Welcome to Orexo Q4 Report 2024. For the first part of the conference call, the participants will be in listen-only mode. During the Q&A session, participants are able to ask questions by dialing *5 on their telephone keypad. Now I will hand the conference over to CEO Nikolaj Sørensen and CFO Fredrik Järrsten. Please go ahead.
Thank you very much, and welcome to this full-year report and fourth quarter. This quarter has been extremely intensive for Orexo. A lot of things have happened, both on the business side, but definitely also more on the corporate side, and we'll come back to that. I think the headline of this quarterly report is "Resolving Issues: Unlocking More Flexibility," and I think that's truly what we've done during the quarter by reviewing some of the assets on the balance sheet, also made some internal transactions. We have closed the Sun litigation, and I think in that way we are cleaning up the business and have a much better position moving forward to decide what's the best strategy to create shareholder value and to grow the business.
Today I'm joined by Frederik, who will take us through the financial overview, but I'll give a business overview, and then we'll end up with a little comment on the future value drivers in the company. First, a little headline of the quarter, so the quarter in brief, it's on page 5. In the quarter, as we had anticipated and guided, we have a full-year positive EBITDA, and we also had a positive EBITDA in the quarter. This is significantly better than last year, and that is explained predominantly by reduced OPEX or solely by reduced OPEX. One of the things that is very important for us is to see subsidized revenues and to see that it's stabilizing after some years following the loss of exclusivity of our key competitor.
We are now seeing subsidized revenues, which are, you can say, in this quarter basically similar to the last quarter, a similar quarter last year. We have seen that during the year. There was a little drop in the beginning of the year and in Q2, but now we have seen a stabilization of the sales. We also have been working, of course, with OX124. I know many of you have been expecting and hoping for getting more clarity on this. We have made good progress with the FDA, but we're actually now sitting in a situation with a supplier of a very critical component to the product and the device, which had their problems getting this through their quality systems, and we're waiting for that to come through before we can give any firm guidelines on the timing.
That has unfortunately been delayed several times, and that creates a little more uncertainty on our side on when we can finish the test that has been required by FDA. OX640, I hope most of you have seen this very good clinical data we presented earlier this year of the study that we finished just before Christmas. This is really strengthening the case for OX640 as we once again see an excellent bioavailability. We also see that now with patients with allergic rhinitis, something that we saw at the FDA discussions before the approval of the competing product NEFI. This was a lot of focus on the patients with allergic rhinitis, and we decided we need to see how the powder reacts in that situation.
We actually saw an accelerated effect from patients with allergic rhinitis, which is really good because allergic rhinitis is something that is quite often seen with anaphylaxis. OX640, I think, has gone from clarity to clarity in that sense. To the corporate changes. We have made some, after we settled the ZUBSOLV case, it opened up for some changes in our balance sheet around the ZUBSOLV IP, something that we've been discussing internally for a while. We moved now the ZUBSOLV IP and manufacturing rights from the parent company out to a separate fully owned subsidiary, and that gives much more clarity around what is the ZUBSOLV business and what is R&D, but also gave an opportunity to look at the value of ZUBSOLV and then revalue the ZUBSOLV IP on the balance sheet of the parent company. Frederik will comment on that a little later.
In addition, as we press released, during the quarter, we terminated the contract or agreed with Gaia to terminate the contract on the Praxis. It was a mutual agreement. With that also come an impairment. We have also looked at the two other digital assets, Bobeda and Modea, and made a decision together with the board of directors that the main part of the business case for Bobeda was associated with access to reimbursement from insurance companies. We see that that requires more investments and has become a little more difficult with this, or become more difficult with CMS guidelines that came out recently. We have also decided to impair the value we have for Bobeda on the balance sheet.
The performance in, if we look at the full year and look at the guidance we provided, we expected the market to grow 2%-5%, and we were somewhat close to the middle of this with 3%. What was positive is that we actually seen an increased growth rate during Q3 and now also Q4, where we actually had a 6% growth compared to last year. That is a good sign for 2025. As you will see later, we have, however, decided to keep the same guidance for 2025. In terms of subsidized, we said we would have the same sales this year, 2024, as we had 2023. We're very close, but as we've said, since Q2, where we saw this dramatic decline in inventory with the wholesalers, that that would be a challenge to get back to that level.
We did see that the wholesaler levels improved somewhat in Q4, but not to the level that we started the year with. A lot of the deviation from the target is actually explained by changes in wholesaler inventory. We were close, but we've decided to clamp the distance now, so we did not go all the way. For the OPEX, we're significantly lower than the guidance, and we said we should be below SEK 530 million, and we were at SEK 469 million. This is a result of continued cost control, and people working in the company have seen how we have worked on office spaces. There are some fewer colleagues also in the company. Our digital business has seen a dramatic decline in expenses over the last few years. It is also when we did the guidance, it was with the anticipation of approval of OX124 this year.
Had that happened, we would have had to take some launch expenses that were included into the guidance that we could not take because the product did not receive the anticipated approval in the middle of 2024. Group EBITDA, we said we should be positive full year, and we have been that. We are that with nearly SEK 50 million. To subsidized performance or U.S. commercial. The main thing here, and really, really important for us, has been to resolve the litigation we have been in with Sun Pharmaceuticals for more than four years. We reached the settlement with Sun in December, and you could say that why did we go into a settlement? We won in the district court, and we now had appealed and had good chances to win on the appeal.
My experience and our lawyers' experience with the U.S. legal system is even the best case comes with some risk. Of course, if we were failing in the court of appeal, there would be no appeal opportunities, or there would be no reasonable appeal opportunities. With that, we were basically betting on the full revenue of the company. ZUBSOLV is close to 100% of our current revenues, and losing exclusivity could have quite severe consequences for the company. To get this certainty, even though we give away a few years in the end, is really good for the business for the next few years and gives us the certainty that's needed to look both from a strategic perspective and operational perspective how we drive the company best forward to create shareholder value and growth.
Looking a little more into the market, as I said before, the market growth went up in the fourth quarter with +6%, full year at 3%. For the full year, we see that commercial is really the driver of the growth rate, and together with Medicare, but commercial is the biggest segment. Medicaid has declined year over year. We think this is very much associated with some changes into the emergency policies that came during COVID, where people are now moving from Medicaid into commercial. While we're seeing growth here in commercial, we think some of that growth is actually existing patients moving from one insurance coverage to the other. What is interesting is looking into the end of the year, we actually see a much more homogeneous growth rate with commercial growth of +3% quarter over quarter and Medicaid of +2% quarter over quarter.
Quite similar growth rate in the end of the year. For subsidized, we had some, again, quite stable quarter in terms of demand. This is number of prescriptions quarter over quarter, slight growth year over year. We're basically stable. We see that across, of course, the different segments where we are stable in commercial. We've seen some growth in the public segment, but we've also seen a decline on a full-year basis in UnitedHealth Group and Humana. All in all, a quite stable subsidized business, more or less on the decimal 0% growth year over year. When we look a little forward into subsidized, what we're very pleased with in 2025 is that we nearly keep our market access. We see that the commercial market access is continued at 98%, which is market leading. In the public segment, we're losing a little with 1%.
That is in Medicare, so 1 percentage point down. In Medicare, there are some changes that we have our eyes on right now. There is a new rebate system in Medicare where we see that it is probably beneficial for Zubsolv on a gross-to-net price basis. However, we also see some of these Medicare providers, they have put more favorable terms in for generics. There is an attempt to guide patients to the generics, or at least increasing the copay for patients who are on Zubsolv. To see that dynamic could have a negative impact on our volume, while we actually think these changes could have a positive impact on our price. How that turns out in net sales is something we have to monitor quite closely. So far, we have not really seen any dramatic impact of that now being one month into the year.
If we look at the overall expectations to 2025, as I said before, we expect the market growth to be similar to this year. We give a range of 2%-5%. We expect net sales. Now we give a little range here from $50 million-$55 million, and that's really based on this Medicare uncertainty that we're building into this. Of course, there's always a risk that we will see some changes during the year to market access. All in all, we think the subsidized is in a very steady place, a good profit contributor to the company and quite stable sales. For digital therapies or digital mental health programs, we have the long-anticipated CMS policy finally came out in October, where we saw that now pathways, which is really good for digital health products.
What's not so good for us is that this requires a registration with FDA, such as a 510(k) as a medical device. To get that registration, you need a certain level of clinical evidence. When we look at our three programs, none of them are in their current state ready for that 510(k) registration. There is a little different by program to program. There would be a need for additional investments to meet that level with CMS. That has led us, together with Gaia, to agree that with the Praxis, we should terminate the contract. As I said before, also, we have decided to impair Modea. For Modea, we still see some opportunities, and we did during the end of the quarter.
Actually, a healthcare provider in the U.S. received a small grant to start testing Modea on a group of patients, which is within this what we have talked about before, the MAD core concept we're working on. With Modea, there are still pathways, and it's, of course, much more synergistic with our pharmaceutical business than Modea and the Praxis. To our products under development. I'll start with OX124. Unfortunately, this is one of my disappointments, is that we didn't receive a clear timeline for when we can resubmit. We have talked to FDA. We have gone through the complete response letter. We believe we have a proposal that will effectively address the points raised by the FDA. As always, FDA will not give you a guarantee that if you provide this data, we will approve. They want to see the full dataset before they review it.
There is always a risk that FDA could come back and ask for more data. We have presented, and we know exactly what test that we have to do. I think the uncertainty here is a little more about what kind of stability data they look for. We are proposing an accelerated stability program, and we are building more and more stability data all the time from our historic data. When we get to submission, there will be even more data than when we filed last time. However, and this is where it is frustrating because there is very little we can do from Orexo, since this is not only a powder, this is requiring a device and a secondary package. We are dependent on suppliers of these parts to the product.
This is where one very critical supplier has faced issues in their own quality control of their manufacturing and have had to upgrade their manufacturing. During that process, they have not met the quality standards that they have set up before they can release the product. That is just like anyone else sitting in that process. Since we are working with life-saving products, you want to be certain that the product is meeting certain quality standards. This is, of course, where we are in the hands of our supplier to solve this issue. This is out of our control, and we are, of course, talking to them nearly daily, but we are still waiting to get that final go when they can supply the product. Before we have that, it is very hard for us to give a timeline for OX124 resubmission.
When we receive it, we are all set to start the testing of the product and resubmit to FDA as soon as possible. OX640, we have continued to take some very good steps. I said in the beginning, we did this test with 30 healthy volunteers. All of them, however, are allergic, so we could create an allergic provoke, an allergic reaction in terms of allergic rhinitis. We could test the group both on a clean OX640. We could test it in two different doses. We could also test them with an intramuscular, and we could test them when they have allergic rhinitis. That gave us excellent data to look at the bioavailability to ensure we decide we go forward with the right dose.
What, again, was really, really positive is that we saw that the allergic rhinitis actually accelerated the uptake of epinephrine when that was present. We are now in full focus of preparing manufacturing. We are looking into the final commercial dose and formulation that will enable us to move into commercial manufacturing. We are also in continuous talk with potential partners. The really positive thing here again is that the new data has actually triggered interest from parties that we have not spoken to before. We have some new parties who are in the data room looking at the product. Hopefully, we will have an ability to move forward in partnership for OX640 during the year. We have two other things that have happened, maybe a little more minor in terms of short-term, at least.
Gesunder, fantastic opportunity for Gesunder with our former OX MPI project. It now has the name Vipoglanstatt for endometriosis, an area that is really underserved with a significant patient need. We are very pleased to see that Gesunder could make a successful capital raise in a quite difficult market. In that process, we agreed with Gesunder to convert our rights to future royalties into an ownership in Gesunder. We received shares worth SEK 19.2 million. The other partnership that went through in the quarter is together with the Swedish company Abera, who has been working with vaccine development for the last 30 years. Abera has received a grant by CEPI, and CEPI is working to prevent future pandemics and working with new creative ways of creating new vaccines.
With the grant that Abera has received from CEPI, we can go forward and together work on taking their vaccine technology into Amorphox. This is really in line with our strategy to show and get even more data how Amorphox can be used in larger molecules, where we think there's a large opportunity for the product or for the technology platform, Amorphox. With that, I'll leave the word to Fredrik to take us through the financial and legal highlights.
Thanks, Nikolaj. On page 17, we look at our revenue. If we start by looking on the top part of the page, you can see that total revenue in Q4 amounted to SEK 160 million.
Of that revenue, subsidized within U.S. commercial is the main contributor with $152 million for the quarter, which is slightly up year over year with approximately 1% following a favorable pay mix and a positive FX impact of $1.5 million. In relation to HQ and pipeline revenues, again, we had significantly lower abstract royalties accrued based on lower expected sales following the gradual decline, as we have seen when agreements for the abstract royalties for individual countries expire. Also commenting on subsidized ex-U.S. revenues, which for the quarter were higher than last year, explained by higher sales of tablets to our partner Accord Healthcare. For the full year, these revenues are significantly lower than last year, explained by the shift from low-margin product sales of tablets to Accord towards high-margin royalties from Accord on their own sales.
If you look at subsidized specifically and Q4 compared to Q3, you can see in the waterfall graph on the bottom part of the page that the main reason for the significant increase in net revenue of 16.1% is the positive higher wholesaler inventory stocking effect of SEK 9 million, which is then quite the opposite effect compared to Q3 when we had a major negative destocking effect. The demand for subsidized in net revenue terms is also positive in the quarter in the open segment. Quarter over quarter, we can also see a stabilized demand in UnitedHealth Group and Humana. There is also a slightly favorable pay mix effect, as well as a positive FX impact quarter over quarter of SEK 4.9 million. In conclusion, you can also see in the graph that in local currency, the subsidized net revenue increased by 12.4% between the quarters.
Going to the next page, our P&L. Happy to conclude that we had a very strong finish for the year in relation to our EBITDA, which landed at SEK 29 million for Q4, actually the best EBITDA since 2019. If we look at our operating expenses in Q4, the counted number of SEK 236 million is not comparable year over year because of these non-recurring items affecting OPEX this quarter. That is the one-time non-recurring impairment of the intangible assets totaling SEK 99 million and the value recognition of SEK 19 million for shares in Gesunder that was accounted for in the quarter. Now, if we exclude those non-recurring items, OPEX would come out at SEK 156 million, which then is in line with OPEX Q4 last year.
Doing the same exercise for the full year, adjusted OPEX, including depreciation, would land at SEK 578 million, which is then a 12% reduction from last year. In the quarter, we did have some higher legal expenses due to the DOJ investigation and resolving the IP litigation, as well as some higher R&D costs for both OX640 and OX124. They were partly offset by a positive FX effect on revaluations of balance sheet items. Also, the average US dollar strengthened slightly in the fourth quarter compared to last year, and FX effect on P&L and EBIT was a positive SEK 1.3 million. Also, to make it more comparable, we defined in the report an adjusted EBIT, excluding the write-downs, which in Q4 then was a positive SEK 1.2 million.
The corresponding adjusted EBIT number from our U.S. business amounted to SEK 34 million for the quarter, which is a margin of 22.3%. On the next page, we show our cash flow, and we had a positive trend in cash flow for the quarter. Liquid funds, which is cash, cash equivalents, amounted to SEK 123 million at the end of Q4. That is an increase by SEK 8.4 million from the end of Q3. We should not forget that we also have SEK 30 million exposure in our own bond as a potential source of funds. We had cash flow from operating activities of SEK 6.2 million, primarily impacted by positive operating earnings when adjusted for the write-down of intangible assets. We paid interest of SEK 13 million for the new bond loan. That was SEK 2.1 million higher than last year, SEK 23 million higher year to date. We also received interest of SEK 4.2 million.
Adjustments for non-cash items include change in provisions. This quarter, there was a negative effect of SEK 4.7 million following timing of payments of payer rebates. Operating cash flow was also affected by a negative change in working capital of SEK 2.1 million. Total cash flow for the period ended up at SEK 0.5 million. Adding an FX effect on cash of SEK 8 million, that adds up to the increase in cash of SEK 8.4 million since end of Q3. Also, in Q4, our parent company equity increased significantly following a string of events completed in the quarter. In the waterfall chart, we show these events and their effect on parent company equity.
Firstly, by our B-Leapbox, reaching a settlement in the patent litigation with Sun Pharmaceuticals enabled us to explore a fair value of our subsidized business, which up until then had not been recognized in our balance sheet. Following the settlement, we completed an internal transaction where the subsidized US business, consisting of patents, supply, manufacturing of subsidized, was transferred to a wholly owned subsidiary called B-Leapbox at a fair market value, which was assessed by an independent external party at approximately SEK 1.1 billion, which then was the profit that Orexo made on the transaction and consequently affected the parent company equity. In that exercise, taxable income for Orexo AB is offset against current or previous year's losses carried forward.
I mentioned Gesunder earlier, and that is the SEK 19 million from the value recognition accounted for in the quarter, and that increased our equity following signing of the agreement on the conversion of rights to shares. This conversion was then completed in connection with Gesunder's capital raise in January this year. We also had a negative effect from the impairment of intangible assets to Praxis and Vorvida, totaling SEK 99.2 million, and also an accelerated amortization of activated subsidized clinical studies that amounted to SEK 9 million. With those events, parent company equity at 31st of December ended up at SEK 1,027 million. Financial outlook, we show the financial outlook for 2025, stating that we expect the market growth of 2-5% to continue. Outcome 2024 was 3%.
Subsidized net sales in US dollar, which for 2024 was $53 million, is expected within the interval of $50-$55 million. OPEX, excluding depreciation and amortization in 2024, amounted to SEK 469 million. That is expected within the interval of SEK 460-500 million. Finally, group EBITDA maintaining the key metric of a positive EBITDA for the full year 2025. As you remember, this was a positive in 2024 with SEK 49 million. With that, I leave back to Nikolaj.
Thank you, Fredrik. Maybe worth saying for the financial outlook is we're basing that on an exchange rate of 10.5 Swedish kronor per dollar, which is right now the dollar is just around 11.
You can say the lower the value of the Swedish kronor, the better the result for us, as we have all of our income in dollar and a decent amount of the expenses are in Swedish kronor also. Coming to the legal update, we have already talked about the settlement with Sun, hopefully for the last time. The one that we are working on is the subpoena we received more than four years ago from the U.S. authorities or Department of Justice. We continue to believe that the investigation has no merit and that we have been working with all means possible to be compliant. We also realize that these processes rarely go away of itself. In the U.S., there is an expectation that you negotiate a settlement or go to court. We find here that a settlement solution is more preferable for the company.
We have been working to find a resolution with that. As this is the Federal Department of Justice, those of you who follow U.S. politics will know that there is quite a turbulent period right now. That, of course, is affecting somewhat the process in the U.S. currently. This is, of course, an area that we'd like to resolve as soon as possible also. Moving a little to the future value drivers, we have not updated this since the last time. We are now, based on all of the changes we have made, looking into how we should structure and work forward with our different asset classes. It is very important for us where we state right now to continue working to optimize our profitability, maintain the subsidized revenues, and hopefully even improve from our current levels.
It is to ensure that our existing product subsidized, but also the future products have a good access for patients to get them. That is working through reimbursement and other policy initiatives to ensure that this can reach the patients. We have our Amorphox technology where we are looking for what is the optimal way to apply this technology. This is also an area where we will intensify our efforts during the first half of this year, to more streamline our efforts around the Amorphox technology, to ensure we focus our resource where we have most value. With that, I will open up for questions and answers. Thank you.
If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad.
The next question comes from Samir Devani from RX Securities. Please go ahead.
Hi guys, thanks for taking my questions. I think I've got a couple. I guess the first one is around OX124 and just trying to clarify my understanding of what the situation is currently. Nikolaj, I'm wondering if you can help me just, I know you can't give a specific timeline, but maybe a best and worst case outcome for you in terms of timing to get the key part from the manufacturer for the device. When you've got the part in hand, how long from there before you can resubmit to the FDA?
On OX124, I can give you the second question as well if you want me to. I can do that, so yeah. Yep, please. Okay, I start answering the OX124 question here first.
Sorry, the second question is really just around Amorphox and maybe if you. Okay, fine. Yeah, fine.
Okay, I will take the first question then. OX124, I would say the concern we have right now is that we have been delayed several times from the supplier. I think in the worst case, this will be in the summer. In the best case, this will be in the first part of Q2. I think the likelihood is probably that it comes a little later into Q2. When it takes from there on, it really depends on if everything moves as planned, we would believe this is taking somewhat more than six months before we can supply. What we're looking at could then be in the first quarter of next year. That's where we are in that could be a scenario.
I will say here that the uncertainty is quite high because we are really depending on a supplier. Of course, the number of tests we're going to do also comes with a risk.
I totally appreciate that. Yes, I totally appreciate that. Just to confirm, you said Q1 2026 would be when you would be refiling with the FDA. Is that a scenario?
That's a scenario, and it could be both plus and minus, but that's a scenario just looking at where we are right now.
Okay, fine. The second question was just on Amorphox, and I was wondering if you could maybe just remind us how many feasibility deals you currently have for the technology and how many of those potentially over the next 12 months would get to a go/no-go position from a licensing deal perspective.
We have some that are non-disclosed, so I have to be a little cautious here. You can say the one we have with SOBI is at the go/no-go decision, and the decision is sitting with SOBI. We have delivered, and the results we have delivered are definitely in line with the expectations of that project moving up first. I think this is into SOBI prioritizing where to put the investments for the future pipeline. This is sit there, but of course, we continue to deliver data to SOBI also as we wait. That one is at a go and no-go decision. The timeline again is sitting with SOBI and not really with Orexo. We have the Abera, which is a small collaborative and where, of course, right now that process and even Orexo's expenses are covered by external grants.
I think that's part of the plan moving forward also. Here we are expecting some of the results, of course, here during the first half of the year. We will make a collaborative decision with Abera how to move forward. Apart from that, we are running right now, as we speak, another feasibility test on another technology also in a more collaborative spirit. We will see where that takes us. We have some former projects where we have delivered results where, for example, there is a U.S. company who have been working with an NCE where we again delivered some good data to the U.S. company, but they have to go back based on some data they received on the compound that they had to review.
Here, I think again, that one could turn into a continuation, but that's again really depending on the progress for this U.S. company. We have a few former projects that we have run through where, again, Amorphox have actually delivered on every single test we have done. All of us who work in the pharmaceutical industry know that one step is to start a feasibility study with the R&D department. If you deliver positive results, it is moving off the ladder often to the executive team and sometimes even at a board level to get into a prioritization. Here, it's about timing and that, of course, some of the older projects could also come back and start up as a collaboration. We have several discussions ongoing with other companies at the moment that hopefully would lead into additional feasibility studies.
That's great. Thanks very much.
Okay.
The next question comes from Klas Palin from Carnegie. Please go ahead.
Yes, hi there. Thanks for taking my questions. I just wonder if you could share your thoughts how your cost would be affected in 2025 following the discontinuation of the Praxis and now also writing down Vorvida.
The OpEx would, of course, have a significant impact because a large share of the OpEx have been continued depreciation of the assets. If you look at the net cost, we have not invested that much during the year. It is not that significant amount, probably around somewhere around SEK 5 million-SEK 6 million. That is predominantly related to the in-licensing cost from the Praxis and Vorvida. Yeah. Just curious why you do not fully have terminated the collaboration with Gaia over Vorvida. Is that just a timing issue or anything else?
We have a discussion with Gaia for how to best proceed with the product. We do have some progress, for example, within the veteran affairs that we would like to, and Gaia liked to capitalize on. I think in these partnerships, it's good that we have a collaborative approach to how we can optimize the opportunities for the product moving forward. I think for the Praxis, it was a contractual window that made it more easy. For Vorvida, it needs to be a discussion between us and Gaia, but we have a good constructive dialogue with Gaia about it. I think that's what I can say at the moment. I think Vorvida is an excellent product, but it's quite clear that for Orexo's footprint commercially, we would need to have reimbursement from the insurance companies to be able to leverage that.
I think here Vorvida is better managed in the hands of companies who have a more consumer focus.
Okay. Thank you so much. My last question. I'm very well aware that the new administration is in the very early stages, but have you picked up any signs from the new administration that perhaps you believe might affect your U.S. business when it comes to risks or opportunities?
Sorry, I didn't hear the first part. New administration's off. Oh, the administration with Donald Trump. I'm sorry. I missed the beginning here. It's a new administration.
The new administration in the U.S. Yeah.
I think right now it's written a little in the stars exactly what happens in the U.S., both in terms of tariffs. We are not impacted or subsidized from tariffs as that is manufactured in the U.S., even some of the excipients are sourced outside.
At the moment, we do not see any major impact on or any impact on subsidized from a cost perspective. For OX124, the sourcing is more international, both Europe and Canada. That could, of course, have some impact moving forward. When we look at other initiatives, it is quite clear that he is talking a lot about fentanyl. That, of course, is giving us some confidence that the likelihood that there would be restrictions on access to rescue medications and treatment. We do not see that that is an area where he would cut down. I think, on the contrary. We saw that last time also. He quite quickly put down a group just to work with the opioid epidemic. That is something that I actually believe we know from firsthand sources that there is a high engagement for that within his nearest family.
Okay. Thank you so much.
Thank you, Klas. I'm just a little sorry here. It's all for me. I'm sorry that this is a new system, first time we're using this. There appears to be a little lack in the timing here, so I apologize for that. We have a few questions from the net. One is around we talk about the growth of the market to 5% and why don't we work to influence the growth. I will say one of our claims to fame is that Orexo was absolutely instrumental to increase the number of patients that can be treated in the U.S. That's when we saw the growth rate actually historically went from high single digit to double digit growth. I would say that had not happened without Orexo.
Historically, we have worked intensively to improve access to treatment with buprenorphine, naloxone, and I would claim again that this had not happened without Orexo. The situation right now is that part of the growth in this market is actually going to new formulations. To our good friends and colleagues at Kemiros, their product in the U.S. appears to be doing quite well. The same goes for Indivior who have their Sublocade in Depo formulation. They do not cannibalize into the existing market, but they definitely take some of the growth rate from the market. That is part of it. As Orexo, with a 2% market share, I think it is very hard for us to motivate in larger investments to grow the market. The U.S. is such a big market.
For us to really drive that is associated with significant expenses unless we can work very focused, as we've done historically, to improve access by improving the number of patients the doctors can treat, by improving reimbursement as we have worked within several states to ensure that patients can get access to all different products without any restrictions. For example, in the U.S., they work a lot with what's called step edits. It's working with copays. To reduce the number of step edits, copays, it is to work with insurance companies to ensure that when you go to your doctor, you don't have to wait a week before you can actually get paid for your pharmaceutical, that you can leave the doctor with access to a product. We've done a lot of that historically, and we're still working on this.
I think these larger really dramatic changes to the market are behind us because right now buprenorphine and naloxone is free to prescribe to basically any physician in the U.S. That makes it a little more difficult for us to really grow. I think we need a bigger market. Just to give some sense, because I have worked in a company that had the ability to grow a market, when I worked at Pfizer, my sales force, or the sales force working with the products I was responsible for, was 1,500 people. That is to compare with a little more than 30 people who have been working with us in the U.S. There is a limit to what we can do. We have a question regarding SOBI, and I think I have answered that question already.
Then we have here, how is the strategic review progressing? Are you looking to sell ZUBSOLV? We have not started a full strategic review. I think the focus for us in Q4 has been to settle. It has to be to increase the transparency. The company, for example, with the move of ZUBSOLV into B-Leapbox, as Fredrik is talking about, we now have a situation where we better can review all of the different assets and see what's the best way forward. That, of course, is including how do we ensure that we have the best platform to sell ZUBSOLV. It's quite clear, as I said before, we have a small field force. It's a very big market. There are a lot of physicians who can prescribe ZUBSOLV today. For Orexo to hire a field force of 100-200 people is not possible.
I think we need to look at opportunities for how we can expand that footprint. There are several different options to do that. One of them could be, of course, that someone would want to pay a certain high amount because it needs to be a high amount to acquire ZUBSOLV. Right now, the big focus for us is to maintain the good sales we have in the U.S. to keep a very efficient sales force in place. We are working on the other areas in parallel. Is ZUBSOLV produced in the U.S. or imported and exposed to potential tariffs? I think I explained that. That is manufactured and packaged in the U.S. However, as any pharmaceutical product in the world, there are excipients used in the manufacturing, which are global.
I don't think there are any products today which have a complete sourcing within one country. That also goes to Zubsolv. Right now, we have a good inventory of all of our excipients. The major cost of goods, which is what is most subject to tariffs, is all done in the U.S., the major part of the cost of goods. I believe that was the last question I have received. With that, I want to thank all of you for listening to the Orexo fourth quarter and full year result call and wish all of you a good day. Thanks a lot.