Photocure ASA

OSE:PHO

Earnings Call Transcript 2021-Q2

[Daniel Schneider, President & CEO]

All right. Well, welcome. This is Dan Schneider, President and CEO of Photocure. With me today is Erik Dahl, CFO, and you've plugged into the Photocure results for second quarter 2021.Next slide. Just reminder, disclaimers are in fact for today's presentation. Next slide. Top line second quarter highlights. We've had progress in both commercial regions despite the continued pandemic, COVID-19. We had 66% revenue growth in the second quarter. That's 87% positive constant currency. EBITDA of positive NOK 5.8 million. We also had 3 key study publications. One of them actually emanating from our own U.S. registry, which is fantastic. And partnership activities continue with Asieris dosing the first patient for Cevira in Europe, [ pivots ] Phase III trial. And Genotests in Chile filed its MAA on a fast track review and expect more information as time goes on.Next slide. I'd like to give you a really quick COVID-19 update. Access restrictions continued due to the third and fourth waves. We're now entering into the delta wave, unfortunately, for the world. Access restrictions continued in most of the U.S., but large metropolitan cities have started to ease up a little bit. We've gone after those businesses. In Europe, severe lockdowns and restrictions continued into Q2. However, there has been successful interactions in established markets but does present unique challenges connecting with customers in re-launch markets going forward. The outlook for both regions, pending the handling by the authorities of COVID-19 Delta surge. There'll be continued interruptions through the second half, and it is expected to impact the second half business.Next slide. So the Cysview/Hexvix revenue development through the COVID-19 pandemic has now spanned 5 -- actually 6 quarters now. And it will continue for a while, we believe, despite the challenges. We're able to reacquire European business and successfully launch in those territories last year and expand our global brand. Our U.S. business was up in 2020 and continues to grow in the first half of this year while we contained our cost to keep the business well capitalized. I'm actually very proud of this performance. The chart demonstrates the resiliency of the business, and we are well prepared to take the next level as COVID-19 becomes less of a factor.Next slide. Next slide, we'll talk about the segments. All right. Q2 momentum. In the U.S., Q2 of 2021 started out slow due to COVID-19 resurgence. However, we had a 53% unit growth versus quarter 2 of last year and a 26% unit growth versus quarter 2 of 2019. This is a sequential nearly 20% unit growth versus Q1 of this year. Access restrictions began lifting in Q2. However, we caution that COVID-19 Delta variant has begun to impact the business once again. We expect momentum to continue in our contracting efforts, and I'm very proud to say that may produce the highest month of Cysview kits sold in company history.Next slide. So Q2, favorable trends in the U.S., exceeding pre-COVID levels, continued strong growth in the U.S. We can observe monthly volatility through 2020 and 2021. So it still remains a very volatile situation as we move through the COVID impacts. Next slide. The U.S. continued the Blue Light Cystoscopy placements. We've had 20 new tower installations in the first half of 2021. We placed 8 in the second quarter. However, there were component backorders that delayed the final installation of another 4 towers, which would have brought us up to 12 for the quarter.We are aware that Karl Storz is intending to bring a new imaging equipment upgrade expected sometime in 2022. We know that's due to the fact that they're offering multiple programs that ease the transition on obsolete protection plan, financing transition packages. Due to this positive development, some customers may choose to postpone purchasing new systems as we move towards the -- as we look towards the installation rates in the second half of this year and early 2022. However, I think for anyone who's been following our business for the past, I'll say a decade, the equipment that is on the market is quite old. This is standard definition technology. So we're excited and hopeful the new technology will further accelerate the business in the future.But right now, our focus is on driving more utilization, more physicians using it, more patients being treated by Blue Light Cystoscopy per installed tower, and we're continuing to build a strong pipeline of new accounts. The current pipeline looks very good, and interest remains extremely high. Many, however, are buying -- and many are installing and are buying the obsolescent protection plan. However, some are postponing purchases, we believe, in the second half.Next slide. The key initiatives to drive growth in the U.S. Continuing the contracting: ongoing contracts with large health systems and community-based urology groups. We have a strong foothold in the veteran affairs, where recent tower installations and pipelines building interest and demand with key VAs in the U.S. We have strong engagement in peer-to-peer interactions, particularly through non-personal promotional efforts. And we're expanding brand awareness, opening doors for sales reps through advertisements, mailers in building a lead generation machine.Next slide. Let's talk about Europe. Momentum is building in Europe. Second quarter unit, up 9%, catching up to pre-COVID levels compared to 2019, which I think is fantastic. Successfully reconnecting with leading KOLs throughout the European community. We have established cooperation projects with the capital equipment manufacturers with mutual training and action planning for the second half, now completed and ready for execution. There has been a change in trend, a positive change in trend in the large European future growth markets, including France, United Kingdom and Italy.Next slide. Favorable trend continues in Europe as well, but still some levels of uncertainty. We're back to pre-pandemic levels in Q2 with a slower start at the beginning of this year, but kept pace and exceeded the 2019 levels from March through June. So this is a positive development in Europe, showing that we have gained traction, and we're starting to pull out.Next slide. The large untapped European markets. We're reversing and stabilizing the key European growth markets. The change in trends in these large European markets of France and U.K. and Italy demonstrate the impact of Photocure's direct sales force in these markets. In fact, in the U.K., we had our installation and patients' first dose in over 10 years with a new installation of a Blue Light Cystoscopy in the last week. That's fantastic developments as things continue to improve throughout Europe.Next slide. So the key initiatives to drive growth in Europe. Establishing key advocacy: identifying the strongest advocates for Blue Light Cystoscopy, now that we are directly in the markets of Europe. We're working very, very closely with the Blue Light Cystoscopy equipment manufacturers, in particular, Richard Wolf-led cooperation opportunities and realizing common business interests. We're engaging with the key opinion leaders in building our own faculty and had our first advisory meetings. This is a group of experts that are out there educating about the advantage of the Blue Light Cystoscopy and developing centers of excellence throughout Europe that were once -- that were not there in the past.Next slide. I'll turn it over to Erik. Erik?

[Erik Dahl, Chief Financial Officer]

Thank you, Dan. Well, as usual, I will start with a financial review of our 2 main segments. It's U.S. and Europe, obviously. And then we will follow-up with the consolidated income statement, and we're looking -- we will be looking at the cash flow and the balance sheet at the end. Foreign exchange has again had a significant impact on our results for the quarter as well as year-to-date. In the first half year, measured as an average, U.S. dollar has declined 13% and euro 5% compared to the first 6 months of 2020. In short, the FX impact in Q2 or for Q2 was revenue being negatively approximately NOK 10 million, impact of NOK 10 million, which is about 11% of revenue. And for EBITDA, we had a negative impact of NOK 2 million. Year-to-date impact was negatively approximately NOK 14 million for revenue and for EBITDA, negative NOK 2 million.When we go through the financials, please keep in mind that unless other currencies specified, all amount mentions will be in Norwegian kroner or as I frequently say, NOK or kroner. Let's start with the segment view. I'm going to start with U.S. And we conclude that our sales are still impacted by the pandemic, but to a lesser extent than in the second quarter 2020. The company increased the U.S. unit sales in the second quarter by 53% compared to the same quarter in 2020, and revenues increased year-over-year with 131% to NOK 31.4 million in the quarter. Some of the growth was driven by an accrual of NOK 11 million taken in the second quarter of 2020 associated with the potential discount that we might have had to give. But a lot of it is obviously driven by the impact of the work that we're doing in the business.Foreign exchange has had a significant negative impact on our growth in the quarter. The FX impact in the second quarter compared to Q2 2020 was negative 16%, measured in dollars and adjusted for the 340B related accrual, the discount in second quarter of 2020. The year-over-year revenue growth in Q2 was 56%, which is 3 percentage points higher than the unit sales growth in the same period. Direct costs in the second quarter are in U.S. dollar at the level with second quarter last year. It's increasing 2% to 3%. In kroner, we have a reduction of 13% due to FX. Direct costs include local sales, its local marketing, local medical and also local G&A cost.We have on a number of occasions said that we are investing in the U.S. market. With COVID 19, however, it has been made no sense to increase these investments due to very limited access to customers. Therefore, cost containment has been and is important. As the pandemic loses grip, we should, however, expect increased activity level and expenses to drive further revenue growth. And we see the first signs of this in the second quarter compared to the first quarter 2021, we have an increase in operating expenses in dollars of approximately 6%. The contribution was negative NOK 1.2 million in Q2 and negative NOK 4.8 million in year-to-date. EBITDA was negative NOK 7.9 million in the second quarter, and this is an improvement from second quarter last year of NOK 17 million.Moving on to Europe. And that segment, we see that the European business is still impacted by the pandemic, but like U.S., to a lesser extent than in the second quarter 2020. In market unit sales in Europe in the second quarter of '21 increased 24% compared to the second quarter last year. This is a strong growth driven by added commercial resources since the reacquisition of the Hexvix business in Continental Europe last year. But obviously, the growth is also driven by lower sales in the second quarter 2020 due to the surge of the COVID-19 pandemic.By country, we find that unit sales in Germany, as well as priority growth markets like France and U.K. in the second quarter, was at level or higher-than-average quarterly sales in 2019 before the pandemic. Revenues in the European segment increased 44% to NOK 57.6 million in the second quarter. The growth was negatively impacted by a royalty true-up accounted for in the second quarter of 2020, which included an adjustment of NOK 13 million for royalty from Ipsen related to fourth quarter of 2019 as well as first quarter of 2020. Foreign exchange also had a negative impact on the growth rate. In the second quarter, FX negatively impacted European revenues by approximately 8%.If we adjust for the royalty true-up last year and the FX impact this year, the year-over-year growth was approximately 130% in the second quarter. It's driven by inclusion of the European business. It's driven by less impact from COVID-19, and it's driven by added resources in the European commercial organization. Direct costs increased year-over-year, NOK 18.6 million in the second quarter and sequentially from the first quarter with NOK 7 million. The increase both sequential and year-over-year is driven by the investments in the local European commercial structure. We expect to increase headcount and cost as COVID-19 results.During the pandemic, cost containment has been important, and we have deferred hiring and kept spending low without disrupting the business. We ended the quarter with a contribution of NOK 30.4 million and an EBITDA of NOK 17.7 million or 31%. This is lower than the second quarter of 2020 but driven by the royalty true-up accounted for in the second quarter of 2020. And that totaled NOK 13 million. And if you adjust for this royalty true-up, we have an EBITDA improvement in the second quarter of NOK 10 million.Let's look at the consolidated income statement. Total revenue, NOK 90.4 million for the second quarter, which is an increase of 68% from last year. Main drivers were the inclusion of the European business from Ipsen, lower COVID-19 impact than second quarter last year as well as overall growth of the business. However, the revenue growth was partly offset by an FX impact of approximately 11% in the quarter. Year-to-date revenue was impacted by the same drivers. But in addition, we have received -- we did receive in the first quarter, an upfront payment from Asieris of $750,000 or NOK 6.4 million.Operating expenses increased 29% in the second quarter compared to second quarter last year. Year-to-date, the year-over-year growth was 26%. Contributing to this increase was the investment in Photocure's European commercial organization required to support and drive the revenue growth in Europe. Total direct expenses in the second quarter for the European organizations were NOK 23 million, an increase of NOK 18.6 million from last year. And if you adjust for this investment, our operating expenses are at the level with last year, a result of cost containment throughout the organization, however, also helped by foreign exchange.Sequential growth in operating expenses from Q1 to Q2 was NOK 13.5 million, and again, very much driven by the European buildup of the organization. During the pandemic, we have maintained our policy not to reduce number of customers facing employees. We have maintained our sales resources. And as far as possible, maintain customer-related activities during the pandemic. It's our view that this will speed up the sales rebound as the build returns from the pandemic.Looking at the EBITDA. Second quarter, NOK 5.8 million, which is an improvement of NOK 14.7 million from same period 2020. Year-to-date EBITDA was NOK 24 million, again an improvement from last year, this time of NOK 13.7 million. The improvement is driven by increased revenue, including the inclusion of the European business as well as cost containment throughout the organization. Depreciation and amortization in the quarter, NOK 6.1 million. Year-to-date, NOK 11.9 million. Main cost item is the amortization of the intangible asset related to the turn to European business from Ipsen. In Note 6 to the accounts, we have explained the treatment of the intangible assets and goodwill from the purchase price allocation exercise.We had restructuring costs of NOK 3.2 million year-to-date 2020. The restructuring cost is related to the transition activities for the European business that we did last year. Net financial items. Net cost of NOK 7.3 million in the second quarter and a net income of NOK 0.8 million year-to-date. Included is the accrued interest cost for the deferred consideration to Ipsen, in total, NOK 5.7 million in Q2 and NOK 11.3 million year-to-date. Furthermore, and due to currency fluctuation, we incurred a net currency gain of NOK 15.9 million in the first quarter of the liability, which was partly offset by a currency loss of NOK 2.5 million in the second quarter. Again, I refer to Note 6 to the accounts for explanations.Tax expenses in Q2, NOK 3 million negative and year-to-date, a cost of NOK 8.2 million. Tax income and expenses related mostly 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 year-to-date a net profit of NOK 4.6 million compared to a net loss of NOK 26.4 million same period last year.Let's look at the cash balance and cash flow. Net cash flow from operations was positive NOK 8.4 million in the second quarter and NOK 0.2 million year-to-date, mainly driven by EBITDA and working capital development. Year-to-date working capital is driven by the inclusion of the European business, which is impacting, in particular, accounts payable and receivables. Cash flow from investment in Q2, negative NOK 6.9 million, and cash flow from financing in Q2, positive NOK 9.3 million. Both items were driven by IFRS 16 lease accounting. That gives us a net cash flow in the second quarter positive NOK 10.8 million and year-to-date positive NOK 5.3 million. And with this cash flow, we end the second quarter with a cash balance of NOK 340 million.Balance sheet. We end the quarter with total assets of NOK 777 million. Non-current asset was NOK 352 million at quarter end. This included customer relationship with NOK 154 million. Customer relationship 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 42 million. Customer relationship is amortized on a straight-line basis over 10 years, while goodwill is subject to impairment testing. Inventory and receivables were NOK 85 million at quarter end at level with Q1 and an increase from last year of -- end of last year of NOK 7 million. This is driven by the inclusion of the European business from Ipsen.Long-term liabilities, NOK 165 million include the earnout liability of NOK 128 million and a long-term interest-bearing debt, of which $25 million is due after 1 year. Total interest-bearing debt, including short-term part was NOK 50 million and is a loan secured from the state guarantee scheme for loans related to COVID-19. The loan is a 3-year term loan. First year is interest-only. Thereafter, quarterly repayments of NOK 6.25 million. The earnout liability totaling NOK 128 million represents the capitalized value of estimated future earnout payments to Ipsen. The liability is subject to 10-year annuity. And finally, equity at the end of the quarter, NOK 526 million or 68% of total assets.And this concludes my part of the presentation, and Dan will continue. Thank you.

[Daniel Schneider, President & CEO]

All right. Thank you, Erik. Nice job. Slide 19. So let's talk about the strategy for shareholder value creation. Slide 20, please. So our ambition is still to become the standard of care in this $1.9 billion total addressable market. We have low penetrations in most of Europe and the U.S. moving -- our ambition is to move those penetration rates to the DACH and Nordic levels. We believe the key success factors are in place with approval, acceptance, access, activated awareness, continued excitement around Blue Light Cystoscopy throughout the world and acceleration in our commercial investments, but smartly as we're coming through the COVID periods.Next slide. So how are we good? We're going to deliver transforming solutions, improving the lives of bladder cancer patients. Right now, we're concentrated on the acceleration in the expand phase, accelerating our current breadth and depth of Hexvix and Cysview. Expansion throughout geographies around the world. We also assess our current partnerships around the globe to make sure that they're delivering the value and the expectations and performance that we expect. We're now moving and thinking through the acquisition transformation stage. Looking at these, we're well positioned and ready to build a strong pipeline and execute on a roll-out strategy.Our confidence and success is based on really 4 things. We are an expert in non-muscle-invasive bladder cancer from R&D and clinical trials through the commercial. We've achieved a solid position among top KOLs and patient associations around the globe. Our strategy for Photocure is focused approach to portfolio expansion, starting with bladder cancer, whether it be the detection, diagnostic, surgical guidance or treatment of bladder cancer. And we don't -- and we believe no other company is dominating this space leaving a open territory for Photocure to fill. [Audio Gap]So anticipated milestones and corporate priorities moving forward. We are focused on regaining our prior sales momentum once the COVID-19 pandemic has lifted and in significant decline. I think we've managed it very smartly through this -- through basically the last 18 months. We anticipate another 6 months of impact from COVID Delta. We'll continue geographic expansion by penetrating many of the untapped European markets as well as looking for licensing or change in partnership throughout the globe. We'll execute on contracting with group purchasing organizations and large health systems throughout the U.S., leveraging our value-based pricing.We'll present and publish additional clinical data, some of them emanating out of our own patient registries on the advantages of Blue Light Cystoscopy with Hexvix and Cysview. We'll publish and also present at conferences and journals. We'll report on the progress of partner companies and projects, and we'll continue to evaluate the strategic product or business opportunities looking for add-ons to our current portfolio.Next slide. So in summary, final slide. We'll continue to execute despite the ongoing COVID-19 impact. We'll deliver a strong Hexvix/Cysview revenue growth, and we delivered a strong revenue growth in quarter 2 of 2021. We've achieved a positive EBITDA. Our cash position increased by NOK 10.8 million. We installed -- our partner installed, we supported 8 Blue Light towers. 4 were delayed due to component backorders. We do anticipate the second half to begin to slow as customers or partner prepare for a new version of Blue Light Cystoscopes to hit the market in 2022. But the good news is that the pipeline and interest remains extremely high.I like in this to -- if you're driving a car with no air conditioning, no radio for the last 10 years and every other car on the road has air conditioning and the radio, and now you have the opportunity to not only get air conditioning and a radio but power windows and everything else. So it's anticipated that the customers will anticipate this new system and may postpone the purchase for a few months until the new system comes out. In the meantime, we're focused on delivering and driving more units per scope that has already been placed. And that's through the key initiatives in both commercial regions and also through our licensing partners. And we believe we're well positioned and a strong position for post-pandemic growth.So with that final slide, I think we'll move to Q&A and turn it over to our Head of IR, David Moskowitz. David?

[David Moskowitz, Head of Investor Relations]

Yes. Just had to unmute. Thanks, Dan. I appreciate it. Great. So we'll look at the queue, and we will have our first question from Rickard Anderkrans from ABG.It's a 2-part question, Dan, so I'll read you the first part, and then we'll get back to the second. First part is on Karl Storz. Will they require a down classification from the FDA before launching the next-generation Blue light equipment?

[Daniel Schneider, President & CEO]

Answer is no. There is no down classification at this point. So they would initiate a PMA change. So this will not -- this doesn't start a down classification. It's just upgrading their system. But I will say that it has -- this has been something anticipated by Karl Storz for well over 4, 5 years. It is, as I've mentioned in prior presentations, being under a Class III PMA requirements, it is extremely costly, resource-intensive and complicated to upgrade the equipment. So the fact that Karl Storz is offering obsolescence programs and bridging financing programs leads us to believe that they're on the verge of a new system coming out, which this system that's on the market today is well over a decade old. This is unusual in the device world to have a piece of device on the market that long with no changes. So we're very excited about this development.

[David Moskowitz, Head of Investor Relations]

Great. Great. And following that, could you provide more details on what effects you expect from that hardware upgrade on a longer-term basis?

[Daniel Schneider, President & CEO]

I don't -- I won't guide on that exactly. But I will say that customers recognize that while Blue Light Cystoscopy has tremendous advantages, the visualization is a little bit short of the latest technologies on White Light with a high DEF. So our Blue Light is standard definition today, and this would be going to high DEF is our expectation. So this would be like watching the old boot tube TVs with a big concave or convex screens and now moving to a 5K High DEF plasma TV, much more crisper. And we think that will impact surgeon's ability to resect. They're going to see more -- see it clearer and maybe be even better job at resecting the tumors. So...

[David Moskowitz, Head of Investor Relations]

Okay. Very good. And we have another question from our analyst from Norne, Tomas Skeivys.What is the exact timing for the new cross stores equipment coming out?

[Daniel Schneider, President & CEO]

We don't know. To be honest with you, they have to -- we believe they're submitted to the FDA, but timing is dependent upon FDA approval. So what we're saying right now is this will be in probably early 2022. Again, all of this is pending FDA approvals.

[David Moskowitz, Head of Investor Relations]

Okay. Very good.

[Daniel Schneider, President & CEO]

Yes. Just let me add, that is why a lot of customers will still move forward with the current system and the obsolescence protection program is basically paying a slight premium to then get a automatic exchange for the new equipment when it comes out. So as I mentioned, it's going to slow, I think, some of the installation, at least, that's what we believe. We'll see what really happens. It could be that it doesn't do anything, but I wanted to be honest about that, that we anticipate a new system coming out, and it may have an impact over the next 6 months.

[David Moskowitz, Head of Investor Relations]

Okay. Great. And a follow-up from Tomas. Is the hardware upgrade applicable to both rigid and flexible scopes?

[Daniel Schneider, President & CEO]

This is rigid only.

[David Moskowitz, Head of Investor Relations]

Okay. We have a question, a financial question. When do you hope to reinstate the financial guidance for the company?

[Erik Dahl, Chief Financial Officer]

I wish I had a firm and good answer for you, really. What -- we're making forecasts, obviously, I'm trying to see into the future. But every time when we do that, I figure I'm making a forecast for COVID, not for the financials of Photocure. And I think that's a keyword. We need to have a stable situation with COVID before we can reinstate or give a guidance to the market. It wouldn't be fair otherwise.

[Daniel Schneider, President & CEO]

And that also includes foreign exchange, which is highly volatile at this time.

[David Moskowitz, Head of Investor Relations]

Okay. Great. Another question coming in. Just it would appear. Considering Photocure's long-term strategy, which I suppose is in process, can you elaborate further on your ambitions? Is it fair to suggest that the company should commit to more than just detection but rather include active treatment and the combat of cancer care?

[Daniel Schneider, President & CEO]

Yes. Yes. Absolutely. I did say it in the press today, so I probably circumvent the question ahead of time. But yes, if you think about a uro-oncologist treating a patient, there is a sweet spot. When that patient is first detected and diagnosed to the first TURBT followed on with surveillance, throughout that process, and there's a slide that's in our investor deck. It shows basically a grade square where the uro-oncologist is really performing some level of detection, surgical resections and/or treatment. And we think any product, tool or procedure that is done in that space is actually our sweet spot. Our key and our call point is the uro oncologist. So anything he or she uses is something that is a fair game for Photocure into the future.

[David Moskowitz, Head of Investor Relations]

Great. Thanks, Dan. Okay. Right now, I'm showing another questions in the queue. So why don't we give it 15 or 20 more seconds to see if any come in? Otherwise, we'll wrap it up. Okay. It looks like that's all we have this morning in the queue. So Dan, I'll turn it back to you to closing remarks.

[Daniel Schneider, President & CEO]

Okay. Well, I want to thank everyone for joining us today. We're very pleased with the performance, particularly over the last 18 months through COVID. If you look at the organization, it's in a very, very strong position. I've been very clear, we have managed ourselves quite well. When COVID lifts and it's lifted, it's ebbed and flowed throughout the last 18 months, we were there ready to capitalize on the reopenings, and we are there again. And I think that bodes well for us. Had we taken drastic cost-cutting measures, reduce commercial effort, et cetera, we would be in a very, very different position today. So I feel very, very confident where we're -- where we are and where we're heading, and I'm excited about the future, the second half of this year and into 2022. So look forward to speaking to everyone again soon. Thank you.