Orexo AB

STO:ORX

Earnings Call Transcript 2022-Q1

[Operator]

Welcome to the Orexo Audiocast with teleconference First Quarter 2022. [Operator Instructions]

Today, I am pleased to present Nikolaj Sorensen, Chief Executive Officer. Please go ahead with your meeting.

[Nikolaj Sørensen, executive]

Thank you very much. And sorry for the short delay. We had some technical issue here at the Orexo side.

So I'm very proud to present our first quarter results we file from Orexo. This is a very strong first quarter given the conditions that we're working under. And we think that there are a lot of positives signs in the way that we're developing the company forward based on what had happened during this first quarter.

From a practical perspective, I will say we received some questions by e-mail, and I have already seen there are some questions post up on the chat forum. We will answer those in as good as possible both during the presentation but also afterwards. But for those of you who won't get your question answered, I propose that you just send an e-mail to our Investor Relations mailbox, and we will answer them by mail as soon as possible.

So starting on the presentation. We start with the short overview. So today, we will have a -- together with me, I have Joe DeFeo. I should say that also our CFO. And the way we've set up the presentation is going through a short summary of our key achievements during the first quarter some business updates on the different business segments, U.S. pharma pipeline and digital therapeutics, we will go into the financials, and then we will talk a little about why we believe that Orexo is well set to drive good value in the future.

So starting up with our key achievements. We -- if we look at headquarter, pipeline at the start, we are making good progress towards the filing in the fourth quarter this year of OX124. Nothing has really delayed us as we see it right now. But of course, there's an intensive work going on in the organization to prepare the filing later this year.

We've also made good progress in OX640, where we are now planning to initiate the first clinical trial during the summer. We continue to get better and better in stability data from the project, which we believe is a very important differentiator in this space.

And then we have also made our first shipment of ZUBSOLV to Accord in Europe. The first sales was recorded this quarter where the vast majority is from the shipments. So we are selling products to Accord Healthcare. We also received a milestone when the first shipment was received by Accord. And then when they start selling to customers in the different markets, we will receive a royalty. But this first sale was payment for the supply of product, which we are responsible for at Orexo.

In U.S. pharma, we have worked intensively to broaden our reimbursement in the largest segment in the market, the Medicaid segment, and we are very pleased to see the second largest Medicaid state in the U.S., New York state. Added Orexo as a preferred product of -- since March 22, and we are now reimbursed across basically all inhabitants in New York. With that, we are improving the access in this fast-growing segment, the public segment from 42% up to 48%. So nearly half of all of the patients have now access to ZUBSOLV without any restrictions.

We have worked a lot to improve access to physicians. And here we see the combination with our ZUBSOLV field force and also modia is a very good door opener in a lot of those sales calls where we can see the quality of the call and the frequency of the calls go up when we have a dialogue with modia.

When it comes to Digital Therapies, it's continued slow progress. Our big focus have been on securing a solid reimbursement pathway. That's something we have seen in the first customer discussions we had with both vorvida and deprexis that it has been cumbersome and it is something that is important that we, as a company, have a streamlined process and know exactly how we can help our customers to get the reimbursement pass-through when we work through medical benefits. We believe we are there with Trinity Health, and we are basically expecting to see the first patients coming through very soon. I'll come back to that later.

What's important in the long-term for digital therapies and what we have seen for several of the other players in the space have highlighted a lot in their communication is how you create federal systems to manage these reimbursement systems. And there, we have seen several new initiatives, which will improve access to reimbursement for different products in different categories.

And then when it comes to modia, we have seen now 250 patients are now using modiaONE in their OUD treatment and that in modia in the OUD treatment and that's based on this program we call modiaONE, which is basically a trial program where selected customers are offered a few number of licenses that they can use in the clinics to test modia on their patients. And we are now actually exceeding 270 with some decent margin as we had a pretty good pickup the last week.

We also have, in total, we are still working to make also vorvida and deprexis available, and we are now exceeding 1,800 total users of our digital therapies in the U.S. As you recognize when you see the sales, a lot of this is in trial programs, and that's basically something we have decided to focus on given the difficulties we have seen to get the reimbursement systems up and running, but I'll come back to that later.

Looking at the financials. We have seen our revenues is growing basically across the line. Of course, some of that is because the foreign exchange has been favorable for us in this quarter on the revenue line, but also we saw, for example, ZUBSOLV, we have increased prices and we have a more favorable mix of customers, which, of course, is also something that is sustainable throughout the year, that kind of growth as you can grow revenue both on volume but also on price, and we have successfully grown our volume on price. And the same when it goes to other pipeline projects, basically, all of them have seen some growth during the first quarter.

What's as important in particular, in light of some of the feedback we got on our first quarter call is to show how we can work with our cost base, which we have deliberately worked to create what I call [ rubber-banding ] to ensure that we can accelerate when needed, but also we can decelerate when we see that some revenue-generating activities take longer time. And if you look at the total cost line for our U.S. pharma and DTx , you will see that, that has shrinked between the quarters and that is basically because of activities to both focus our DTx efforts right now on these big health care providers and ensure we get the reimbursement systems up and running. So we have canceled all direct marketing activities. And also, we are looking at how we can deploy our field force in the most optimal way given the issues we've had due to COVID of accessing physicians.

And I will remember while -- or remind you that while our revenues is, of course, benefited from a strengthening dollar, our cost base where the majority of the Orexo cost is actually also dollar-denominated this is negative. And in light of that, it's good to see that we actually improve our -- reduce our cost in SEK also.

Then we have our cash position where we still have a very solid cash position. Some of you have noticed, I know the cash flow for the quarter, but I don't think anyone working with accounting would be that concerned because this is really moving around account receivables and around accounts payable. So we're reducing our accounts payables. So we're paying short-term liabilities and we're increasing our account receivables as some of the payers, as you will recall from Q4 have extended their payment period and some of this -- a lot of the sales pick up in Q1 was in the latter part of Q1. So we haven't got that cash paid yet. We have looked at our outlook, and we have reduced our OpEx guidance a little in the outlook and be more specific.

Moving into U.S. pharma, and I will move to Page #8. The highlight of the quarter is, of course, the New York Medicaid. It's a market where we today have more than 10% market share in commercial, that does include these former exclusive contracts with Humana and at UnitedHealth Group. And even though we have seen a decline in volume for these 2, we still have a disproportionately high market share within both Humana and United. If we take those out, our market share in commercial in New York is about 7.2%. So that give you an indication of how we compete when we are competing on a level playing field with others.

In Medicaid, where we have not been reimbursed before our market share is about 0.5%. So you can see there's a good headroom for growth in New York. And to manage that, we have increased our field force. We're doing that from April because we weren't really certain about how the Medicaid listing would look like before March. So we started recruitment in March, and now we're ready to expand our field force here in April.

We have started, as we said, working with modia, and we see quite a lot of synergies because when we work with opioid use disorder treatment, it's called MAT in the U.S. Medical Assisted Treatment. Medical is ZUBSOLV assisted treatment is modia. So being able to take that holistic discussion with the customers and show how Orexo is actually addressing one of the biggest concerns among a lot of prescribers in the U.S. is access to quality counseling. That put us up on a pedestal in terms of dialogue with the customers and increase the depth and quality of those interactions, which I'm sure will support ZUBSOLV in the long run as well, of course, modia is benefiting from the long-term relationship we have with a lot of customers for ZUBSOLV.

We have seen when we look at demand, a slight decline quarter-over-quarter of 3.6%. We did guide that when we went into the year, we see that basically, every year with the exception of last year which was due to COVID, we have seen a reduction in the first quarter. And the reduction is predominantly within the commercial segment and that's where you see the high co-pays, which are normally settled or reset at the calendar start. So when you in December, you basically get most of your prescription paid by insurance company coming into January that's where you have to pay basically all of it yourself until you get up to whatever level you have in your insurance contract of high deductibles. So how much can you -- do we need deduct before you get it covered.

So we have seen this dip. And if you look at the graph, you will see that there is this small dip coming into January. But after that, it's more or less a straight line throughout the quarter.

And if you look at the below those numbers, as I said, here we have some commercial contracts in particular United and Humana, who both of them are working with quite high co-pays and high deductibles. We saw a drop in the beginning of the -- during Q1, but then we've seen others, for example, Caremark Commercial, ESI and Cigna, Medicare. We have seen Kentucky continuing to grow. So we do have growing accounts behind the overall quite flat development.

Looking at the overall market in the U.S., the -- I want to switch the right slide. Here we are. So looking at the overall market in the U.S., the market growth rate continues to be relatively low year-over-year, we are within our guidance of 5% to 8%. But we did see that the development quarter-over-quarter actually was slightly negative. Some of that is a calendar effect as we have 2 less days in Q1 as what we have in -- had in Q4. But also, we again have the overall effect of these commercial -- in particular, commercial insurance customers who have a calendar reset of their co-pays.

We have seen COVID-19 have had a quite significant effect in this market. We have seen a lot of physicians reducing the number of new patients, reducing access to their clinics. And of course, as COVID-19 is getting under control and the societies are opening up, we believe that will have a positive effect on the market. We also see on a national level, a lot of activities. What is interesting right now is a lot of what you call opioid litigations in the U.S. are right now generating a lot of cash input into the state, which are supposed to be used to improve treatment of opioid misuse.

So what we would expect is to see a lot of these money that are now paid out by other pharma companies, pharmacy chains and so forth will now be invested into improved access to treatment for patients in different states. And that's, of course, an area where Orexo is very active to work with the states to see how we can support them both with ZUBSOLV, but also with modia, and the say, the comprehensive offering that we can have with both ZUBSOLV and modia.

As we said before market access is improving for ZUBSOLV and we have now modia launch. So we have believed that there are good growth drivers both on the market level but also on ZUBSOLV moving forward.

Moving into our headquarter and pipeline. We will start to say we believe that we have one of the more exciting pipelines in the industry in Sweden at least, which is based on that we are so close to the market that -- we are developing products based on the feedback that we see. And we also now have a technology that we believe is unique in terms of the features that we have in amorphOX.

Our most advanced pipeline is OX124 and you could say, OX125 because a lot of the work we're doing in OX124 right now is basically a one-to-one applicable on OX125 and in the future also OX640. And we're making good progress. To be able to file with the FDA late this year. But of course, I just need to say that there's so much work needed behind these products, not -- because it's not only a powder, it's also a device, it's a packaging solution and all of that needs to meet the FDA requirement. So of course, there are always risks for a slight delay, but we believe that we're now on track to meet our target for the year.

With OX640 which we have also think is an incredible product and everyone I've talked to who have family members who are suffering from allergies or themself are suffering from allergies understand the important benefits that we can have here. It's a $2 billion market that's been growing with high single-digit percentage in the last few years. It's dominated by auto-injectors like EpiPen who are very expensive, have very short shelf life, most EpiPen coming out of pharmacies have less than 12 months on shelf life.

And what we can come with here is an OX640 where you have excellent stability data, and I can't underline that enough. It is excellent. It's completely stellar to any other product that we have seen. Other companies are promoting data, which is mediocre compared to what we have on OX640.

And what do you want, if you have an issue with high risk of allergic shocks, of course, you want to have a product that works. If you're on the beach and have the product lying in your rugsack in high temperature, if you are out skiing and you have low temperatures around you. But for the auto-injectors they are supposed to be stored at room temperature, and we have good data showing how sensitive they are to variations in temperature. But here, we have a powder that have shown to be highly effective in -- it's maintaining its properties in temperatures up to 50 degrees.

We have our first clinical trial during the summer. Are there any reasons to believe that it will work? I think there are good reasons to believe it will work because there are other nasal sprays that have been tested for adrenaline, and there is a nasal uptake of these products. So we know that adrenaline can be delivered through the nose in the mucosa. We know from our 3 clinical trials we have done with OX124 and OX125 that our powder is -- have a very favorable pharmacokinetic profile. So we think that there are very good reasons to believe that our clinical trial will be successful during the summer.

Coming to our most latest and we haven't talked that much about it pipeline is we do have a product that we call OX-MPI, but our partner call GS-248. It's a product for systemic sclerosis. They got orphan drug designation approved by the FDA for the treatment of systemic sclerosis. That's very important because it helps you to accelerate development time lines. It reduces the expenses and it prolongs the IP or the intellectual property right you have for the product when you get it launched in the U.S.

They have a Phase II product -- project ongoing. We expect the results during the summer. And when -- for this project, even though Gesynta have acquired all of the rights, we are not involved in the project. We do have a right to a tiered double-digit share of future revenues where the structure depends on what kind of commercialization we see.

Going a little further into OX124. And we are, as I said before, we are on good track. What we need to have ready for the filing and stability data and also usability data where we're testing how the product is used by say, normal human beings in different age groups and how they understand our instructions and that they actually deliver this nasal spray in the nose as expected. So these studies are going on. And of course, even though we have a lot of learnings from other similar products, that is always something that come with some uncertainty could delay the filing. But right now, we are on track with the filing in the late this year.

Moving to amorphOX. People who are educated in drug delivery would understand the beauty of amorphOX. And at least every time I have been part of presenting this to other pharmaceutical companies, and we've done that quite a lot a in the few last months to some of the leading biotech companies of the world. They understand the value of amorphOX.

And what is it that we believe we have? We have shown in clinical trial a superior pharmacokinetic property where we have rapid onset, higher peak overall exposure compared to liquids, [ not much ] even more important for a lot of companies right now, in particular, those with larger molecules is to find a way where you can keep products stable under different conditions. And this is why we have tested a multitude of APIs in the product, and we have several APIs several more than what we have -- where we have projects right now.

We have formulated them. We have stability data on them. And when we have the capacity, we have the ability to take some of these projects into real projects, out-license them or with some of the discussions we have with other pharma companies have more attractive opportunities by applying our technology platform to their substances that will, of course, be where we focus our resources. But we do have excellent stability data, both on small but also on large molecules.

We have 3 granted patents, and we have patent protection with some of the patent applications, we have filed all the way up to 2042. So you understand this quite recently, we have added more product patent applications in the U.S. So we actually find this amorphOX platform is incredibly exciting, and I'm very pleased to see that we get a similar reaction when we present it to those who really understand it, which are often the head of pharmaceutical development at larger and leading biotech companies.

Moving into our digital therapies, and I will move 2 slides ahead here. One of the big obstacles not only for Orexo, but for every company is working with digital health solutions, not only therapies, is the access to reimbursement. It's something that where we have been very -- we were very optimistic when we launched but due to the COVID-19 situation that some of the insurance companies and health care providers then would be pragmatic and find ways to provide individual solutions to innovative products, but we haven't really seen that and neither have any of our competitors.

So to get these federal initiatives in place, it's incredibly important for this industry to prosper and to develop. And what we have seen during the last -- say, just the last 2 quarters is that we saw this remote therapeutic monitoring code and CPT code coming in Q4. We talked about that in our last quarterly report. And during this quarter, we have seen HCPCS code or health care common procedure coding systems for prescription digital therapies that would be for modia when we have finalized our 510 -- our clinical trial and made our 510(k) application, got that approved.

And the same, we have this an initiative on a federal level in the Congress, and it's a bipartisan initiative with quite broad support right now to ensure that patients under Medicare and Medicaid also get access to prescription digital therapies. That means that they have 510(k) approved, and that is what's relevant for modia when we have the study results and have received a 510(k) approval.

Right now, modia is commercialized under what we call emergency use authorization. That mean we can commercialize it, but we can't do it as a prescription product, but we are still -- it's still available to commercialize in the U.S. under the emergency use authorization we have received from FDA.

So what have we done in the last year? We have -- over the last quarter. As we decided in -- during the second half of last year to [ stuck ] with our direct-to-consumer promotion we have decided to focus on giving key stakeholders access to try our products. So we are working with both health care providers, we are working through labor associations or nurse associations. We're working with medical students. And of course, we still have consumers who is buying access to modia and deprexis to ensure we have people who have positive experience of the products.

That one, we have seen quite a lot of growth last year, but also during this year, we have seen several patients are users of our products.

For modia, we're doing a very targeted effort, as I talked about before, called modiaONE where we provide free access to a few number of licenses per clinic where the clinics can test that modia actually deliver on their promises. What's was incredibly positive and encouraging from this is that we're receiving very positive feedback. We are seeing clinics who are opening up for working with us to test the reimbursement pathways that we know exist within the medical benefit route.

So there are reimbursement pathway that works, but it's something just like we have to do with deprexis and vorvida where we work with Trinity Health, we also for modia has to work with actual clinics to test if these products are -- how this reimbursement system works. And that is basically where I would say we have learned deprexis in the details, but now I'm pleased to see that we actually have quite a few users, and the feedback we get is very positive.

So what's to expect from our DTx. We have worked, as you know, with Trinity Health, and I do -- would say it is a little of a luxury that we have a very engaged partner who is willing to put resources from administrative resources to clinicians, to their medical director even up to their CEO to work with Orexo to define treatment programs and also identify feasible reimbursement pathways.

And what we have seen during this last quarter is action that we believe that the reimbursement pathway would work. But due to the setup within Trinity Health, there are some issues internally in how they would administer the treatment programs and payment through this medical benefit, which is quite complex, if I should go through it. But it is a new way of working for them, and that's something that we have had to work with that [indiscernible] path to set up the right processes. We believe we are basically nearly there. So we expect the first patients to come in very, very soon.

When we had that experience and all of the learnings, and remember, Orexo, we are a pharmaceutical company. And even though we understand market access quite well, then there's a lot of learnings here. This is a new way that we have identified through the medical benefit route to get paid for our products. That is basically no other companies that have worked with. So there's a lot of innovation coming through this reimbursement pathway. But when we have the Trinity Health, I believe that there is a strong opportunity to take those learnings and dramatically shorten the time to implementation with other health care providers.

And we have been a little hesitant to start up with other health care providers because we know that there's not -- there are a lot of questions that we haven't been able to answer correctly before now when we have finalized the process with Trinity Health.

We're also working now with some of these opioid use disorder clinics to implement the reimbursement pathways for modia, and we hope to get started with the first of them here during the quarter, so we can roll that broadly during the second half of this year.

Our collaborations with Sober Grid, Justmiine and E-HBS are all progressing. Sober Grid, we have had a little of an issue at their site because they have had some significant changes in the leadership, where they had a new CEO appointed a few months back. So it has been a little slower than we would have expected during the first quarter. But now, we have a good collaboration with the new CEO, and we hope that, that's something that we can expand on during this year.

I will move into -- we'll now move into our financial and legal section, and I will leave to Joe DeFeo to take us through. So Joe, I will let you take over here.

[Joseph DeFeo, executive]

Good afternoon. Go to Slide 20. You could see that ZUBSOLV grew 9.7% year-over-year, which was excellent growth. We also saw -- continue to see better-than-expected royalties for both Abstral and Edluar, which help our revenue as well. And then we've had our first shipment to Accord Healthcare care for ZUBSOLV outside the U.S. So overall, you could see that revenues grew by over 20% versus last year. So good strong revenue growth.

When you look at U.S. pharma and specifically ZUBSOLV versus Q4, normally what you see is Q1 is a difficult quarter because the wholesalers hold a higher than normal inventories at year-end due to the holidays. And then also Q1 is difficult because there's high deductibles in the commercial segment. However, we've been able to grow ZUBSOLV's revenue by 4.1%.

You can see the lower demand which I mentioned is mostly due to high deductibles in the commercial segment and the drop in inventories. But we've had a very good positive payer mix. We've been able to increase prices. We continue to have positive experience with our returns and then also the positive FX impact, which continues today as the dollar continues to be stronger going in April. So we could see a more positive effect in Q2. So overall, we see a 4.1% increase in ZUBSOLV over Q4 when generally, it's always a negative in Q1. So that's good revenue movement in Q1.

Next slide, Slide 21. If you see from a P&L perspective, we'll focus first. When you look at EBITDA, you could see that, that was positive 2.8%. From an EBIT perspective, we've been able to cut our losses by 2/3. So our EBIT loss was only 1/3 of what it was last year. A lot of -- most of that due to our better revenue. We do have higher COGS, which is due to a negative FX impact. So that offsets some of that revenue growth.

But then when you look at our operating expenses, we continue to optimize our commercial expenses in U.S. pharma and in DTx and focus our expenses on where we can grow the business and don't spend where there's not opportunities. So that's been able to give us a positive impact on our operating expenses. We also have seen lower legal expenses, but we've been able to take this money and invest it in both modia study and our OX124 development ensure that, that stays on track for filing later this year.

So our operating expenses came down from last year despite our focus on investing in our pipeline. You can also see that U.S. pharma had a very strong EBIT margin of 60.4% and versus 52% last year, which was also a good number. So we continue to optimize our profitability in our U.S. business.

Next slide, Slide 22, our cash flow from activities -- from operating activities. We do obviously have a negative cash flow, but this is less than what it was last year. And some of the negatives are purely timing issues. When you look at -- as I mentioned in Q1, the beginning of the quarter you have sales are lower because the wholesalers are bringing down inventory levels. And what we've seen is sales more in the back half of the quarter. So the pickup in the overall sale to wholesalers. That means that our accounts receivables are still sitting on the books. They're not collected for the back half sales. There was less collections in Q1. So that impacts our receivables in a negative way.

And to a certain extent, that also explains our current liabilities. Some of it is purely timing of when rebates are paid. We paid the rebates on with the higher demand in Q4. We haven't seen the -- we haven't gotten the bills from the managed care organizations for the back half of the sales. The sales have happened in March. And then to a lesser degree, annual bonus payouts are paid out in the quarter. So that was also a negative impact in current liabilities.

So we expect those are more of a timing issue on the receivables and current liabilities. We do have -- did have a positive impact from inventories. As inventories were lower in the quarter, we will see some pickup in production in the rest of the year. So that may offset a little bit the other way.

So cash flow from operating activities was negative. But as Nikolaj mentioned earlier, we still sit with a very, very strong cash position.

From a legal side, there's no changes in Q1. I don't know, Nikolaj, you would like to add anything here.

[Nikolaj Sørensen, executive]

No, I think that's exactly as it is. We -- the patent litigation is moving on a schedule, and it is progressing on the schedule even though even among lawyers, there have been some issues with COVID-19 but there's nothing really new to that one.

And then on the subpoena, there have actually not been any activities, and that's one explanation also to why the legal costs have gone down. We don't know what will happen with this, but right now, there's not been any real activities. Very little in Q4 and basically nothing in Q1.

[Joseph DeFeo, executive]

And next slide, Slide 24. We have updated a couple of our financial outlooks in a positive way. Our lead product net sales, ZUBSOLV. Net sales will decline slightly in the first half of 2022 versus the back half of 2021. And we do expect second half sales for ZUBSOLV will increase over Q1. And one of the main reasons, as Nikolaj mentioned, we have access to New York Medicaid.

From a group OpEx, you see in Q1 that we've reduced our expenses and optimize them, I'd like to say. We do expect our OpEx will decline from 2021 to SEK 650 million to SEK 700 million, based on the current business plans and then the activity in the legal process. So those 2 were updated in a positive way.

With that, I'll turn it back to Nikolaj.

[Nikolaj Sørensen, executive]

Thank you, and I'll just highlight on the lead product net sales in the first -- in the first guidance, the thing that we have changed is that we have been more specific in sales, it's in U.S. dollar, so it's local currency because clearly, this -- we shouldn't take too much pride in the Swedish krona is weakening to the dollars, but of course, it's helping us quite dramatically on the sales line, but we do believe to see improvement in sales in the second half in U.S. dollar also. And we think that New York Medicaid will be a good driver of that.

Moving into future value drivers and just summarizing why do we believe in Orexo. And I, of course, have asked a decent-sized shell then Orexo have also felt the pain during the last quarter. And that's something that is, of course, a great concern to me to the Board and to management. And also a little of a mystery, I must admit, in particular, some of the reactions we have seen recently, for example, yesterday to something we believe is extremely positive we saw a very negative reaction. So that's a little -- one of the peculiarities of the stock market, I guess.

So why Orexo? Of course, I know that we have a patent litigation for ZUBSOLV, I would say, with the information I have right now, that's not keeping me awake at night. We have some good experience from running patent litigations previously. And if we prevail in that, we still have a patent protection for ZUBSOLV all the way until 2032, and that's actually just doing the math. It's 42 more quarter and that will, of course, even be ZUBSOLV sales after patent expiration. And I will leave it to you to do the math, what 42 quarters if we can keep the EBIT contribution margin, what that would lead to for valuation, but it's definitely not where we are right now.

We also see that even in this very competitive market where we have quite low price generics, we have actually managed to strengthen our market access. In public, we were down just about 30% a few years ago. And then after that, we have seen additional generic entry coming in, but our U.S. organization actually managed to improve market access in the public segment while protecting our commercial market access.

I think that puts ZUBSOLV in a quite unique position to be the only branded product in the market in the U.S. And just to give us as a comparator then the branded Suboxone Film in commercial in New York state where we have been more leveled in competition is just a few percentage points ahead of Orexo and market share and with 10.2% market share in New York state in commercial.

So we have an organization who under tough conditions that actually have been stellar in the way that they have worked with market access. And why that's important is because when we come with product like OX124, we're just coming in competing with other products. It's not low priced. The generics that are in that market have priced themselves basically at the same price as the incumbent. But we see that, that could be a place where there would be future price competition.

We do have a better clinical profile than the incumbent with our naloxone rescue medication opioid overdose. But we do see that our performance in market access is going to be important. And likewise, for other products that we're working with and compound products that we could in-license when our financial position and maybe share price is improving somewhat, we will have an opportunity to approach other companies and to use that competence to promote that product in the U.S. And of course, even for our digital therapies having good relationships with the insurance company is important.

So U.S. pharma is an incredible, important asset for the company. And again, I would challenge anyone on the call to try to do their own valuation on our U.S. pharma business and see what kind of market cap you come up with.

Then when it comes to our pipeline, again, it's something I would might wish that I could be valued just on the pipeline and people would actually look at the strength of our amorphOX platform and the pipeline we have OX124, coming in with a clinical differentiated profile to the market leader in a sizable market.

OX640, which is coming in most likely with superior pharmacokinetic profile just like we've seen with OX124, we will see if that's true after the clinical data. But what we do know is that we have a superior stability, which, of course, is incredibly important for people who want to know that the product works when they need it. And if you look at the size of OX640 comparing it to epinephrine, you wouldn't understand that our OX640 could fit into most pockets whereas the epinephrine auto-injectors take up more space.

And for our amorphOX platform, it is incredibly encouraging to have dialogues with Head of R&Ds and qualified people in leading biotech companies because they understand the value of amorphOX platform. What I'm saying here is not that we have any data to show that it will work, but we have so much data on a multitude of APIs that it's creating an interest, and we hope to do some feasibility studies with other pharma companies to show how amorphOX could help them to find new ways of drug delivery, but also increase the stability of the APIs.

And then we have digital therapies. Clearly, a space where things have taken much longer than I would have anticipated. When we started 2 years ago, we would have done things different, of course, with what we know right now. But during this time, we have invested quite heavily in developing a technical system to basically distribute these tools to end customers is to manage reimbursement systems, is to ensure that the payment goes to the right people as there's no pharmacy chain as you use for pharmaceuticals, we need to develop that system on our own. And the system we have is proprietary for Orexo. It's scalable, so we could add more products into this also.

We are in an early stage, but again, it's interesting to see the valuation of quite small entrepreneurial companies and compare it to Orexo market cap and see where we are. And when you look at where we are at the moment in the U.S., we are recognized as one of the leading players.

My last slide is the next slide here, we have a lot of milestones coming up. We do believe that we'll see some DTx sales coming through Trinity Health during this quarter, which, of course, will help us to show sales progression. We have good dialogues with several other customers both employers or large corporations who could use it.

We're working with E-HBS to make it available for employers. We have some companies where we have been working with for quite a while, where we also hope to soon see it convert into active commercial contracts. But I must admit a lot of these dialogues have been impacted by COVID-19, but that effect, I guess, is soon over, so we could start. We can't use that as an excuse as we move forward.

Second half of this year, we have OX124 filing. We have data for OX640. modia coming into commercialization. I think ZUBSOLV sales progression not at least in New York would be interesting to monitor. So a lot of exciting milestones coming up for the company during 2022.

With that, I will end my presentation and move over to question-and-answers.

[Nikolaj Sørensen, executive]

And as I said, we received some -- I'll just start with -- I have some questions that I received that I would just take before we open up for people on the call and in particular, one question is some of you might have noticed we have a large and new international institutional investor who have sent us some questions, and that's around OX640, where there's a question about what are the peak sales opportunity.

We haven't gone into the details of OX640 projections. But what is interesting is that when you look at the naloxone market, that market has moved from auto-injectors to nasal sprays completely after the introduction of NARCAN and the market grew from there.

OX640 will have a negative effect in the term that it will have longer stability than the auto-injectors. But at the same time, with the size, if we can have a good clinical profile with the stability data, it's difficult to see that nasal sprays won't be dominating in the market for epinephrine as we move forward.

And when we come to amorphOX platform, and I have received several other questions on that also. So not only this one, but there's a question about scalability. And those of you have noticed, at least one investor have looked into our patents. We have a patent that is covering quite a lot of APIs. We have seen that it can be used both in smaller molecules and in larger molecules. And therefore, we have quite a lot of scalability in the amorphOX platform and our commercial process that we set up for OX640 is applicable for quite a lot of these APIs. Some of them would need some unique adjustments. But for most of these APIs, we could use the existing commercial manufacturing platform.

And now, I will open up for questions for those on the call before I go back to some of the written questions.

[Operator]

[Operator Instructions] The first question comes from Samir Devani from RX Securities. .

[Samir Devani, analyst]

Congrats on a good quarter. I've just got a couple of questions. Good to see the first shipments going to Accord. I was wondering if you can just help us understand whether -- what territories Accord is planning to roll out first? I guess that's my first question.

And then second one is just on OX640. There's obviously a clear rationale against the auto-injector. I'm just wondering how you would pick OX640 against [indiscernible] messy product their intranasal epinephrine.

[Nikolaj Sørensen, executive]

So if we start with Accord. So we are doing shipments out from our Romanian packaging site. So and that shipment has gone to quite a few markets. And based on where we have sent material and what languages are expected, Spain will be one of the earlier countries and also some of the Eastern European countries have actually made some orders. Same likewise, in Sweden, there's actually reimbursement approved for ZUBSOLV. So I think Sweden is another market where we could expect to see some sales relatively soon. I think that plan is now during Q2.

But of course, this market in Europe is -- a lot of that is institutional. So it's something that I think -- sometimes we need to go through a little longer process than just going out and gain prescriptions from physicians.

When it comes to OX640, then there are other nasal sprays, both in development and there's one that I have been -- both, I believe, in Europe. The one big differentiator, I think, is when we look at the stability data that we have compared to those who are in the market, we are on a different planet. So our stability is much longer. It's much more solid than what we have seen for any other product, basically in any other delivery format in the market.

And again here looking at allergic reactions is something that is a global problem. It's something that can happen to you when you're in -- Africa, it can happens to you when you're up in the north of Sweden. So you have to have products that you know would work under all conditions. And then we believe here that OX640 has a very superior stability data to anything we have seen. Then of course, there could be companies who have data that they have not shared.

[Operator]

[Operator Instructions]

[Nikolaj Sørensen, executive]

Okay. I can -- in the interim, I can look at some of the questions we received on the chat and try to take those. Then the -- we have one question about ZUBSOLV sales in to Accord. The payment you received in deliveries, is that including the royalties or only prepayment to cover [ Orexo COX ].

It's only prepayments to cover [ Orexo COX ] and we have an agreed price with a court. So a little depending on volumes and others, there is a slight profit to cover our fixed costs also at Orexo.

Then there's a question about savings in DTx. And I would say in the DTx, the amount of spending that we had in DTx in Q1 is significantly less than what we had in Q4. But there is one big difference in that is that there's a different profile of the expenses. And here, to be fair, some of the improvement in EBIT margin in the U.S. pharma part is actually because we have allocated more costs to DTx as the sales resources are working with modia.

So it's not like if that had not happened, we wouldn't have seen the same jump. We would still have very good profit margin in the U.S. pharma, but not to the same extent, had we not increased that. So the majority of the expenses today on DTx is actually allocated expenses from U.S. pharma. And as you say, I think it's around SEK 40 million in total expenses. So you would know about SEK 20 million is allocated expenses.

Then we have a share which is employees. And here so far, we have not made any changes to our employees. And we have some direct expenses related to promotion. That cost has gone down quite dramatically from last year. But we expect to see some increase as Trinity Health and others improve because we need to pull through those contracts. I mean when Trinity Health starts we also need to work with resources to make the patients aware of these new solutions and also to educate their clinicians.

And then finally, we have invested quite a lot of money in developing the systems to manage patients. And what we have to do is to develop systems that are delivering on the same data privacy as any medical record system because we have systems where you can identify the patients and their mental health issue. That means that those systems have to live up to the highest standards of data protection. And that's why we're working with a company like Accenture to develop that, which have been quite an investment during the last few years also.

Then we have some long-term contracts that we had with -- when we started to be able to have the right resources available for DTx. We had to sign longer contracts to work -- to ensure we had customer support centers and others for our consumers. And as we clearly stopped that last year, we have -- in this quarter, we had some admin fees associated to terminating the contracts to some of these customer support centers as we now see a different profile of the utilization of the DTx.

So we do expect DTx to show some savings this year for sure. But really, the DTx cost is driven by how successful we are to get contracts with companies like Trinity Health.

If we get larger health care providers than Trinity Health, that could even trigger an increased investment. But if we don't, that would, of course, see a much lower expenses for DTx.

Then we have -- are there any -- any calls -- questions that have come in?

[Operator]

Yes, sir. We have one question from Gergana Almquist from Redeye.

[Gergana Almquist, analyst]

And I have several questions on this one. So my first one is about the OX124. Could you explain a little bit about what the delay is related to and the submission for marketing authorization? A bit more detail.

[Nikolaj Sørensen, executive]

I think we have said for OX124, we have set the second half has been the target for the filing for all the time. So what we're saying now maybe is we believe to be later in the last part of 2022. That, I believe is aligned with what I said in the last quarter call also. So and then we expect to get approved in 2023. So it's a 9-month approval.

The one part, if you go further back in time, we have -- we had -- I hope that we will get fast track in the U.S., and we didn't get that. Now we know why that was because FDA just a few months after actually approved 2 new products, which were high-dose products of naloxone.

[Gergana Almquist, analyst]

But otherwise, the production and the other process in place for the product?

[Nikolaj Sørensen, executive]

Yes. No. I think right now, there's no. We are on track with what we communicated in the last, I believe, since last year when we got this fast track, I think it was exactly a year ago.

[Gergana Almquist, analyst]

And then about the medical benefit reimbursement pathway for digital therapies. So how much is exactly the reimbursement for a therapy through this pathway?

[Nikolaj Sørensen, executive]

So that's both...

[Gergana Almquist, analyst]

Is it roughly now with the budget or...

[Nikolaj Sørensen, executive]

No. It's -- first, it depends on payers. So it's different by payer. It depends on product. But to give you an example, several payers have payment for alcohol misuse which is about $2,000, and that covers both counseling and also the physician's time. So the physician would receive a consultant compensation for a treatment program of 6 months of $2,000, and that should then cover both counseling, and that's where we have a confirmation that vorvida would qualify as counseling in that bucket.

So the complexity we have seen in medical benefit is that, that kind of bundled setup is very common when it comes to specialty care and hospital care. But when it comes to primary care, they are more used to get paid for each interaction that they have with the patient, and therefore, it becomes a little more complex for them to manage and they want to see certainty that they get paid. And that's why I believe Trinity Health would be a good benchmark to show that you actually get paid and get approved by the insurance companies.

[Gergana Almquist, analyst]

Sure. And how much of this money will be then for Orexo's treatment? Out of the total? Do you have any numbers on that?

[Nikolaj Sørensen, executive]

So the price of -- the list price of vorvida is SEK 599. And we -- from further discussions we have with customers in the U.S. is that it is some kind of a staircase in terms of volume. So if you use more, you will get a better price. So it depends on -- it's a little volume based, but of course, there will be some rebates compared to the list price.

[Gergana Almquist, analyst]

And then lastly. Yes.

[Nikolaj Sørensen, executive]

Just Gergana, of course, this is competitive information. So I won't share exactly what kind of rebates that...

[Gergana Almquist, analyst]

Okay. About amorphOX, do you have any concrete conversations with partners on this technology or anything related to out license...

[Nikolaj Sørensen, executive]

We have agreements with -- we have agreements in process with partners for basically do a test whether amorphOX can work on the API. And then if that is successful, that could then lead to a collaboration project.

But here, the -- of course, they come with products that they have not found a good way to formulate or to keep stable. And that also means that we can do the formulation, but then there's a lot of testing that needs to be done to see that the API acts in exactly the same way as it did in the way that they intend and often that is injectables. That the API after being formulated in amorphOX behave in the same way. And this, of course, behave could be in terms of chemical properties, but also when it comes to larger molecules, it could be the activity level of the larger molecule that we need to measure.

So there's some way to go, but it's quite exciting to talk to some of these quite advanced biotech companies who quite a lot of them are -- this is our #1 concern right now is to find ways of efficient delivery and keep that product stable.

So we hope we can solve that, but I will say that we have no license agreement right now. And the way we're setting it up is to offer to do feasibility studies together with them to see whether that works. And if it works, then we can move into more concrete collaborations.

[Gergana Almquist, analyst]

Okay. And then my final question is, what else could you do to stabilize the ZUBSOLV sales going forward?

[Nikolaj Sørensen, executive]

Sorry, you said...

[Gergana Almquist, analyst]

The ZUBSOLV sales.

[Nikolaj Sørensen, executive]

Stopped license. I'm sorry.

[Gergana Almquist, analyst]

No, no. What we need you to stabilize the sale of ZUBSOLV.

[Nikolaj Sørensen, executive]

Sorry. Sorry, Gergana, it's me here. So I think if you look at the data right now, the -- it is actually interesting to see that drop in Q1 was nearly all of that was during the last month -- of last June 1 few weeks of the year. And that is what we've seen in other years is that patients stopped because they have to pay the full amount when they get into the pharmacy and might even move over to generic to basically get up to their high deductibles before they might move back to ZUBSOLV.

So it's not uncommon to see that. But for the last 2 months, we have seen very stable sales. And now we're expecting to see the effect coming in from New York, which I hope could help us to grow the sales even further. So I think that there are some good reasons to believe that ZUBSOLV could move from decline to growth at least when we go into the second half.

And then we do have a situation where -- to be quite frank, the -- before COVID, we had our field force in more than 90% of all visits to a clinic. The field force met the doctor. The data during COVID-19 is around 50%. So 50% of the visits we do to the clinic, we can meet the doctor. So and that's moved down from 95%. The number of calls per day is also falling dramatically because quite a few doctors have reduced the opening hours. So we can't be as effective in the way we work with our field force. And we see that is improving quite rapidly right now as concerns with COVID is reduced. Okay?

[Gergana Almquist, analyst]

Okay. Any other steps you can take to increase the ZUBSOLV sales?

[Nikolaj Sørensen, executive]

No. I think, again, we continue to work with market access. And as we've seen, we can target share with more than 10%. So I think New York is in much better position to that. And there are other states like that where we are working to see if there are ways or we could get added into the Medicare or Medicaid market access. So I think that will help us for sure.

So I think that market access is a precondition to sell anything in the U.S., both pharma and DTx. So you can get it reimbursed. And then I think to have our field force out there being able to talk to the customers is also something that is incredibly important and we have not been able to do that effectively in the last 2 years.

[Operator]

There are no further questions. Dear speakers, back to you.

[Nikolaj Sørensen, executive]

Thank you. So I'm just looking here, we have some questions about ZUBSOLV guidance, and I believe I talked about that, about how employers -- how we can work with large employers about integrating DTx. And that is something that we're working on also. And here again, we have some very advanced discussions, but we have not closed them yet. But I do believe that we will have some successful collaborations with employers moving forward.

But even the largest employers are quite small compared to the large health care providers. So you can say Trinity Health is a medium-sized -- medium-sized health care provider in the U.S., but they do treat, I believe, more than 400,000 patients have in their neighborhood and the geographic area they cover, I believe, it's close to 2 million patients. So of course, that's not that many employers will get up to that number.

Then we have OX640. There are some concrete proposal on other APIs, someone who have been reading through our patents, I can see here. And I wouldn't say that we are working with other APIs than the one we have in our projects, both for patent purposes but also to show them how we can formulate them. And this right now is simply a matter of prioritization and capacity in the organization that limits us from starting new projects with amorphOX of internal projects.

Do you practice in vorvida? Whether there's any clear synergy with ZUBSOLV? There is this clear synergy between ZUBSOLV and modia. I agree with that. Deprexis and vorvida, we don't have that. And this is one thing we did start out in the beginning. We started to use our ZUBSOLV sales force for vorvida. That didn't work out simply because of the complexity with reimbursement and also a lot of the physicians they work with addiction treatment didn't work a lot with alcohol.

There's a proposal here whether we could work with a generic to promote generic deprexis. So, right now, we haven't done that, but we're, of course, looking at other opportunities to broaden access for these 2 products. For example, looking at other pharma companies who could collaborate with us who have a product in the relevant space.

And then there's a question about early momentum in New York Medicaid and how big opportunity could be beyond 2022?

So New York Medicaid is a the $180 million gross market. It's a Medicaid. So there's quite heavy rebates. So you have to deduct a sizable rebate and I won't disclose exactly where we are with New York Medicaid, but it is -- if those if you're doing math on our gross to net, I would say that's -- we need to do that also in New York Medicaid to get to the net sales opportunity, but that's still a sizable number. So even if you should, let's say, take half to make it simple. That's about $90 million. It is a higher rebate than that, I would say.

But then we have our market share in New York and if we exclude Humana and United, it's -- we have about 7% market share. And I think over time, there's no reason why Medicaid shouldn't be in the same neighborhood as where we have seen with some of the commercial contracts. So some -- I think that shows that it could be a quite sizable opportunity from where we are right now for Orexo.

And I think that was the last question I have had here. So thank you a lot for all of you who are listening in. Again, I would just summarize that I believe the first quarter financially was quite strong for us both on the top line and on the profitability line. If you look into our cost right now, there's a lot of nonrecurring expenses in the company at the moment, both to legal expenses, clinical trials and to the final development of OX124, which right now is in the most expensive period of any product development time line. That's just up before you're filing the product.

So if you deduct those nonrecurring, you don't need to deduct that many of those. And you would see that the company is basically in a solid financial state right now, but we are investing in some pharmaceutical development programs, some clinical trials. And unfortunately, we have to take some quite sizable legal expenses also for the patent litigation, which I hope will decrease significantly when we get into 2023.

With that, I will thank all of you for taking time to listen to us, and I can see most of you have followed us throughout the entire presentation for more than an hour. So thanks a lot for that, and wish you a good day. Goodbye.