Edited Transcript of PHO.OL earnings conference call or presentation 7-May-20 1:00pm GMT

OSLO May 8, 2020 (Thomson StreetEvents) — Edited Transcript of Photocure ASA earnings conference call or presentation Thursday, May 7, 2020 at 1:00:00pm GMT

Well, good afternoon to everyone in Norway. It is 9 a.m. in the U.S., so good morning on my end. Welcome to Photocure’s results for first quarter 2020. I’m Dan Schneider, President and CEO. Joining me today will also be Erik Dahl, CFO.

Next slide. The usual disclaimers are in place for today’s presentation.

Slide 3. So I’m going to take you a little bit through who we are. We’ve got a lot of new investors who’ve joined the Photocure family. So I’ll tell you a little bit about the company and a little bit about the product, and then we’ll get into some of the results. Photocure at a glance, we have our corporate offices in Oslo, Norway with a U.S. office in Princeton, New Jersey. We are a commercial stage pharmaceutical company focused solely on bladder cancer with operations — direct operations in the U.S. and the Nordics and partnerships around the world.

Our revenue growth is in excess of 23%, and we have over NOK 330 million in global in-market sales. Our market cap today is approximately NOK 1.7 billion and average trading volume, significant liquidity at 649,000 average 3 months. There have actually been over 0.5 million patients treated with our product to date, and we continue to see accelerated growth around the globe.

Slide 4. So our mission is to deliver transformative solutions, which improve the lives of bladder cancer patients. And we see this really in a 4-step strategy. The first is accelerate, and that’s the part that’s been going on for the better part of the last 8-plus quarters. We’re driving the breadth and depth of Hexvix and Cysview usage in all the key accounts, growing our business.

The next step is expansion, generating sales in new geographies and some of the partnerships that we will form around the world or in the case of the recent acquisition in Europe directly. And also, continue to look for ways to enhance the value of Hexvix and Cysview, which we’ll talk about later in today’s presentation in terms of potential all the uses or life cycle management.

The third step is acquire, whether it’s partnering or in-licensing synergistic assets that strengthen our overall portfolio or acquire companies of products in the bladder cancer space.

And finally, transform, building a global bladder cancer company with pipeline and partner acquisitions for the future. We believe that this platform will be the foundation for transformative deals and value growth over the long term.

Slide 5. A little bit about the disease that we’re treating. It’s one of the largest unmet needs. In fact, if you go back 5 to 10 years, there’s been very little that have been done in this space, and many of the old ways of treating bladder cancer had not been changed. But that has changed of recent. It is the ninth most common cancer in the world with over 0.5 million new cases diagnosed every year and over 200,000 deaths, of which primarily 75% are males. Surprisingly, to many, it’s the #1 most expensive cancer in the world to treat. And in the U.S. alone, over USD 5.7 billion are spent treating cancer. The reason for that is a high reoccurrence rate. 61% of the patients diagnosed will have a reoccurrence in the first year and 78% will have a reoccurrence within 5 years. It’s on long ongoing treatment process.

The progression is probably even more disturbing. Progression from non-muscle invasive, which is treatable, to muscle invasive where it becomes very, very serious can range up to 50%, making it very dangerous cancer over time. And overall, it’s debilitating. It’s a lifelong follow-ups with repeat surgeries and cystoscopies and potential for urinary dysfunction, patient fears, anxieties and confusion.

Next slide. Slide 6 speaks to the patient journey and how a patient gets diagnosed. It begins with some sort of cytology. It could be blood in the urine for symptoms. It could be blood in the urine, it could be pain, discomfort, et cetera. The patient will find themselves going to a physician, urologists, who will then scope them in the outpatient setting to see if they see anything that’s suspicious. This is done under white light. It’s also the setting in which we are not indicated. I often get asked that question why did they not use Blue Light in the very first cystoscopy. Primarily, we’re not indicated for that. But secondarily, about 80% or 85% of patients that come into that very first diagnostic cystoscopy are not bladder cancer patients. They have other issues. If there is something suspicious, the patient is then brought into the emergency room, over to the far right where you see the orange circle. In the operating room, the transurethral bladder resection takes place in which they go into the bladder and look for what they found as suspicious and see if they find any other cancer or capillaries. Assuming they do, they will then resect or cut those cancer bleedings out, and then they will save the patient and determine what type of treatment regime and follow-up they will need. The patient will then be put on to a long-term surveillance calendar, depending on how they rank, whether it’s high, low or medium grade, would determine how often they need to come back to see the physician for an in-office surveillance cystoscopy.

In the OR, about 700,000 procedures are done between Europe and the U.S. In the surveillance setting, another 1.6 million procedures are conducted, continually surveillancing and looking for bladder cancer. It is in these 2 settings where we believe Blue Light Cystoscopy can have the greatest impact. We believe it should be used for the first surgical treatment when in their first thought to have bladder cancer and for all intermediate and high-risk, non-muscle invasive bladder cancer patients during surgical treatment and surveillance and follow-up, a tremendous market opportunity and an ability to make a tremendous impact on patient care.

Next slide, Slide 7. Slide 7 depicts the product. And I like in this sales model, this business model to the razor blade business model. To the left is Hexvix/Cysview. It’s taken up selectly by cancer cells in the bladder when it’s instilled an hour prior to a procedure. Under Blue Light, it glows bright pink, giving clear margins and surgical guidance. To the right is a tower in a cystoscope. In this case, it could become — it could come from Karl Storz, Wolf or Olympus who provide these. In the U.S., it’s Karl Storz only, who’s indicated in the U.S. However, rest of world, it could be any one of the other 3 manufacturers. It’s a combination of these 2 drug device pairing up that provide the Blue Light Cystoscopy capabilities, and it gives us a better visual contrast between the benign and the malignant tumors.

Slide 8. And this is the difference, and this is why it makes a big difference in patients’ care. The picture to the left on this slide depict a patient, who under white light, which has been the standard of care for years and years, it seem to have no cancer. There would be no concern, and that patient would be sent home believing they’re cancer-free. But under Blue Light, with Cysview or Hexvix that had been instilled an hour prior, you clearly see that there is cancer in the walls of the bladder. What’s the risk? Well, the risk is that 20% to 35% of cancer patients will be missed if Blue Light Cystoscopy had not been used. Furthermore, the risk could be the wrong classification leading to the mismanagement of the disease. A patient can go home believing that they’re cancer-free and be told that they’re low-risk patient only to find out that they have CIS, carcinoma in situ, which is a very flat lesion, which actually is depicted in this picture, very, very difficult to see under White Light and only under Blue Light Cystoscopy with Cysview or Hexvix can it really be seen completely. So a real risk for the patient. Or an incomplete resection of bladder tumors, leading to increased recurrence and progression. If you recall, back on Slide 5, I talked about the reoccurrence rate upwards of 50% and progressions — recurrence up to 80% and progressions 50% of the time to get to muscle invasive. This is where we believe Blue Light should and can become the new standard of care in treating patients with non-muscle invasive bladder cancer.

Slide 9. Slide 9 is probably one of the most important slides to drive home this importance of Blue Light Cystoscopy in the role it can play in patients care. It provides an accurate and complete first TURBT, which is critical for patient outcomes. On the right side of this slide, you’ll see the non-muscle invasive bladder cancer, NMIBC, and the 5-year survival rates look pretty good, 88% to 98% or better. To the right of that, in red, is muscle invasive bladder cancer. Once the cancer gets deep into the muscle tissue, their survival rate plummets to as low as 15%. It’s deadly.

On the lower — underneath the bar chart is a graph with basically the stages of cancer, low, high T1 and CIS, carcinoma in situ, which I mentioned is the flat lesion, which is very, very difficult to see under White Light. Look at the progression in reoccurrence rates. CIS alone, which, again, this is best seen and visualized under Blue Light Cystoscopy, has upwards of a 73% reoccurrence rate and over 50% progression to muscle invasive bladder cancer. Saying that again, 50% chance that a patient with CIS will progress in muscle invasive bladder cancer with a survival rate that could plummet to 15%. It’s here where we believe Blue Light Cystoscopy can make the most dramatic impact on patient care.

So now you understand a little bit about the company and the product, I’m going to turn it over to Erik, who will move to Slide 10 for highlights in the financials on Q1. Erik?

——————————————————————————–

Erik Dahl, Photocure ASA – CFO [2]

——————————————————————————–

Thank you, Dan. Well, in this part of the presentation, we will first walk through the major highlights from the first quarter and into the second quarter. We will then look at the financials, and finally, look at the main financial terms agreed with Ipsen.

So let’s start Slide #11, looking at the highlights, and it’s definitely been some eventful months. And it was topped by the 27th of April with the agreement with Ipsen Pharma. We agreed on key terms for the return of Hexvix sales, marketing and distribution rights in Europe and other markets currently controlled by Ipsen. We’re taking direct control of our Hexvix/Cysview in key regions. We support the ambition to — of becoming a global leader in bladder cancer with a solid basis for expansion and further growth opportunities. We are taking back a profitable business with a great growth potential, and we expect the deal to be EBITDA accretive already from 2021.

On the product side, we announced in February that the United States patent and trademark office granted a U.S. patent covering the use of Blue light Cystoscopy with Hexvix/Cysview as new adjuvant therapy in the treatment of bladder cancer in patients who are scheduled for cystectomy. And Dan will review this later in the presentation.

We are working closely with our key opinion leaders, patients, organizations and customers to generate media coverage for our products in the U.S. We are getting significant attention, and the last evidence of this was the coverage in Fox News L.A. in January. Dan will, later in the presentation, give an update on Asieris, our license partner for Cevira. We did in first quarter received $1.5 million, which is according to contract and adding to our cash balance.

Looking at the financials, some starting comments. We will look at the financials for our 2 segments, obviously, followed by the consolidated income statement, the cash flow, and finally, the balance sheet. And given the volatility in the currency market, it makes sense to first add a couple of comments on the currency impact on our income statement for the quarter. The FX impact in first quarter was for revenue positively, approximately NOK 4 million. And for EBITDA, it was neutral. So this reflects approximately 8% of revenue as well as 8% on operating cost.

Moving on to Slide #12, segment reporting. I’ll start with the commercial franchise. And the headlines for the commercial franchise in the first quarter are that we will continue — we are continuing the strong revenue growth in U.S. We are, however, impacted by COVID-19 at the end of the quarter. Expenses are at level with fourth quarter 2019 in constant currencies. Year-over-year increase from first quarter 2019 was about 8% in constant currencies. As in previous quarters, the trend with declining growth rates continues.

Total Hexvix/Cysview revenue in first quarter increased 6% compared to first quarter last year. In constant currencies, we had a small decline, about 2%. In-market unit sales decreased 1% in the first quarter. We continued the strong growth in U.S. In U.S. dollars, we had 21% revenue growth in Q1. This was driven by growth in in-market unit sales of 17% for the quarter. The numbers were impacted by COVID-19 at the end of the quarter.

U.S. is the largest and fastest-growing region for Photocure with a revenue growth driven by improved productivity as well as added sales resources. Furthermore, we have had significant growth in installed base of Blue Light Cystoscopes. A total of 238 blue light cystoscopes were installed at the end of the quarter, which is an increase of 15% in the quarter and 60 — of 15 units in the quarter and 67 units or 39% over the last 12 months.

Nordic revenues decreased 7% in the quarter. The decline was driven by large deliveries to hospitals in Denmark at the end of last year as well as some impact of COVID-19, which was at the end of the quarter. In Sweden, the development has been very positive, with first quarter being the best quarter ever.

Revenues from our partner business decreased 18% in Q1. The decline is mainly driven by building of COGS to partner and is expected to be adjusted for in the second quarter. Unit sales decreased 2% in the quarter. We had another quarter of growth in Germany with unit sales reaching all-time high. Total revenue, including milestones and other sales, increased 5% in Q1. Other revenues in Q1 2019 include IFRS 15 adjustments of NOK 0.8 million. We had no such adjustment this year, which explains the difference in other revenue.

The operating expenses, excluding depreciation and amortization, increased year-over-year, 16% in the first quarter. The growth includes 8% currency impact. So the growth rates in constant currencies continues to decline as it did last year.

EBITDA for the commercial segment was negative $3.5 million in the first quarter. And obviously, the EBITDA is impacted by COVID-19.

The financials for our development portfolio is driven by the license agreement for Cevira with Asieris. Last year, we received $5 million signing fee payment from Asieris as per the agreement. In addition, we accrued revenue of 2 development milestones totaling $3 million, which are committed and timed. The fees from Asieris is accounted for according to IFRS 15. Revenue recognition in 2019 was, therefore, based on contract value of $8 million, applying the currency exchange rate at time of executed contract. We received $1.5 million of the accrued milestone in the first quarter, obviously impacting cash flow but not revenue for the quarter.

Operating expenses continued to decline. The reduction from last year was NOK 1.9 million or 59% in the first quarter. And 2019 expenses included the impact from one-off costs related to signing of the license agreement with Asieris later in the year.

Moving to Slide 13, looking at the consolidated income statement. I will use this slide to add a few comments on the operating — or to the operating costs for the consolidated company. Operating costs increased year-over-year 11% in first quarter. The increase was driven by an 8% currency impact in the quarter, leaving about 3% increase in constant currency. This is mostly related to commercial costs and program expenses. The increase from fourth quarter 2019 was 1%, and in constant currencies, a decline of approximately 3%. This is to some extent also reflecting cost-reduction initiative due to COVID-19.

Q1 EBITDA was negative NOK 4.8 million compared to negative NOK 1.5 million in Q1 last year.

Depreciation and amortization were at NOK 3.9 million. The main single item within depreciation and amortization is the amortization of the investments in the Cysview Phase III program. This item has a quarterly amortization of 2 — or has a quarterly amortization of NOK 2.5 million. This project is closed, and the remaining amount net after amortization is NOK 7.1 million. This will be fully amortized by the end of 2020.

We had restructuring cost in the first quarter, NOK 1.9 million. The restructuring cost relates to the work performed in connection with the agreement with Ipsen.

Net financial income, NOK 5.7 million in the first quarter driven by foreign exchange gains in the quarter.

We had significant tax expenses in first quarter. This is related to our tax asset and tax loss carryforward in the parent company. In other words, it’s not tax payable. The amount is driven by significant profit in the parent company, partly driven by currency gains. After net financial items and tax, we have in Q1 a net loss of NOK 17.7 million compared to a net loss last year of NOK 4.9 million in the first quarter.

Let’s look at the cash flow, Slide #14. Net cash flow from operations, positive NOK 3 million in the first quarter compared to negative NOK 15.7 million last year first quarter. Improvement was mainly driven by milestone payments from Asieris of $1.5 million as well as less outflow from working capital in the quarter. The impact from changes to working capital for the quarter was negative NOK 6.6 million compared to negative NOK 12.5 million first quarter 2019.

Cash flow from investments, small amount, negative NOK 0.4 million compared to positive NOK 0.5 million in 2019. And cash flow from financing, also a small amount, negative NOK 0.4 million compared to negative NOK 0.2 million last year. And the cash flow from financing is mainly driven by payment of lease liability, which is a result of IFRS 16.

Net cash flow, positive NOK 2.2 million this year first quarter compared to negative NOK 15.4 million first quarter last year. And this gives us a cash balance at the end of the first quarter of NOK 127.6 million.

Some words about the balance sheet. At the end of first quarter, total assets, NOK 240 million; included cash, totaling NOK 128 million; noncurrent assets, NOK 54.6 million at quarter end, includes a tax asset of NOK 25.4 million and investments in tangible and intangible assets totaling NOK 11.3 million. And these investments are mainly related to intangible assets from the Cysview Phase III program. We also find an other line totaling NOK 17.8 million as part of noncurrent assets. This relates to the remaining NOK 1.5 million receivables at Asieris. In addition, other line includes the balance sheet impact of adoption of IFRS 16 on lease accounting. And we have a similar increase in long-term liabilities also driven by IFRS 16. You will find an explanation to these amounts under Note 8 to the accounts.

Inventory and receivables declining from year-end, now at NOK 57.8 million compared to year-end of NOK 61.6 million. In terms of fundings, as previous quarters, no interest-bearing debt and an equity of NOK 190 million or 79% of total assets.

As a summary of the financial part of the presentation, I have 3 items. First of all, we continue our revenue growth in the U.S. with year-over-year revenue growth of 21% measured in U.S. dollars and a unit growth of 17%. The growth is lower than the previous quarters, driven by COVID-19 last weeks of March.

Secondly, looking at our operating costs, these have remained relatively stable compared to last quarters. We have a decline compared to fourth quarter 2019 and a growth measured in constant currencies of approximately 3% compared to first quarter last year.

And finally, we had a positive cash flow in the quarter, and we are ending the quarter with a cash balance of NOK 127.6 million. This cash balance, together with the equity issue in April, has given us a solid balance sheet, enabling us to take control of and develop the European business from October 1 this year.

And this drives us to talk a little bit about the Ipsen deal. As you know, we have signed a term sheet with Ipsen. And the term sheet defines the key financial terms of the agreement that — an agreement that the parties are working on now.

I’m at Slide 17. Looking at the key financial elements of the term sheet. First of all, what Ipsen will return? Ipsen will return all rights to Photocure, sales, marketing and distribution for all markets currently controlled by Ipsen.

Secondly, when will Ipsen return the rights? The transfer will be October 1 for the main countries, and we are together developing a transition agreement as well as a transition plan to ensure a smooth and controlled transfer. Countries that are currently not commercialized by Ipsen will be transferred upon signing of the agreement. This may be interesting for us to — it may be interesting for us to get control as soon as possible. As you know, there are potential partners out there, which might be interested in some of these countries.

And finally, what Photocure will pay? We will pay Ipsen EUR 15 million on the date of transfer, meaning October 1. And furthermore, we will pay Ipsen an earn-out of 10% to 15% the first 7 years and 7.5% the next 3 years.

This deal will completely change our financials. Overnight and before impact from any improvements, our revenue will increase with around 50%. We will have a balance sheet and a cash flow, which will enable us to have another view on how to structure and optimize our funding, including debt.

And this concludes my part of the presentation, and Dan will continue by discussing the European opportunity.

——————————————————————————–

Daniel Schneider, Photocure ASA – President & CEO [3]

——————————————————————————–

Okay. Great. Thank you, Erik. Exciting from a financial standpoint. As we turn to Slide ’18, it’s even more exciting from a strategic and value creation standpoint. I am extremely excited about this opportunity, and I’m going to take you through a few slides as to why I’m really excited about this. I’m glad that we’ve gotten this back from Ipsen. It was priority 1 nearly from day 1 when I started the company 17 months ago. It had lots of fits and turns to get here, but we’re here. And we’re on the eve of something really, really transformational for Photocure.

So from a strategic standpoint, we’re going to have the ability to apply the commercial success and strong growth that we are currently having in the U.S. to the U.S. and European — to European market. We have deep knowledge of this product and disease state. So our minimal learning curve, it’s not as if we acquired something we have no understanding of. We’re, in fact, basically getting our own baby back. We’re leveraging our international expertise. As you know, we have partnerships around the world. We understand the international markets. We have partnerships with the Keppel equipment manufacturers, very, very strong relationships with them. Ipsen did not have strong relationships with them, so we feel there’s a really strong possibility and actually a commitment already that we will be leveraging each other to explode in the European market. We have the ability to build a scalable business and a platform for future acquisitions and growth, exciting. When you look at Photocure prior to this acquisition was pretty much a U.S. Nordic company, very difficult to entertain acquiring companies or products or doing partnerships when you can only pick and choose certain countries. But now to say that we have a global presence in the major markets, Europe and U.S., is very powerful. And again, this builds on our credibility of becoming a true bladder cancer company on a global scale.

From a value creation opportunity, we expect revenue growth targeting in excess of 20% to 30% annual growth in the current Ipsen territories. Some of those territories will grow at over 100% based on where they’re at today. Some of the more mature ones, such as Germany, may be growing in the single digits. But nonetheless, the totality of Europe will grow nearly 30% year-over-year in the near term. We expect to be EBIT accretive starting in 2021, so it’s already a profitable business for us.

The European penetration, which is unfortunate that we’ve had to weather this for these many years, but fortunate from the standpoint of opportunity for us, is that the overall penetration is basically under 5%. That excludes Germany, Switzerland and Austria, where they’ve done a much more robust effort and have maintained that business. But for the rest of the opportunity, it’s under 5%. We see an ability to grow that to the Nordic levels of 40% penetration.

And then we’re going to do this through focused European investment and maximizing our revenue returns. Most of what we need to build in Europe are revenue-generating positions, sales and marketing positions. We don’t see ourselves adding tremendous amount of infrastructure to support this business, so it should be highly leveraged by the sales forces.

And in addition to this, in the agreement, we are intending to bring over the sales reps from Germany. And this is extremely important in a deal like this because Germany represents about 75% to 80% of the total revenues and all the profitability of the European market to date. And getting those reps who have the relationships already in place and the business already established is an important part of this transaction, and we’re excited for that to happen.

Let’s go to Slide 19. This is — it depicts a little bit more clearly as to where we are in terms of penetration. Nordics, 40% penetration. We’ve commercialized that directly ourselves. In Europe, the penetration in non-DACH countries, as I said, is under 5%. That includes Spain, Italy, U.K., et cetera. And then there’s a tremendous amount of countries where the penetration is essentially 0 or approaching 0. And in some cases, in the case of the U.K., we’re on the guidelines. And at one point, there was commercial effort and sales — 2 sales reps there. They have since, over the course of the 3 or 4 years, have withdrawn the sales efforts, withdrawn the commercial efforts, and that business has basically dwindled back down.

In addition, what’s really positive news as well, and I don’t think most people understand, when GE commercialized for Photocure back in the early 2000s, they actually had placed over 700 blue Light cystoscopes throughout Europe. We know that up to — at least up until last year, Ipsen had focused in on around 200 or so accounts, it’s even that, and most of those were focused in Germany. So we know that there are over 500 cystoscopes deployed throughout Europe that need to be reignited, and we need to find the urologists to basically champion this procedure back into their clinics. And we’ve already had a reach-out from a major worldwide KOL in Spain who’s wanting Blue Light Cystoscopy to be brought to Spain. So this is exciting, exciting developments.

From a market size potential, Europe has 165,000 new cases a year and over 50,000 deaths. In the U.S., about half that size and about half the deaths. From a procedural standpoint, though, they’re fairly equal, around 350,000, 315,000. The price, there is a difference, obviously. Hexvix in Europe is about half the price of the U.S. price. Germany has the highest penetration. In the U.S., we are now moving into the 5% to 10% penetration range. And those of you who have followed us for the last 7 to 8 quarters, you’ve seen tremendous growth rates. That penetration continues to pick up, and the momentum continues to build and accelerate. We’ve added growth rates in excess of 35%. And I think what was lost a little bit in the financials for everyone in the first quarter is our largest month ever was February in which we had well over 60% growth year over prior year. And that, I think, points to a lot of what we have put into this business in 2019 to get it prepared for 2020. Albeit COVID has entered the scene, it’s a temporary situation, one which we think will return back to normal.

Let’s go to Slide 20. Slide 20 shows you about what we’ve witnessed with Ipsen and actually, in fact, our own Nordics. And as many of you know, we’ve made changes commercially inside Photocure. We have a new head in Nordics. That slight drop from 43% to 40%, most of that is actually happened in Denmark, but we have tremendous opportunities in the other countries as well, and we’re starting to see that impact right now. But what’s really interesting is if you take a look at that curve for total EU running at around 15% to 16% for the better part of 5 years, that penetration rate has stayed flat. And if you look to the right, you can see where the handoff of GE and the trajectory they were on, and then it was handed off to Ipsen, the trajectory that they took off on. Initially, they started growing. But if you actually place that trend curve or trend line over the last 4 or 5 years, it’s absolutely flat, if not decreasing. What’s really covered up here is the fact that Germany continued to grow, and it’s a large market, and it covered up the rest of Europe that was slowly dwindling away. So we see tremendous opportunity. As I said, Europe, we believe we can get it up over time up to the penetration rates of the Nordics.

From — Slide 21. From a synergistic opportunity, we believe we can leverage all of our internal expertise. From an organization standpoint, we’ve already identified a European General Manager. We will be announcing that individual. We’ll also — she or he will be leading an organization of 20 FTEs, our full time equivalents. Most of them, as I mentioned, are sales individuals, maybe a market or 2 and maybe 1 finance person to support, count the money bars. It’s supported — most of it will be supported by the global functions, such as training, medical and marketing programs that we already have in place. So we’re not having to build those from the beginning.

From a scalability standpoint, we have the infrastructure, the synergies and the global approach and the consistent global brand that we’ll bring into the market. We’ll implement all the best practices that we’ve learned in the U.S. and the Nordics, and we’ll leverage those across the globe.

From a strategy, it’s very simple in Europe. We’re going to drive the use of Hexvix in the existing clinics. And as I mentioned, there’s approximately 500 cystoscopes deployed that we need to go find and we need to get lift back up and get them treating patients with Blue Light Cystoscopy. We’ll also be looking to expand the number of clinics. Partnerships with Karl Storz, Olympus and Wolf, we believe we can grow the business in Europe and open up more accounts.

Increasing our KOL efficacy and engagement. I think the engagement from Ipsen — if you think about Ipsen, and I don’t want to malign them so much because, honestly, they were focused on their other businesses, small molecule pharmaceutical business. Hexvix/Cysview is a very unique drug device combination. It’s a pharmaceutical product that sells like a device, so it requires sales, service and support. It requires effort, but that effort has tremendous returns. And they didn’t engage probably at the level that you’ll see us engage with the KOLS, the advocacy groups, the patient support groups if they exist, and things of that sort, so — and also putting effort into the market access piece of this. Market access looks good in Europe. As anything with market access, you always are working to improve it. Whether it’s on a country level or not, you always have to be vigilant in this space as we are in the U.S. as well.

And then from a culture and ambition standpoint, the organization over the last 18 months has really transitioned to a really forward-leaning performance-based culture dedicated to commercialization of Hexvix and Cysview and the bladder cancer market in general. We have ambitions. We’ve been driving change, and we intend to become a global player in bladder cancer.

So let’s get into Slide 23 in terms of positioning ourselves for growth and why I’m so excited about this. Slide 23, again, 9 consecutive quarters of record growth in the U.S. Even despite COVID this last quarter, we were able to increase our revenues.

Slide 24, I think is an important slide for everyone to kind of look at because I get often asked, “Dan, you’ve got a lot of cystoscopes out there. What’s going on? How are these translating into business?” I think you have to really pause and think about what’s happened over the last 8 quarters and how many cystoscopes have been placed compared to the years prior. In fact, if you look at 2012, on the left side of this slide, 23 cystoscopes claim to have been installed. However, 17 of those came straight out of the clinical trial. So really, the installation was 6. On average, they average around 14, 15 every year until 2018. 2019, we have exploded with an average of around 15 to 16 placements per quarter. First quarter 2020, we are right on track with the same average around 15. I will say that COVID will impact the installations, at least in the near term, as hospitals have focused in on the resources needed for treating COVID. But nonetheless, we are still placing them. In fact, we have a major institution in Buffalo, New York, Roswell, who has purchased a flex and 6 scopes to go with it. They intend to do a lot of surveillance up in that big medical center. We also have, as I mentioned in the past, Kaiser, has completed their evaluation. And just as of a couple of weeks ago, they gave us the green light, so we now have the license to hunt in all Kaiser institutions across the country. This is huge because Kaiser is a closed system. You cannot go into a Kaiser system without the corporate office allowing you, which means you have to get evaluations and you have to have their blessing to go and sell your products there. We have that blessing. And Kaiser is a bellwether type of account where if you can get Kaiser, you have a story to be told to all the other major IDHNs, Integrated Delivery Health Networks, across the U.S. So we see that as a second half and onward opportunity for Photocure.

So overall, I’m excited about where we are. I think you’ll start seeing the cystoscopes. COVID may affect the number of installations to a certain degree, but it doesn’t mean that we don’t have opportunity here to drive more units per scope, and that will be our focus throughout 2020.

On Slide 25, we take a look at the relative size and value of the markets. And what’s really interesting here is we said, for the U.S., these 5 key success factors had to be in place. We had to have the approval for surgical and surveillance in the U.S. We have that in Europe. We said we have to have acceptance on major and local guidelines. We had to have that in the U.S. to be successful to accelerate the business. We have that in Europe. For access, permanent and favorable reimbursement was important to the U.S. It’s equally important to the Europe. And for the most part, we have permanent and favorable reimbursement in Europe. It’s a matter of us going after it. From activated awareness, we have patient demand. We have KOL demand. We have physicians asking about Blue Light Cystoscopy. It’s a growing interest among uro-oncologists. And finally, accelerate. The only way we’re going to accelerate the business in Europe is to invest in it, and we’re going to do that and do it the right way.

On Slide 26, real quickly, global supportive environment and awareness. You’ll notice I added a few more of the major guidelines that support Blue Light Cystoscopy, including Germany and France, major markets. Again, reemphasizing that we are a standard of care — can and will become a standard of care for the detection and management of bladder cancer. We have high adoption rates in the U.S. in all the major cancer centers. We have patient preference and growing awareness, favorable reimbursement. And we are a strong partner with BCAN, who is a patient advocacy group in the U.S. We’ll look to build similar relationships with advocacy groups in the rest of world.

Slide 27. This speaks a little bit to the expand. Earlier in the presentation, I talked about expanding geographically. Also, I talked about expanding the use of our own product. And this was announced earlier back in 2019, where we have some early results showing there may be direct antitumor effect in immune cell activation by Hexvix/Cysview. What this means is that [primarily] is a diagnostic, but potentially could have some level of therapeutic effect. We’ll continue to investigate that, not really ready to commit to a trial nor do you necessarily need a trial to be successful here. What you need is evidence that this may, in fact, have an effect on patient care.

And then the other thing is we’re going to look for ways for enhancing the detection and a physician experience in the use of Hexvix and Cysview in combination therapy. So basically, enhancing our own product and coming out with the next versions that are better than the last version.

Slide 28, IP protection strategy.

29, this slide, I think is very important for everyone to understand. It was a key, key focus last year as we looked at our products both coming off patent. It came off patent in Europe in September, it will come off patent in November in the U.S. this year. I am sleeping as sound as a baby because of these 5 strategies we have put in place over the course of the last 18 months. First, from an IP and Intellectual Property standpoint, we carry multiple patents. We have other patents still pending. You’ve seen the recent patent that is orange book listed. We have the regulatory data protection on the flexible use — on the use of Cysview in flex in the U.S. So we have — we feel like we have enough IP wrapped around the product to make it ugly enough that most generic companies won’t want to bother with it.

From a desk research market size, there’s no straight access, just straightforward way to access sales data. It shows up as all other under ATC classification. So in other words, if a generic manufacturer is looking for the next best thing to genericize and they’re usually looking for pills to press something quick, fast and easy, this is not quick, fast and easy. But if they could find it, it would be very difficult to find it. They would have to actually access our data and our annual reports to kind of get a read on to how much Hexvix and Cysview is actually being used in the world. It just doesn’t — it doesn’t show up, it doesn’t bubble up into opportunity for them.

From a technical and manufacturing hurdle standpoint, a couple of key things. We’re working through the EU and U.S. monograph, tightening the specification so that the — if a generic manufacturer want to come in, they would have to have extreme precision in how they develop our product. We also want to — we also have a freeze dry API under aseptic conditions. It’s a solvent in a vial or a prefilled syringe. It’s a manual, semi-manual packaging and labeling process. All 3 of those things immediately to generic manufacturer, there’s nothing easy about any of that. It’s not simple. We go through 4 different places, 4 different plants throughout Europe to manufacture our product. It just doesn’t look attractive to a generic manufacturer.

And then we have the only commercial exclusivity with commercial-grade medical API. In other words, if a generic manufacturer wanted to begin manufacturing Hexvix, they would have to find another API manufacturer out there with commercial-grade product to begin the manufacturing process because we have the exclusive arrangement.

From a regulatory hurdle standpoint, it’s even more difficult. It’s a drug device combination requiring an ANDA for the drug, a PMA for the device. There’s multiple FDA offices. It requires participation of 2 companies: the generic manufacturer, if they were going to attempt this; and then the device manufacturers, who is Karl Storz, Wolf and Olympus. And I can tell you that they are not interested in working with a generic manufacturer. To do so, they would have to hand data over to them. And they know that if they work with a generic manufacturer, the sales, service and support that someone like Photocure provides them and their product, because we’re in combination with them, is far exceeding anything a generic manufacturer is going to do.

And then there’s no clear approval process. In fact, bioequivalence is very tough. We have not been able to even establish bioequivalence, and we’ve tried many different ways. A generic manufacturer would have to find some way of establishing bioequivalence that would be very, very difficult.

If those 4 reasons aren’t reason enough, the fifth is probably the top of the cake, and that is the commercialization of the product. You’ve seen what happens when Ipsen withdrew from markets. You know what happens when you don’t put commercial effort behind a product like this. It is more of a device type sell, even though it’s a pharmaceutical product. And device products require hands-on interaction with physicians in the OR suites. A generic manufacturer has no interest of going into OR suites and putting sales forces up. What they want to see is put a product up on a list, and it automatically be substituted. And unfortunately, that’s not the way this product sells, and it’s not going to work and it’s not going to be successful for a generic manufacturer, and they understand that.

The other thing, if you don’t believe all those 5 reasons, at the very top, I talk about the fact that there has been no photodynamic therapy ever that has experienced generic competition. Visudyne and Metvix are in the market today. Metvix is a product that we actually have partnered off. That product has been off patent since 2016, it’s still growing at double digits. That should tell you a little bit about how interested generic manufacturers are not going to be in this space.

And if all that isn’t enough, we do still continue with strategic key initiatives. On Slide 30, we talk about continuously monitoring the landscape. We work with a company called TPR. They are the preeminent in this. They scour the earth for imports, exports, API, regulatory filings. They interview generic manufacturers, anyone and anything that would have anything that would lead to believe that anyone is going to do anything with generics. This organization is able to uncover. To date, there is no one interested. No one’s looking at it. No one has begun to even think about genericizing Hexvix across the globe. We know that, that outward look, we do it on a yearly basis, looks out 2 to 3 years. So we know at least for the next 2 to 3 years, there’s absolutely no competition on the horizon.

We’ll continue to strengthen our customer engagement, continue to bring value into those offices. We’ll continue product development, and as I mentioned, IP rep as well as patents that might be pending. And then if all else, we will — and are prepared to launch an authorized generic. So splitting the SKUs and creating a genericized version of our own product to make it even less attractive to generic manufacturer if we needed to. That’s, again, a preparation. That’s not an intention to actually do this unless we needed to do it from a defense mechanism standpoint.

So I feel very good about where we are from a protection — patent protection standpoint, and I feel we have a long way into the future before we have to worry about something like that. And I commend the team of Photocure for really putting a lot of effort into this over the last 1.5 years.

Slide 31 is Cevira license agreement and really high level. Cevira — as we talk about, Photocure is a company focused in on bladder cancer. Cevira is our product. It’s one of the other photodynamic therapies that we had come up with. The other one was Visonac. Visonac was a product used in treating acne. That product has been permanently shelved. It’s not really commercially viable. But when we came here — when I came here with Cevira, this is a fantastic product. We were fortunate to find an absolute amazing partner in Asieris, Chinese-based company. You know the deal, we announced it’s worth upwards of $250 million in potential. They have been on a fast-track, highly focused, highly engaged pathway. I would tell you that you can do a lot of deals in the life science space, and those deals could fall flat if the partner decides not to be as excited about the opportunity as you. I mean we saw it a little bit with Ipsen where — how they kind of let our product kind of dwindle over the years. This is not the case with the Asieris. Asieris is moving very, very quickly. They’re in final negotiations with the Chinese FDA on the CTA. We expect that soon. And then they expect, knock on wood, that they will have first patients in, in the later half of this year, which will be fantastic, and that actually triggers another milestone payment for Photocure. So very excited. They took full ownership of this product. They are experts with it. They’re excited about it. We’re excited about it, about what it could mean to patient care and more to come as they announce their development. But that revenue stream now feeds our ambitions to become a global bladder cancer company.

So Slide 33 — Slide 34. As I mentioned, COVID has impacted our businesses. It has impacted all businesses around the globe. But we remain very optimistic. And I remain optimistic because this is a temporary situation, and cancer doesn’t wait. So while there has been a postponement in cancer treatment, particularly right when COVID hit in March up until probably mid-second half of April, patients were postponed from the treatments as hospitals were overrun with COVID patients or they’re determining new ways of processing patients through to make it as risk-free as possible, cancer didn’t stop. Cancer progressed. As we know from the progression rates and reoccurrence rates, this is highly dangerous for cancer patients. So we know those patients are starting to — are coming back into the clinics for the procedures. A lot of the guidance coming out from the major bodies are saying those patients need to come back, in particular, high and intermediate risk, which, as I mentioned earlier in today’s presentation, is exactly the sweet spot we operate in. High and intermediate risk patients are exactly where Blue Light Cystoscopy makes the most dramatic impact. So we see that as a real positive.

We see 2 really strong selling points for using Blue Light Cystoscopy, in particular after a postponement. The first is that Blue Light Cystoscopy with Cysview or Hexvix provides a complete TURBT. So getting it right the first time back, getting complete margins, complete resections and a complete and accurate risk stratification so that patient can be treated accurately into the future is extremely important, and Blue Light Cystoscopy provides that.

The second part is that we believe there’s an opportunity in flex as well. We work with our partner Karl Storz, in particular, in the U.S., and they have come up with multiple types of financing packages, including deferments, et cetera, where we think we can accelerate and we’re going to attempt to accelerate flex installations in the second half of this year. With all the overrun resources in the hospitals, there is an opportunity to brew some of those patients and some of those procedures back into the physician’s offices. And having flex in the offices will allow those physicians to continue treating their patients and generating revenue, which is important to them, and not being held hostage, so to speak, from the hospitals that cannot accommodate the procedures. So those are 2 selling angles that we intend to take on the backside of recovery from the COVID-19. And this is why it gives me great optimism.

And I think the final point is this is a temporary situation. This is not as if a competitor entered the market and we’re going to battle this for years and years. This is a temporary situation. We know we have the momentum. We know we have the excitement and acceleration. We know that we have the interest in Blue Light Cystoscopy. We got major systems throughout the U.S., and we know we will have them in Europe as well who want to bring Blue Light Cystoscopy in. The timing may shift by a few months, but it is inevitable. And that’s why I’m excited about this.

So let’s get to the last couple of slides. Slide 35, this is our guidance, and I think most have seen it. We’re going approximately NOK 1 billion revenue by 2023. First quarter revenue grew at 21% in the U.S., driven by 17% growth in unit sales. We do see near-term temporary pressure on revenue for COVID-19. However, we do see a rebound and a steady return to normal as we get through the second half of this year provided COVID is resolved. But 2023 guidance, we see group revenue ambitions in the range of NOK 1 billion and EBITDA margins approximating 40%. As you can see, we’re moving very, very quickly to a very different type of company.

So in conclusion, on Slide 36, we aspire to create a leading bladder cancer company: accelerate, expand, acquire and transform. And as I reflect on this past year, for those who have been with me for the last 18 months, I think about the fact that we’ve expanded our commercial organization and invested in, and we’ve got tremendous growth rates going. We’ve got opportunities with Kaiser, Roswell and other institutions. We have a partnership with Cevira, which now drives revenue in that further fuels our ambition to become a bladder cancer company. We’ve begun investigation with the life cycle management of therapeutic effects and also the enhanced surgical guidance of our own product. We’ve protected our asset to the point where we don’t believe there’s any generic threats in any intermediate or short term. We’ve also regained control of global rights to our own product, giving us a global platform, upon which we can continue to accelerate the growth of Photocure. And we will weather COVID. And I asked everyone, stay tuned, more exciting things for Photocure in the near future.

With that, we’ll open it to questions and answers, Slide 37.

================================================================================

Questions and Answers

——————————————————————————–

Erik Dahl, Photocure ASA – CFO [1]

——————————————————————————–

Okay. We have some questions on the net. We have at least time to take a few of those. The first question is as follows. Is the revenue and EBITDA ambitions for 2023 only in the Hexvix/Cysview portfolio and excluding any mergers and acquisitions?

Maybe I can take that, Dan?

——————————————————————————–

Daniel Schneider, Photocure ASA – President & CEO [2]

——————————————————————————–

Sure.

——————————————————————————–

Erik Dahl, Photocure ASA – CFO [3]

——————————————————————————–

Yes, and this is Hexvix/Cysview portfolio and Hexvix/Cysview only. We have not calculated any mergers or any acquisitions in this. That does not mean that we won’t do any before 2023, but it’s not in the numbers.

We have another one. There it is. Approximately 40% EBITDA margin is seen as a ceiling or can it be more beyond 2023.

This is very much a scale game, and it’s a productivity game. And it’s a productivity per salesperson as well as productivity per scope. And I think looking at scale, looking at the number of sales people, feet on the street that we have today compared with the total headcount, approximately, I would think we’re about 60%, and that will increase even further with the inclusion of Europe. So that should drive productivity even further. Number of — on the revenue per salesperson varies between countries. And there are some super countries that is having a sale or revenue per salesperson, which exceeds NOK 10 million. And then obviously, you’re getting to an EBITDA margin, which is way beyond the 40%. And then finally, we have — we’re working on improving the number of units sold per tower installed in the hospitals by adding specialized salespeople, which you may want to comment on, Dan, if you want to.

——————————————————————————–

Daniel Schneider, Photocure ASA – President & CEO [4]

——————————————————————————–

Sure. Adding specialized salespeople. So in the U.S. in particular, I think you’ve seen us invest in the U.S. We’ve expanded the footprint. One of the things around our penetration into cancer centers across the U.S., we weren’t covering all geographies in the U.S. So major swaps of the U.S. geography were not covered, which we are not covering today. In addition, we talk about the 2 types of salespeople we now have deployed. It’s, again, supporting more of a device-type sales process, which is what we have. We have the surgical sales executive who’s a hunter, and they’re out acquiring new accounts and getting the installations going. And then we have the clinical support specialists, who comes in behind them, sits inside the accounts on a daily basis, sitting through cases, getting more physicians within the institution to use Blue Light Cystoscopy and expanding the patient selection. So they’re deforming the accounts and trying to gain greater productivity and leverage out of each account. That went into effect this last half of last year, and we’ll start seeing the effects as we go into — well, into this year minus the effects of COVID. But nonetheless, a very strong sales model that produces — we expect to produce increased revenues.

——————————————————————————–

Erik Dahl, Photocure ASA – CFO [5]

——————————————————————————–

I have another one for you, Dan. Question is how do you assess the prospects for procurement decision-making processes in the U.S. hospitals relating to purchases of new scopes in light of the impact of the corona situation.

——————————————————————————–

Daniel Schneider, Photocure ASA – President & CEO [6]

——————————————————————————–

Yes, we’re assessing that. It’s still early. Some accounts, we have a lot — we have an active pipeline. And accounts that are near term, we believe we’re going to complete and get through near term being ahead of 70% or 80% chance of closing this year. And we think those accounts will move forward. But let’s not fool ourselves. The impact on some of the institutions has been significant from a financial standpoint. New York City, L.A., San Francisco, Washington D.C., these are major cities for us for business as well as COVID hotspots. So what COVID has done is it awakened the U.S. hospital institution or hospital systems. And looking at — do they have the right equipment to treat COVID, and one of the key things is respirators. I think that goes without saying around the world. So as we look at the way they’re going to allocate what capital budget they have, we know that they’re going to put priority on respirators in case COVID makes a return into the fall. However, cancer is steadily in its own right, and we’re getting signals that’s not going to stop, things like that. Capital equipment, that is not related to something that’s maybe life-threatening sort of thing, probably it’s going to be put on the back burner. But we think that the Blue Light Cystoscopes, while will be slowed, and there will be some — there may be some additional hurdles, we do feel like we’ll still be able to install more this year, and we will.

——————————————————————————–

Erik Dahl, Photocure ASA – CFO [7]

——————————————————————————–

Yes. Maybe this one is also for you, Dan. The question is what about flexible scopes in Europe?

——————————————————————————–

Daniel Schneider, Photocure ASA – President & CEO [8]

——————————————————————————–

Yes. Interesting. There, Ipsen never really put effort into it. So tremendous opportunity in Europe. It depends on reimbursement, of course, but that was one of the sticking points we have with them over the last 18 months as we’ve had the ability to sell into the surveillance market, and you’ve sold nothing. And so we are putting pressure on them. They were beginning to make that effort, but really no result at this point, so we see it as an opportunity for us in Europe along with the rigid. But like I said, there are over 700 rigid scopes deployed throughout Europe, of which only Ipsen focused on less than 200. So there’s a tremendous opportunity just in what’s installed already to get it up and running. It’s a lot easier to get something started up and running again than try to sell capital equipment from the very beginning. We’ve got an opportunity to shorten that time line to results, and that’s what we intend to do.

——————————————————————————–

Erik Dahl, Photocure ASA – CFO [9]

——————————————————————————–

One last question. And again, Dan, it’s for you. Are there possibilities of commercialization of Hexvix in China?

——————————————————————————–

Daniel Schneider, Photocure ASA – President & CEO [10]

——————————————————————————–

Yes, yes. We are in conversations on China, South Korea, including also South America. So we continue to have these conversations and negotiations, and all I can say is stay tuned. These deals take time, and you want to make sure it’s right for Photocure. You got to make sure you have the right partner. We do not want to end up in a situation where we partner off our product, and it doesn’t go anywhere. That doesn’t do us any good. So we’re very thorough in our diligence and our expectations. So stay tuned. There’s things we are working on, and we think there’s opportunity, all right?

——————————————————————————–

Erik Dahl, Photocure ASA – CFO [11]

——————————————————————————–

I think that was it, Dan.

——————————————————————————–

Daniel Schneider, Photocure ASA – President & CEO [12]

——————————————————————————–

Okay. Awesome. Well, thank you, everyone. I appreciate you hanging in here. Hello from Philadelphia.

Source Article