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Introduction and History. 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
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Introduction and History • 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 Sirona Biochem (Parent Company) 605-889 West Pender Street Vancouver, BC, Canada Responsible for all business and financial matters TFChem (Wholly Owned Subsidiary) Voie de l’innovation, Pharma Parc II Chaussée du Vexin, 27100 Val de Reuil CosmeticValley, France Responsible for all research and development
What Do We Do – Our Proprietary Technology • 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 Molecule
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 • Ciprofloxacin (Bayer) – 5th most prescribed antibacterial in USA Lipitor Ciprofloxacin
Competition Sirona Biochem’s competition exists in the following areas: • Academic Institutions • They do not focus on commercial potential • They prefer to publish their results, compromising commercial opportunity • These laboratories cannot be acquired • In-house laboratories of pharmaceutical and cosmetic companies • These scientists are generalists, focusing on all areas of chemistry. They are not specialists with careers focused only in fluorination chemistry. • 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 • We are not aware of any direct competitors, this is a very difficult science • There are other fluorination laboratories but they do not focus on carbohydrate stabilization • An example of Sirona’stechnical ability: Since its discovery in 1969, scientists have been trying to synthesize the glycoprotein found in fish living under the Antarctic ice caps. • Almost 45 years later, Sirona is still the only company to synthesize this glycoprotein, successfully stabilizing it for human use.
Sirona Biochem’s Performance January 27, 2014
Revenue Model and Financial Support • Sirona develops and patents its own compounds, resulting in: • Licensing Fees • Milestone Payments • Royalty Streams • Sirona engages in research and development partnerships to create custom-tailored compounds • Joint Ventures • Limited Partnerships • Fee For Service • 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
Pipeline Cosmetic Products Pharmaceutical Products
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
Recent News – January 2014 Collaboration with Jean-Michel Cousteau, Fabien Cousteau and Explore Green - January 13, 2014 • 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. • 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. • 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 • 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. • 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. • We already have a Letter of Interest in the compound from one of the world’s largest consumer packaged good companies.
Recent News – January 2014 (Cont’d) Exclusive Licensing Agreement Signed with Wanbang BioPharma - January 27, 2014 • 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 • 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. • 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 • 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. • Target launch by Obagi of TFC-849 products is Q4, 2014.
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.
Why Invest – Near Term Potential We are working to finalize our next partnership with the French Government • Building on the success of our skin lightening grant from the French Government and European Union: • 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. • 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.
Why Invest – Mid Term Potential Past 15 month’s performance as a predictor of next 15 months • Sirona Biochem has accomplished the following: • Turned around a declining share price from a low of $.035 per share to current price of $.175 per share • Grown the market cap from $2.7M to $19M • Raised $3.5M including the last private placement, a $1M bridge that was oversubscribed in less than a day • 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 • 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. • 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. • 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. • 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.
Why Invest – Long Term Potential We are setting ourselves up to be acquired • Sirona is building a high margin, managed-risk business model in two extremely lucrative marketplaces. • 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: • 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. • 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 • 2013 Optimer Pharmaceuticals Inc. acquired by Cubist for an aggregate upfront cash consideration of $551 Million. • 2011 GlycoMimetics’ entered into partnership with Pfizer. The agreement provides potential value to GlycoMimetics of over $340 Million, plus tiered, double-digit royalties. • 2005 Glycart acquired by Roche. Roche trading at 255.800 CHF ($280 USD) as of Jan 8, 4:00 PM EST
Diabetes2012 statisticsfrom 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.
Emerging Markets Lead Diabetes Growth By 2030, experts predict that Type 2 Diabetes will grow by: US 25%, India 66%, and China 44%
Recognized Potential for Our Technology • Vancouver, British Columbia – December 7, 2012 – SironaBiochem 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 SironaBiochem’s SGLT Inhibitor, SBM-TFC-039, with canagliflozin and were conducted on Zucker Diabetic Fatty (ZDF) rats. • SironaBiochem traded 11,137,860 shares in the next 5 days SironaBiochem’s SGLT Inhibitor Performs Better Than Johnson and Johnson’s SGLT Inhibitor, According to Study
Sirona Biochem Signs LOI with China’s #1 Ranked Anti-Diabetic Company, Wanbang Pharma Vancouver, British Columbia – August 19, 2013 – Sirona Biochem Corp. (TSX-V: 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.
The Skin Lightening Project is co-financed by the European Union and Europe Witnesses in Haute-Normandie with the support of the European Regional Development Fund (E.R.D.F.). • CaseStudy #2 • Cosmetic Marketplace –SkinLightening
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
The Risk of Arbutin and The Opportunity for SironaBiochem 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. Breaks Down Into Toxic SironaBiochem’s Skin Lightening Project • Our goal was to develop a safer and more effectivecompound 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 More effective tyrosinase inhibition than arbutin. Safer tyrosinase inhibitor than arbutin.
Sirona Biochem’s Compounds Are More Effective ThanBothArbutin Compounds • 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 a-arbutin TFC-849 b-arbutin TFC-723
Toxicity Risk Study: Hydroquinone Release Concentration µg/mL Both TFC-723 and TFC-849 are stable unlike Alpha and Beta Arbutin No hydroquinone was released in all tested conditions (chemical, biological)
Skin Lightener Project schedule * *Patent:WO 2012/160218, Priority Date 26/05/2011.
Sirona Biochem Signs LOI with Obagi Medical Products, Subsidiary of Valeant Pharmaceuticals Vancouver, British Columbia – September 30, 2013 – SironaBiochem Corp. (TSX-V: SBM.V OTCQX: SRBCF) announced today the signing of a Letter of Intent whereby SironaBiochem 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
Case Study in Development #3 • Cosmetic Marketplace -Anti-aging
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
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.
SBM’s Anti-Aging Compound Shows Impressive Fibroblast Protection • Cell viability remained approximately 95% with SBM compound • Nutrient deprived control viability decreased to 8% by Day 7
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.
Carbohydrate-Based and Fluorinated Chemistry Examples
Sugar Based Drugs Vidaza (Anticancerdrug) Xeloda (Anticancerdrug) Vancocin (Antibioticdrug) Lovenox (Anti-coagulantdrug) Lexiscan (Anti-coagulantdrug)
Sugar Based Drugs Glycosides are widely used in cosmetics for all sort of applications: surfactant, moisturizing, cleansing, depigmenting, antioxydant, ..
FluorinatedDrug Examples Lipitor (Cholesterol-loweringdrug) ($7,688Million) Crestor (Cholesterol-loweringdrug) ($4,404Million) AdvairDiskus (Anti-ashmadrug) ($4,637Million)