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PIONEERING HIGH DEMAND COMPLEX GENERICS
XBRANE BIOPHARMA AB
Investor presentation – 12 October 2017, GT30, Stockholm
• INTRODUCTION AND COMPANY SUMMARY
• XLUCANE PROGRAM
• SPHEROTIDE PROGRAM
• LONG TERM AMBITION
AGENDA
2008 2015 2020 2025
2.5 BEUR
80 BEUR
SIGNIFICANT BIOSIMILAR/COMPLEX GENERIC MARKET OPPORTUNITY EMERGING
100 BEUR
30 BEUR
Total sales of off-patent originator
drugs
Total sales of biosimilars
and generics
2.5 BEUR
XBRANE PROVIDES AFFORDABLE MEDICINES TO A GLOBAL POPULATION
4
SPHEROTIDE: MITIGATE PROGRESSION OF PROSTATE CANCER XLUCANE: PREVENT BLINDNESS AMONGST ELDERY
ATTRACTIVE RISK/REWARD PROFILE
Novel drugs Biosimilars/ Complexgenerics
Small moleculegenerics
Development cost: + $1 billion <$100 million <$10 million
Likeliehood of success: 10% 50-75% 90%
Price to originatordrug:
100% 70-80% Down to 10%
Differentiators: • Patent protection• Clinical/regulatory• Sales & Branding
• Development capability• Low cost production• Sales & Branding
• Price• Sales & Branding
XBRANE HAS DEVELOPMENT CAPABILITY AND PROPRIETARY LOW COST PRODUCTION TECH
BIOSIMILARS
• 16 employees, 7 PhDs, 89 scientificarticles, 1 patent
• Patented low cost productiontechnology
• State of the art pilot scalebiosimilar development laboratoryin Stockholm
• Successfull development of Xlucane(pilot scale)
• Contract ManufacturerBiotechpharma in Lithuania
• Collaborations with clinical, regulatory and IP expert consultants
LONG ACTING INJECTABLES
• 4 employees (2 PhDs), externaldevelopment team of 6 scientists
• Deep expertise and know how in PLGA microspheres
• Proprietary low cost productionapproach and equipment
• Successfull development and scaleup of Spherotide
• GMP certified production line
• Collaborations with clinical, regulatory and IP expert consultants
7
EXPERIENCED ORGINASATION WITH DEEP EXPERTIESE IN SWEDEN AND ITALY
MANAGEMENT TEAM
MARTIN ÅMARK
CEO
• M Sc. in Industrial Engineering and Management from Lith and MBA INSEAD
• +8 years experience as management consultant from Bain & Co
DAVID VIKSTRÖM
CTO
• Ph.D. in ”expression and targeting of proteins in E. coli. ”
• +13 years experience in protein expression, 16 original scientific publications (peer reviewed)
• CTO at Xbrane since 2010
SIAVASH BASHIRI
Head of Biosimilars
• M Sc. in Molecular biotechnology from Uppsala University
• +7 years experience from life science, most recently from Agilent Technologies as head of sales EMEA
CARLO COLOMBO
Head of Production
• Ph. D in Industrial Chemistry from University of Milano
• +15 years of experience from pharmaceutical manufacturing as head of production for several generic
production units
PAOLO SARMIENTOS
Head of Slow release generics
• Ph.D in Bioorganic chemistry from University of Neapel
• +25 years of experience from leading positions at Pfizer, Genetica and Menarini.
• Last 15 years as CEO of Primm
BOARD OF DIRECTORS
SAEID ESMAEILZADEHPh.d, Chairman of the board
• Professor in Material Chemistry from Stockholms universitet
• CEO Serendipity Innovations.
• Founder of several technological intense companies in Seden acting in life science, clean tech and medtech
• Numerous awards for entrepreneurship
KARIN WINGSTRANDM.Sc, Non-executive director
• M.Sc i Pharmacology from Uppsala University
• Previous global head of clinical development Astra Zeneca
• Broad experience from international pharma market with focus on clinical development and regulatory aspects
MARIS HARTMANISPh.D, Non-executive director• Ph.D. in Bio Chemistry at Royal Institute of Technology Stockholm• Previous CEO of Medivir AB and BioPhausia AB• Previous senior positions within Gambro, Amersham and Pharmacia• +30 years experience from leading positions in pharmaceutical market
PETER EDMANPh.D, Non-executive director
• Previous CSO and head of R&D at Swedish Orphan Biovitrum
• Previous leading positions at Pharmacia, Astra, Astra Zeneca.
• Laborator at Swedish Medical Products Agency
• Professor in drug delivery technologies
ALESSANDRO SIDOLINon-executive director
• Degree in biology at Pavia University in Italy
• CEO of Axxam SpA.
• Board assignments for FEDERCHIMICA, Italian Association of Business Angels, ALISEI and Externautics SpA
• Author of more than 50 scientific publications and holds several national and international patents
GIORGIO CHIRIVINon-executive director
• Degree in finance and business administration from the University Luigi Bocconi in Italy
• Head of Mergers & Acquisitions at UBI Banca SpA.
• Board assignment for Axxam SpA.
SUSANNA HELGESEN
CFO / Head of Investor Relations
• M Sc. In Business Administration and Finance from Stockholm University.
• Background from finance industry and worked within equity research for 4 years. Executive experience
from international energy sector.
DINA JURMAN
Head of Clinical Affairs
• M.Sc. in Biomedicine from Uppsala University
• Background as Director Clinical Operations at IRW Consulting AB as well as Clinical Operations
Manager consultant at Amgen Sweden.
AGENDA
• INTRODUCTION AND COMPANY SUMMARY
• XLUCANE PROGRAM
• SPHEROTIDE PROGRAM
• LONG TERM AMBITION
XLUCANE – PREVENT BLINDNESS AMONGST ELDERLY
9
• Biosimilar of Lucentis® with global sales of 3.2 BUSD, global segment sales of approx. 8 BUSD (VEGFainhibitor market)
• Used in treatment of several severe eye diseases thatleads to deteriorated vision and in worst case blindnessamongst elderly
• Currently high cost of treatment, justified due to highcost avoidance to society
10
PATENTED TECHNOLOGY UP TO 8X AS PRODUCTIVE IN PRODUCTION OF PROTEINS
PATENTED TECHNOLOGY: REGULATING PRODUCTION
INTENSITY IN E.COLI INCREASE OVERALL PRODUCTIVITY
RESULTS: +8X MORE PRODUCTIVE AND UP TO 85% LOWER
PRODUCTION COST VS. STANDARD SYSTEMS
XBRANE TECH: REGULATE PRODUCTION INTENSITY
STANDARD SYSTEMS: ON AND OFF
PRODUCTION IN E.COLI CELLS
Note: Based on average of in total 10 different customer projects
0
25
50
75
100
125
Production cost (index)
85%
BIOSIMILARS/COMPLEX GENERIC DEVELOPMENT FOCUS IS ANALYTICAL SIMILARITY
BIOSIMILAR/COMPLEX GENERICS NOVEL DRUGS
Pilot scale production and
analytical similarity
GMP commercial scale
production and analytical
similarity
Phase I/III
Phase I/II
Phase III
Production and
analytical
characterization
XLUCANE PROGRAM OVERVIEW
DEVELOPMENT STEPS
Pilot scale production and
analytical similarity
GMP commercial scale
production and analytical
similarity
Phase I/III
• PROGRAM OVERVIEW
• Achieved high level of analytical similarity in accordancewith EMA/FDA requirements
• High yield expression technology leads to low COGS
• Scale up in collaboration with CMO BiotechPharma
• LOI with Biotechpharma for commercial scaleproduction
• Agreement on design of pivotal phase I/III trial withEMA/FDA
• Market authorisation application anticipated 2020
• Key patent expiry 2020/2022 US/EU, other patents avoided
Ongoing
Planning
Primary structure
The amino acid sequence
Higher order structure
The way the amino acid sequence has
folded itself due to bondings to itselfBinding characteristics
The way the protein binds to the specific target
it is supposed to bind to in the human body
Biological activity
The actual biological effect on
human cells when the protein
binds to the specific target
PurityThe percentage of the actual
specific protein relative to
potential impurities
VEGFa
RanibizumabRanibizumab
13
XLUCANE: ACHIEVED HIGH LEVEL OF ANALYTICAL SIMILARITY
14
XLUCANE: THE COMMERCIAL OPPORTUNITY
EU average biosimliar price as % of originator
EU average biosimilar penetration vs. originator
Source: IMS Health, FDA
ORIGINATOR SALES PRICE PENETRATION
AsiaRest of world
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
G-CSF EPO HGH
0%
25%
50%
75%
100%
0 1 2 3 4 5 6 7 8
Years after launch
G-CSF
HGH
EPO
0
1
2
3
4
Global sales of Lucentis
$B
N
$3.2BN
US
Rest of world
EU average increase in treatment days of product from launch of biosimilar to 2015
TREATMENT DAYS
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
110%
G-CSF EPO HGH
AGENDA
• INTRODUCTION AND COMPANY SUMMARY
• XLUCANE PROGRAM
• SPHEROTIDE PROGRAM
• LONG TERM AMBITION
SPHEROTIDE - MITIGATE PROGRESSION OF CANCER
16
• Worlds first generic to Decapeptyl® with global salesof 0.5 BUSD, global segment sales of approx. 3 BUSD (GnRH analogues)
• Regulate hormone levels to mitigate progression ofcancer (prostate cancer and breast cancer)
• Also used in treatment of endometriosis and uterinefibroids
GMP CERTIFIED PRODUCTION LINE FOR LONG ACTING INJECTABLES
17
TECHNOLOGY
• Proprietary equipment – low cost approach
• GMP certified as of February 2017
PRODUCTION FACILITY
Active ingredient (API) encapsulated in microsphere of biodegradable polymer
Active ingredient (API) released in controlled way over time after
injection as the microsphere degrades
SPHEROTIDE PROGRAM OVERVIEW
DEVELOPMENT STEPS
Pilot scale production and
analytical characterization
GMP commercial scale
production and analytical
characterization
Phase IIIPlanning
• PROGRAM OVERVIEW
• Achieved high level of analytical similarity for 1 month and 3 month formulations
• Similar PD/PK behaviour in mini-pigs/rats as originator
• Proprietary commercial scale GMP production line
• Market Authorization in Iran for 1 month product via localpartner
• Agreement on design of pivotal phase III trials with BfArM(German authorities) and FDA
• Market authoriation application for EU/US anticipated 2019
• Key patents covering 1 month and 3 month formulationsexpired
Average generic price as % of originator price Average generic penetration (%)
0
125
250
375
500
625
M U
SD
Europe
Asia
Americas
Middle East and Africa
500 MUSD
Source: IMS Health, FDA
*Calculated on basis of average penetration of 65% and 50% price reduction vs. originator
0
25
50
75
100
Europe US Japan Iran China0
25
50
75
100
1 2 3 4 5 10 15 20
Number of generic competitors
Expected span for Spherotide
19
SPHEROTIDE: THE COMMERCIAL OPPORTUNITY
ORIGINATOR SALES (2015) PRICING PENETRATION
Average penetration around 65%
AGENDA
• INTRODUCTION AND COMPANY SUMMARY
• XLUCANE PROGRAM
• SPHEROTIDE PROGRAM
• LONG TERM AMBITION
21
XBRANE LONG TERM AMBITION
Become a world leading
developer of biosimilars and
complex genericsLead on proprietary low
production cost technology
Build strong local
competence in
biosimilar/complex generics
• Contribute actively to global health equality
• Have a broad productportfolio
• Take select products all wayto market authorization
• Compete head to head withestablished biosimilardevelopers
• Strong local resource and competence pool for development
• State of the art developmentinfrastructure
• Expand technological”toolkit” (cell lines, promotersystems, upstream/ downstream, analytics)
• Integrated collaboration withCMOs
SHAREHOLDERS AND SHARE DATA
LIST OF SHAREHOLDES, 2017-09-30 MARKET CAP DEVELOPMENT OVER TIME (SINCE XBRANE IPO)
Shareholder No. of shares Ownership, %
Serendipity Ixora AB 1,295,723 21.75%
Paolo Sarmientos 327,295 5.49%
Försäkringsaktiebolaget Avanza pension 257,992 4.33%
Nordnet Pensionsförsäkring AB 184,276 3.09%
Active Invest-Sweden AB 163,934 2.75%
Michael Löfman 160,000 2.69%
Martin Åmark 111,890 1.88%
Christer Skogum 111,800 1.88%
Swedbank försäkring 111,350 1.87%
Jan-Willem De Gier 89,223 1.50%
10 largest shareholders in total 2,813,483 47.23%
Summary others 3,143,287 52.77%
Total 5,956,770 100.00%
0
20
40
60
80
100
120
2016-02-03 2016-05-03 2016-08-03 2016-11-03 2017-02-03 2017-05-03 2017-08-03
XBRANE Share price development
SHARE DATA INFORMATION
Market cap.: 589 MSEK
Ticker: XBRANE
Stock market list: Nasdaq OMX First North
Outstanding shares: 5,956,700
Convertible shares: 661,207
XBRANE VALUATION CONSIDERATIONS
SELECTED RELEVANT BIOSIMILAR LICENSING DEALS PEER GROUP VALUATION
Company
Current market
capitalization
(MSEK)
Number of
products in
development
Lead biosimilar
candidate
originator product
Lead biosimilar candidate
development stage
Xbrane Biopharma 589 2 Lucentis® To initiate comparative study (Phase III)
Formycon 3,206 4 Lucentis® Currently conducting Phase I/III study
Pfenex 580 9 Lucentis®Have concluded Phase I study, currently
evaluating strategic options
Coherus BioSciences 6,771 3 Neulasta® BLA/MAA submitted
Momenta Pharmaceuticals 7,980 10 Humira® Comparative study (Phase III)
Date Company PartnerOriginator
product
Up-front
paymentMilestones Royalties Other
Dec-16 Rituxan® 101 MUSD 236 MUSD N.D. –
Nov-16 Rituxan® 10 MUSD 30 MUSD N.D. –
Oct-16Rituxan® &
Herceptin®160 MUSD – 50% –
Jan-16Six different
biosimilars45 MUSD 200 MUSD 50% –
Feb-15 Lucentis® 51 MUSD 291 MUSD Double-digit Terminated
Dec-13 Santos Holding Lucentis®Single-digit
MEUR
Three-digit
MEUR– –
Aug-13 Enbrel® 30 MUSD 221 MUSD – Terminated
Jun-11 Enbrel® N.D. 720 MUSD – –
Source: GlobalData, Company disclosures, FactSet
DISCLAIMER & RISK FACTORS
DISCLAIMERAn investment in the shares of Xbrane Biopharma AB (publ) (“Xbrane” or the “Company”) is associated with various risks. A number of factors influence, or can influence, Xbrane’s operations, both directly and indirectly. According to the Company, the key risk factors and circumstances of major importance, which are regarded
as material to Xbrane’s operations and future development, are described below in no particular order of importance or claim to be exhaustive. Accordingly, the risks described below do not represent the only risks faced by the Company or its stakeholders. In addition, further risks and uncertainties of which the Company is
currently not aware of or perceives as being insignificant could also develop into factors that could have a material adverse effect on Xbrane’s business, results of operations or financial condition. Such risks could lead to a significant decrease in the value of Xbrane or its financial instruments, and investors can potentially lose
whole or parts of their investments f any of the risks described below, or another risk of which the Company is not aware of, actually were to occur, the Company’s business operations, financial position and earnings could be materially adversely affected. This could also result in the price of the shares of Xbrane declining
significantly and in an investor losing his/her investment in part or in full. Apart from this section, investors should also pay attention to other information, not exclusively in the presentation. The presentation also contains forward-looking statements that are dependent on future events, risks and uncertainties. Xbrane’s true
result can deviate materially from the expected results in its forward-looking statement as a consequence of several factors, including but not limited to the risks that are described below.
RISKS RELATED TO THE COMPANY AND ITS INDUSTRYXbrane’s product candidates must undergo extensive pre-clinical and clinical testing, the results of which are uncertain and could substantially delay or prevent the product candidate from reaching the market
Xbrane is currently engaged in the development of several complex generics in microsphere technology as well as biosimilars. Most of the products in Xbrane’s product pipeline is at an early stage of process development. All of Xbrane’s product candidates must undergo extensive pre-clinical and clinical studies in order to
demonstrate the respective product candidate’s safety and efficacy in humans before it can receive regulatory approval to be launched on the market as finished products. Clinical studies are expensive and time consuming and their outcome and results are highly uncertain. There is a risk that the Company may not
successfully complete their pre-clinical and studies, which may lead to that the commercialization of product candidates will be delayed or, in worst case, prevented.
The Company’s product candidates may not obtain regulatory approval when expected, if at all, and even after obtaining approval, the products will be subject to ongoing regulation
The process for marketing approval is in general cost and time consuming, requires extensive documentation and the timing of marketing approval is difficult to predict. Neither the Company nor its partners has yet applied for marketing approval for any of the Company’s product candidates and Xbrane and its partners may
lack the necessary experience to efficiently and successfully conduct such proceedings. Delay or failure to obtain marketing approval for the product candidates could adversely impact the ability to commercialize the product candidates and could substantially impair the Company’s ability to generate revenues. Even after
marketing approval, products may, inter alia for safety reasons, be subject to further studies or may be subject to limitations on their indicated uses and may be withdrawn from the market for various reasons. Further, the costs of compliance with applicable regulations, requirements or guidelines could be substantial, and
failure to comply could result in significant sanctions.
Delays in clinical studies could result in increased costs and jeopardize the Company’s ability to achieve regulatory approval
Delays in clinical studies are common and can occur for a variety of reasons. The Company does not know whether future clinical studies will begin on time, will need to be redesigned or will be completed on schedule, if at all.
The Company may infringe other existing patents or intellectual property rights and may face litigation which may be costly and time consuming
The Company operates in the field of developing and producing complex generic pharmaceuticals of which existing patents have expired. The Company’s success will depend in part on its ability to operate without infringing or misappropriating the proprietary rights of others. Since the pharmaceutical industry continuously
develops and expands and more patents are granted, the risk increases that any technology or product developed by the Company may give rise to third party claims of patent infringement. The Company may expend significant time and effort and may incur substantial costs both in defending such claims but also in asserting
its proprietary rights against third parties.
Risk related to maintaining granted authorizations and failure to receive extensions to current authorizations
The Italian Medicines Agency has, in February 2017, granted Xbrane a Good Manufacturing Practice (GMP) certification for its Spherotide production facility in Italy. The GMP certification is related to the production of Spherotide as a 1 month formulation in bulk. It allows Xbrane to sell and export Spherotide to partners
seeking local market authorization for the product as well as to produce material for the clinical trials required for market authorization in Europe. If Xbrane fails to maintain the the granted GMP certification, or other certifications and/or authorizations, or fails to get any of such certifications/authorizations, it could have a
material adverse effect on the Company’s operations, earnings and financial position.
Risk related to distribution agreements regarding selling, marketing and distributions of the Company’s products
Xbrane is dependent on international sales of the Company’s products. In order to market and sell Xbrane’s products internationally, the Company uses external partners in several countries. For example, Xbrane has signed a distribution agreement with the Israeli Company BioAvenir for sales and marketing of Spherotide in
Israel and have also agreed to a non-binding agreement with a leading Chinese pharmaceutical company regarding the distribution of Spherotide on the Chinese market. Xbrane is dependent upon such agreements and if Xbrane fails to meet the obligations under the agreements and if the any of the agreements for this or any
other reason is terminated, it could have a material adverse effect on the Company’s operations, earnings and financial position.
Lack of demand in newly developed product candidates
Current and future research and development of new product candidates forms the basis of the Company’s operations. The Company continuously evaluates the potential of developing new products and further developments of existing products. However, to be successful in the field of research and development of new and
existing products the products must meet the market requirements and market demands. In case of a lack of demand of newly developed product candidates following a successful research and development process, it could have a material adverse effect on the Company’s operations, earnings and financial position.
The Company is dependent on certain key employees and qualified personnel
Xbrane’s ability to retain and recruit qualified employees is of great importance for the Company’s future success and growth opportunities, and there is a risk that recruitment cannot be successfully completed or that recruitment cannot take place on satisfactory terms in relation to competition from other companies in the
industry, universities and other institutions.
Xbrane is exposed to currency exchange due to international operations
Xbrane is domiciled in Sweden and reports its financial position and earnings in SEK and is conduction distribution and sales internationally. Xbrane’s revenue currently consists primarily of payments in accordance with distribution agreements with external partners. Currency fluctuations associated with the purchase and sale
of goods and services in currencies other than SEK give rise to a so-called transaction exposure which could have a material adverse effect on Xbrane’s operations and results.
RISK RELATED TO THE COMPANY’S SHARESShare ownership
Investing in shares always entails taking risk. Since an investment in shares can increase or decrease in value, there is a risk that an investor will not be able to recoup the whole amount of capital invested. The development of a listed share depends on company-specific factors and factors that concern the capital market in its
entirety. Such factors may also increase the volatility of the share price. It is impossible for Xbrane to control all of the factors that may affect its share price, which is why every investment decision concerning the Company’s shares involves risk assessment and should be preceded by a careful analysis.