Orexo AB

STO:ORX

Earnings Call Transcript 2021-Q1

[Operator]

Hello, and welcome to the Orexo Interim Report Q1 2021. [Operator Instructions]Today, I am pleased to present CEO, Nikolaj Sørensen. Please go ahead with your meeting.

[Nikolaj Sørensen, President & CEO]

Thank you very much, and welcome to all of you who are dialing in and follow us on the Internet. Together with me today, I also have Joe DeFeo, who will address our financials a little later into the presentation.So as a short introduction, the first quarter is always a more challenging quarter for Orexo than others because we have an expected seasonal effect in the U.S. so. This year, the seasonality was accentuated by the calendar, where we had less calendar days compared to Q4, but we even had less working days also compared to Q1 last year.Just looking at how the calendar looked like, it actually has an even more dramatic impact as we were losing 2 shipping days, and Joe DeFeo will talk a little more about the impact from that as we proceed. So I will move to the third page and -- or fourth page and give a short update on where we stand as a company.So if we look at the development on ZUBSOLV, clearly, the development from -- compared to Q1 last year is down. That's something we have seen throughout the year is a declining demand on ZUBSOLV. All of that is explained by the change in the exclusive contracts with UnitedHealth Group and Humana. But also in the cash segment, as we have seen, the generics prices have gone down, the people who are paying cash for ZUBSOLV has declined somewhat. However, when we look on a quarter-over-quarter basis, it actually looks okay for ZUBSOLV, in the sense that on a weekly average basis, we are seeing a rather stable segment development. And we have also seen that even some of the subsegments, for example, the commercial segment in the open part has actually increased.But converting this into net sales, the shipping days, the calendar days is hitting us on a quarter-over-quarter basis. But of course, the main driver compared to last year is the demand data, but an equal driver this year is also foreign exchange development, and Joe DeFeo will talk more about that.When it comes to the digital therapies, we have made a pretty good progress, I think, in terms of starting up a partnership with Magellan for modia, where we're going to collect real-world evidence. Magellan is one of the largest players within opioid-use disorder and to work with them to test the concept, I think will be a fantastic opener when we get the results if they, as expected, will show a positive effect on treatment.We also have, as you know, we have done some tests of different reimbursement pathways and why letters still to translate into volumes in terms of sales. We have this a confirmation that the medical benefit route is something that works for vorvida. It's something we've tested in Pennsylvania and are now rated to roll out to more states and also to include deprexis. Finally, on our headquarter pipeline, not so much has happened since the Q1 in terms of development away from the time lines. Our OX124 project continue to progress according to plan. We have filed an or got approved a new pattern for ZUBSOLV. And a good news actually, right after the quarter ended our patent in Romania have got their facilities audited by the Romanian authorities and are now ready to package ZUBSOLV. So we are on track to have a European launch of ZUBSOLV in the second half of this year.Moving to the sixth page. So short reminder about OX124. It's an opioid rescue medications for people who overdose with opioids. What the target profile of this product is really against people who overdosed with fentanyl to have something that is faster and more powerful than the alternatives await -- available today. And unfortunately, during the pandemic of COVID-19, we have seen the opioid epidemic costing a significant increasing amount of deaths. I'm just looking at the data from October 2019 until September 2020, we've seen more than 87,000 deaths. This is a jump up from on an annual basis in 2019, I believe it was 82,000. But the forecast is that, that number on a full year basis of 2020, unfortunately, is much higher. So there's no doubt that there's an increasing need for more product alternatives and other particular products that will help reversing overdoses with products like fentanyl.A very short update on where we are. So we continue to, right now, testing our commercial supply chain. So as I've talked about before, FDA has set a quite high bar in terms of reliability demand. And that put a lot of strength on our quality system and how we are testing the product, and this is something we are doing setting up right now. So while we have the supply chain in place with all the partner contracts in place, we now have to establish a high-quality supply chain and have all of the methods in place to secure that we have a reliable product. All of that is the big focus of the Swedish organization right now.During the quarter, as we said, this actually happened just when we published our Q1 report. We didn't get the fast track designations. So now the plan is to file with the FDA in the middle of 2022, provided that everything else go according to plan. And what we -- the next big milestone will be our pivotal trial that we are still planning to commence very late in Q2 with the results coming in Q3. And that would enable us for a filing in the middle of '22 and a launch in 2023. Moving to the next page. So now I'm going to talk a little about our digital therapies. And then this time, as we have evolving in our commercial profile, and we just launched a new deprexis homepage.here in early April. We are putting some of the graphical profiles to show what it is that we believe is unique with these products. And it's really about the personalized product that every person has a product that adapts to their need, it's clinically tested. We have trusted techniques where we have using cognitive behavioral therapy, which has been proven over and over again to be an important element of, for example, depression treatment.And it's -- these are all products that are available, of course, 24/7 whenever you need it as some of these screen dumps we have here on the first page is illustrating.So moving to Page #9. So what has happened during the quarter is that while I would like to see the sales picking up more, we definitely have made some good progress. We have the agreement with Magellan and under the Magellan umbrella, we have 2 more insurance companies, Blue Cross Blue Shield, I believe, in New Jersey and Massachusetts have signed up to participate in the trial. Also, we expect more insurance companies to sign up to be a part of this real-world evidence testing. We are reaching out to employers and we have an agreement in place with a large U.S. tech company who is now testing vorvida and deprexis with a smaller sample of their employees, and if successful, they would be ready to roll it out on a commercial basis to all of their employees potentially even globally.We have several health care providers who are in the process of including vorvida and deprexis into the treatment programs. It is something that, again, I would hope to see go much faster than it is, but I also have to respect that, for example, one of the larger ones we're working with, wants to make sure that the entire reimbursement process was ready, and it was cleared with all of their larger insurance companies before they started. So rather than go on a trial and error basis, they basically wanted to set up all of the systems and get clearance from the insurance companies. And this has basically taking 6 months for them to get to the point where we are right now where they're starting to compare the rollout to their patients. And we have a couple of others, both regional and local health care providers, who are moving into the phase where they're integrating these products into the treatment programs. The basis for their reimbursement is a little the same as what we have tested in Pennsylvania, and that's basically what we have in Pennsylvania is an integrated offer where we have a physician who is involved into the treatment of the patient and then add on our digital therapies, and then we get paid for the product through medical benefit. This has worked out well in Philadelphia -- Pennsylvania for most patients, not all, but most patients. And we're now expanding this into 3 more states, and it will also be the basis for the rollout of the deprexis, which we're kicking off right now.We do see, from a relatively low basis that sales is improving. And what we have done right now is that we have worked a lot with different pilot tests to test different commercial concepts. Being a relatively small company, we have decided and rather do a big national rollout of the products. We are testing in kind of in a selected groups of consumers, selected group of partners, the products to see what works and what doesn't work. And clearly, some of the ideas we have tested has not worked. And others, we do see have a positive effect. And some of the learnings we've made during Q1 is that our initial upfront price of $750 was a little too high. And now we have reduced that to $599, which enabled us to have a monthly installment plan of $99 to get below the $100 seems to be an important driver.We have also -- because we see that there is a lot of uncertainty what is a digital therapy. So how does it really work? We have introduced a money back guarantee on vorvida. So people who, after 60 days of utilization, they can come and ask to get their money back if they have -- if they're not satisfied with the outcome of the product.This, of course, come with a little risk, but I think where we are right now, it's a way to get people over the hurdle of understanding is this something for me. And based on the evidence we have from our clinical trials, we do believe that the vast majority of people testing it would find that the products are helpful.So -- and then we have looked at different marketing channels. We have done programmatic marketing, where we have basically a banner ad for vorvida to social media ads in different shapes and forms. And now we have found that the best -- where we have most effect and most conversion is through the social media. So we have made a little more of a boost on this. And I think some of these changes together is probably the explanation why we have seen now in April that our sales of vorvida have actually exceeded the full Q1 sales. So we have seen a jump up in April, but admittedly from a relatively low level.Moving to the next page, Page #10. So where are we? We have our 3 products where 2 of them, we are utilizing the emergency youth authorization that FDA opened up for in April last year. It's vorvida and modia. That means that we apply for an approval in parallel with commercializing or making the products available. The practice has already been registered by the FDA under something called 513. That was GAIA, that was before Orexo was involved. So that's available, and we don't need to use that emergency use authorization. And moving the next way to make the products available. We did during last -- the middle of last year have set up the first homepages for vorvida the practice under us.vorvida.com and us.deprexis.com. They've been available since the middle of last year. Then our strategy has been to work through different pilots and trial users. So finding partners are willing to test the product so we can get some real feedback to see what commercial instruments works and not. And here, we have done multiple different trials on, in particular, vorvida, and now we're also starting with deprexis and some of the partnerships you have seen previously with, for example, Trinity Health in North Dakota, Texas nurses has also included deprexis. And with modia, we start now together with Magellan as I talked about recently. And just a reminder, Magellan is not a no name in the U.S. It is one of the largest players and particular within the space of opioid use disorder. They're actually the third largest player in the U.S.This is moving us into a targeted launch of the products. And here, we have started with vorvida, and we have had our field force including vorvida in the meetings I've had with physicians, we have done, I said, different types of test in commercialization everything from banner ads to social media. We're now taking those learnings and put that into the practice. And one of the things we will do with the practice is that we will actually have a dedicated field force in selected regions. So we have selected a few regions in the U.S. where we will now have a fully dedicated field force for the practice. That means it's not the huge field force who will carry into practice, but we will have a dedicated feed force for the practice. modia, we're expecting to have this targeted launch in second half of this year.From a reimbursement perspective, we haven't signed, although you would have known about agreements with large insurance companies, but we have tested this medical benefit route in Pennsylvania, and it has turned out to work. It is somewhat the same route as several of the health care providers who are now being ready to implementing our digital therapies into their care programs will also use a similar route but adapted to their environment with different payers. And we will do the same with deprexis. And at the same time, we are, of course, continuously pursuing and discussing with insurance companies to get a broader blanket reimbursement of the products. But that is something that we know from pharmaceuticals is taking time, and it takes probably even longer time for digital therapies as very few insurance companies today have a fixed strategy on how they're going to treat digital therapies. When we have seen a reimbursement work, that's when we will have a broader launch and basically step up to commercialization of the products.In parallel, we're working a lot to find distribution and commercial partnerships and a group of companies that we are negotiating with at the moment. I'm talking to, for example, telemedicine providers who we believe is a good fit with our digital therapies. So that's an area where we hope we can soon announce some progress. And we have since previously announced a partnership with GoGoMeds as a distribution partnership. This is a route that we believe will be effective, and we're looking at other types of partners who have good relationships and are credible in the fund of the customers that we see. So it's an area that we believe a lot in.So just to say, where do we focus at the moment? We are working a lot with employers. So we have a dedicated team now just working with employer leads. That's for example, this U.S. tech company come in. We, of course, continue our reimbursement discussions and negotiations with payers. We are now starting up our deprexis launch. And in contrast to vorvida where we added vorvida to our existing ZUBSOLV team, we will , with deprexis, actually have a small but dedicated field force team in selected regions reporting right into our digital therapy unit.And then we're looking for partnerships with health care providers and with other, say, nontraditional partners where we can set up a distribution agreement where they basically buy our products and then they distribute it to their customers through either their health care provider as a medical benefit or with other customers using their network to end customers.So this is -- so looking at the next quarter, I think we are taking a good step forward, and we're really looking forward to the launch of deprexis on a little more broader base, even though it's been available for a while. We haven't put a lot of effort behind deprexis partly because we needed to develop a solid marketing material and platform for deprexis and wanted to take the learnings for vorvida into that launch. So we're not wasting money on activities we've seen didn't work for vorvida.Finally, moving to Page 12. This is a little boring, but I think it's important when you look at our revenue -- now when we expect to see the revenues jump up from both vorvida and deprexis. I just want to make you aware how we are using that. So and here's an example for a patient who is buying cash through our online platform for vorvida, that's $599 and for deprexis of $399. So that is when we will get the cash flow. We get paid upfront, but the revenue recognition is coming in for vorvida a sixth every month. So basically, you will have about $100 coming in, in revenue recognition every month until the end of the license. And for deprexis, that is a 3-month. So that means that you will see a buildup on the balance sheet where we'll have future revenues coming -- deferred revenues coming into our -- for the digital therapies, and they will then be recognized based on the length of the treatment. For modia that will also be a 6-month process. And I think that is -- that will become an important element when we start to see the sales pick up on our digital therapies.So moving into ZUBSOLV on Page #14. A short highlight is we have seen the market growth has gone down a little from being a solid double digit for while it's now 9%. But that number is a little tricky because, first of all, it was fewer working days in Q1 this year than last year. And also, we saw a boost in demand in March last year just before COVID-19 and the lockdown came. We actually saw a big jump in the demand in the market. And I think a lot of that was patients who were basically building their own inventory of medication.So it's a little tricky to use the Q1 last year over Q1 this year. However, if we look ahead, we do see that there is actually just yesterday, there was a signed -- or it was registered a new guideline from the HHS, so the health department in the U.S., where they now open up for every health care provider in the U.S. to prescribe buprenorphine products without having to go through the education and training that they did before. They still do need to register when they do prescribe, but it's basically just a registration. So there's a little administration around it. But they are not the same requirements they were before. So the hurdles to prescribe buprenorphine has gone down significantly from 2 days ago to today. And that was -- that guideline was registered yesterday on April 28.The -- we also know that the Biden administration is working or there's a bilateral -- there's a collaboration between Democrats and Republicans right now discussed a new legislation in Congress, which will take away all requirements on buprenorphine prescription. And that, of course, improving access to the product will have a boosting effect on the market.When we look more specifically on ZUBSOLV. We have seen that our access to physicians has improved during Q1 compared to Q4, but we do see that we're still significantly below the interactions that we had with in particular, the end customer, the physician than what we had in pre-COVID levels. But as we're now approaching in the U.S. a very high degree of percentage of both our employees and our customers have been vaccinated, and we see more and more states like California, Texas and others are basically opening up again and going back to normal. We expect this to normalize during the next quarter or maybe into Q3.And then when we look at ZUBSOLV, we have seen a positive development on market access. So we were added to Express Scripts commercial and Medicare formularies last year and some of them during last year, but follow from January 1. In particular, Medicare has shown a pretty good growth now in Q1 within Express Scripts. We are today the only branded product on the top 3 U.S. PBMs for 2021, which is covering nearly 60% of the market.A future possible driver is that we saw just a few weeks back, the State of Kentucky passed the legislation, which potentially could open up for access to all Medicaid plants in Kentucky. Kentucky is the fourth largest state in terms of buprenorphine utilization in the U.S. And today, we actually don't have a sales rep in Kentucky because such a large percent of that is within the Medicaid space. And we are not covered by the managed Medicaid and fee service Medicaid in Kentucky. But with this new legislation, there is a door open that we hopefully can see an improved access during 2021. And if everything goes right, we could even see a complete access to the State of Kentucky's Medicaid, which is, as I said, the fourth largest in the U.S. could be a substantial driver of improved access during the second half of this year.Moving to Page 15. So looking at the sales development. Here, we have seen the said the overall market growth has gone down a little. If we compare to last year, it is a little lower in what we call the open segment. That's because we have all of the commercial market there. They have not grown the same as we've seen in Medicaid. But if you look compared to the last quarter, we're actually seeing quarter-over-quarter, the open segment has been stable, whereas the non-reimbursed market has gone down a little from Q4 to Q1. Again, some of that decline is explained by the less number of selling days in the first quarter compared to the fourth quarter. And also, if you look at the calendar, when the public holidays were located.Breaking that into ZUBSOLV on Page 16. We have seen that our open business is more or less stable, should I subsegment the open business into other, as, for example, commercial and Medicaid. We have actually seen both of them growing then there's some institutional sales, which have gone down a little. So overall, on the open market, we have a slight positive. It's actually higher than 0. But if we just look at the commercial and our open market in Medicaid, it has actually grown with a few percentage points during the quarter compared to Q4. Compared to last year, it is down -- it sector, as you can see, it's also quite stable in the open market. And what is really driving the decline in demand is still United, in particular, Humana is nearly flat. We haven't seen Humana gone down during Q1 in any high degree. But the UnitedHealth Group has -- we have seen a decline during Q1 to over Q4. And that has been the major driver for us during the last year in terms of declining demand.In the non reimbursement market, we have seen a little decline. It's on quite low numbers. So as you can see here, there's -- looks like a flat line, but still slightly down. But overall, I'm quite happy to see on a weekly average basis, that we actually keep our open market is stable. And if we into the commercial and Medicaid, we have seen those 2 segments grow during the first quarter, which is positive.And just looking ahead, we still believe that our continued -- our good market access in, for example, Express Script is something we're convinced will continue to drive some growth. We have seen that Kentucky could possibly open up for more reimbursement in the second half of this year. We have this increased access to MAT opioid used to order treatment that Joe Biden just implemented. So that is something we believe will drive the market. We see that our field force are gradually coming back to the same as we've seen before, and as we have seen before, and I believe in Q2, we will approach what we have before COVID and definitely in Q3, I'm quite convinced we see similar access as we had pre-COVID.And then we are coming into the -- getting closer and closer to the launch of modia. And I really think that modia could be an important figure for ZUBSOLV also because we can now offer a complete package to our patients, to our payers and to our physicians where we both have the cycle social support coming to PTX, and we also have the medication. So I think that Campo is going to be an exciting opportunity for us moving forward.With this, I will leave the word to Joe DeFeo to take us through some of the financials. Joe, please.

[Joseph DeFeo, Executive VP & CFO]

Thank you, Nikolaj. Good afternoon. If we go to Slide 19, we'll start with our revenue.Our revenue is down 24%, which is predominantly due to ZUBSOLV. However, as you'll see in the next slides, most of that decline was happening over the first 3 quarters of last year. In the fourth quarter, the demand slowed, the demand decline slowed. And as you'll see, Q1, it's really stabilizing as Nikolaj mentioned. Very small amount of digital net revenue at this point. Abstral and we talked about that decline over the past year. We still have a little bit of that revenue, and we still have Edluar revenue. So there overall, it's a 24% decline in revenues.Next slide. You could see the demand reductions. They happened mostly the first 3 bars. They happened mostly in the first 3 quarters of last year. Wholesaler inventory is fairly flat, slightly increased over last year. We did have a negative returns adjustment. We have a positive price increase that we took a 3% price increase January 1. That's helped revenue. And as you may recall at the beginning of the COVID crisis, the dollar strengthened significantly around 10% is actually Q1, it was 9.7% last year. So exchange is a negative impact on our revenue for ZUBSOLV. So ZUBSOLV revenue down 22.6% over prior year.Next slide. However, when you look at Q1 versus Q4, you could see in the first 3 bars that the demand decline is very small. In fact, the open segment is basically flat and then the nonreimbursed and United and Humana, it's very small declines. So we are stabilizing our demand. When you look at the biggest decline, it's really related to shipping days of inventory. Every year, you'll see a buildup of inventory at the wholesaler level at the year-end and a drawdown in Q1, partly due to holidays getting -- holding inventory over the holidays and also anticipating a price increase, which, yes, we took 3% in Q1. But we also had 2 less shipping days. We ship our products on Tuesdays and Thursdays. And as you could see, April 1 was on a Thursday. So from that, just that point, you saw a decrease in sales. And overall, like I said, there was 2 less shipping days, and that is really the main driver of decline in sales from Q4. You could see the positive impact from the price increase of 3% and FX impact was very modest decline. So overall, 11% decline driven by less shipping days in Q1 over Q4.Next slide. We continue to improve our operating margin. It grew to 55% for U.S. Pharma. We -- as ZUBSOLV matures, we are improving our profit margin. We continue to optimize our spending on the brand, and we expect this to continue to improve over time. So we're optimizing our revenue, I mean, we're optimizing our profits, and we're optimizing our cash flow from Zubsolv.Next slide, 23. This is our overall P&L. We talked about the revenue reduction versus prior year. We also, on a cost of goods sold, slightly down, but there's an increase in COGS, which is related to DTX We had some costs that we were obligated on the deprexis and vorvida brands. So there is some cost of $2.8 million in there, which minimizes the benefit of cost of goods sold that we normally have.Selling expense is increased. That's predominantly due to the DTX investments that we mentioned, partly offset by lower selling expense in U.S. pharma, which we -- as I mentioned, we optimized our expenses on ZUBSOLV to ensure that we're maintaining our profitability.Administrative expenses are up that slightly. That's mostly due to the IP litigation in the U.S. There's -- it's also offset by some lower costs on our long-term incentive programs. R&D slightly up. We optimize our portfolio. We're focusing on launching OX124. So we do have a modest increase in R&D investment.Other operating income and expense, that's basically related to exchange. As you know, we have U.S. dollars in the company for our U.S. business. And so therefore, we have a gain in Q1, but not as big as last year when there was a significant increase in the dollar. So overall, our EBIT is down and our EBITDA is down, but it's a more modest decline than expected. We -- as I mentioned, we make sure we're managing our expenses appropriately. Like I said, optimizing our spending on our R&D portfolio around OX124. And also continuing to monitor our spending on DTX and focusing on where we believe the growth drivers will come and not wasting money on other areas, which may not be ready for investment.Next slide. We had a very good bonds issuance in Q1. We redeemed our old bond, and we issued a new corporate bond of SEK 500 million. We got a very favorable rate. It was very -- it was oversubscribed. We did. So we had a good increase in our cash position, as you could see from the cash flow standpoint. Our operating activities had a modest decline as we make sure we manage our expenses appropriately, and we drive good cash flow from ZUBSOLV. Our investment activities are related to our DTX business. And also our development organization as we purchased some equipment for that. So overall, our cash flow is good and our liquid funds are good in the quarter. So definitely a good situation.And now from an outlook standpoint on Page 26, you can see that the continued COVID pandemic makes it significant uncertainties around our financial outlook for the year. So we're conservatively managing our cost base. We do expect the market for buprenorphine to pick up and show double-digit growth as we move along in the year. We had our normal seasonal decline for ZUBSOLV, but we do expect to see some stabilization and growth of the brand going forward. From an OpEx standpoint, we're driving the increased R&D spending as we move along with OX124 and our DTX investments will increase as we see opportunity for sales progression and the market environment improves. We do expect U.S. pharma EBIT to be around 50%. We did that in -- we actually beat that in Q1. We expect that to continue. And this outlook is basically based on the December exchange rates were which are slightly stronger dollars than where we are now.I'll turn -- I'll turn it back to Nikolaj for the rest of the presentation.

[Nikolaj Sørensen, President & CEO]

Thank you very much, Joe. And I would just comment on the U.S. pharma EBIT expectations. We actually increased the expectations from a range of 45% to 50% to now to be around 50% for the year. So it's a slightly more optimistic view on our U.S. pharma EBIT.Moving into our legal cases. So with this will not happen a lot on neither the subpoena nor the patent infringement litigations. We are still kept in the dark in terms of what are the basis for the subpoena. But we have had a decent expense during the first quarter because our lawyers in the U.S. have gone through all of the documentation that we have handed over to the authorities, and to secure that there is nothing incrementing in those documents. And also, we've had a process ongoing and still have with the authorities about which documents that they should have access to in the company.So we -- but all of that is based on -- that we still don't know what is the reason. The positive is that going through all of the documents we have sent in, we still can't see anything that we have done wrong in the U.S.In terms of the patent infringement litigation, that one is now following the schedule that you have for these cases. We will come into the discovery phase, basically starting now, and that means that we will start sharing more documentations material and engaged experts, so we do expect to see an increased expense on our patent litigation against Sun Pharma. That process is, however, benefiting from our previous patent litigation, so we don't expect to see even remotely the same amount of money that we invest into the previous case against Teva Actavis.Moving to Page #28. So some of the value drivers, we did say that we would have agreements with insurance companies, DTx companies, and we have announced an agreement with Magellan and 2 Blue Cross Blue Shield insurance companies who will conduct a real-world testing of the products. We are still moving in negotiations with insurance companies. The frustrating part is that we don't really get a note from the insurance companies. What we hear from several of them is we need to find an overall strategy for how to manage these digital therapies rather than making individual choices or agreements with one company. And coming from a Swedish environment, you somehow can understand it that a lot of these insurance companies have more people that they manage than we have people living in Sweden. So it is a quite large administrative machinery that we need to get into.So while I would hope when it goes faster, we also have to respect that this is not trivial to come in with a new category of treatment into the space. The positive part is that our medical benefits route has shown up that it actually works.We are working -- as I said, we are now increasing our efforts with a dedicated team working with employers in the U.S. And we have this quite well-known U.S. tech company, we're doing a pilot with at the moment. I would say we are not getting paid for the licenses that they are testing as a group of their employees. But this is coming out positive. They are ready to have an agreement that covers the entire company. And that could become a very important reference case for other employers. But we're now focusing -- basically, from Q1, we have started to focus more and more on employers as we see that could be faster than working with some of the insurance companies.We're also working with health care providers, and we have now agreements in place and are quite advanced discussions with several health care providers, both some regional and local providers. So we do expect that to pick up during the second and third quarter.Coming to the next page, we have ZUBSOLV stabilization and growth. The weekly looks quite good and promising for the next -- for the rest of the year. But of course, just looking at the Q1 result as a whole, we were impacted by the calendar year of 2021. Our pivotal trial for OX124 is expected in Q3. And there we are now on track to launch ZUBSOLV together with our partners, Accord Healthcare in the second half of 2021. And finally, we expect during the second half to really step up the game with modia to start integrating that into our sales cost for ZUBSOLV, which I think could be a very nice commercial synergy between these 2 products.And with that, I will thank you for your attention and open up for questions, if there are any.

[Operator]

[Operator Instructions] And we have a question coming from the line of Samir Devani from Rx Securities.

[Samir Devani, Research Analyst]

I think I have 3. So maybe just kick off ZUBSOLV. As we're coming out of the pandemic, I just want to sort of tease a little bit more on the guidance. Is it your expectation that dollar revenues for ZUBSOLV will be higher this year than last year? For. question one. Question 2 is just on your comment about having a dedicated field force for deprexis I'm just trying to understand the rationale there in light of the fact that reimbursement is still not really in place. So why you've driven to make those calls now if patients can't get reimbursement? And then the final question is just on, you made the comment about the EUA for vorvida and modia. What steps are you taking to make those EUAs formal approvals?

[Nikolaj Sørensen, President & CEO]

Okay. Thank you. So if we start with the pandemic revenues. I think the bar to exceed last year's revenue for ZUBSOLV is quite high because we have seen a decline of demand from -- in particular, from UnitedHealth Groups throughout the year. But I do believe that from that -- there's a good chance that Q1 will be -- will set the floor, and then we'll see a growth on a quarter-over-quarter basis from where we are right now. But whether that will take us all the way up to exceeding last year, I think we'll -- that's a high bar because so it's a reasonable high drop in even in demand from Q1 last year. However, you do have a market where you see and probably an accelerating market demand because of the changes made by the Biden administration, which could help. So that was on the ZUBSOLV. On deprexis and the field force. So it's really -- it's a dedicated field force in particular in 2 regions, I believe is Northeast and 1 more region where we're adding some field force. And the target is actually to do what we call direct contracting with health care providers. And as we have seen with vorvida in the test we did in Pennsylvania, and we have confirmed even by some other health care providers who are testing the same going through their own administration and routes in Pennsylvania. It was us managing the reimbursement, and we have seen others who are now testing the same just going straight to the insurance company, and it works. So for deprexis, the target is actually to get the health care providers to buy access to the licenses directly from us, and then they will get reimbursement to medical benefit from their insurance companies. And that we have seen with vorvida works for a relatively large group of patients. And we know that one of our health care providers have gone through the work for the last 6 months. They have talked to all of their top insurance companies to ensure that they will accept reimbursement claims coming that way, and they have got acceptance that it works through the medical benefit route.Then we have seen in our Pennsylvania system that in particular patients on Medicaid often get a no, but people within commercial insurance that actually works. So I think this is -- so it's rather than Orexo going out, it's -- we are trying to find a way to integrate deprexis into the existing treatment program of people who suffer from depression. And then they -- the physician can get paid through medical benefits.When it comes to our emergency use authorization. With vorvida, we have already filed an application we did that before the pandemic hit us last year, and then it's basically been on pause. So that one is in process and I heard back from the authorities just a few weeks back. So now they have started to look at the vorvida application.When it comes to modia, we would need to submit an application just like we have done for vorvida. We have not done that yet because we are now collecting -- starting up our wheel work evidence testing with Magellan, and we're also starting a clinical trial during the summer for modia. So that will come a little later, but we do need to file an application just like we would have done before the pandemic.The positive is that so far, FDA at least are leaning towards letting products that have been filed under that emergency use authorization will be -- they will stay in the market as long as they are delivering on the requirements for an application so they can stay in the market while FDA are reviewing their application. But for vorvida, we have, as I said, filed an application and for modia our plans, and we are working towards completing a file with FDA also.

[Operator]

The next question comes from the line of Josefine Persson from Nordea.

[Josefine Persson, Analyst]

So earlier this month, the European pharmaceutical company, Ethypharm acquired rights for the use of the precise and in some countries in Europe. And as you mentioned in your quarterly report, awareness and evidences are needed before we can expect the market to accelerate. So do you think that this Ethypharm's new offering in Europe can have any impact for Orexo and the U.S. markets? What are your thoughts on this?

[Nikolaj Sørensen, President & CEO]

No. I do think that -- I think that it was Ethypharm took it, and I know the CEO of Ethypharm quite well, Bernard. So I look forward to work together with Ethypharm to see what we can do to promote this. And I think the more -- what happens at least the way I would react, if I'm exposed to a new treatment, which I believe is something that could help me, I would start Google, and I would say what kind of references can I find? Are there any credible partners that I can see. And that, of course, will help us when people see that this is actually utilized in Europe, for example. And Ethypharm, you say is a relatively well-established and large European pharmaceutical company. So I think it won't hurt us for sure that they are working with this also. And given that we have already a pretty good relationship with them, I think there's a good route for future collaborations for that. And I think some of the -- at least the work with GAIA, our partner, who I think is working fine, but some of the commercial concepts that we are asking them to add on to the product, of course, will help now that there is another dedicated pharma company who is seeing this as an independent business opportunity. That they could -- we can work together to identify opportunities to improve the product and in particular, demonstration products is something that we are talking a lot with GAIA about.

[Operator]

The next question comes from the line of Gergana Almquist from Redeye.

[Gergana Almquist, Equity Analyst]

Nikolaj, I have a question about the manufacturing of OX124. You mentioned last time that there were some difficulties or some issues producing or putting a machine in place necessary for large care production? And also, could you elaborate on the cost like producing ?

[Nikolaj Sørensen, President & CEO]

So I do think that the complexity with OX124 and what takes time and where Orexo is -- has a more challenge than we have with ZUBSOLV is the combination of a device and a pharmaceutical. And where we are very good at the pharmaceutical component, the device we are relying on other partners. And that, I think if any one of my manufacturing and development people are listening to the call, I think they would probably not to say that there are new learnings nearly daily on this. The positive is that -- I heard from the lead inventor of the product this morning say this, if anyone wants to copy this as a generic company, they will have their hands full because it has not been a linear development, and this is a unique product. It's a nascent powder device, and there is actually just 1 commercial product out there today who is using that format.So -- And I still find that I'm quite confident about our ability to deliver on similar resources we had in our first clinical trial. And the standard pharmaceutical development, we are on track. So far, we are also on track from an operational perspective, but it is more complex. In particular, as FDA have increased the bar and sold in terms of reliability, which just mean that we need to add on controlled parameters so many more times into the supply chain. So -- and that's the way you work with these high-reliability data. It's not like we need to take 100,000 devices and see that they work. But we need to put in checkpoints all over the supply chain to ensure that we deliver on this.And that, of course, leads into your next question about cost of goods. And the cost of goods of this product is going to be higher than a traditional pharma product. I think that's the basis. And -- but we have been, of course, been looking at all the public information we have about the lead product knockout , and we believe that looking at the total cost of sales that they have, we can -- we should be able to compete with that.That is one of the targets, but they do have a more established technology, which is helping them. I also think it is something to bear in mind. I've seen some comments about generic pricing should generics enter the market. And I know that Narcan in a battle with . While it will probably create some price pressure, it is not trivial to supply a device with a reliability of 99.99%. It is -- even for the generic companies, this will be a harder process. And I think I would expect -- of course, I can't guarantee, but I would expect that the price pressure will be less than what we have seen in -- we would have seen if it was just a tablet.

[Gergana Almquist, Equity Analyst]

So the large-scale manufacturing is in place or would be in place?

[Nikolaj Sørensen, President & CEO]

Our supply chain is in place right now. So we have the different steps is in place, but what we need to do now is that we need to build in the quality systems control testing product. But we could start to manage. If we were a tire manufacturer or something that where there was less requirements, we could start manufacturing now, but we are not. So we need to .

[Gergana Almquist, Equity Analyst]

And I have a question about -- you mentioned marketing to social media as the most appropriate channel. Could you explain exactly how?

[Nikolaj Sørensen, President & CEO]

So -- and that is for vorvida. I think there's a difference for vorvida and deprexis and modia. Deprexis and modia are much more integrated into a treatment program that most physicians are using today. So if you're depressed, you would normally go through your physician. If you have opioid use disorder problem, you would also normally have a contact with your health care provider. If you have -- if you're drinking too much, you would much more really go -- as a first stop go to your physician. So that's where we see for drinking counseling and others, it's much more a consumer-based market, and that's something we have learned. When we ask physicians before, a lot of them see a lot of people with problematic drinking. But they are not used to take care of it. So that's the learning we had. And when we go into our marketing efforts, we have tested what we call programmatic banner advertisements, putting it in different homepages, and we have tested social media. And the positive part, of course, is we can monitor exactly how many people come in from what channel and what is the conversion rate. And we have seen that the conversion rate from social media in the quite limited scale that we have advertised is actually better than the industry average, whereas the conversion rate from banner advertisement is much lower. And for that, we have seen that social media, we are better at targeting the advertisement to the right audience. And this is one where we -- again, it had been a big company who had raised several hundred million dollars to do the commercialization, we would probably gone broke already now. But what we're doing is we're testing different groups of people and see how does this convert -- how many -- do we see a conversion. And then if it works, we're expanding. And based on the review we had in the end of Q1, we have decided to move resources from some of our marketing activities, in particular, the programmatic and also some other marketing activities we had for vorvida and start more on using Facebook and Instagram and other social media channels. And so far, at least they have had some effect in combination, I guess, with an adjusted pricing scheme.

[Operator]

There are no further questions at this time. Please go ahead, speakers.

[Nikolaj Sørensen, President & CEO]

Okay. No, I appreciate a lot of your time to listen to us. It's not been the most fun day for me, looking at the stock price. And I think this first quarter is always a tough quarter for Orexo, but this year was a little tougher than I probably would have expected looking at the weekly sales data a few weeks back. But again, some of that -- I think there's a good explanation behind which is giving confidence this was a kind of a nonrecurring situation for Q1.And on the digital therapies, I think we have to accept that this is something where we will continue doing the grinding. And rather than just go with a big effort across the board to ensure we get volume, we are testing, testing, testing different concepts. And when we find what I call beachheads, we are kind of -- we expand from there. So when we see something works, we are ready with a very strong financial situation to expand. And this is what we, for example, are seeing now with some social media, when we now start the broader launch of deprexis even though it has been available, we haven't put a lot of effort behind it. That is something we'll utilize for that. So I think we are moving in the right direction and we, of course, would have loved that to go much faster. But as you can see on our balance sheet, our cost, we're also quite cost conscious in the process.And so, I do think that there are several positive indicators. If we took away United and cash, we would have seen a growth of ZUBSOLV in -- on average weekly demand. So that is the situation for ZUBSOLV, and I think that has given me some confidence that with some improved access during the year here, we can see a good development of ZUBSOLV also.And finally, we are continuing to look at business development opportunities. Now with the cash we have in the bank. It opens up for new opportunities. But again, we will do that quite conscious about what we have learned in digital therapies and in pharma.With that, I would thank all of you for your attention here in the afternoon, and wish all of you good rest of the day. So thank you.