Photocure ASA (OSL:PHO)
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Sep 14, 2026, 2:16 PM CET
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Earnings Call: Q3 2020

Nov 10, 2020

Dan Schneider
President and CEO, Photocure

All right. Great. Good afternoon and good morning to those in the U.S., and good afternoon to those in Norway and other parts of Europe. My name is Dan Schneider, I'm the President and CEO of Photocure. With me today is Erik Dahl, CFO, and we're here to present the Photocure ASA results for third quarter 2020. Next slide. Typical disclaimers are in place for today's presentation. Next slide. Just to give you a brief overview, and I'm proud to say that we can now claim this, we have direct sales both in Europe and the U.S., beginning on October 1st in Europe, and worldwide rights and partnerships throughout the globe. We are now actually approved and in use in over 30 countries across the world. We have over 100 employees now that we've absorbed and built out the European operations.

We treated well over half a million patients. Total revenues in 2019 were approximately NOK 32 million. The map to the right shows where we're direct, which is the darker blue. The purple is partnered countries. You can see Chile down on the far bottom of the slide. What's not pictured, obviously, is Australia and New Zealand, which could not fit into today's slide. Next slide. Reminder on our mission. The mission is delivering transformative solutions to improve the lives of bladder cancer patients across the globe. We see this in basically four phases. Phase I and phase II are where we are today, the acceleration phase, where we've invested more heavily in our commercial organization, increasing the depth and the breadth of Hexvix and Cysview use across the countries that we're directly in.

We use expansion, phase II, which includes the acquisition of European rights to expand into geographies around the globe, partnerships with companies like Genotests and others across the globe, and other countries. In addition, expanding it in terms of the use of the product and taking a look at whether there are enhancements to the product to improve the surgical guidance and the diagnostic and possibly the therapeutic benefits of the product. Moving on to phase III is the acquisition phase and partnering, in-licensing. A very good example of that is Combat Medical in the Nordics. We're doing quite well, which is an HIVEC system. We'll look at continuing to add to our portfolio with products that are very synergistic, used by the same types of physicians in the same settings of care.

Finally, transform, and it's building into a complete global bladder cancer company, inclusive of pipelines and other acquisitions. Next slide. Highlights for the third quarter. I am extremely pleased with the results and our continued rebound out of the depths, I guess, of Q2's COVID impacts. We had a 17% U.S. unit sales growth this quarter. We've had a 14% increase in revenues for Hexvix and Cysview. This is adjusted with some of the one-off costs in the transition of the European rights and operations of building out. I'm proud to say that we are now live in Europe, and that began officially on October 1st, although we had a little bit of a lead -in with people working behind the scenes and establishing the strategic planning that goes with it and setting up the MAH transfers and also the supply channels.

Thanks to all those individuals throughout Photocure who put a lot of long hours in to make this a reality, and I have to say, it came without any hitches. It was as smooth as I've ever seen a transition. I think in addition to that—and we'll get into it a little bit more—having many of the sales force from Ipsen come over with the product ensures the transition and the continuity to be very smooth, and we think we can pick up running. Finally, partnership news. We announced that Asieris NMPA, which is basically the old Chinese FDA, has approved for the start of the phase III in China. We expect that will happen here soon. In addition, we also inked a deal with Genotests for Hexvix rights in Chile. Next slide. A reminder on the disease itself.

It has been chronically underserved for generations. It's the sixth most common cancer in the world, with over 550,000 new cases annually across the globe and over 200,000 deaths. It's also one of the most expensive. I think that often surprises both patients and physician and payers. It has the highest per-patient lifetime treatment cost of any other cancer. That's because once diagnosed, it is a lifelong treatment. Hopefully you don't progress to muscle invasive, where more invasive procedures are used. In the U.S. alone, it's about a $5.7 billion expenditure. From a recurrence standpoint, it has a very high recurrence. Over 61% of patients have recurrence within the first year. By the fifth year, nearly 80% are now going to see recurrence and have to be retreated.

It's progressive, and this is the most important part of treating Non-Muscle Invasive Bladder Cancer : you want to keep it non-muscle invasive. Once it becomes muscle invasive, you undergo cystectomies, which is having your bladder removed, and more invasive procedures, and it really changes a person's life. The progression rates run from 1% to upwards of nearly 50% for patients progressing to muscle invasive within five years, and that obviously plummets survival rates significantly. Next slide. Here's the product itself and how it works. We believe blue light cystoscopy can and will become a new standard of care. It doesn't come without effort. It does require the commercial and medical teams to really go to work throughout the globe. The drug itself is a colorless, reconstituted solution that's instilled into the bladder. It uses the body's own biology to detect malignant cells.

Oftentimes, we hear people comment that it is a dye. It is not a dye. It is actually a biologic reaction within the cells, and once it is absorbed, it is actually seen glowing bright pink. The malignant cells glow bright pink under blue light and give very clear margins. Gives a physician the ability to see all the cancer throughout the bladder. We believe Hexvix blue light cystoscopy offers improved detection during surveillance, and this could lead to reduced recurrence versus a white light cystoscopy alone. Next slide. On our way to becoming a standard of care, it is probably one of the most important elements, finding ourselves on the major guidelines, both globally and nationally. Cysview Hexvix has and is on the major guidelines: AUA, EAU, SUO, NICE, AFU, the German guidelines, and many regional guidelines throughout the world.

We'll continue to work on improving our positioning, but this is a great foundation upon which you can build a standard of care as a reference. Next slide. This slide depicts the journey of the patient. I'll take you from left to right. Patient finds blood in the urine and some other symptoms. They move down the continuum to the right. They go to urologist offices. The urologist will perform an initial cystoscopy. This is not generally done under blue light. Probably very rarely, if ever, would it ever be done under blue light. We actually do not have the indication to be used in this setting for an initial diagnosis.

If bladder cancer is suspected, if they see polyps or otherwise, or perhaps they have blood in the urine but a negative cystoscopy, they will schedule the patient into the OR and perform a TURBT, which is a surgical procedure to remove any polyps and cancerous tissues in the bladder. There are over 700,000 cases in the U.S. and the EU5. I say the EU5 because, as you know, we've taken over complete European rights, so that number obviously is higher now that we have all of Europe. Once the tumors are all removed, the patient is then also staged and asked to come back for ongoing surveillance. If they're high risk, they may be asked to return to the physician's office in three months. Intermediate might be six months, and maybe if it's low risk, it might be outwards of a year.

If the patient returns, he'll come back to the physician's office. This is where, if you circle underneath , we talk about the regular surveillance of cystoscopies. According to the risk stratification, there are over 2.3 million of these cystoscopies that take place in the U.S. and Europe. If the patient is clean, they'll be asked to come back in six months, three months, a year, whatever, depending on, again, the risk stratification. If the physician sees something in the bladder and they see additional cancer, they may do some low-level procedure, but quite often they will refer them back into the OR for a complete TURBT. This cycle continues for the patient for the remainder of their life, trying to keep them from moving to the far right, which is progression to muscle invasive.

That gray area where you have the two red dots is where blue light cystoscopy is most dramatically going to change a patient's life and prevent them from moving to the right side of this slide, which is where there is a plummet in life expectancies of patients who end up with Non-Muscle Invasive Bladder Cancer . Okay. Next slide. I'm going to hand over to Erik Dahl, who will give everyone an update on our financials. Erik?

Erik Dahl
CFO, Photocure

Well, as usual, in this part of the presentation, we will do a financial report. Please be aware that the numbers used in the next slide are the reported IFRS numbers, but I will obviously comment by using the adjusted numbers. Let's start with the commercial franchise. The headlines for the commercial franchise in Q3 are, first of all, the rebound from the pandemic we experienced at the end of Q2 continued into Q3. The commercial franchise was obviously heavily impacted by transition activities in Europe. However, if you adjust for these activities, Q3 EBITDA was positive NOK 4.2 million. We see total Hexvix adjusted revenue in Q3 increased 14% compared to Q3 last year. This includes adjustments for the inventory changes in Q3 at Ipsen. Without these adjustments, the revenue decreased. Okay. We are sorry about this. Apparently, the sound disappeared when I started.

Just to make sure that I get every item included there, we're going to start with this slide, financial highlights from the third quarter. We have two major streams that are defining the financials in the third quarter. First of all, we have a strong business performance, which was driven by significant revenue growth as well as positive adjusted earnings in the quarter. U.S. volume is up 17% in the quarter, and European volume was up 7%. Adjusted revenue increased year-over-year 14% in the quarter, and adjusted revenue and earnings are after eliminating one-off costs related to the transition of the Ipsen activities. The European transition is the second stream in the quarter. We have gone through a major transformation of the global business as we are building and integrating the European business. The European transition alone is adding 50% additional revenue for the company going into next year.

The transition, however, does not come without one-off costs. We have said previously that the transition will cost us around NOK 30 million. In the third quarter, we incurred NOK 15 million, and year-to-date, the transition cost was NOK 18.6 million. I do see us incurring costs in the fourth quarter as well, but the total cost of the transition will be well below the NOK 30 million we have indicated previously. The one-off items incurred are of various types. We have identified the items well below on this slide number 11, in the column that is marked red. Starting with the revenue, obviously, the transition impact includes reduced revenue. We did not want Ipsen to remain with an inventory after the transition, as we do not want a competitor out there.

We agreed with Ipsen to reduce the shipping of goods to Ipsen in the quarter, and we also agreed to take back inventory remaining at the end of the third quarter. The impact of revenue was NOK 8.9 million, and on cost of goods sold, NOK 2.5 million. The transition costs also include operating costs relating to the European organization established during the third quarter. The cost in Q3 of that organization was about NOK 1.5 million. Finally, we had one-off restructuring costs, including recruitment costs, various setup costs, and legal fees. Adding the revenue impact and cost impact, we get to a total transition impact of NOK 15.1 million in Q3. Adjusting for the transition impact, we have an adjusted revenue of NOK 58.5 million in Q3, which represents a growth of 14% from the third quarter of 2019.

Furthermore, we have an adjusted EBITDA of NOK 2.5 million positive, compared to last year, NOK 8.3 million. Keep, however, in mind that last year, EBITDA was driven by a milestone payment from Ascletis of NOK 8.7 million. Looking at Hexvix Systems only, we have an improvement from Q3 2019 of approximately NOK 3 million. To conclude, and in spite of COVID-19, we have improved our Hexvix Systems revenues and EBITDA performance compared to last year. Looking at the details, we will start with the segment performance, and I will look at the commercial franchise first. The headline for the commercial franchise in the third quarter is, first of all, the rebound from the pandemic. We have experienced that in Q2 as well as in Q3. Then also the commercial franchise has obviously been heavily impacted by transition activities in Europe.

However, if we adjust for these activities, Q3 EBITDA was positive NOK 4.2 million. Total Hexvix Systems adjusted revenue in Q3 increased 14% compared to Q3 last year. This includes adjustments for the inventory changes in Q3 at Ipsen, and without these adjustments, the revenue decreased 3% in the quarter. Year -to -date, adjusted revenue growth was 8%, and foreign exchange impact was 9%-10%. In the U.S., Q3 revenues increased 20% to NOK 30 million. Unit sales increased 17% in the quarter, a clear rebound from the pandemic. Year-to-date, U.S. revenues increased 13% to NOK 80 million, and foreign exchange impact was approximately 10%. We are growing the installed base of blue light cystoscopes, although due to the COVID-19 pandemic, not at the same rate as last year.

During the first nine months, 30 cystoscopes have been installed, driving the total installed base to 253 cystoscopes, which is a growth of 20% compared to the third quarter last year. Nordic revenues decreased 3% to NOK 9.7 million in Q3. The decrease was driven by sales from the extraordinary COVID-19-related safety stock purchased by the Danish authorities in the second quarter. Nordic revenues increased 6% year-to-date. In constant currencies, we had a decline of 2% year-to-date. Partner revenue is obviously heavily impacted by transition activities with Ipsen. Unadjusted, we had a revenue decline of 40% in the quarter. Adjusted for the transition, the partner revenue grew 16% in the third quarter. Quarter FX impact was approximately 8%, and in-market unit sales were up 7%.

In real terms, looking at the development of our in-market sales, this was a good quarter, reflecting a rebound from the COVID-19 pandemic. Year-to-date, adjusted partner revenue was at NOK 52.9 million, an increase of 6%. Currency impact was positive, about 10%. The in-market unit sales decreased year -to-date by 7%. The German unit sales were at the same level as last year. Total revenue, including milestones and other sales, declined 4% in Q3; however, it increased 13% adjusted for transition. Other revenues in 2019 include IFRS 15 adjustments. We have no such adjustment this year, which explains the difference in other revenues. Operating expenses, excluding depreciation and amortization, increased year-over-year 12% in Q3 and 17% year-to-date. Q3 adjusted for transition costs of NOK 1.5 million was 8%. Driven by sales and marketing costs as well as FX.

Year-to-date, the main contributor to the increase is currency impact. The remaining is mainly driven by costs related to non-cash-related share-based compensation, as well as scaling of the group activities within regulatory and marketing. EBITDA for the commercial segment was negative NOK 3.7 million in the third quarter and negative NOK 13.7 million year-to-date. Adjusted for transition activities, the Q3 EBITDA was positive NOK 4.2 million, reflecting an adjusted EBITDA margin of 7%. Year-to-date, EBITDA adjusted for transition was negative NOK 5.8 million, obviously negatively impacted by the COVID-19 pandemic. Looking at the development portfolio. Development portfolio has been driven by the license agreement for Cevira with Asieris. Last year, we received a $5 million signing fee payment from Asieris. In addition, we accrued revenue of two development milestones totaling NOK 3 million.

The fees from Asieris are accounted for according to IFRS 15. Revenue recognition in 2019 was therefore based on contract value, which was $8 million, applying the currency exchange rate at the time of the executed contract. We received $1.5 million of the accrued milestones in the first quarter of 2020, obviously impacting cash flow but not revenue for the quarter. In the third quarter of 2019, we received $1 million in milestone payment from Asieris, impacting the Q3 results for last year. Operating expenses continued to decline for the development portfolio. The reduction from last year was year -to-date NOK 4.7 million or 46%. The decline is partly driven by one-off expenses in 2019 related to the signing of the license agreement with Asieris. Let's go to the consolidated income statement. We recognize the revenue numbers. Let's have a look at the cost base.

Operating costs increased 8% in the third quarter. Adjusted for transition, the increase was 5%. Year-to-date, the operating cost increased 13%, and adjusted for the transition, 12%. Again, the main contributor to the year-to-date increase in operating cost was the currency impact of approximately NOK 11 million, or 7%. The remaining, a total of approximately NOK 6 million, was mainly driven by non-cash costs related to the share-based compensation as well as scaling of the group activities. We see that many companies have reduced the number of customer-facing employees due to the COVID-19 pandemic. We have not done that. We have maintained our sales resources and, as far as possible, maintained customer-related activities during the COVID-19 pandemic. We believe the benefit of being prepared was demonstrated with a rapid sales rebound in the second and the third quarter.

EBITDA in Q3 was negative NOK 5.4 million and adjusted for transition, positive NOK 2.5 million. Year-to-date, EBITDA was negative NOK 19.1 million, and adjusted for transition, negative NOK 11.2 million. Q3 and year -to-date 2019 EBITDA was driven by a sign-on payment from Asieris of $1 million. Depreciation and amortization year-to-date: NOK 11.6 million. Main single item within depreciation and amortization is the amortization of the investments in the Cysview phase III program. The remaining amount will be totally or fully amortized by the end of this year. We had restructuring costs of NOK 10.4 million year-to-date. The restructuring cost relates to the transition activities for the European business that we have already discussed. Net financial income, NOK 8.2 million year-to-date, which is mainly driven by and related to foreign exchange gains. Tax expenses year-to-date, an income of NOK 0.2 million.

We had significant tax expenses in Q1, which were related to our tax asset and tax loss carryforward and therefore not tax payable. In Q3, however, we had a tax income of NOK 8 million. After net financial items and tax, we have year -to-date a net loss of NOK 32.6 million compared to a net loss last year of NOK 10.7 million. Cash flow. Net cash flow from operations was negative NOK 9.9 million in the third quarter and positive NOK 4.5 million year-to-date. Year-to-date, the improvement from last year was NOK 14.3 million and partly driven by the milestone payment from Asieris of $1 million in Q1, as well as improved working capital. The impact from changes to working capital year-to-date was positive NOK 10.2 million and driven by accruals and payables, partly offset by increased inventory.

Cash flow from investments was year -to-date negative NOK 166 million, obviously driven by the acquisition of rights from Ipsen. Cash flow from financing year-to-date is positive NOK 358 million, driven by private placements and bank financing. We had two private placements in the second quarter, 27th of April and 24th of June, raising a total net of NOK 302 million. We also secured bank financing of NOK 50 million in the second quarter. Net cash flow was negative NOK 177 million in Q3, driven by the acquisition of rights from Ipsen. Year-to-date, the net cash flow was positive NOK 196 million, driven by additional funding in Q2, partly offset by the acquisition in Q3. This gives a cash balance at the end of the third quarter of NOK 322 million.

Looking into the fourth quarter, we know that we have taken over the European revenue, and we know that activity, or that revenue, will drive account receivables in the fourth quarter. As we described when we described the Ipsen transaction, this will drive a negative working capital in the fourth quarter. We then estimated about NOK 25 million of negative working capital related to account receivables, and we believe that is going to be the number.

Looking at the balance sheet. At the end of Q3, total assets of NOK 608 million. Non-current assets NOK 227 million at quarter -end. This included marketing rights acquired from Ipsen of NOK 167 million. It also included a tax asset of NOK 38 million and investments in tangible and intangible assets totaling NOK 6 million. We also find another line within non-current assets totaling NOK 16 million. This relates to the remaining $1.5 million receivable on our associates.

In addition, this other line includes a balance sheet impact of the adoption of IFRS 16 on lease accounting. Inventory and receivables are NOK 60 million at quarter end, reduced from year-end NOK 62 million. The loan carries a floating interest. Effective interest rate at the end of the quarter was 2.7%. Thereafter, quarterly equal repayments. Equity, finally, at the end of the third quarter, NOK 492 million or 81% of total assets. This concludes my part of the presentation, and Dan will continue by discussing the U.S. and European business.

Dan Schneider
President and CEO, Photocure

On slide 17, just talking about Europe here. The overall strategy is to move the markets. We have a tremendous untapped market in the U.K., Spain, Italy, and other countries. I think recently we announced in the U.K. we've already formed a very strong relationship with KARL STORZ , who has 100% of the scope placements there. We are sharing a booth at BAUS, which is the urology conference in the U.K. It is a fantastic virtual booth in which we're highlighting blue light cystoscopy, which, quite frankly, has not been highlighted in years. This is a fantastic opportunity for us. Looking at the DACH region, 30%-35% penetration. France at roughly around 15% penetration. We believe there's still growth in those regions to move them to the Nordic penetration rates of 40% or better. There's tremendous unlocked potential still in Europe.

Many countries have barely been touched, and we're seeing opportunity 30 days into our launch. Slide 18. All key commercial resources are in place. I also mentioned early in the presentation that 100% of the previous Ipsen DACH sales force from Germany has come over, which is fantastic, as it has ensured a smooth transition. We pick up immediately where they left off on the 1st of October. All distribution channels have been built, legal entities established in Germany and France, and all MAHs have been moved over of the 19 that needed to be moved over. Majority. There's a couple in Italy and Greece, which we're working on, but that was expected. We'll have Ipsen continue to supply while we do the commercial work in those countries. Moving on to slide 19. Talking about the U.S., slide 20.

I think this demonstrates the growth signs that are coming out of COVID. I think the slide to the right probably is the best depiction. As you can see, the tremendous trough compared to prior years in April of this year, the quick recovery out, and then the exiting out of September back to an all-time high for us. In fact, the highest month ever. Fantastic recovery in the U.S. I think that's attributed to having our commercial people in place and utilizing both personal where we can, as well as digital and virtual means to meet our customers' needs and serve our patients. I think that has bode well for us, and that was always our strategy, a slingshot strategy, knowing that COVID was a temporary situation. Going into Q4, we know that COVID is making some sort of a return.

What we believe is that the institutions, the physicians' offices, are far better prepared and are going to want to see the patients. If patients choose on their own not to venture out, that is obviously their choice. What we're hearing from our customers is that they don't see any major disruption in their ability and capacity to treat bladder cancer patients into Q4. We'll see. Obviously, no one has a crystal ball to see how it all will go, but we do not expect a trough like April to happen again. Slide 21 is the installation of cystoscopes. We have 30 on the year so far, 33 flex, and 220 rigid. Flex is starting to pick up a little bit now, and we think that still remains a growth engine for us.

I think all in all, given a year like this, having 30 installed to date, we'll have more in Q4, and still bodes well for us going into the new year. I think I mentioned early in the end of last year's quarterly or end-of-year presentation that our big strategy this year was to drive more units per scope. Having that strategy in place, coupled with installing new scopes, is boding well for us going into the future. This is all despite the challenges of the pandemic. The challenges are that institutions have, in some cases, frozen their capital equipment, or in other institutions, if they shut down, the installations are delayed. We see the pipeline as having just moved out into the future for those accounts that were queued up for this year.

Moving to slide 22, this depicts the relative penetration rates of the markets, and you can pretty much see the rest of the EU and U.S. as being a major opportunity for us. DACH still has growth in it. We actually see opportunity 30 days in, and we'll be going after it. We have all the right success factors in place, from approvals and acceptance to access and activated awareness. I think we've got engaged capital equipment manufacturers as well as patient advocacy groups throughout Europe and the U.S., and we've now put the commercial engine in place to accelerate the sales. Slide 23. There is increasing media attention on BLC procedures. We were featured in UroToday on the 11th and 24th of June and the 13th of September. We've also been in Norwegian Patient Association magazines in September. Again, the growing interest in blue light cystoscopy continues.

Slide 24. Increasing media attention, particularly on the European markets. There was a lot of write-ups on this. I think we can conclude that the transition was fantastic. It was smooth. We saw no disruption, and we're going to carry forward into the fourth quarter and forward. Again, as days go by, I see more and more opportunities to really do some good work in Europe. Moving to slide 25. On to slide 26 from summary and outlook. Current year guidance: Q3 rebound will continue into Q4, although we know that there are COVID implications now as we're heading into Q4, both in Europe and in the U.S. We do believe hospitals are better prepared. Procedures might be postponed, but they're eventual. This is a disease that has to be treated.

There may be restricted access to the OR, but as I've mentioned in the past, we can be there personally. We've also Zoomed in on OR procedures where need be. We also are asked in some circumstances to assist physicians, particularly if they're new to doing blue light cystoscopy during the COVID pandemic. Equipment budgets have been temporarily reprioritized. A lot of those capital budgets were shifted to respiratory equipment and things to treat COVID earlier this year. We do see some of those budgets being loosened. Where they have been, we're going to try very hard to bring capital equipment in and get ourselves set up in Q4. If not, it'll be into next year. Again, the pipelines remain. They just may be pushed out a little bit.

In conclusion, we maintain our ambition of worldwide revenues of NOK 1 billion in 2023, by the end of 2023. With our approximate EBITDA of 40%, we'll do that through the accelerate, expand, acquire, and transform. With that, I'll move to the last slide for Q&A. I know I ran quickly through those, with the challenges we had with audio, I thought it'd be better to get right to Q&A. Open it up from here. Thank you.

Erik Dahl
CFO, Photocure

Thank you, Dan. I have the question from the web. I'm just going to start at the top before all the comments about no sound. The first one here is from Thomas Gaivis. The marketing rights on the balance sheet, is there going to be any amortization of these rights over time? We're in the process of doing a PPA, a Purchase Price Allocation, these days together with KPMG. There will be either an amortization or impairment test, or a quarterly impairment test, depending on how this asset is classified. There will be amounts between EBITDA and EBIT certainly. I have another one from Thomas Gaivis. How quickly are you going to enter the markets where Hexvix is not available now in Europe? Any more specific or concrete plans? Do you want to take that, Dan?

Dan Schneider
President and CEO, Photocure

I heard something about Europe and countries, perhaps that were not as bad.

Erik Dahl
CFO, Photocure

Okay, let me repeat. Can you hear me now?

Dan Schneider
President and CEO, Photocure

Yeah.

Erik Dahl
CFO, Photocure

Okay. How quickly are you going to enter the markets where Hexvix is not available now in Europe? Any more concrete plans?

Dan Schneider
President and CEO, Photocure

Yeah, we're actually in the process of assessing that. I was in meetings two weeks ago where we're going through many of the other countries where Hexvix is actually supplied. MAH is available. Countries in the Baltics, Estonia, Latvia, et cetera. What we're assessing now is whether a direct salesperson or persons would make sense. Would the return be there? Early conclusion is it may well in fact be the case. We have to make sure access reimbursement is set up properly and that we can put the right amount of effort behind it. We can move as quickly as the opportunities present themselves. Currently, the European operation is approximately, including the support staff that's with it, around 24, 25, or 26 people. There's a finance person, a marketing person, a market access person, and a supply person that support.

Majority is a sales organization in the major countries of DACH, France, the U.K., Italy, and Benelux. We do see opportunities in those other countries. Spain, in particular, comes to mind. Poland, another large country that we think is not only an opportunity, but there's already a built-up pent-up interest in bringing blue light cystoscopy through the KOLs that have heard about it and would like to lead it in those countries.

Erik Dahl
CFO, Photocure

Okay. I have a question from Nicolas Deflon. You previously stated that Asieris is estimated to submit its application for market approval in 2022. Does this include the U.S. and EU?

Dan Schneider
President and CEO, Photocure

This is China, 2022, for China. I would say put it towards the end of 2022, assuming they can get a first patient in this year. You're going to look at probably a good year, then they have to pool the data, submit, and then they have time for an approval. We think data in 2022 with an approval in 2023 for China. EU and U.S., they'll assess coming out of this trial. They'll do an interim analysis and determine what, how, and when they will design and launch the next trials necessary for European and U.S. rights. We expect European-U.S. approvals maybe late 2023 and 2024, probably more like 2024.

Erik Dahl
CFO, Photocure

A question from Anders Lunde. When do you think the first patient , Cevira, is coming?

Dan Schneider
President and CEO, Photocure

Hopefully soon. That's all the indications there are. They got everything lined up. Trial sites are in place. Enrollments have begun. It should be any day.

Erik Dahl
CFO, Photocure

A question from Thomas Gaivis . Can you comment on the cost base in the fourth quarter versus the third quarter and the significant changes? I think I'll take that one. Yes, there will be a significant change because the cost base of Europe will then be included in our P&L. What we have said previously is that we will incur additional costs annually in Europe of approximately NOK 90 million, for the full year, that is. I don't think that the fourth quarter will reflect that run rate. It's going to be slightly less, but obviously there will be an additional amount on the spending driven by Europe. I have one from Rickard Anderkrans. There seems to have been a stocking in Ipsen territories in the third quarter given the increase in volumes. Can we expect that to cycle out in Q4 2020? Let me take that.

It seems that some larger customers have stocked some units at the end of the third quarter in anticipation of Photocure taking over the distribution in Europe. We don't think that is significant, but there might be some impact. It's very difficult to estimate how much that impact will be. I have one from Andre Evensen. Why do some hospitals choose rigid over flex for new installations?

Dan Schneider
President and CEO, Photocure

Erik, I can't hear you.

Erik Dahl
CFO, Photocure

Okay. It's.

Dan Schneider
President and CEO, Photocure

I can't hear you.

Erik Dahl
CFO, Photocure

Why do some hospitals choose rigid over flex for new installations? You still can't hear me.

Dan Schneider
President and CEO, Photocure

I can't hear you.

Erik Dahl
CFO, Photocure

I'll try once more. Why do some hospitals choose rigid over flex for new installations? You can't hear?

Dan Schneider
President and CEO, Photocure

I can't hear you.

Erik Dahl
CFO, Photocure

Can you do anything about it?

Speaker 3

Yeah. Okay, I'll try with this.

Erik Dahl
CFO, Photocure

Can you hear me now then? This is on?

Speaker 3

Yes.

Erik Dahl
CFO, Photocure

Okay. Can you hear me?

Dan Schneider
President and CEO, Photocure

Yeah, I can hear you now.

Erik Dahl
CFO, Photocure

You can hear me now?

Dan Schneider
President and CEO, Photocure

I can, yes.

Erik Dahl
CFO, Photocure

Okay. I can hardly hear you. The question was from Andre Evensen: Why do some hospitals choose rigid over flex for new installations?

Dan Schneider
President and CEO, Photocure

Well, they're two different settings of care. Rigid has a very clear, obvious, and long history of benefit in the OR practice with blue light. When you're going in for a TURBT, you know the patient has cancer. You're very highly confirmed to have cancer. You're going to want to go in with a rigid and get everything you can see. Blue light is a very easy sell there. In the surveillance market, it's an easy sell, but obviously reimbursements and things have to be obviously lined up with it. That's the value that we're bringing, that they can do some of these procedures in the surveillance setting.

If they're doing a white light surveillance, they may have missed something, and you doing blue light and doing a low-level procedure and bringing them back to the OR, they can assure that that patient will be discharged and put on the right follow-on treatment. Some institutions have brought in flex before rigid, but generally it's rigid before flex.

Erik Dahl
CFO, Photocure

Another question from Eddie Palmgren. You have quite a lot of cash. Are you currently evaluating M&A targets? Can you hear me?

Dan Schneider
President and CEO, Photocure

Oh, yes. M&A targets, yes. That's part of our strategy. Step three and four are looking for products and small companies, and again, the products can be agnostic to drugs or devices. I think that's one of the fortunate things about being at Photocure. W E understand the device side as well as we understand the pharmaceutical side. We can compete. We also have extremely strong relationships in the Uro -oncology space, which makes us a very attractive partner to either someone who'd want to sell or hand their product to us to do the selling for them, or if they want to sell themselves or the company. We'll be looking at those things going into the future. The number one priority for us this year was Europe.

Erik Dahl
CFO, Photocure

Let's just see here. Nicolas Deflon, I'm not sure if I had this question before, but Has Asieris started its phase III study? If not, when will they start? Will it trigger a milestone payment? If so, what is the amount?

Dan Schneider
President and CEO, Photocure

It will trigger a payment. We've accounted for it. We expect the first patient to be dosed soon, as in probably this quarter. I will say this about Asieris: what I meant to say in the prior answer. Asieris' development plan and milestone were also dated in terms of a timestamp. They had to get to this point by a certain time. That time point was actually next July. If they're bringing a first patient in in this quarter, they are ahead of what the original development timelines were expected to be, which would be fantastic, and that's what we expect. They've been a fantastic partner. They're extremely excited and extremely capable. I couldn't ask for a better partner right now to take Cevira.

Erik Dahl
CFO, Photocure

One more from Nicolas Deflon. You said that expected cash flow from EU operations will be negative NOK 25 million in Q4. When do you expect it to be positive? I think you're referring to my statement on account receivables and how we expect the account receivables to build up in the fourth quarter as we take over the European business. That's a one-off event. We expect the cash flow from the European business to be positive in 2021 for the full year. I think we are slowly approaching the end. Let me see. Have one more look here. No, I think that's about it. Okay, Dan. I think we're ready to close.

Dan Schneider
President and CEO, Photocure

Okay. All right. Great. Thank you, and I apologize for some of the technical difficulties. Hopefully, you got a lot out of today's presentation. We look forward to speaking to you at Q4. Thank you very much. Bye-bye.