Coloplast A/S

Coloplast A/S

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Q4 FY2020 · Earnings Call TranscriptNovember 3, 2020

APIChatGPT

Operator

Hello and welcome to Coloplast full year financial results 2019 to 2020 conference call. The call has an expected duration of one hour.

I will now hand over to President and CEO of Coloplast, Kristian Villumsen. Please begin.

Kristian Villumsen

Thank you operator and good afternoon and welcome to our full year 2019/2020 conference call. I am here joined by our CFO, Anders Lonning-Skovgaard and our Investor Relations team.

And we will start with a short presentation by Anders and myself and then open up for questions. Please turn to slide number three.

This year has been one of the most challenging years in our company's history. Few anticipated the severity and speed with which COVID-19 impacted the global population in early 2020.

Through a strong global crisis management, we swiftly put all necessary measures in place to keep our people safe, continue to serve our customers and maintain business operations. Our teams across the world have managed the situation locally and I would like to sincerely thank everyone in the company for assuming this responsibility and for approaching this complex situation in an innovative way to deliver on our priorities.

I would also like to take this opportunity to thank our clinician partners for their commitment to serving patients throughout this very difficult time. Our full year results were negatively impacted by the cancellation of elective procedures in our interventional urology business as well as a negative impact from the pandemic on our wound and skin care business in China and on our chronic care business in Europe, in particular in the U.K.

We continue to adapt our business to the challenging situation and we are encouraged by the largely stable underlying growth in the U.S. and in our emerging markets.

We delivered 4% organic growth, an EBIT margin of 32% and a return on invested capital of 46%. A solid set of results, I believe, in a year which has been unlike any other in the history of our company.

We have seen lower growth in new patients in ostomy and continence care as a result of the COVID-19 outbreak. Broadly speaking, across markets surgeries and procedures have picked up again in our key markets new patient levels are normalizing.

The challenge is currently in Europe and we are unfortunately seeing what can probably best be described as the second wave of the virus. We do not know what the second wave will look like.

In Q4, we saw flat growth in several countries in Europe due to limited growth in new patients. And in the U.K., due to the extended lockdown and measures put in place by the NHS to handle the COVID-19 crisis, there has been a significant decline in screening, referrals and operations.

The situation in the U.K. has improved and new patients discharge is now, around 80% to 90% of pre-COVID levels, up from an April low of around 60% of pre-COVID levels.

Anders will speak more about guidance later but we are seeing a more challenged European business as we move into 2021, also bearing baseline in mind. As we navigate the crisis, we are adapting our business and commercial activities and continuously rebalancing our go-to-market model.

In many of our markets, our sales forces are still working from home and in response we have accelerated our digital investments. We continue to build stronger capabilities in virtual education, remote support and digital sales with tools now deployed globally.

As we continue to mitigate the pandemic and focus on business continuity, we are also working to ensure that we emerge stronger from the crisis. As this year draws to a close, I feel optimistic about our future, which holds many opportunities for growth.

We hosted our Capital Markets Day at the end of September and to recap the core of the new Strive25 strategy is all about innovation and growth in our two core geographies, U.S. and China.

The strategy will be supported by key growth enablers, including our efficiency agenda, our people and culture agenda and our sustainability agenda. We expect to deliver 7% to 9% organic growth per annum and more than 30% EBIT margin.

The work is well underway. We remain confident in our long term guidance and the underlying market growth and potential for growth in the segments we serve.

Today, the Board of Directors approved an ordinary dividend of DKK13 in addition to the dividend of DKK5 paid in connection with our half year results. This brings the total dividend for the year to DKK18 per share compared to DKK17 last year.

Our guidance for 2021 is an organic revenue growth of 7% to 8% and a reported growth in Danish krone of 4% to 5%. The reported EBIT margin in Danish krone is expected to be 31% to 32%.

In 2021, we will continue to prioritize investing for growth and invest up to 2% of revenues in incremental growth initiatives, focusing particular on Asia, interventional urology and digital initiatives. Before we take a closer look at today's results, I would like to spend a few minutes on the acquisition of Nine Continents Medical that we announced today.

Please turn to slide number four. At our Capital Markets Day in September, we spoke about pursuing acquisitions within adjacent markets in our interventional urology business.

Today, I am very pleased to announce that we have completed the acquisition of Nine Continents Medical, an early-stage company pioneering urological overactive bladder treatment with tibial nerve stimulation. Globally, around 80 million people suffer from overactive bladder, which is a condition that causes a frequent and sudden urge to urinate.

The condition impacts a person's ability to work and socialize and the overall quality of life. Many of these people suffer in silence.

So-called first-line therapies including behavioral and lifestyle changes often yield poor results and second line therapies including a variety of pharmacological options are often associated with negative side effects. Patients who fail first and second line treatment may be offered more invasive treatment options, so-called the third line therapies such as Botox injections, percutaneous tibial nerve stimulation and sacrum nerve stimulation.

Of the 80 million people globally that suffer from overactive bladder, approximately 40% seek treatment and of those about three million patients globally are candidates for third line therapy. Today, less than 10% of these patients are actually treated and the market is around $1 billion in size growing around mid single digit.

The company that we have acquired, Nine Continents, have developed an innovative third line therapy that is not in the market today to compete with the treatments that I mentioned before. The device is an implantable tibial nerve stimulator.

It's a miniaturized subpar unit placed in the lower leg under local anesthesia during a short minimally invasive procedure. The solution requires no patient activation, no recharging nor any recurring doctor visits and it builds on the clinically proven mode of action from percutaneous tibial nerve stimulation which is an overactive bladder treatment available in the market today.

The feasibility data that we have so far is promising and the next step will be to design and execute the pivotal study which is expected to begin during 2021 and continue until 2023, 2024. I am very excited about this acquisition.

It represents a long term growth opportunity for Coloplast in a large underserved market. The technology is exciting and it is the type of opportunity we wish to pursue..

It's a minimally invasive procedure that takes place outside of the operating theater and a device that, if successful, can make people basically forget about their condition and live a normal life. This fits perfectly with Coloplast's mission.

As the adoption of implantable tibial never stimulation increases and if the Nine Continents product is successful, we are looking at a very large growth opportunity for our interventional urology business. Now with that, let's take a closer look at today's results.

Please turn to slide number five. In Q4, we got back into positive organic growth territory and posted 2% organic growth.

The quarter was impacted by challenges due to the COVID-19 outbreak as we had expected, but there were also positives. In ostomy care, organic growth was 6% for the full year and growth in Danish krone was 5%.

Q4 organic growth was 3% and growth in Danish krone was flat. From a product perspective, growth continues to be driven by our SenSura Mio and Brava supporting products in larger markets like the U.K., U.S.

and Germany. SenSura Mio Convex continues to be the main contributor to growth, driven by both Europe and the U.S.

Brava supporting products delivered double digit growth for the year, driven by growth in the U.S., China and the U.K. Our SenSura and Assura/Alterna portfolio growth was driven by China, Latin America and tender deliveries in Russia.

In Q4. China and the U.S.

were the key contributors to growth. And in Europe and in particular in the U.K.

was challenged by lower growth in new patients due to COVID-19. Phasing of tender deliveries in Russia last year impacted growth negatively due to a very tough comparison period.

Across the ostomy care business, growth in new patients has been negatively impacted as only the most acute ostomy surgeries have taken place following the COVID-19 outbreak. The impact has been the largest in Europe, in particular in the U.K., which is Coloplast's largest market in Europe.

Growth in new patients continues to improve, albeit at a slower pace in Europe and is still too early to fully assess the impact of the second wave of COVID-19. In continence care, organic growth was 6% for the full year and growth in Danish krone was likewise 6%.

In Q4, organic growth was 4% and growth in Danish krone was 2%. From a product perspective, the SpeediCath ready-to-use intermittent catheters continue to drive growth.

SpeediCath Flex contributed positively to growth, especially in the U.S. and across the European markets.

SpeediCath Compact catheters continued to drive growth in countries like the U.K. and France.

And sales growth for Peristeen products remains satisfactory, driven by France, the U.S. and the U.K.

From a country perspective, the U.S., Argentina, Germany and Italy were the main contributors to growth in Q4. And growth in Europe and mainly the U.K.

was challenged by lower growth in new patients due to COVID-19. Across the continence care business, growth in new patients has been negatively impacted due to the COVID-19 outbreak as only the most acute patient groups such a spinal cord injuries have been treated whereas other patient groups including multiple sclerosis and the BPH patients have often postponed their treatment.

The impact has been the largest in Europe and in particular the U.K. and growth in patients now continues to improve, albeit at a slower pace in Europe.

In interventional urology, organic growth was down 7% for the full year and growth in Danish krone was also down 7%. In Q4, organic growth was flat and growth in Danish krone was down 3%.

The negative growth for the full year was mainly due to the decline in sales of Titan Penile implants and Altis single incision slings due to the cancellation of elective surgeries in the U.S. within men's and women's health.

Elective procedures in the European business were also negatively impacted resulting in lower sales of disposable surgical products. Elective procedures recovered during the second half of the year at an encouraging pace.

And despite the surge in COVID-19 cases in several key revenue states in the U.S., the recovery in our men's and women's health business has continued. We delivered flat growth for the fourth quarter, but in October the business returned to growth driven by men's health in the U.S.

We continue to invest in commercial initiatives including the launch of the endourology portfolio in the U.S. In wound and skin care, organic growth for the full year was 1% and growth in Danish krone was flat.

Organic growth for wound care in isolation was flat. In Q4, wound and skin care delivered negative 3% organic growth and wound care in isolation delivered 1% organic growth.

The Biatain Silicone portfolio was the main contributor to growth driven by the U.S. and Germany.

Growth in Biatain Silicone was offset by a decline in revenues in the Biatain and Comfeel product portfolios, primarily in China, which has seen a significant decline in hospital activity on the wound care side due to COVID-19. The European wound care business improved significantly in Q4 compared to Q3, in part driven by a good contribution from the recently launched Biatain Fiber portfolio.

Biatain Fiber has now been launched across seven markets and continues to be well received. China and the wider emerging markets region contributed negatively to growth in Q4 due to a decline in hospital activity and sales related to COVID-19.

The skin care business reported double digit organic growth in Q4 due to increased demand for InterDry and EasiCleanse products, which is correlated with an increase in non-COVID hospital admissions in the U.S. The Compeed contract manufacturing business contracted from growth in Q4 impacted by lower demand due to the COVID-19 pandemic.

On a separate note, before I hand over to Anders, I am pleased to release our new sustainability report. A few noteworthy achievements this year include a further reduction in occupational injuries.

41% of our production waste is now recycled, up from 32% last year and 67% of our production now runs on renewable energy. As part of our new strategy, we have launched several new ambitious targets to reduce emissions and improve our products and packaging and I look forward to reporting on our progress.

With this, I will now hand over to Anders who will take you through the financials and outlook in more detail. Please turn to slide six.

Anders Lonning-Skovgaard

Thank you Kristian and good afternoon everyone. Reported revenue for the full year increased by around DKK600 million or 3% compared to last year.

Most of the growth was driven by organic growth which contributed around DKK700 million or 4% to reported revenue. Foreign exchange rate had a negative impact of DKK32 million or minus 1% on reported revenue.

A positive effect from a favorable development in the U.S. dollar and British pound against the Danish krone was offset by a significant decrease in the value of the Argentinean pesos and Brazilian real against the Danish krone.

Please turn to slide seven. Gross profit was up by 4% for the full year to around DKK12.6 billion.

This equals a gross margin of 68%, on par with last year. The gross margin was positively impacted by operating leverage, driven by revenue growth as well as savings from the GOP4 program, including the closure of the Thisted factory in Denmark in 2019.

The gross margin was also positively impacted by restructuring cost of DKK43 million in the comparison period last year. The gross margin was negatively impacted by product mix due to the decline in U.S.

sales in interventional urology. Increasing cost in Hungary due to salary inflation and labor shortages also weighed on the gross margin.

There was a further negative impact on the gross margin from extraordinary costs related to the COVID-19 outbreak. The gross margin includes a positive impact from currencies of around 30 basis points.

In Q4, the gross margin was 69%, on par with last year. The distribution to sales ratio for the full year came in at 29%, on par with last year.

The 2% increase reflects increased investments in sales and marketing activities across multiple markets and business areas, for example in China, the U.S. and the U.K.

The impact from these investments was offset by lower travel and sales and marketing activities expenses due to the COVID-19 situation. In Q4, the distribution cost decreased by 1% compared to last year, reflecting strong cost control as well as sustained investments.

The admin to sales ratio for the full year and Q4 came in at 4% of sales, on par with last year. The R&D to sales ratio for the full year and in Q4 came in at 4% of sales, in line with last year.

Overall, this resulted in an increase in operating profit of 5% for the full year, corresponding to an EBIT margin of 32% compared to 31% last year. The EBIT margin contains a positive impact from currencies of 20 basis points.

The EBIT margin was positively impacted by cost-saving initiatives and lower spending following the COVID-19 outbreak. Please turn to slide eight.

Operating cash flow for the full year amounted to around DKK4.8 billion, compared with around DKK4.4 billion last year and includes a positive impact of DKK197 million related to a reclassification of lease payments following the adoption of IFRS-16. The positive development in cash flows was mainly due to an increase in operating profit of DKK298 million.

Cash flow from investing activities was impacted by investments in automation, IT and the new factory in Costa Rica. CapEx investments amounted to DKK931 million for the full year, up DKK295 million compared to last year.

As a result, CapEx accounted for 5% of revenues compared to 4% last year. As a result, the free cash flow for the full year was an inflow of DKK3.9 billion, against DKK3.8 billion last year.

Adjusted for the DKK197 million, positive impact from IFRS-16, the free cash flow was down by 3%. Our cash conversion for the full year was 90%.

Net working capital for the full year amounted to 23% of sales compared to 24% last year. Inventories increased by around DKK300 million, due to an increase in inventories of strategic products.

Trade receivables decreased by around DKK200 million, due to an increased focus on payment terms in primarily emerging markets. Due to the COVID-19 outbreak, I continue to monitor trade receivables closely.

We also continued to pay smaller suppliers earlier. In Q2, a new share buyback program was launched totaling DKK500 million and it was completed during our Q4.

Full year return on invested capital after tax before special items was 46% against 48% last year. Excluding the impact from IFRS-16, return on invested capital would have been 48% and on par with last year.

Please turn to slide nine. For 2021, we expect revenues to grow 7% to 8% organically and 4% to 5% in Danish krone.

Phasing of growth is expected to be back-end loaded with low single digit growth in the first half of the year and double digit growth in the second half of the year. The organic growth guidance is based on four key assumptions.

First, interventional urology will be positively impacted by the comparison period in 2019, 2020. Second, there is an uncertainty around growth in new patients across chronic care in the U.K.

and other markets, especially in Europe. In addition to a tough comparison period, the lower growth in new patients will lead to weaker growth in the chronic business in the first half of the year.

Underlying growth in the U.S. and emerging markets is expected to be largely stable.

Third, there is an uncertainty around the resumption of hospital activity impacting wound and skin care. This is partly offset by the comparison period in China and France in 2019, 2020, as well as the full year impact of the Biatain Fiber launch.

Fourth, we have no current knowledge of any significant healthcare reforms whereas last year we saw a large negative impact from the French healthcare reform. Finally, the guidance also assumes a stable supply and distribution of products across the company.

Due to the depreciation of the U.S. dollar, British pound, Brazilian real and the Argentinean peso against Danish krone, reported growth in Danish krone is expected to be 4% to 5%.

The currency impact is based on spot rates as of November 2. For 2021, we expect a reported EBIT margin in Danish krone of 31% to 32%.

The reported margin in Danish krone is expected to be positively impacted by the Hungarian HUF but this is offset by the depreciation of the U.S. dollar, Brazilian real, Argentinean peso against the Danish krone.

As a result of the COVID-19 outbreak, we have exercised strong cost control and we have also seen a natural reduction in cost due to lower travel cost and sales and marketing spend. We expect this natural cost reduction to continue into the first half of 2021.

To ensure that we emerge strongly from this crisis, we continue to invest for growth and invest up to 2% of sales in incremental investments into innovation and sales and marketing initiatives. For 2021, the bulk of investments will go into interventional urology, Asia and consumer and digital investments.

We announced acquisition of Nine Continents Medical today and during 2021, we will primarily invest into R&D, including clinical trials. The gross margin will be positively impacted by operating leverage and the global operations plans four and five.

The positive impact is expected to be partly offset by cost pressure in Hungary from wage inflation and labor shortages as well as trends or cost related to the transfer of machines to new factory in Costa Rica. Sustainability investments will also impact the gross margin.

Overall, the expectation is that the gross margin for 2021 will be in line with 2019, 2020 factoring in a positive impact from currency. We expect our net financials to end the financial year 2021 at around zero.

This is primarily due to hedging gains on the U.S. dollar and British pound against the Danish krone, offset by losses on balance sheet items denominated in a number of foreign currencies, including the Argentinean peso.

CapEx guidance for 2021 is expected to be around DKK1.1 billion and is driven by investments in automation initiatives as part of GOP5, the next factory expansion in Costa Rica, more capacity for new and existing products as well as IT and sustainability investments. Our first volume of factory in Costa Rica will be operational at the start of 2021.

Next year will be an important transfer year that we will see the transfer of around the 15 machines to Costa Rica. Finally, our effective tax rate is expected to be around 23%.

Thank you very much. Operator, we are now ready to take questions.

Operator

[Operator Instructions]. Our first question comes from the line of Lisa Clive from Bernstein.

Please go ahead.

Lisa Clive

Hi. Thanks very much.

I just have two questions on the guidance. First of all, could you be very specific around what your assumptions are around the second wave for COVID and the potential for disruptions of elective procedures which obviously will have effect on urology but as well your wound division?

And then second, I know you don't typically do this, but could you give us some indication of what your guidance on the top line is by division? I suppose just because it's much more important this year given the COVID variables?

Thank you.

Kristian Villumsen

Thank you Lisa. Good questions.

We are not going to guide by division. I will put some color to each of the businesses.

Regarding your first questions related to the COVID, we not assuming, I will be explicit about that, another, if you will, fundamental lockdown of elective procedures. So we are seeing in the U.S.

that elective procedures are continuing. We are seeing that also in Europe, I would say, our view is and this is also what gets back to us from our markets is that the healthcare systems are in a very different shape now than they were back in March.

There are processes in place, PPE in place, ventilators in place. So we think that's a sensible base case.

On impact by division, we were not giving specific guidance when it comes to growth rates. But for chronic, it will be, like Anders said, a weaker first half, basically driven by, I will say, baseline effect from last year and if you will, a yet somewhat lower growth in the new patients in the period from March and onwards primarily in Europe.

On the wound care, we are seeing I think good performance in Europe. We are also seeing good impact from the Biatain Fiber launch.

We are also seeing good performance in North America. Really, the challenge has been more in China and EM.

And I am expecting that we are going to get back to growth in this year, good growth in wound care in China. In interventional urology, as you can imagine, of course, is that lead to the revision of guidance back in March and had clearly the largest impact from COVID.

We will have a significant impact the other way this year, driven by baseline.

Lisa Clive

Thanks.

Operator

And the next question comes from the line of Veronika Dubajova from Goldman Sachs. Please go ahead.

Veronika Dubajova

Hi guys. Good afternoon.

Thank you for taking my questions. I will keep it two, please.

One, just would love to understand which markets outside of U.K. you are seeing a slowdown in a new patient generation, if I can call it that, for chronic care?

And I guess kind of what your thoughts are, one, of the duration of that? And two, do you think these are patients that are disappearing from the system altogether?

Or do you think like mortality? Or do you think we will see a pent-up demand at some point in time in the future?

Just would love to get your thoughts on that? And I guess related to that, I seem to remember that when we talked at Q3, your guidance was for the U.K.

to be flat. Clearly given that Europe was flat in fourth quarter, I suspect the U.K.

either. So you had a lot of other markets that were flat.

So if you can get some granularity on that, that would be great? And then my second question is just the competitive environment in ostomy and I know you get asked this question every quarter.

But if I look at the divergence between your growth rate and the growth rate of your closest publicly listed peer, the gap has been narrowing pretty substantially over the past six to seven quarters. And I know you are saying you not seeing any change.

But will just love to get an update and how you are thinking about the narrowing of that gap? Is there something we should be reading into that or not at this stage?

Thanks guys.

Kristian Villumsen

Thank you Veronika. I am not sure I took note of all the questions.

So Anders will supplement me here. Let me start from the top on which countries that we have seen negatively impacted in Europe.

U.K. is at the top of the list because of its size.

We have also seen significant negative impact in a number of the smaller markets in Europe. It's typically highly correlated with incidents of COVID.

We have seen good performance from Southern Europe and from Germany. So I hope that gives a bit of color.

So it's mostly U.K. and the number of the smaller markets in Europe.

So European markets posted 0% growth in the quarter. But IU was positive, wound care was positive and the flat growth in chronic was principally the U.K.

plus a number of smaller markets like I talked about. But IU positive and wound care positive for Europe.

What was the second question? Maybe I will just address the ostomy competitiveness.

So we have grown 6% on the year for ostomy care, which is still significantly above market 3% for the quarter and still our read is above competition. Ostomy care is a long play, Veronika.

And I wouldn't read too much into quarterly figures. I would be looking at moving annual totals.

But of course, we also pay close attention to activities from competition. Anders, anything you want to add?

Anders Lonning-Skovgaard

I missed the question after your first one.

Veronika Dubajova

Yes. Then my second question was just the patients that you are not seeing in the chronic care segment.

Do you think, this is a temporary delay? And if so, how long until it gets better?

Or is there risk that there is an element of mortality in here which means there might be some duration to the depressed growth rate, if I can call it that?

Anders Lonning-Skovgaard

Yes. So I think the truth is a bit in between.

So for some of the patients, it will be just literally just a postponement. But I am also painfully aware that a number of the healthcare systems are projecting higher mortality rates from colon cancer, simply because some of the screening programs are not operating at full capacity or not operating at all.

And objectively, the surgery levels have been a bit depressed. So I think you are going to see some level of excess mortality, particularly on the colon cancer side.

Veronika Dubajova

Okay. And can I just confirm, I think you have said in Q3 that you expected the U.K.

to be flat. It sounds like it was not flat, that it was down.

Is that fair?

Anders Lonning-Skovgaard

It was flat.

Veronika Dubajova

It was flat. Okay.

Understood. Okay.

Excellent. Thanks guys.

Operator

And the next question comes from the line of Christian Ryom from Nordea Markets. Please go ahead.

Christian Ryom

Hi. Good afternoon and thank you for taking my questions.

I have two as well. So my first question is also on the NPD inflow and maybe whether you could talk to sort of when, for how long you potentially foresee this having an impact on your growth rates?

Because as I understand your business and your cost benefit from an accumulating base of users and the slower inflow thus risks having some knock-on effects in the next quarters. Can you maybe help us a little bit with just how to think about that dynamic?

And then my second question is to the OpEx growth for next year. Whether we should also expect that to be back-end loaded?

Thank you.

Kristian Villumsen

If I start, Christian, with your first question. So really, it is going to depend on how the virus plays out and how quickly healthcare systems get, if you will, fully normalized.

But please also bear in mind that we have a couple of very significant baseline effects on the on the year also for Europe. The first two quarters last year were very strong in particular.

The second quarter was an exceptionally strong quarter for Europe. So there is also a baseline effect in there.

But there is an uncertainty there I don't think I can accurately predict when we will be a fully out of it. It's going to depend on how the virus pans out.

But that the good thing is that we know that it is going to pan out. The question is the profiling and how fast.

Anders Lonning-Skovgaard

And Christian, in terms of your question related to the OpEx growth. Yes, you should also expect that to be back-end loaded.

I am assuming that the global travel ban, the prudence that we have in terms of our cost will continue throughout this quarter and into the second quarter. When that is said, we have initiated the investments into the urology business.

As you might recall, we put quite a few of the activities within urology on hold during our second and third quarter last year. But we have initiated those activities again throughout the fourth quarter.

And as a consequence of the acquisition of Nine Continents, we are also starting up investments into that area over the next couple of quarters. But overall, I am expecting the OpEx growth to be back-end loaded as well.

Christian Ryom

Okay. Thank you very much.

Operator

And the next question comes from the line of Michael Jungling from Morgan Stanley. Please go ahead.

Michael Jungling

Great. Thank you.

Good afternoon. Three questions, please.

Firstly, on the 2021 guidance. What margin guidance or what would the margin guidance have been if you did not acquire Nine Continents?

Or perhaps you can do it the other round and say what the dilution will be from the acquisition? Question number two is also on the 2021 guidance.

I am not quite sure what you mean by the assumptions that you have made on page 17 for this year's guidance with respect to the uncertainty around growth in new patients across chronic care. Is it included or is it not included?

What I mean by that is, if the COVID crisis continued at a higher rate as we are seeing now, are we including that in the guidance or not? And then question number three is, the Nine Continents Medical product, can you sell this through your existing sales force or do you need to build a specialized sales force that can cater for these new devices?

Thank you.

Anders Lonning-Skovgaard

So thanks for the questions, Mike. Let me start with the question around the investments we will into to the acquisition we just made.

So the guidance of an EBIT margin of 31% of 32% would not have changed if we have not done this. When that is said, we have committed ourselves to invest up to 2% of revenue into new activities to drive growth and this is the one of the key initiatives into 2021 and we are going to increase our R&D spend within IU and we will also invest into a team to run the clinical studies.

Kristian Villumsen

And Michael, on your second question when it comes to guidance around the new patients. So we are, if you will, on the negative side we are not assuming a complete lockdown.

I mean, that will be a change to our outlook, similar to what we saw in March or a significant disruption of elective procedure. We are assuming that the current level that we have in Europe is going to continue for at least the next couple of quarters.

When it comes to your question around Nine Continents and the sales force, the product will fit nicely within our existing sales force. But of course, once and I will also emphasize that the first job now is to do the clinical work and get us through pivotal and get the product reimbursed.

Assuming that that happens and depending on the strength of the product, I mean we will also be of course willing to invest more heavily if we think that that is what is required to maximize the potential.

Michael Jungling

Great. Can I just follow-up on the uncertainty around growth in new patients.

So if I assuming this correctly, so the next sort of two quarters, the expectations are for not lot of new patient growth but then to improve in the remaining two quarters of the year. Broadly speaking, that's what your guidance is suggesting?

Kristian Villumsen

Broadly speaking, continuing at the current level, Michael.

Michael Jungling

Great. Thank you.

Operator

And the next question comes from the line of Kit Lee from Jefferies. Please go ahead.

Kit Lee

Thank you. Two questions, please.

Firstly, I just wanted to get some color on your U.S. chronic care performance in 4Q, whether that was back to double digit growth or will it be running at a lower level?

And then my second question is just to get your latest thoughts on the digital channel. Do you now see a more permanent shift to the budgeted sales and marketing going forward which might potentially make your cost base more efficient?

Thank you.

Kristian Villumsen

Thanks. Good questions.

U.S. chronic care performance has continued to be strong here in Q4 and we are delivering both a quarter and a year with double digit growth.

We are very satisfied with that. And really strong performance on the ground from our U.S.

team. We have also launched a new member to the SpeediCath family, a new product that fits into the '51 category in the U.S.

called SpeediCath Soft, which we think is going to be a nice addition to the portfolio in the U.S. To your question on the digital channel, to me, we have certainly expanded significantly on the digital front.

We have deployed a number of tools and made an investment into both training our people and deploying the tools globally. I suspect that these are going to be at least a semi-permanent mix of the go-to-market model.

And at the very least, you are going to find, I think, a large number of customers who you are actually going to better serve through these types of channels going forward. But my base scenario is not that COVID is going to continue.

My base scenario is it will, at some point, stop, right. And we are going to get back to something that looks a lot like what we used to have with much better access.

And we know from customers that there is a real thirst for getting back together. And when we are talking about doing training, when we are talking about doing in servicing of accounts, these are what you might call a contact sport.

And there is a lot of hunger in the market to get back to that. So I don't envision that it's going to fundamentally change the cost structure of the commercial organization.

If anything, it's going to expand its reach.

Kit Lee

That's great. Thank you.

Operator

And the next question comes from the line of Scott Bardo from Berenberg. Please go ahead.

Scott Bardo

Hi guys. Thanks for taking my questions.

First questions, please. I wonder if you could just give a little bit more color on Oliver Johansen's departure.

Obviously, only a few weeks ago, he was giving us an innovation update of the company and now he has left. I am not sure if that's performance related or anything connected with Ambu issues.

If you could just give us a little bit more understanding there, that will be helpful, please? Second question, sorry if I missed this.

But did you call out what you are seeing with respect to new patient growth in the fourth quarter and for the full year, both for ostomy and continence? Any feeling for how those patient numbers look like, that would be a very helpful, please?

And lastly, on the Nine Continents acquisition, it looks to be quite an interesting little pre-revenue and technology company. $145 million is obviously a meaningful sum, given that revenues aren't expected for four or five years or so.

So I wonder if you could help us understand please how you go about valuing the startups or what is the sort of opportunity for this product, if it comes to market? Thanks.

Kristian Villumsen

Thanks Scott. Lots of meat on at least two of those three questions.

Let me start from the top with your question about Oliver Johansen. Please don't read anything into that.

Our innovation projects are continuing just as we presented them. As you know, we changed the structure of the company just recently in connection with the Strive25 strategy and the Nicolai Buhl Anderson now heads of the innovation area.

Nicolai is basically reconfiguring his team for what he thanks is the job at hand. So please don't read anything into this.

That's related to neither performance nor Ambu. This is Nicolai setting his team.

When it comes to the inflow of new patients for Q4 and the full year this year. As you know, we had the bulk or if you will, the most dramatic impact to the business back in the March, April and May timeframe when healthcare systems were also most badly hit.

And we have basically seen patient inflow starting to pick up from that timeframe throughout the months until this year it's been at a slower pace in the U.K. And like we said earlier, the U.K.

is sitting at around index 80 or 90 to pre-COVID levels. So it's certainly not gone but it is not back to growth from pre-COVID levels.

When it comes to Nine Continents, well, good question. As you heard from our presentation of the of the strategy, we are adamant that this should become a significant growth contributor to the group.

That is going to require that we expand beyond the segments that we are in. We have done a very serious piece of work when it comes to scanning literally many hundreds of companies and ranking them pretty much based on the strength of the technology, team, et cetera.

And for a number of the segments that we are in, we have developed what you might call a target list. For overactive bladder, where Nine Continents Medical are developing new product, this was a company at the top of the list from our view.

It went up for sale a bit earlier than we had expected. But the valuation reflects that the size of the underlying medical need is very significant.

It reflects that the existing alternatives, the patients of the existing treatment options really should be improved and can be improved and the strength of what we believe is the technology here. So of course, you model out different scenarios for what kind of pickup and what type of share that you could get.

You also model up different scenarios even if you might fail. And that's how you get to a perspective on value.

And then, of course, there is a negotiation with the selling side and this is where we came out. In my mind, Scott, this is a strategic play on behalf of the company.

Overactive bladder is big segment. It's got a lot of people suffering from this condition.

And they really deserve better treatment options than they have today. So I am pretty excited about it.

But also humble that we need to show clinical results and reimbursement before we can really start talking about how it's going to contribute to the company. But in the scenario that we get through that with good results, this will be very important to the group.

Scott Bardo

Yes. Brilliant.

Thanks for the answers. And maybe just a quick follow-up, please.

I think for the capital markets that you outlined there's quite a lot of innovation programs going on at Coloplast and you are still expected to sort of maintain this 4% R&D ratio. I mean, does that still hold, despite this Nine Continents acquisition?

I would imagine running a Class III device clinical study is not going to be cheap for a product that has a big market potential. I just wonder if that guidance still encompasses this acquisition?

Thanks

Kristian Villumsen

It does, Scott. We can manage within this guidance and we think that, well, we are going to make a very serious effort on this device.

Scott Bardo

Great. Thanks for the questions.

Operator

And the next question comes from the line of Maja Pataki from Kepler Cheuvreux. Please go ahead.

Maja Pataki

Hi. Good afternoon.

Also two questions from my side, please. The first one is a question around guidance.

You have talked a lot about the baseline that you have coming out of this year, which is understandable in favor. But I was wondering, how do you think about pent-up demand when it comes to intervention in urology?

Is this something that you believe is existing? And is that baked into your guidance?

And then my second question relates to the acquisition of Nine Continents. You point out what the current third generation or third line therapies are.

Could you give us a bit more indication on which of the pockets is actually leading? And can you tell us also if it is possible, in a short answer, what the shortcomings are of the current third line therapies?

Thank you very much.

Kristian Villumsen

Great questions. Just when it comes to the question on pent-up demand in interventional urology, we believe that there is not that much a pent-up demand.

The growth that we are seeing now is, if you will, clean. There may be some level of that.

But separating out how much how much it is, is, I would say, it's almost unknowable. Our team's view is that it is quite limited.

When it comes to the question around Nine Continents, let me see if I capture all of the sub-questions that you had. So the prevailing treatment out there in third line.

So one is Botox, Botox injections. And clearly there's both, a couple of questions related to that.

One is the actual efficacy of this treatment working and the other one is that you actually have to go back for Botox injection at regular intervals. The more invasive option is the to sacrum nerve stimulation, which is a market that was invented by Medtronic and that Axonics has now recently launched a product into.

Of course, these are very invasive procedures where people have to undergo, in some cases, multiple surgeries to get to results. And of course, that is going to be something that everybody will think about before they undergo that type of treatment.

The alternative that we are talking about here is tibial nerve stimulation. And there are solutions to that in the market today.

But they require you to go to the doctor to go through treatment. The implant that we are talking about here would be less invasive.

It's basically a miniaturized version of an implant that will be done in the outpatient setting and you wouldn't have to go to the doctor. Basically, it's a one-time procedure and it's something that you could be using for years, if you responded to treatment.

I think you had some question around guidance was there that I missed. What was that?

Maja Pataki

No. That's perfectly fine.

Just to understand, is Botox the most common third line therapy because it's not invasive. I am just trying to understand how to market for a third line therapy just roughly split?

No, no numbers, just magnitudes.

Kristian Villumsen

So the Botox market today is about a $300 million market. If you look at the PTNS market, so the percutaneous tibial nerve stimulation, that's around $60 million market today.

But of course, that is very correlated also with the types of solutions that are out there. The bulk of the market now sits in sacrum nerve stimulation where Medtronic it the market leader and Axonics as the runner up.

That's a market of $700 million today. So that's how it breaks down.

Maja Pataki

Thank you very much.

Operator

And the next question comes from the line of Martin Parkhøi from Danske Bank. Please go ahead.

Martin Parkhøi

Martin Parkhøi, Danske Bank. Just coming back to the acquisition, Kristian, it's a rather new area for you.

Can you talk about now it's a pivotal trial starting next year? What are the normal attrition rates in a pivotal trial like that?

I am just trying to see what kind of risk there is? And then secondly, can you speak a little bit about the cost that you could be likely to incur, if this will be a marketed product?

Because I guess the $145 million are only one-off payment, an upfront payment. And then final question, just like anecdotal stories, can you talk about how, I know it's been difficult after you have won the huge GPO contract in U.S., but have you been able to gain some traction?

Kristian Villumsen

Thank you, Martin. I am going to have to take a pass on the attrition rate and pivotal trials, but I promise you I will do some investigation for when we meet each other next.

To your question on cost, as I understood, it was related to the total cost of the acquisition and subsequent milestone. We aren't disclosing the size of what it is.

I will say also, we have to get to the milestone first. It's related to, of course, us getting successfully through the clinical work and getting FDA approval.

But I can say, it's significantly less than the upfront, significantly less. And then anecdotally, on ostomy care, we have built a strong pipeline for accounts within the GPO.

And we have seen the first conversions. But access on the OC side one is more restricted than it is on the on the continence side.

So it has acted as a bit of a damper on progress. But I am still very satisfied that the business is posting double digit growth in both ostomy and continence are pulling their weight.

Martin Parkhøi

And then just a follow-up question. It's probably actually a completely new question.

Just on the contract manufacturing on the Compeed, is this completely neutralized because you have both growth in wound care and skin care in the quarter, but the division is minus 3%? How should I look at that with the comparison base in the coming quarters?

Anders Lonning-Skovgaard

Yes. Martin, let me take that one.

So our contract manufacturing of Compeed is around 15% of our total wound and skin franchise. And it is true that in our fourth quarter last year, we had a significant impact from the COVID.

So it has a negative growth, a quite significant negative growth. And that's actually also our assumption into 2021 that due to the COVID situation and the low activity levels in the society, it is impacting our contract manufacturing business.

Martin Parkhøi

Okay. Thank you.

Operator

The next question comes from the line of Niels Leth from Carnegie. Please go ahead.

Niels Leth

Good afternoon. My first question is kind of a housekeeping question.

So, one, when would you expect to initiate amortizations related to the non-medical acquisition? And how many years would you amortize the acquisition price over?

And my second question is, when it comes to your acquisition strategy, would you consider to enter the urology endoscope market through acquisitions? You mentioned that you have an interest to enter this space on your Capital Markets Day.

Thank you.

Kristian Villumsen

So Niels, let me take the first one in terms of our amortization assumptions. So we will start the amortization in the year when we launched the product.

And my assumption for now is it will be amortized over 15 years.

Anders Lonning-Skovgaard

And Niels, when it comes to your question regarding scope, the work that we are doing right now is focused on distribution agreements and that's our focus.

Niels Leth

Okay. Thank you.

Operator

And the next question comes from the line of Annette Lykke from Handelsbanken. Please go ahead.

Annette Lykke

Thank you so much. My first question would be, if you could maybe say a little bit about the growth trends in the quarter for the division that has relation to elective surgery.

Has it been sort of the same recovery? Or have you seen some sort of slowdown in association with the second COVID wave?

And then just some housekeeping question. Net finance, what should we expect for the full year?

Could you give some kind of indication here? And then the net negative effects of around 3%, should we assume more or less the same for this whole segment?

Thank you.

Kristian Villumsen

So Annette, just a point of clarification that your question on elective surgery, if that is related to interventional urology. The trend that we have seen through the quarter has been improving and it's also the improvement has continued into the month of October.

We have pretty good visibility on the surgery level. So we have not seen any impact from a second wave of COVID on the IU surgery levels.

Annette Lykke

And either for the wound care activation?

Kristian Villumsen

So wound care, it has played out differently depending on market. Skin in the U.S.

has come through the quarter well. Wound care in Europe has come through the quarter quite well.

The challenge has really been wound care in emerging markets and China.

Annette Lykke

Okay. Thank you.

Anders Lonning-Skovgaard

And Annette, in terms of what you said, the household questions. So financial items for 2021, I am expecting a level of around zero.

And the last question you had that was around the currency effect, right?

Annette Lykke

Yes.

Anders Lonning-Skovgaard

Yes. So overall for 2021, I am expecting a negative currency effect of around 3%.

So we are expecting a reported growth of 4% to 5%. And my current view is that it's more or less equally split across our franchises.

Annette Lykke

Okay. Great.

Thank you for taking my questions.

Kristian Villumsen

Okay. Operator, this is a as far as we are going to get today.

I just want one wrap-up comment to Martin Parkhøi's question about attrition rate in these types of trials. We would say now from having gotten the input that typically this would be quite low and under 10%.

But here during COVID times, attrition rates have been higher, but more to come on that front, Martin, when we see each other. From our side, thank you, all of you, for dialing in and for your interest in the company.

Continue to stay safe. Thank you very much.

Operator

This now concludes our conference call. Thank you all for attending.

You may now disconnect your line.