20.12.2021 07:55:21 CET | Demant A/S |
Intern viden
Selskabsmeddelelse nr. 2021-16 20. december 2021
Opdatering vedr. frivillig markedskorrigerende handling
foretaget af cochlear implants-forretningen
Som tidligere meldt ud den 14. oktober 2021 har Oticon Medical, som udgør Demant-koncernens Hearing Implants-forretningsområde, indledt en frivillig markedskorrigerende handling (field corrective action) ved at tilbagekalde et antal endnu ikke implanterede Neuro Zti-implantater og midlertidigt at stoppe salget af nye implantater.
Selvom det fortsat er behæftet med en vis usikkerhed, så mener vi nu at have identificeret hovedårsagen til problemet, som skal findes i fremstillingsprocessen og ikke i selve designet af implantaterne. Vi arbejder i øjeblikket på at implementere og verificere en løsning på problemet for at kunne sikre høj og konsistent proceskvalitet. Baseret på vores aktuelle vurdering forventer vi nu at kunne genoptage vores salgsaktiviteter i Q3 2022 og at kunne øge salget gradvist i de efterfølgende måneder. Denne tidsplan er afhængig af, at årsagen til problemet bliver endeligt verificeret og valideret, hvilket også indebærer godkendelse fra de relevante eksterne instanser.
Indtil implantatsalget kan genoptages, vil omsætningen i Hearing Implants bestå af salg af eksterne lydprocessorer til eksisterende brugere af cochlear-implantater samt af salg af benforankrede høresystemer, som forventes at forblive upåvirket af tilbagekaldelsen. Som tidligere udmeldt udgjorde dette salg ca. 65 % af den samlede omsætning i Hearing Implants inden den frivillige markedskorrigerende handling.
I midten af oktober viste undersøgelser, at op til 3.976 Neuro Zti-implantater potentielt var påvirket, og at i alt 28 implantater på dette tidspunkt enten var blevet eksplanteret eller var under overvågning for mulig eksplantering. Pr. 19. december 2021 var sidstnævnte tal øget til 43 implantater. Indtil videre er antallet af rapporterede hændelser således forblevet lavt, og de fleste brugere vil højst sandsynligt ikke opleve nogen problemer. Nok så vigtigt er det, at der fortsat ikke er rapporteret nogen sikkerhedsproblemer relateret til implantaterne, og at der stadig ikke er nogen bekymringer i forhold til sikkerheden for eksisterende brugere.
Der er ingen ændringer i forhold til vores tidligere vurdering af, at den frivillige markedskorrigerende handling vil medføre engangsomkostninger på ca. DKK 70-100 mio. i 2021.
Medmindre den ovenfor nævnte tidsplan for genoptagelse af salget af implantater ændrer sig, eller medmindre øvrige forhold kræver, at vi giver opdateringer, så forventer vi ikke at komme med yderligere særskilte opdateringer vedrørende den frivillige markedskorrigerende handling.
I tilfælde af spørgsmål kontakt da venligst en af nedenstående kontaktpersoner. I henhold til vores finanskalender planlægger vi offentliggørelse af vores årsrapport for 2021 den 8. februar 2022.
Yderligere information:
Søren Nielsen, koncernchef og adm. direktør
Telefon +45 3917 7300
www.demant.com
Øvrige kontaktpersoner:
René Schneider, CFO
Mathias Holten Møller, Head of Investor Relations
Trine Kromann-Mikkelsen, VP Corporate Communication and Relations
Om Demant A/S
Demant is a world-leading hearing healthcare group that offers solutions and services to help people with hearing loss connect with the world around them. In every aspect, from hearing devices, hearing implants, diagnostics to audio and video solutions and hearing care all over the world, Demant is active and engaged. Our innovative technologies and know-how help improve people’s health and hear-ing. We create life-changing differences through hearing health.
Vedhæftninger
2021-16 Opdatering vedr. frivillig markedskorrigerende handling fra cochlear implants-forretning.pdf
20.12.2021 07:55:21 CET | Demant A/S |
Inside information
Company announcement no 2021-16 20 December 2021
Update on voluntary field corrective action
by the cochlear implants business
As previously communicated on 14 October 2021, Oticon Medical, which constitutes the Hearing Implants business in the Demant Group, has initiated a voluntary field corrective action by recalling a number of non-implanted Neuro Zti cochlear implants and has temporarily halted sales of new implants.
While uncertainties still exist, we believe that we have now identified the root cause of the issue, which is related to the manufacturing process and not the design of the implants. We are currently working on implementing and verifying a solution to the issue to ensure high and consistent process quality. Based on our current assessment, we now expect sales activities to be resumed in Q3 2022 and ramped up in the subsequent months. This expected timeline is subject to final verification and validation, including approval by relevant external bodies.
Until implant sales are resumed, revenue generated by Hearing Implants will comprise sales of external cochlear implant sound processors to existing users as well as bone anchored hearing systems, which are still expected to remain unaffected. As previously communicated, such continuous sales accounted for around 65% of total revenue for Hearing Implants prior to the voluntary field corrective action.
In mid-October, investigations showed that up to 3,976 Neuro Zti implants were potentially affected and that a total of 28 implants had either been explanted or were at that time under surveillance to be explanted. As of 19 December 2021, the latter number had increased to 43 implants. So far, the number of reported incidents has thus remained low, and most users are unlikely to experience any issues. There have still not been any reported safety events in relation to the implants, and there are still no safety concerns for existing users.
There are no changes to our previous assessment that the voluntary field corrective action will result in one-off costs of around DKK 70-100 million in 2021.
Unless the timeline for the resumption of implant sales mentioned above changes, or unless other developments require us to give an update, we do not expect to provide further separate updates on the voluntary field corrective action.
Please reach out to the contact persons listed below with any questions. As per our financial calendar, our Annual Report is scheduled for release on 8 February 2022.
Further information:
Søren Nielsen, President & CEO
Phone +45 3917 7300
www.demant.com
Other contacts:
René Schneider, CFO
Mathias Holten Møller, Head of Investor Relations
Trine Kromann-Mikkelsen, VP Corporate Communication and Relations
About Demant A/S
Demant is a world-leading hearing healthcare group that offers solutions and services to help people with hearing loss connect with the world around them. In every aspect, from hearing devices, hearing implants, diagnostics to audio and video solutions and hearing care all over the world, Demant is active and engaged. Our innovative technologies and know-how help improve people’s health and hear-ing. We create life-changing differences through hearing health.
Attachments
2021-16 Update on voluntary field corrective action by cochlear implants business.pdf
