Sonova Holding AG (SOON) Earnings Call Transcript & Summary

Ladies and gentlemen, welcome to the Sonova Conference Call. I am Shay, the Chorus Call operator. [Operator Instructions] The conference is being recorded. [Operator Instructions] The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Mr. Arnd Kaldowski, CEO. Please go ahead, sir.

Shay, thank you for the introduction here. Good morning, everyone, thanks for being available on such short notice. As I think it's normal, if you have an ad hoc information you want to share with the capital market, I think a lot to digest on the press release we have shared this morning with you, therefore, we wanted to give you a chance to hear how we voice it over and then leave space for Q&A. I'm intending to talk for about 8 to 10 minutes, and then we have about 0.5 hour for the Q&A. De facto, we've announced 2 significant points here with regard to a voluntary field corrective action on our AB business as well as a better performance than what we have expected and guided on the Hearing Instruments side. I think there's 2 smaller notes in there in the press release with regard to the coronavirus and current movement on the FX side. Let me first go to the Advanced Bionics side. We have informed today that AB initiates a voluntary field corrective action. This means that AB has notified the relevant regulatory bodies that it will retrieve un-implanted devices. That means we're pulling the inventory, which may be in the hands of clinics out of the market of the initial version of the HiRes Ultra and the Ultra 3D implants as of today. This action was initiated in immediate response to AB's quality system recording recent increases of cases with declining hearing performance. Ultimately, this requires some of the devices to be exchanged with regard to the patients where this decline of hearing performance was measured, but it is a small number. The testing of the affected devices showed that physiological fluid ingresses at the electrode, ultimately interrupting the stimulation, and leading to a decrease in hearing performance. I think, first, I want to express that we very much regret this event, particularly with regard to the recipients impacted. I think every case is one too much if we think about it from the patient perspective. And this is our utmost concern, hence, our proactive and early reaction here to what was a low number of cases. At the same time, it's very important to us to state that we have not seen this, in any case, being or creating any health risk or health hazard to the respective recipient. So you need to look at this as a performance-related matter, where the device doesn't improve the hearing as much as we had intended, but it is not a health or safety issue. We're also speaking about a very limited number of cases. To date, less than 0.5% of the over 16,000 recipients have been explanted. And based on the AB's quality system monitoring, which we do on a regular basis with all of the devices in the market, the vast majority of the Ultra implants continue to function properly without any degradation for the patients. Nevertheless, in an abundance of caution, AB decided to voluntarily initiate this field action. I want to explain the relevance with regard to device availability. When we talk about the initial version of the device, that was the implant which we have sold and implanted over the last 3 years, which we pulled out of the market with regard to the inventory in hands of the clinicians. It is currently superseded by a recently approved new version. The improvements addressing the issues were developed with the help of independent health care practitioners, after analyzing the first limited number of cases. These improvements reflect AB's efforts to continually enhance its products and are approved by major regulatory agencies, namely, we have approvals of FDA, the TÜV and Canada Health at this point of time. And we're in the process of rolling out these improved versions. We have started so over the last couple of weeks. During the deployment of the new version of the devices, we expect AB's business to be negatively affected. Partially because while we're doing the changeover, you can imagine that there may be some concerns on the doctor's side, but at the same time, we also are in the process of ramping up or have started to ramp up our manufacturing, but don't have all of the inventory at hand at this point of time we need in this transition period. In addition, we flagged in the press release that we expect onetime operating costs in the range of CHF 40 million to CHF 50 million, which we expect to book in the current fiscal year for this voluntary field corrective action. I now want to move on to the update on the Hearing Instruments business. And obviously, on a much more positive note here, I'm happy to report that Sonova's Hearing Instruments business is performing better than we had anticipated in the second half of the year so far. We continue to see good market reception across the key markets for the Phonak Marvel, including the expansion of functionality and capabilities of the model we did with the Marvel 2.0 in August 2019. In addition, you may remember that we flagged the increased investment into the sales force and in some marketing capabilities in the wholesale business when we talked about the half year results. And we've seen that those investments are starting to pay dividends in those markets where we have chosen to do those kind of investments. A key highlight continues to be in the U.S. where we gained market share across all major channels. I'm sure most on the call here are following the Veterans Affairs numbers and it's obviously a very strong performance when we get above the 50% mark here from a market share perspective. You're well aware about the private label contract with a large U.S. retailer, but we also see good growth and good market share winning on the independent side, given the improvements to the sales process but also the Marvel impact. In summary, we saw better-than-expected growth despite the more challenging comparison base after the anniversary of the successful model launch and, therefore, we're ahead of what we had expected at this point of time on the HI business on the top line. So trying to bring this now all into, let's say, a number perspective and what does it mean for the outlook for the current fiscal year. In light of the higher growth in the Hearing Instruments business and despite the temporary headwind from the voluntary field action at AB, we're raising our outlook for the full year. We've shared that we raised the growth expectation from 8% to 10% to 9% to 11% as well as adjusted EBITA growth to 14% to 17% from the 12% to 15% we had guided for. This is in local currencies. As before, the guidance for adjusted EBITA growth excludes restructuring costs. In addition, it does not consider the onetime costs related to the voluntary field corrective action I mentioned before. Allow me a quick commentary on the currency side. We've observed already "negative currency headwinds" in the first half. The Swiss franc has strengthened further since when we met in November. We have, therefore, decided to provide an indication of the estimated headwind for the year here, based on the current exchange rates. At this time, we expect the sales to be reduced by around 3% points (sic) [ 3 percentage points ] and the adjusted EBITA by around 6% points (sic) [ 6 percentage points ] in Swiss franc. Using our new guidance ranges would imply an increase in sales of 6% to 8% and a growth on the adjusted EBITA of 8% to 11% in Swiss franc. Of course, the exact impact will depend on the currency development for the remainder of the year. With that, I hope this gave a good summary of what we have shared in the press release. I would open it now for questions. And by the way, I didn't say that Hartwig is next to me, so I need to turn some of the questions to Hartwig.

Hi, guys.

[Operator Instructions] Your first question comes from the line of Michael Jungling, Morgan Stanley.

I have 3 questions. Firstly, when it -- and these are all related to the AB, please. The first one is on patients. Can you comment on whether these patients suffered pain or other side effects when they had the electrode explanted? I'm not talking about the procedure itself, but did they experience pain or something when the implant was faulty inside their skull? Question number two is on the Cochlear Implants business, should we expect sales growth in the second half of your current fiscal year to be negative growth? And then thirdly, when it comes to the cochlear provision of CHF 40 million to CHF 50 million for this recall, can you provide some insights into how you got to this number, some math behind the number of patients you think will be impacted as well as costs and damages that you think will be attracted to the recall?

Michael, thank you. Thanks for the question. On the patient side, very good question. No, there has been no reports in any shape or form that people had pain or side effects. What in reality happens, the signal you get to the hearing nerve gets weaker. So people really recognize that the improvement they had in the hearing performance isn't there, but there is no indications that there would be any pain nor would we understand that from the error we have analyzed. I think on the CI sales growth side, I think we have factored in the, let's say, lower growth post the field corrective action into our guidance overall. So you may think about AB doing even better than what the number would tell you because on the CI side, obviously, post their few corrective action, we're a couple of weeks in that transition. But we have chosen to not share that number. We factored it in. So I think the overall is, I think, what the sum of the 2 is. With regard to the CHF 40 million and CHF 50 million, what we have gone through on the best available information is what do we have to think in terms of write-off of inventory at hand, what are the product returns we expect, which we can't fulfill because we don't have enough inventory yet and then a cautious reserve for product liability claims, and that's what's making up the CHF 40 million to CHF 50 million. It's -- we are not in a position to share any prediction go forward. We've used our cautious assumptions here. We do have certain experiences, but I think we are taking the CHF 40 million to CHF 50 million as a good midpoint of our expectation.

Okay. And can I just confirm, is the total number of implanted patients, is it around 16,000 for the product?

Yes. It's the Ultra product line, which is the majority of our products, that 16,000. We started with the first version 3 years ago. So that's the total number of recipients who have received the implant.

Right. So the 16,000 is the base number of which further faults could occur if this issue was to escalate. Is that correct?

Yes. I think that's a fair way to think about it.

Next question comes from the line of Veronika Dubajova, Goldman Sachs.

It's Veronika here. I have 2 questions, please, one on the hearing business and one on CI. Arnd, can you help me understand? I'm just looking at the upgrade to the guidance this morning. And I know -- appreciate there's a lot of moving parts. But if I sort of look at how well you've done in the VA since the November contract, I sort of get to, excluding the VA, the business in wholesale is maybe growing 6% to 7%, which really, I mean, in the context of the market growth at 5% to 6%, isn't particularly impressive. Am I doing something wrong with the math there? Or had you assumed already some pickup from the VA when you gave us the guidance? Or is that really right and you're, excluding the VA, maybe excluding Costco, really not seeing a huge amount of traction with Marvel? That's my first question. My second question, just looking at this voluntary field action, I guess you're a couple of weeks in. I'd be curious to understand what feedback you've had from surgeons so far, and how you're kind of trying to assess the reputational damage. Obviously, it's a fairly substantial change to product design. It's not an insignificant fault, so I'm just curious if you can share any experience from the field on whether this has knock-over impact onto your competitive position in the medium term.

Yes, Veronika, thank you for the questions. I think on the HI side, I'm not quick enough to do the math you did here. But I think if I look at the growth rates in the different channels, we do see good growth in the independent stand-alone, which for us is the most relevant litmus test after the VA performance with regard to the performance of the Marvel. So I think I need to go back to the number and run the numbers the way you did. But in general, we're looking at good momentum in the Marvel and clearly one where we're seeing good market share development, particularly in the U.S. So no concern on our side. I think we had expected that the VA, it's always a couple of months response curve until you have a new product, so we did expect still some uplift there. We also knew about that there's a pricing change coming at some point of time. So I think we were not surprised by that. But 50% is high, but we did expect some positives there. I think on the CI side, the revised version of the implant is not a very dramatic change of the implant. It really has taken factors in which allow us to be convinced, and we've seen that in the internal testing that it is significantly more robust. I think the doctors with whom we have worked closely on that improvement are very convinced about it. As you can imagine, these are the largest institutions, and these are the ones who are also the most sensitive with regard to product quality. So we feel good about of the feedback of the doctors on the way we've taken, keeping them in the loop and active in the process. They are also important because they tend to be key messengers to the rest of the market. And we know that they have onboarded the new version of the product as one they are actively implanting. So I think we're in the good place there.

Arnd, can I just ask, as a point of reference, on your prior implants, what's the explant rate that you would have seen a couple of years in? Just to help us understand sort of how significant the 0.5% is that you're referencing today.

I think you're talking about a similar number over time. It is unfortunate but it does happen that implants get explanted. So I think the -- with the 0.5% still clearly below our thresholds from a quality management system perspective, which you would expect fits a level at something which is normal. So the 0.5% is really an early initiation of the voluntary field action here.

Next question comes from the line of Sebastian Walker, UBS.

Two, if I could, please. One, on the CHF 40 million to CHF 50 million, does that include any write-downs on the old implant from an R&D perspective? Anything that's been capitalized there? And then the second question, just more broadly given the commentary around the investments in H1 paying dividends now in terms of growth rates for the Hearing Instruments business, could you maybe just give us an update on how we should think about OpEx development in the second half versus H1, whether you're going to accelerate any investments or whether we should expect more of a flat development?

Sebastian, thank you. On the CI side, there is no need. And therefore, we haven't factored it in of any write-off on R&D investments. As I said, the revised version is a continued improvement type of approach. So the vast majority of the technology is the same. And then with regard to the investment side here, I think as we have said during the first half year, we have initiated investments. There are still some increases if you think about your OpEx run rate because we were in the process of scaling up the sales force. But in general, the OpEx side is in a good place, as you can also see from the improved fall through, which our guidance would indicate relative to the first half of the year. So I think we're seeing an even better leverage than we have seen in the first half year from the growth here.

Next question comes from the line of Maja Pataki, Kepler Cheuvreux.

But one question from my side, please. You've mentioned that in the CHF 40 million to CHF 50 million, you also include some forward liability claims, some provision for that. Could you share with us what your assumption is based on that? What kind of patient population do you think could come through on the -- from the next patient point of view? And how shall we think about that going forward?

Maja, thanks for the question. I think in general, when we look at the case I was describing here, you're looking at "a lower end" of an impact to the respective patient. As we said, there's no safety issue. There's no pain. There is no side effect we're aware about or we would, at this point of time, expect. So you're talking about a significantly lower exposure per patient. That's one factor here from, as I said, all we know at this point of time. I think we wouldn't like to share the exact number of what we have predicted here with regard to the number of claims. You know we have a good experience, sadly, from all of our Vendor B discussions, so we used our model there. We used the assumptions behind it with regards to how many people would come forward, and what is the likelihood of them having a valid claim and what would you pay for that. And that got us to the assumptions we have in here. It is not the majority of the CHF 40 million to CHF 50 million. So in that regard, we look at the case as being very different than any one we had more experience with just given the, let's say, smaller impact to the individual.

Understood. Just to follow up quickly. Can you tell us how long you have been monitoring that and how -- for how long you have been aware of it, just to kind of take an assumption on -- or get a feeling for the momentum that is building up?

I think we are aware about singular cases of this situation, and somewhere in the range of about a year. Keep in mind, we set the implants about for years out in the market, so you have an S-curve behind there at the beginning as it wasn't -- this technology wasn't available for all use cases. So that's, I think, the time line there. The progression isn't -- I don't want to say too much about it, but we're not alarmed by the progression. If not, we would have done different things here with regard to the onetime cost. But we had very early, let's say, singular cases some 9 to 12 months ago and started to work on an improvement there.

[Operator Instructions] The next question comes from the line of Daniel Buchta, Vontobel.

So maybe just a bit on the strategic point of view of this product recall. I mean, if I look back at the history of your Cochlear Implants business, I mean, it was having difficulties. But in the past 1, 1.5 years, you entered -- quite job in showing above-market growth and bringing the profitability to a level of a mid-teens level, at least moving in that direction. I mean now we have a setback again in this business. Is on the strategic point of view something changing here? I mean, you still have a goodwill of, I think, a bit more than CHF 300 million on the balance sheet related to the acquisition back in the days, while earnings -- I mean if I net all -- everything you have earned in the past couple of years and deduct CHF 40 million to CHF 50 million from it, you probably didn't make much money at all over time. I mean how is all that to be seen? And so yes, strategically, how committed are you still to that business?

Daniel, thanks for the question. So I think the first statement, we are strategically committed to the business because we see the benefit of having this as part of our portfolio for people with a hearing loss. We also think, and we can see this also from competitors in the market, at least one, that you can operate this business in a very attractive way from a growth and profitability side. Now if you look at our last 18 to 24 months, outside of what we announced today, we were on a good pathway to improve the profitability, which was always the Achilles heel in the discussions we had together. And I think we had a good 400 basis points EBITA improvement over that period of time, every 12 months. And we know enough levers to continue that journey. I think for us, this is unfortunate. We will need to get through the period we have ahead of ourselves. But I think the fundamentals are there to continue that journey after that interim period here. I also believe, given that we're reacting early here, we are very proactive with the doctors. We had some of them involved on the analysis as well as on the improvements. I think we can keep the "reputational damage" to more of a transition phase rather than a long-term phase. So all in all, I think you'll see us having to go through this period now, and then you'll get us back to -- we have good technology. We will grow the profitability, and the case, in general, stays intact.

That was the last question.

If we have no more questions, then thanks so much for jumping on the call on such short notice and working with us through all the ins and outs here. We know we didn't make it too easy this morning, but I hope it was helpful to listen in. And I wish everyone a good day. Thank you.

Ladies and gentlemen, the conference is now over. Thank you for choosing Chorus Call. And thank you for participating in the conference. You may now disconnect your lines. Goodbye.