2020 Outlook and Key Priorities

2020 Outlook

 
DKK million

Revenue

Operating expenses

Operating income

2020
Guidance

4,750 – 5,150

(3,850) – (3,950)

850 – 1,250

2019
Actual Result

5,366

(2,728)

2,638

Key 2020 Priorities

Genmab proprietary* products
  • Tisotumab vedotin1 – Phase II innovaTV 204 safety and efficacy analysis in recurrent/metastatic 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 and 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 RMS
Teprotumumab5
  • U.S. FDA decision on Phase III OPTIC active thyroid eye disease submission

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