertainty associated with the pandemic, including the volume of future IVD EUA requests the FDA may receive.

Biovica will receive monthly updates regarding the anticipated timeline for reallocation of resources back to non‐COVID related activities and resumption of the submission review. When the FDA resumes the review, Biovica will provide an estimated time for completing the review.

“The ongoing pandemic is posing challenges for everyone in society, and we are not immune. We see the pause as temporary and hope that the FDA can resume normal activities as soon as possible. We continue to work toward making the test available to US patients as early as possible and are currently reviewing our timeline,” said Anders Rylander, CEO of Biovica.

© Modular Finance, source Nordic Press Releases

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Financials
Sales 2021 3,00 M 0,36 M 0,36 M
Net income 2021 -38,5 M -4,59 M -4,59 M
Net cash 2021 134 M 15,9 M 15,9 M
P/E ratio 2021 -33,3x
Yield 2021 -
Capitalization 1 315 M 157 M 157 M
EV / Sales 2021 394x
EV / Sales 2022 27,7x
Nbr of Employees 21
Free-Float 75,2%
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Income Statement Evolution
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Mean consensus UNDERPERFORM
Number of Analysts 3
Average target price 67,00 SEK
Last Close Price 46,50 SEK
Spread / Highest target 122%
Spread / Average Target 44,1%
Spread / Lowest Target -33,3%
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Managers and Directors
NameTitle
Anders Rylander Chief Executive Officer & Director
Lars Erik Holmqvist Chairman
Adam Germunder Operations Director
Cecilia Driving CFO, Head-Human Resource, IR & EVP
Mattias Bergqvist Director-Clinical Development
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