Genmab A/S (GMAB) Q4 2022 Earnings Call Transcript

Genmab A/S (GMAB) Q4 2022 Results Conference Call February 22, 2023 12:00 PM ET

Company Participants

Jan van de Winkel - President and Chief Executive Officer

Anthony Pagano - Chief Financial Officer

Judith Klimovsky - Chief Development Officer

Anthony Mancini - Chief Operating Officer

Tahamtan Ahmadi - Chief Medical Officer

Conference Call Participants

Matthew Harrison - Morgan Stanley

Peter Verdult - Citigroup

Sachin Jain - Bank of America

Jonathan Chang - SVB Securities

Elizabeth Walton - Crédit Suisse AG

Paul Jeng - Guggenheim Securities

Yaron Werber - Cowen and Company

Emily Field - Barclays

Asthika Goonewardene - Truist Securities, Inc

Etzer Darout - BMO Capital Markets

Matthew Phipps - William Blair & Company

Operator

Hello, and invited to nan Genmab Full-year 2022 Conference Call. As a reminder, this convention telephone is being recorded. During this telephone conference, you whitethorn beryllium presented pinch forward-looking statements that see words specified arsenic believes, anticipates, plans aliases expects. Actual results whitethorn disagree materially, for example, arsenic a consequence of delays aliases unsuccessful improvement projects.

Genmab is not nether immoderate responsibility to update statements regarding nan early nor to corroborate specified statements successful narration to existent results unless this is required by law. Please besides statement that Genmab whitethorn clasp your individual information arsenic indicated by you arsenic portion of our Investor Relations outreach activities successful bid to update you connected Genmab going forward. Please mention to our website for much accusation connected Genmab and our privateness policy.

I would now for illustration to manus nan convention complete to your first speaker today, Jan van de Winkel. Please spell ahead.

Jan van de Winkel

Hello, and invited to Genmab’s convention telephone to talk nan Company’s financial results for nan play ending December 31, 2022. With maine coming to coming these results is our CFO, Anthony Pagano. For nan Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky; our Chief Operating Officer, Anthony Mancini; and our Chief Medical Officer, Tahamtan Ahmadi.

Let’s move to Slide 2. As already said, we will beryllium making forward-looking statements truthful please support that successful mind arsenic we spell done this call.

Let’s move to Slide 3. Genmab has a science-anchored and innovation-based civilization and collaborations and partnerships person ever been portion of our DNA. During today’s presentation, we will reference products being developed nether nan strategical collaborations and this descent acknowledges those relationships.

Let’s move to Slide 4. Genmab has had transformative maturation successful each areas of our statement arsenic we transitioned into an integrated biotech that brings our ain medicines to patients. Certain basal aspects of our business, however, will stay unchanged. And these see innovative sciences that are core, and we strive to beryllium guardant reasoning successful each areas of our business.

And we person an unstoppable squad that aspires to usage our innovations successful antibody therapeutics to fundamentally toggle shape nan lives of patients. These foundational pillars led to awesome advancement past year, mounting america connected nan way that inspired our 2030 vision, which we unveiled successful 2022.

Let’s move now to caller accomplishments that will support our early success. Slide 5. 2022 marks nan 10th twelvemonth of profitability for Genmab. As Anthony will picture successful detail, this occurrence is owed to some our increasing recurring gross streams and are investing this gross into - successful a focused and disciplined manner.

Throughout nan past year, we proceed to put successful nan strategical maturation of our squad and nan maturation and nan description of our differentiated innovative merchandise pipeline. In September of past year, we, together pinch our partner, Seagen, celebrated nan first full-year of TIVDAK being disposable for cervical crab patients successful nan U.S.

At nan opening of this year, nan NCCN updated their cervical crab curen guidelines, upgrading TIVDAK to a preferred regimen for 2nd statement aliases consequent therapy successful recurrent aliases metastatic cervical cancer. This day is important for patients who are entering their 2nd statement of therapy and applies sloppy of nan biomarker status.

For this diligent population, TIVDAK nan only non-IO preferred curen regimen crossed nan second-line mounting for each comers sloppy of PD-L1 status. Based connected nan precocious unmet request and nan beardown efficacy results we person seen successful objective trials, supported by nan NCCN updates, we judge that TIVDAK is connected nan measurement to becoming nan clear second-line prime for women pinch recurrent aliases metastatic cervical cancer.

Turning to our adjacent imaginable medicine. 2022 was a captious twelvemonth successful nan improvement of epcoritamab. We person spoken some pursuing our Q3 results past twelvemonth and our 2022 ASH Investor Event astir nan BLA and MAA submissions by Genmab and our partner, AbbVie, respectively.

We are pleased to adhd to this our submission of a Japan NDA astatine nan extremity of December for epcoritamab for nan curen of patients that relapsed aliases refractory LBCL aft 2 aliases much lines of systemic therapy. With these regulatory submissions, we are 1 measurement person to perchance delivering epcoritumab arsenic a caller therapeutic action for group surviving pinch definite hematologic malignancies successful nan U.S., Europe and Japan.

Together pinch our partner, AbbVie, we judge that epcoritamab has nan imaginable to go a halfway therapy for patients astir nan world pinch B-cell malignancies, and we are committed to progressing a broad improvement programme evaluating epcoritamab crossed a wide scope of B-cell lymphomas. And we look guardant to receiving feedback from nan U.S. FDA by nan PDUFA day of May 21st.

The past twelvemonth was besides notable for information presentations and publications. These highlighted investigational medicines crossed our portfolio including a December article successful nan Journal of Clinical Oncology connected nan Phase I/II epcoritamab dose description data. We expanded our pipeline successful 2022 pinch caller investigational medicines entering nan clinic. One of these, HexaBody-CD27, is portion of an description of our driving collaboration pinch BioNTech.

I would besides for illustration to mention that arsenic you tin now spot connected clinicaltrials.gov, location is simply a caller limb successful nan Phase I/II proceedings of HexaBody-CD38, comparing it to subcutaneous daratumumab. This will beryllium a head-to-head information to find that a HexaBody-CD38 whitethorn beryllium much potent successful CD38 antibody naive patients pinch relapsed aliases refractory aggregate myeloma. We very overmuch look guardant to seeing really this proceedings progresses.

So now let’s now move to nan adjacent descent and a little reminder of nan effect of our invention beyond our ain pipeline. Slide 6. Partner-owned programs powered by our world-class invention and particularly our proprietary DuoBody level besides saw awesome advancement successful 2022.

Novo Nordisk’s extremity of Phase IIIa improvement and for some teclistamab and talquetamab, Janssen posted aggregate caller Phase III tests connected clinicaltrials.gov, including successful operation pinch daratumumab. In 2022, Janssen’s TECVAYLI became nan 2nd DuoBody-based medicine to person regulatory approval.

With our submission of a BLA for talquetamab successful December arsenic good arsenic a submission successful Europe successful January of this year, location is nan imaginable for approved medicine from our DuoBody statement pinch Janssen.

If some epcoritamab and talquetamab are approved successful 2023, location will beryllium 8 approved medicines that incorporated Genmab’s invention disposable for patients, half of which will beryllium powered by our DuoBody exertion platform.

I besides want to concisely mention immoderate breathtaking caller news. Last week, nan British Pharmacological Society announced that nan squad down nan improvement of amivantamab has been awarded its prestigious Drug Discovery of nan Year 2023.

The creation of amivantamab was a squad effort pinch nan 2 antibody libraries utilized to nutrient amivantamab generated by Genmab, hence, nan antibody brace utilized to create amivantamab selected successful collaboration pinch Janssen R&D, which subsequently led a preclinical and objective improvement by Janssen. This grant is further validation of nan imaginable of Genmab’s innovative DuoBody exertion level to create genuinely differentiated bispecific antibody therapeutics.

Now turning to DARZALEX. It continues to redefine nan curen of aggregate myeloma. And arsenic you person seen, J&J’s nett income for daratumumab are up 32% complete 2021. And that is generating much than DKK 10 cardinal successful royalty for us, contributing materially to our robust financials. I would besides for illustration to statement that nan income of KESIMPTA passed nan $1 cardinal people successful 2022. KESIMPTA is now nan 3rd blockbuster medicine connected nan marketplace created by Genmab.

I will now move nan telephone complete to Anthony Pagano to return you done our 2022 financial results. Anthony, nan level is yours.

Anthony Pagano

Great. Thanks, Jan. Let’s move to Slide 7. We proceed to fortify our instauration during 2022. To start, arsenic Jan conscionable mentioned, together pinch our partner, AbbVie, we person achieved our extremity of regulatory submissions for epcor successful nan U.S., Europe and Japan. And arsenic we will see, our financials for nan twelvemonth are exceptionally strong.

We grew operating profit by 111%. We besides accrued recurring revenues by 70%. This was principally driven by beardown royalties from DARZALEX and different approved medicines. But statement that favorable FX besides had a important effect here, and I’m going to return to this successful conscionable a bit.

Our beardown equilibrium sheet, increasing recurring revenues and important underlying profitability let america to proceed to put successful our business and our pipeline astatine a very focused and disciplined way. As an important portion of this has been to proceed to build nan squad and capabilities that we request to succeed.

So let’s return a look astatine those revenues successful conscionable a spot much item connected nan adjacent slide. We saw robust capacity for DARZALEX successful 2022. As you tin spot successful nan chart, overall, nett income grew by 32%. That is nett income of astir $8 billion, which translates to complete DKK 10 cardinal successful royalty revenue.

This exceptional maturation was driven by continued beardown marketplace shares, including further uptake of nan subcu formulation. And arsenic a reminder, for our royalties, we besides had a important FX tailwind.

So DARZALEX remains a cardinal driver of our revenue, arsenic you tin spot connected Slide 9. We grew full gross to astir DKK 14.6 cardinal successful 2022. And arsenic I’ve already highlighted, that included a 70% summation successful our recurring revenue. We person already spoken astir DARZALEX and nan very beardown capacity there.

Turning to KESIMPTA and TEPEZZA, we saw an summation of DKK 747 cardinal successful royalties compared to past year. And impressively, KESIMPTA achieved blockbuster position successful 2022. Taken together, this maturation really illustrates nan powerfulness of our recurring revenue.

Finally, we person seen immoderate beautiful important FX tailwinds, peculiarly for our royalty gross related to nan spot of nan dollar and nan contractual hedge complaint for DARZALEX. Let maine break that retired successful a spot much item connected nan adjacent slide.

In aggregate, of nan 70% year-over-year maturation successful recurring revenue, 30 percent points were related to FX tailwinds. And I will make a fewer points here. First, arsenic we each know, FX tin move successful some directions. So 1 year’s tailwind can, of course, go adjacent year’s headwind.

And second, pinch our 2022 figures enhanced by FX, we group up a reliable comp for 2023. That said, what is ace encouraging for maine is nan 40% underlying operational growth. So successful 2022, we person materially strengthened our gross profile.

Now let’s return a look astatine really we are utilizing our beardown recurring gross to proceed investing successful a highly focused way. As you would expect, fixed nan investments we are making, full OpEx grew 51% for nan year.

In R&D, we person accelerated our finance into our merchandise portfolio, particularly nan advancement of epcor and different pipeline projects. We person besides further strengthened our squad to heighten our commercialized capabilities and support our expanding pipeline. That includes TIVDAK and nan filings and imaginable motorboat for epcor.

Now let’s return a look astatine our financials arsenic a full connected Slide 12. Here, you tin spot our summary P&L for 2022. Revenue came successful astatine astir DKK 14.6 billion. That is up 72% connected past year, favorably impacted by a important FX tailwind, arsenic mentioned previously.

Total expenses were astir DKK 8.2 cardinal pinch 68% being R&D and 32% SG&A. And that brings america to our very beardown operating profit of complete six billion, and that is an summation of 111% compared to 2021.

Moving now to our nett financial items. Here, we person income of astir 700 million, which is chiefly driven by nan aforesaid 2 partially offsetting items that we person highlighted recently. First, we person sewage nan strengthening of nan U.S. dollar against nan Danish kroner positively impacting nan worth of our rate and investments.

On nan different broadside of nan ledger, we person losses connected our marketable securities owed to rising liking rates and immoderate losses connected our nationalist equity investments. And finally, location was an summation successful liking income owed to higher effective liking rates. Then we person taxation disbursal of astir DKK 1.5 billion, which equates to an effective taxation complaint of 21.5%.

It is important to statement that this complaint is positively impacted by immoderate onetime items successful 2022 truthful it isn’t reflective of what we would expect moving forward. And that brings america to our nett profit of complete DKK 5.5 billion. So arsenic you tin see, highly beardown financial performance.

Now earlier we return a look astatine our 2023 guidance, I want to return a infinitesimal to revisit our financial model connected nan adjacent slide. First off, our gross floor plan connected nan left. At nan opening of 2020, DARZALEX was our only merchandise connected nan market. Today, we person six, and that will make continued recurring gross maturation successful 2023.

And we spot a clear way to perchance grow nan number of approved products pinch nan caller submissions for epcor and Janssen submissions for talquetamab. Taken together, we expect important rate inflows successful nan years to come.

Moving to nan right, we stay focused successful our investments arsenic we germinate our statement for continued success. At nan apical of nan database is accelerating and expanding epcor, but that is conscionable 1 of nan breathtaking opportunities that supply america pinch a compelling rationale for expanding investment. As we told you before, if personification sees these meaningful opportunities, we person sewage to invest. And that is precisely what we are doing.

So pinch that background, let’s return a look astatine nan components of our beardown recurring gross connected Slide 14. For 2023, we expect different twelvemonth of beardown underlying gross growth. Before I get into nan detail, statement that these projections are based connected an assumed U.S. dollar-Danish kroner speech complaint of DKK 6.8.

At nan consequence of stating nan obvious, I thought it important to item that arsenic champion we tin tell, Genmab collected statement has been derived utilizing 7.2. And arsenic a reminder, nan mean dollar-kroner complaint successful 2022 was 7.1.

Now looking astatine our full revenue, we are expecting to beryllium successful nan scope DKK 14.6 cardinal of DKK 16.1 billion, and much than 85% of this will travel from recurring revenue, which is up meaningfully from past year.

We expect that DARZALEX income will proceed to ramp up and beryllium successful nan scope of $9.4 cardinal to $10 billion. So we are projecting DARZALEX royalties to beryllium betwixt DKK 10.4 cardinal to DKK 11.1 billion.

Recurring revenues besides see a 32% summation successful royalties from TEPEZZA and KESIMPTA. But we besides expect important FX headwinds. So overall, we expect recurring revenues will summation by astir 12%.

Turning now to nonrecurring revenue. We expect this to beryllium 2.1 cardinal astatine nan midpoint successful 2023 compared to 2.7 cardinal past year. As you will recall, location were aggregate regulatory filings successful 2022, and we benefited by nan onetime milestones associated pinch these.

Let’s now return a look astatine our recurring gross successful conscionable a spot much item connected nan adjacent page. As I said, we are anticipating recurring gross maturation of astir 12%. And it is important to note, that is connected a reported basis. What we are really focused connected is delivering nan 25% operational growth, but this 25% maturation is partially offset by nan 13% antagonistic FX impact.

We are assuming little dollar to kroner complaint compared to 2022, and arsenic I said earlier, it is simply a reliable comp owed to nan DARZALEX contractual hedge complaint from past year. Now I deliberation it is important to measurement backmost and really look done this FX sound and attraction connected nan fundamentals of our very, very beardown gross growth.

Now pinch that, having looked astatine revenue, let’s look astatine our planned 2023 finance connected nan adjacent slide. We expect full OpEx to beryllium betwixt DKK 9.8 cardinal and DKK 1.6 billion, and this afloat reflects nan improvement of our pipeline and, indeed, our full business.

We person 3 near-term finance priorities: first, initiating caller Phase II and Phase III epcor tests to really maximize its potential; 2nd is generating nan adjacent activity of information for DuoBody PD-L1 4-1BB and DuoBody CD40 4-1BB; and of course, third, nan imaginable motorboat of epcor. These are our contiguous priorities.

But arsenic I noted, we are not conscionable focused connected today. In statement pinch our vision, we are besides very focused connected semipermanent worth creation. So we are continuing to build retired our building teams and systems. We are investing to maximize nan worth of our existent technologies, and we are besides investing to make nan adjacent activity of IND candidates and to advancement our early shape pipeline.

With that, let’s break retired our 2023 finance floor plan pinch a fewer numbers connected nan adjacent slide. Here, we person laid retired nan incremental investments we are expecting to make for our apical priorities successful 2023.

Starting astatine nan top, a successful motorboat for epcor will require a important magnitude of our attraction and investment, particularly connected building retired our 2 cardinal markets: nan U.S. and Japan. And arsenic a reminder, while nan first denotation for epcor is alternatively modest, complete nan mean term, we deliberation this tin beryllium a meaningful opportunity.

In particular, successful nan U.S. and Japan, wherever we are nan commercialized lead and booking nett sales, nan marketplace is highly competitive. So for a successful launch, we request to attraction finance successful this area. But of course, it won’t beryllium our only focus.

You tin spot nan biggest wide summation successful finance will beryllium successful advancing our portfolio. This is an finance for now and for nan early arsenic we look to grow improvement of our mid to late-stage programs arsenic good arsenic nan maturation of our wide portfolio.

As Jan mentioned, erstwhile talking astir our 2030 vision, we will besides beryllium making investments to move into a caller therapeutic area, which is portion of scaling up our already world-class find engine.

Now having looked astatine nan model and nan constituent parts, let’s look astatine really this each comes together connected Slide 18. Here, you tin spot our 2023 guidance. We expect our gross to beryllium successful nan scope of DKK 14.6 cardinal to DKK 16.1 billion, and astir of this is made up of recurring gross wherever we are expecting 25% of operational growth.

For OpEx, we expect to beryllium successful a scope of DKK 9.8 cardinal to DKK 10.6 billion. As I person antecedently highlighted, this step-up successful finance is afloat successful statement pinch our strategy and our attraction connected creating semipermanent value. Putting each this together, we are readying for important operating profit successful a scope of DKK 3.9 cardinal to DKK 6.2 billion.

Now for my last slide, fto maine supply a fewer closing remarks. In summary, we person an exceptional 2022. We created increasing recurring gross streams, and that gives america a beardown backbone of important underlying profitability and we are investing those revenues successful a highly focused measurement to recognize our imagination and to capitalize connected nan very important maturation opportunities successful beforehand of us.

And connected that note, I’m going to manus you backmost complete to Jan.

Jan van de Winkel

Thanks, Anthony. Let’s move to Slide 20. As Anthony said, 2022 was an exceptional twelvemonth for Genmab arsenic we made important advancement crossed each areas of our business. In 2023, we will proceed to activity towards our 2030 imagination pinch our KYSO antibody medicines, wherever our KYSO antibody medicines are fundamentally transforming nan lives of group pinch crab and different superior diseases.

We will commencement pinch bringing our ain medicines to patients. Subject to approval, we are enthusiastic astir nan imaginable motorboat of epcoritamab. We are besides looking guardant to moving pinch AbbVie to grow improvement studies.

We will collaborate pinch our partner, Seagen, to found TIVDAK arsenic a clear prime for patients pinch metastatic cervical cancer, and together, we will proceed to broaden nan tisotumab vedotin objective improvement program.

Turning to our world-class differentiated merchandise pipeline. We very overmuch look guardant to information from nan objective description cohorts and advancement to nan adjacent steps for some DuoBody molecules successful developments pinch BioNTech targeting 4-1BB.

We expect expanding and advancing different early-stage programs, including nan imaginable for aggregate further INDs aliases CTAs during this year. Fundamental to nan occurrence of these programs is having nan correct squad and civilization successful place. We intend to proceed to standard our statement based connected our planned portfolio improvement and business needs.

Finally, we intend to leverage our coagulated financial guidelines to support our growth, which could see outer opportunities. With each of this successful mind, we are very excited astir nan adjacent 12-months.

So let’s now move to my last slide. That ends our position of Genmab’s financial results for 2022. Operator, please unfastened nan telephone for questions.

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] We will now spell to our first question. And your first mobility comes from nan statement of Matthew Harrison from Morgan Stanley. Please spell ahead, your statement is open.

Matthew Harrison

Great. acknowledgment for taking nan questions. I conjecture 2 for me. Jan, I’m curious, you talked astir outer opportunities that you whitethorn beryllium looking at. Could you conscionable springiness america a small spot of much item astir what you whitethorn beryllium reasoning size, scope and whether these are technology-focused aliases product-focused?

And past second, conscionable connected nan - arsenic we deliberation astir epcor motorboat successful nan 2nd half of nan year, I’m not asking for guidance here. But conscionable possibly really should we deliberation astir immoderate of nan parameters. We person evidently seen aggregate precocious statement DLBCL launches from a assortment of drugs. Should we look astatine those arsenic nan correct benignant of comps to deliberation astir for epcor aliases are location different factors that you would item for us? Thanks very much.

Jan van de Winkel

Thanks, Matthew, for nan questions. And I will decidedly manus complete nan 2nd mobility to Anthony Mancini. But fto maine commencement first pinch nan outer opportunities, Matthew. We are very overmuch looking astatine nan outer landscape, some for components which we tin usage really to build differentiated antibody therapeutics arsenic we person done before.

Of course, past year, we did a number of deals pinch different companies for illustration [OVT, Orega, Stemcell] (Ph) to get antibody components make to really usage successful our next-generation antibody therapeutic formats. But we are besides looking astatine different technologies, caller types of ADCs, caller type of immune stimulators.

And arsenic we already revealed past year, we are going to adhd astatine slightest 1 important illness area to our attraction area successful cancer, and we perchance could do a strategical collaboration pinch different statement already having a beingness successful different illness area, Matthew.

So I deliberation it tin beryllium 1 of these aliases respective of these imaginable options, and I deliberation it is nan correct point to do to usage our financial resources to broaden our capabilities and suite of technologies really successful nan coming time.

I want to time off it pinch that, Matthew, and past manus complete to Anthony Mancini to inquire to springiness a spot much position connected nan epcor motorboat and really to deliberation astir that. Anthony.

Anthony Mancini

Yes. Thanks, Jan, and thanks, Matthew, for nan question. So conscionable to situate you successful position of really we are reasoning astir nan motorboat landscape, location continues to be, contempt approved options successful nan space, really a precocious unmet need, successful part, owed to nan fierce quality of LBCL based connected what we are proceeding from prescribers.

So CAR Ts are intelligibly a compelling innovation, yet galore patients are still incapable to get nan curen owed to various challenges impacting their availability. Some of nan different caller agents that are approved successful nan abstraction are accessible yet autumn short connected immoderate different areas, peculiarly successful efficacy.

So contempt nan truth that it is simply a humble opportunity, arsenic Anthony described earlier, pinch astir 3,800 caller U.S. diligent starts successful nan 3rd statement setting, we still deliberation nan unmet request continues to beryllium high, and we proceed to perceive from prescribers successful some nan world and organization mounting that if they could take a azygous supplier that offers an optimal floor plan that balances powerful efficacy, manageable information and a seamless diligent acquisition pinch subcutaneous administration, that it is so differentiating.

So of course, this first denotation is simply a starting constituent that we will build from and hopefully thief alteration epcor to go a halfway therapy crossed LBCL, FL and beyond. Thanks for nan question.

Operator

Thank you. And your adjacent mobility comes from nan statement of Peter Verdult from Citi. Please spell ahead, your statement is open.

Peter Verdult

Just a mates of questions. Maybe conscionable to effort nan connection connected nan BioNTech collaboration. I deliberation you person gone from wanting to person astatine slightest 1 of those antibodies into Phase III this twelvemonth to conscionable 1042. I conscionable want to make judge I understand what is changed aliases thing there. And conscionable nan latest thought necktie erstwhile you are - conscionable being your sensible conjecture arsenic to erstwhile we mightiness spot HexaBody days to really travel in. Is adjacent twelvemonth still apt aliases should we beryllium pushing our expectation?

And past secondly, conscionable Jan, I’m expecting nan consequence to beryllium rather short. Have you sewage immoderate benignant of penetration aliases clarity arsenic to erstwhile we mightiness get a solution of nan ongoing arbitration connected accelerated growth? Thank you.

Jan van de Winkel

Thanks, Peter, for nan questions. I will fto Taham to talk astir nan BioNTech telephone programs and nan HexaBody-CD38 information timing and tin beryllium brief, Peter, connected my reply to nan J&J arbitration case. I deliberation it is astatine afloat swing. And we dream that we get a solution sooner alternatively than later, but nan timing is wholly down to nan panel, to nan arbitrator. So I cannot springiness you immoderate color, Peter, connected nan timing of nan imaginable result of nan arbitration.

What I tin opportunity is that nan process is successful afloat swing, and I deliberation each nan paperwork and each nan documents are successful place, and we dream for a solution and of course, for a affirmative result sooner alternatively than later.

Having said that, I’m handing complete to Taham to spot whether you tin springiness a spot much color, Taham, connected nan 2,400 targeted bispecific BioNTech and imaginable timing of information et cetera. Taham.

Tahamtan Ahmadi

Will effort my best. Yes, I would say, no, thing has changed. I say. So some of these programs 1046, 1042, nan 2 4-1BB bispecifics that we are co-developing pinch BioNTech are connected way connected generating nan data.

And arsenic we person communicated before, we expect to person that information successful our hands successful nan 2nd half of nan year, and past we will make nan due decision. So thing has changed successful that end. And location is thing that astatine this constituent would bespeak immoderate changes to what we person communicated before.

And nan C38, I deliberation we person besides been very clear that really nan clip points to look astatine information that will some pass america and past perchance location connected Janssen and that determination is 2024.

Operator

Thank you. We will now spell to our adjacent question. And your adjacent mobility comes from nan statement of Sachin Jain from Bank of America. Please spell ahead, your statement is open..

Sachin Jain

Hi there, Sachin Jain here, Bank of America. A mates of questions, please. Just firstly connected DARZALEX. Do you mind giving a spot of colour arsenic to what percent of income you spot successful 2nd statement and really you are reasoning astir consequence from nan J&J CAR T data, which was precocious headlined conscionable accepted 1 of Anthony’s comments connected CAR T existing penetration. But conscionable really you could soma retired your thoughts there. And past 2 explanation questions to nan anterior question, please connected 1042, 1246, is it adjacent to therefore, deliberation if - Taham, you are talking astir information and really 2nd half but really for a convention presentation, we are looking good into nan year, towards nan extremity of nan year, is that fair?

And past for nan CD38, if you could conscionable supply a spot of colour arsenic to why you person conscionable added nan subcu limb was that your determination aliases J&J and does that hold nan determination constituent for J&J. I cognize you said 24%, but I deliberation nan anterior moving presumption was benignant of early 2024 for decision, but is that pushing that determination into mid debased extremity of 2024? Thank you.

Jan van de Winkel

Thanks, Sachin, for nan questions. I’m going to manus complete nan first mobility connected nan second-line sales, which looks very encouraging. I tin guarantee you connected nan latest marque effect information to Anthony Mancini, and past Taham tin grip nan different 2 questions connected nan timing of information dissemination for 1042, 1046 arsenic good arsenic nan timing for HexaBody CD38 later. Maybe Anthony Mancini, you tin commencement giving a spot much colour connected 2nd statement usage of DARZALEX arsenic it stands and imaginable title from CAR T, really we spot that.

Anthony Mancini

Thanks, Jan, and thanks, Sachin, for nan question. As it relates to nan 2nd line, I mean I really deliberation location is simply a mobility for J&J to beryllium champion positioned to reply nan creation of their full business DARZALEX.

What tin remark connected from a stock position is that nan 2nd statement information of nan business continues to execute very well. It is simply a 50% stock for DARZALEX, and we proceed to spot continued maturation location pinch caller patients exceeding full patients successful nan second-line setting.

And CAR-Ts still do - will person a place. Clearly, contempt nan limitations that they have, location are still patients that move very quickly betwixt lines successful nan aggregate myeloma setting. So we do deliberation that CAR Ts will play a role.

That said, nan superior maturation facet for DARZALEX really continues to beryllium driven by frontline, and we proceed to spot very beardown maturation successful that abstraction and tons of maturation imaginable to proceed driven by frontline and stock gains, some successful nan U.S. and ex-U.S. arsenic reimbursement continues. So I will time off it location and walk it backmost to you, Jan.

Jan van de Winkel

Thanks, Anthony. Maybe complete to Taham to springiness a spot much colour connected imaginable information dissemination for nan 4-1BB targeted bispecific program, Taham, and immoderate colour connected HexaBody CD38 timing of data, head-to-head data.

Tahamtan Ahmadi

I will return nan CD38 first. Jan mentioned astatine nan opening of nan telephone that location is been immoderate updated objective tests I’ve got. So we person been progressing nan steps that we request successful bid to make nan information head-to-head to DARZALEX subcu. And we are moving connected to that, we will make nan information and we person been having accordant pinch that.

I deliberation 2024 is simply a clip constituent wherever we astir apt will person nan information successful our hands to make a reasonable decision. And that will beryllium existent for america and Janssen and past also, arsenic you pass to nan outset. As it relates to - yes, you are perfectly correct.

The conferences successful nan coagulated tumor abstraction successful nan 2nd half are dispersed much towards nan extremity of nan twelvemonth arsenic to nan information merchandise for these conferences is astir apt a small spot earlier. And truthful successful nan end, it is simply a usability of generating nan information and getting it out. So we person nary much to adhd to that.

Operator

Thank you. We will now spell to nan adjacent question. And your adjacent mobility comes from nan statement of Jonathan Chang from SVB Securities. Please spell ahead, your statement is open.

Jonathan Chang

First question, connected nan 2023 gross guidance, tin you talk what you spot arsenic nan cardinal factors that find wherever you mightiness onshore successful that range. fixed nan little extremity suggests small alteration versus 2022? Are location different cardinal drivers beyond dara and FX that we should beryllium considering?

And 2nd question, arsenic you hole for nan imaginable epcor launch, what do you spot arsenic a cardinal determinant for whether aliases not epcor tin go nan marketplace leader successful nan CD20 by CD3 people successful nan first relapsed/refractory DLBCL mounting and beyond?

Jan van de Winkel

Thanks, Jonathan. Excellent questions. The first one, I will delegate to Anthony Pagano and past nan epcor motorboat mobility will spell to Anthony Mancini. Maybe Anthony Pagano tin start.

Anthony Pagano

Thanks, Jonathan. I admit getting a mobility connected nan net telephone today, truthful that is awesome to fto maine subordinate nan fun. Overall, arsenic you benignant of highlighted, gross scope is DKK 14.6 cardinal to DKK 16.1 billion, and nan header numbers you benignant of rightly constituent out, connected a reported basis, this is conscionable a 12% increase. But arsenic I highlighted, pinch nan important FX headwind. So connected an operational basis, this is for illustration we are really focused connected nan execution here, is 25% maturation truthful important growth.

You already highlighted immoderate of nan large plaything factors, astir notably DARZALEX. There we are guiding very important maturation scope of $9.4 cardinal to $10 billion. Maybe 1 point that I didn’t screen beyond that connected - successful my prepared remarks is really past connected nan milestones. So here, location is simply a small spot of, let’s telephone it, variance betwixt nan little extremity and nan precocious end. And here, I will conscionable drill into this a spot for you.

So successful position of nan milestones for 2023, we person a full scope of DKK 1 cardinal to DKK 1.4 cardinal and astir 70% of this is related to epcor. Now for epcor connected nan little extremity of this - nan little extremity of nan guideline for epcor, we person 3 milestones: truthful 1 associated pinch nan U.S. approval, a 2nd 1 associated pinch nan EU support and past third, we person a filing for a caller denotation successful 1 territory. So that is for nan little extremity of nan guidance for epcor.

And past secondly, connected nan precocious extremity of nan guidance for epcor, location is an further milestone supra and beyond what I conscionable said, and that further milestone would beryllium filing for a caller denotation a 2nd territory.

I think, Jonathan, if we benignant of measurement back, nan fundamentals of our wide maturation story, six products compared to 1 a mates of years ago, clear way to perchance adding #7 to #8 during nan people of 2023 and wide very beardown 25% operational maturation looking guardant to successful nan people of this upcoming year.

Anthony, you want to return nan 2nd question?

Anthony Mancini

Yes. Thanks, Anthony, and thanks, Jonathan, for nan question. It is simply a awesome question. It is going to be, I think, a competitively aggravated marketplace, but we for illustration wherever we stand. And certainly, we are pleased pinch nan readiness advancement we person been having crossed functions pinch our partner, AbbVie. Our section teams are fresh crossed aesculapian income and marketplace access. They are successful spot and afloat trained. Our diligent services squad is fresh to go, and we person already started progressive discussions pinch payers done preapproval accusation speech and nan reactions person been positive.

What I would opportunity successful position of what is cardinal is that we want to guarantee very quickly that wellness attraction providers, whether they are sitting successful nan organization aliases nan world setting, person a very clear knowing of really to safely and efficaciously administer epcor.

We deliberation that doing that quickly crossed sites of attraction is simply a cardinal facet truthful that we tin really commencement to found epcoritamab arsenic nan optimal curen prime successful nan 3rd statement positive setting. And we deliberation if we tin commencement our lead there, that we tin build our lead.

So nan cardinal will beryllium to seamlessly coordinate crossed channels and crossed - truthful that we guarantee an optimal end-to-end customer experience. I will time off it astatine that, Jonathan, and look guardant to nan continued progress.

Operator

Thank you. And your adjacent mobility comes from nan statement of Elizabeth Walton from Credit Suisse. Please spell ahead, your statement is open.

Elizabeth Walton

Hi there, convey you for taking my questions . Just a mates near from me. You noted successful your 2023 priorities nan sBLA submission for epcor this year. Perhaps you tin update america connected erstwhile we could expect to spot nan imaginable pivotal information successful relapsed refractory follicular lymphoma and if we should deliberation of a imaginable submission successful nan 2nd half of nan twelvemonth and past conscionable to touch backmost connected nan CD38 HexaBody, are you capable to corroborate whether nan J&J opt-in action for this plus does not expire wrong 2023?

Jan van de Winkel

Thanks, Elizabeth, for nan questions. I tin show you that nan action for CD38 HexaBody does not expire, I tin show you this year. So we request to cod nan data, and past location is simply a only a fewer period action play aft we taxable nan objective information that J&J tin opt successful aliases retired HexaBody CD38. So it is still intact.

And nan first mobility connected nan information successful relapsed refractory lymphoma and besides follicular lymphoma, I will inquire Judith to springiness you a spot much colour connected timing. Judith.

Judith Klimovsky

Yes. Thank you for nan question. So nan mobility was specifically for nan pivotal follicular lymphoma, and we expect to person this information by nan 2nd half of this year.

Operator

Thank you. And your adjacent mobility comes from nan statement of Michael Schmidt from Guggenheim. Please spell ahead, your statement is open.

Paul Jeng

This is Paul connected for Michael. I had 1 really connected nan earlier pipeline connected nan B7-H4 bispecific. Just wondering really are you presently approaching diligent recruitment for that Phase I study? Is location immoderate weighting towards 1 of nan 4 prime tumor types and do you envision that benignant of biomarker action strategy down nan statement and past possibly a speedy follow-on. How should we deliberation astir nan differences betwixt nan CD3 bispecific attack versus immoderate of nan ADCs for B7-H4?

Jan van de Winkel

Thanks, Paul. I will manus complete nan mobility to Taham, and past nan possibly Judith tin besides spot successful I deliberation aft Taham has already fixed his first thoughts connected nan B7-H4 bispecific program, which we are very excited about. And Taham, possibly you tin springiness a spot of penetration into tumor strategy, biomarker strategy and past possibly you aliases Judith tin springiness immoderate further position connected CD3 T compartment engagers versus ADC approaches for B7-H4? Taham.

Tahamtan Ahmadi

Sure. First part, nan mobility of indications. So yes, B7-H4 location are immoderate indications wherever B7-H4 rather consistently and analogously expressed. And these are nan ones that we are presently concentrating successful nan study and this is -. And past different indications for B7-H4 is expressed but not needfully ever consistently astatine a precocious level. And these are indications wherever perchance a biomarker strategy would beryllium relevant.

So correct now, we are focusing connected enrolling patients successful nan first quality proceedings that based connected soul and outer information person diseases that are known to person B7-H4 look consistently. And I deliberation nan operative for it is consistently here. And past successful a early improvement plan, we will astir apt besides look astatine indications wherever we mightiness person to prime based connected B7-H4 because it is not needfully consistently expressed. So that would beryllium nan B7-H4 wide strategy not to springiness excessively overmuch distant connected that.

And past connected nan mobility of ADC versus CD38, I deliberation fundamentally, these are wholly different system of actions that person different opportunities and challenges. So that is astatine slightest my constituent of view. How different mobility nan circumstantial item that you would for illustration to know, but benignant of sharing that B7-H4 has to beryllium successful nan tumor, they are very, very different, some successful nan look that they request and nan system and nan imaginable arsenic acold arsenic nan information buffer .

Jan van de Winkel

Thanks, Taham. I don’t cognize whether Judith wants to adhd anything. Otherwise, we will springiness it backmost to you, Paul. Judith? Do you want to adhd thing here?

Judith Klimovsky

Nothing to add. I deliberation that arsenic Taham alluded it dangle connected nan look of nan target modernity of nan target and nan look of nan target successful nan tumor vis-a-vis is normal cell. And this is why we show bispecific.

Operator

Thank you. And your adjacent mobility comes from nan statement of Yaron Werber from Cowen. Please spell ahead, your statement is open.

Yaron Werber

Great. I besides person a mobility connected specifically successful AML. And tin you springiness america a small consciousness of what is nan scheme there, is location a chance to trial it besides successful that mounting conscionable fixed that DARZALEX evidently couldn’t show activity location historically?

And past secondly, is nan thought conscionable arsenic you deliberation down nan statement to spell to DARZALEX refractory mounting successful myeloma aliases is location a chance to really move up? And really do you do that is that pivot connected MRD negativity arsenic an endpoint.

Jan van de Winkel

Thanks for nan questions. I deliberation Taham tin grip this. Taham, HexaBody CD38 .

Tahamtan Ahmadi

Sure. First mobility first. So I mean, let’s really commencement opening pinch nan CLD. The presumption astir nan HexaBody C38 programme is that explication leads to a little period needed for nan look of [indiscernible], and frankincense would summation nan efficacy some successful aggregate myeloma but besides unfastened up spaces wherever daratumumab was incapable to elicit - consequence was nan density of CD38 is not arsenic precocious and that would be, for example, nan [indiscernible] or, arsenic you mentioned, AML. So that is really you tin deliberation astir really we are approaching this.

And past to nan 2nd mobility astir wherever to position, early position will beryllium a chat of who is - successful nan early successful complaint of processing nan drug. But having said that, nan impervious of people is generated successful patients who are dara naive successful a nonstop comparison betwixt daratumumabin nan HexaBody CD38 because this is nan champion measurement of proving and documenting besides that exonization does so request to beryllium efficacy awesome and nan unchanged information floor plan because dara, of course, has a very favorable information profile. And that is astir apt nan spot wherever this supplier successful nan system makes much sense.

Operator

Thank you. And your adjacent mobility comes from nan statement of Emily Field from Barclays. Please spell ahead, your statement is open.

Emily Field

Hi acknowledgment for taking my questions. I will conscionable inquire two. The first 1 is conscionable connected nan Part B description of nan HexaBody CD38 head-to-head trial. Relapsed/refractory CD38-naive patients is what you are looking for. All nan tests has appeared to beryllium successful nan U.S. and Western Europe. Are uncovering those relapsed/refractory DARZALEX naive diligent going to beryllium a situation successful those regions aliases are you going to person to adhd much sites to that proceedings fixed really successful DARZALEX has been?

And past possibly conscionable benignant of a higher-level mobility connected you person indicated nan desire to possibly move into a therapeutic area. Is that thing wherever we would get immoderate insights into what that would beryllium successful 2023. Is that thing that would beryllium wholly organically developed a Genmab aliases supplement it pinch business development? Just immoderate early colour you could springiness location would beryllium helpful.

Jan van de Winkel

Thanks, Emily, for nan questions. I will return nan 2nd 1 for sure. And nan first one, I tin manus complete astir apt to Taham. So for nan caller therapeutic illness area, that will beryllium a operation of activity we do internally astatine Genmab.

We already person programs successful a caller illness area active. We will astir apt commencement speaking astir that, Emily, astatine nan clip that nan molecules are fresh to beryllium moving into nan clinic, for illustration we do now besides for nan programs.

But it will apt beryllium supplemented by strategical woody aliases strategical deals and imaginable BD deals besides to fundamentally accelerate nan move into nan caller illness area. We are reasoning of adding 1 very ample illness area which tin encompass different diseases. So this year, you will decidedly perceive much astir that but astir apt successful nan discourse of strategical interactions pinch different party, Emily.

I want to time off it to that for now and past inquire Taham to fundamentally talk a spot much astir wherever tin we find nan patients for nan head-to-head cohorts successful nan HexaBody CD38 trial. Taham.

Tahamtan Ahmadi

Sure. yes. So perfectly correct. Direct consequence of nan betterment that daratumab had connected nan life of patients pinch aggregate myeloma is, indeed, that those patients who person relapsed refractory aggregate myeloma and not yet exposed to that to what are getting little and less.

Having said that, we do person astir apt nan champion penetration partially because connected this entry, we collaborate pinch our partner, Janssen, connected wherever location are still regions successful nan world wherever because of wellness attraction entree issues aliases different issues that much penetration successful nan relapsed mounting is possibly not arsenic high. And past obviously, are going to attraction our halfway successful nan proceedings successful these regions. So...

Jan van de Winkel

Thanks, Taham. And Emily, we are not worried astir recruitment there. That is, I think, safe to say. I deliberation location are immoderate areas wherever we tin so to enlistee specified patients. And we now cognize pinch nan progressive doses of HexaBody CD38, truthful we are very enthusiastic astir progressing that caput to head, and hopefully person nan information by first half of adjacent twelvemonth aliases earlier.

Operator

Thank you. And nan adjacent mobility comes from nan statement of Asthika Goonewardene from Truist. Please spell ahead, your statement is open.

Asthika Goonewardene

Hi guys, acknowledgment for taking my questions. Just want to get backmost to HexaBody-CD38. On clinicaltrials.gov, you person accrued nan recruitment - target recruitment adding to complete 270 patients. So that is an summation of astir 120. But beyond nan 2 head-to-head - connected nan head-to-head component, location are, arsenic you know, nan description cohorts successful different indications. So tin you break retired really galore patients you purpose to enlistee specifically for nan head-to-head arms arsenic good arsenic nan description cohorts and past conscionable connected epcor, conscionable want to get your thoughts connected which combinations of epcor and different agents successful earlier lines of LBCL do you spot panning retired next? Thanks.

Jan van de Winkel

Thanks, Asthika, for nan questions. And I deliberation I will manus complete some to Taham. I don’t know, Taham, whether you want to springiness afloat transparency connected really large nan cohorts are. We time off that up to you. And definitely, you tin estimate connected nan imaginable combinations successful LBCL, of course, successful nan early-stage disease. Taham.

Tahamtan Ahmadi

Yes. So we person not - and astir apt should not wholly disclose, but location is simply a contractual size to nan caput to caput comparison that we are meeting. That is partially portion of nan update, not only. So location is nan different cohorts caput to caput comparison a small spot refractory cohort successful AML cohort. Some of it is nan update connected the, but I wouldn’t spell into nan specifications of trial.

On nan early combinations, location is simply a batch of work, obviously, done besides successful collaboration pinch a partner, AbbVie, some successful nan relapse and past successful nan beforehand line. I deliberation nan 1 frontline study that is going to travel up is nan 1 successful aged patients who are not basal candidates for - which we are utilizing arsenic an opportunity to research caller combinations pinch chemo.

Operator

Thank you. And your adjacent mobility comes from nan statement of Etzer Darout from BMO. Please spell ahead, your statement is open.

Etzer Darout

Great, acknowledgment for taking nan question. Just 1 much connected HexaBody CD38, if you are not wholly exhausted yet connected that. So conscionable connected nan head-to-head study pinch daratumumab conscionable wondering if you tin thief america deliberation astir benignant of benignant of efficacy information benchmarks. I guess, ultimately, what level of activity would you want to spot to move that programme forward?

Jan van de Winkel

Thanks, Etzer, for nan question. And indeed, HexaBody CD38 is apparently nan victor coming for each nan questions. So that makes Taham besides nan victor because he is doing a batch of that for that program. Taham, you are on, again.

Tahamtan Ahmadi

Okay. Talking astir benchmarks. So nan only benchmark that we tin mention to astatine this constituent is nan information group of nan - what was information connected clip bid study aliases 501. They are somewhat different. So it ends up being [atomab] (Ph) having a consequence complaint of astir 30%, a small spot less. So if you return that, past location is 1 benchmark. The different 1 to look astatine is, of course, extent of response.

And past location is different portion of nan equation that is nan uncertainty successful that information that was generated successful nan clip framework 2012, 2013, whitethorn not needfully bespeak nan efficacy of daratumumab successful a corp that whitethorn beryllium wholly different because modular of cares person changed. The operation of units and put these inhibitors.

In operation frontline has moved forward, different mechanisms person been introduced to relapsed setting. So possibly patients are delicate and naive to daratumumab, but half already been exposed to immoderate of nan narcotics that person been successful nan BCMA class, for example.

And that is why I deliberation nan head-to-head comparison is nan champion measurement to really get to nan bosom of whether hexamerization leads to heighten C1Q mining to heighten CDC and, done that, to heighten efficacy either by expanding nan wide consequence complaint and/or by expanding nan extent of response. And I deliberation these are some parameters to look at.

Operator

Thank you. We will now return our past mobility for today. And nan past mobility for coming comes from nan statement of Matthew Phipps from William Blair. Please spell ahead, your statement is open.

Matthew Phipps

Hi acknowledgment for including me. I was wondering connected GEN1042. You mentioned moving into late-stage development. Is it safe for america to presume that caput and cervix successful combo pinch chemo and pembro for illustration you showed astatine ESMO IO aliases is it excessively early to jump to that conclusion. And past for nan hematologic T compartment engagers, we person now seen 2 rather different labels from nan FDA regarding hospitalization suggestions aliases requirements during dose escalation betwixt [indiscernible] and TECVAYLI. Just wondering if you guys person immoderate thoughts connected wherever epcor mightiness onshore for nan hospitalization and BCL convey you.

Jan van de Winkel

Thanks, Matthew, for nan questions. And I deliberation nan first one, we tin beryllium speedy connected nan 1042, I deliberation it is excessively early to reason really to position it because we are really doing frontline operation therapy successful 4 different cancers, Matthew.

You person seen immoderate very encouraging early caput and cervix crab information which we are besides very excited about. But I deliberation it is excessively early to make a telephone there, but we will travel to that conclusion connected adjacent steps this year. So a very breathtaking twelvemonth for 1042. I will time off it astatine that.

And past I fundamentally want to inquire Judith to springiness a spot much colour connected hospitalization for T compartment engages because so different labels, arsenic you already alluded to, Matthew. We are alert of that, for sure. Maybe Judith you tin springiness a spot of colour there. .

Judith Klimovsky

Yes. So convey you for nan question. And location are different examples. We are very alert that nan information floor plan of epcor is good managed pinch nan existent guidances successful nan protocols. We requested a azygous time hospitalization aft afloat dose. And arsenic you know, only 60% of patients presented CRS and astir of it people one.

So this is nan information that we are sharing pinch authorities. And based connected that, we mightiness person different recommendations. It is very early to estimate which one, but we consciousness very comfortable pinch nan measurement it is managed and nan information floor plan of epcoritamab.

Jan van de Winkel

Thanks very much, Judith. I deliberation that is it, Matt, for now. And past I will springiness immoderate closing remarks. So convey you each for calling successful coming to talk Genmab’s financial results for 2022. If you person further questions, please scope retired to our Investor Relations team. We dream that you each enactment safe, support optimistic and stay healthy, and we very overmuch look guardant to speaking pinch you again soon.

Operator

Thank you. This concludes today’s convention call. Thank you for participating. You whitethorn now disconnect.