Genmab A/S (GMAB) Earnings Call Transcript & Summary

March 26, 2020

Nasdaq Copenhagen DK Health Care Biotechnology shareholder_meeting 63 min

Earnings Call Speaker Segments

Jørgen Madsen

attendee
#1

[Interpreted] Good afternoon. I'm Jorgen Kjergaard Madsen. I am the Genmab's External Legal Adviser, member of -- a partner of Kromann Reumert. And I have been appointed as Chairman of this Annual General Meeting. Before we open the Annual General Meeting, I'd like to comment on the special circumstances that are relevant for today's meeting. Genmab has been keeping a keen eye on the development and the spread of COVID-19. And as a preventive measure and on the basis of recent guidance from Danish authorities, and in the interest of shareholders, management and staff, we have decided to minimize the physical presence of this meeting, and it is more or less virtual Annual General Meeting. We are live screening. And this means we comply with the social distancing rules and the restriction on numbers in a single room. This means also that there will be no service of food because we are trying to minimize problems. This, of course, does not benefit the development and the compliance with the Annual General Meeting procedures, but it is in line with the Danish government and the Danish authorities' provisions and also measures that we have seen a number of other Danish listed companies taking. And with these few comments, I would just like to give the floor to the Chairman of the Board, Mats Pettersson. He is also present via a webcast and a phone line. You have the floor, sir.

Mats Pettersson;Chairman of the Board

executive
#2

Thank you very much, Jorgen, and good afternoon and welcome to Genmab's Annual General Meeting. So I'm Mats Pettersson, Chairman of the Board of Directors. I would like to introduce the other members of our Board, most of whom, like me, are also attending this virtually. The Deputy Chairman, Deirdre Connelly; members Anders Gersel Pedersen; Pernille Erenbjerg; Paolo Paoletti; and Rolf Hoffmann, they're all present in different locations in the world. We also have 3 employee Board members: Peter Storm Kristensen; Mijke Zachariasse; and Dan Bruno. I believe Peter is in the meeting today. Then we have our company's Executive Manager, Jan G. van de Winkel, Genmab's CEO, who is here today. And joining us remotely are Anthony Pagano, the new Chief Financial Officer; Judith Klimovsky, our Chief Development Officer, looks after all research and development activities; and our new COO, Anthony Mancini, responsible for overseeing Genmab's commercial, corporate development, business development and information technology functions. To officially start the proceedings of today's meeting, I will now give back the floor to Jorgen Madsen, next slide.

Jørgen Madsen

attendee
#3

[Interpreted] Thank you very much. And before we move on to the formalities, I'd like to remind you that the AGM is being live-streamed. You can follow it in Danish or in English via our homepage. Otherwise, first of all, I have to establish whether this has been convened in accordance with the legislation and the Article of Association. It has to be within the municipality of Copenhagen, that is in compliance because we are at the Marriott Hotel, and it has to be within 4 months of the conclusion of the annual report. And also a notice has been given, which has to be minimum 3 and maximum 5 weeks. And this has been done by publication on the homepage of the company and a publication in NASDAQ Copenhagen and also a written notice to those shareholders who have so requested. And I have noted that this has been undertaken on the 28th of February 2020. The agenda and the complete proposals, the annual report and the various documents and the information required with the -- under Danish legislation has been available on the homepage within the deadline prescribed. And there is nothing on this agenda that actually requires the presence of a certain share of shareholders. And otherwise, we had called it. So I note that this has been convened in accordance with the legislation and the Article of Association. And if there's no objection to this, I will take this and register it in our minutes. First of all, let's look at the items on the agenda. First of all, 3 items concerning the report by the Board of Directors on the company's activities during the past year, the presentation and adoption of the audited 2019 annual report and resolution to discharge the Board of Directors and executive management and resolution on the distribution of profits as recorded in the adopted annual report. And I am proposing that we take these 3 items on block as is traditional in this company. Chairman of the Board, Mats Pettersson will introduce, and he will be followed by the CEO, Jan van de Winkel; and the CFO, Anthony Pagano, who will speak in turn. And we will have Mats Pettersson and Anthony Pagano, who will be participating via the online connection, whereas, Jan van de Winkel is present here in the Marriott Hotel. After these 3 items, we have 4 election of Board of Directors; item 5, election of Auditor; and item 6, proposals from the Board of Directors. And I would like to inform you that we have received no proposals from shareholders. And I think we should postpone the introduction to the proposals from the Board of Directors, when we reach this item on the agenda. I can also inform you that today at this AGM, we have a representation of about 55% of the voting shareholders and on the basis of proxies and letter votes, we have received there is the necessary majority for adopting the proposals proposed to the AGM today. I now give the floor to Mats Pettersson, Chairman of the Board, who will give us the Board report. Next slide.

Mats Pettersson;Chairman of the Board

executive
#4

On the next slide. Here, we have the forward-looking statement, and I wanted to draw your attention on the fact that this presentation will include just 8 months overlooking. And Genmab is a biotech business. And as we all are aware about that drug development is not always a straightforward journey from aid to serve. So it is important to understand that we discussed -- what we discuss today is our aim and that there may be external events that cause us to change course in the future. Next slide. As a reminder, why we are all here today, Genmab is focused on the creation and development of antibody therapeutics to preform cancer treatment. This focus on cancer and antibodies is guided and inspired by our core purpose to improve the lives of patients. And the company's purpose is linked to a laser-sharp focused strategy. We focus on our core competence of being able to identify the best disease target, develop unique, best-in-class or first-in-class antibodies and develop next-generation technologies. We then turn this innovative science into medicine. This in turn has allowed us to build a profitable and successful biotech company. And of course, our success is also due to the support we have from you, our shareholders. I would like to take the opportunity to thank you for supporting us so as that we achieve our vision of transforming cancer treatment. Now I would like to hand over to Genmab's CEO, Jan van de Winkel. Jan will discuss in greater detail Genmab's accomplishments last year as well as our key goals and plans for this year. So next slide, please.

Jan van de Winkel

executive
#5

All right. Thank you, Mats, and thank you to everyone joining us for this meeting remotely. Genmab is closely monitoring the development of the COVID-19 pandemic and following the recommendation from various authorities, including global and local governments and health agencies. Our top priorities at this time are to ensure the health and safety of our employees and our collaborators and also ensuring business continuity. To this end, Genmab has established a COVID-19 response team that I Chair, that has developed and implemented precautionary measures like those we are taking today. These are unprecedented times, and we are grateful that we are still able to share this company update with you all. Looking back, 2019 was an extraordinary year and I now will provide you with a brief overview of our recent successes and share a glimpse of what you can expect from Genmab in 2020. Next slide. Looking back on 2019, I can very confidently say that we are over-delivering on Genmab's commitments. 2019 was Genmab's best year so far, with strong advancements in our proprietary pipeline and growth of new competencies to solidify our organization. As of this January, there were 19 Genmab-created products in clinical development. And as of yesterday, there are 20 Genmab-created more products in clinical development. And of the Genmab-created products in clinical trials, we now own 7 of them, at least 50%. In 2019, we also completed the enrollment and the potentially registrational Phase II innovaTV 204 study of tisotumab vedotin. And we moved 2 DuoBody programs, together with our partner, BioNTech, a German company in Mainz, into the clinic, and presentations of data at major medical conferences were given, including for DuoBody-CD3xCD20, which we now know as epcoritamab. Our track record of success is also demonstrated by Genmab-created products currently on the market. Ofatumumab originally approved as Arzerra, our first product for certain CLL indications, now has the opportunity to change the lives of patients with relapsing multiple sclerosis or relapsing MS. Novartis, which is developing ofatumumab, submitted applications for approval in relapsing MS to health authorities in the U.S. and Europe. And excitingly, in the U.S., this application has been accepted under priority review. This could mean that we potentially see an approval of ofatumumab in relapsing MS already in the U.S. as soon as this June. The third Genmab-created product on the market is teprotumumab in development by a company called Horizon Therapeutics. This was approved this year in January by the FDA as TEPEZZA, for thyroid eye disease. Partnerships also have been and will continue to be key components of Genmab's growth. In 2019, we entered into multiple new strategic collaborations, including agreements with CureVac, Tempus and yet another agreement with Janssen, this time involving HexaBody-CD38, a next-generation CD38 antibody product that we are super-excited about. Our financial position has also, like our pipeline, being strengthened exponentially during 2019. And last year, along with our incredibly successful U.S. IPO, Genmab had its seventh year of profitability. Similar growth can be seen in our highly skilled and dedicated team. So let's move on to the next slide for some more details on Genmab's exceptional employees. We have continued to strategically add new capabilities and competencies that will allow Genmab to stay on the cutting-edge of innovation, support our ambitious 2025 vision and help us to continue to add to our already robust and exciting pipeline. All of it will provide more value to both patients and to shareholders. We are also proud that we are hiring a diverse workforce. And now we have more than 42 nationalities represented across all of our different locations, focusing on recruiting based on the right skills and competencies, regardless of gender, age or ethnic differences. So let's now move to the next slide and our lead commercial products, DARZALEX. Much of Genmab's growth over the past few years, including the growth of our new capabilities, is related to the incredible success of DARZALEX. Over 115,000 patients have now already received DARZALEX and treated with DARZALEX since the launch in November of 2015. And last year, it received key approvals in frontline multiple myeloma indications, including the highly anticipated approval in the U.S. of DARZALEX in combination with Revlimid and dexamethasone. I would also like to mention 2 more recent events. In January, DARZALEX was approved in Europe, in combination with bortezomib or VELCADE, thalidomide and dexamethasone. And previously, it was approved in the U.S. already in this indication. So in both territories, it's the first DARZALEX-containing regimen approved for transplant-eligible patients. Also of key significance for DARZALEX going forward, last year, Janssen submitted applications for approval in both the U.S. and in Europe, in July, for a subcutaneous formulation of the drug. This will be a game changer for both patients and physicians as it reduces the time needed for dosing of daratumumab from several hours to just 5 minutes. DARZALEX also continues to be a commercial success, reaching near triple blockbuster status last year. As anticipated, Genmab achieved 2 large sales-based milestones for 2019: $100 million milestone for sales passing $2.5 billion in sales in a calendar year; and then $850 million milestone for passing of -- sales of $3 billion in a calendar year. And as a reminder, sales milestones are calculated on the basis of the terms of the license agreement we set up between Janssen and Genmab in August 2012. Next slide, please. Our key achievements for 2019 continue our track record of success. And we have many since we were founded in '99. Genmab created products that have led to 35 INDs, which means 35 molecules were tested in the clinic, 20 of which are in active clinical trials and 3 are now approved commercial products. Our financial success is tied in large part to one of these products, and that's DARZALEX, which is considered a game-changing therapy for patients with multiple myeloma or myelomatosis as they say here in Denmark. And as I mentioned, our revenue has expanded exponentially over the past 2 decades, and we anticipate 2020 to be the eighth year in a row of profitability. Our U.S. public offering, initial public offering, which I've mentioned briefly before, was the largest biotech IPO in the U.S. in 2019. And remarkably, it was the second largest U.S. IPO ever by a biotech company. We now plan to use the momentum provided to us by our accomplishments and a solid revenue base to continue our track record of success into this year. Let's move to the next slide, where I would like to highlight the areas in which we plan to strategically invest in the coming year. To continue to deliver on general promise of developing truly differentiated antibody therapeutics for patients, we intend to significantly increase our investment in both epcoritamab, the DuoBody-CD3xCD20 molecule and DuoBody-PD-L1x4-1BB to accelerate the clinical development within this year. We are focusing on these particular products because we believe in their potential to become important new treatments, should they eventually be approved. Starting with epcoritamab, we believe that this could be a best-in-class product. This confidence comes from the preclinical and early clinical data we have seen and form its subcutaneous modes of administration, a feature that differentiates this medicine from other CD3, CD20 product candidates from other companies. We are planning a highly comprehensive and aggressive development plan for these products across a variety of hematological malignancies and lines of treatment. Then let's move over to DuoBody-PD-L1x4-1BB, one of the products we are developing along with BioNTech. This has the potential to be a first-in-class and provide Genmab with a truly differentiated PD-L1 products. There's a high unmet medical need to improve on so-called checkpoint inhibitors, and we have seen strong preclinical data and encouraging early signs of activity in certain patients with solid cancers. The escalation phase of the first-in-human clinical study in solid tumors is ongoing. Our track record of previous success gives us the confidence that we will be able to capably maximize the potential of these product candidates towards key oncology markets. Next slide, please. In addition to our targeted investment in the clinical-stage product candidates, I just discussed, based on our world-class science, we are continuing to strengthen our pipeline with novel product candidates, you can see here. We are also investing in new cutting-edge technologies that will facilitate our ability to continue to create breakthrough products for ourselves as well as for our partners, another important space into which we are significantly investing as data sciences. Our partnership with Tempus in last September gives us access to a massive amount of clinical genomic and biomarker data, which will help us to identify, which patients will benefit the most from our products. In addition, this breadth and depth of information will allow us to identify potential new and better targets for future therapeutics and to significantly accelerate the clinical development. Of course, we will also continue to focus on our core competency of antibody research. This includes an expansion of our early discovery programs and bolstering of translational medicines capabilities in the U.S. in our Princeton facility. Together, these investments will allow Genmab to maintain its position as an innovation powerhouse by continuing to generate and develop new, first- and best-in-class products that create substantial value for both patients and for shareholders. So now let's move to the next slide and our key priorities for 2020. Here is a detailed look at some of our other key priorities we have for 2020. As you can see, the most significant area of advancement is expected to be with our own proprietary pipeline of product candidates, where we are responsible for at least 50% of the development. This includes potentially adding new product candidates in the pipeline with planned IND and CTA filings for HexaBody-CD38, the next-generation CD38, and an exciting bispecific DuoBody-CD3x5T4. We expect daratumumab to continue to evolve with additional data readouts, also our Phase III trials, and regulatory submissions. Most importantly, and I referenced that already earlier, we very much look forward to the potential approval of the subcutaneous formulation of daratumumab in both the U.S. and in Europe. Similarly, we are highly anticipating the potential approval in the U.S. of a subcutaneous formulation of ofatumumab for relapsing multiple sclerosis. The final milestone we have on our list, the approval in the U.S. of teprotumumab, as I mentioned, already has been achieved. And of course, we are actively monitoring the potential impact of COVID-19 pandemic in -- on our 2020 priorities. So next slide, please. In conclusion, we believe that by investing in our pipeline, technologies, people and partnerships, we can create substantial value for both shareholders and patients in the future. As revenues from DARZALEX sales continue to grow, we can continue to build value by investing in new product opportunities. And our aim is to control our own destiny and keep a larger slice of the sales of products that reach the market. To ensure we can do this, we are selectively investing to build new capabilities in areas such as commercial, medical affairs and translational research. We are actually on a transformational journey, both as a company and as we set out to fundamentally transform the next-generation of treatments in oncology using our unique proprietary technologies. And a nice thing for all of you Genmab is only at the beginning of this journey. We have a foundation all in place, we can look forward to a very exciting future, one where Genmab products, where we own at least half or more of the rights, has transformed cancer treatments. And we have a rich pipeline of Knock-Your-Socks-Off antibodies. So thank you very much for your attention and continued support. We hope that you all remain safe and healthy in the coming time. I'm very pleased to hand over to my colleague, Anthony Pagano, our new CFO, to discuss the 2019 financials, so please move over to the next slide.

Anthony Pagano

executive
#6

Thanks, Jan. This is my first AGM as CFO of Genmab. Some of you will know that I've been here at Genmab since 2007. Right now, with COVID-19, it's clearly a challenging time for everyone. But looking through the immediate disruption, I can also say, it's an exciting time for the company given our future potential. Over the last few years, we've built a solid financial foundation for Genmab. Last year was another successful year for us financially. And over the next few slides, I want to bring that to life for you. So I'm going to discuss the results for 2019 and our 2020 financial guidance. Next slide, please. Before I get into the results and the guidance, I want to set some context. I'd like to spend a moment explaining our overarching financial framework. Now we created this framework pre-COVID-19, but it is still a useful way to think about our business. First off, let's think about our revenue profile. On the left-hand side, you can see the component parts of our current and future recurring revenue streams. We are looking forward to the continued growth and expansion of DARZALEX. You can also see ofatumumab and TEPEZZA, and there's a lot to be excited about here going forward. As we've heard from our partners, these are both potential blockbuster products. And we are really excited about the potential of adding 2 additional recurring revenue streams in the years to come. Next, on to our focused approach of investing in R&D, shown on the right. We'll continue to be focused and disciplined in our investments. And we're going to expand and accelerate our potential winners, as well as investing will remain focused on the bottom line. In 2019, we delivered our seventh consecutive year of profitability, and we continue to have a strong balance sheet with a significant cash position and no debt. When we put this all together, we have a robust financial framework and a strong foundation to continue to execute against our 2025 vision. Let's move to the next slide and our 2019 financial results. So let's start with our summary P&L and some of the highlights. 2019 was another record-breaking year for Genmab, with record revenues, record operating income and record net income. In 2019, revenue came in at DKK 5.37 billion, an increase of 77%. The increase was primarily driven by higher DARZALEX royalties and milestones. Total expenses in 2019 were DKK 2.73 billion, with 87% being R&D and 13% G&A. We significantly increased our investment in 2019 as we advanced our clinical pipeline. Operating income was up over 90% to DKK 2.64 billion, primarily driven by higher revenue. The increase in corporate tax expense is due to higher operating income and a higher effective tax rate. In 2018, we had a larger benefit relating to deferred tax assets. That brings us to the net result, where we reported net income of nearly DKK 2.2 billion, up almost 50%. And now let's take a look at our revenue in more detail on the next slide. I'd like to focus your attention on the graph on the right, which tells the story behind our strong revenue performance in 2019. Here, you can see the 2 key drivers of revenue growth. First, the largest increase in revenue is really an illustration of our key theme of recurring revenue growth. DARZALEX royalties grew more than 80% to DKK 3.13 billion. The royalties come from Janssen's DARZALEX sales of nearly $3 billion in 2019. The second key driver was our DARZALEX milestone, which grew from DKK 586 million in 2018 to DKK 1.78 billion in 2019. The milestones primarily related to 2 large sales-based milestones. Remember, these were the last of the sales-related milestones under the daratumumab agreement, so they won't be recurring moving forward. As well as increasing revenues, we also increased our investment in our pipeline, our team and our capabilities. And that brings us to our next slide. The change in expenses between 2018 and 2019 is shown in the graph on the left. Operating expenses increased by around DKK 1 billion, which was driven by the accelerated investment in our product portfolio. More than half of the expense increase was due to the additional investment in our product pipeline, including the advancement of our clinical and preclinical programs. We've also spent more on expanding our very talented team at Genmab. As we've hired key team members to support our growing product pipeline and continued efforts to build commercial and other capabilities. Looking at the chart on the right, you can see our operating income of DKK 2.64 billion. This compares favorably to our original 2019 guidance of DKK 2 billion and our last published guidance of DKK 2.35 billion. Overall, these are very strong results for 2019 and a great illustration of our robust financial framework that I described earlier. Moving to the next slide, let's take a look at our 2020 guidance. Before I provide you with our 2020 guidance, I'd like to highlight a few key points. We issued this guidance on February '19. As you are all well aware, circumstances have changed since then. We are closely monitoring the situation with COVID-19. The environment is challenging, and the situation is evolving rapidly. As you heard from Jan, in the first instance, our priority is with our people and our broader set of stakeholders. From a financial perspective, there may be an impact, but it's too early to tell whether it will affect our guidance and at this stage, what the impact may be. Having said that, let's take a look at the numbers, and let's start with our summary P&L at the top of the page. We expect our revenue to be in the range of DKK 4.75 billion to DKK 5.15 billion. That's down modestly from last year as a result of nonrecurring DARZALEX sales milestones of DKK 1.68 billion. We anticipate our 2020 operating expenses to be in the range of DKK 3.85 billion to DKK 3.95 billion. This step-up in investment represents our enthusiasm for our pipeline for all the reasons we've already covered. Putting this all together, we're planning for substantial operating income in 2020 in a range of DKK 0.85 billion to DKK 1.25 billion. Now let's review the key components of our revenue. As you know, continued strong market growth led DARZALEX to near triple blockbuster status in 2019. For 2020, we anticipate that sales will continue to ramp up significantly. We expect sales to grow somewhere between 30% and 40% and be in the range of $3.9 million and $4.2 billion. So DARZALEX is really continuing to deliver for us and on a clear path to leadership in multiple myeloma. Based on the strong sales expected in 2020, we're projecting DARZALEX royalties to be in the range of DKK 4.08 billion to DKK 4.48 billion. Cost reimbursement revenue is expected to increase, driven by our Seattle Genetics and BioNTech collaborations. So our 2020 guidance here is at DKK 475 million. Other revenue consists of other milestones and royalties with a 2020 guidance of DKK 200 million. Included within this number are somewhat modest figures for royalties from ofatumumab and TEPEZZA. Without any of the large milestones we saw in 2019, we are still expecting revenue to approach nearly DKK 5 billion at the midpoint of our 2020 guidance. At the bottom of this slide, you can see that we are investing in 3 main areas: our projects, our people; and overall building out of our capabilities and business support. Let's zoom in on our project costs for a moment. These account for more than half of our total investment and are also driving more than half of the growth of our cost base in 2020. In fact, 38% of our project investment will be directed specifically towards DuoBody-CD3xCD20 and DuoBody-PD-L1x4-1BB, two of the programs we are looking to expand and accelerate in 2020. And 87% of the increase in our project investment relates to these same 2 programs. This is in line with our focused investment approach, where we invest in our pipeline and accelerate and expand the development of our potential winners. Now I will move to my final slide. In conclusion, I think, in times like this, it's useful to take a step back and reflect on our business and our financial position. We have a very strong foundation with sound fundamentals. We have great recurring revenues, and they're growing. And we're using those revenues to invest in a really focused and disciplined way. We're investing in both our highly innovative and differentiated product pipeline as well as the team to deliver it. And especially important in today's environment, we've got a robust balance sheet, $1.6 billion of cash at year-end and no debt. Clearly, in the short term, COVID-19 is affecting everyone's lives. Structurally and certainly, over the medium term, we anticipate continued recurring revenue growth and will continue to invest in R&D, all driving towards our 2025 vision. Thank you for your attention and your continued support. Now I'd like to hand this back over to Jorgen Madsen.

Jørgen Madsen

attendee
#7

[Interpreted] Thank you very much. That was the report by the Board of Directors on the company's activities. It was the presentation of the annual report and the proposal that the profit of DKK 2,116,000,000 be transferred to next year. I can also say that the Auditor, PWC, has given a report with no reservations or comments for the annual report. For this item on the agenda, we have received a letter from the Association of Danish Shareholders that I have been asked to read aloud, and I will. It is from Mr. Klaus Feldmann on behalf of the Association of Danish Shareholders. Hello. My name is Klaus Feldmann. I come from the Danish Shareholders' Association, which works in the interest of Danish Private Shareholders. I thank you for the link to the Danish summary. The annual report in Danish is obviously not produced. However, it is a wish from the Danish Shareholders' Association and the Danish Shareholders when the company is domiciled in Denmark. Firstly, congratulations on the very nice results and the very nice increase in equity. Next, I will ask if dividends are being planned for the shareholders. And finally, I would like to ask about the expectations of DARZALEX, ofatumumab and epcoritamab in 2020, also in relation to the coronavirus. We also thank many super-talented and highly motivated employees for their great efforts during the year. We wish Genmab good wind ahead, and we hope that 2020 will be a good year despite the coronavirus. Thanks for the word. And that was from the Danish Shareholders' Association by Klaus Feldmann. And let me ask if the Chairman would like to come back. I think, the CEO, Jan van de Winkel, will like to respond.

Jan van de Winkel

executive
#8

Thank you for that nice letter, Klaus. Let me first come back to your wish to see a Danish annual report. We have actually written a resume that you also referred to, and that is actually highly appreciated by most of the shareholders. We speak with the Danish shareholders. And also, there are many, many other Danish-listed companies who don't even write a resume. So I think we're actually helping shareholders to really stay on top of what the company is doing. So I wanted to just start with that. And then we'll go into your dividend question. But I can tell you that our goal at Genmab, as I explained in my presentation, is to develop very strong products that make actually a real difference to cancer patients compared to current therapies. And to achieve this, our priorities are actually to advance the product pipeline in a focused and disciplined manner by accelerating the development of the potential next winners, and we have actually pointed out 2 potential next winners today in the presentation, both in my and in Anthony Pagano's parts. And then also to invest in our promising early-stage portfolio, the innovative technologies. So Genmab has a real name and new capabilities. We need to actually keep and maintain a very strong capital position to ensure financial flexibility. For example, when we want to do partnership deals, and we will do partnership deals in the future. So therefore, at this stage, we do not plan to return capital to investors via dividends or share buybacks. And then next, the expectations on DARZALEX, ofatumumab and epcoritamab in relation to the coronavirus pandemic, we are very, very closely watching and monitoring the situation with the COVID-19 pandemic. We have actually no changes to our expectations for DARZALEX, ofatumumab and/or eculizumab at this time. So we actually anticipate the approval of the subcu DARZALEX formulation in the first half of this year in the U.S. and in the second half in Europe, assuming a normal review process. So J&J will report earnings and Q1 DARZALEX net sales on April 14. This is probably the first time that you can actually see an impact, if any, on the DARZALEX sales for this year. And we will actually report on our Q1 data on May 6 with potential updates on DARZALEX sales as well as on the sales guidance. We anticipate ofatumumab in relapsing MS to get a U.S. approval in June of this year because it has priority review. And for epcoritamab clinical trial, I'm happy to say that this is actually on track. And we are actually actively engaging with a number of biotech and biopharma powerhouses for partnering of this super-exciting product candidate as we speak, and a lot of that is, of course, now going via telepresence and via video or regular telephone calls because of the difficulties in traveling by air, but it's going well. And that's, Jorgen, where -- I want to leave at that.

Jørgen Madsen

attendee
#9

[Interpreted] Thank you very much. That was the reply for the Danish Shareholders' Association. I have not received any further questions or comments. And as I do not see any requests -- are there any requests for the floor in this room? Then I will ask you to go to the rostrum down here and state your name for the record.

Unknown Attendee

attendee
#10

A few years ago, I attended the general meeting, and there was a lady. She was the CEO, or was she the Chairman, I can't remember that, that she talked about the company has some clinical studies together with the company called GlaxoSmithKline concerning asthma medicine. I have asthma myself. So I'd like to know did there come anything out of this? Or are you out of this line altogether?

Jørgen Madsen

attendee
#11

[Interpreted] Thank you for that question, and I give the floor to Jan van de Winkel.

Jan van de Winkel

executive
#12

Thank you, Jorgen, and thank you for the question. We indeed had an interaction with GlaxoSmithKline. That was primarily around Arzerra, which is an antibody, which we developed for cancer -- treatment of cancer. And at that time, this antibody was also tested in some other indications, probably not asthma, but definitely in a number of other diseases. And what I did today is actually update you that this will become a very, very important medicine, we believe, for treatment of relapsing MS, multiple sclerosis, which is also an autoimmune disease, but not under the leadership of GlaxoSmithKline. Because in 2015, ofatumumab, which is the name of the antibody, was moved over from GlaxoSmithKline to Novartis. So Novartis is now developing ofatumumab for relapsing MS. There's no activities in asthma. But what you may actually have remembered is that in the early days, where Lisa Drakeman was the CEO of the company, who probably spoke about ofatumumab, we also had an interaction with Roche. And for Hoffmann-La Roche, some of the programs were actually in asthma. So you remember that correctly. But unfortunately, those programs have been stopped and not went further or forward. This is the decision of Hoffmann-La Roche and not Genmab's. So this is part of our business. Sometimes, you need to try new candidate medicines in new areas. And sometimes you are successful, I think, a very good example is teprotumumab. I want to say a few words about that. Teprotumumab was developed by Genmab in 2002, together with Hoffmann-La Roche, for the treatment of cancer. And unfortunately, the drug didn't work in cancer after having spent over $200 million, Hoffmann-La Roche decided to stop that development. The good thing is that they moved over teprotumumab to a group of investors called River Vision, and they tested that antibody in Graves' eye disease, thyroid eye disease, which is a disease for which no treatment exists at this moment. And guess what, the data -- the clinical data were absolutely spectacular in Graves' eye disease. The drug got priority review. It got a breakthrough therapy designation. And as of January this year, I was happy to say this drug is now on the market as TEPEZZA, which is the very first drug ever in the world for treatment of Graves' eye disease. Doctors are super-enthusiastic about using that in patients with Graves' eye disease. And I can tell you neither Roche nor us could have even dreamed of develop a drug for Graves' eye disease at that time. So this is what happens in biopharma. Sometimes you find applications or ways of using drugs in totally new areas. And sometimes, unfortunately, like I discussed, some drugs don't work in areas where you hope them to work. So that's probably where I need to leave at that. But thank you for the question.

Jørgen Madsen

attendee
#13

[Interpreted] Thank you very much. If there are no further questions or remarks, and that does not seem to be the case, then I will take that to mean that the Annual General Meeting has taken the report by the Board of Directors, take note of the report that they have approved the annual report, that they have given discharge to the Board of Directors and the executive management and that they have approved the resolution on the distribution of profits. That leads me to item 4 on the agenda. And that is the election of members for the Board. And here, I will give the floor to the Chairman of the Board, Mats Pettersson.

Mats Pettersson;Chairman of the Board

executive
#14

So each year, we evaluate the composition of the Genmab Board to ensure that we have the right mix of competencies for an international biotech company and consider whether changes need to be made. While it has been an honor to lead the Genmab Board of Directors during the past 7 years, it is now time for me to make a change and step down. But I'm pleased to recommend reelection of the rest of the current AGM elected Board members with Deirdre Connelly proposed as new Chairman and Pernille Erenbjerg proposed as a new Deputy Chairman. Also Jonathan Peacock is proposed as a new addition to the Board. And I will now run through the competencies and biographies of the Board members for election. So next slide, please. Deirdre Connelly was elected to the Board in 2017 and is standing for reelection for a 1-year period, currently, the Deputy Chairman, she is proposed, as I said, to become the new Chairman. She brings extensive experience in drug launches and corporate governance to the Board, both of which will become increasingly important as Genmab continues to grow. So next slide, Pernille Erenbjerg was elected to the Genmab Board in 2015 and is standing for reelection for a 1-year period. Pernille is proposed as a new Deputy Chairman of the Board. Pernille qualifies as an audit committee financial expert and adds valuable financial expertise to the Board. Next slide. Anders Gersel Pedersen has served on Genmab's Board since 2003 and is also standing for reelection for 1-year period. Anders continues to provide important insights into the biotech industry and the Danish investment community to the Board. Next slide. Paolo Paoletti was also elected in 2015 and is also standing for reelection for 1-year period. Paolo's broad pharma and oncology experience gained during its tenures at GlaxoSmithKline and Eli Lilly makes him a valuable Board member for Genmab. Next slide. Rolf Hoffmann was elected to the Genmab Board in 2017 and is also standing for reelection for a 1-year period. Rolf's significant commercial experience is a valuable competency that Genmab will need as we work towards achieving our 2025 vision. Next slide. And the Board also recommends electing Jonathan Peacock for the Board for a 1-year period. Previously CFO at both Novartis and Amgen. He brings with him extensive experience in corporate finance, strategy and international expansion in the pharmaceutical industry. He also has a degree in economics, he's a chartered accountant, and also has a background as a partner at McKinsey and Price Waterhouse. Next slide. In addition to the Board members elected by the general meeting, we also have 3 employee-elected Board members, Peter Storm Kristensen; Mijke Zachariasse; and Dan Bruno. All 3 of the employee Board members were elected to the Board last year for a 3-year period. And I will now hand back to the Chairman of the meeting, so he can lead the election of the Board of Directors. Next slide.

Jørgen Madsen

attendee
#15

[Interpreted] Thank you very much. As it appears from the proposal, all of the Board members, except for the Chairman, Mats Pettersson, are proposed for reelection. And the Board proposes that Jonathan Peacock is elected as a new member. We have not received any further proposals for other candidates. And as I do not see any proposals from the room, I can simply state that we have reelected, Deirdre Connelly; Pernille Erenbjerg; Anders Gersel Pedersen; Paolo Paoletti; and Rolf Hoffmann and that we have elected Jonathan Peacock. Congratulations to all of you. By the end of this item, I must ask if there are any remarks from Jan van de Winkel on the election to the Board.

Jan van de Winkel

executive
#16

Thank you, Jorgen. There's definitely some remarks. I would like to actually thank Mats Pettersson on behalf of the whole company as well as the Board for many excellent contributions over 7 years and for many stimulating and inspirational discussions and feedback. This was greatly appreciated, Mats, and of extraordinary importance for the company and its growth. And I can tell you, it was also fun to work with you. So thank you, Mats, on behalf of us all, and wishing you the very, very best for the future.

Jørgen Madsen

attendee
#17

[Interpreted] Yes. Thank you very much. I'm sure we would hear and applaud if we had a full room today. We will hear a bit of an applaud from the persons present today. That leads me to item 5 on the agenda today. The election of auditor. Here, the Board of Directors proposes reelection of PricewaterhouseCoopers. In accordance with the recommendations of the Audit and Finance Committee, there are no other candidates, and I can state that PricewaterhouseCoopers have been reelected as the company auditor. Congratulations. That brings me to item 6 on the agenda. These are the proposals from the Board. And let me just mention that out of the 3 proposals, it is only item 6C, the technical change of the Articles of Associations that it is required to be adopted by an affirmative vote of no less than 2/3 of the votes cast as well as the voting share capital represented at the general meeting. We'll take the proposals one at a time. First of all, item 6A, the proposal for the adoption of a new remuneration policy. And here, I give the floor to our Deputy Chairman, Deirdre Connelly.

Deirdre Connelly

executive
#18

Thank you, Jorgen. As prescribed by the newly implemented section 139 of the Danish Companies Act on adoption of a remuneration policy for members of management, the Board of Directors proposes to adopt a new remuneration policy for the Board of Directors and the executive management of Genmab. During 2019, the company's compensation committee appointed independent compensation advisers to support a review of Genmab's compensation. The review was made in light of Genmab's business strategy and the feedback we have received from our shareholders as well as the voting guidance services or proxy advisers in connection with a program of engagement with our largest shareholders and those proxy advisers. The elements of the proposed remuneration policy are designed to be competitive when compared to the compensation programs and levels of compensation in other similar international biotech and biopharmaceutical companies in the U.S. and in Europe. The proposed remuneration policy has been designed to align the interest of shareholders, the company's Board of Directors and executive management and will allow the company to position pay not at U.S. levels, but in a way that enables us to create compensation packages, which are attractive internationally and at the same time, are in alignment with our values. As a consequence of the adoption of this proposal, the company's remuneration principles will automatically be repealed, and Article 14 of the Articles of Association regarding these principles will be deleted. And as a consequence of that deletion of Article 14, the number of the Articles of Association will change, whereby the current Article 15 will become Article 14 and so forth. With that, I will now hand back to Jorgen, who will continue proceedings regarding the agenda item.

Jørgen Madsen

attendee
#19

[Interpreted] Thank you for the introduction. We have not received any questions or comments on this item. And since I don't see anything in the room, I can conclude that this item on the agenda has been adopted. And now we have item 6B. It is the adoption of the remuneration of the Board of Directors for this year. As you will see from the details on the screen, this is an unchanged situation compared with last year, and we have not received comments or questions on this item either, and I hear nothing in the room. So I take that this item has been adopted. Then we have 6C, an amendment to Article 6 of the Articles of Association concerning the book and registration of our shareholders. VP Services have been merged with its parent company, VP Securities A/S, and that is the only reason why we have this on the agenda. We needed to adjust this. And there are no comments or questions on this item. And I, therefore, note that it has been adopted. And item 7. This is the usual item of authorizing the Chairman of the Annual General Meeting to register the changes that have been made with the Danish Business Authorities, and we have no questions or comments on this item either. And I don't think there's anybody in the room either. So I can take it that this item stands adopted, which means we now have the last item on the agenda, which is any other business. And we have not received any material either and if nobody present in the room wishes to speak, I will just note that we have exhausted the agenda. I will now step down from my duties here and thank everybody for the excellent AGM. And this, of course, is an extraordinary one, and I now give the floor to the Chairman for a conclusion. Next slide.

Mats Pettersson;Chairman of the Board

executive
#20

Thank you very much, Jorgen, for this. And thank you very much for every year, you have so brilliantly steered and guided us through the AGMs. But as you know and all of you that this is my last shareholders' meeting in Genmab. And I would like to thank all the shareholders for having elected me as Chairman over the last 7 years. As you all know, These have been fantastic years, not only for the extraordinary value creation, as a matter of fact, more than 10x since I started, but even more important that more than -- today, more than 100,000 cancer patients live longer and with high-quality life, thanks to medicines developed by Genmab. And I'm convinced that the Board of Directors you have elected today have all the skills and experience to further strengthen and guide Genmab in the future. I wish all of them good luck and good health. I am especially pleased that Deirdre Connelly will take on the chairmanship position after me. My last and deepest felt thank you goes, however, to our CEO, Jan van de Winkel. He is the mastermind and force behind the successes in Genmab. His passionate belief in the fact that combination of science and knowledge be turned into life-saving medicines is a single most important trait of Genmab. It's embedded in its DNA, so to say. The vision he and the company have now, will, in my mind, guide and lead the company to even further successes in the future. I wish Jan, his management, all employees, all the best in the future. And, once again, thank you very much for 7 amazing years, as well for the very warm words I heard from Jan. I will cherish those now in the COVID-19 times and hopefully for a long time thereafter. So thank you very much, and hope your health will be with you. Bye.

Jan van de Winkel

executive
#21

All right. I think that concludes today's meeting. Thank you all for the active participation. Really appreciate it, and stay safe, stay healthy. Please. [Portions of this transcript that are marked [Interpreted] were spoken by an interpreter present on the live call.]

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