creation of onxeo skilled international board of directors bioalliance pharma, a ... first line...
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Looking-Forward Statements
This communication expressly or implicitly contains certain forward-looking statements concerning Onxeo SA and its business. Such statements involve certain know and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Onxeo SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Onxeo SA 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 SA 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) or on Onxeo's website (http://www.onxeo.com).
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Business overview
Established in 1997 in France, listed on Euronext Paris in 2005
Develops innovative treatments addressing significant unmet needs in Orphan/Oncology diseases
Two advanced clinical programs and two supportive care registered/marketed products
Cash FY13: €11.3 million
Strong expertise and innovation
50 employees (70% R&D) with full-range of expertise from preclinical to registration & business development
Two technological platforms (Lauriad® and Transdrug™)
Fully proven expertise with two successful NDAs/ MAs
Extensive IP portfolio
Highly experienced management team and a highly skilled international Board of Directors
BioAlliance Pharma, a French Biotech company…
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With a clear growth strategy Build on a leader in orphan oncology field
PRODUCT DISCOVERY PRECLINICAL PH1 PH2 PH3 REGISTRATION MARKET
Livatag® Primary Liver Cancer
Validive® Oral Mucositis
AMEP®/Synfoldin Metastatic Melanoma
And accelerate growth with strategic corporate development transactions
Lean on our advanced product pipeline development
Breakthrough highly innovative products in diseases with strong unmet medical need and large sales potential (up to €800M)
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BioAlliance Pharma & Topotarget, the perfect fit for a merger
Business overview BioAlliance Pharma
Established in 1997 in France, listed on Euronext Paris in 2005 ( BIO )
50 employees w/ expertise from preclinical to registration, IP & BD
Develops innovative treatments addressing significant unmet needs in Orphan/Oncology diseases
Two advanced clinical programs and two specialty products registered/marketed products
Average 3 months: market cap 170 M€, liquidity 1.8 M€/day
Business overview Topotarget
Established in 2000, listed on NASDAQ OMX Copenhagen ( TOPO)
12 employees
Focused on late-stage programs in orphan oncology
Beleodaq®, lead product registered in the U.S., strong partnership with US pharma Spectrum (SPPI).
Average 3 months: market cap 75 M€, liquidity 0.4 M€/day
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… to create a leader in orphan oncology, based in Europe
Supported by a highly complementary pipeline of late-stage products with several significant value-creating events in both the short and medium term
Benefiting from operational efficiencies: combined knowledge-sharing, and a diversified revenue stream driving growth
Resulting in a broadened shareholders base with increased market capitalization and increased attractiveness to investors
Under the leadership of an experienced management team and supervised by a highly skilled international Board of Directors with proven track records
Dedicated to the development of innovative therapies for orphan oncology diseases with increased value creation for shareholders
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Onxeo, our vision, our mission
Driven by a strong vision:
“To be a global leader and pioneer in oncology, with a focus on orphan diseases, to make the difference”
Dedicated to its mission:
“We are determined to develop innovative medicines to provide patients with hope and improve their lives“
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Onxeo corporate profile & key strengths
Headquartered in Paris, Listed on Euronext Paris and NASDAQ OMX Copenhagen
– Shareholders approvals of the merger: 27 & 30 June, 2014, Merger completion: July 22, 2014
– Name change August 1st , Onxeo shares will be listed from August 6th on both markets
Approximately 60 employees, strong expertise from preclinical to registration, BD & IP
Dedicated to orphan oncology diseases, for diseases with high unmet needs
– 3 technological platforms/assets and multiple potential applications
– 3 programs in advanced clinical development, synergic while independent
– 3 products approved Europe and/or US
International partnerships
– Spectrum for Beleodaq® (North America, India)
– Innocutis for Sitavig® (USA)
– Sosei for Loramyc® in Japan
– …
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Experienced Management Team and Board of Directors
Highly skilled Franco-Danish management team
CEO: Judith Greciet, 15 years in strategy and operations
Onxeo Executive committee will be enlarged with Topotarget key expertise
Track record of bringing products through the FDA and EMA approvals process (Belinostat, Loramyc®/Oravig®, Sitavig®, ..)
International Board of Directors reflecting the spirit of the company
International Board of Directors chaired by P. Langlois (former CFO of Aventis SA), with the addition of Bo J. Hansen (Chairman of SOBI) from Topotarget
Shareholders represented by Financière de la Montagne (N. Trebouta) & Per Samuelsson (Healthcap)
Experienced individuals highly skilled in strategy, product development, pharma and biotech environment, external growth, M&A and financing
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Growth strategy: Build on a leader in orphan oncology
PRODUCT PH PH2 PH3 REGISTRATION LAUNCH MILESTONES
Beleodaq® ( PTCL 2nd L)
US registered July 2014
Combo BelCHOP (PTCL 1st Line)
Livatag® (HCC 2nd Line) Ph 3 Read-out end 2016
Validive® (Oral Mucositis) Ph 2 preliminary data Q4 2014
NCI sponsored Studies Solid Tumors & Lymphomas In patients with Hepatic Dysfct
Onxeo advanced product pipeline Belinostat: two to four additional indications anticipated in hematology/solid tumors with a sales potential > €250M worldwide
Livatag®/ Validive®: extended indications to enlarge market value potential
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BELEODAQ® Advanced HDACi with large potential
Beleodaq® (Belinostat) , HDAC inhibitor, epigenetic compound
Only pan HDACi with oral and IV formulations
Increase in acetylation of histone and non histone proteins: induces cell cycle arrest, apoptosis and decrease in tumor proliferation
Effective as monotherapy and combination therapy
Large clinical development already performed
Indications in hematology and solid tumors
More than 1200 patients treated through phase I - III clinical trials
IP and regulatory status
Long-term IP, until 2027 in the U.S.
NDA granted by FDA on July 3, 2014 in second line PTCL
Orphan status granted in US and Europe
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BELEODAQ® Accelerated Approval granted from FDA in PTCL
Peripheral T-cell lymphoma – PTCL
A subtype of non-Hodgkin’s lymphoma (NHL) which affects T-cells
Estimated global incidence of 12,000/year (10-15% NHL)
Only conditionally approved products available in the US in second line
Beleodaq® (Belinostat) pivotal phase II in PTCL 2nd Line
Positive trial (BELIEF study) showing efficacy and favorable safety profile
– N =129, open label study in patients with relapsed or refractory PTCL
– 25% Overall Response rate - 8.3 month median duration of response
– Low incidence of myelosuppression, well tolerated in patients with low platelets
Angioimmunoblastic T Cell lymphoma (AITL) - subgroup of BELIEF study (17%):
– 45% Overall Response rate - 8.3 month median duration of response
Phase III randomized confirmatory trial: first line in combo with CHOP
First line treatment in PTCL: Beleodaq® + CHOP versus CHOP
On going: Phase I combination Belinostat + CHOP in naive PTCL patients
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LIVATAG® to overcome resistance in HCC
Doxorubicin nanoformulated
Proprietary Transdrug™ platform
Design to bypass tumor cell resistance – Encoded by multidrug resistance (MDR) genes – Ions pair doxo/PIHCA preventing doxo – MDR interactions
Hepatocellular Carcinoma (HCC)
782.000 new cases & 746.000 deaths yearly
40 to 60% of patients are diagnosed at late stage, highly resistant
One approved drug: Sorafenib for advanced HCC
IP and regulatory status
Intellectual protection until 2032
Orphan status in both Europe and US, Fast track designation in US
Sales potential estimated up to 800m€
Mechanism of action of Livatag®
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LIVATAG® “ReLive” Phase III trial to assess efficacy
400 patients study
Initiated in 2012, study extension in 2013
US: IND obtained in Dec 2013, implementation ongoing
Europe: Germany, Italy, Spain, Russia, Austria, Belgium, Bulgaria
+ 30% of patients enrolled
4th DSMB held in April 2014 with positive recommendation
Estimated timelines: LPI end 2015 / Preliminary results end 2016
Multicenter randomized controlled open label vs Best Standard of Care Efficacy (OS) and safety of Livatag® (20 and 30mg/m² - slow IV) vs BSC after
failure or intolerance to sorafenib
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VALIDIVE® to prevent severe oral mucositis
Validive® innovative therapeutic new option
Mucoadhesive tablet (Lauriad®) delivering early and sustained concentration of clonidine directly in the mouth to preventing severe oral mucositis
α- 2 receptor inhibition with strong antiinflammatory properties
Oral mucositis
Inflammation and ulceration of oral mucosa induced by chemo-radio therapies
Highly frequent in H&N cancer patients > 80%
150.000 H&N cancer patient/year, leading to severe OM thus radiotherapy breaks or delays & increased hospitalization
No preventive treatment approved in solid cancer
IP and regulatory status
Orphan status in Europe, IP until 2029
Fast track designation allowing accelerated review by FDA
Sales potential estimated between 200 and 400m€
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VALIDIVE® Phase II – Data expected by end 2014
Daily application for up 8 weeks with a 4-week follow up
185 patients enrolled by early May 2014 - LPI
Preliminary results expected in 4Q2014
Primary endpoint: % Efficacy of Validive® 50 μg and 100 μg vs placebo
International board of experts in place to advise on development
strategy and medical positioning of Validive® in oral mucositis
Multicenter, randomized, double-blind placebo-controlled, to assess
Validive® efficacy to prevent severe oral mucositis in H&N cancer patients
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Non core product Sitavig®: A 2nd NDA Establishing our Know-How
Sitavig®
One single 50mg mucoadhesive tablet to treat recurrent labial herpes
International Licensing strategy with partners in the US, Brazil and Korea
Commercialization in the US since July 2014 by partner Innocutis, specialized in dermatology
Strong IP until 2029/2030 in major markets
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Onxeo, a unique short and mid-term newsflow to drive value
Beleodaq®
Launch in the US by Spectrum Pharma 3Q 2014
Phase I combination Q2 2015
Validive® Phase II trial
Preliminary results 4Q 2014
Phase III trial H2 2015
Livatag® Phase III trial (recruitment ongoing)
Next DSMB 4Q 2014
End of recruitment (LPLV) 2Q 2016
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Key financial highlights
Strengthened financial parameters Proforma financial information – June 30, 2014
Consolidated cash balance: 19.2 M€
Consolidated revenues H1: 13.9 M€
including 13.2 M€ in cash/equity milestones from US partner Spectrum (Approval for filing of Beleodaq® NDA – Feb. 2014)
H2 financial drivers 10 M€ shareholder’s loan from Financière de la Montagne (July 2014)
25 M$ milestone to be received from US partner Spectrum, triggered by the July NDA
approval of Beleodaq®
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Key financial highlights
10,4% 4,3%
85,3%
Financière de la Montagne / Idinvest Partners HealthCap Funds / HBM Healthcare Others
Strengthened Capital Market Position Heightened international visibility
Dual listing in Paris and Copenhagen / Tickers Euronext & Nasdaq OMX: Onxeo
Increased critical mass
Market capitalization 200 M€ - Share price 6.37€ ( 09/09)
Liquidity Euronext 1 month 1.2 M€ - Paris Total shares: 31,482,333
Reinforced shareholders base with key long term shareholders
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Onxeo, a leader and pioneer in orphan oncology… to make the difference
A winning player
Operating in an attractive market: orphan oncology
With a strong pipeline: 3 advanced development programs with multiple applications
Proven expertise with accomplished teams
Bright future for additional value creation
Significant short-term and mid-term catalysts
Heightened attractiveness for US and European-based investors
Dedicated to develop innovative medicines to provide patients with hope and improve their lives
49 Bld du Général Martial Valin
75015 Paris - France
Tél. +33 (0)1 45 58 76 00
Fax +33 (0)1 45 58 08 81
www.onxeo.com