OSE Immunotherapeutics SA
(ISIN:FR0012127173); (Mnémo:OSE) today reports it annual financial
results as of December 31, 2016, and provides an update on the key
achievements as well as the company’s outlook for its agonist and
antagonist immunotherapies.
“We achieved significant progress in 2016,
including securing two partnerships with world renowned
pharmaceutical groups that ensure the focused development of our
disruptive immunotherapies for auto-immune disorders.” said
Dominique Costantini, CEO of OSE Immunotherapeutics. “In addition,
we met key preclinical and clinical development goals for our
immuno-oncology franchise specifically for our lead product
Tedopi®, as well as OSE-172 (Effi-DEM). We intend to broaden our
pipeline in immuno-oncology over the next few months, including for
our most advanced clinical product, Tedopi®, which will be
evaluated in combination with checkpoints inhibitors and in new
cancer indications. Moreover, with financial results which, for the
first time, show an annual net profit of 21 million euros and a
financial visibility until the second half of 2018, the company is
in a solid financial position to take the next steps of its
growth.”
2016 KEY MILESTONES
MERGER-ABSORPTION international
player, leader in innovative immunotherapies of activation and
regulation.
IN IMMUNO-ONCOLOGY: CLINICAL AND PRECLINICAL
ACHIEVEMENTS Tedopi®, an innovative
proprietary combination of neoepitopes, began in early 2016 a
pivotal clinical phase 3 registration study in advanced lung cancer
in Europe and in the United States. Tedopi® is the Company’s most
advanced product, with the phase 3 study expected to be completed
by the end of 2018.
* €155 M (Janssen Biotech) + €272 M (Servier)** Including a
badwill of €24.4 M due to the merger operation
OSE-172 (Effi-DEM), a new
generation checkpoint inhibitor targeting SIRP-α receptor (i.e. to
block suppressive myeloid and macrophage cells), has demonstrated
compelling preclinical results in various cancer models, presented
at multiple scientific international conferences in 2016.
A non-interventional study in patients with
hepatocellular carcinoma (HCC, primary liver cancer) was initiated
in May 2016. This study is a private-public research program
supported by the French National Cancer Institute (INCa, Institut
National du Cancer) and the Direction Générale de l’Offre de Soins
(DGOS, the French access to healthcare services). This
collaborative research program aims to evaluate SIRP-alpha in
several types of tumor.
IN AUTO-IMMUNE DISEASES: STRATEGIC PARTNERSHIP
AGREEMENTSFR104, CD28-antagonist, was
licensed to Janssen Biotech (Group Johnson & Johnson) in July
2016 to pursue clinical development in auto-immune diseases at the
conclusion of the phase 1 trial.
OSE Immunotherapeutics is eligible to receive up
to a potential total of €155 million which includes an option
exercise fee of €10 million which was paid in August 2016 and
potential development, regulatory and commercial milestone payments
as well as royalties on sales.
The positive phase 1 clinical results of FR104
conducted in healthy subjects demonstrated the product’s good
tolerance and first signal of its immunosuppressive activity.
OSE-127 (Effi-7), an antagonist
of the interleukin-7 receptor (IL-7), was the subject of a license
option agreement with Servier, announced in December 2016 for the
development and commercialization of the product in auto-immune
diseases.
OSE Immunotherapeutics is eligible to receive up
to €272 million including an upfront payment of €10.25 million
which was paid in January 2017 and additional payments totaling €30
million upon the exercise of a two-steps license option. These
steps will finance the development of OSE-127 (Effi-7) up to the
completion of a phase 2 clinical trial planned in ulcerative
colitis, an autoimmune bowel disease. Further payments will be
linked to the achievement of clinical development and registration
in multiple indications, as well as sales milestones with
double-digit royalties on sales.
Preclinical studies have demonstrated the
product’s efficacy in in vivo models of ulcerative colitis, a
T-cell mediated disease. These results were presented at the annual
international congress of immunology, « Federation of Clinical
Immunology Societies », in June 2016.
2017 OUTLOOK
IN IMMUNO-ONCOLOGY: EXTENSION OF
THE FRANCHISE AND DEVELOPMENT OF TEDOPI®
THERAPEUTIC POTENTIAL
In addition to the ongoing pivotal registration
study with Tedopi® in advanced lung cancer, OSE Immunotherapeutics
is considering a phase 2 clinical trial with Tedopi® in combination
with a checkpoint inhibitor in the same indication, in
collaboration with a European research institution.
The Company is also evaluating potentially
extending the development of Tedopi® into new cancer indications
(pancreas, bladder cancers) with exploratory phase 2 studies, in
partnership with collaborative oncology groups.
IN AUTO-IMMUNE DISEASES: TO PURSUE THE
PRODUCT’S CLINICAL DEVELOPMENT THROUGH PARTNERSHIPS
Following the positive phase 1 results with
FR104, and the license agreement with Janssen Biotech in July 2016,
the product’s clinical development will be pursued in auto-immune
diseases.
Currently in preclinical stage for ulcerative
colitis, further development of OSE-127 (Effi-7) through phase 2
will be pursued as part of the EFFIMab consortium, led by OSE
Immunotherapeutics and including private and public partners. Per
the license option agreement signed at the end of 2016, Servier
will be responsible for further development of the product
following phase 2.
The Company will pursue the research of new
collaborative or license agreements, which can be initiated at
different stages of product development, with players involved in
the field of activation and regulation immunology and in
therapeutic combinations of high clinical interest.
2016 ANNUAL RESULTS
Meeting of Board of Directors of OSE
Immunotherapeutics was held on March 28, 2017. Following the
opinion of the Audit Committee, the Board approved the annual and
consolidated financial statements prepared under IFRS at 31
December 2016. These accounts have been audited by the Statutory
Auditors.
The key figures of the 2016 consolidated annual
results are reported below (and presented in the attached
tables):
In k€ |
12/31/2016 |
12/31/2015 |
Operating result |
17 499 |
(5 420 |
) |
Net result |
20 666 |
(5 584 |
) |
Available cash* |
17 766 |
15 133 |
|
Consolidated balance sheet |
89 547 |
16 995 |
|
As of December 31, 2016, available cash*
amounted to €17.8 million following the license agreement for FR104
signed with Janssen Biotech in July 2016.
During the first quarter 2017, OSE
Immunotherapeutics’ cash position was reinforced by a €10.25
million payment triggered by the license option agreement for
OSE-127 (Effi-7) signed with Servier at the end of December
2016.
For the first time, as of December 2016, the
Company recorded a net annual profit of €21 million as a result of
the license agreement for FR104 with Janssen Biotech in July 2016
which triggered a payment of €10 million, and of the merger of
Effimune and OSE Pharma to create OSE Immunotherapeutics in May
2016.
Current operating expenses represented €8.2
million, including €5.2 million of R&D expenses, versus €5.4
million for the same period of 2015, in line with the acceleration
of R&D portfolio development, and in particular the pivotal
phase 3 study of Tedopi® launched in Europe and in the United
States.
The total consolidated balance sheet amounted to
€90 million against €17 million as of December 31, 2016.
As of today, the Company has funds for
operations until the second half of 2018.
These results are in line with expectations with
all stated clinical targets delivered on schedule in
2016.
* Cash and cash equivalents and Current
financial assets
RISK FACTORS
The risk factors affecting the Company are set
out in paragraph 4 of the reference document filed with the French
financial market authority ("AMF") on June 8, 2016.
REFERENCE DOCUMENT AND ANNUAL FINANCIAL
REPORT
The Company intends to file with the AMF a
reference document and an annual financial report for 2016. These
documents should be made available to the public in the second
quarter of 2017.
OSE Immunotherapeutics will comment on major current issues
and on its annual financial statements during an Analyst meeting
which will be held on March 30, 2017 at 10:00am CET at the “SFAF” -
135, boulevard Hausmann - 75008 Paris and during an audio/web
conference the same day at 6:00pm CET:Audio
connection numbers: FR : +33 170 770 943 ;
UK : +44 2033679461 ; US
: +1 8554027761Webconference:
http://www.anywhereconference.com?UserAudioMode=DATA&Name=&Conference=135306981&PIN=32341749Audio
playback numbers and reference: FR : +33 172 001 500;
UK : +44 2033679460 ; US :
+1 877 64 230 18REF : 306981# |
ABOUT OSE
IMMUNOTHERAPEUTICSOur ambition is to become a
world leader in activation and regulation
immunotherapiesOSE Immunotherapeutics is a biotechnology
company focused on the development of innovative immunotherapies
for immune activation and regulation in the fields of
immuno-oncology, auto-immune diseases and transplantation. The
company has a balanced portfolio of first-in-class products with a
diversified risk profile ranging from clinical phase 3 registration
trials to R&D:
In immuno-oncology:
- Tedopi® (OSE-2101), a combination of 10 optimized
neo-epitopes to induce specific T activation in
immuno-oncology - Currently in registration Phase 3 trial
advanced NSCLC HLA A2+ patients EU /US - Orphan Status in
the US - Registration expected in 2019 - A Phase 2 with
Tedopi® in combination with a checkpoint inhibitor in
NSCLC is considered in 2017.
- OSE-172 (Effi-DEM), new generation checkpoint
inhibitor targeting the SIRP-α receptor - In
preclinical development for several cancer models.
In auto-immune diseases and
transplantation:
- FR104, CD28-antagonist in immunotherapy -
Phase 1 trial completed – For the treatment of
autoimmune diseases and for use with transplantation -
Licensed to Janssen Biotech Inc. to pursue
clinical development.
- OSE-127 (Effi-7), interleukin receptor-7
antagonist - In preclinical development for
inflammatory bowel diseases and other autoimmune diseases.
License option agreement with Servier for the
development and commercialization.
The portfolio’s blockbuster potential gives OSE
Immunotherapeutics the ability to enter global agreements at
different stages of development with major pharmaceutical
players.
Immunotherapy is a highly promising and growing
market. By 2023 Immunotherapy of cancer could represent nearly 60%
of treatments against less than 3% at present * and the projected
market is estimated at $67 billion in 2018 **.
There are more than 80 autoimmune diseases that
represent a significant market including major players in the
pharmaceutical industry with sales towards $10 billion for the main
products. The medical need is largely unmet and requires the
provision of new innovative products involved in the regulation of
the immune system.
*Citi Research Equity**BCC Research
Click and follow us on Twitter and
Linkedlnhttps://twitter.com/OSEIMMUNO https://www.linkedin.com/company-beta/10929673/?pathWildcard=10929673
Forward-looking statementsThis press release
contains express or implied information and statements that might
be deemed forward-looking information and statements in respect of
OSE Immunotherapeutics. They do not constitute historical facts.
These information and statements include financial projections that
are based upon certain assumptions and assessments made by OSE
Immunotherapeutics’ management in light of its experience and its
perception of historical trends, current economic and industry
conditions, expected future developments and other factors they
believe to be appropriate.These forward-looking statements include
statements typically using conditional and containing verbs such as
“expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”,
their declensions and conjugations and words of similar import.
Although the OSE Immunotherapeutics management believes that the
forward-looking statements and information are reasonable, the OSE
Immunotherapeutics’ shareholders and other investors are cautioned
that the completion of such expectations is by nature subject to
various risks, known or not, and uncertainties which are difficult
to predict and generally beyond the control of OSE
Immunotherapeutics. These risks could cause actual results and
developments to differ materially from those expressed in or
implied or projected by the forward-looking statements. These risks
include those discussed or identified in the public filings made by
OSE Immunotherapeutics with the AMF. Such forward-looking
statements are not guarantees of future performance. This press
release includes only summary information and should be read with
the OSE Immunotherapeutics Reference Document filed with the AMF on
8 June 2016 under the number R.16-052, the consolidated financial
statements and the management report for the fiscal year 2015, as
well as the Merger Document registered with the AMF on 26 April
2016 under number E.16-026, all available on the OSE
Immunotherapeutics’ website.Other than as required by applicable
law, OSE Immunotherapeutics issues this press release at the date
hereof and does not undertake any obligation to update or revise
the forward-looking information or statements.
APPENDICES
Consolidated Profit & Loss |
|
P&L in kEuros |
|
12/31/2016 |
12/31/2015 |
Turnover |
|
|
383 |
|
4 |
|
Total Revenues |
|
383 |
|
4 |
|
Research and development expenses |
(5 149 |
) |
(2 245 |
) |
Overhead expenses |
|
(2 792 |
) |
(1 322 |
) |
Expenses related to shares payments |
(679 |
) |
(1 857 |
) |
Operating Profit/Loss -
current |
(8 236 |
) |
(5 420 |
) |
Other operating products (Janssen) |
10 000 |
|
0 |
|
Other operating expenses (INSERM) |
(2 325 |
) |
0 |
|
Other operating products (badwill) |
24 360 |
|
0 |
|
Other operating expenses |
|
(6 300 |
) |
0 |
|
Operating Profit/Loss |
|
17 499 |
|
(5 420 |
) |
Financial products |
|
146 |
|
71 |
|
Financial expenses |
|
(53 |
) |
(225 |
) |
Profit/Loss Before Tax |
|
17 592 |
|
(5 573 |
) |
Income Tax |
|
|
3 074 |
|
(11 |
) |
Net Profit/Loss |
|
20 666 |
|
(5 584 |
) |
Conversions gains and losses |
(29 |
) |
(95 |
) |
Global Profit/Loss |
|
20 637 |
|
(5 679 |
) |
Basic and diluted earnings per
share |
1,65 |
|
(0,59 |
) |
Consolidated Balance Sheet |
|
Assets in kEuros |
|
|
12/31/2016 |
12/31/2015 |
Intangible assets |
|
|
52 600 |
0 |
Tangible assets |
|
|
110 |
65 |
Financial assets |
|
|
142 |
54 |
Deffered tax assets |
|
|
157 |
0 |
|
Total non current assets |
|
53 009 |
119 |
Trade receivables |
|
|
12 318 |
0 |
Other accounts receivables |
|
|
6 454 |
1 742 |
Current financial assets |
|
|
2 881 |
5 801 |
Cash and cash equivalents |
|
|
14 885 |
9 332 |
|
Total current assets |
|
36 538 |
16 876 |
Total assets |
|
|
89 547 |
16 995 |
|
|
|
|
|
|
|
|
|
|
Equity & Liabilities in kEuros |
|
|
12/31/2016 |
12/31/2015 |
Stated capital |
|
|
2 858 |
2 010 |
|
Total shareholders' equity |
|
64 525 |
14 476 |
Non current financial liabilities |
|
|
1 197 |
204 |
Non current deferred tax liabilities |
|
|
5 003 |
0 |
Non current provisions |
|
|
158 |
10 |
|
Total non current debts |
|
6 358 |
214 |
Current financial liabilities |
|
|
587 |
776 |
Trade payables |
|
|
4 256 |
1 129 |
Other payables |
|
|
3 148 |
302 |
Other debts and accruals |
|
|
10 672 |
98 |
|
Total current debts |
|
18 663 |
2 304 |
Total liabilities |
|
|
89 547 |
16 995 |
Consolidated Statement of Changes in Equity |
|
In kEuros |
Share capital |
Share premium |
Currency translation transactions |
Own shares |
Retained earnings and result |
Total consolidated equity |
|
|
|
|
|
|
|
Consolidated equity as at December 31st, 2014 |
1 605 |
1 700 |
|
(4 |
) |
0 |
|
(4 104 |
) |
(803 |
) |
|
|
|
|
|
|
|
Consolidated result |
|
|
|
|
(5 584 |
) |
(5 584 |
) |
Currency translation transactions |
|
|
(95 |
) |
|
|
(95 |
) |
Global consolidated result |
- |
- |
|
(95 |
) |
0 |
|
(5 584 |
) |
(5 679 |
) |
Capital variation |
397 |
20 967 |
|
|
|
|
21 364 |
|
Warrant subscription |
|
157 |
|
|
|
|
157 |
|
Capital increase expenses |
|
(2 146 |
) |
|
|
|
(2 146 |
) |
Shares based payments |
7 |
291 |
|
|
|
1 559 |
|
1 857 |
|
Own shares transactions |
|
|
|
(279 |
) |
5 |
|
(274 |
) |
|
|
|
|
|
|
|
Consolidated equity as at December 31st, 2015 |
2 010 |
20 969 |
|
(98 |
) |
(279 |
) |
(8 125 |
) |
14 476 |
|
|
|
|
|
|
|
|
Consolidated result |
|
|
|
|
20 666 |
|
20 666 |
|
Actuarial difference |
|
|
|
|
(20 |
) |
(20 |
) |
Currency translation transactions |
|
|
(9 |
) |
|
|
(9 |
) |
Global consolidated result |
- |
- |
|
(9 |
) |
0 |
|
20 646 |
|
20 637 |
|
Capital variation |
27 |
825 |
|
|
|
|
852 |
|
Merger |
821 |
27 334 |
|
|
|
|
28 155 |
|
Merger costs |
|
(479 |
) |
|
|
|
(479 |
) |
Revenue recognition - Effimune impact |
|
|
|
|
864 |
|
864 |
|
Orion warrants - cancellation of shares based payment accounted as
of 12/31/2015 |
|
|
|
|
(339 |
) |
(339 |
) |
Warrant subscription |
|
7 |
|
|
|
|
7 |
|
Deffered tax |
|
|
|
|
3 |
|
3 |
|
Capital increase expenses - Effimune |
|
(53 |
) |
|
|
53 |
|
0 |
|
Share based payments |
|
|
|
|
305 |
|
305 |
|
Own shares transactions |
|
|
|
111 |
|
(68 |
) |
43 |
|
|
|
|
|
|
|
|
Consolidated equity as at December 31st, 2016 |
2 858 |
48 603 |
|
(107 |
) |
(168 |
) |
13 341 |
|
64 527 |
|
Consolidated Cash Flow Statement |
|
|
In kEuros |
|
|
|
12/31/2016 |
12/31/2015 |
|
|
|
|
|
|
|
|
|
Consolidated result |
|
|
20 666 |
|
(5 584 |
) |
+/- |
|
Depreciation, amortization and provision expenses |
|
107 |
|
99 |
|
- |
|
Badwill |
|
|
|
(24 365 |
) |
|
+ |
|
Derecognition of asset |
|
|
6 300 |
|
|
+/- |
|
Shares
based payments |
|
|
680 |
|
1 857 |
|
+/- |
|
Other calculated income and expenses |
|
7 |
|
(4 |
) |
|
|
Cash flow before tax |
|
|
3 395 |
|
(3 632 |
) |
|
|
|
|
|
|
|
+ |
|
Financial
charges |
|
|
(8 |
) |
43 |
|
- |
|
Income tax
expenses |
|
|
(3 074 |
) |
|
+/- |
|
Working
capital variation |
|
|
370 |
|
(1 025 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOW FROM OPERATING ACTIVITIES
(A) |
684 |
|
(4 614 |
) |
|
|
|
|
|
|
|
- |
|
Tangible
assets increase |
|
|
(30 |
) |
(43 |
) |
+/- |
|
Financial
assets variation |
|
|
141 |
|
(279 |
) |
+/- |
|
Mutual finds units accounted in current financial
assets |
2 920 |
|
(5 888 |
) |
+/- |
|
Change in scope of consolidation |
3 163 |
|
|
+/- |
|
Loans and
advances variation |
|
|
(89 |
) |
(26 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOW FROM INVESTING ACTIVITIES
(B) |
6 105 |
|
-6 236 |
|
|
|
|
|
|
|
|
+ |
|
Capital
increase (including share premium) |
|
137 |
|
20 188 |
|
+/- |
|
Own shares
transactions |
|
|
(98 |
) |
5 |
|
- |
|
Capital
increase and merger expenses |
|
|
(479 |
) |
(2 146 |
) |
+ |
|
Warrant
subscription |
|
|
7 |
|
157 |
|
+ |
|
Loans
subscription |
|
|
11 |
|
1 263 |
|
- |
|
Loans
repayment |
|
|
(821 |
) |
(345 |
) |
- |
|
Financial
charges |
|
|
8 |
|
(43 |
) |
+/- |
|
Other flows
from financing activities |
|
0 |
|
4 |
|
|
|
|
|
|
|
|
|
|
CASH FLOW FROM FINANCING ACTIVITIES
© |
(1 234 |
) |
19 083 |
|
|
|
|
|
|
|
|
+/- |
|
Currency
translation transactions (D) |
|
0 |
|
1 |
|
|
|
|
|
|
|
|
|
|
CASH VARIATION E = (A + B + C +
D) |
|
5 555 |
|
8 234 |
|
|
|
CASH OPENING BALANCE (F) |
|
9 330 |
|
1 096 |
|
|
|
CASH CLOSING BALANCE (G) |
|
14 885 |
|
9 330 |
|
|
|
DIFFERENCE : E (G-F) |
|
|
0 |
|
0 |
|
As of December 31, 2016 the available cash
is as follows:
In kEuros |
|
31/12/2016 |
31/12/2015 |
Cash & equivalents according to IAS 7 |
|
14 885 |
9 330 |
Current financial assets |
|
2 881 |
5 801 |
Available Cash |
|
17 766 |
15 131 |
Contacts
OSE Immunotherapeutics
Sylvie Détry
sylvie.detry@ose-immuno.com
+33 143 297 857
Contacts media: Alize RP
Caroline Carmagnol
oseimmuno@alizerp.com
+33 647 389 004
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