Earnings Release • Feb 13, 2018
Earnings Release
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BerGenBio ASA: Results for the Fourth Quarter and Full Year 2017
Bergen, Norway, 13 February 2018 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
multiple cancer indications, announces its results for the fourth quarter and
full year 2017. A presentation of the results by the Company's senior management
team will take place today at 10.00 am CET in Oslo - details below.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "BerGenBio has
made solid progress during 2017 and achieved all of the milestones we outlined
at the time of our IPO in April. We have advanced, as planned, our clinical
development strategy for bemcentinib, the recently accepted generic name for our
lead candidate BGB324, such that it is now being evaluated in six Phase II
clinical studies in multiple cancer indications. These trials are designed to
deliver initial proof-of-concept of bemcentinib's potential as a future
cornerstone of cancer therapy in combination with immuno-oncology drugs, chemo-
and targeted therapy. Initial clinical data presented during the year continue
to give us confidence that bemcentinib is a very exciting drug candidate with
broad application across many types of cancer, and in combination with existing
and emerging modalities of cancer treatment. We will continue to drive these
trials towards interim read outs in mid-2018 and look forward to an exciting
year ahead."
Q4'17 highlights
· First patients enrolled and dosed in Phase II trials of bemcentinib (BGB324)
in combination with KEYTRUDA® (pembrolizumab) in non-small cell lung cancer
(NSCLC) and triple negative breast cancer (TNBC)
· Clinical data presentations at global cancer conferences continue to
highlight bemcentinib's safety and promising efficacy profile
FY'17 highlights
· Successful initial public offering (IPO) raising NOK 400m has enabled
BerGenBio to fund and advance its broad and ambitious Phase II clinical
development programme with bemcentinib
· BerGenBio enters clinical collaborative agreement with Merck & Co., Inc.
(MSD) for two immunotherapy trials in patients with advanced NSCLC and TNBC
· Six clinical trials open and recruiting to establish clinical proof-of
-concept of bemcentinib's potential to be a cornerstone of cancer therapy across
multiple cancer indications
· Clinical and scientific data updates at global conferences consistently show
improved clinical benefit and immune modulatory effect of bemcentinib-containing
therapy
· Good progress advancing the development of companion diagnostics in parallel
with all clinical trials to identify patients who are most likely to benefit
from bemcentinib treatment
· BGB149 anti-AXL antibody programme on track to enter the clinic in H2 2018
Post FY events
· First efficacy endpoint met in Phase II trial of bemcentinib/TARCEVA®
(erlotinib) combination in NSCLC
· Bemcentinib was well tolerated in all patients enrolled across three
combination trials with KEYTRUDA thus far (n=34)
· Single agent therapy with bemcentinib led to a diversification of the T-cell
receptor repertoire in relapsed / refractory acute myeloid leukaemia (AML) and
myeloid dysplastic syndrome (MDS) patients indicative of immune activation
Financial Summary
+-----------------------+---------+-------------+--------------+--------------+
|Key Figures (NOK | Q42017| Q42016| FY2017| FY2016|
|million) | | | | |
+-----------------------+---------+-------------+--------------+--------------+
|Operating revenues | - | - | - | - |
+-----------------------+---------+-------------+--------------+--------------+
|Operating expenses | 47.5| 28.0| 183.7| 131.6|
+-----------------------+---------+-------------+--------------+--------------+
|Operating profit (loss)| (47.5)| (28.0)| (183.7)| (131.6)|
+-----------------------+---------+-------------+--------------+--------------+
|Profit (loss) after tax| (47.6)| (27.9)| (182.2)| (129.8)|
+-----------------------+---------+-------------+--------------+--------------+
| | | | | |
+-----------------------+---------+-------------+--------------+--------------+
|Basic and diluted | (0.96)| (82.81)| (4.01)| (419.68)|
|earnings (loss) per | | | | |
|share (NOK) | | | | |
+-----------------------+---------+-------------+--------------+--------------+
|Net cash flow in the | (28.8)| (25.4)| 208.5| 87.8|
|period | | | | |
+-----------------------+---------+-------------+--------------+--------------+
|Cash position end of | 370.3| 161.8| 370.3| 161.8|
|period | | | | |
+-----------------------+---------+-------------+--------------+--------------+
Presentation and Webcast Details
A presentation by BerGenBio's senior management team will take place at 10.00 am
CET at:
Felix Konferansesenter, Bryggetorget 3, 0125 Oslo
The presentation will webcast live and the link will be available at
www.bergenbio.com in the section Investors/Reports and presentations/Webcasts. A
recording will be available shortly after the webcast has finished.
The results report and the presentation will be available at www.bergenbio.com
in the section: Investors/Reports and presentations from 7:00 am CET the same
day.
-End-
About BerGenBio ASA
BerGenBio ASA is a clinical-stage biopharmaceutical company focused on
developing a pipeline of first-in-class AXL kinase inhibitors as a potential
cornerstone of combination cancer therapy. The Company is a world leader in
understanding the essential role of AXL kinase in mediating cancer spread,
immune evasion and drug resistance in multiple aggressive solid and
haematological cancers.
BerGenBio's lead product, bemcentinib (BGB324), is a selective, potent and
orally bio-available small molecule AXL inhibitor in four Company sponsored
Phase II clinical trials in major cancer indications, with read-outs anticipated
during 2018. It is the only selective AXL inhibitor in clinical development.
The Company sponsored clinical trials are:
· Bemcentinib with TARCEVA® (erlotinib) in advanced EGFR mutation driven non
-small cell lung cancer (NSCLC)
· Bemcentinib with KEYTRUDA in advanced adenocarcinoma of the lung, and
· Bemcentinib with KEYTRUDA in triple-negative breast cancer (TNBC).
· Bemcentinib as a single agent and combination therapy in acute myeloid
leukaemia (AML) / myeloid dysplastic syndrome (MDS)
The clinical trials combining bemcentinib with KEYTRUDA in adenocarcinoma of the
lung and TNBC are conducted in collaboration with Merck & Co., Inc. (Kenilworth,
NJ, USA), through a subsidiary.
In addition, a number of investigator-sponsored trials are underway, including a
trial to investigate bemcentinib with either MEKINIST® (trametinib) plus
TAFINLAR® (dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial
combining bemcentinib with docetaxel in advanced NSCLC.
BerGenBio is simultaneously developing a companion diagnostic test to identify
patient subpopulations most likely to benefit from treatment with bemcentinib.
This will facilitate more efficient registration trials and support a precision
medicine based commercialization strategy.
The Company is also developing a diversified pre-clinical pipeline of drug
candidates, including BGB149, an anti-AXL monoclonal antibody.
For further information, please visit: www.bergenbio.com
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary
of Merck & Co., Inc., Kenilworth, NJ, USA, TARCEVA® is a registered trademark of
OSI Pharmaceuticals, LLC., marketed by Roche-Genentech. TAFLINAR® is a
registered trademark of Novartis International AG and MEKINIST® is a registered
trademark of GSK plc.
Contacts
Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304
Tom Henrik Sundby
Finance Director, BerGenBio ASA
+47 477 54 415
Media Relations
David Dible, Mark Swallow, Marine Perrier
Citigate Dewe Rogerson
+44 207 638 9571
Forward looking statements
This announcement may contain forward-looking statements, which as such are not
historical facts, but are based upon various assumptions, many of which are
based, in turn, upon further assumptions. These assumptions are inherently
subject to significant known and unknown risks, uncertainties and other
important factors. Such risks, uncertainties, contingencies and other important
factors could cause actual events to differ materially from the expectations
expressed or implied in this announcement by such forward-looking statements
This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.
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