Genmab A/S (GMAB) 2017 Q4 法說會逐字稿

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  • Operator

  • Good day, everyone, and welcome to the Genmab Q4 Report 2017 Conference Call. Today's conference is being recorded.

  • During this telephone conference, you may be presented with forward-looking statements that include words such as believes, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. Genmab is not under any obligation to update statements regarding the future nor to confirm such statements in relation to actual results unless this is required by law.

  • At this time, I would like to turn the conference over to Jan van de Winkel. Please go ahead, sir.

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • Hello, and welcome to the Genmab conference call to discuss the company's financial results for the period ended December 31, 2017. And joining me on today's call is David Eatwell, our CFO.

  • Let's move to Slide 2. As already said, we will be making forward-looking statements, so please keep that in mind as we go through this call.

  • Let's move to Slide 3. Genmab is built on a firm and solid foundation. We have 2 products on the market, an additional 4 proprietary programs in clinical development as well as an extensive innovative preclinical pipeline. Our 2 proprietary antibody technologies are helping us to fuel our growing pipeline and provide revenue streams from collaborations.

  • As David will describe today, we also have a very solid financial base that will allow us to continue to invest in our pipeline going forward. Put together, these key building components are what will allow us to be sufficient by 2025, to have our own products that have transformed cancer treatments, and we have a pipeline of "knock your socks off" antibodies.

  • Let's move to Slide 4. We are taking a number of steps to build a stronger Genmab for the future. In 2017, we doubled our proprietary clinical pipeline, and we are continuing to make investments in our preclinical pipeline that will allow us to build a highly innovative product pipeline of the future.

  • Specifically, our target is to file 4 new investigational new drug applications over the next 4 years. The DARZALEX royalties we received from our collaboration with Janssen will help us fund these pipeline investments. We are also working to build our commercialization and launch capabilities to allow us to bring our own product to the market in the future.

  • In order to build up these capabilities, we're hiring new staff to expand our competencies and training current staff to ensure we can meet the new challenges that lie ahead. While this growth is exciting and offers new opportunities for Genmab as a whole, for employees as well as investors, we are focused on carefully monitoring and controlling it.

  • Let's move to Slide 5. 2017 was another very successful year for Genmab, in which we saw a lot of progress with DARZALEX, with sales coming in at the high end of our guidance range as well as robust progress with our pipeline, in particular, with tisotumab vedotin.

  • Three new regulatory approvals for DARZALEX were obtained last year in all 3 major markets: Europe, the U.S. and Japan. We reported strong clinical data from the Phase III ALCYONE study of daratumumab in front-line multiple myeloma and submitted regulatory applications on the basis of the data in the U.S. and in Europe.

  • At the prestigious American Society of Hematology annual meeting last December, we reported exciting updates from a large number of daratumumab studies in multiple myeloma, including impressive data with the new subcutaneous formulation. Notably, deep and rapid clinical responses were observed with daratumumab in the orphan disease light-chain amyloidosis.

  • Multiple new clinical studies of daratumumab were started in 2017, including Phase III studies in multiple myeloma as well as in amyloidosis. Some of these new studies are used in the subcutaneous formulation of daratumumab. It's good to find a competitive advantage.

  • In addition, Janssen filed an IND in rheumatoid arthritis, a potential new disease area for daratumumab. Rapid focus and the development of daratumumab has led to the achievement of further milestones in our collaboration with Janssen, with Genmab earning DKK 1.1 billion in milestones for 2017 for both clinical development progress and reaching new sales levels.

  • DARZALEX has been launched in various lines of multiple myeloma in the U.S., in 25 European countries and in Japan. Excitingly, sales of DARZALEX passed the $1 billion mark in November last year, making it a blockbuster drug. We continue to be very pleased with the extraordinary growth of DARZALEX sales, which reached over $1.2 billion by the end of 2017, an astounding increase of 117% compared to 2016.

  • We also made great progress with our tisotumab vedotin program last year. We reported positive preliminary Phase I/II data in cervical cancer, and subsequently, Seattle Genetics exercised their option to co-develop tisotumab vedotin. Genmab and Seattle Genetics now share costs and worldwide profits for the program on a 50-50 basis, and we are starting a potential regulatory trial and will dose the first patients in the first half of this year.

  • We also filed INDs for 2 new exciting programs, DuoBody-CD3xCD20 and HexaBody-DR5/DR5. Finally, for the fifth year in a row, we are profitable. We had our operating results in 2017 at the highest level in the history of Genmab.

  • I'm pleased to now turn the call over to David to describe our excellent financial results for 2017 and guidance for 2018. David?

  • David A. Eatwell - CFO and EVP

  • Thank you very much, Jan. Jan was being too modest there. As he just mentioned, it was a record selling year for Genmab but not only with the operating results but it was also the highest-ever revenue for the company and the highest-ever cash position. So let's move to Slide 6 and review the income statement.

  • Revenue for the period came in at DKK 2,365 million. That was an increase of DKK 549 million or 30% compared to 2016. The increase was primarily driven by the higher DARZALEX royalties. You can see on this slide that the total royalties more than doubled year-on-year, and this year's royalty income of DKK 1,061 million exceeded the total expense base of DKK 1,021 million. This is a significant milestone for Genmab as we're at the point of sustainable profitability. And with the future expectations for DARZALEX, we expect the royalty expense ratio to continue to improve.

  • Those total expenses in 2017, as I said, were DKK 1,021 million and that was an increase of DKK 258 million or 34%, which was primarily related to the advancement of tisotumab vedotin and the additional investment in our product pipeline. And we also increased the number of employees to support the expansion of our pipeline and the increased number of products in the clinic.

  • Moving to the operating result. We had an operating income of DKK 1,344 million for 2017 compared to DKK 1,053 million in 2016. The increase of DKK 291 million was driven by higher revenue, which was partially offset by those increased operating expenses in 2017.

  • The net financial items were a net loss of DKK 280 million in 2017 compared to a net income of DKK 77 million in 2016. The net loss for 2017 was driven by foreign exchange movements, which negatively impacted our U.S. dollar-denominated portfolio and our U.S. dollar cash holdings.

  • Corporation tax for 2017 was an income of DKK 40 million compared to an income of DKK 57 million in 2016. As a result of significant royalty and milestone income in 2017, we ended the year in a taxable income position. However, the tax expense was offset by the recognition of additional deferred tax assets, leading to the tax income in total of DKK 40 million.

  • Finally, our cash position increased by DKK 1.5 billion during 2017, mainly due to our operating income of DKK 1,344 million and proceeds from warrant exercises of DKK 215 million. This resulted in a cash position at the end of December of DKK 5.4 billion.

  • Moving to Slide 7 on our performance against our 2017 guidance. On this slide, we show the actual result for 2017 compared to the original guidance issued in February 2017 and the very last guidance for the year that was updated in November. Throughout the year, we maintain the operating expenses within the original guidance and actually came in towards the lower end of that range.

  • For the revenue, we upgraded the guidance twice, both times due to the earlier than anticipated achievement of daratumumab milestones. And of course, the DARZALEX revenues of $1,242 million were towards the upper end of our original guidance range of $1.1 billion to $1.3 billion. By controlling those expenses, the operating income and the cash position both benefited from the increased revenues.

  • Now let's take a look at the revenue in more detail on Slide 8. The breakdown of the revenue by category is shown on the left-hand side of this slide. Milestones were still the largest portions of our revenue of DKK 1,133 million and were similar to 2016. However, the royalty income came in a very close second place in 2017 and doubled year-on-year to DKK 1,061 million. Deferred revenue from our collaborations was DKK 90 million in 2017, virtually the same as 2016. Reimbursement income came to DKK 81 million in 2017 compared to DKK 15 million in 2016. The increase of DKK 66 million was primarily driven by our collaboration agreements with Seattle Genetics and BioNTech.

  • The graph on the right bridges the revenue between the 2 periods. The change in revenue is mostly driven by the DARZALEX royalties. DARZALEX royalties grew from DKK 458 million in 2016 to DKK 1,013 million in 2017, an increase of DKK 555 million. Janssen's DARZALEX sales were $1,242 million in 2017 compared to $572 million in 2016. The increase in sales of $670 million was driven by the strong uptake following the additional regulatory approvals both in the U.S. and in the EU.

  • Next, let's go to the operating income on Slide 9. The graph on the left compares the change in expenses between 2016 and 2017. As you can see, there was an increase in the operating expenses of DKK 258 million, which was driven by the advancement of tisotumab vedotin, which accounted for 26% of the total expense increase.

  • We also increased the investment and expanded both our clinical and preclinical pipeline. Headcount costs, including share-based compensation, have also increased year-over-year as we've hired key personnel to support our product pipeline growth, build commercial competencies and strengthen the management team. G&A costs and other support functions also continued to increase as we expand our facilities to support our future growth.

  • Looking at the chart on the right, you can see the increase in the operating income from DKK 1,053 million to DKK 1,344 million. As previously discussed, the increase of DKK 291 million was mainly due to the higher revenue, partially offset by the increased operating expenses.

  • Now let's discuss the 2018 guidance on Slide 10. This slide shows an overview of our 2018 guidance compared to the actual result in 2017. We expect the 2018 revenue to be in the range of DKK 2.7 billion to DKK 3.1 billion. Our projected revenue consists of DARZALEX' royalties of approximately DKK 1.75 billion, and that's based on Genmab's estimate of DARZALEX net sales of somewhere between $2 billion and $2.3 billion or a midpoint of $2,150 million.

  • DARZALEX sales to rapidly advance in 2018 with the growth in U.S. market share, particularly in the second-line setting where we see a long duration of treatment and increased numbers of patients on treatment. In Europe and the rest of the world, we'll also continue to see more countries coming on stream and the full year benefit of recent launches such as in Japan and Spain and Italy. We also expect to see the introduction in first-line MM with the anticipated approval of daratumumab plus VMP, although that particular regime is not widely used in the U.S.

  • We also project daratumumab milestones of DKK 550 million in 2018. As I previously indicated, that is quite a bit lower, about half compared to the DKK 1,109 million that was achieved in 2017. A commercial net sales-based milestone is the main driver of the daratumumab milestone income in 2018.

  • The guidance for 2018 also includes the onetime payment from Novartis for approximately DKK 300 million. You'll recall that, that related to the transition of Arzerra from commercial availability to compassionate use in the non-U. S. markets. Royalties will continue to be earned from all net sales of Arzerra.

  • The remainder of the revenue mainly consists of cost reimbursement income from Arzerra royalties and DuoBody milestones. The overall quality of the revenue continues to improve, with the DARZALEX royalty income in 2018 making up a larger portion of our revenue and continuing to cover all of our operating expenses. We anticipate that our 2018 operating expenses will be in the range of DKK 1.4 billion to DKK 1.6 billion, which mainly consists of the advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5 and DuoBody-CD3xCD20 as well as other products in our pipeline.

  • In 2018, we'll spend about DKK 765 million on our top 10 key projects. That's just over half of our total expense base. We expect the operating income for 2018 to be approximately DKK 1.3 billion to DKK 1.5 billion compared to the DKK 1,344 million in 2017.

  • We are, of course, again projecting our cash flow to be positive in 2018, and our priority for capital allocation is, first, to increase the investment in our preclinical and clinical pipeline and invest in our vision for 2025; second, to continue to scout for opportunities to in-license or co-own new product opportunities and to invest in potential new formats [for] technologies; and finally, third, to have a strong capital position to maintain investor and creditor confidence. Therefore, at this stage, we do not plan to return capital to investors by either dividends or by share buybacks. Note that as usual, the 2018 guidance does not include any new large potential deals.

  • In summary, another record year for 2017, increasing royalties from DARZALEX in 2018, enabling Genmab to increase the investment to selectively advance our pipeline and create even more value.

  • Now I'd like to hand back to Jan to discuss our 2018 goals. Jan?

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • Thanks, David. Let's now move to Slide 11. We expect 2018 to be another exciting year at Genmab. We expect additional regulatory approval for DARZALEX in the U.S. and Europe based on the data from the Phase III ALCYONE study in front-line multiple myeloma. We anticipate the start of new trials for daratumumab and expect to report data in both the front-line multiple myeloma setting as well as from studies and indications other than multiple myeloma.

  • Both the Maia and CASSIOPEIA Phase III studies are event-driven and current estimate support data readouts in 2018. The studies of daratumumab in combination with (inaudible) in solid tumors are open and actively enrolling, with potential early data in the second half of this year.

  • For ofatumumab, we look forward to the rapid completion of recruitments in the 2 large Phase III studies of the subcu formulation in relapsing MS. For tisotumab vedotin, we foresee the start of Phase II studies in cervical cancer and studies in additional solid tumor indications within this year.

  • Our pipeline will be further strengthened by other advancements, including the start of the expansion phase in the ongoing Phase I/II HuMax-AXL-ADC trial, focus on both the HexaBody-DR5/DR5 and the DuoBody-CD3xCD20 Phase I/II studies as well as acceleration of our proprietary immuno-oncology DuoBody programs towards the clinic. We continue to be committed to disciplined financial management with controlled company growth and smart investments, including investment in our highly innovative product pipeline.

  • Let's move to the last slide, Slide 12. That ends our presentation of Genmab's full year 2017 financial results. Operator, please open the call for questions.

  • Operator

  • (Operator Instructions) And we'll take our first today from Thomas Bowers with Danske Bank.

  • Thomas Bowers - Analyst

  • A couple of questions from me. First of all, could you maybe put some flavor on the DARZALEX sales guidance? I mean, U.S. sales growth had been trending a bit slower lately based on the RX numbers, and of course, also no real impact from the BMP in the U.S. So I'm just wondering if you're seeing rest of world sort of catching up to the U.S. sales for the year if you end up in the high end of the guidance. And then second question just on the royalty, the fixed royalty you guide for, DKK 1.75 billion. Could you maybe disclose what sort of average royalty percentage you put into that number? And then thirdly, I'm just wondering, is there any upside to the guidance? There are 2 milestones. So any possible data readouts that you do not include in the guidance, and also maybe if you've reach another sales-based milestone? I think I'll stop there.

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • Thanks, Thomas. I think these questions are all 3 perfect questions for David. And David, go ahead.

  • David A. Eatwell - CFO and EVP

  • Yes, I think with -- we do expect to see a rapid continuation of growth at DARZALEX in 2018. I think we have to remind ourselves that it was a phenomenal performance in 2017 getting to blockbuster status, really in just its second full year. But some of the drivers, we expect second line to continue to grow, as I say. At the moment, we're in a #2 position in terms of U.S. market share in the second line with a market share of about 20%. And that has been rising throughout 2017. We started -- the share for DARZALEX combinations in 2017 started at around 10%. By the end of the year, it got up to 20%. We expect that to rise. We also look at new patient starts so we've seen that new patient starts have been coming through at a higher level than the overall market share. And with the second line, you've got very long duration of patients who are staying on treatment. They're staying on longer. New patients are coming in, so you're actually stocking or building those number of patients that are being exposed to DARZALEX. Now it can take time to come through. We've again been talking to physicians and doing market research. And again, what we'd heard anecdotally before but now again confirmed by surveys is that when a doctor has a patient on second line on a particular regime, they tend to leave well alone. And really when something begins to go astray with those patients, then they'll be thinking about adding DARZALEX through there. So I think that will be [out the year]. If you look at second line, third line, fourth line, my expectation and hope is that the second line is where we'll see the majority of the growth. I think in third line in the U.S., we've got about 1/3 of the market share. Very similar between DARZALEX or REVLIMID, they've got around 1/3 each. And so I think that one is -- we might gain -- get some little gains there, but I don't think that one is going to be the driver of growth for the U.S. Although we have been some -- seeing some switching around. We saw in Q4 of 2017 that daratumumab Pomalyst [decks] has been now overtaken daratumumab REVLIMID decks as the most used daratumumab combination in the third line. Fourth line, we're already #1 position. We're already around 40% market share, although we do see some change there with less use of the mono and again more use of the combinations, particularly daratumumab Pomalylst again. So I think with the U.S., we will see continued growth. We have seen physicians that are looking very much forward to the first line setting. As you said, we don't see DVMP as being a major contributor to first-line in the U.S. in 2018, but we do see that the combination of daratumumab REVLIMID [decks,] which we hope to get data in the H2 2018, to be a real driver of frontline growth for DARZALEX in the U.S. in 2019. We do expect to see considerable growth in rest of world. We got some fairly large markets like Japan, where we only had one month sale really in 2017, so we got the full year benefit there. In Q4, as you know, we saw quite a nice pickup in the number, $130 million of sales rest of world in Q4 compared to $87 million or you want to put that price adjustment through, $107 million in Q3. So considerable growth coming through in Q4 and some of the newer countries coming through contributing. So we are seeing -- we were -- at the beginning of the year, where a vast majority of the sales were coming from Germany and Japan, we're seeing that decline. Germany and France are still very important to the rest of the world number, but we're now seeing some other countries coming in that are at Spain, Italy, Brazil all beginning to contribute. And again, a lot of those we expect to continue to accelerate. Plus we've got the DVMP. We got the PDUFA date for May in the U.S. but we would expect approval in August 2018 in Europe and also filing in Japan in 2018 as well. Again, you're not going to get all countries immediately coming on stream, but again, we would hope and expect to get German sales and maybe some French sales for DVMP and frontline in 2018. So hopefully, that gives you some flavor on our confidence around the DARZALEX midpoint range of $2.15 billion. In terms of the average royalty, the DKK 1.75 billion DARZALEX royalties, that does relate to the USD 2.15 billion midpoint for the DARZALEX sales. We did note in our guidance that we have got an exchange rate now of the U.S. dollar-Danish kroner of DKK 6.00. So I can do the math for you, if you take the DKK 1,750 million, convert it at an exchange rate of DKK 6, that will be $292 million, divided by the $2,150 million would give you an average royalty rate for 2018 at that midpoint of about 13.6%.

  • In terms of upside for milestones, I did mention when we gave you some of the directional guidance for 2018 that I did expect the DARZALEX or daratumumab milestones to be lower in 2018. And I also projected that, that actually will be right in 2018. Now you'll recall the original contract was around $1 billion of milestones. We're about halfway up to the end of 2017. We've collected $481 million. That means there's just over $500 million left to go. We are now getting to the end of the multiple myeloma milestones. Only a few more of those to come through, so no big surprises for any extra multiple myeloma milestones. We will have further milestones to come through, and we do have one large DARZALEX sales-related milestone included in this guidance for 2018. And then, the remainder of moneys to come through will be on the non-multiple myeloma setting, so there are some still future milestones to come through. But as we look at it today, we do expect to actually collect on the vast majority, if not all, of that $1 billion of milestones for the DARZALEX collaboration with Janssen. So hopefully, that answers your questions, Thomas.

  • Operator

  • And we'll take our next question from Sachin Jain with Bank of America.

  • Sachin Jain - MD

  • Sachin Jain from Bank of America. Some similar topics. So David, if I may, just to follow on from the prior question. So first, any comments on the latest U.S. prescription data, which was referenced in the prior question, which has slowed down a little bit sequentially? Any perspective there, and do you assume an inflection of that sequential growth rate within the guidance? Secondly, just to be a bit more specific around your commentary that was there was no material ALCYONE sales reflected. Can you get to the bottom end of your guidance in the scenario where ALCYONE was very limited i.e., close to 0? And then finally, any perspective on the wider range you've used within guidance this year versus last year? So those are questions for David. Just one very quick one for Jan on the solid tumors. Confirming 2H '18, which is in line with prior commentary, (inaudible) saying there have been some potential discussion of earlier data dependent on Janssen seeing an earlier read. Is that still a possibility or is it just firmly 2H now?

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • Why don't we start, Sachin, with the last question and then David can think a little bit more about further perspective on the guidance for DARZALEX? Solid tumors data can come from 2 sources from either from BMS or from Janssen. From Janssen, I've heard quite firmly, Sachin, that they would be in the second half of this year. And from BMS, we think that the data may come in the second half of this year, but there could be upside surprises but we don't have any control over that session. So I will stick to the second half '18 because that's what I can say more firmly now to you. David?

  • David A. Eatwell - CFO and EVP

  • Yes, very good. So going through the 3 questions there on the sort of perceived slowdown, if you like, on sales between December and January. Actually looking at the Symphony data, they -- just of the institutional data, daratumumab, $93.2 million in the month, was the new highest month for U.S. sales according to the Symphony data. So I know everyone's sort of starting going back looking at number of days and holidays and everything else. I think we can get a little too much in the detail around the actual daily sales overall, but $93 million is a new highest month for DARZALEX in the U.S. But indeed, because that's got to rise considerably throughout the year. It can't stay at $93 million a month and to meet these types of numbers, so we do expect that there will be growth. And I'll refer back to my previous answer where we expect to see those growth numbers come through. To get to the lower end of the range to the $2 billion, can we get to that number without a U.S. approval of ALCYONE? I'm not expecting much from dara VMP for the U.S. That's really not an indication that it's used very much. But feedback from some of the market research that John Keating have been doing recently, we did hear a lot of anticipation and excitement from U.S. physicians sort of getting ready for the front-line use. So there could be some usage there but it's not sort of a major factor for us to sort of say look, to get to the bottom end, to get to the $2 billion, we must get some U.S. sales for DVMP. I would hope to get some DVMP sales in Europe, but again, that would mainly be around Germany. We hope to get approval in August. Maybe we'll get some sales in September to December for Germany and maybe a bit for France. So you can say, well, yes, some of that's in there but within that $2 billion to $2.3 billion range. So DVMP is not something that's sort of keeping us awake for too long at night. Third question was really why have we widened the range? Well, in 2017, it was a lot smaller number. We had a range of $1.1 billion to $1.3 billion, so there's a delta there between the 2 numbers of $200 million. We've gotten a number which is sort of getting close to doubling at the bottom end of $2.0 billion to $2.3 billion so there's a delta between the 2 numbers of $300 million. So it was just because the number was larger. If we had gone for another logical number and gone to $2 billion to $2.2 billion, then you'd be saying, okay, you only got a $200 million and the number is a lot bigger. Why have you got a tighter range? So I don't think there's a huge amount to be read into that.

  • Operator

  • And we'll take our next question from Michael Novod with Nordea.

  • Michael Novod - Director of Healthcare, Healthcare Analyst & Sector Coordinator

  • It's Michael from Nordea in Copenhagen. Also a few questions. Going back to sales outside of the U.S. and access, could you provide some more comments to the recent GBA review of DARZALEX in the second line? Does this mean there's, say, immediate access and reimbursement also in the second line at the current price for DARZALEX in Germany? Do you expect that to accelerate sales in Germany? And then secondly, if we look at the pattern for administration of DARZALEX in the U.S., we've seen more and more hospitals talk about the 90-minute infusion. Is that something that you also have feedback on from the hospitals that could ease up some bottlenecks and thereby also supporting your 2018 guidance? And then lastly, regards to the distribution of the sales, do you expect this to be, say, a very back-end loaded sales acceleration in the U.S? Or do you believe that it has got to be more or less evenly split with stable growth over the year, the coming quarters?

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • Thanks, Michael. I think 2 questions here for David again. Let me speak briefly about the 90-minute infusion because we already see that, that is being contemplated and used in Denmark in some hospitals and have also heard, actually, over the last 2 weeks that also in Germany, that the 90-minute infusion is going to be implemented because there are bottlenecks in capacity in hospitals for infusion with DARZALEX. So yes, I think that the 90-minute infusion concept is welcomed by doctors. I've heard it also from hematologists here, Michael, and they are going to use it from here on. And the same, I have heard also, from major U.S. institutions. So I think that will accelerate the use of DARZALEX going forward. Of course, there is, indeed, a bottleneck especially, what I understand, in the health care -- community health care centers in the United States, where there is a limitation of a number of infusion chairs. We have heard that this could actually, on the shorter term, really accelerate the use of DARZALEX. And the big acceleration will be in 2020, I think, with the subcu formulation we are making very, very good progress with the recruitment of the noninferiority Phase III. You've also now seen the Phase II and the 3-year settings with different combination therapies either with REVLIMID or with PRD or VMP, which is a study that Janssen intends to use to -- in combination with the noninferiority Phase III study to get a broad label for the subcu formulation. So the real [DuoBody] acceleration is expected in 2020, but we will see acceleration already this year. And that is being built in to the models and in the guidance we have given you today, Michael. So maybe David can comment on the first and the third question, give more color on the distribution of sales outside the U.S. and also inside the U.S. David?

  • David A. Eatwell - CFO and EVP

  • Yes, I think with the -- referring to the German review, I think that was something that was very positive. I think we got the second top ranking there for the value of DARZALEX as a product. So I think that's going to be positive probably from 2 counts: one is on continued price reviews that you go through as labels expand within Germany. So I think with that classification of the product, then I think that would bode well in terms of any further German price reductions. I'm not saying that the price would hold, but you would think it would make sense there, given the value of the product that they've identified that perhaps the pressure on reducing prices further will be somewhat less than it otherwise would have been. I think also with that rating as well, I would imagine with the physicians with that rating, it's another reinforcement, not just the clinical data but from the German review as well to sort of say that this is a very valuable product to use in your armory treating multiple myeloma patients. So it's a positive signal. How much of a positive signal is difficult to actually put a dollar figure to it overall. In terms of the acceleration of sales, I do expect those to continue to build quarter by quarter throughout the year. As I said, we saw with the second line going from a 10% market share in the U.S. at the beginning of 2017 to a 20% market share by the end of the year. I do expect that to penetrate and to continue to grow. And part of that again will be the patient stacking. So as you got new patients that come on board in Q3, Q4 of 2017, they're going to be there for all the year. And again new patients that come in Q1 will be there for all of '18, Q2 all '18. And so you're going to see those patients stacking up and more patients on treatment. And with the second line, you've got a very long duration of treatment so you haven't got that tail of patients dropping back off again quite as quickly as you would, say, in the fourth line setting. So we would expect to see acceleration and a growth of the U.S. month by month, quarter by quarter as we go through 2018. Outside rest of the world, you would see the same thing. There's still a number of countries to come on. There was around, I think Janssen had mentioned, 25 European countries. But remember, some of those are just getting their approvals now in the mono fourth line setting, so there's still quite a number of those 25 that have also now got to go through the process of getting the full pricing approval in the larger second line setting with DRd or DVd. So I think all of that will bode well for quite some considerable growth for our rest of world sales for 2018.

  • Michael Novod - Director of Healthcare, Healthcare Analyst & Sector Coordinator

  • Can I just ask one follow-up, please? Because we're now 3 weeks into February. We all say today and the past week has been extremely focused on the monthly sales, perhaps too focused. But does this also mean that when you guide as you do, that you have access to weekly sales, that you are encouraged by what you see in terms of [pick up?] Are you willing to comment on that in February?

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • David?

  • David A. Eatwell - CFO and EVP

  • Okay. I was going to let you answer that one, Jan, but (inaudible).

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • I can start off.

  • David A. Eatwell - CFO and EVP

  • No, no, that's fine. We do purchase the IMS weekly sales data so that's why we gave some directional guidance. And we did say in December that we would be looking at as much latest data that we could get our hands on. We do look at that weekly IMS data, and I would say that over the last 3 weeks data, we've been continuing to be encouraged with the direction that it's going for the U.S. market. We're also now trying to gain the access. And with first data coming through from Japan, we'll have to see how reliable that data is and how it compares to the quarterly data and royalty statements we get from Janssen. But we're also trying to collect the Japanese data as well and we'll watch that Japanese growth with great interest.

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • So I can only echo that, Michael, and I would say we are very encouraged by what we see very recently, very nice trending up in the U.S. And as David said also, some early good data from Japan. So yes, we use that in the guidance range which we have now delivered to the market.

  • Operator

  • And we'll go next to James Quigley with JPMorgan.

  • James Patrick Quigley - Analyst

  • A couple, please, again focused really on the sales milestone. Can you confirm that you're expecting 1 milestone in 2018, and is that for crossing the $2 billion sales mark? And should we expect on further crossing of additional $1 billion sales mark, the milestones to come through on sales? Then on the wider revenue guidance, adding up the DKK 1.75 million (sic) [DKK 1.75 billion], DKK 300 million of Novartis and DKK 500 million -- or DKK 550 million of DARZALEX milestones, that leaves a gap of sort of DKK 100 million to DKK 500 million. In the (inaudible) report, the deferred income is going to be pretty much gone by the sound of things. So are we expecting a significant step-up in reimbursement income from Seattle Genetics sort of in the DKK 200 million to DKK 300 million range? And then finally on tisotumab vedotin, the cervical cancer combination, is this going to be with Avastin or is it going to be in a novel combination?

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • Thanks, James, for the questions. Again, 2 questions for David and let me take the third one. We are still discussing different combinations and there will be new combinations, James, which we are contemplating in cervical cancer and front line. And I can tell you that we are also very, very actively working now on other tumors. And we will see, I would say, more than one study which we want to do in probably a handful of solid cancers this year. And we will update you further during the year on which indications that will be. And we expect further data, clinical data from the Phase I/II study in seven different cancers in the second half of 2018. And then, David, maybe on the first 2 questions.

  • David A. Eatwell - CFO and EVP

  • Sure. Yes, first off, with the sales milestone, it is a large sales milestone. It is one milestone. I can't tell you what the sales hurdle is for that because Janssen had asked us not to declare those sales milestones until they're achieved. But it is one large sales milestone. There are several more large milestones to come related to sales hurdles. Sorry, I can't confirm at how they're spaced out over the future periods. But I referred to earlier that out of the $1 billion total milestones, we've collected in about half. We've got about another $500 million to go, and the largest portion of that is related to sales hurdle milestones. And in terms of the revenue overall, if we look at the guidance, we got DKK 2.7 billion to DKK 3.1 billion. If we take the midpoint there of DKK 2.9 billion, you're quite right. If you look at the DARZALEX royalties of DKK 1,750 million, the DARZALEX milestones of DKK 550 million and the Novartis onetime payment of DKK 300 million, that's a total of DKK 2.6 billion. So that does mean that we've got other revenue to come in to reach that midpoint number of around DKK 300 million. That can include DuoBody milestones, it can include continued Arzerra royalties. On the U.S. sales and any remaining rest of world sales for Arzerra and also includes reimbursement income from our collaboration partners, most of it coming from BioNTech and Seattle Genetics. And we've seen members. Seattle Genetics came into the 50-50 in August 2017. So we've got a full year benefit of the actual share of costs on a 50-50 basis with Seattle Genetics. So that number will be rising. Total reimbursement income was about DKK 81 million in 2017. It will be quite a bit larger in 2018.

  • Operator

  • And we'll take our next question from Keyur Parekh with Goldman Sachs.

  • Keyur Parekh - Equity Analyst

  • Two questions, please. The first one, can you just help us think through the growth that you are expecting in 2018? If you can give us some more color around the geographic breakdown of that growth, so just help us build through the 2017 actual DARZALEX sales versus 2018. And then secondly, on the Japan side, David, can you give us a sense for what Q4 number was for Japan and what you are expecting in terms of 2018? Should we think of that ramp as being like Germany or if there's any other market where you would draw an analogy to what the Japan ramp should look like as we go through the various months in 2018?

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • Thanks, Keyur. Two perfect questions for David again.

  • David A. Eatwell - CFO and EVP

  • I think with the -- let's start with the Japanese one first. Remember, it was only first commercial sales in November so you only really had a very few weeks of the Japanese number. I do know what Janssen's sales were for the month of December. Unfortunately, I can't give you that detail. You'd have to refer that back to Janssen if they would be willing to give you that number or not. But in terms of growth expectations for 2018, we've got a range of the 2 billion to 2.3 billion. I don't really want to start getting into cutting that number any further at this particular point. I would say in terms of growth percentage, we'd expect more from rest of world just because there's complete new countries coming on, countries like Canada, Japan, U.K. starting to use their [cancer fund]. Now if you compare sort of Japan, somewhat similar market size to Germany, could you use that sort of launch success in Germany as a marker for Japan? I think one significant difference we've got to figure between the two, there's that in Germany when we first started off the launch there, it was in the fourth line monotherapy setting. What we got in Japan, we didn't have the monotherapy approval but more importantly, we got relapsed refractory multiple myeloma in combination either with REVLIMID or with Velcade. So I think with Japan, you've actually got a wider label available for launch. And also, we know with the Japanese market, there is a lot of use of Velcade, they're already well -- very keen on using that. They use more Velcade and REVLIMID. It'll be interesting to see how the Japanese sales actually develop overall and how much the use of Velcade with daratumumab compares with the daratumumab compared with REVLIMID. So I think there are some sort of encouraging signals for Japanese growth for 2018 but a little early at this stage to figure out what the adoption rate could be. But of course, Janssen have got a good presence in Japan and a good track record there for product launches.

  • Keyur Parekh - Equity Analyst

  • If I could just follow up on that a little bit. Just since I know you've kind of mentioned a bit about kind of expanding geographies versus kind of existing countries where you would have incremental penetration across kind of indiscernible] for the second line. Just help us think through kind of the incremental revenue, how much of it comes from new geographies versus existing geographies.

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • David?

  • David A. Eatwell - CFO and EVP

  • Yes, we haven't got that level of detail going through by individual country. It's a case of looking at the larger countries then looking at some of the new countries coming through, looking at that development, looking at quarter 1, quarter 2, quarter 3, quarter 4 for 2017 and we're particularly looking at that trend rate of Q4 to Q3 to be able to extrapolate and say, okay where is the growth coming through from some of these? And then there is new approvals sort of slated for countries that have got 0 sales for 2017. Janssen does share with us their regulatory pathways and where they're going around the world and when they expect to get regulatory approval and when they get the pricing approval. But again, I'm afraid I can't share that proprietary Janssen information with our investors or analysts.

  • Operator

  • We'll go to Carsten Madsen with SEB.

  • Carsten Lønborg Madsen - Research Analyst

  • Carsten from SEB. A couple of questions here as well. I know it's probably still early days but when it comes to retreatment of DARZALEX, for example, if you see a second-line patient that relapses, are you seeing any evidence that DARZALEX is being used as a combination again in a third-line setting? Do you have any data on that? And then, I was also wondering now there's this intense focus on the monthly data, do you -- what's your assessment -- do you actually think it's fair and accurate to look at number of daily treatment days because in some of the infusion centers, they're also open on the weekends, so maybe it's probably misleading to actually look to adjust for number of working days? And then finally, a couple of household questions. The tax in 2018, what do you expect there, David? And also, I noticed that you don't provide any guidance on net cash position or maybe I missed it. Could you also talk a little bit about that one?

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • Thanks, Carsten. I think 4 questions for David.

  • David A. Eatwell - CFO and EVP

  • Yes, I think in terms of the retreatment in third line, we haven't been on the market that long yet for the second line. The good news is, is that the duration, on average, is so long in the second-line. Thankfully, those patients aren't moving into third line so much. We haven't got much data on that. There was some data as shown on retreatment, and the so-called PFS 2 and it was showing that if you had been a patient that had been exposed to daratumumab early in the treatment regimes, that those patients actually then did better when they got through to relapse and then got onto the next round of treatment. So I think there's some very early encouraging clinical data on that, but probably a little early to sort of figure out exactly how the sort of the cycle is going to go through. What we would expect for the future and I think Celgene have also said this is, they would expect quite an adoption in the frontline assuming approval for REVLIMID/dex combination and then probably switching to a second combination in second line and, of course, if it's Celgene, they'll be quite happy to go to the dara pom dex in the second line, whereas eventually you might want there be other choices, either going with Velcade. Of course, Amgen might like to go for daratumumab Kyprolis in the second line if you've relapsed on the DRd. So I think at the moment, from market research work that we've done, we've seen quite an acceptance from physicians to already mentally accept that there will be daratumumab used many times but with different combination partners, perhaps doing first line with an IMiD, and then switching to a proteasome inhibitor or switching to -- from a REVLIMID to a Pomalyst. Good news for us is that we're quite happy if they keep switching those combinations as long as daratumumab is in the mix. To your second question in terms of monthly treatment and treatment days, I think it's also worth remembering the accuracy of data, whether it's Symphony, whether it's the IMS data, whether it's comparing those gross data with the net sales of Janssen. There's plenty of moving parts there. I know you guys mostly focus on the Symphony data. We also buy our IMS weekly and monthly data. You do see some switch around, and it can be as black and white as sort of saying Symphony 1 month is growing between month A and month B and IMS is the [opposite], there's a slight decrease. Looking over a quarter or looking over a year, Symphony IMS data is very close together. But you've got to be a little bit careful of sort of getting too doom and gloom and say, one month's down $2 million. It might be in IMS that it actually went up $2 million. But over time, it tends to even out. But of course, everybody's intensely interested in the short-term trajectory of DARZALEX, but I think we also have to sort of step back and sort of say as well, "This is great. It's a blockbuster. Reached the blockbuster status, reaching a double blockbuster status, we think, in 2018." But it's also looking and saying, "Look, what's the long term on it and really penetrating the first line is going to be the next wave of growth hopefully with DRd in the U.S. in 2019." But then following through on that in 2020 and 2021 when you start getting the switch to subcutaneous formulation, I think that again will be another wave of increase for DARZALEX, more combination data, longer-term data where you're going to get to see long-term MRD negativity rates, long-term PFS rates and then importantly, going to be several years, I think, before we get mature overall survival data to really see the long-term value and the penetration of DARZALEX into the multiple myeloma market. And not just penetrating the market, also growing the market as well with some of these very long durations. Now to get onto a couple of more fun subjects of tax for 2018. There is some detailed notes on the tax in the annual report. I know it's only just been issued so you haven't had a great deal of time to look at it but if you look at note 2.4 annual report, Page 81, it does give you a little bit more clue there on terms of the NOLs that are remaining and some of those NOLs relating to U.S. Minnesota plant that expire in 2018. But overall, and these are sort of very rough numbers and there's a lot of complication around tax, that you've got NOLs of about DKK 4.4 billion. We state that DKK 1 billion of that expires in 2018 and won't get used. So you've got about DKK 3.4 billion of tax overall. If you use an overall average rate of 22%, that means that you've got about DKK 800 million. Now, you got in the A/S is about DKK 500 million of that. We've already put up on the balance sheet, DKK 300 million, so for the parent company, you've got about a DKK 200 million potential for the credit to come through the P&L, depending on our confidence and where the profits go, the company and the investments go over the future years. So it's about DKK 200 million or so for A/S, for the Danish company, and there's also about another DKK 300 million of potential deferred tax asset, most of that relating to the U.S. Now, of course, most of our profits are in Denmark because that's where the DARZALEX royalty comes and where the daratumumab milestones come in. We make some small profits in the U.S. based on cross-charge back to the mother company, so it's going to be quite a longer-term use of that deferred tax asset for the U.S. But hopefully, that gives you some guide. If you look at the longer term, you really want to be looking at using around a 22% tax rate for Genmab. But you've still got a couple hundred million credit still to come at some point to credit back to the P&L. In terms of not guiding for the net cash, I think we're cash flow positive, I think, in cash. Thankfully, it's no longer a story of how the cash runway is and how many months of cash runway we've got left to go. We expect to be obviously cash flow positive in 2018. Overall, you would expect our cash improvement for 2018 to be somewhat similar to the operating income. We haven't got a great deal of capital expenditure, plus you got noncash items like the equity charges and depreciation. The one thing I would point out in terms of the cash though is that you will get a working capital adjustment depending when the large milestones come through. And also with the rise in royalties with the growth of DARZALEX, you're always going to have the Q4 royalty outstanding at the end of the year, and with growing sales, growing royalties, that means you're going to have a negative working capital adjustment. But overall, we'll be over the DKK 6 billion of cash at the end of 2018. And some of it will depend on Janssen as [they did] in '17, they were entitled to pay the $50 million sales milestone in January. They elected to pay it early and that's why we ended up with a DKK 5.4 billion of cash position at the end of 2017.

  • Operator

  • And we'll take our next question from Peter Welford with Jefferies.

  • Peter James Welford - Senior Equity Analyst

  • Just a couple left. Firstly, just on the OpEx. I know that it was originally a sort of provisional or whatever the word used was, guidance back in December. You talked then about 40% to 50% increase in OpEx, looks like actually close to 60%. I wonder if anything sort of happened in your thinking to revise your top end of the range there for potential OpEx during the year. Secondly, then just on CASSIOPEIA. Is it a potential interim analysis of that trial we could see this year? Or is that the (inaudible) that, that first analysis that could potentially happen of the actual primary end point? And then just a quick one then, there's an impairment that we booked through in the 4Q fourth quarter, it's only small, but I wonder what that relates to.

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • Thanks, Peter, for the questions. I will go only for the CASSIOPEIA question. There is an interim foreseen this year and the primary endpoint is stringent, complete response -- number of stringent, complete responses. And that's the only trial where we used this endpoint. It is agreed upon with -- by the FDA and by the EMA. We expect it in the summer of this year. And hopefully, we can base it -- basically file also based on that data, Peter. I'll leave the other 2 questions to David.

  • David A. Eatwell - CFO and EVP

  • Yes, thank you, Peter. With the expenses overall, as you look at our guidance page, we have the expense of DKK 1,021 million in 2017. We've got a range of DKK 1.4 billion to DKK 1.6 billion, so it's 40% to 60% there. We take the midpoint just for mathematical numbers to start with. So DKK 1,021 million for 2017, midpoint of DKK 1.5 billion for 2018, that's an increase of DKK 479 million or 47%. As I mentioned when I was talking through some of the revenue numbers earlier, we had reimbursement income of DKK 81 million in 2017. That will rise because -- particularly with Seattle Genetics and some of the BioNTech program, that number will rise probably to a little over DKK 200 million in 2018. So if you take the expense number and you take off that reimbursement amount, unfortunately, accounting-wise, we're not allowed to do that. We have to record it as revenue. But if you sort of say, look, that's really what it's doing is effectively netting these expenses, then you're going to have a net expense of around DKK 940 million for 2017. And that's going to grow to about the DKK 1.3 billion in 2018. So if you go DKK 940 million to DKK 1.3 billion as a net expense, then that's a 38%. Now you can see where I was getting my 40% to 50% when we gave the directional guidance back in December. So that's talking around the midpoint there. Of course, if we go up to the DKK 1.6 billion then it's probably going to be good news because we're advancing something or advancing more trials. If it's something we're doing with [FISO] and [FISO's] spending more money, then we're going to get more reimbursement back from Seattle Genetics. So I still think if you're looking at that midpoint, whether you're looking at the gross expense, whether you're trying to do it net, it's somewhere around that sort of 37% to 47% type of increase. Hopefully, that helps.

  • Peter James Welford - Senior Equity Analyst

  • That's great. And so the 23 million impairment?

  • David A. Eatwell - CFO and EVP

  • The impairment relates to some assets we bought a number of years ago. We don't have plans to utilize those assets so we just took the charge for those in 2017.

  • Operator

  • And we'll take our next question from Wimal Kapadia with Bernstein.

  • Wimal Kapadia - Research Analyst

  • Wimal Kapadia from Bernstein. Just following on from one of the earlier questions from Michael. I'm just trying to better understand the penetration in the hospital versus the community setting. So the community still accounts for about 70% of MM patients, so I'm just trying to understand if dara usage to date is skewed to one particular setting? And the reason I ask this is just to try and see the sense of how much infusion time is actually a hinderance to uptake. So any comments there will be great. And then, I guess, a high-level question on the company itself. So 2018 BCMA data will continue to read out through the year, and quarterly DARZALEX sales in multiple myeloma will continue to be scrutinized quite heavily by the market. So what can Genmab do to move debate on the name? So what data or milestone through the year give investors another branch to the Genmab story?

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • Thanks, Wimal, for 2 very interesting questions and I will try to handle them both and I will ask only David to give some further color on the first question. Penetration in hospitals versus community health care centers. What I understand from our partner (inaudible) is that there's about -- it's over half of the patients is being treated in the U.S. right now in health care -- community health care centers, probably close to 70% and that is a real bottleneck there with the number of infusion chairs being available for daratumumab infusions because of the lengthy duration of the infusions. And we believe that, that is really a bottleneck right now. There is also considerable use in hospitals, but the majority is in the health care -- community health care centers, which is not uncommon [apparently] for patients have ages between 65 and like 75, the majority, and because they want to be treated close to their homes and David can perhaps add some further perspective. And the second question is 2018, I think what is really important for Genmab to position is I think is further trials, which shows further ambition by Janssen and Genmab to basically expand the landscape of daratumumab can be used. We will see new Phase IIIs this year beyond the 12 Phase III trials that's already announced ongoing and also in different settings in new combinations. So there will be new, I think, potential for further growth and penetration of the market in the future. Then I think data -- there will be further data from the Maia study, from the CASSIOPEIA study. And most importantly, I think that is probably the most important branch is probably data in solid tumors for where the preclinical data actually gets better and better, the evidence gets stronger and stronger that daratumumab could potentially lead to activation of the immune system in cancer patients, which we have already seen in multiple myeloma but in a number of solid cancers. There's also a lot of CD38+ regulatory cells present in or around the tumor. So when these would be knocked out by daratumumab leading to activation of T cells and clonal expansion of T cells, which are the important killer cells of the immune system, then I think we should also expect good data in some solid cancers. And I think that is probably -- the most important is data. And that beyond daratumumab, because that's all I think more important for Genmab is further progress with tisotumab vedotin. I already talked about a handful of other cancers which we will start clinical studies in at least one or more studies this year, which we're planning to cover with Seattle Genetics and progress with other programs like AXL-ADC where we expect data -- the first data in the second half where we continuously -- continue to progress the study (inaudible). So I think to actually make the value proposition much broader than just daratumumab right now, the majority of the focus is on daratumumab. But I think key data will be to actually show to the outside world that Genmab is an innovation powerhouse. I mean, we will do this again. There's multiple potential winners in our pipeline already. Once that becomes clear, I'm sure we will get recognition for that, and that will go in parallel with the continued expansion of the market for daratumumab to continue to increase in income generated by daratumumab next year, assuming very positive data from the Maia study. Around the summer of this year, expect turbo acceleration of the income based on the very important penetration of the frontline market in the U.S. because of the combination with REVLIMID and daratumumab. And I think that in combination should, I think, have us, I think, broaden the value proposition and increase and strengthen the value proposition from here. David, do you want to add some further color on the first question on the split between hospitals and community health care centers for dara in the U.S.?

  • David A. Eatwell - CFO and EVP

  • No, I think you've answered that well, Jan. I don't think I've got much more level of detail on that. I think the 90-minute infusions, as that gets more adopted, it will be helpful. How helpful it will be, haven't got sort of good data. We know from some of the market research work that we've done is that the, overall, the physicians love DARZALEX. They love the efficacy, they like the comparatively good safety profile particularly compared to other MM drugs. What they don't like is that long first infusion. That is an inconvenience to them. Some of it is splitting it into 2 infusions. And the infusion-related reactions, which again, compared to other drugs, are minor, more of an inconvenience, if you like. And some -- we've had some feedback as well, okay, you've got 8 infusions to do in that first 8 weeks before they drop down to biweekly and then every 4 weeks. So anything on the 90-minute infusions is going to be positive on that but on the longer term, of course, that's going to really be helped by the introduction of subcu.

  • Operator

  • And we'll take our next question from Jacob Lademann with Carnegie.

  • Jacob Lademann - Research Analyst

  • A couple of questions also related to DARZALEX guidance for 2018. You have talked about a few times that the duration of treatment in second line is fairly long. Can you maybe talk about what you are using for average treatment duration in your model and projections for 2018? Also looking at some of the European countries, you mentioned that only reason you have been reimbursed or provided coverage to actually treat in late-stage disease in -- as monotherapy. So for instance, looking at the country like the U.K., is it your understanding that the limitations are in place to actually limit use to late-stage therapy? Or I mean, is there actually -- I know you're sort of obligated to the [patient] to adhere to what is reimbursed and so on. But is there actually a possibility for doctors to circumvent the system? And yes, just to confirm that in your guidance for 2018, you only relate to the actual approved reimbursement settings in the European countries? And just finally also, could you talk about how the average European price level looks compared to the U.S.?

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • Thanks, Jacob, for hanging in so long and for the very good questions. I think these are all for David again.

  • David A. Eatwell - CFO and EVP

  • Yes, I think the duration in the second line does mean those patients will be stacking and building through. I think in terms of the specific 2018 guidance, we haven't got sort of a duration number built into sort of calculate that number. It's probably getting into too fine a level of detail when you've got some sort of fairly broad assumptions that you have to make when you're sort of building this number and the range of number overall. In terms of the U.K., it was good news that more patients can now get exposed to DARZALEX. It is limiting there. I'm talking from memory now so I may be wrong, but I think it was something like 7,000 patients that they were estimating that would now be able to benefit from DARZALEX. So there's still further room to go to actually get a wider approval for the U.K. from their cancer fund and to increase that patient numbers as we go forward into future years. In terms of pricing, I'm afraid that, overall, that's going to be, apart from what's in public domain, it's going to have to be a question for Janssen overall. As you know, they launched in Germany actually at a price that was higher than the U.S. price. They did have that German price review in 2017. And that brought the price down to, depending on where the exchange rate was moving around, very similar to the German price to the U.S. price. Now over time, you're going to still see U.S. price increases, although DARZALEX has seen very modest price increases compared to some other products, particularly compared to Celgene's REVLIMID and Pomalyst. So you do expect still, despite the pricing environment in the U.S., to see price increases going in the U.S. whereas the way that the majority of the European markets, you probably launch at your highest price and then as volumes increase and the label gets larger, you're probably going to continue to see renegotiations of those prices and the price come down over time. So I haven't got an overall average number. That's not something that Janssen shared and I'm afraid if they had, I wouldn't be able to share it with you, Jacob.

  • Operator

  • And we'll take our next question from Anastasia Karpova with Kempen.

  • Anastasia Karpova - Research Analyst

  • Two super quick questions. On CASSIOPEIA, do you think that stringent, complete response in the interim in the consolidation setting would be significant or convincing enough to drive sales in those transplant-eligible patients and change the treatment paradigm? And second, with more and more data coming in for AXL as a target, do you already pencil in Phase II trials for AXL-ADC in your 2018 budget?

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • Thanks, Anastasia, for the questions. We believe that by having strong, stringent, complete response interim data, that will be a basis -- a good basis for both approval as well as for use of the combination of VTD -- dara VTD. We've had extensive discussions with hematologists and with the regulatory authorities, so we are very confident that strong data, which are significant, would drive the usage in that front line setting. We both know that, that's not the largest market. I mean, that is a pretty limited market for a non-transplant setting, but we believe that this is the first trial ever which uses that endpoint and we are super excited about that. And that is shared -- that excitement is shared by the doctors which we have been speaking with in the different continents. Then, the next question on AXL, we are very excited about the preclinical profile of that drug. I also said probably before that we are much more rapidly expanding the dose escalation than originally foreseen. From that you can conclude that apparently we can dose patients at higher and higher amounts of the drug, and we are pretty hopeful that we can actually come with early clinical data in the second half of this year. And at the same time, go into expansion cohorts in multiple cancers where we hopefully have seen signals already in the dose escalation part. So we are not, per se, penciling in Phase II studies at this moment. What we are doing, basically cohorts, different cohorts which we want to initiate literally in the coming months, Anastasia, and then hopefully, data from those cohorts next year in 2019.

  • Anastasia Karpova - Research Analyst

  • Great. Maybe a short follow-up on CASSIOPEIA. Do you have any -- where should we expect the second half -- the second part of the trial with the maintenance setting coming out?

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • Yes. That should be -- could be a lot later, actually, because we believe that when the data is really, really good, that, that could be quite a long time. I haven't seen the projections recently, Anastasia, but that would definitely be beyond 2020, I think.

  • Operator

  • And at this time, I'd like to turn the call back to Jan van de Winkel for any additional or closing remarks.

  • Jan G. J. van de Winkel - Co-Founder, CEO and President

  • And this closing remarks will be very brief. So thank you all for calling in today to discuss Genmab's financial results for the full year of 2017. And we look forward to speaking with you again soon.

  • Operator

  • Thank you. And that does conclude today's conference. Thank you for your participation. You may now disconnect.