SBM-Introduction-012..

Report
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Introduction and History
Sirona Biochem (Parent Company)
605-889 West Pender Street
Vancouver, BC, Canada
TFChem (Wholly Owned Subsidiary)
Voie de l’innovation, Pharma Parc II
Chaussée du Vexin, 27100 Val de Reuil
Cosmetic Valley, France
Responsible for all business and financial matters
Responsible for all research and development
•
Founded in 2009 by its current Chairman, Dr. Howard Verrico, Sirona Biochem’s first transaction
was to acquire an exclusive global license to TFChem’s SGLT2 Inhibitor
•
In 2011, Sirona Biochem acquired TFChem. As a result of the transaction, the founder of TFChem,
Dr. Geraldine Deliencourt-Godefroy, became the largest shareholder and Chief Scientific Officer in
Sirona Biochem
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What Do We Do – Our Proprietary Technology
Molecule
Under normal circumstances the bonds between
carbohydrate atoms are unstable and break down in
the presence of enzymes.
The natural instability in carbohydrates can cause:
• Decreased efficacy
• Toxicity and safety issues
• Rapid pharmacokinetics requiring multiple daily doses
and inconvenience for patients
• Decreased shelf life for compound storage
Molecule
Sirona Biochem has developed a proprietary
technology that strengthens the bonds between these
atoms using fluorine chemistry.
The resulting increase in stability can cause:
• Greater efficacy
• Minimized or eliminated toxicity and safety issues
• Slower-acting pharmacokinetics, fewer doses,
increased profitability, increased patient compliance
• Longer shelf life and cheaper storage costs
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Fluorination - Background
Approximately 15% of drugs since 1960 have been fluorinated.
In 2012, Sigma Aldrich reports that 8 of 39 FDA approved drugs were
fluorinated.
Blockbuster Examples of Fluorinated Pharmaceutical Compounds:
Lipitor (Pfizer) –Best selling pharmaceutical compound over the past
decade
Lipitor
Ciprofloxacin (Bayer) – 5th most prescribed antibacterial in USA
Ciprofloxacin
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Competition
Sirona Biochem’s competition exists in the following areas:
o
o
o
•
Academic Institutions
o
They do not focus on commercial potential
o
They prefer to publish their results, compromising commercial opportunity
o
These laboratories cannot be acquired
In-house laboratories of pharmaceutical and cosmetic companies
o
These scientists are generalists, focusing on all areas of chemistry. They are not specialists with careers focused only in
fluorination chemistry.
o
We have sat across the table from the Head Scientists of some of the world’s largest companies and we consistently hear:
“we can’t wait to learn how you do this”
Direct Competitors
o
We are not aware of any direct competitors, this is a very difficult science
o
There are other fluorination laboratories but they do not focus on carbohydrate stabilization
An example of Sirona’s technical ability: Since its discovery in 1969, scientists have been
trying to synthesize the glycoprotein found in fish living under the Antarctic ice caps.
o
Almost 45 years later, Sirona is still the only company to synthesize this
glycoprotein, successfully stabilizing it for human use.
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Sirona Biochem’s Performance
Ticker Symbols
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Market Cap
$19M
Outstanding Shares
108.07M
Fully Diluted Shares
161.7M
Burn Rate
$150K/Month (net of grant funding)
January 27, 2014
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Revenue Model and Financial Support
1.
Sirona develops and patents its own compounds, resulting in:
Licensing Fees
Milestone Payments
Royalty Streams
2.
Sirona engages in research and development partnerships to create custom-tailored
compounds
Joint Ventures
Limited Partnerships
Fee For Service
3.
Grants are earned to offset operational costs and organizational growth objectives
Sirona and TFChem have previously received grants from:
$1.9M from the European Union and Region Haute Normandie (France)
$90K from IRAP and Going Global, Canadian Government
Sirona and TFChem are in the final stages of application for another major grant from the
French Government
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Pipeline
Cosmetic Products
Compound Library
Project Status
Partner
Skin lightening
SBM-TFC-849 Complete
SBM-TFC-723 Complete
Obagi/Valeant
Anti-aging
In development
CCHMC
Sunscreen
In development
Pharmaceutical Products
Compound Library
Project Status
Partner Stage
SGLT
SBM-TFC-039 Complete
Wanbang/Fosun China
Cell preservation
In development
French Gov’t
Inflammatory Disease
In development
JV with Bloom Burton
Anti-infective
In development
JV with Bloom Burton
Biological Ingredients
IPGMim Complete
Available for purchase
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Scientific Awards
Francinov Prize
•
France’s Acclaimed “Red Medal”; Recognizing Research and Innovation
French Ministry of Research Award
French Senate Enterprise Award
Life Sciences Recognition, Tremplin Enterprise
France’s National Institute of Industrial Property (INPI)
Trophy of France
•
For Strength in Intellectual Property
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Patents
Internal Number
B TFC-001
B TFC-002
B TFC-003
External Number
PCT/FR2007/000683
WO/2007/128899
PCT/EP2009/053970
WO/2009/121939
Description
Fluorination Technique,
compounds, process, uses
SGLT inhibitors, Tyrosinase Inhibitor
compounds, process, uses
Country
Status
Europe
Granted
USA
Published
Canada
Published
Europe
Granted
USA
Granted
Canada
Published
PCT/EP2011/073822
WO/2012/085221
GlycoProteMim®: Biological material preservation,
Cancer vaccine, compounds, process, uses
PCT
Filed
PCT/EP2012/065547
IPGMim®: Inducer for Recombinant protein production
in E. Coli, compounds, process, use
PCT
Filed
B TFC-005
PCT/EP2012/060050
WO/2012/160218
SGLT inhibitor, Tyrosinase Inhibitor,
compounds, process, uses
PCT
Filed
B TFC-006
Filling Process Under Way
GlycoProteMim®: Biological material preservation,
anti-aging compounds, process, uses
PCT
In Negotiation
B TFC-004
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Recent News – January 2014
Collaboration with Jean-Michel Cousteau, Fabien Cousteau and Explore Green - January 13, 2014
o
Jean-Michel Cousteau and Fabien Cousteau will become Brand Ambassadors for Sirona
Biochem and Explore Green will leverage its media, scientific and commercial contacts to
broadcast our partnership’s alliance and goals.
o
The Cousteau name and brand will be attached to each appropriate compound that Sirona
creates. This will increase the value of the technologies, through greater brand awareness and
the commercial value of a Cousteau-branded product offering.
o
Sirona Biochem will contribute its cosmetic, pharmaceutical and scientific expertise and Sirona
will become a primary scientific resource for the potential commercialization of new technologies
discovered by the Cousteaus, Explore Green and their network.
Collaboration with Cincinnati Children's Hospital Medical Center - January 15, 2014
o
Cincinnati Children’s Hospital Medical Center ranks third in the nation among all Honor Roll
hospitals in U.S. News and World Report’s 2013 Best Children’s Hospitals ranking.
o
We will combine our respective patented technologies with the intent to create an anti-aging
cream that will be an outlier in the almost $300B anti-aging cosmetic marketplace.
o
We already have a Letter of Interest in the compound from one of the world’s largest consumer
packaged good companies.
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Recent News – January 2014
(Cont’d)
Exclusive Licensing Agreement Signed with Wanbang BioPharma - January 27, 2014
o
Terms of the agreement include $9.5M in licensing and milestone fees and ongoing royalty
payments for all sales in the People’s Republic of China
o
Wanbang Biopharma will assume all fiscal and management responsibilities for the clinical
development, regulatory approvals, sales and marketing in China. This removes the potential risk
and burden of $100M investment from Sirona in this compound’s development.
o
Wanbang Biopharma will provide Sirona with ongoing access to all clinical data throughout the
compound’s development. With every phase of clinical success, Sirona’s SGLT2 inhibitor grows
its value for licensing opportunities everywhere else in the world.
Global Licensing Agreement Signed with Obagi (Subsidiary of Valeant Pharma) - January 29, 2014
o
Obagi and the entire Valeant Pharmaceutical family of companies have secured the exclusive
global rights to Sirona’s skin lightening compound TFC-849 in return for a licensing fee and
ongoing royalty payments.
o
Target launch by Obagi of TFC-849 products is Q4, 2014.
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Private Placement – Terms and Use of Funds
Terms of the Private Placement
•
•
•
•
Private Placement: $5.3M CDN
Share price: $.16 CDN
Warrant Offering: ½ Warrant at $.27 CDN Valid for 3 years
8% Finder’s Fees and 8% Finder’s Warrants
Use of Funds
•
•
•
•
To more than double the size of TFChem’s building
To hire 28 new scientists, operational and administrative staff in TFChem
To hire additional business development support for Sirona Biochem
To secure 2 years of operating capital for Sirona Biochem and TFChem
Net Benefit to Shareholder
•
Sirona Biochem’s revenue potential and net value increases directly in proportion to the number of new
compounds we transact. More compounds created equal more potential licensing fees, milestone
payments and royalty payments
•
If being valued as an acquisition, a multiple will be applied against current revenue and predictable
milestone and royalty revenue. We need to grow as quickly as possible to maximize an early acquisition
valuation.
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Why Invest – Near Term Potential
We are working to finalize our next partnership with the French Government
o
Building on the success of our skin lightening grant from the French Government and
European Union:
o
We have requested support from the French Government to grow TFChem; tripling the size of
the building and hiring 28 new employees to support new compound development.
o
Sirona’s business growth will be driven by increasing the number of licensing transactions it
completes. More compounds equal more licensing fees, milestone payments and royalty
streams.
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Why Invest – Mid Term Potential
Past 15 month’s performance as a predictor of next 15 months
o
Sirona Biochem has accomplished the following:
o
Turned around a declining share price from a low of $.035 per share to current price of $.175 per share
o
Grown the market cap from $2.7M to $19M
o
Raised $3.5M including the last private placement, a $1M bridge that was oversubscribed in less than a day
o
Sirona has signed LOI’s to license the compounds that are ready for transaction. These agreements will
complete the transition from Sirona being a speculative pre-revenue company into an revenue generating
business engaged with some of the most credible global brands in the world
o
Sirona has already got a Letter of Interest for it’s next compound and it is not yet completed. Work should begin
shortly on the collaboration with CCHMC to create a leading anti-aging cosmetic cream. The project has
already been in the news in multiple US, Canada and European publications. The potential for this compound to
be licensed in 2014 is real.
o
Sirona has secured a Joint Venture with Bloom Burton, Canada’s leading healthcare investment bank, where
Sirona will endeavor to create seven new compounds in the anti-infective and anti-inflammation therapeutic
areas. Once the compounds are created, Bloom Burton will be responsible for all financing, clinical
development, regulatory requirements and transactions. Sirona and Bloom Burton have an un-dilutable share
structure in the Joint Venture for dispursement of all transaction revenue.
o
As Sirona grows its share price and market cap as a revenue generating company, we are working towards
uplisting to a senior exchange in the US to support new investment and increased trading volume. Graduating
to a new exchange should be a material event in our growth.
o
As Sirona continues to successfully create commercial products for cosmetic and pharmaceutical applications,
there will be an increasing amount of focus on Sirona as a target for acquisition by major drug and cosmetic
companies trying to secure new product pipelines. There is an ongoing history of these acquisitions taking
place in each of our target industries.
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Why Invest – Long Term Potential
We are setting ourselves up to be acquired
o
Sirona is building a high margin, managed-risk business model in two extremely lucrative marketplaces.
o
Not only will we be attractive as an acquisition by a cosmetic or pharmaceutical company looking to increase its bottom line, Sirona
as a drug and ingredient discovery company represents a future pipeline of products for any acquiring company. We believe this is
the more likely catalyst for Sirona being acquired and there is a history of acquisitions supporting this model:
o
The royalty fees from our skin lightening compound should become active in early 2015 and we will be receiving milestone
payments during the development of our SGLT2 Inhibitor. The opportunity of fee-for-service chemistry for big pharma companies
and new product transactions in anti-aging cosmetics are very possible. The expansion of TFChem will enable us to take on more
projects, finish them more quickly, and transact them earlier. The long term potential of 10+ new products being created and
licensed per year is realistic.
o
We have already had our first conversation about being acquired. The more time we are given to grow, the more attractive we will
become.
Successful Transactions – Indicators of Potential Value
o
2013 Optimer Pharmaceuticals Inc. acquired by Cubist for an aggregate upfront cash consideration of $551 Million.
o
2011 GlycoMimetics’ entered into partnership with Pfizer. The agreement provides potential value to GlycoMimetics of over $340
Million, plus tiered, double-digit royalties.
o
2005 Glycart acquired by Roche. Roche trading at 255.800 CHF ($280 USD) as of Jan 8, 4:00 PM EST
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www.sironabiochem.com
Canada
USA
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TM
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Appendix
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Case Study #1
Diabetes – SGLT2 Inhibitor
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Diabetes
2012 statistics from the International Diabetes Federation (www.idf.org)
More than 371 million people have diabetes.
By 2030, this will rise to 552 million.
Last year, 4.6 million people died due to
diabetes or related complications and more
than $471 billion US were spent on
healthcare for diabetes.
Global prevalence is drastically increasing.
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Emerging Markets Lead Diabetes Growth
By 2030, experts predict that Type 2 Diabetes will grow by:
US 25%, India 66%, and China 44%
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Recognized Potential for Our Technology
Sirona Biochem’s SGLT Inhibitor Performs Better Than Johnson and
Johnson’s SGLT Inhibitor, According to Study
Vancouver, British Columbia – December 7, 2012 – Sirona Biochem Corp. (TSX-V: SBM),
announced its sodium glucose transporter (SGLT) inhibitor for Type 2 diabetes reduced blood
glucose more effectively than Johnson and Johnson’s canagliflozin, an advanced SGLT inhibitor
being considered for market approval in Europe and the U.S. Studies compared Sirona
Biochem’s SGLT Inhibitor, SBM-TFC-039, with canagliflozin and were conducted on Zucker
Diabetic Fatty (ZDF) rats.
Sirona Biochem traded 11,137,860 shares in the next 5 days
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SBM-TFC-039 Development Status
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Sirona Biochem Signs LOI with China’s #1 Ranked
Anti-Diabetic Company, Wanbang Pharma
Vancouver, British Columbia – August 19, 2013 – Sirona Biochem Corp. (TSXV: SBM, OTCQX: SRBCF) announced today the signing of a Letter of Intent
whereby Sirona Biochem will provide an exclusive license to Wanbang Pharma to
develop and commercialize Sirona’s SGLT2 Inhibitor in the People’s Republic of
China (PRC). In exchange for this license, Sirona Biochem will receive upfront and
milestone payments of up to US$9.5M upon successful achievement of
development and regulatory milestones and then royalty payments for product
sales in the PRC.
About Wanbang Pharma
Wanbang Biopharmaceuticals is a leading pharmaceutical company in China.
Among domestic pharmaceutical companies, Wanbang Pharma is the largest
manufacturer and marketer of a comprehensive portfolio of drugs for diabetes.
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The Skin Lightening Project is co-financed by the
European Union and Europe Witnesses in HauteNormandie with the support of the European Regional
Development Fund (E.R.D.F.).
Case Study #2
Cosmetic Marketplace –Skin Lightening
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Skin Lightening: A Fast Growing Market
$9+ Billion USD Market
9.4% Global growth rate (Asia in double digits)
China is the fastest growing skin lightening
market in the world
North America & Europe emerging markets
Current products ineffective or toxic
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The Risk of Arbutin and The Opportunity for Sirona Biochem
Arbutin, a commonly used skin-lightening agent, is a safety risk
•
•
•
Arbutin is a tyrosinase inhibitor
When arbutin is broken down in the body it releases hydroquinone, a known carcinogen.
Hydroquinone is banned in EU and restricted in USA.
O
HO
OH
HO
Breaks Down
Into
O
OH
HO
O
HO
OH
OH
HO
+
OH
OH
OH
Arbutin
Glucose
Hydroquinone
Toxic
Sirona Biochem’s Skin Lightening Project
•
•
Our goal was to develop a safer and more effective compound than arbutin.
We successfully created two stabilized versions of arbutin; preventing the release of hydroquinone and
eliminating potential adverse events.
Sirona Biochem’s
Skin Lighteners
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More effective tyrosinase inhibition than arbutin.
Safer tyrosinase inhibitor than arbutin.
Sirona Biochem’s Compounds Are More Effective Than
Both Arbutin Compounds
Human tyrosinase inhibition
0.454 mM
0.500
I C 50 (mM)
0.400
0.300
0.244 mM
0.200
0.064 mM
0.032 mM
0.100
0.000
a-arbutin
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TFC-849
b-arbutin
TFC-723
•
TFC-849:
14 times more effective than Beta Arbutin
7 times more effective than Alpha Arbutin
•
TFC-723:
7 times more effective than Beta Arbutin
4 times more effective than Alpha Arbutin
Toxicity Risk Study: Hydroquinone Release
Chemical and Biological Stability of TFC-723 and TFC-849 in vitro
60
Skin (tissue extract) 48H
Concentration µg/mL
50
Fibroblasts extract 48H
40
Keratinocyte extract 48H
Sweat 48H
30
Bis Tris buffer 15 Days
20
Ringer's solution 15 Days
Water (ultrapure) 15 Days
10
0
Beta Arbutin
Alpha Arbutin
TFC-723
TFC-849
Both TFC-723 and TFC-849 are stable unlike Alpha and Beta Arbutin
No hydroquinone was released in all tested conditions (chemical, biological)
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Skin Lightener Project schedule
*
*Patent: WO 2012/160218, Priority Date 26/05/2011.
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Sirona Biochem Signs LOI with Obagi Medical Products,
Subsidiary of Valeant Pharmaceuticals
Vancouver, British Columbia – September 30, 2013 – Sirona Biochem Corp.
(TSX-V: SBM.V OTCQX: SRBCF) announced today the signing of a Letter of Intent
whereby Sirona Biochem will provide a global exclusive license to Obagi Medical
Products to commercialize the skin lightening compound TFC-849. In exchange for
this license, Sirona Biochem will receive upfront and milestone payments as well as
ongoing royalty payments for global product sales.
Valeant Pharmaceuticals jumped 4 percent to C$111.66, a record high, after unit
Obagi Medical Products said yesterday it has acquired a global exclusive license to
market a skin lightening compound from Sirona Biochem Corp.
Reported October 1, 2013 by Bloomberg.com
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Case Study in Development #3
Cosmetic Marketplace -Anti-aging
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Anti-aging a Growing Market
Global anti-aging market projected to be
$114B by 2015
Anti-wrinkle product sales $20B in U.S. alone
Baby Boomers spend more on personal care
than any other age group
Young consumers taking preventative
measures
Fast-growing Asian market
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Anti-Aging Through Cell Preservation - The Genesis
Despite the sub-zero temperatures, fish
living under the Antarctic icecaps are able to
keep their blood from freezing. Naturally
occurring cell preservation compounds
called glycoproteins are found in these fish.
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SBM’s Anti-Aging Compound Shows
Impressive Fibroblast Protection
120
Cell Viability (%)
100
80
60
Control
SBM Anti-aging
40
20
0
Day 0
•
•
Day 3
Day 4
Day 5
Day 6
Day 7
Cell viability remained approximately 95% with SBM compound
Nutrient deprived control viability decreased to 8% by Day 7
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Anti-Aging Compound Development Status
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Sirona Biochem Announces LOI for Collaboration with Cincinnati
Children’s Hospital Medical Center
Vancouver, British Columbia – May 29, 2013 – Sirona Biochem Corp. (TSX-V:
SBM, OTCQX: SRBCF, Frankfurt: ZSB) is pleased to announce the signing of a
Letter of Intent (LOI) to create a collaboration with Cincinnati Children’s Hospital
Medical Center. The goal of the collaboration is to create a novel skin care
technology by combining Sirona Biochem’s patented cell preservation
glycoprotemim with Cincinnati Children’s patented synthetic vernix technology.
About Cincinnati Children’s Hospital Medical Center
Cincinnati Children’s Hospital Medical Center ranks third in the nation among all
Honor Roll hospitals in U.S. News and World Report’s 2012 Best Children’s
Hospitals ranking.
www.cincinnatichildrens.org.
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Carbohydrate-Based and
Fluorinated Chemistry Examples
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Sugar Based Drugs
OH
NH2
O
N
HN
HO
O
O
OSO3H
N
HO
O
OSO3H
O
O
OH OH
N
O
O HO3SO
O
HO
OH
O
(Anticancer drug)
O
(Anti-coagulant drug)
O
N
HO
N
O
N
N
HO
OH
Lexiscan
(Anti-coagulant drug)
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O
O
HO
HO
N
Lovenox
N
H
O H2N
O
H
N
OH
OH
NH2
N
N
H
O
O
(Anticancer drug)
HO
H
N
NH
Xeloda
OSO3H
O
Cl
O
OH
HO
O
OH
HO
F
Vidaza
Cl
O
O
OH
HO3SHN
O
NH
N
O
HO
O
O
O
O
HO
N
O
HO
O
NH2
O
OH
Vancocin
N
H
(Antibiotic drug)
N
H
HN
Sugar Based Drugs
Glycosides are widely used in cosmetics for all sort of applications:
surfactant, moisturizing, cleansing, depigmenting, antioxydant, ..
O
O
O
HO
O
HO
HO
OH
OH
OH
bArbutin
HO
OH
OH
Decyl glucoside (coco glucoside)
O
O
HO
HO
OH
OH
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OH
aArbutin
Raspberry ketone ß-D-glucoside
Fluorinated Drug Examples
F
O
O
N
H
OH
OH
HO
S
O
O
N
O
O
F
F
Lipitor
HO
OH
H
N
HO
N
O S
O
F
Crestor
(Cholesterol-lowering drug)
($7,688Million)
N
OH
CO2H
N
F
Advair Diskus
(Anti-ashma drug)
($4,637Million)
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OH
CO2H
(Cholesterol-lowering drug)
($4,404Million)

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