Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - SCICLONE PHARMACEUTICALS INC | d8k.htm |
| EX-99.1 - PRESS RELEASE - SCICLONE PHARMACEUTICALS INC | dex991.htm |
 Global
Strategies for Life-Enhancing Drugs Corporate Presentation January 2010 Exhibit 99.2 |
 Safe
Harbor Statement This presentation contains forward-looking statements
regarding development objectives and timing expectations. You are urged
to consider statements that include the words "may," "will,"
"would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects,"
“potential,” "plans," "anticipates," "intends," "continues," "forecast," "designed,"
"goal,“ “unaudited,” “approximately,” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that
are difficult to predict and actual outcomes may differ materially. These
risks include the outcome of Chinese governmental processes and decisions and
our ability to respond to those decisions, as well as the response of
manufacturers of generic thymosin alpha-1. These risks and uncertainties also include our ability to identify
and consummate our previously-announced goals of acquiring additional products
to sell, either through licensing or the acquisition of businesses.
Please also refer to other risks and uncertainties described in
SciClone's filings with the SEC. All forward-looking statements are based on information currently available to
SciClone and SciClone assumes no obligation to update any such forward-looking statements. 2 |
 Global
Specialty Pharma Company Profit-driven and Growing • Significant profitability and cash flow positive • 2009 financial results and outlook: • Approximately $72.4 MM revenue (unaudited); 34% increase • Approximately $31.8 MM cash & investments (unaudited) at 12/31/09 • $0.18 - $0.22 current EPS guidance (complete results coming later this quarter) • 2010 revenue guidance $82 – $85 MM; approximately 15% increase • Revenue growth + tight expense management = positive EPS year-over-year
• International Commercial Success • Established business in China with a strong, efficient sales organization • Strong international brand recognition • Plans to further build China business: • Active in-licensing program; DC Bead™ & RapidFilm™ • M&A; significant effort underway • ZADAXIN ® marketed in more than 30 countries • Rich Product Portfolio in Oncology and Infectious Disease • Invest in cost-efficient phase 1 and 2 trials; partner at phase 3 stage • 1 marketed product; developing 2 molecules in 4 indications 3 |
 4 Committed to Sustained Profitability and Growing EPS • Revenue of $72.4 MM A** 2009 Financial Results and Outlook • EPS: $0.18 to $0.22 E** • Cash and investments of $31.8 MM A** * 2006 EPS do not include $8MM settlement received that year **A – Actual (unaudited); E - Estimate $.0 $20.0 $40.0 $60.0 $80.0 $100.0 2006 2007 2008 2009 A** 2010 E** Revenue (MM) EPS: ($.16)* ($.22) ($.18) $0.18 - $0.22 E |
 Specialty Pharma Focus in China: Significant Growth Opportunity for SciClone |
 $60-62 6 • Chinese Pharmaceutical Market • China expected to rank among the top five global pharmaceutical markets by 2012
and 2nd in market size growth • Growth of approximately 23%* over the next three years • Our Position/Opportunity • Longstanding presence in China since ZADAXIN launched in 1996 • China 2009 sales >$69 MM • 1 st class brand: • SciClone and ZADAXIN well-regarded by physician community; • Western manufacturing seal of approval • Strong sales infrastructure in place • Our Growth Strategy • Introducing additional products through in-licensing and M&A • Commercialization rights to the anti-nausea drug ondansetron RapidFilm • Commercialization rights to embolic agent DC Bead • Markets: Hepatitis, cancer populations, infectious diseases • Expanding hospital coverage in tier 2 and 3 cities Growth Opportunity: SciClone in China * McKinsey, 2009 |
 7 • Thymosin alpha 1 (ZADAXIN generic name) included in Class B of China’s National Drug Reimbursement List (“NDRL”) in November 2009
• NDRL consists of >2,100 drugs • Important component of the healthcare reform plan in China • Government aiming for universal healthcare coverage by 2012 • Government to reimburse at least part of the cost of the drug • Set maximum price that will apply in most circumstances • Reimbursement and pricing provisions not expected to go into effect until 2H 2010, though the timing and outcome of any pricing decision is uncertain • Expanded access should help support SciClone’s ongoing efforts to further expand the reach of ZADAXIN in China China Healthcare Reform Plan Update |
 Product Portfolio Product Development Phase 1 Phase 2 Phase 3 Marketed Ondansetron RapidFilm ™ China & Vietnam Italy & 12 countries; global H1N1 Vaccine Enhancement ZADAXIN ® HBV/HCV & Other Indications China, Russia & >30 other countries DC Bead™ China SCV- 07 HCV Global (Ex-Russia) Stage IV Melanoma U.S./Europe Palliative care 8 Marketing approval expected 2011 Marketing approval expected 2010 Marketing approval targeted 1H 2010 Liver cancer Oral Mucositis in Head/Neck Cancer Global (Ex-Russia) |
 ZADAXIN
Development Opportunity: A High Value Drug for H1N1
|
 ZADAXIN Enhancement of Vaccine for H1N1 Virus Description and MOA • ZADAXIN, a synthetic preparation of naturally occurring peptide with immunostimulatory activity which promotes antibody production •Potential to develop ZADAXIN as an enhancer of novel H1N1 flu vaccines globally • Targeting immune compromised population • Approvals in Italy and 12 other countries for influenza vaccine enhancer indication (6-8 injections) Commercial Opportunity • Pursuing extension of existing label in Italy • Emergency approval procedures now in place in most countries • Potential to expand from Italy to EU, ROW 10 |
 11 ZADAXIN Enhancement of Vaccine for H1N1 Virus Development Strategy •Targeting a new dosage regimen effective with one or two injections • Preclinical studies completed in late 2009 • Clinical studies underway in Italy • Using H1N1 vaccine - Novartis Focetria™ Future Development • Past experience showed there may be increased demand if virulence/lethality worsens • Similar to SARS experience •Longer-term opportunity to become part of seasonal flu vaccination regimen for immune compromised populations |
 Phase
2 Drug Candidate in Two Indications: SCV-07 |
 13 SCV-07: Phase 2 Oral Mucositis (OM) Opportunity Description and MOA • Novel dipeptide inhibits STAT-3 signaling leading to dendritic cell maturation and increased Th1 cytokine production • Restores balance in Th1/Th2 helper T cell ratio (ratio shifted to Th2 by radiation) • Subcutaneously as well as orally available Commercial Opportunity •OM after chemoradiation: Vast unmet medical need • Debilitating side effects, including pain, inability to swallow; complications from feeding tubes and extra medical care •400,000* head and neck cancer patients in the U.S. •Exclusive worldwide rights, excluding Russia *Source: NCI |
 14 SCV-07: Phase 2 Oral Mucositis Opportunity Development Strategy • Double-blind, placebo controlled, phase 2 trial to delay the onset of severe OM in head and neck cancer patients and decrease its severity • Enrollment completed in 2H 2009 Future Development • Topline results to be reported in 1H 2010 • Opportunity to prevent mucositis from chemoradiation in other oncology indications |
 15 SCV-07: Phase 2 HCV Opportunity Description and MOA • Novel dipeptide inhibits STAT-3 signaling leading to dendritic cell maturation and increased Th1 cytokine production • Increases Th1-type immune responses (Th1 responses needed for viral clearance of infected cells) • Subcutaneously as well as orally available Commercial Opportunity • HCV represents large unmet medical need; market size >$2 B* in 2008; expected to grow to >$10 B* within 5-7 yrs • Interferon has significant side effects and SOC leads to <50% sustained responses • Limited drugs under development for interferon replacement • Most drugs in development are direct antivirals * Source: Decision Resources, Data Monitor |
 16 SCV-07: Phase 2 HCV Opportunity Development Strategy • Initial 7 day monotherapy study reported at EASL showed SCV-07 is safe • Viral load reduction and increased biomarker (neopterin) of macrophage activation seen in some patients • Phase 2 trial of SCV-07 lead-in monotherapy followed by combination therapy with ribavirin in patients with genotype 1 chronic HCV; relapsed to SOC • Trial initiated in 2H 2009 • Topline results to be reported in 2H 2010 Future Development • Demonstrate a clinically-relevant result in phase 2 • Follow up with additional Phase 2 trial including a STAT- C drug demonstrating SVRs superior to or comparable to SOC but with none of the interferon-type toxicity |
 17 DC Bead: Targeting Liver Cancer in China Description • Embolic agent, delivers chemotherapy drugs • Microscopic beads with dual anti-tumor effects • Deliver doxorubicin, potentially other chemotherapy agents directly to tumor Commercial Opportunity • Exclusive Chinese marketing rights • Market-specific unmet need; Liver cancer one of most prevalent and deadly cancers in China • 271,300 diagnosed population; 64,530 drug-treated population • Leverage existing brand image, marketing and distribution channels, and strong in-country sales expertise |
 18 Ondansetron RapidFilm™ Description • Serotonin 5-HT3 receptor antagonist commonly used to treat and prevent nausea and vomiting caused by chemotherapy, radiotherapy, and surgery • Innovative oral thin film formulation of ondansetron Commercial Opportunity • Commercialization rights in China and Vietnam • 2008 sales of serotonin 5-HT3Serotonin receptor antagonists reached more than $110 million in China • RapidFilm delivery provides improvements over generic and branded formulations of intravenous and oral tablet ondansetron * Source: Decision Resources, Data Monitor |
 Corporate Progress |
 20 Milestones Milestone Timeline 2009 revenue guidance $70-$72 MM; $72.4 MM Actual Completed Complete preclinical studies evaluating the treatment regimen for ZADAXIN as an enhancer of H1N1 pandemic flu vaccine Completed Initiate clinical studies evaluating the treatment regimen for ZADAXIN as an enhancer of H1N1 pandemic flu vaccine Completed SCV-07 phase 2 trial in oral mucositis complete enrollment Completed ZADAXIN H1N1 clinical study topline results Early 2010 SCV-07 phase 2 trial in HCV complete enrollment 1H 2010 SCV-07 phase 2 oral mucositis topline results data 1H 2010 Achieve regulatory approval for DC Bead in China 2H 2010 Establish partnership for Phase 3-ready thymalfasin product candidate in stage IV melanoma; active discussions ongoing Ongoing 2010 revenue guidance $82-$85 MM Ongoing |
 21 Global Specialty Pharma Company Profit-driven and Growing • Significant profitability and cash flow positive • 2009 financial results and outlook: • Approximately $72.4 MM revenue (unaudited); 34% increase • Approximately $31.8 MM cash & investments (unaudited) at 12/31/09 • $0.18 - $0.22 current EPS guidance (complete results coming later this quarter) • 2010 revenue guidance $82 – $85 MM; approximately 15% increase • Revenue growth + tight expense management = positive EPS year-over-year
• International Commercial Success • Established business in China with a strong, efficient sales organization • Strong international brand recognition • Plans to further build China business: • Active in-licensing program; DC Bead & RapidFilm • M&A; significant effort underway • ZADAXIN marketed in more than 30 countries • Rich Product Portfolio in Oncology and Infectious Disease • Invest in cost-efficient phase 1 and 2 trials; partner at phase 3 stage • 1 marketed product; developing 2 molecules in 4 indications
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 Global
Strategies for Life-Enhancing Drugs Corporate Presentation January 2010 |