Sedana Medical AB (publ)

STO:SEDANA

Earnings Call Transcript 2021-Q3

[Operator]

Hello, and welcome to the Sedana Medical Q3 Report for 2021. [Operator Instructions] Today, I am pleased to present CEO, Johannes Doll; CFO, Susanne Andersson; CMO, Peter Sackey; and Commercial Director, Jens Lindberg. Please begin your meeting.

[Johannes Doll, CEO & President]

Thank you. Good afternoon, everybody, and good morning if you're dialing in from the U.S. My name is Johannes Doll, I'm the company's CEO. And since this is my first report for Sedana Medical, I will start with a very brief introduction about myself. Before joining Sedana Medical on October 1, I was the Chief Commercial Officer at Orexo, a Swedish-based pharmaceuticals company, where among other things I was responsible for building up the commercial operations in the United States and plus also leading our corporate development efforts and led our internal development pipeline. Before joining Orexo, I worked 8 years at McKinsey, where I helped clients both in the medical devices industry as well as the pharma industry on a broad range of topics, but with a focus on a lot of product launches and selling, notably hospital selling.If we move to the Page 2. As always, I recommend you read through our disclaimer, as we will be making forward-looking statements throughout this presentation.And with that, let's go to Page 3. In my view, Sedana Medical has a fantastic purpose, which is to improve life during and beyond sedation. And in order to do that, we will do our very, very best, and that is our vision; to make inhaled sedation with our Sedaconda product, a global standard therapy for critical care patients, for mechanically ventilated patients in the ICU. During my first month, I have made it a priority to be out there and meet as many customers as possible. So I have visited around 20 intensive care units in 3 of our most important markets. I had the opportunity to speak to a lot of physicians, a lot of nurses, pharmacists and hospital administrators. And with those impressions, I can now say that I stand behind this vision 100% because having heard our customers speak about how our Sedaconda products do make a product -- do make a difference for their patients every day, and those are, by definition, relatively critically ill patients, that gives me a lot of encouragement and conviction that we are doing the right thing and that we will be successful.If we move to Page 4, the quarter highlights. We are looking back on a very eventful and also successful quarter. We've had net sales of SEK 28 million. That means we have been able to grow the business by 34% in local currency. Year-to-date, that number was 23%. And what I'm very pleased with is that all our regions have contributed to that growth. What's also very encouraging to see is that despite the COVID-19 levels being relatively low throughout Europe in the third quarter, we saw continued use of Sedaconda ACD in non-COVID patients and our customers kept using our products.On the operational side, we have 2 big priorities in the company right now. One is to execute an excellent launch in Europe, and the second one is already now prepared for what will be our largest potential market, the United States. On the European side, we are moving from offering a device to offering a full therapy, including a device and the drug, a volatile anesthetic, isoflurane, for inhaled sedation. And after having gotten the green light on a European level, we have now received 11 out of 15 national approvals for Sedaconda isoflurane and that means that we continue to expect product on the shelf in the first markets towards end of the year, and we will see a pickup in sales in the first quarter.Also during the quarter, we saw our clinical trial results published in The Lancet, and as I'm sure you know The Lancet is probably the most reputable journal in the field, which adds a lot of credibility. And also our country teams are now staffed up and trained and ready for launch.On the U.S. side, we have a big milestone coming up with the IND that we expect to get before year-end. If that goes well, then we expect to start our clinical program in the U.S. next year and anticipate the first patient in around the turn of quarter 1 and quarter 2. Sedana Medical also has a U.S. company now, and we've hired the first couple of employees into that company during the quarter.If we move on to Page 5, so in sales, good robust growth, both in the quarter as well as year-to-date. This is important because the more clinics we get equipped and trained and comfortable to use our Sedaconda product ahead of launch, the better is our platform for the launch coming up. And the third quarter was also a nice continuation of the longer-term sales growth trend over time, which I find also interesting from a perspective because the third quarter tends to be the one that is least affected by COVID-19, so it shows a little bit the underlying growth.If you move to Page 6. As I said, I'm pleased to see that all of our regions have contributed to this growth. Germany, up 9%, continued to be our largest market. This is where we have most of our customers. And with these customers, we are especially pleased to see that despite COVID-19 levels being relatively low, those customers use our product in broad patient groups, and we are not dependent on COVID-19. I'm also happy to see that in our other direct markets, so these are the other markets where we have our own Sedana Medical team out in the field, commercializing our products in the U.K., Spain, France, the Nordics, and Benelux, we have returned to year-over-year growth after the first half of the year has been impacted by very large orders in the year before, during the first COVID waves, and customers in the first half of this year had to work through the inventories they had built up. But now we are back on our growth path with especially nice performance in Spain, France and the U.K.We continue to see very strong demand also in the distributor markets, especially in Latin America. The second-largest market actually for us was Colombia in the quarter. Year-to-date it has been Mexico. So we're seeing some very strong demand from that part of the world where it is probably fair to say that the demand is partly impacted by still relatively high COVID-19 levels in that part of the world.If we go to Page 7. One question that I've gotten a lot over the last month is to what extent is Sedana Medical's performance dependent on COVID-19. The very short answer to that question is Sedana Medical was never intended to be a COVID company. We're not a COVID company now, and we don't see our long-term potential to be affected by COVID. The slightly longer answer, you see depicted on this slide. If you think about what the actual market potential is for us, we are talking about patients who are in the intensive care units, who are mechanically ventilated and sedated. And since these data are not always easily accessible in all countries, it is sometimes tempting to instead analyze where we do have perfect data that you can read in the newspaper every day, which is the number of COVID patients in the ICU.But if I take Germany as an example, it's actually not the perfect proxy because even during the highest peaks of COVID in Germany, we never had more than 30% of COVID patients in the ICU. Not all COVID patients are actually ventilated but currently, that number is down to 52%. Not all of the ventilated patients are sedated and what makes comparison over time extremely tricky is that we are today dealing with a completely different patient demographic in the ICU. It used to be mostly old people. Today it's basically a pandemic of the unvaccinated where we're seeing much younger and previously healthy people in the ICU.What we can say about our view on COVID-19, though, is, yes, we may see fluctuations in sales in some regions, up and down depending on what COVID will do, but we will not be dependent on our long-term forecast on COVID-19. The other thing I will say about COVID-19 is probably one of the key success factors in every launch is your ability to change behavior. In our case, we will have to convince clinics to no longer use IV sedation or propofol for their patients, but change their behavior and start using inhaled sedation and our Sedaconda product. And as a consequence of COVID, we have brought more customers over that hurdle already so we're starting from a slightly better launch platform.If you go to the next page, just to illustrate what I just said, of course, you know that the number of COVID patients in the ICUs have dropped significantly, both in Germany as well as in all our other direct markets as well. If we were a COVID company and if we had followed that same trend, then we should have seen Q3 sales that were much lower than they actually were. But they were quite a bit higher, which again proves that our products are not just used in COVID patients, but very broadly in the customers, and we have some good resilience versus COVID-19.If you move on to Page 9. On the operational side, we have 2 big priorities for the company, which at the same time represent the 2 growth horizons for the company as well. In the short term, we're very focused on executing the launch in Europe. We do that through our direct presence in Germany, U.K., France, Spain, Benelux, and the Nordics. And as has been stated previously, we are aiming at exceeding SEK 500 million in sales in the third year after approvals and that is 2024. On the United States side, approval is still a bit out. So we anticipate approval before the year-end 2024 but we're already very active in preparing for that market. No doubt that the U.S., if you look at the number of ICU beds and also the price levels in the market, is the single most attractive market for us from a market potential perspective. And we have accelerated the review and intensified the review of which go-to-market strategy is best-suited for us to capture that potential, and we will communicate that decision later in 2022.If you move to Page 10, and we will now go through these 2 priorities on the European side. As I said, we have received national approvals in 11 countries. We're still waiting for reply in Spain, Ireland, Poland and Slovenia. Switzerland and the U.K. due to Brexit now have their own registration processes, and we are anticipating approval in 2022. And the only slightly bigger market that is still missing on the list is Italy, where we are planning to submit in the beginning of 2022.We move to Page 11. As we have communicated, we received national approval in Germany in the end of September, which then meant that the label tax and everything else was finished and allowed us to place the first order for the launch stock, which, of course, we have done. As previously communicated, there's roughly a 3-month lead time. We are still expecting products on the shelf towards the end of the year in some markets, including our main market, Germany. In other markets, as you know, there's a local pricing and reimbursement process we have to go through first and depending on how fast that goes, we will have these launches a little later, but we will see pickup of drug sales in the first quarter.If you move to Page 12. What it takes to have a successful launch. You need to prepare the product, you need to prepare the market, you need to prepare the company on the product side. We are in a very nice position, but we will be the first and only on-label option for inhaled sedation of mechanically ventilated adult patients in the ICU. So we are moving from selling a device and being dependent on off-label sales of the drugs to being able to offer the full therapy. We have great products supported by strong clinical trial results, which really mean the difference for the patients. And not least, we have the Lancet publication, which is being very well received by our customers and adds a lot of credibility to our company and to our products.On the market side, we are in a pretty unique situation as well, but we actually do have existing use of the device for inhaled sedation, the Sedaconda ACD, mostly in Germany, but also in a lot of other markets, which, of course, provides a good platform for also launching the drug. We are trying to increase that awareness and that conviction around inhaled sedation by being very present and present at the big congresses, by holding symposia and, of course, to our field staff that is out there with the customers every day.On the company side, we have extended the field teams. We have invested quite a lot in training. We have upskilled our key account managers. They have gotten a license to also work as pharmaceutical sales representatives in the countries where that is a requirement. And everybody is ready and excited for launch.On the U.S. side, there's no doubt in my mind that this is the biggest potential market for Sedana Medical going forward. We are very busy preparing for the clinical program that will start next year, which Peter will talk about in just a second. But we're also stepping up on the commercial side. And what you see here is just to give you a little bit of a view on the market potential. We're comparing the United States with our today's largest market, Germany, where we have sold roundabout for EUR 10 million in the last 12 months, which represents roughly an 8% to 10% penetration of the market potential.If you look at the number of ICU beds, you almost have a factor of 5 in the United States, 107,000 beds. And what we also have put here is a comparison of the list price of propofol, which is the current standard of care for an average patient simply based on the average propofol dose that we have found in our own clinical trial, SED-001. And if you run these numbers, you see that the range for Germany for a day is roughly between EUR 47 and EUR 57. In the United States, those numbers are much higher, in the area of EUR 360 to EUR 438.Now if you've worked with the U.S. before, you, of course, know this, I will still mention in the United States, a list price is not the same thing as a net price for a product like propofol, which is a relatively old product. You will easily see discounts in the area of 40% to 50% which we also got confirmed in some payer research we did a year ago. So you have to take that off the numbers that you see here, but you can still see that both from a volume perspective as well as from a pricing perspective, there is a good opportunity for us in the U.S. And of course, propofol, this price is only one element or one input factor that goes into our pricing strategy. There's others, but the potential, I think, is quite clear.On the next page, Page 14, from a market preparation perspective, as I said, big milestone ahead with the IND that we will hopefully get approved for year-end. If that goes well, we can start our clinical trial. We are expecting the first patient in at the turn of Q1 and Q2. From a market perspective, Peter will speak to the quality of centers that we were able to recruit for the trial, which is really an impressive list. It's basically, the who’s who of the American hospital landscape, which speaks a little bit to the interest that we're getting and the innovation we are bringing and the excitement to be a part of that. And as I said, we've also now -- Sedana Medical has a subsidiary in the U.S. Now we have hired the first 4 clinical education specialists who will be working with the clinical trial sites, getting them trained and set up and helping them throughout the clinical trial.So with that, I will hand over to our Chief Medical Officer, Peter Sackey, and I will be back in the end of the presentation for a very brief summary, and then I'll take any questions that you may have.

[Peter Sackey, Chief Medical Officer]

Okay. So as Johannes mentioned, the data from our pivotal European trial was published in August this year in Lancet Respiratory Medicine. And in this study, we instantaneously described that isoflurane was noninferior to propofol on the primary endpoint, time within target RASS range without rescue sedation. And besides that, we found several benefits with isoflurane, including the reduction of opioid use, increased spontaneous breathing, shorter time to wake up and also good tolerance to isoflurane. So generally, multiple benefits that translated to improved patient outcomes.And we go to the next slide. This also rendered a very strong SmPC where we do not have a 48-hour limit for the use of Sedaconda. It's also the only -- Sedaconda is the only device with which you can deliver Sedaconda. And another strong part of the SmPC includes rapid and predictable wake-up and the return of wakefulness and cognitive recovery within 10 and 60 minutes, respectively, which is very short in -- after ICU sedation.And we go to the next slide. We are currently running our pediatric trial, the IsoCOMFORT study for European country. This is based on the approved pediatric investigation plan by the PDCO, a European agency. And this is the mandatory step up in adult study in order to get the 10-year data exclusivity. And this study starts with the first patient enrolled in the third quarter this year. And this is a study that we had submitted the protocol to the FDA and received a lot of feedback and adapted. Accordingly, we still need to wait for the final approval after IND, which we hope to receive shortly after our IND.Next slide please. When it comes to the adult clinical trial in the U.S., as earlier communicated, based on feedback from 2019 up to this year, we will be doing 2 clinical trials that will include approximately 500 patients in total. And prior to these trials, we need to do some toxicity -- nonclinical toxicity study and also the human factors program, and we've been aiming to run these 2 projects successfully and are now moving towards IND submission. And regarding the 2 clinical trials, besides the patients that will be randomized, we will also be including 3 to 5 run-in patients per ICU [indiscernible] Sedaconda ACD. Isoflurane treated patients in these 2 trials together with the existing trial will constitute the safety database the FDA requires for an NDA.Go to next slide, please. So looking at the overall time line when it comes to the study that contribute to have regulatory approval, the Sedaconda study was completed last year and published this year and then preparations for our -- the FDA approval. The next study is ongoing in 2021, and the 2 U.S. studies are anticipated to start at the turn of Q1, Q2 next year. We also have the investigator-initiated INASED trial that is currently ongoing in France. And with this we anticipate 2 data NDA approved before the end of 2024.Next slide, please. Looking at the U.S. and the current status when it comes to preparations. We feel we're well prepared now to start these clinical trials as we mentioned, [ among other ], based on the significant interest we've met when we exactly with investigators. I mean, trial investigators have to reach out to other [ high rollers ] in clinical trial sedation. The most renowned institutions will be taking part -- in the U.S. will be taking part in the study. We’re currently working on contract negotiations and IRB applications. And as Johannes said, we deployed our first U.S. general staff, clinical education specialists, 4 of them, who will be covering the U.S. and training the ICUs with use of Sedaconda. And all in all, this will lead to initiation of the trial at the turn of Q1, Q2 next year.

[Susanne Andersson, Chief Financial Officer]

Good? Over to financials, yes? So our net sales, like Johannes talked about earlier, increased year-on-year by 34%, which is very good and the most positive was that all regions were contributing to the result, both positive. We had gross profit in the quarter of SEK 19 million, equivalent to a gross margin of 68%. We still see a positive impact to gross margin due to that we have delivered most by sea freight instead of air freight in the quarter. We have -- we target that we will continue this way but also, we do foresee some shipments by air freight and also, we think that prices for freights is estimated to stay at a high rate. We also had a one-time positive impact in the quarter of roughly 1 percentage point, and this was from a reclassification to general and admin. There was some cost of goods sold moved to general and admin OpEx.And on the other side, we have the market mix where we had increased sales in our distributor markets with some of the lower margins that actually to be down a bit. But it's still very positive to see that we had a good development in the gross margin. And year-to-date, it's about 66% compared to 65% last year.And coming down to the EBITDA, we had negative EBITDA of SEK 14 million and margin of negative 50%. Again, we are continuously investing for future. We are in the midst that we are in the middle of the Sedaconda launch and we're spending money there, and that including the MDR approval. We've tried to break out some of it and kind of like a one-time costing in relation to the Sedaconda launch, which is SEK 9 million year-to-date. We've been talking about building up the organization, and we are now roughly at 100 people including consultants or in-house consultants. At the time of Sedaconda launch, just like what has been communicated earlier, the growth will not be the same in coming years, but there will be some minor additions in some selected areas and mainly within sales. I'd say the growth rate we're seeing within staffing will not continue at the same pace, but be a little bit lower and selective.If we move on to the balance sheet and cash. We have cash flow from operations of negative SEK 15 million. And then from the cash flow from the investments was negative SEK 33 million in the quarter. And this is really due to the -- mainly the U.S. clinical studies that's starting to take off and then also the final list within the EU registration. That's, if we look on the balance sheet, roughly half of the number. Actually, SEK 240 million of the balance sheet, roughly half of that is related to the EU registration. And given the market approval in Germany, we will start to depreciate this project over a time period of 10 years. So that will give roughly SEK 1 million a month depreciation. Total cash flow for the period was minus SEK 48 million. And the cash balance at the end of September was SEK 262 million, and we're still a debt-free company with a strong balance sheet and no long-term financial loans.Our largest shareholders by end of September is very similar as they were back in June. It's just [ clearly Handelsbanken ] has increased their holdings a little bit. And I think we still have a very good investor base with some institutional investors.And with that, I'd like to hand over back to you, Johannes for summing up.

[Johannes Doll, CEO & President]

Yes. Thank you. So I hope you got a sense of the performance and the progress we've made in the third quarter. We are quite happy with that third quarter but now our focus is, of course, very much on the future and on the 2 big priorities that we have ahead of us, which is prepare for the launch in Europe, which we feel like we're very much on track to do that. And also, even though it's still a few years out, already have at least one eye on the U.S. market and intensify those preparations because it will become the largest potential market.And with that, I thank you for listening, and I'll open it up for questions. Please, moderator.

[Operator]

[Operator Instructions] Our first question comes from Peter Östling with Pareto Securities.

[Peter Östling, Life Science Analyst of Equity Research]

Two quick ones. I noticed that on the slide describing the U.S. clinical trial, there has been some additions where you say that besides randomized patients, 3 to 5 run-in patients will be recruited per ICU. Can you elaborate a little bit what that is and how that will affect the study?

[Peter Sackey, Chief Medical Officer]

Yes. So the run-in patients are due to the fact that Sedaconda ACD is not approved yet in the U.S., meaning that before the randomized trial starts, there will not be any prior experience like there was in Europe, obviously, that's SED-001. In order to gain efficiency in titration of the sedative in this assessor-blinded study, we will be doing training. This is educated, of course, but it's also important that the clinical staff in these ICUs feel comfortable and then they have to dose the drug correctly and they'll have to troubleshoot and so on and so forth. After the training that will be done, we [ will continue presentation ] and the dry run training. Our staff will be present and we'll start patient in every ICU that are treated with Sedaconda ACD and they'll be able to support the local educators. From a [ study improvement ] perspective, we believe this will be an improvement simply also because we will be testing for a relatively short time to include acute patients and being experienced, and we hope to keep up that momentum to go-live training with [ insulin ] patients.

[Peter Östling, Life Science Analyst of Equity Research]

So these 3 to 5 patients will not be part of the actual study population?

[Peter Sackey, Chief Medical Officer]

Correct. They will be part of the randomized control population. They will contribute to the safety database, however.

[Peter Östling, Life Science Analyst of Equity Research]

Okay. Great. Then just another question on the U.S. You've added the first staff over there just recently. How many do you think that you will have a year from now? 5, 10 people? Or...

[Johannes Doll, CEO & President]

So this -- yes, this question, of course, depends a lot on what we decide to do with the U.S. and as you know, we have guided that we are currently very intensively looking at that assessment, which go-to-market strategy is the best. And we will communicate that. The options on the table, I can say so much is, on the one hand, is Sedana Medical could decide to build up our own commercial operations, launch Sedaconda product, do that own commercial operations. That's one scenario. The other scenario would be we would go with a local partner and not build up the organization. Or, of course, there's options in between and some hybrid models that we're looking at as well. And depending on what that decision will be, of course, that also drives very much what the organization will be at launch, and it also will drive what the organization will be over time. So giving you a specific number at this point, I'm sorry, I can't do that yet.

[Peter Östling, Life Science Analyst of Equity Research]

Okay. Fair enough. Just finally, before I go back into the queue. On the slide where you compare Germany with United States on ICU beds, propofol list price, current penetration, so forth. The current price per day for propofol, is that the price that you will aim for Sedaconda? Or will you aim higher?

[Johannes Doll, CEO & President]

It is one of the input factors that we will take into consideration when setting the price. But of course, the price will depend on multiple different factors. In Germany, of course, you know that we are charging a premium versus propofol because we are bringing more value added as key benefit would have come out of the clinical trial of inhaled sedation versus the standard therapy with propofol, so we're charging a premium. What exactly we will do in the U.S. will depend on a number of different factors, but it is quite comforting to know that the starting level of the reference treatment is quite a bit higher than that is the case in Germany. But of course, in general, if there's a benefit that you're bringing, that should be reflected on the price also.

[Peter Östling, Life Science Analyst of Equity Research]

Okay. So the initial guidance given by Sedaconda of around EUR 20 per day seems a little bit low then for Germany and rest of Europe?

[Johannes Doll, CEO & President]

I think you mean EUR 200, right? And EUR 20 would indeed be very low.

[Peter Östling, Life Science Analyst of Equity Research]

Yes.

[Johannes Doll, CEO & President]

So yes, I'm not sure if you heard, we have exactly guided to EUR 200 in the United States. We will see a higher price than we currently have but in Germany, where I think a good number, as I previously stated, is around EUR 100 per treatment day for inhaled sedation and you can expect that number to be higher in the United States.

[Peter Östling, Life Science Analyst of Equity Research]

Yes. No, of that EUR 100, around EUR 20 was for the drug and EUR 80 for the device, but that is -- that has changed, obviously, then?

[Johannes Doll, CEO & President]

Yes, I don't -- well, I will not -- so, of course -- let's put it this way. We're just ahead of launch. We have invested quite a lot of money into a clinical trial. We're moving from off-label to on-label. We were moving from offering a device to a device and the drug. All of that will be reflected in the pricing strategy for the European market as we launch now. And then fast-forwarding a couple of years to the United States, we are expecting a higher price than you will see in Europe.

[Operator]

Our next question comes from Carl Mellerby with SEB.

[Carl Mellerby, Equity Research Analyst]

I have a couple, if I may. If we're starting off -- you mentioned that, yes, of course, you're targeting including 30 centers across the U.S. in the 2 upcoming clinical studies. How many do you have so far? And then in terms of regions outside Europe and U.S., specifically China, any update on when we can expect the approval for the ACD there? And then lastly, in terms of OpEx, is it possible to provide some form of guidance here in terms of total OpEx levels for next year? You mentioned EUR 59 million sort of one-off costs related to the Sedaconda launch year-to-date which, of course, won't come back, but then you like to have some additional beefing up of the organization coming in and you started some preparations related to that. So any form of guidance on how like OpEx levels you're developing in relation to 2021 would be very helpful.

[Peter Sackey, Chief Medical Officer]

This is Peter Sackey. The first was about the U.S. and how far we have come with -- can you please repeat the question, I didn't quite follow.

[Carl Mellerby, Equity Research Analyst]

Okay. It was related to the how many centers have you recruited so far for the studies in the U.S.?

[Peter Sackey, Chief Medical Officer]

So currently, we have 26 centers that are interested that has given [ slightly different ] data. And currently, none of those types have been disclosed by us. So all sites that are used to doing large clinical trials.

[Johannes Doll, CEO & President]

So then I will comment on the question outside South of Europe, and I think Susanne can take the OpEx question. So one general comment I will make, and I think I've made it clear in the presentation that the focus areas, the priorities are in Europe and then even with a higher potential underlying in the U.S. Of course, we will exploit opportunities in other parts of the world where we think we can do that. As you can, for example, see now as we get very strong traction in Latin America. The way we are thinking about this, we are now pursuing a very fact-based approach country-by-country, where we are looking very closely at the market potential, so number of ICU beds, number of ventilator patients, price level, things like that. But beyond the theoretical market potential, we are also very closely looking at how likely are we going to be successful in this market.So is this a health system that is able and willing to pay for an innovation like the one we are bringing? Can we actually access all the ICU beds that you find in the official statistics? We have a distributor that we think can pull it off both on the device side and potentially also on the drug side. And all of that, we put in relation to how much investment is required to be successful in that market. So some markets, as you know, will require local studies. Others, you can rely on those years you have submitted in other places. So very fact-based approach. And since my task is to look after other people's money, at this point in time, we will not shy away from deprioritizing markets that sound big, but the numbers do not work out. So that's just my general thoughts on the business outside of Europe and the U.S.When it comes to China, specifically, and the situation in China, is we have signed an agreement with a Chinese distributor back in 2019. There was a number guidance given in the press release at the time of an amount that we will earn over the time of this agreement. The submission and getting approval is the responsibility of the Chinese partner. Of course, we are supporting that for the product-specific parts. We would have wished, of course, in the normal world view, we would be over there with our teams and working hand-in-hand, be a bit closer. But from our side, from what our -- under our control, we have finished all these elements of the dossier. We have handed over all the data that are required in our view. And now it's up to the partner to decide when to put in that submission. But to answer the question also, the submission has not yet gone in.As I said, from our perspective, it should go in relatively fast, but it's outside of my control. And then I will not comment on approval timelines because that goes for the all countries, but specifically in China and speculating about how fast the Chinese authorities will move on this product is a bit difficult to say, but the submission should go in relatively soon.

[Susanne Andersson, Chief Financial Officer]

And then should I answer to the OpEx question in as well? I want to refrain from giving any guidance but in order to help some, I can say that through 2021, we've been building up progressively our organization throughout the year. So it's by end of September that we are ramping 100 people within the company. And again, we don't see that we will be growing staff at the same pace as we have done. And like you pointed out, we also had some sort of one-time costs related to the preparation work for the Sedaconda launch. But also, we hope that we will be able to do some marketing once we have the standard launch and everything. But I -- and also, I think even if we are now, let's say, 100 people at the end of September, Q3 is never a good quarter to have as a base either given the vacation period, et cetera. But I hope that will help you a little bit about thinking on your [ loss ] without really giving an exact guidance.

[Operator]

[Operator Instructions] We have no further questions. I hand back over to our speakers.

[Johannes Doll, CEO & President]

Yes. Thank you very much for the attention. Thanks for dialing in, and I wish you a nice day.