Photocure ASA (OSL:PHO)
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Earnings Call: Q4 2020

Mar 3, 2021

Dan Schneider
President and CEO, Photocure

All right. Well, good afternoon and good morning, depending on where you're calling in from around the world. This is Photocure's results for year-end and fourth quarter 2020. I'm Dan Schneider, President and CEO, and with me today is Erik Dahl, CFO. The usual disclaimers are in place for today's presentation. Let's go with a little bit of the background on Photocure and the product Hexvix/Cysview. We've treated over a half million bladder cancer patients worldwide. In fact, I think the number has reached 637,000 and growing rapidly. We have direct sales in both U.S. and Europe, and otherwise, worldwide partnerships around the globe, recently announcing our China partnership with Asieris. We do about NOK 256.5 million in 2020. We're approved for use in over 30 countries. We currently have 90 employees, as we've recently built our European operations up.

As I said, we treated well over half a million patients. Our strategy is pretty straightforward. Strategy steps one and two are focused on Hexvix/Cysview, ways to accelerate the brand itself, drive the breadth and depth of Hexvix and Cysview use, and expand geographically, and also enhancing the product itself. Stages three and four are around acquisitions and transformations. These are in-licenses, acquisitions, and building out and strengthening the portfolio in bladder cancer. It is all in our purpose to deliver transformative solutions to improve the lives of bladder cancer patients across the globe. The highlights for the fourth quarter, I'm sure most of you have read the reports. We've had a 48% growth in U.S. revenue, 66% growth adjusted for Hexvix and Cysview globally. Our European operations went live October 1st, seamlessly transitioning from Ipsen to Photocure. We had partnership news.

Cevira's first phase III patient was dosed in Q4 2020. We announced the partnership with Asieris for Chinese rights for Hexvix in China. We ended the quarter with an increased cash balance to NOK 334.9 million. Let's talk a little bit about the disease itself and what we're treating, and why this opportunity is so fantastic for us at Photocure. Bladder cancer is a chronically underserved segment of all the oncologies. The sixth most common cancer in the world. There are 550,000 patients annually that are newly diagnosed, with over 200,000 deaths, of which 75% are men. It's most expensive. I think that often shocks people. It's the highest per patient lifetime treatment cost of any cancer. The reason is the patients, once diagnosed, will go through a lifetime of procedures.

Its recurrence rates are also quite astoundingly high, up 61% within the first year of being diagnosed, and 78% recurrence rates within five years. Probably the most dramatic is the progressions. It's key to keep the patient, if you can, in a non-muscle invasive category, where treatments are much less invasive. Going to muscle invasive can often lead, ultimately, to death. A five-year progression from 1% to over 45% to muscle invasive. Clearly, there's a need to do a better job of treating bladder cancer patients around the globe. We believe we have that treatment. Hexvix/Cysview, for the better detection and management of non-muscle invasive bladder cancer. This is a razor blade business model. This is a drug device combination for better visual contrast, so you can tell the difference between benign and malignant cancer cells. On the left is our product, Hexvix/Cysview, the razor.

It preferentially accumulates in bladder cells, and under blue light, glows bright pink. It is a lyophilized powder that is reconstituted and instilled into the bladder an hour prior to procedure. On the right side is the capital equipment sold by Karl Storz, Wolf, or Olympus around the globe. It's only sold by Karl Storz in the U.S. Down in the lower right, we show the difference between a rigid scope, which is used during surgical resections, and a flexible scope used during outpatient cystoscopies. Next slide. I do apologize, I didn't say next slide on my first couple, but hopefully you're following along. We should be on slide eight, and this is a picture of what the dramatic difference is between the current standard of care, which is white light, and what we believe will become the new standard of care under blue light.

On the left side is a pictorial depicting what a physician would see under white light cystoscopy when they put the scope inside the patient's bladder. In this scenario, they see nothing. However, if they were instilled with Cysview or Hexvix an hour prior to procedure and a blue light equipped cystoscope was turned on, they would clearly see that there is malignant cancer cells, clearly defined margins, and the opportunity to do a perfect resection. The key benefits are very clear. There's improved detection and a more complete surgical resection. You also have a much more accurate risk classification, and the reason why that's important is because that risk classification will determine the follow-up procedures necessary for that patient.

In the case of this picture, this patient would go home believing they are cancer-free and probably wouldn't return to their physician until there was significant blood in their urine or other kind of complications. However, if this is CIS on the right under blue light, this patient would be categorized as high risk and asked to return within a week to have a surgical procedure, and three months after that, and three months after that, and onwards and onwards. Risk classification is extremely important in the treatment of cancer. Also, it improves better patient monitoring and the surveillance of cystoscopies. As the patients come back for follow-ons, using blue light will detect these sorts of cancers.

It's detected 21% of the recurrent patients over white light. What's most dramatic is 35% of patients with CIS are detected with blue light that are not detected with white light alone. As you know, CIS is one of the more deadly and high-risk cancer cells. Next slide. We have the complete support of all the major global and national guidelines, AUA, EAU, SUO, NICE, AFU, German, both from a global standpoint as well as even local and regional support. There's a strong body of evidence and strong supportive environment for the use of blue light cystoscopy in the detection and management of bladder cancer. Next slide. This slide depicts the journey of the patient. This shows the loop that I was talking about why this disease is an expensive disease. It's expensive cancer to treat. The patient enters into the process on the left.

They generally will have blood in their urine or some other kinds of symptoms. They'll go see their general practitioner, who will refer them to the urologist. The urologist, at that moment, will perform a cystoscopy. They'll go inside the person's bladder in the office setting and take a look and see if they see anything suspicious. They combine those findings with a cytology, perhaps a blood test of sorts, and determine whether that patient likely has cancer. I do say that about 85% of the time, it's usually something else, but for the 15%-20% of the time, it could be and probably is bladder cancer. If bladder cancer is suspected, they now enter into the loop, and the loop is they go into a surgical setting and have a TURB, transurethral resection of the bladder tumors, basically carving out the bladder cancer that they see.

There are over 700,000 procedures done in the U.S. and EU annually. We believe blue light cystoscopy is a perfect place to use it. As I mentioned in the prior slides, getting the diagnosis correct from the get-go is very, very important to the patient's staging and future treatment. Using blue light in that very first TURB is extremely critical, and we believe blue light cystoscopy can become the standard of care. After the patient's cancer cells are removed, they're then put on some sort of chemotherapy or BCG treatment and then asked to return for a follow-on cystoscopy. At that point, you're in the lower part of the loop, the second red dot, where the physicians will ask you to come back to the office, and they'll take another look inside your bladder.

Again, blue light cystoscopy can prove to be a very important component to the accuracy of finding the cancer and treating it. There are over 1.65 million procedures between the U.S. and the EU. When I say the EU, I'm talking about the EU 5, not the broader Pan-Europe. There's still even more than that that are out there. This is a tremendous cost structure for these patients. They'll continue through this loop for their lifetime. The whole key to this is not to end up in the red zone, the progression zone, to muscle invasive. If they go muscle invasive, this leads to cystectomies, which is their bladders are taken out, and a very different lifestyle, and oftentimes metastases and things of that sort. Very, very important that they stay in this gray circled area, and we believe blue light cystoscopy can improve their outcomes overall.

Next slide. We're well-positioned. Commercial organization in place for all the major markets across the globe. We have a sales force of 35 in the U.S. We have another 27 in Europe. We have a growing global footprint with partnerships in Canada, Chile, China, Australia, New Zealand. We continue to look for other opportunities to bring blue light cystoscopy to the patients that are suffering across the globe. Next slide. I'd like to turn it over to Erik Dahl to go through the financials. Erik?

Erik Dahl
CFO, Photocure

Thank you, Dan. Well, in this part of the presentation, we will start with a financial review of our segments, and then we will follow with the consolidated income statement, the cash flow, and finally, the balance sheet. First, we need to add some comments about the impact from foreign exchange on the results. In short, the FX impacts for Q4 was for revenue positive approximately NOK 4 million, and for EBITDA positive approximately NOK 2 million. Full year, the FX impact was positive on revenue of NOK 18 million, and for EBITDA, a positive NOK 4 million. I would also like to highlight the impact of the inclusion of the former Ipsen business in our accounts.

This transaction has an impact on the income statement as well as the cash flow and the balance sheet. I will comment on this when we get to the relevant slides. You will find detailed information in the report, both in note one and also in note six. With this, let's discuss the financials. All amounts that are mentioned in this presentation will be in NOK unless other currency is specified. I will start with the segment reporting and focus on the commercial franchise first. The headlines for our commercial franchise for Q4 are, first of all, that we had great results in the quarter. We had a revenue growth of 66% in the quarter and an EBITDA of almost NOK 18 million. We had a successful transition and launch of the European Hexvix operations and had the commercial rights transferred to Photocure on October 1st.

Q4 shows a positive impact from this transaction on both revenue and EBITDA. U.S. shows great performance in the quarter, with volume growth of 11% in the quarter in spite of growing impact from the COVID-19 pandemic. We do see a resurgence of the pandemic late in Q4, which caused some of our territories to decline compared to the prior year period. Despite these challenges, the revenue for our commercial segment increased both for the quarter and for the year. Total Hexvix/Cysview revenues in Q4 increased 66% compared to Q4 2019. Full year growth was 20%, and in constant currencies, the full year growth was 11%. In market unit sales decreased 7% in Q4 and full year with 5%. Unit sales was obviously impacted by the pandemic.

In the U.S., Q4 revenues increased 48% to NOK 41.1 million, and unit sales increased 11% in the quarter in spite of development of the pandemic. On the other hand, U.S. revenue in Q4 was also impacted by a partial release of the Medicare-related accrual that we accounted for in the second quarter. We accrued then $1.2 million, and as this topic now is closed, we were able to release $900,000, or about NOK 8 million, of this accrual. Full year U.S. revenues increased 15% to NOK 113 million. In U.S. dollar, the revenue increase was about 7%. In spite of the pandemic, and therefore limited access to institutions, we are growing our installed base of blue light cystoscopes. During 2020, 45 cystoscopes have been installed, driving the total installed base to 268, a growth of 20% from fourth quarter 2019. In fourth quarter alone, we installed 15 cystoscopes.

Europe. The revenues for Europe in 2020, as we reported, includes now full year Nordic revenues, as well as sales and royalty revenues from Ipsen the first three quarters, and also our in-market sales in the fourth quarter. The total Europe revenues increased 83% to NOK 56.6 million in Q4. The increase was obviously positively impacted by the revenue contribution from the successful transition of the Ipsen territories in the quarter. Unit sales declined in Q4 with 11%. This was due to challenging market conditions associated with the COVID-19 pandemic, which impacted patient treatment volumes in the quarter. Also impacting unit sales was stocking imbalances with our customers that accrued safety stocks of Hexvix during the first and more recent surges of COVID-19.

These stocking imbalances include the safety stock acquired by the Danish authorities earlier in 2020, which then was sold by the authorities in the market mainly in the fourth quarter. Full year revenue increased 24% to NOK 141 million. Full year revenue was negatively impacted by reduced shipping of goods to Ipsen in the third quarter. We also, in the third quarter, agreed to take back inventory remaining at the end of the quarter. The impact on revenue on this transaction was NOK 8.9 million in Q3, and also for full year, and the impact on cost of goods sold was a credit of NOK 2.5 million. Full year unit sales declined 8%.

The operating expenses in Q4, excluding depreciation and amortization, increased 47% to NOK 73 million. The increase is mainly driven by investment in Photocure's European commercial organization, as well as impact from foreign exchange of approximately 6%.

Full year operating expenses increased 25% to NOK 233.7 million. The increase was driven again by investments in Europe and also by currency impact. EBITDA for the commercial segment was NOK 17.9 million in Q4 and full year, NOK 4.2 million. Adjusted for one-off transition cost related to the Ipsen agreement of NOK 7.9 million, the full year EBITDA was positive, approximately NOK 12 million, which is an improvement from full year 2019. We accomplished this in spite of the COVID-19 pandemic. The financials for our development portfolio has been driven by the license agreement for Cevira with Asieris. In 2019, we received $5 million signing fee payments from Asieris. In addition, we accrued revenue in 2019 of two development milestones totaling $3 million, which were committed and timed.

The fees from Asieris were accounting for according to IFRS 15, and revenue recognition in 2019 was therefore based on contract value of $8 million. The Asieris transaction resulted in revenues of NOK 56.4 million in the fourth quarter of 2019, and full year 2019, a total of NOK 65.1 million. In 2020, we received $ 1.5 million in the first quarter from Asieris, and we also received another $1.5 million in the fourth quarter. This obviously impacted cash flow, but no revenue in 2020 as revenue recognition has been done in 2019. Operating expenses continued to decline for the development portfolio. The reduction from 2019 was full year NOK 5.3 million, or 39%, and the decline is partly driven by one-off expenses in 2019 related to signing of the license agreement with Asieris. Now to the consolidated income statement.

You'll recognize the revenue numbers from the segment analysis that we just went through. Let's first look at the cost base on this slide. We see operating cost increased 43% in the fourth quarter. Full year, the operating cost increased 21%, or NOK 41.8 million. Contributing to this increase is, first of all, the investment in Photocure's European commercial organization, which is required to support the European sales, and total amount full year is about NOK 19 million. Secondly, we have the impact from foreign exchange. Full year impact is approximately 6%. Finally, we have non-cash costs related to share-based compensation, as well as scaling of the group activities within regulatory and marketing. We see that many companies have reduced 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 the rapid sales rebound in Q2 and Q3. EBITDA in Q4 2019 was NOK 54.8 million, excluding the Asieris fees, the Q4 2019 EBITDA was NOK -1.6 million. Q4 2020 EBITDA was NOK +15.2 million , a significant improvement from same quarter 2019. The improvement is mainly driven by the inclusion of European business, as well as the partial release of the second quarter accrual for Medicaid-related discounts. Full year EBITDA was NOK -3.9 million, as compared to full year 2019 EBITDA of NOK 58.9 million, and NOK -6.2 million, excluding the Asieris fees of NOK 65.1 million.

Depreciation and amortization full year NOK 19.3 million, and this includes the amortization of the investments in the Cysview phase III program, a total of NOK 10 million for the full year. This program was fully amortized by the end of 2020. In addition, depreciation and amortization full year as well as Q4 includes NOK 4.2 million of amortization of the intangible asset related to the return of the Hexvix sales. In note six to the accounts, we have explained the treatment of the intangible assets and goodwill from the purchase price allocation of the Ipsen transaction.

We had restructuring cost of NOK 2.5 million in the fourth quarter and NOK 12.9 million for the full year. The restructuring cost relates solely to the transition activities for the European business. Net financial items was a cost of NOK 5.4 million in Q4, and income of NOK 2.8 million for the full year.

Q4 and full year includes a total of NOK 6.4 million of accrued interest cost for the deferred consideration to Ipsen, meaning the future earn-out payments to Ipsen. Note six to the accounts will help the explanation to this. Tax expenses in Q4 and income is an income of NOK 10.6 million. Full year an income of NOK 10.8 million. Driving the Q4 tax amount is the impact of the tax deduction of depreciation of goodwill from the Ipsen transaction, as well as cost related to private placements. Tax income and expenses relate to our tax asset and tax loss carryforward in the parent company. In other words, it's not tax payable.

After net financial items and tax we have for the full year a net loss of NOK 22.4 million, compared to a net profit of NOK 31.8 million full year 2019. We move on to the cash flow statement.

Net cash flow from operations was NOK +11.1 million in Q4, and full year NOK +15.6 million. Both for the quarter and full year, the decline from 2019 was driven by payments from Asieris in 2019. The inclusion of the European business had a one-off negative impact on working capital in Q4, as we from October 1st are invoicing the customers in Europe. Cash flow from investments was full year NOK -167 million, driven by the acquisition of rights from Ipsen. Cash flow from financing full year NOK +361 million, driven by private placements and bank financing. We had two private placements on April 27 and June 24th, raising a total net of NOK 302 million. We also secured bank financing of NOK 50 million in Q2. Net cash flow Q4 NOK +13 million, driven by milestone payments from Asieris of $1.5 million.

Year-to-date net cash flow was NOK +209 million, driven by additional funding in Q2, partly offset by the acquisition in Q3. This gives us a cash balance at the end of the year of NOK 335 million. Next is balance sheet. At the end of the year, we had NOK 776 million of total assets. Non-current asset was NOK 364 million at year-end. This included customer relationships of NOK 163 million. Customer relationships is the intangible assets identified in the purchase price allocation for the Ipsen transaction. Non-current assets also include goodwill from the Ipsen transaction of NOK 144 million, and a tax asset of NOK 50 million. Customer relationships is amortized on a straight line basis over 10 years, while the goodwill is subject to impairment testing. Inventory and receivables were NOK 77 million at year-end, an increase from year-end 2019 of NOK 16 million.

This is driven by the inclusion of the European business from Ipsen, as we from October 1st are invoicing the customers in Europe. The long-term interest-bearing debt of NOK 50 million is a loan secured under the state guarantee scheme for loans related to COVID-19. The loan carries a floating interest. Effective interest rate at the end of the year was 2.7%. The loan is a three-year term loan. First year interest only, thereafter quarterly payments of NOK 6.25 million. The earn-out liability totaling NOK 143.7 million represents the capitalized value of estimated future earn-out payments to Ipsen. The liability is subject to a 10-year annuity. We accrued NOK 6.2 million as interest expenses for the earn-out liability in Q4 2020. Finally, equity at the end of the year, NOK 508 million or 65% of total assets.

This concludes my part of the presentation, and Dan will continue by discussing the U.S. and European businesses. Thank you.

Dan Schneider
President and CEO, Photocure

Okay, great. Thank you, Erik. Let's move to slide 18, if we could. U.S. position for growth. This is the monthly kit volume over the last three years' comparators. As you see, the fourth quarter, all three months exceeded the 2019 level, even though we still were experiencing the COVID-19 volatility in 2020. I think also notice the dramatic dip in April and May, then coming back out, recovering, as Erik said, keeping the sales force intact and optimizing the opportunity. We are now hitting another slighter trough from COVID-19 with limited access, patients maybe not seeking treatment as they should. We expect that will recover over the period of the first half of this year. Still a great year in terms of kit volume. Next slide 19. This is probably the most exciting news.

When you think about COVID and the limitations of getting into the ORs, the key to getting cystoscopes placed is getting in ORs, getting into the hospitals to place them. To have 45 placed in 2020, a third highest ever in a COVID-ridden year, where a lot of the year we were locked out of these hospitals, but still yet succeeded, and in fact, reached basically the rates of 2019 in the fourth quarter of placing 15 scopes was, I think, quite astounding. On top of that, of the 15 scopes placed, five of them were flex. We're seeing a growing trend and momentum in the flex market, approximately 40-some odd percent growth year-over-year. Really, really good results.

This is a key indicator for our future is the scopes, again, are the razors, and our kits are the razor blades which we make the money on. This is a very encouraging development, even in a COVID-ridden year. Slide 20. Slide 21. Let's talk a little bit about Europe. We look at Europe in basically four segments. We have the established Hexvix markets, the Nordics, where we had been direct sales for the past decade. We have a 40% penetration rate, meaning that 40% of the patients who could benefit from blue light cystoscopy are getting blue light cystoscopy. It's a very high level. We have the active Hexvix markets. These are markets previously held by Ipsen. It's the DACH region, France and Benelux. We see a very good penetration in DACH, but the opportunity to grow to the Nordic levels of 40%.

We see France and Benelux are roughly at 10% penetration. More opportunity. Put a lot of effort in there. We have two untapped markets. One is the large EU markets, which is the U.K., Italy, Spain, and Poland, where either Ipsen had not launched into or they exited the market four or five years ago. We roughly call it about 0% penetration. We see tremendous growth opportunities in those markets. We have the untapped small EU markets, the Baltics, Czech Republic, Hungary, Ireland, Greece, Portugal. Smaller markets. 0% penetration yet. In all these markets, there is demand. There's the opportunity to work with any one of the three capital equipment manufacturers. What's interesting to know is that the European market is approximately the same size as the U.S. market in terms of number of TURBTs and deaths per year.

The opportunity is tremendous. We're looking forward to, as COVID begins to subside, really starting to accelerate penetration in these regions of the world. All the resources are committed for Hexvix. We went direct promotion on Next slides, please. On slide 22. Direct promotion initiated on the 1st of October went extremely well, seamlessly. We don't believe we lost any sales along the way. It was a light switched off for Ipsen and the light switched on for us. A tremendous job to the team on the Photocure side for really shepherding that through. We now have expanded the EU commercial team from the seven employees that once occupied only the Nordics to 27 that cover Pan-Europe. They came on board and are off to the races. Five very experienced country managers.

All the distribution channels were built, and I think most importantly maybe is that we consider that this segment is even a positive as a segment on its own and still has tremendous growth opportunities. Next slide 23. When you look at all the segments and markets together, you can see the tremendous opportunity that rests within the U.S. and the E.U. If we can reach the same levels of penetration as the Nordics, you can imagine the amount of revenue that could be brought in. We see this becoming the standard of care and reaching a potential in an addressable market of $1.9 billion. Said another way, we've got all the key success factors in place. We have the approvals in place, both surgical and surveillance. We have acceptance in all the major and local guidelines. We have the access of permanent favorable reimbursement.

We have activated awareness in that patients are demanding it, physicians are asking for it. Finally, the acceleration, which really rests on our side, the execution piece, which is getting the right people set up to do the job. Because of these tailwinds, we believe we're going to be extremely successful, and this is a growth story for the company. Despite COVID-19's headwinds this past year, we still had, I think, a remarkable year. Next slide. Let's move to the next slide 25. This is the deal with Asieris for Cevira. This is a value from a license of a non-core asset. Asieris, reminding everyone, is a Chinese subsidiary focused on genitourinary diseases. The product that they are licensing from us is Cevira. It's for pre-cervical cancer. It's a breakthrough single-use integrated drug device technology.

The terms of the deal had a total valuation of potential of about $250 million, and we're most pleased with the speed at which Asieris is moving. What's happened in the fourth quarter is basically they had first patient dosed on the phase III study, which was approximately eight to nine months ahead of what we thought the development pathways would be. We also were able to issue a new patent on the product to cover them out until 2034. Tremendous opportunities. We don't expect to hear anything really changing in this space, that are going to move forward and continue enrollments over the next year and year and a half. Next slide. We'll go to this next slide 27. Summary and guidance. The story is just continuing to execute. We're positioned for growth.

We had sales increase in Q4 in fiscal year 2020, year-over-year, despite the impacts of COVID-19 pandemic. A significant slowdown in April and May, recovery through the third quarter, and then as we experienced in the fourth quarter, and everyone knows across the globe, between the resurgence, a new strain of COVID, I would say the slower rollout of vaccines than we probably hoped, it has had a little bit of an impact on our performance. We've been able to place 45 Scope towers in 2020. We had a positive EBITDA in Q4. Our cash position grew to NOK 335 million from NOK 322 million last year. We integrated the entire European Hexvix acquisition and consolidated our rights worldwide to Hexvix and Cysview in all the major markets across the globe.

We now control the world and begin partnerships in markets that we don't want to go direct in. We managed through a very challenging year, but kept the team on board to recover sales as quickly as COVID lifts. The pandemic itself is not resolved, and so the long-term ambition guidance has been suspended at this moment until we get a clearer view on this second wave of COVID. New guidance will be issued when COVID is better managed and is in a decline, and I think despite all that, I think you can see very clearly that Photocure is well-positioned for a very strong growth post-pandemic, returning or exceeding our prior growth rates once the pandemic lifts and we have access, patients return to the clinics, and physicians begin performing the procedures. We'll go to the second last slide 28. The investment highlights for you.

Photocure has an established position as an innovative leader in a very large underserved market of bladder cancer. We believe we have a best-in-class product, Hexvix Cysview, that should be and will become the standard care in bladder cancer treatment. We're accepted on all the major treatment guidelines. We have reimbursement support in our major markets, and our penetration efforts are continuing. We have demonstrated commercial execution, will continue to do so. We believe there's a significant upside potential, not only in the U.S., where our relative penetration is 5%. If you can imagine, with a total addressable market valuation of nearly $2 billion, to get that to the Nordic levels would be multiples of $100 million. We believe we can get there one day. We also are quite pleased with the significant upside potential that we see in Europe.

Now we've gained rights, we're getting a clearer view of what the opportunity are and quite excited about that. Then we have the ROW, rest of world partnering opportunities, such as you've seen with Chile and China last year. Finally, our ultimate ambition is to grow organically and inorganically. We have plans to acquire new products, technologies, or businesses to build our bladder cancer franchise on a global level. I want to thank you. We'll go to the last slide, and I'll open it up for Q&A. Thank you.

Erik Dahl
CFO, Photocure

Okay. I got some questions on the internet here. First of all, the question is from Niklas de Flohn, "Do you expect any additional restructuring expenses Q1 2021?" I picked that question because it's a very simple answer. No. Next question from Rickard Anderkrantz. "Did you get scope placements in the Kaiser accounts in the U.S. in Q4? How is the progress with that account?

Dan Schneider
President and CEO, Photocure

We've begun the scope placements with Kaiser. It'll continue to roll out throughout the course of 2021. We're quite excited about the opportunity. I think that's one of several opportunities we have in the U.S. We also struck a deal with the Inova integrated delivery health network system in the D.C. area. That was another fantastic opportunity. We continue to incur more and more of these. It's beginning to gain its own momentum. We're excited about the opportunity. Again, there's limited access for patients nonetheless, and for physicians accessing it, for us to access, but we're quite pleased with the continued excitement on Kaiser's side to bring blue light cystoscopy to their patient base.

Erik Dahl
CFO, Photocure

Thank you. A question from Thomas Skåle, "Could you please elaborate on the likely cost development this year and beyond?" I'll do that, but I hate always to have to go back to the COVID-19 situation. If the COVID-19 situation as we see it now continues during the first half, I expect relatively limited cost changes or cost increases in the first half. We do need to staff up and finalize the staffing of the European organization, but it's limited how many medical programs and marketing programs you can run because we still don't have access to the customers in a 100% way. There is fairly limited travel cost, et cetera. Now, if COVID is reduced or disappears by the end of, or in the second half, I do believe to see a cost increase.

I do believe to see programs being started. I do believe to see activities increasing. It's not going to be an explosion. There will be a limited increase in cost. The European organization, we do need to staff up and finalize the building up. A question again from Rickard Anderkrantz. "Have you started to gain traction in large untapped markets in Europe?" You want to take that, Dan?

Dan Schneider
President and CEO, Photocure

Yeah, I can take that one. Yes, we have. Slowly. COVID, as you can imagine, with limited access to clinics, has limited our interactions. Yet we've been able to already commit and place some scopes, which is fantastic. Kits and involvement with the KOLs has been substantial. We expect that once COVID dissipates over the course of the first and second quarters of this year, we'll get in, and we'll be able to accelerate the sales. I think most importantly, we've been able to profile the accounts, identify the opportunity, and align our resources behind it for when we are back into those clinics to really drive sales.

Erik Dahl
CFO, Photocure

Okay. Question from Carl Norén. "What do you expect for in-market growth in the EU during 2021? I understand that this is hard to give a figure, but just more on a high level." We can continue what you just said, Dan, about the development on the growth markets in Europe. If COVID-19 retracts, we do expect to see an increase of in-market sales or volume in Europe. We do expect that. COVID makes it very difficult to give an estimate and a good insight into what's going to happen.

Dan Schneider
President and CEO, Photocure

I think I might add to that, Erik, if you don't mind.

Erik Dahl
CFO, Photocure

Yeah.

Dan Schneider
President and CEO, Photocure

As you think about the markets, both U.S. and Europe, despite COVID-19, there's nothing really selling against us. What's selling against us is our own efforts, and our efforts are predicated or depend on our access and getting into those accounts. As you can imagine, as access improves, we're putting a full force commercial effort and press on this, and we'll regain the momentum we had pre-COVID-19, if not more.

Erik Dahl
CFO, Photocure

To further add on that, Dan, given the increase of the blue light equipment in U.S., 45 new installations. We have a different starting point in 2021 than what we had in 2020. Definitely. Question from Niklas de Flohn, this will have to be one of the last questions. "Are you actively looking for acquisitions?"

Dan Schneider
President and CEO, Photocure

Yeah. The short answer is yes. We are. We want to find the right opportunity that adds value to you, the shareholders. That is something that's meaningful to patient care and physicians' treatment of those patients. You'll have to stay tuned. This is not something that happens overnight, but the process has begun with the identification and assessment of those opportunities.

Erik Dahl
CFO, Photocure

I got another question from Jon Henrik Lund this time. "Has there been any positive effects for Photocure during the pandemic?" I believe there has.

Dan Schneider
President and CEO, Photocure

I'll answer that one. I'll tell you what some of the positive things that come out of pandemics or any challenge in life. You find new ways of doing things either more efficiently or better or faster. We've had to think differently. We've had to be agile, one of our key values, in addressing a market that's changed on us overnight. I think we've done a pretty darn good job of that. We have the ability now to do virtual details or virtual visits with physicians, even into the OR settings where Zoom is turned around with laptops, and they're able to watch and guide the physician through the procedure. I think the other thing that's a positive is that COVID-19 has affected the way patients are flowing in and out of the clinics and in for procedures.

You can imagine, cancer didn't stop during the pandemic. It continued to grow. Patient may not have come back. As we go back to talk to physicians, we really highlight the idea that isn't it better to get that first TURBT correct with blue light cystoscopy, a very good, clean, perfect resection. Then if a pandemic or something interrupts patient care, you feel more confident that you've gotten everything you should have gotten, and that when they return, it hasn't progressed at a faster rate or that there's tumors that you've left in the body. Again, another positive outcome is it's been able for us to position our product in a much more important and prominent place in the physician's mind. There's been a lot of other, obviously, opportunities, but those are some ones that come to mind, just cold calling.

Erik Dahl
CFO, Photocure

Good. Regretfully, I have to stop here. I will keep a list of the questions that we still haven't been able to answer and try to get back to you guys.

Dan Schneider
President and CEO, Photocure

All right. Well, thank you.