14.10.2021 08:24:05 CEST | Demant A/S |
Intern viden
Selskabsmeddelelse nr. 2021-13 14. oktober 2021
Meddelelse om frivillig field corrective action foretaget af cochlear implants-forretningen
Oticon Medical, som udgør forretningsområdet Hearing Implants i Demant-koncernen, har besluttet at foretage field corrective action og tilbagekalde endnu ikke implanterede Oticon Medical Neuro Zti-implantater og midlertidigt at stoppe salget af nye implantater. Tilbagekaldelsen relaterer sig udelukkende til identificeringen af nogle funktionsproblemer i et lille antal implantater, og der er ikke rapporteret sikkerhedsproblemer med implantaterne.
Oticon Medicals kvalitetssystem har for nyligt registreret en stigning i antallet af eksplanteringer af Neuro Zti-implantater samt i antallet af implantater under overvågning for eksplantering. Dette skyldes forringelse af den hermetiske lukning, hvorved de elektroniske komponenter i implantaterne over tid eksponeres for fugt, hvilket resulterer i, at elektronikken sættes ud af drift og ikke længere fungerer. Undersøgelser har vist, at de potentielle funktionsproblemer kan henføres til en afvigelse i produktionen, som påvirker op til 3.976 Neuro Zti-implantater. Pr. 13. oktober var i alt 28 implantater blevet eksplanteret eller var under overvågning for eksplantering. Der er ingen bekymring for sikkerheden for eksisterende brugere, og de fleste brugere vil højst sandsynligt ikke opleve nogen problemer.
Som følge af denne frivillige field corrective action forventer koncernen ikke yderligere salg af nye cochlear-implantater i resten af 2021, og det midlertidige stop for salget vil formentlig fortsætte ind i 2022. Indtil salget af implantater genoptages, vil omsætningen i Hearing Implants bestå af salg af eksterne lydprocessorer til eksisterende brugere af cochlear-implantater og af salg af benforankrede høreløsninger, som forventes at forblive upåvirket. I de seneste måneder har dette fortsættende salg udgjort ca. 65 % af den samlede omsætning i Hearing Implants.
Ud over tabt omsætning vil denne frivillige field corrective action også resultere i visse engangsomkostninger, som i 2021 forventes at beløbe sig til DKK 70-100 mio. Disse engangsomkostninger vil sandsynligvis omfatte returneringer af allerede solgte implantater, nedskrivning af lageret relateret til de pågældende implantater, visse hensættelser etc. De fleste af disse omkostninger vil sandsynligvis ikke påvirke cashflowet i år.
Hvis vi ser bort fra ovennævnte engangsomkostninger, er koncernens forventninger til 2021 uændrede.
For nærværende mangler vi klarhed omkring varigheden af det midlertidige stop for salg af nye cochlear-implantater, men vi forventer, at det vil fortsætte ind i næste år og dermed få en væsentlig negativ effekt på omsætningen i Hearing Implants i 2022. Indtil problemet er løst, vil vi gøre alt, hvad vi kan, for at afbøde den økonomiske effekt, og vi vil informere yderligere efter behov.
“Til trods for en lav forekomst af funktionsproblemer med vores cochlear-implantater har vi nu truffet denne frivillige foranstaltning for at leve op til vores løfte om at levere produkter af højeste kvalitet i alle henseender. Heldigvis medfører disse problemer ingen bekymringer omkring sikkerheden for eksisterende brugere, men vi er naturligvis meget kede af den forstyrrelse og ulejlighed, som dette medfører for vores patienter og kunder, og vi vil gøre alt, hvad vi kan, for at hjælpe dem med at løse de problemer, de måtte støde på,” siger Søren Nielsen, koncernchef og administrerende direktør i Demant.
I tilfælde af spørgsmål kan man kontakte en af nedenstående personer. I henhold til vores finanskalender offentliggør vi vores periodemeddelelse den 2. november 2021.
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
2021-13 Meddelelse om frivillig field corrective action foretaget af cochlear implants-forretningen.pdf
14.10.2021 08:24:05 CEST | Demant A/S |
Inside information
Company announcement no 2021-13 14 October 2021
Notification of voluntary field corrective action by the cochlear implants business
Oticon Medical, which constitutes the Hearing Implants business in the Demant Group, has decided to take voluntary field corrective action by recalling non-implanted Oticon Medical Neuro Zti implants and to temporarily halt sales of new implants. The recall is entirely related to the identification of performance issues in a small subset of implants, and there have been no reported safety events with the implants.
Oticon Medical’s quality system has recently identified an increase in the number of Neuro Zti implant explantations and in the number of implants under surveillance to be explanted because of a loss of hermeticity whereby electronic components in the implants over time get exposed to moisture, causing the electronics to shut down and stop working. Investigations have shown that the potential performance issues relate to a manufacturing deviation, affecting up to 3,976 Neuro Zti implants. As of 13 October, a total of 28 implants had either been explanted or were under surveillance to be explanted. There are no safety concerns for existing users, and most users are unlikely to experience any issues.
As a consequence of the voluntary field corrective action, the Group expects no further sales of new cochlear implants in 2021, and the temporary halt in sales is likely to extend into 2022. Until implant sales recommence, revenue for Hearing Implants will comprise sales of external cochlear implant sound processors to existing users and of bone anchored hearing systems, which are expected to remain unaffected. In recent months, such continued sales have accounted for around 65% of total revenue for Hearing Implants.
In addition to lost revenue, the voluntary field corrective action will also result in certain one-off costs, which are expected to amount to DKK 70-100 million in 2021. These one-off costs are likely to include certain returns for credit of implants already sold, write-down of inventory related to affected implants, certain provisions etc. Most of these costs are not likely to affect the cash flow this year.
Excluding the one-off costs mentioned above, the Group’s outlook for 2021 remains unchanged.
At this point, we lack clarity on the duration of the temporary halt in sales of new cochlear implants, but we expect the halt to extend into next year and thus to have a material negative impact on revenue for Hearing Implants in 2022. Until the issue is resolved, we will work diligently to mitigate the financial impact, and we will provide further information as needed.
“In spite of a low prevalence of performance issues in our cochlear implants, we are undertaking this voluntary action to stay true to our commitment of delivering products of the highest quality in all aspects. Fortunately, the issue does not entail any safety concerns for existing users, but we are of course truly sorry for any disruption and inconvenience that this may cause for our patients and customers and are committed to supporting them in resolving any issues they may experience,” says Søren Nielsen, President & CEO of Demant.
Please reach out to the contact persons listed below with any questions. As per our financial calendar, our Interim Management Statement is scheduled for release on 2 November 2021.
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
2021-13 Notification of voluntary field corrective action by cochlear implants business.pdf
