We estimate sales of SEK 23m this year, growing at a CAGR of some 42 percent to 2024 to reach non-risk-adjusted sales of SEK 66m. By then, we estimate TK210 ELISA and UBC Rapid will have taken hold in the US and will thus start contributing as well.
FDA-odotuksia IDL-portfolion osalta:
Still, the company intends to initiate studies using its rapid test for bladder cancer
diagnostics (UBC Rapid 2.0) in the US ahead of a potential 510(k) filing. We deem an eventual
entry into the US market a relatively lengthy process and do not expect an eventual FDA
approval until 2024.
Ja TK210 ELISA:n osalta odottavan aika on pitkä:
We expect AroCell to await a potential FDA approval for Biovica’s DiviTum, which could be seen by early 2022. We believe that an eventual FDA approval could follow for AroCell by 2024.
Osittainen FDA-hakemus on edelleen suunnitteilla:
We highlight that AroCell’s coming prostate cancer FDA filing is unaffected and an eventual approval for this specific indication for TK210 ELISA could be granted ahead of the breast cancer indication.
Tuotejakauma tällä hetkellä:
Following the acquisition, AroCell has three main product offerings: TK210 ELISA (breast and prostate cancer) UBC Rapid (bladder cancer) TUBEX (typhoid fever)
IDL:n myynti teki uuden ennätyksen Saksassa, jota myöten kurssi hienoisessa nousussa. Mutta tulos vielä vahvasti miinuksella:
Reporting period July 1st – September 30th
Net sales amounted to 6,029 (0) KSEK
Profit after financial items amounted to -18,950 (-6,371) KSEK
Cash flow from operating activities for the period amounted to -7,180 (-5,580) KSEK
Earnings per share before and after dilution amounted to -0.16 (-0.08) SEK
Tuollainen haastattelu putkahti Redeyelta. Ei itsellä tuo ruotsi taivu niin hyvin, että osaisin tuolta mitään kalastella. Löytyiskö kieli-ihmistä, joka voisi tuosta pääpointit suomentaa?
TK1-testin ja FDA:n osalta odottavat ensisijaisesti Biovica-päätöstä ja rivien välistä voi lukea että toivovat vahvasti hyväksymistä, koska se helpottaisi myös Aron hakemista. Toki suunnittelevat koko ajan eri lähestymistapoja. Ei mainitse De Novoa nimeltä, vaikka toimittaja sen tekeekin.
Lyhyen tähtäimen sijoitushoukuttimena ennen kaikkea IDL:n tuotteet jotka myyvät hyvin Saksassa.
Milloinkas tuon Biovican osalta on odotettavissa päätöksiä?
Mutta eihän tuo yllätys ollut, kun nyt ei ole rahahanoja oikein ja pitäis tehdä kaikki TK210 -tutkimukset uudelleen mahdollista 2023 De Novoa varten.
E:
No, niinhän tuossa ilmoituksessa itse asiassa sanotaankin:
AroCell will use the proceeds from the Rights Issue to finance the process of receiving FDA approval for UBD Rapid and AroCell TK 210 ELISA in the US as well as the process of receiving IVDR approval for UBC Rapid 2.0 and TK 210 ELISA in Europe.
Mitä tämä nyt meinaa osakkeen omistajan näkökulmasta, en ymmärrä kunnolla tätä. Yhden omistamasi osakkeen arvo vaihtaa arvoa tuohon 0,75SEK arvoiseksi ja diluutio tulee olemaan 50%?
Osakkeen arvo puolittuu, mutta ei se välttämättä silti ole tuo 0,75€.
Markkinat määrää mikä sen arvo tulee olemaan. Todennäköisesti ei arvo kuitenkaan, kovin nouse ennen kuin anti on suoritettu.
AroCell enters into a partnership with ZECEN Biotech for distribution in China
AroCell has today signed a Supply and License agreement with ZECEN Biotech for the distribution of the product TPS® CLIA on their automated platforms on the Chinese market.
In 2019, AroCell’s subsidiary IDL Biotech began a collaboration with ZECEN Biotech regarding automation of the TPS® tumor marker on all of ZECEN Biotech’s automated systems. The project has proceeded well and therefore a commercial agreement has now been concluded.
The registration process has now begun with The National Medical Products Administration (NMPA) in China, former CFDA, and the product is planned to be available in the Chinese market by the end of 2022.
“The development project with ZECEN Biotech has been very successful and we are now pleased to be able to conclude this agreement which gives us access to their automated platforms to reach the major hospitals in China. This is an important step in our strategy to focus on near-patient rapid tests, as well as automation of our products,” says Anders Hultman, AroCell’s CEO.
According to the agreement, ZECEN Biotech will pay a royalty to AroCell based on sales in China. Several factors will affect revenue. These factors are uncertain and at this stage prevent us from predicting future revenues.
Looks like this is a newly published study (20 dec) on the UBC Rapid test in bladder cancer. Maybe the aim is to try to increase the scope of the UBC Rapid test by also target early stages and recurrence?
TK210 ELISA (breast and prostate cancer)
