1 by Dr. C. Y. Cheng CEO Company Introduction Feb. 25, 2011
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Microsoft PowerPoint - company profile-20110225 with english
versionCompany Introduction
Basic Data of Formosa Labs
• Date of Establishment: Dec. 29, 1995 • Capital: NTD 671 mil • # of Employees315 ( on Feb. 18, 2011) • Major products: UV filters, Vit. D Derivatives, Anti-inflammatory and Analgesic Agents, etc • Address: No. 36, Hoping Street, Louchu County, Taoyuan 33842, Taiwan R.O.C.
33
Milestone (1)
• Dec. 1995 Founded by Dr. C.Y. Cheng as a contract research laboratory.
• Apr. 2000 Started cGMP production of API’s.
• May 2001 Filed EU DMF’s of Alfacalcidol and Calcitriol.
(EU DMF’s of multiple products now filed in more than 20 countries)
• Jun. 2002 Filed US DMF of Leflunomide. (Total 29 on file now).
• Nov. 2002 Inspected by DOH, Taiwan.
(GMP certificates on 19 products have been granted.)
• Sep. 2003 Upgraded ISO 9001 compliance certificate to version 2000. (current version 2008).
• Oct. 2004 Passed PAI by US FDA for Leflunomide API. (Total of 6 API products are now used in formulations marketed in the US, 4 ANDAs and 2 NDAs.)
• Mar. 2007 Passed PAI by US FDA for UV-filter Avobenzone.
• Nov. 2007 Passed GMP inspection by BSG of Hamburg, Germany. (Behörde fün Soziales,
Familie, Gesundheit undVerbraucherschutz represented the inspection of EU )
(for 3 APIs)
44
• Apr. 2009 Passed PAI for Gadodiamide by PMDA of Japan.
• Jun. 2009 Passed 3rd PAI by US FDA for 7 APIs (2 NDAs and 5 ANDAs).
• Sep. 2009 Granted a Gold medal for Commercialization of Technology in 2009 Taipei-Biotech Award.
• Nov. 2009 Granted the 1st place award in 2009 Taiwan Biopharmaceutical Industry Show.
• Oct. 2009 Signed a new 5-year supply agreement with DSM for the supply of UV filters.
• Oct. 2009 Commissioned new facilities for the production of high-potent APIs.
• Nov. 2009 Listed on Taiwan’s Emerging Stock Exchange. (stock code: 4746)
• Jun. 2010 Commissioned a new multi-purpose building (for RD, QC, QA, etc), and an automated warehouse.
• Oct. 2010 Formed a joint venture with ARZ, Israel in Taiwan.
• Nov. 2010 Passed PAI for Mycophenolate Mofetil by Cofepris of Mexico.
• Dec. 2010 Singed a collaboration agreement with Beijing Odyssey Chemicals Co., Ltd.
• Dec. 2010 Established Formosa Pharmaceutical Company as a wholly owned subsidiary.
• Dec. 2010 Application for IPO was approved by the Board of TWSE.
5
Signing of a Collaboration Agreement with
Beijing Odyssey in Dec. 2010
6
B.S. in Accounting, Ming Chuan University, Taipei Financial Manager, Lightwave Link Company and CPI Company, etc VP of Finance, LC United.
M. S. (Organic Chemistry), Providence University, Taichung, Taiwan Research Chemist / Deputy Supervisor of Research, Siegfried Chemicals, Inc
Ph. D. (Organic Chemistry), National Tsing Hua University, Hsinchu, Taiwan Lecturer at National Tsing Hua University Chemistry Department Chemist / Deputy Supervisor / Supervisor of Research ,Siegfried Chemicals, Inc.
Ph.D. in Chemistry, University of Zurich, Switzerland Plant Manager & Technical Product Manager of Roche Vitamins, Ltd President of LC United
Ph. D. (Medicinal Chemistry), University of California, San Francisco, USA Associate Professor / Professor, National Taiwan University, Taipei, Taiwan President of Formosa Laboratories, Inc. Chairman of LCU Corp. Chairman of Formosa Laboratories, Inc.
Education & Experience
Support Michelle Lo
35PresidentPeter Bircher
2. Custom synthesis of APIs for brand drugs
3. API supply for new drug development
Formulator)
that have pharmacologic effects. API’s can be
produced by chemical synthesis, extraction of
natural products, fermentation/cell culture, or
any combination of these processes.
AlanAlanAlanAlan
9
11
Huge growth in the use of generic drugs in the future due to
(1) Governments in most countries increasingly focus
on healthcare systems and drug price control.
(2) Major brand drugs are loosing patent protection.
(Total value: $150 billion by 2015)
Huge growth in the use of generic drugs in the future due to
(1) Governments in most countries increasingly focus
on healthcare systems and drug price control.
(2) Major brand drugs are loosing patent protection.
(Total value: $150 billion by 2015)
22 Brand companies continue to outsource API production for cost-down.Brand companies continue to outsource API production for cost-down.
33 Due to global warming and the general public paying more attention
to sun protection and skin care. UV-filters will maintain a yearly growth rate
of 3-5%
Due to global warming and the general public paying more attention
to sun protection and skin care. UV-filters will maintain a yearly growth rate
of 3-5%
US$ bn
2008~2013F
0
20
40
60
80
100
120
140
160
NT$
0%
5%
10%
15%
20%
25%
30%
Sales forecast from the API industry
11
Vit. D Derivatives
Cholesterol and Phosphate Binders
1. APIs
Revenue distribution based on products
13
11
22
33
44
55
Strong R&D capabilities and ability to deliver non-infringing APIs in time.
Comprehensive production lines and abundant experience in cGMP production.
Good reputation in quality with full audit record by foreign authorities. (Thomson Reuters lists Formosa Labs as an “Established” API manufacturer.)
Stable and cost-effective supply of raw materials, including the establishment of long term tolling relationship with selected Chinese suppliers.
Strong experience in global marketing and sales.
Our Competitive advantages
Teva Par
Mylan Hospira
Sandoz Apotex
Watson Mallinckrodt
15
Pfizer
Novartis
Sanofi-Aventis
GlaxoSmithKline
AstraZeneca
Roche
(1 CNS agent and 1 respiratory agent)
Contract manufacturing of 1 CNS API
Major end-user of UV filters
Formosa clients include Top-10
Formosa
Labs
17
USUS 7,645,911 B2
USUS 7,491,712 B1
Colestipol, Fludiazepam, Flupentixol, Leflunomide,
Meprobamate, Melitracen, Mifepristone, Mycophenolate
Nonivamide, Taltirelin
2008 Colesevelam, Calcium acetate, Montelukast, Temozolomide
2009 Sevelamer HCl, Orlistat, Sevelamer Carbonate
2010 Maxacalcitol, Lapatinib, Tegafur
API products developed in-house
20
11
Two NDA drugs using APIs supplied by Formosa launched in 2009
Iloperidone (Fanapt, US, May 2009)
Capsaicin (Qutenza, Europe, May 2009; US, Nov. 2009)
Two NDA drugs using APIs supplied by Formosa launched in 2009
Iloperidone (Fanapt, US, May 2009)
Capsaicin (Qutenza, Europe, May 2009; US, Nov. 2009)
22
(responsible for process scale-up and API supply)
Domestic: 4
Foreign: 5
(responsible for process scale-up and API supply)
Domestic: 4
Foreign: 5
21
1. UV filters
Due to global warming and the general public paying more attention to skin care, 3-5%
annual growth is expected.
A new 5-year supply agreement with DSM was signed Oct. 2009.
2. Generic APIs
3 polymer APIs (1 Cholesterol and 2 Phosphate Binders) will loose their patent protection
between 2013 and 2015, with a combined formulation market value of > $1.5 bil. The sale
of these 3 APIs will be the major source of revenue growth within 5 years.
3 Vit. D derivatives will loose patent protection in 2012, 2014 and 2015 respectively.
1 respiratory agent will loose patent protection in 2012.
3. China market
Formosa is setting up a joint venture with our business partner in Beijing and also
registering our API products in China through local agents. China market will be a major
source for our revenue growth.
22
1,708
2,044
1,899
95%
81%
19%
63%
2007 2008 2009 2010(self-prepared)
Sales
Gross Margin would be Improved by Products Portfolio
23.86%
62.0%
38.0%
Blue: Therapeutic APIs; Light blue: UV-filters; Orange: Total gross margin
24
25
Basic Data of Formosa Labs
• Date of Establishment: Dec. 29, 1995 • Capital: NTD 671 mil • # of Employees315 ( on Feb. 18, 2011) • Major products: UV filters, Vit. D Derivatives, Anti-inflammatory and Analgesic Agents, etc • Address: No. 36, Hoping Street, Louchu County, Taoyuan 33842, Taiwan R.O.C.
33
Milestone (1)
• Dec. 1995 Founded by Dr. C.Y. Cheng as a contract research laboratory.
• Apr. 2000 Started cGMP production of API’s.
• May 2001 Filed EU DMF’s of Alfacalcidol and Calcitriol.
(EU DMF’s of multiple products now filed in more than 20 countries)
• Jun. 2002 Filed US DMF of Leflunomide. (Total 29 on file now).
• Nov. 2002 Inspected by DOH, Taiwan.
(GMP certificates on 19 products have been granted.)
• Sep. 2003 Upgraded ISO 9001 compliance certificate to version 2000. (current version 2008).
• Oct. 2004 Passed PAI by US FDA for Leflunomide API. (Total of 6 API products are now used in formulations marketed in the US, 4 ANDAs and 2 NDAs.)
• Mar. 2007 Passed PAI by US FDA for UV-filter Avobenzone.
• Nov. 2007 Passed GMP inspection by BSG of Hamburg, Germany. (Behörde fün Soziales,
Familie, Gesundheit undVerbraucherschutz represented the inspection of EU )
(for 3 APIs)
44
• Apr. 2009 Passed PAI for Gadodiamide by PMDA of Japan.
• Jun. 2009 Passed 3rd PAI by US FDA for 7 APIs (2 NDAs and 5 ANDAs).
• Sep. 2009 Granted a Gold medal for Commercialization of Technology in 2009 Taipei-Biotech Award.
• Nov. 2009 Granted the 1st place award in 2009 Taiwan Biopharmaceutical Industry Show.
• Oct. 2009 Signed a new 5-year supply agreement with DSM for the supply of UV filters.
• Oct. 2009 Commissioned new facilities for the production of high-potent APIs.
• Nov. 2009 Listed on Taiwan’s Emerging Stock Exchange. (stock code: 4746)
• Jun. 2010 Commissioned a new multi-purpose building (for RD, QC, QA, etc), and an automated warehouse.
• Oct. 2010 Formed a joint venture with ARZ, Israel in Taiwan.
• Nov. 2010 Passed PAI for Mycophenolate Mofetil by Cofepris of Mexico.
• Dec. 2010 Singed a collaboration agreement with Beijing Odyssey Chemicals Co., Ltd.
• Dec. 2010 Established Formosa Pharmaceutical Company as a wholly owned subsidiary.
• Dec. 2010 Application for IPO was approved by the Board of TWSE.
5
Signing of a Collaboration Agreement with
Beijing Odyssey in Dec. 2010
6
B.S. in Accounting, Ming Chuan University, Taipei Financial Manager, Lightwave Link Company and CPI Company, etc VP of Finance, LC United.
M. S. (Organic Chemistry), Providence University, Taichung, Taiwan Research Chemist / Deputy Supervisor of Research, Siegfried Chemicals, Inc
Ph. D. (Organic Chemistry), National Tsing Hua University, Hsinchu, Taiwan Lecturer at National Tsing Hua University Chemistry Department Chemist / Deputy Supervisor / Supervisor of Research ,Siegfried Chemicals, Inc.
Ph.D. in Chemistry, University of Zurich, Switzerland Plant Manager & Technical Product Manager of Roche Vitamins, Ltd President of LC United
Ph. D. (Medicinal Chemistry), University of California, San Francisco, USA Associate Professor / Professor, National Taiwan University, Taipei, Taiwan President of Formosa Laboratories, Inc. Chairman of LCU Corp. Chairman of Formosa Laboratories, Inc.
Education & Experience
Support Michelle Lo
35PresidentPeter Bircher
2. Custom synthesis of APIs for brand drugs
3. API supply for new drug development
Formulator)
that have pharmacologic effects. API’s can be
produced by chemical synthesis, extraction of
natural products, fermentation/cell culture, or
any combination of these processes.
AlanAlanAlanAlan
9
11
Huge growth in the use of generic drugs in the future due to
(1) Governments in most countries increasingly focus
on healthcare systems and drug price control.
(2) Major brand drugs are loosing patent protection.
(Total value: $150 billion by 2015)
Huge growth in the use of generic drugs in the future due to
(1) Governments in most countries increasingly focus
on healthcare systems and drug price control.
(2) Major brand drugs are loosing patent protection.
(Total value: $150 billion by 2015)
22 Brand companies continue to outsource API production for cost-down.Brand companies continue to outsource API production for cost-down.
33 Due to global warming and the general public paying more attention
to sun protection and skin care. UV-filters will maintain a yearly growth rate
of 3-5%
Due to global warming and the general public paying more attention
to sun protection and skin care. UV-filters will maintain a yearly growth rate
of 3-5%
US$ bn
2008~2013F
0
20
40
60
80
100
120
140
160
NT$
0%
5%
10%
15%
20%
25%
30%
Sales forecast from the API industry
11
Vit. D Derivatives
Cholesterol and Phosphate Binders
1. APIs
Revenue distribution based on products
13
11
22
33
44
55
Strong R&D capabilities and ability to deliver non-infringing APIs in time.
Comprehensive production lines and abundant experience in cGMP production.
Good reputation in quality with full audit record by foreign authorities. (Thomson Reuters lists Formosa Labs as an “Established” API manufacturer.)
Stable and cost-effective supply of raw materials, including the establishment of long term tolling relationship with selected Chinese suppliers.
Strong experience in global marketing and sales.
Our Competitive advantages
Teva Par
Mylan Hospira
Sandoz Apotex
Watson Mallinckrodt
15
Pfizer
Novartis
Sanofi-Aventis
GlaxoSmithKline
AstraZeneca
Roche
(1 CNS agent and 1 respiratory agent)
Contract manufacturing of 1 CNS API
Major end-user of UV filters
Formosa clients include Top-10
Formosa
Labs
17
USUS 7,645,911 B2
USUS 7,491,712 B1
Colestipol, Fludiazepam, Flupentixol, Leflunomide,
Meprobamate, Melitracen, Mifepristone, Mycophenolate
Nonivamide, Taltirelin
2008 Colesevelam, Calcium acetate, Montelukast, Temozolomide
2009 Sevelamer HCl, Orlistat, Sevelamer Carbonate
2010 Maxacalcitol, Lapatinib, Tegafur
API products developed in-house
20
11
Two NDA drugs using APIs supplied by Formosa launched in 2009
Iloperidone (Fanapt, US, May 2009)
Capsaicin (Qutenza, Europe, May 2009; US, Nov. 2009)
Two NDA drugs using APIs supplied by Formosa launched in 2009
Iloperidone (Fanapt, US, May 2009)
Capsaicin (Qutenza, Europe, May 2009; US, Nov. 2009)
22
(responsible for process scale-up and API supply)
Domestic: 4
Foreign: 5
(responsible for process scale-up and API supply)
Domestic: 4
Foreign: 5
21
1. UV filters
Due to global warming and the general public paying more attention to skin care, 3-5%
annual growth is expected.
A new 5-year supply agreement with DSM was signed Oct. 2009.
2. Generic APIs
3 polymer APIs (1 Cholesterol and 2 Phosphate Binders) will loose their patent protection
between 2013 and 2015, with a combined formulation market value of > $1.5 bil. The sale
of these 3 APIs will be the major source of revenue growth within 5 years.
3 Vit. D derivatives will loose patent protection in 2012, 2014 and 2015 respectively.
1 respiratory agent will loose patent protection in 2012.
3. China market
Formosa is setting up a joint venture with our business partner in Beijing and also
registering our API products in China through local agents. China market will be a major
source for our revenue growth.
22
1,708
2,044
1,899
95%
81%
19%
63%
2007 2008 2009 2010(self-prepared)
Sales
Gross Margin would be Improved by Products Portfolio
23.86%
62.0%
38.0%
Blue: Therapeutic APIs; Light blue: UV-filters; Orange: Total gross margin
24
25
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