Genmab — Interim / Quarterly Report 2016

Aug 9, 2016

August 9, 2016; Copenhagen, Denmark;
Interim Report for First Half 2016

Highlights

-- Net Sales of DARZALEX® (daratumumab) by Janssen for the first half of 2016
were USD 209 million, resulting in royalty income of USD 25 million (DKK
168 million)
-- 2016 financial guidance improved
-- Announced European conditional marketing authorization of DARZALEX for
heavily pre-treated or double-refractory multiple myeloma
-- Achieved USD 30 million milestone for first commercial sale of DARZALEX in
Europe
-- Announced positive topline result in Phase III POLLUX study of daratumumab
in relapsed or refractory multiple myeloma
-- Announced that U.S. Food and Drug Administration (FDA) granted priority
review to sBLA for ofatumumab (Arzerra®) in combination with fludarabine
and cyclophosphamide (FC) in relapsed chronic lymphocytic leukemia (CLL)
-- Announced that the Committee for Medicinal Products for Human Use (CHMP)
issued a negative opinion for Arzerra as maintenance therapy in relapsed
CLL
-- Announced Phase III studies of ofatumumab in relapsing multiple sclerosis

“The two major highlights during the second quarter were the rapid European
approval of DARZALEX and positive Phase III data from the POLLUX study.
DARZALEX was successfully launched by our collaboration partner Janssen shortly
after the approval, triggering a milestone payment of USD 30 million to Genmab.
We were also very excited about the Phase III POLLUX study data which showed
that daratumumab in combination with lenalidomide and dexamethasone led to a
significant improvement in progression free survival in treatment of relapsed
or refractory multiple myeloma,” said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab.

Financial Performance First Half

-- Revenue was DKK 524 million in the first half of 2016 compared to DKK 281
million in the first half of 2015. The increase of DKK 243 million, or 86%,
was mainly driven by higher royalty and milestone revenue under our
daratumumab collaboration with Janssen.
-- Operating expenses were DKK 366 million in the first half of 2016 compared
to DKK 244 million in the first half of 2015. The increase of DKK 122
million, or 50%, was due to the additional investment in our pipeline of
products, including the advancement of tisotumab vedotin, HuMax®-AXL-ADC,
HexaBody®-DR5/DR5, DuoBody®-CD3xCD20, and our other pre-clinical programs.
-- Operating income was DKK 158 million in the first half of 2016 compared to
DKK 212 million in the first half of 2015. The decrease of DKK 54 million,
or 25%, was driven by the one-time reversal of the ofatumumab funding
liability of DKK 176 million in 2015 combined with increased operating
expenses in 2016, which were partly offset by higher revenue in 2016.
-- On June 30, 2016, Genmab had a cash position of DKK 3,762 million compared
to DKK 3,493 million at December 31, 2015. This represented a net increase
of DKK 269 million, which was driven primarily by income from operations
and the proceeds from the exercise of warrants for DKK 82 million.

Business Progress Second Quarter

Daratumumab

-- May: Achieved a USD 30 million milestone triggered by the first commercial
sale of DARZALEX in Europe.
-- May: Announced that the European Commission (EC) granted a conditional
marketing authorization for DARZALEX for heavily pre-treated or
double-refractory multiple myeloma. The approval followed a positive
recommendation for DARZALEX from the CHMP of the European Medicines Agency
(EMA) in April.
-- May: Announced that the Phase III POLLUX study (MMY3003) of daratumumab in
combination with lenalidomide and dexamethasone in patients with relapsed
or refractory multiple myeloma met the primary endpoint at a pre-planned
interim analysis (Hazard Ratio (HR) = 0.37 (95% CI 0.27-0.52),
p<0.0001). Patients who received treatment with daratumumab in
combination with lenalidomide and dexamethasone had a 63% reduction in risk
of their disease progressing, compared to those who did not receive
daratumumab. The median progression free survival (PFS) for patients
treated with daratumumab in combination with lenalidomide and dexamethasone
has not been reached, compared to an estimated median PFS of 18.4 months
for patients who received lenalidomide and dexamethasone alone. Janssen
will engage in a dialogue with health authorities about the potential for a
regulatory submission for this indication.
-- April: Reported more detailed data from the Phase III CASTOR (MMY3004)
study of daratumumab in combination with bortezomib and dexamethasone
versus bortezomib and dexamethasone in patients with relapsed or refractory
multiple myeloma. The study met the primary endpoint of improving PFS; HR =
0.39,
p<0.0001. The median PFS for patients treated with daratumumab has not
been reached, compared to median PFS of 7.2 months for patients who did not
receive daratumumab.
-- April: Announced that MorphoSys filed a complaint at the U.S. District
Court of Delaware against Genmab and Janssen Biotech, Inc. (Janssen), for
patent infringement under U.S. patent no. 8,263,746 based on activities
relating to the manufacture, use and sale of DARZALEX in the United States.
Genmab and Janssen disagree with the allegations made by MorphoSys in its
complaint for patent infringement and intend to vigorously contest those
allegations.

Ofatumumab

-- June: Announced that the CHMP of the EMA issued a negative opinion on the
use of Arzerra as maintenance therapy for patients with relapsed CLL.
-- June: Announced that Novartis will start Phase III studies of the
subcutaneous formulation of ofatumumab in relapsing multiple sclerosis (MS)
with enrollment of patients to start in September 2016.
-- May: Announced that the U.S. FDA granted Priority Review to the
supplemental Biologics License Application (sBLA) for the use of ofatumumab
in combination with FC for the treatment of patients with relapsed CLL.

Subsequent Event

-- July: The U.S. FDA granted Breakthrough Therapy Designation for DARZALEX
injection in combination with lenalidomide and dexamethasone, or bortezomib
and dexamethasone for the treatment of patients with multiple myeloma who
have received at least one prior therapy.
Breakthrough Therapy Designation is a program intended to expedite the
development and review of drugs to treat serious or life-threatening
diseases in cases where preliminary clinical evidence shows that the drug
may provide substantial improvements over available therapy.

Outlook
Genmab is improving its 2016 financial guidance published on April 20, 2016 and
reiterated on May 10, 2016, due to increased revenue and operating expenses
resulting in increased operating income and cash position.

Conference Call
Genmab will hold a conference call in English to discuss the results for the
first half of 2016 today, Tuesday, August 9, at 6.00 pm CEST, 5.00 pm BST or
noon EDT. The dial in numbers are:

+1 212 444 0481 (US participants) and ask for the Genmab conference call
+44 20 3427 1914 (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.

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

The interim report 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 product
discovery and development, 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 section
“Risk Management” in Genmab’s annual report, which is available on
www.genmab.com and the “Significant Risks and Uncertainties” section in the
interim report. Genmab does not undertake any obligation to update or revise
forward looking statements in the interim report 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 trademark of Novartis AG or its affiliates.
DARZALEX® is a trademark of Janssen Biotech, Inc.

CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark

Download the full Interim Report for the first half of 2016 on attachment or at
www.genmab.com.