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2016-02-17

Camurus AB: Full year report January-December 2015

IPO and start of global Phase III trials for CAM2038

Fourth quarter 2015

? Net revenue MSEK 36,3 (144,9).
? Operating result before items affecting comparability -4,9 (96,6).
? Operating result after items affecting comparability -40,4 (96,6)
MSEK.

? Result after tax MSEK -31,8 (74,9), including items affecting
comparability of MSEK 27,7 (0).

? Earnings per share before dilution SEK -1,05 (3,14) and after
dilution SEK -1,05 (2,97).

? Cash flow from operations MSEK 39,5 (146,7).
? Cash and cash equivalents MSEK 716,1 (0,0).
? First patient dosed in a pivotal Phase II trial of the opioid
blocking effect of CAM2038.

? First patients dosed in two Phase III trials of CAM2038 for
treatment of opioid dependence.

? Treatment completed of all patients in Phase II study of CAM2032
for treatment of prostate cancer.

? Richard Jameson appointed as Chief Commercial Officer and Member
of Camurus' Executive Team.

? Camurus' share listed on Nasdaq Stockholm on 3rd December.
January - December 2015

? Net revenue MSEK 154,8 (208,2) MSEK.
? Operating result before items affecting comparability MSEK -30,5
(62,3).

? Operating result after items affecting comparability MSEK -204,1
(62,3).

? Result after tax -159,5 (48,3) MSEK, including items affecting
comparability of MSEK 135,4.

? Earnings per share before dilution SEK -6,33 (2,06) and after
dilution SEK -6,33 (1,92).

? Cash flow from operations MSEK -5,7 (69,4) MSEK.
? Positive results from two clinical Phase I trials of CAM2038
(subcutaneous once-weekly and once-monthly buprenorphine) versus
daily sublingual buprenorphine (Subutex?).

? Fast Track granted by FDA for CAM2038 for treatment of opioid
dependence.

? First patients included in pivotal Phase II and Phase III
registration trials of CAM2038.

? Completion of Phase II trial of CAM2032 for treatment of prostate
cancer.

? Two development milestones with total payments of 5 MUSD received
from Novartis regarding CAM2029.

? Two new collaboration projects initiated with international
pharmaceutical corporations.

? License- and distribution agreement signed with Solasia Pharma
regarding episil? in Japan and China.

? Camurus' share listed on Nasdaq Stockholm.
Significant events after the end of the period

? License agreement signed with Rhythm Inc. for extended release
FluidCrystal? setmelanotide for treatment of genetic obesity.

SEL thousand 2015 2014 2015 2014
Oct - Dec Oct - Dec Jan - Dec Jan - Dec
Net revenues 36,3 144,9 154,8 208,2
Operating result before -4,9 96,6 -30,5 62,3
items affecting
comparability
Operating result -40,4 96,6 -204,1 62,3
Result for the period -31,8 74,9 -159,5 48,3
Cash flow from operating 39,5 146,7 -5,7 69,4
activities
Cash and cash equivalents 716,1 0,06 716,1 0,06
Equity ratio in Group, % 78% 59% 78% 59%
Total assets 816,3 207,7 816,3 207,7

CEO comments on fourth quarter

The fourth quarter was exciting. Important Company highlights was the
IPO on Nasdaq Stockholm and the start of two Phase III trials of
CAM2038 for treatment of opioid dependence. The recruitment of
Richard Jameson as Chief Commercial Officer, with the responsibility
to lead our commercial organization in Europe, was another key event.

The development of CAM2038, weekly and monthly subcutaneous
buprenorfin injections, for treatment of opioid dependence, and
collaboration with our U.S. partner Braeburn Pharmaceuticals, has
continued to develop very positively during the fourth quarter. After
discussions and alignment with both the European and US healthcare
agencies (EMA and FDA) the pivotal clinical program for marketing
approval of CAM2038 was initiated with the start of two Phase III and
one Phase II trial in opioid dependent patients.

There is a large medical need for new treatment alternatives against
opioid dependence that can improve treatment outcomes and on the same
time reduce the risks of diversion, abuse, misuse, and accidental
pediatric exposure that are associated with current daily products.
Opioid addiction has become an epidemic in the U.S., yet it is
under-recognized and few medicines are in development for its
treatment. A chronic, relapsing disease, opioid addiction can lead to
overdose and death. According to the Center for Disease Control and
Prevention, opioid-related overdose deaths hit a record high in the
U.S. of nearly 29,000 in 2014, corresponding to almost 80 deaths each
day. The number of heroin related overdose deaths have quadrupled in
only five years. Camurus and Braeburn are firmly committed to
reducing the negative impacts of opioid addiction on individuals and
society by developing best-in-class long-acting treatment
alternatives. We aim to complete the ongoing Phase III efficacy trial
in 2016 and submit marketing approvals applications in Europe and
U.S. during 2017.

CAM2038 is also being developed for treatment of pain. A first Phase
II study in opioid dependent patients with chronic pain is planned to
start during the first quarter of 2016.

Together with our partner Novartis, we are in the process of
completing a Phase II study of our long-acting octreotide product,
CAM2029, in two patient groups with acromegaly and neuroendocrine
tumours, respectively. Results are expected during the second quarter
2016. In parallel, manufacturing preparations are ongoing for the
planned start of two pivotal Phase III registration trials.

During the fourth quarter, treatment of the last patients were
completed in the Phase II trial of our product CAM2032 for advanced
prostate cancer. Results are expected during the second quarter of
2016.

Several other promising drug product candidates are also being
assessed in preclinical studies by our capable research and
development teams. We are planning to take at least one of these
product into clinical development during 2016. In addition, we have a
number of very exciting collaboration projects with international
pharmaceutical and biotech companies, including the collaboration
with the U.S.-based company Rhythm on a long-acting peptide product
for treatment of genetic obesity, which resulted in a new license
agreement in the start of 2016.

To prepare for the launch of CAM2038, we have begun the process of
building a commercial organization with initial focus on the opioid
addiction market in Europe. In December, we announced the appointment
of Richard Jameson to the position as Chief Commercial Officer with
the responsibility with the responsibility for leading to leading
this strategic endeavor. Richard has broad experience from different
senior commercial roles across a number of specialty pharmaceutical
companies and markets. Most recently, he was responsible for leading
a commercial organization across Europe, the Middle-East and Africa
focused on the opioid dependence field.

Following our successful IPO, we have built a solid platform enabling
an effective execution of all parts of our strategy: expanding our
product pipeline, advancing new products to the market and preparing
the launch of CAM2038 in Europe. We will also continuing our
significant investments in research, innovation and development of
our world-leading technologies.

Fredrik Tiberg
President and CEO

For more information:

Fredrik Tiberg, CEO and Head of Research
Tel. +46 (0)46 286 46 92
fredrik.tiberg@camurus.com

Rein Piir, VP Investor Relations
Tel. +46 (0)70 853 72 92
ir@camurus.com

The information in this press release is disclosed by Camurus AB in
accordance with the Swedish Securities Markets Act and/or the Swedish
Financial Instruments Trading Act. The information was submitted for
publication at 07.00 a.m. on 17 February 2016.

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http://news.cision.com/camurus-ab/r/full-year-report-january-december-20...
http://mb.cision.com/Main/13456/9915568/478012.pdf

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