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MarketScreener Homepage  >  Equities  >  NASDAQ OMX COPENHAGEN  >  Genmab A/S    GMAB   DK0010272202

GENMAB A/S

(GMAB)
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Genmab : 2019 Full Year Financial Results_Conference Call Slides

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02/19/2020 | 11:35am EDT

Year End Results

Period Ended December 31, 2019

Forward Looking Statement

This presentation contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to our products), are forward looking statements. Such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward looking statements. Such forward looking statements are based on numerous assumptions regarding our present and future business strategies and the environment in which we will operate in the future. The important factors that could cause our actual results, performance or achievements to differ materially from those in the forward looking statements include, among others, risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of our products in patients, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. Further, certain forward looking statements are based upon assumptions of future events which may not prove to be accurate. The forward looking statements in this document speak only as at the date of this presentation.

2

Key Achievements 2019

Pipeline & Company Highlights

Pipeline Progress

  • IND submitted for DuoHexaBody®-CD37
  • Enrollment complete in potentially registrational Ph II innovaTV 204 study of tisotumab vedotin1 in recurrent / metastatic cervical cancer
  • Preliminary data from Phase I/II studies of enapotamab vedotin and DuoBody®-CD3xCD20 (epcoritamab) presented at major medical conferences
  • First patients dosed in Ph I studies of DuoBody-PD-L1x4-1BB (GEN1046)2 and DuoBody-CD40x4-1BB (GEN1042)2
  • Data from Phase III ASCLEPIOS I & II RMS studies of SubQ ofatumumab3, followed by submission by Novartis for approval in U.S. - submitted in EU in 2020
  • New strategic partnerships including CureVac AG, Janssen Biotech, Inc., Tempus

Company Highlights

  • U.S. IPO making Genmab a dual-listed company
  • Strategic growth of new competencies throughout the company
  • Improved revenue by 77% vs. 2018 - 7th year of profitability

3

RMS = relapsing multiple sclerosis; SubQ = subcutaneous; IND = Investigational New Drug; IPO = Initial Public Offering 150:50 development with Seattle Genetics; 250:50 development with BioNTech; 3Developed by Novartis

Key Achievements 2019

DARZALEX® (daratumumab)

MorphoSys' patent infringement complaint dismissed - patents invalid, no further proceedings, case over

Regulatory submissions

• U.S. & EU for SubQ formulation

USD 2,998M net sales by Janssen in 2019 - resulting in DKK 3,132M in royalties

Regulatory approvals

  • U.S. split dosing regimen
  • U.S., EU & Japan based on Ph III MAIA (D+Rd, NDMM NTE)
  • U.S. based on Ph III CASSIOPEIA (D+VTd, NDMM TE) - EU in 2020
  • Japan based on Phase III ALCYONE (D+VMP, NDMM NTE)
  • China monotherapy

Positive topline results in MM

  • Ph III COLUMBA (SubQ vs IV) study
  • Ph II GRIFFIN (D+VRd, NDMM TE) study
  • Ph III CANDOR (D+Kd, RRMM) study, sBLA submitted in U.S. in 2020

USD 100M & USD 150M sales milestones reached on basis of license agreement terms

Rd = lenalidomide and dexamethasone; VTd = bortezomib, thalidomide and dexamethasone; VMP = bortezomib, melphalan and prednisone; VRd = bortezomib, lenalidomide and dexamethasone; Kd = carfilzomib and dexamethasone; NDMM = newly diagnosed multiple myeloma; TE = transplant eligible, NTE = not transplant eligible; RRMM = relapsed / refractory multiple myeloma; sBLA = supplemental Biologics License Application

Income Statement: Year Ended December 31

2019

2018

Change

2019

2018

DKK millions

USD millions *

Darzalex Royalties

3,132

1,708

1,424

469

256

Darzalex Milestones

1,778

586

1,192

266

88

Other Revenue

456

731

(275)

68

109

Total Revenue

5,366

3,025

2,341

803

453

R&D Costs

(2,386)

(1,431)

(955)

(357)

(214)

G&A Expenses

(342)

(214)

(128)

(51)

(32)

Operating Expenses

(2,728)

(1,645)

(1,083)

(408)

(246)

Operating Result

2,638

1,380

1,258

395

207

Net Financial Items

221

232

(11)

33

35

Tax

(693)

(140)

(553)

(104)

(21)

Net Result

2,166

1,472

694

324

221

* USD 1.00 = DKK 6.6759 (Danish Central Bank spot rate on December 31, 2019)

5

Revenue 2019 vs. 2018: Year Ended December 31

77%

All amounts in DKK millions unless otherwise noted

6

Operating Result: Investing in Our Pipeline

Operating Expenses increased 66% (+DKK 1,083M), driven by additional pipeline investment

Revenue growth outpaced expense increase - driving DKK 1,258M higher Operating Result

All amounts in DKK millions unless otherwise noted

7

Advancing Pipeline: Delivering on Our Promise & Creating Value

Accelerating Development of Potential "Next Winners"

DuoBody-CD3xCD20 (epcoritamab)

  • Potential best-in-class:SubQ administration
  • Pre-clinical /preliminary clinical data shows encouraging safety & efficacy
  • Expeditious and Comprehensive clinical development plan (DLBCL, FL, CLL)
  • RP2D decision & expansion cohorts initiation

DuoBody-PD-L1x4-1BB (GEN1046)

  • Potential first-in-class:Next generation IO utilizing DuoBody technology
  • Unmet medical need
  • FiH clinical study: escalation phase is ongoing
  • 50:50 BioNTech

Delivering on Genmab's

Promise for Patients

Track Record of Success

8

Advancing Pipeline: Delivering on Our Promise & Creating Value

Bolstering early stage portfolio

  • DuoBody-CD40x4-1BB1
  • DuoHexaBody-CD37
  • DuoBody-CD3x5T4
  • HexaBody-CD382
  • Data science

Adding new

technologies Expanding early stage discovery programs

Enhancing clinical development capabilities

Delivering on Genmab's

Promise for Patients

Track Record of Success

9

1GEN1042, 50:50 w/ BioNTech; 2Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement w/ Janssen Biotech, Inc

Framework for 2020 Guidance

Recurring Revenue Growth

  • Continued Growth & Expansion of DARZALEX
  • Additional Potential Blockbuster Products:
    • Ofatumumab in Relapsing Multiple Sclerosis (RMS)
    • TEPEZZA for Thyroid Eye Disease (TED)

Focused Investment in R&D Growth

  • Focused Investment on pipeline & capabilities
    • Accelerating & Expanding Development of
      Potential Winners
  • 8th Consecutive Year of Profitability
  • Impact of Potential Partnering Activities Not Included

Recurring revenue has grown

Pipeline has grown from 2 clinical programs,

~3x from 2017 to 2019

beginning of 2017 to 7* by the end of 2019

10

*IND for DuHexaBody-CD37 submitted Q4 2019

DARZALEX: On the Path to Establishing Market Leadership

DARZALEX Sales Development (USDm)

3,500

3,000

2,998

2,500

2,025

2,000

USDm

1,500

1,242

1,000

572

500

0

2016

2017

2018

2019

Key Observations

DARZALEX sales growth of 48% in 2019

  • DARZALEX a near triple blockbuster in 2019
  • Continued strong market growth and share gains
  • USD 250m in commercial milestones achieved
  • Around USD 180m in remaining milestone payments

Sales of USD 3.9bn - USD 4.2bn expected in 2020

  • Significant opportunity for growth in 1L MM market
  • SubQ DARZALEX approval in U.S. expected in H1 2020
  • Market share gain in the U.S. and RoW driven by uptake in all lines of treatment
  • 7 approved indications in U.S., late stage to 1L MM

Redefining Treatment of Multiple Myeloma Globally Across all Lines of Therapy

11

Revenue Guidance

DKK Millions

2019

2020

Comments

Actual

Guidance

DARZALEX Royalties

3,132

4,075 - 4,475 DARZALEX Net Sales USD 3.9 to 4.2 billion

DARZALEX Sales

1,684

-

USD 250 million in sales milestones achieved in 2019

Milestones

Cost Reimbursement

342

~475

Seattle Genetics and BioNTech collaborations

All Other

208

~200

Includes other milestones and royalties

Total Revenue

5,366

4,750 - 5,150

  • DARZALEX royalties to grow 30% to 43%
  • DKK 475m of cost reimbursement provides meaningful contribution towards our R&D investment

All amounts in DKK millions unless otherwise noted

12

2020 guidance assumes a USD/DKK exchange rate of 6.5

Overview - 2020 Guidance - Pipeline Investment

Expense Detail

2019

2020

DKK Millions

Guidance

Change

%

Comments

Actual

Mid-Point

Project Investment

1,573

2,200

627

40%

Driven by Top 10 Projects

Personnel Costs

645

900

255

40%

Increase in 2020 by 175 FTEs

Business Support

472

700

228

48%

Including Technologies & Systems, Commercial & Medical Affairs

Depreciation

38

100

62

163%

Expansion of our leased facilities

Total Operating Expenses

2,728

3,900

1,172

43%

Total Project Investment

*

*38% will be invested in

30% DuoBody CD3xCD20 & DuoBody PDL-1x4-1BB - two of the programs we are looking to expand and accelerate in 2020.

Project Investment Growth

Key Drivers of DKK 627m increase**

**87% of the increase in our project investment relates to DuoBody-CD3xCD20 & DuoBody-PDL1x41BB programs.

(epcoritamab)

All amounts in DKK millions unless otherwise noted

13

2020 guidance assumes a USD/DKK exchange rate of 6.5

2020 Guidance

DKK Millions

2020 Guidance

2019 Actual

Revenue

4,750 - 5,150

5,366

Operating expenses

(3,850) - (3,950)

(2,728)

Operating income

850 - 1,250

2,638

  • DKK 1.7bn of non-recurring DARZALEX sales milestones in 2019
  • DARZALEX royalties of ~DKK 4.1bn to ~DKK 4.5bn to fuel 30% to 45% recurring revenue growth
  • Growth in operating expenses driven by expanding and accelerating our clinical pipeline

All amounts in DKK millions unless otherwise noted

14

2020 guidance assumes a USD/DKK exchange rate of 6.5

Takeaways for 2020 Guidance

Recurring Revenue Growth

• Continued growth and expansion of DARZALEX

Focused Investment in R&D Growth

• Focused investment in pipeline & capabilities

    • Estimate USD 3.9 to USD 4.2 billion sales range
    • No sales-related milestone payments
  • Additional potential blockbuster products: Ofatumumab in RMS & TEPEZZA for TED
    • Significant long-term potential
    • 2 additional recurring revenue streams
    • 2020 impact not significant
  • Recurring revenue: growth of 30% - 45%, >DKK 4bn
    • Focus on potential winners and pipeline candidates
    • Project investments up 40% in 2020
    • 38% of project investments in DuoBody-CD3xCD20 (epcoritamab) and DuoBody-PD-L1x4-1BB
  • 8th consecutive year of profitability
    • DKK 1 billion of projected operating profit at mid- point
  • Impact of potential partnering activities not included

On Track for a Transformative Year

15

Key 2020 Priorities

Building a Strong Differentiated Product Pipeline

Priority

Targeted Milestones

Genmab proprietary*

» Tisotumab vedotin1 - Phase II innovaTV 204 safety & efficacy analysis in recurrent/metastatic

products

cervical cancer and engage U.S. FDA for BLA submission subject to trial results

» Tisotumab vedotin - data on other solid tumor types

» Enapotamab vedotin - data to support late stage development

» Epcoritamab (DuoBody-CD3xCD20) Phase I/II - decision on recommended Phase II dose &

initiate expansion cohorts

» HexaBody-DR5/DR5 Phase I/II - advance dose escalation

» DuoBody-PD-L1x4-1BB2 Phase I/II - initiate expansion cohorts

» DuoBody-PD-L1x4-1BB initial data in H2 2020

» File INDs and/or CTAs for 2 new products

Daratumumab3

» U.S. FDA and EMA decision on Phase III COLUMBA multiple myeloma SubQ submission

» sBLA and MAA Submission Phase III ANDROMEDA amyloidosis

» sBLA and MAA submission Phase III APOLLO multiple myeloma

Ofatumumab4

» U.S. FDA decision on regulatory dossier submission in multiple sclerosis

Teprotumumab5

» U.S. FDA decision on Phase III OPTIC active thyroid eye disease submission

*Certain product candidates in development with partners, as noted.

16

1. 50:50 dev. w/ Seattle Genetics; 2. 50:50 dev. w/ BioNTech; 3. In dev. by Janssen; 4. In dev. by Novartis; 5. In dev. by Horizon Therapeutics

Q&A

Upcoming Investor & Other Events

Deutsche Bank Virtual Conference, March 18-19 Genmab Annual General Meeting, March 26 Kempen Life Sciences Conference, April 21-22

Disclaimer

Genmab A/S published this content on 19 February 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 19 February 2020 16:34:06 UTC

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