Company Announcement
Copenhagen, Denmark; March 4, 2014 – Genmab A/S (OMX: GEN) today published its Annual Report for 2013. Below is a summary from the report of business progress and financial performance for the year, and financial outlook for 2014. The full report is attached as a PDF file and can be found on the investor section of the company’s website, www.genmab.com .
IMPRESSIVE 2013 ACHIEVEMENTS
Business Progress Maximizing the value of ofatumumab
- Stated objective met
- Reported positive top-line results from Phase III study of ofatumumab in combination with chlorambucil versus chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL)
- Continued Phase III maintenance study in CLL following interim analysis by Independent Data Monitoring Committee (IDMC)
- Reported positive top-line results from Phase II study of ofatumumab in combination with bendamustine in patients with untreated or relapsed CLL
- Initiated new Phase III study of ofatumumab given subcutaneously to treat pemphigus vulgaris
- Reported positive top-line data from a Phase II study of subcutaneous ofatumumab in relapsing remitting multiple sclerosis (RRMS)
- Other achievement
- Received Breakthrough Therapy Designation from Food and Drug Administration (FDA)
Expansion of Arzerra ® (ofatumumab)
- Stated objective met
- Launched in Japan, now available in all major markets around the world
- Submitted regulatory applications to broaden label for Arzerra in US and Europe
- FDA granted priority review for Arzerra supplemental Biologics License Application (sBLA)
- Other achievement
- GlaxoSmithKline sales of Arzerra increased in British pounds by 25%, resulting in DKK 131 million in royalty income to Genmab
Fully exploit the potential of daratumumab
- Stated objective met
- Initiated new Phase II study of daratumumab as a monotherapy in double refractory multiple myeloma
- Presented data from Phase I/II study of daratumumab in combination with lenalidomide to treat relapsed or refractory multiple myeloma
- Announced new Phase Ib study of daratumumab in combination with backbone treatment regimens to treat front line and relapsed/refractory multiple myeloma
- Presented updated data from Phase I/II study of daratumumab in relapsed/refractory multiple myeloma
- Other achievement
- Received first milestone from Janssen for clinical progress
- Received Breakthrough Therapy Designation and Fast Track Designation from FDA
- Received Orphan Drug Designations from FDA and European Medicines Agency (EMA)
Expanding our pipeline
- Stated objective met
- Submitted Investigational New Drug application (IND) and Clinical Trial Applications (CTAs) for HuMax ® -TF-ADC in US and Europe
- Initiated first Phase I study of HuMax-TF-ADC in solid tumors
- Presented updates on HuMax-TF-ADC and DuoBody ® platform at multiple conferences
Progressing next generation technologies
- Stated objective met
- Expanded DuoBody collaboration with Janssen
- Reported first pre-clinical data for a DuoBody project in Janssen collaboration
- Reached three milestones in Janssen DuoBody collaboration
- Janssen activated the fourth, fifth and sixth DuoBody programs
- Reached first development milestone in DuoBody collaboration with Novartis
- Novartis activated second DuoBody program
- Presented pre-clinical validation of HexaBody™ technology
Driving value through collaborations
- Stated objective met
- Roche reported Phase II inclacumab data; decided to make inclacumab available for partnering
- River Vision Development Corporation initiated Phase II study of teprotumumab in active thyroid eye disease
- Entered agreement with ADC Therapeutics Sarl to develop an ADC of HuMax-TAC
Disciplined expense management, reduce cash burn
- Stated objective met
- Reduced cash burn & lengthened cash runway
- Improved operating result by DKK 186 million
- Sold Minnesota manufacturing facility
Financial Performance
- Revenue increased by DKK 179 million, 37%, from DKK 485 million in 2012 to DKK 664 million in 2013, mainly driven by higher revenue related to our daratumumab and DuoBody collaborations with Janssen, as well as Arzerra royalties.
- Operating expenses were reduced from DKK 601 million in 2012 to DKK 594 million in 2013.
- As the operating expenses were virtually flat, the operating result improved by DKK 186 million from a loss of DKK 117 million in 2012 to an income of DKK 69 million in 2013.
- The net result for discontinued operation amounted to a net income of DKK 42 million in 2013.
- 2013 year end cash position of DKK 1,557 million, compared to DKK 1,516 million as of December 31, 2012.
2014 OUTLOOK
| Income Statement (DKKM) | 2014 Guidance | 2013 Actual Result |
| Revenue | 725 – 775 | 664 |
| Operating expenses | (600) – (650) | (595) |
| Operating income continuing operations | 90 – 160 | 69 |
| Discontinued operation | - | 42 |
| Cash Position (DKKM) | 2014 Guidance | 2013 Actual Result |
| Cash position beginning of year* | 1,557 | 1,516 |
| Cash used in operations | (50) – (100) | (167) |
| Proceeds from private placement | 972 | - |
| MN facility sale | - | 52 |
| Warrant exercises | - | 156 |
| Cash position at end of year* | 2,400 – 2,500 | 1,557 |
| *Cash, cash equivalents, and marketable securities | ||
Conference Call
Genmab will hold a conference call in English to discuss the results for the full year 2013 today, Tuesday, March 4, at 6.00 pm CET, 5.00 pm GMT or noon EST. The dial in numbers are:
+1 866 682 8490 (US participants) and ask for the Genmab conference call +44 1452 555131 (international participants) and ask for the Genmab conference call
A live and archived webcast of the call and relevant slides will be available at www.genmab.com .
About Genmab A/S Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company’s first marketed antibody, ofatumumab (Arzerra ® ), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab’s validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab’s strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com .
Contact: Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com
This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, 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. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com . Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in relation to actual results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab ® ; the Y-shaped Genmab logo ® ; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo™; the HexaBody logo™; HuMax ® ; HuMax-CD20 ® ; DuoBody ® ; HexaBody™ and UniBody ® . Arzerra ® is a registered trademark of the GSK group of companies.
Company Announcement no. 09 CVR no. 2102 3884
Genmab A/S Bredgade 34E 1260 Copenhagen K Denmark
