2014 Consolidated Financial Results
· Successful strategic merger and acquisition of Danish company Topotarget
giving birth to Onxeo
· Products’ major achievements:
· Beleodaq® approval in the US for PTCL 2nd line treatment and launch by US
partner
· Validive® phase II positive data
· FY 2014: proforma net profit of €7.3m (excluding one-time cost) and cash
reserves increased to €57.2m
PARIS & COPENHAGEN, Denmark--(BUSINESS WIRE (http://www.businesswire.com/))--
Regulatory News:
Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO) (Euronext Paris, NASDAQ OMX
Copenhagen: ONXEO), an innovative company specializing in the development of
orphan oncology drugs, today published its 2014 consolidated accounts and
provided a review of its 2014 achievements and a preview of the 2015
perspectives.
“2014 will remain a pivotal year in the Company’s history. As first major step
of our corporate growth strategy implementation, we merged with Topotarget mid
-2014 acquiring Beleodaq®, a promising asset with large potential indications,
enlarged the team with seasoned Danish professionals and on top of that,
received significant milestones from Spectum following Beleodaq® first approval
in July.
“Besides, our pipeline has also significantly progressed. Notably Validive®,has
obtained positive phase II results in the prevention of severe oral mucositis,
in which it showed a reduction of incidence of this highly burdening condition
“At last, from a financial standpoint, the company has significantly increased
it cash reserves ensuring a stronger position and allowing to reach full speed
in the development of our promising coumpounds.
“Overall, 2014 will remain as the year when the company has become the Orphan
Oncology Innovator, symbolically marking its transformation with the new name
Onxeo.
“I would like to specially thank my team for achieving these ambitious goals,
going through this transformation to build the new Onxeo. I also thank all our
shareholders, institutional and individual, for their support and confidence
throughout this unique year and express to them all our utmost commitment to
success,” said Judith Greciet, CEO of Onxeo.
2014 Highlights and perspectives
Expansion of key orphan oncology programs
Company’s key orphan oncology programs Validive®, Livatag® and Beleodaq® are
high added-value programs focusing on significant and unmet medical needs,
showing strong sales potential. In 2014, the team has reached important
development milestones, which contributed to increase the overall company value:
Beleodaq® (belinostat)
· In July 2014, the Food and Drug Administration (FDA) granted conditional
marketing authorization in the USA for the treatment of patients with relapsed
or refractory peripheral T-cell lymphoma (PTCL) in 2nd line treatment after
failure of standardized chemotherapy used in first line (CHOP protocol). As per
contract, this approval has triggered a $25 million milestone payment from
Spectrum Pharmaceuticals which was received in November. The commercialization
of Beleodaq® by the Spectrum Pharmaceuticals’ oncology sales team has started in
late July 2014 with positive level of sales estimated to around 5M USD,
resulting in first royalties for Onxeo.
· Following this conditional marketing authorization in 2nd-line PTCL, a
Beleodaq® Phase III trial is planned to be initiated H1 2016 for the same PTCL
patients but in first line of treatment, combined with CHOP, expanding therefore
the indication from 2nd to 1st line of treatment.
· Prior to this Phase III initiation, a phase I study with the combined
treatment Beleodaq® + CHOP (BelCHOP) is ongoing to determine the optimal dose of
the combination and its safety profile. This study is expected to recruit up to
28 patients by Q3 2015 and is the preliminary step of the phase III trial. .
· Beyond PTCL, Beleodaq® profile and first data advocate for the development
of new promising orphan oncology indications. The company is currently
discussing with its partner to finalize future product development plans.
Validive® (clonidine Lauriad®)
· End of October 2014, Onxeo reported positive preliminary top-line results of
the large international Phase II trial comparing the efficacy and safety of
Validive® versus placebo in the prevention of oral severe mucositis in 183 head
and neck cancer patients. Validive® has shown to reduce of 16% (absolute value)
the incidence of severe oral mucositis in treated patients versus placebo, to
delay the occurrence of the mucositis and allow a higher intensity of radiation
before appearing. The safety profile of Validive® was very good with no major
safety issue.
· The study's advisory committee, made up of internationally recognised
experts, has confirmed that these data were supportive to further pursue
Validive® development plan and recommended advancing its development program
through a Phase III study on the same patient population. This Phase III trial
evaluating Validive®’s efficacy is being prepared and the Company plans to
initiate it in 2015.
· Validive®’s development will benefit from the "fast track" status obtained
from the Food and Drug Administration in January 2014. This status is granted
for drugs developed for life-threatening diseases for which the medical need is
strong. It facilitates interactions with the FDA and optimizes review duration
during development and registration.
· Oral mucositis is a very severe adverse effect of chemoradiation therapy
which, at a severe stage, is highly painful and debilitating. There is no
current preventing option for such disease and the need for such treatment is
particularly high.
Livatag® (doxorubicin Transdrug™)
· Active recruitment in the Phase III trial ReLive in primary liver cancer,
with 40 % of planned patients already randomized. In 2015, the international
expansion of ReLive will be supported by broadening the ReLive trial into new
regions such as MENA (Middle East North Africa) countriesto optimize recruitment
rate.
· The product safety profile has been so far confirmed, twice again in 2014,
by the trial’s Data Safety Monitoring Board who meets twice a year to review all
the safety data of the treated patients.
· Livatag® also obtained FDA “fast track” status for treating hepatocellular
carcinoma as a second-line treatment after sorafenib In addition, the product’s
patent protection was reinforced in February 2014 with a new family of patents
protecting its specific dosing regimen, and issued by the European Patent
Office. This second patent family significantly strengthens and extends the
product’s patent protection in Europe until 2032 against the marketing of
generics.
Major development for the Company, the creation of Onxeo, resulting from the
merger of BioAlliance Pharma and Topotarget
2014 was a cornerstone year for the Company which became Onxeo in August,
through the merger between BioAlliance Pharma SA and Topotarget A/S. This was a
major first step in the company growth strategy implementation .
This operation has enabled the company to gain critical mass in orphan oncology,
its strategic field, as a European player with competitive advantages:
· An enlarged and advanced clinical pipeline,
· A reinforced team with strong scientific skills,
· A US based co- development and commercial partner on Beleodaq®,
Onxeo is listed on both Euronext and Nasdaq OMX in Copenhagen. The market
capitalization has reached the 250 M€ threshold, which positions the company
among the leading biotechs in Europe.
2014 consolidated financial information
2014 consolidated accounts reflect the successful implementation of Onxeo growth
strategy through the merger with Topotarget. The strategic partnership attached
to lead product Beleodaq® has indeed brought to the company significant revenues
consisting of cash milestone payments from Spectrum Pharmaceuticals as well as 1
million Spectrum shares, sold by Onxeo during the Summer. These revenues,
together with the new financing organized end 2014 have significantly
strengthened the overall cash position.
The accounting of the merger has the following consequences in the consolidated
accounts:
· The operation itself is booked as an acquisition, for the total
consideration of €83.4m. After deduction of the book value of contributed assets
and liabilities, the preliminary goodwill of €44.3m has been entirely allocated
to intangible assets, representing acquired IP R&D and synergies.
31/12/2014 31/12/2013
Intangible assets 87 932 23
Other non-current assets 1 120 1 277
Current assets 5 720 5 104
Cash and cash equivalents 57 227 11 328
TOTAL ASSETS 151 999 17 732
Shareholder's equity 121 971 7 888
Differed tax losses 13 805 0
Liabilities 16 223 9 843
TOTAL LIABILITIES 151 999 17 732
· The merger accounting effective date being June 30, 2014, the consolidated
P&L account does not include the activity of Topotarget over H1. In order to
facilitate the reading of the accounts, a proforma consolidated P&L account is
presented below to reflect the merger as if it had occurred on January 1, 2014.
Consolidated P&L is also presented below.
€ '000 31/12/2014 31/12/2014 31/12/2013
proforma
Recurring revenues from licensing 1 625 1 625 755
agreements
Non recurring revenues from 33 674 20 455 530
licensing agreements
Other revenues 1 1 181
Total revenues 35 300 22 081 1 467
Purchases (249) (249) (264)
Personnel expenses (8 266) (7 116) (5 347)
External charges (14 646) (13 563) (10 687)
Taxes other than on income (311) (311) (298)
Depreciation and amortization, (1 025) (972) (233)
net
Allowances to provisions, net (63) (63) 60
Other operating income 0 5
Other operating expenses (424) (424) (125)
Total operating expenses (24 983) (22 697) (16 888)
Current operating income / (loss) 10 317 (616) (15 422)
Share of results of associates (77) (77) (29)
Other non-current operating (9 734) (4 861) 0
income and expense
Operating income / (loss) 505 (5 554) (15 450)
Financial income 55 5 126
Income tax (2 966) (2 150) 0
Net income/(loss) (2 406) (7 699) (15 325)
Net income/ (loss) excluding non 7 328 (2 838) (15 325)
-current expenses (one-time
costs)
Revenues on a proforma basis are mostly driven by non-recurring items linked
with license agreements. Beyond the milestones and the 1 million shares received
from Spectrum upon registration of Beleodaq® for a total of $43m (out of which
$25m over H2), Onxeo also booked a $2m upfront payment from new partner
Innocutis (Sitavig®). Recurring revenues grow as well as a result of the
simultaneous launch in the Summer 2014 of Beleodaq® and Sitavig® in the United
States.
Operating expenses are naturally impacted by the new perimeter of the company,
with additional workforce from former Topotarget, based in Onxeo Danish branch
in Copenhagen, and the new R&D program with Beleodaq®. As a whole, R&D expenses
in the consolidated accounts on a proforma basis increase by 48%, from €10m to
€14.8m, due to Beleodaq® developments in first indication PTCL and also the
deployment of Livatag® international phase III in HCC and relating clinical
manufacturing program.
Consolidated accounts are significantly impacted by two non-recurring items:
· Merger-related costs of €4.8m (proforma €9.7m)
· An income tax due by the Danish branch on Beleodaq® revenues of €2.2m
(proforma €3m)
Excluding these non-recurring costs, Onxeo consolidated annual result is a loss
of €2.4m and on a proforma basis a profit of €7.3m.
From a cash standpoint, 2014 has been a year of considerable change : cash
reserves have soared from €15.5m to €57.2m, due to the Spectrum milestones as
well as the capital increase completed in December 2014. This financing,
together with Financière de la Montagne shareholder’s loan brought total net
proceeds of €37.5m at year-end.
“The successful implementation of our merger is clearly shown by the quality of
acquired assets, source of immediate and significant revenues and cash
additions,” said Nicolas Fellmann, Chief Financial Officer of Onxeo. “The
strengthened cash position provides a visibility of over two years and enables
us to pursue an optimized and efficient development of our R&D programs, while
at the same time monitoring closely other operating expenses.”
Onxeo will comment on major current issues and its annual financial statements
during its SFAF meeting which will be held on March 5, 2015 at 9:30am at the
Company’s headquarters (49 boulevard Martial Valin, Paris 15°, France), and
during the audio/web conference the same day at 5:30 pm:
Tel: +33 (0)1 70 77 09 43
Webconference:
http://anywhereconference.com?UserAudioMode=DATA&Name=&Conference=135292673&PIN=
4
73081 (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fanywherec
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6a)
Audio Playback Numbers : +33(0)1 72 00 15 00
Audio Playback Reference : 292673
About PTCL
Lymphoma is the most common blood cancer. Hodgkin's and non-Hodgkin's lymphoma
are the main two forms of lymphoma. The lymphoma survives when the lymphocytes,
a type of white blood cell, increase abnormally and accumulate in one or more
lymphatic ganglions or in lymphatic tissue. Two types of lymphocytes may
develop: B lymphocytes (B cells) and T lymphocytes (T cells). Peripheral T-Cell
Lymphoma (PTCL) is a sub-type of non-Hodgkin's lymphoma. In the United States,
PTCL accounts for around 10 to 15% of non-Hodgkin's lymphoma and its global
incidence is estimated at 12,000 cases each year.
About oral mucositis
Severe oral mucositis is a particularly invalidating pathology induced by
radio/chemotherapy treatments and very frequent in patients with head and neck
cancer. It may induce intense oral pain and eating disability requiring enteral
or parenteral nutritional support. Thirty per cent of patients need to be
hospitalized as a result and symptoms can force patients to stop treatment for
an undefined period thus reducing treatment efficacy. Oral mucositis has
currently no validated curative or preventive treatment.
About primary liver cancer, or HepatoCellular Carcinoma
Hepatocellular carcinoma (HCC) or hepatocarcinoma is the most common of the
primary liver cancers (85% to 90%). It is an aggressive cancer which is
resistant to chemotherapy. It is the second highest cause of death from cancer
worldwide. It is commonly diagnosed at an advanced stage at which time few
therapeutic alternatives exist, presenting a strong therapeutic need. The risk
factors are well known: infection by hepatitis viruses (B and C),
overconsumption of alcohol (another major cause of cirrhosis) and metabolic
diseases, especially obesity, a growing cause of cirrhosis and HCC.
About Onxeo
Onxeo has the vision to become a global leader and pioneer in oncology, with a
focus on orphan or rare cancers, through developing innovative therapeutic
alternatives to “make the difference”. The Onxeo teams are determined to develop
innovative medicines to provide patients with hope and significantly improve
their lives.
Key products at advanced development stage are:
Livatag® (Doxorubicin Transdrug™): Phase III in hepatocellular carcinoma
Validive® (Clonidine Lauriad®): Phase II in severe oral mucositis: Positive
preliminary top-line results
Beleodaq® (belinostat): registered in the US in peripheral T-cell lymphoma
For more information, visit the
website www.onxeo.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3
A
%2F%2Fwww.onxeo.com&esheet=51052614&newsitemid=0&lan=en
-US&anchor=www.onxeo.com&index=2&md5=f3ed839928fb30762dd1da229746f6d1)
Disclaimer
This communication expressly or implicitly contains certain forward-looking
statements concerning Onxeo and its business. Such statements involve certain
known and unknown risks, uncertainties and other factors, which could cause the
actual results, financial condition, performance or achievements of Onxeo to be
materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements. Onxeo is providing this
communication as of this date and does not undertake to update any forward
-looking statements contained herein as a result of new information, future
events or otherwise. For a discussion of risks and uncertainties which could
cause actual results, financial condition, performance or achievements of Onxeo
to differ from those contained in the forward-looking statements, please refer
to the Risk Factors ("Facteurs de Risque") section of the 2013 Reference
Document filed with the AMF on April 7, 2014, which is available on the AMF
website (http://www.amf
-france.org (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww
.
amf-france.org&esheet=51052614&newsitemid=0&lan=en
-US&anchor=http%3A%2F%2Fwww.amf
-france.org&index=3&md5=e2e3d6fb91da2fb3f66377192c6a6370)) or on the company’s
website
(www.onxeo.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2F
w
ww.onxeo.com&esheet=51052614&newsitemid=0&lan=en
-US&anchor=www.onxeo.com&index=4&md5=4a124cf26934da025e38dc28148c2d01)).
Onxeo S.A.
Judith Greciet, CEO
j.greciet@onxeo.com
Nicolas Fellmann, CFO
n.fellmann@onxeo.com
+33 1 45 58 76 00
or
Alize RP
Caroline Carmagnol / Sophie Colin, +33 6 64 18 99 59 / +33 1 44 54 36 62
onxeo@alizerp.com
2014 Onxeo Review and 2015 Perspectives
| Source: Onxeo SA
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