Camurus AB

STO:CAMX

Earnings Call Transcript 2022-Q1

[Operator]

Hello, and welcome to Camurus Audiocast and Teleconference Q1 2022. [Operator Instructions]

[Audio Gap]

[Fredrik Tiberg, executive]

Thank you so much. Good day, everyone, and thank you very much for taking the time to joining our results call today.

Before starting the presentation, please note our forward-looking statements. So here is the agenda for our earnings call today. We will start with the first quarter highlights, followed by a financial update by Jon Garay, our new CFO. Then Richard, our Chief Commercial Officer, will give a commercial overview before we move over to the pipeline and an update on our late-stage R&D programs. As usual, we will finish off with some key takeaways, followed by Q&A.

As you may have seen already in the report today, Camurus had a really good start of the year with strong performances across company functions. Notably, we achieved an important financial milestone in the reporting of positive operational results in the quarter. This was driven by continued strong top line growth and an effective use of operational and R&D resources.

Consequently, we maintained our stable cash position and are on track to reach profitability during the second half of the year. This, while also investing approximately SEK 0.5 billion in the development of our promising late-stage pipeline.

On the commercial side, we continue to execute according to plan and are achieving high double-digit year-on-year sales growth. We strengthened our leadership in established markets in EU and Australia, accelerated sales of Buvidal in important growth markets and improved market access through new approvals and funding streams.

On the R&D side, we submitted a variation application for Buvidal in chronic pain in Australia, which is now under review, alongside a corresponding application in the EU. Our Phase III programs of CAM2029 in acromegaly and neuroendocrine tumors continue to progress, and we completed preparations for the start of a clinical Phase IIb study in the third indication, polycystic liver disease. Finally, we achieved a Phase III milestone in the partnership with Rhythm Pharmaceuticals.

So with these positive highlights, I will hand over to Jon for a financial update.

[Jon U. Alonso, executive]

Thanks a lot, Fredrik. Good afternoon, everyone, and wish you are all doing well. Our Q1 interim report has been published this morning, and we would like to share with you now the main highlights of our financial performance in Q1 '22.

From a total revenue point of view, we achieved SEK 220.3 million in Q1, delivering a growth of 75% versus same period last year. Our total revenue this quarter is made up of product sales, SEK 202 million, growing at 63% versus prior year, which means a growth of 56% at constant exchange rates. Order revenue was SEK 18 million in the quarter, including SEK 9 million milestone received from Rhythm Pharmaceuticals. Overall, compared to Q1 '21, our total revenue grew by 21%.

Our operating result for the quarter was positive and reached SEK 4.8 million. This means a SEK 31 million improvement versus Q1 2021, and the trend displayed by the chart shows our commitment to profitability. As Fredrik mentioned earlier, it is the first quarter we have achieved a positive result since the listing of our company.

Our cash position at quarter end was SEK 400 million, which is a 7% reduction versus Q1 prior year. As you may have seen in our cash flow statement published this morning, our cash flow from operations before working capital has been positive by SEK 21.5 million, while working capital has increased in the amount of SEK 29 million. Accounts receivables and inventory explain that increase in working capital, which is driven by our company growth.

If we now move to next slide, we can see the main components of our operating result and its evolution both as reported and at constant rates. Our gross margin improved by 59 basis points as reported versus the same period prior year. Our marketing and distribution expenses grew 28% to support market penetration and expansion of Buvidal in own territories. R&D expenses increased by 42%, mainly driven by continued progress in the 3 ongoing Phase III studies of CAM2029 for the treatment of acromegaly, neuroendocrine tumors and polycystic liver disease. The decline shown in general and administrative expenses is mainly driven by the high legal expenses in 2021.

Our operating result became positive by SEK 5 million, thanks to priorly explained profitable growth, plus a delay in a CAM2029 R&D milestone cost that will be achieved later this year. As we continue investing in our pipeline, it will take a few more quarters to see our profitability stabilizing.

Finally, we maintain our full year guidance for 2022 as communicated by mid-February. No change at the moment. Please remember our guidance does not take account of potential $35 million development milestone on U.S. approval of Brixadi.

Thanks a lot for your attention today, and I would like now pass the word to Richard, who will take us through the commercial update.

[Richard Jameson, executive]

Thank you, Jon. Good afternoon, everyone. So in Q1, we continue to make good progress with Buvidal, with sales above SEK 200 million for the quarter, 63% up on the same period last year and 12% above a strong Q4 2021. We now estimate we have more than 27,000 patients in treatment, with an additional net 2,000 patients starting treatment in the quarter.

The Nordics and Australia continues to be high performers. In both markets, we've had excellent penetration and gained significant share. In the Nordics, we now have an estimated 50% of the buprenorphine patients. And overall, more than 20% of all patients in treatment are now on Buvidal. In Australia, we have 35% of the buprenorphine segment, an 80% share of the long-acting treatments and a similar penetration to the Nordics of 20% of all patients in treatment.

Alongside these successes, we've also seen good momentum in other future growth markets, with growth above 15% versus previous quarter in U.K., Germany and in France. We're also establishing the utility of Buvidal across treatment settings with continued growth in community treatment and further success in criminal justice settings, including a first-line recommendation in Australia. So we maintain our positive outlook for Buvidal as we continue to work across markets, addressing the hurdles to ensure patient access and the patients receive an informed choice of treatment options.

Following the significant progress in Scotland and Wales, England is now accelerating as the government funding and focus to build a world-class treatment system begins to take effect. The '22 -- 2022 allocation of the $780 million funding announced earlier has now been allocated to the top 50 regions with the highest unmet need. Novel long-acting opioid medication is now on the menu of options in the indicative planning material that commissioners should consider when assessing where to make an investment.

In France and Spain, we continue to work on accessing funds and made significant progress. In Spain, 88% of patients in treatment now live in a region where access to Buvidal is now approved. In France, we've initiated treatment in both criminal justice and community settings with very positive feedback. Furthermore, the importance of continuity of care and access to innovative treatments in opioid dependence led to the publishing of a public interest article in Le Monde, the leading national newspaper. The article was cosigned by both physicians and members of Parliament calling for funding for innovative treatments such as long-acting buprenorphine.

In Germany, we also had a strong Q1 as we've seen some promising market development as experience and awareness of Buvidal grows. We also continue our work to expand into new geographies, with ongoing pricing and reimbursement processes with expected outcomes in a number of countries, allowing us for additional launches in the next 2 quarters. We're also planning launches in large MENA markets in 2022, in 3 of those, and have other regulatory submissions underway in the region. Our progress is aligned with our long-term goal that more than 100,000 patients will be in treatment with Buvidal by 2026.

We continued, as I said, to make progress on the regulatory side with Buvidal. In the quarter, we received market approval in Lebanon, adding to early approvals in Europe, Australia, U.K., Switzerland, New Zealand and Israel. We are progressing market authorization applications in 5 additional countries in the Middle East, including 2 new submissions made during Q1.

In the U.S., following the issuing of a CRL to Braeburn in December, Braeburn have been working on the remediation plan, and we expect clarity on the Brixadi NDA resubmission time line in Q2 '22.

So on that, I'll hand back to Fredrik.

[Fredrik Tiberg, executive]

Okay. Thank you, Richard, for the update. Now moving over to the R&D pipeline and top-level progress in our late-stage development programs in chronic pain and rare diseases.

So starting with the ongoing label extension to chronic pain. We prepared and submitted a new variation application to extend the indication for Buvidal to include chronic pain, this time to the Australian Therapeutic Goods Administration, TGA. This Type C variation application is currently under review by TGA, along with the corresponding application submitted to EMA in November 2021. In the EU, CHMP opinion, followed by EC approval decision, is expected in the second half of 2022. While in Australia, an approximate time line for a decision is in first half of 2023. We're looking forward to continued agency collaboration during the remaining part of the review processes.

During the quarter, we also progressed our prelaunch preparations and completed additional market research together with a third party, including introduced with leading clinician experts in selected EU markets. This study confirmed the significant unmet medical need in chronic pain, in particular, in patients with or at high risk of opioid dependence. The study also demonstrated a high degree of willingness to use Buvidal for treatment of chronic pain in this population and a sizable market opportunity of more than EUR 150 million in Europe and Australia. If approved, Buvidal could be the first long-acting injectable product for treatment of chronic pain, adding to the current indication of opioid dependence.

With its short update on chronic pain, let's move over to the octreotide subcutaneous depot program in development for treatment of acromegaly, neuroendocrine tumors and polycystic liver disease.

As we have previously presented, Camurus has several clinical development programs ongoing with CAM2029 targeting different rare disease indications. Ongoing clinical studies include 2 Phase III trials in acromegaly, which both are in final stages of recruitment; the recently started Phase III study, the SORENTO study, in patients with gastroenteropancreatic neuroendocrine tumors, GEP-NET. This is an active controlled study with the primary objective to demonstrate superiority in progression-free survival with CAM2029 versus standard of care.

During the quarter, we also completed preparations and regulatory interactions for the start of a Phase IIb study, POSITANO, in patients with polycystic liver disease, for which there is currently no approved medical treatment. In all these programs, we have recently introduced our newly developed injection pen. This state-of-the-art device has several convenience benefits, allowing for easy self-administration by patients and other advantages.

Here follows a status update on ongoing trials and activities. So starting out here with acromegaly. We have 2 ongoing Phase III trials, 1 randomized controlled trial and 1 long-term safety study. So far, 122 of target 148 patients have been enrolled. Here, we have had some challenges due to the war on Ukraine, which led to the stop of new recruitments in Russia and a shift of our focus to completing patients already included in the study. This has resulted in an approximately 3-month long delay of the randomized controlled study, which we plan to partly catch up by accelerating other processes. Phase III results are currently expected early 2023. And in parallel, we are preparing for regulatory submissions.

In GEP-NET, we have 38 out of 95 clinical sites activated in the SORENTO study, which was started in Q4 last year. 23 patients are now randomized, and recruitment is accelerating as new sites are activated. The interest in the study is high.

Finally, in polycystic liver disease, PLD, we had a Type C meeting with the FDA and aligned on the patient-reported outcomes tool that we have developed specifically for this Phase II/III program. Patient recruitment is starting during the quarter. We have had high expectations for these programs -- we have high expectations for these programs, which overall are making good progress and are well received. Third-party market research indicate that peak sales across the 3 target indications for CAM2029 are above USD 1 million.

So before concluding the R&D update, it is worth mentioning our partner Rhythm's recent progress with our weekly formulation of setmelanotide for treatment of genetic obesity diseases. In Q1, Rhythm dosed the first patient in their Phase III switch study, triggering a milestone payment to Camurus. A second Phase III study in de novo patients with Bardet-Biedl syndrome is planned to start in the second half of this year.

In summary, we continue to build value for shareholders and patients through commercial execution, where we are strengthening our leadership in opioid dependence treatment in the EU and Australia, accelerating growth in high-potential markets and working diligently to improve access and funding.

Our pipeline is progressing with significant investments made in our Phase III programs in rare diseases, alongside progress in our partner programs. We're expanding the indication for Buvidal to chronic pain and continuing our successful life cycle management efforts.

In addition, we are looking forward to getting clarity about the resubmission time line for Brixadi from our U.S. partner, Braeburn, this quarter. We are pleased with our growth progress towards profitability and pipeline development and are now also exploring the opportunities for additional inorganic growth.

With that said, thank you for listening. Now passing the word to the operator for the Q&A.

[Operator]

[Operator Instructions] Our first question comes from the line of Viktor Sundberg from Nordea.

[Viktor Sundberg, analyst]

Congrats on a good quarter. So I have a few questions on your next trial in polycystic liver disease. So first of all, I wanted to understand your trial a bit better. I guess a bit puzzled by the mentioning of patient-reported outcome as a key discussion point. I mean, I guess, liver volume is the main endpoint here as in previous trials in this indication. Just curious what the agency and you discussed with regards to patient-reported outcomes. And perhaps what has the issue been or discussion points. So that's my first question.

[Fredrik Tiberg, executive]

Yes. I'm happy to take that, Viktor, and it's a very good question. It turned out that when we started this program, we had extensive discussions with the FDA about the endpoints. And it was not satisfactory to the agency to rely only on liver volume. So as a key secondary or co-primary endpoint, they wanted to see patient-reported outcomes to looking -- focusing then on symptoms. And there was no such validated tool available in the community or scientifically. So we have spent a very significant time working with leading researchers in this area to develop our own tool. And this is now going to be implemented in the Phase IIb study. So it is a key part of the whole development in polycystic liver disease.

[Viktor Sundberg, analyst]

And given -- also a follow-up here on polycystic liver disease. I mean, given the rare nature of the disease and that most patients are asymptomatic, is the final size of the study confirmed to be 69 as stated in clinical trials? And I'm also a bit curious what your thinking is in terms of the market opportunity here in this indication given that it's very rare.

[Fredrik Tiberg, executive]

Yes. I think, I mean, rare is a relative measure. I would say that our market research suggests that it's a larger indication compared to acromegaly, for instance. So we're talking market estimates of somewhere in the region of SEK 400 million in estimated potential peak sales for this product. So I think -- yes, it's a relative measure here.

And what was your -- sorry, Viktor, can I just repeat the second...

[Viktor Sundberg, analyst]

Yes. Just wanted to confirm if the study size is still 69 patients, as stated in the clinical trials, or if that has changed. That was my question.

[Fredrik Tiberg, executive]

Yes. Well, what I can say right now is that we have, I think, most -- all sites are confirmed. I have to double check if it was exactly that number, but we have a very strong list of clinical sites across the U.S. and Europe with -- all I would say, that's maybe difficult to say, but with many of the leading KOLs in the area involved in the study.

[Viktor Sundberg, analyst]

Okay. Great. And I also have one on Buvidal before I jump back in the queue. So just quickly here in France, you, of course, have had some push factors in some European countries previously. So just wanted to come back to France, which is a big market for opioid dependence. How far have you penetrated in the [indiscernible] system? And when do you think Buvidal could be more widely prescribed among general practitioners so you can reach the bigger pool of patients in that country? Just curious how the progress has been there.

[Fredrik Tiberg, executive]

I think the answer to that question is that we are still quite early days in the penetration of the [indiscernible] system. We do have a very significant interest across clinics. And of course, our team is working in all geographies in France here. But overall, we're starting from a relatively small base. But moving forward -- maybe, Richard, you can fill in on that and give a more...

[Richard Jameson, executive]

Yes. As Fredrik says, it's early stage, but we've seen a positive progress to date. We've just expanded our team as well because of the opportunity that presents in the [indiscernible] system. And although, yes, you're right that primary care is a bigger segment, there's still 30,000 patients in the [indiscernible] and prison system.

[Operator]

And the next question comes from the line of Suzanna Queckbörner from Handelsbanken.

[Suzanna Queckbörner, analyst]

I have two for now. Starting with Buvidal sales and -- sorry, Brixadi and the licensing partner in the U.S. In your report, you mentioned Braeburn and their contract manufacturer in the U.S. have worked on a remediation plan. And I appreciate this is a sensitive question, but perhaps you could explain what that exactly means. Should we expect major or minor changes relating to the manufacturer?

And then on a second -- as a second question on acromegaly. I'm also curious about, given that the U.S. would be the largest market, what kind of measures have you taken to thinking about commercialization in the U.S. as you're currently -- that your sales team is obviously based in Europe and whether you've had interest in licensing partners?

[Fredrik Tiberg, executive]

Okay. Yes. And I think that's a very relevant question. So I mean starting out with the remediation activities going on in the U.S. I mean Brixadi is tentatively approved, as you know, so the CRL was exclusively due to manufacturing related, and as we have stated, quality issues. So they -- there's a number of quality issues that have to be addressed at the manufacturer, and that's the process that is ongoing. We hope to present clarity on this, especially more importantly, on the resubmission. So I will not be able to comment on the exact nature of this. But as we are saying that -- and Braeburn has informed us that they will come with this clarity, we are looking at that with an optimistic view overall.

When it comes to the commercialization rights in the U.S., they are part of the licensing rights that Braeburn has in the U.S., and they have the responsibility for commercializing in the U.S. and setting up that force. Of course, under the agreement of our -- under our license agreement and those commitments.

[Richard Jameson, executive]

And I think she was asking acro.

[Fredrik Tiberg, executive]

You were talking about acromegaly? Sorry, Suzanna. I'm misleading you. With regards to acromegaly, we are definitely looking at the opportunity of setting up our own commercialization efforts in and operations in the U.S. This is a very niche indication initially and a very targeted customer group. And we are looking at that very seriously right now in terms of how and what processes are implemented in the U.S. and structures.

[Suzanna Queckbörner, analyst]

Right. And if I can just add one last question. In terms of Buvidal sales in the Nordics and in Australia, where you see the -- your largest markets just now, what potential do you see for further growth here in terms of within the buprenorphine and long-acting market?

[Fredrik Tiberg, executive]

Well, we see very clear opportunities of continued growth even in markets that are very well penetrated. Maybe, Richard, you can...

[Richard Jameson, executive]

Yes. I mean we're still growing in those markets quite well. It's interesting, in Australia and in Finland, we're seeing the number of patients increase as well. A lot of patients won't come into treatment right, or perhaps I should say, people outside of treatment won't come into treatment because they don't like the rules and regulations associated with daily administered treatment. So we're seeing those markets grow to some extent. So I think there's still growth opportunity in those markets.

[Operator]

And the next question comes from the line of James Vane-Tempest from Jefferies.

[James Vane-Tempest, analyst]

First one, please, just on Brixadi as a follow-up. You talk about sort of the clarity of resubmission in 2Q and sort of quality-related item. But appreciate you can't be specific, but is there any sort of at least kind of categories you can give us or just something for us to understand the nature of the deficiency?

I'll be honest, I mean, given it's been 5 months and we haven't heard anything, I mean, are you concerned that these are actually quite major issues to address in terms of being able to kind of communicate what the specific issues are? That's my first question.

[Fredrik Tiberg, executive]

Well, James, I do think -- I've spoken about this. And of course, we are limited in the communication we can provide. But I wouldn't say -- I mean there are a number of quality deficiencies that had to be addressed. We had this question, I think, since this is the second time now in a row. Our estimates was that they could all -- were all addressable priorly, and I think our view point is the same. So we do think there is good opportunity to handle these issues in a reasonable time frame, but this needs to be confirmed, and we need to get to that clarity from our partner and not...

[Richard Jameson, executive]

Speculate.

[Fredrik Tiberg, executive]

Speculate here. Well, more than speculate because we have, of course, insight into the problems. But I would say they are quite common problems that you would see in -- also in other CRLs issued to various different pharmaceutical manufacturer.

Quality is always -- it's a complicated space, but I don't think there is anything that is exceptionally outstanding here. That's probably my message. [indiscernible]

[James Vane-Tempest, analyst]

No, no, I fully appreciate that. Appreciate the candor. And then, I guess, the other question is, Indivior also made the decision to sort of step up its sales and marketing activities for SUBLOCADE. I mean do you think that impacts the overall market potential of Brixadi if they're able to capture more of the market before that gets launched on to the market?

[Fredrik Tiberg, executive]

Well, I don't think so, really, because if you're looking at the overall penetration of SUBLOCADE in the U.S., it's still very, very small. I mean even though they have -- we have to be clear about the fact that they're doing good progress, but it's still small; percentage -- single-digit percentage of the U.S. market potential. I do think it's only an advantage to see further penetration from Indivior. I have said that all along from day 1, that I think the 2 products are very complementary and I think it's more -- if you're looking at it from a competitive angle, I think it's more trying to capture and -- which I think is important because I don't think daily medication and the way it's really handled now is maybe fully appropriate, although it is an important component of treatment in the U.S. and Europe. But I do think that the importance here is to try to capture more of the daily sublingual market and maybe also the methadone market in the U.S. So I see it more as an opportunity than anything else.

[James Vane-Tempest, analyst]

And my final question is just on the quarter. You mentioned about some of the timing of the R&D, which was going to be in Q1, put into 2Q. And there was some nonrecurring incomes as well. Apologies, if I missed the detail, but you're able to confirm what those numbers were so we can look at what it was on an underlying basis?

[Fredrik Tiberg, executive]

I'll leave it over to Jon here.

[Jon U. Alonso, executive]

The milestone part of revenue was SEK 9 million coming from our partner-driven pharmaceuticals, James. And in terms of R&D, we have not disclosed the number. It is 1 milestone linked to CAM2029, which includes the percentage of patients enrolled. And we were supposed to reach this in Q1. Now we think it's going to be reaching Q2, and the amount that it was supposed to be is SEK 15, 1-5, million.

[Operator]

And the next question comes from the line of Peter Östling from Pareto Securities.

[Peter Östling, analyst]

Maybe it's a little bit too early, but can you say anything about what kind of label you're seeking for the pain product, Buvidal? That's my first question.

[Fredrik Tiberg, executive]

Yes. Good question. I mean, here, we have very much of our focus is on the payer side, and we are concentrating on the population of patients with chronic pain who also have a concomitant opioid dependence or potentially risk of opioid dependence. This is details that we're discussing during the review period with the agency here in Europe and Australia. So it's a subpopulation, which we have targeted. And of course, that's due to a number of different consideration, not the least market access.

[Peter Östling, analyst]

Okay. How -- can you talk anything about how large that market is, number of patients?

[Fredrik Tiberg, executive]

Well, I mean if you're looking at the market research that we have been doing the last -- well, I'd say the last 1.5, 2 years, I would say that in terms of number of patients, it's an additional approximately half of the population were estimated for opioid dependence treatment. So if you would target the 100,000 patients that we have for 2026, we're calculating somewhere around 50,000 patients extra for the chronic pain indication.

Of course, the growth trajectory will start at a different time point. So it means that we'll probably take a little longer time to penetrate that market.

[Peter Östling, analyst]

Yes. I guess that the chronic pain concomitant with opioid dependence is more usual in the U.S. than it is in Europe.

[Fredrik Tiberg, executive]

Well, I think that's interesting. There is -- our research suggests...

[Peter Östling, analyst]

Maybe that's only a notion that I have that opioid...

[Fredrik Tiberg, executive]

I think it's a hopeful notion. Our research suggests that in certain countries, in some significant countries, there is a very big issue and that these patients are not receiving the proper treatment at this moment. But -- so I would say it is definitely a big problem in the U.S., but it's not negligible at all in Europe or Australia.

In Australia, there was a long buildup of pain prescription use, especially codeine, as it was -- the Australian market was unregulated. You had OTC codeine, and there is a big underlying problem buildup through that use in Australia, which you can explore further.

[Peter Östling, analyst]

Okay. Okay. Interesting. And then finally, I noticed that you -- I may have missed this, but it's the first time that I see it that you talk about inorganic activities. What could that entail? If you could elaborate a little bit about that.

[Fredrik Tiberg, executive]

Yes, we're -- of course, I mean, our main focus is on organic growth and developing our pipeline, but we are also exploring opportunities, especially to strengthen our pipeline in Europe and -- or our commercial pipeline, as just said, in Europe and Australia. But another important strategic direction is, of course, building up our future U.S. structure and getting a stepping stone into that market for CAM2029, for instance. So it's 2 targets.

[Peter Östling, analyst]

Yes. So it could mean that you would potentially look for something in the U.S. in order to get commercial structure in place?

[Jon U. Alonso, executive]

Yes. It exactly means that this is one of the areas in which we are analyzing inorganic growth opportunities. That's right.

[Peter Östling, analyst]

Okay. And finally...

[Jon U. Alonso, executive]

[indiscernible]

[Peter Östling, analyst]

Okay. Exactly. So just going back to one of the previous questions about setting up your own sales force in the U.S. You talked specifically about acromegaly. What about the other indications? The NET indications, for instance? I guess that's a completely different kind of target population that you would address.

[Fredrik Tiberg, executive]

I think it's quite well -- yes. sorry.

[Peter Östling, analyst]

Yes. No, go ahead.

[Fredrik Tiberg, executive]

I think it's quite well-suited because, I mean, if you're looking at the approval -- potential approval sequence and so forth, it will be a stepwise approach. I think they are absolutely not incompatible. They are more compatible than incompatible, the 2 indications, acromegaly and NET. And potentially, we could also explore the polycystic liver disease opportunity in our own setting. So we are definitely looking at all of these and additional opportunities as well.

[Operator]

And the next question comes from the line of Erik Hultgård from Carnegie.

[Erik Hultgård, analyst]

I have two, if I may. First, on your guidance, which imply a midpoint around 50% growth over '21. Could you specify a bit on where you expect those patients to come from? Existing markets or first launch markets, Australia, Nordics versus new growth markets, including EU5? And then secondly, can you say something about the penetration that you have achieved in the U.K., Germany and France?

[Fredrik Tiberg, executive]

I'll leave that over to Jon.

[Jon U. Alonso, executive]

So thanks a lot, Erik, for your question. I will take the first one. Our growth for this year is planned to grow. And I will not go into detailed numbers, but some of the markets in which we are now, we are going to accelerate our commercial penetration. We are already doing it. You have mentioned Australia is one of them. Finland is the other one. There was also a question before. So we are planning to accelerate the growth there.

Second one is countries in which we have just launched recently and we need to penetrate faster. We are also doing it. In this category, you have, for example, France, that has been mentioned in this call.

But then the third category is new countries we are penetrating. And without going into details, Middle East and North Africa is one area, which we are penetrating. Fredrik and Richard has mentioned during the presentation that we have submitted a number of applications to 5, 6 countries, and this is going to be another source of growth.

So basically, these are the 3 components that we are expecting to contribute to our growth in '22.

[Fredrik Tiberg, executive]

So I think just to put some nuance on that also. I think if you see that we will basically have quite continued growth in our established markets in the Nordics and Australia, growing from a small base in many of the markets like -- such as the U.K. and -- or not -- yes, in general in the U.K., I would say, not Scotland and Wales, of course, where we have high penetration. And then even smaller base, but with big opportunities long term in Spain and France and other new markets.

Richard, maybe you would like to answer the questions about -- the questions from Erik about the U.K. and...

[Richard Jameson, executive]

Yes. So I mean in terms of penetration and patient numbers, I mean, the U.K., it's a reasonable percentage now. It's getting bigger quickly. France, it's still early days. So we haven't had a huge penetration yet in France to answer those. I think they were the 2 you mentioned.

[Fredrik Tiberg, executive]

Germany as well.

[Richard Jameson, executive]

Germany. Germany, yes. Germany, we're making good progress. We had a very strong quarter in Q1, grew above 20% actually in the quarter. So again, we're seeing some acceleration there. But again, we're not close to the penetration that we've seen in Nordics and in Australia, but I think that means the opportunities there because we know that if we address those hurdles in place, the patients will come into treatment. So we see big opportunities in those markets. And they, of course, part of it is planned in for this year.

[Operator]

[Operator Instructions] We have a follow-up from Viktor Sundberg from Nordea.

[Viktor Sundberg, analyst]

So in Australia, I just wondered they seem to have been moving away from this hard lockdown policy/zero COVID policy that they had in 2021. So any impact from that yet in terms of you getting better access to prescribers? Or if you could put that in perspective, how that's been in 2021 when you had the lockdown policy? And what your outlook is for Australia here during the full year? That would be helpful.

[Fredrik Tiberg, executive]

Yes. I mean the lockdown in Australia, I mean, it was not -- it continues, of course, but for some significant periods of time, places like Melbourne, Sydney lockdown and was difficult to travel between states. We did have an impact in Australia on sales and ability to approach clinicians. I think it was mainly in Victoria that we had some problems of accessing doctors for a period of time. So that had some impact. I don't think it was very significant, to be quite frank. And now it is open. We don't see that it limits our team at all. I would say, at this moment, we have a very positive time going on in Australia right now. So it's moving well. Thank you.

[Viktor Sundberg, analyst]

Okay. Great. And I also had a follow-up in the U.K. market. So this funding that you have seen that is earmarked for drug centers and so on, how much of that have you seen deployed in the U.K. at the moment? Because it's a 3-year program, but has a large chunk of that been deployed already? And do you see money earmarked for Buvidal here in the U.K. at the moment?

[Richard Jameson, executive]

Yes. So we've seen the rollout now. The NHS year starts in April so -- and runs from April onwards. So we're just seeing that come out. As I said, the government have made the allocation of the proportion of that funding is for 2022, which is about 100 -- I can't remember exactly what it is. And that's now been allocated to the 50 areas of highest unmet need where there was a huge change around drug-related deaths and drug misuse. So that's going there.

And part of that allocation is a menu of options that commissioners who fund the treatment can choose to commission for other treatment centers. And in the very clearly long-acting, new, innovative long-added medications, I think it's labeled at, is listed as one of those options. And we see a lot of people that are now -- and a lot of clinics now starting now because they've got that confidence that the funding is in place.

[Viktor Sundberg, analyst]

Okay. Great. And I had a very quick question here on the cost of goods profile. So the gross margin seems to have improved here. Is that something that we could extrapolate for the rest of the year here going forward? Or was it more a onetime cost of goods reduction here in the quarter?

[Jon U. Alonso, executive]

Okay. So thanks all for your question. No, it's not going to be onetime, but we need to improve them when we extrapolate it. If I can elaborate a bit on the question. The first time I met you all, it was in mid-February when we were publishing the result. At another point in time, our gross margin for the full year of '21 was lower, which in the range of 25%. We have a clear commitment to improve the gross margin, and I think we can be in the range of 88%, 87% is more or less our aspiration. But we need to have in mind, I'm going to make the same comment I made in February when we were discussing this topic.

As we enter into new countries, as we are accelerating our growth, in some cases, we will need to do budgets for the new countries with bigger size, and then we may have some challenges to commercialize the product and face write-offs or scrap off product. But in long term, yes, we are aiming to have 87%, 88% regarding some hiccups as we penetrate in new countries. Have I replied your question?

[Viktor Sundberg, analyst]

Yes.

[Operator]

And as there are no further questions, I'll hand it back to the speakers.

[Fredrik Tiberg, executive]

Okay, everybody, thank you so much for joining our call today. I think we have a interesting quarter ahead of us, Q2. And I really look forward to you rejoining then and us being able to present promising -- continued promising future for Camurus and good outcomes of our various activities. So thank you for joining today and looking forward to speaking to you again next call.