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8-K - FORM 8-K - SCICLONE PHARMACEUTICALS INC | d463102d8k.htm |
EX-99.1 - PRESS RELEASE - SCICLONE PHARMACEUTICALS INC | d463102dex991.htm |
A
Top US Specialty Pharma Company Leveraging
China Market Growth
Opportunities
Corporate Presentation
January 2013
SciClone
Pharmaceuticals
Exhibit 99.2 |
2
Safe Harbor
This presentation contains forward-looking statements regarding expected financial results and
expectations. Readers are urged to consider statements that include the words may,
will, would, could, should, might,
believes, estimates, projects, potential,
expects, 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 include risks and uncertainties relating to: changes in results
that may occur in completing the close of SciClones consolidated financial statements for fiscal
year 2012 and completing the audit of SciClones consolidated financial statements for
fiscal year 2012; the course, cost and outcome of regulatory matters; the Companys
ability to execute on its goals in China and on its objectives for revenue in fiscal 2013; the
challenges presented by integrating an acquired business into existing operations; the
variability in earnings on a GAAP basis that may result from non-cash charges related to the NovaMed
acquisition; the dependence on third-party license, promotion or distribution agreements including
the need to renew such agreements; operating an international business; the clinical trial
process, including the regulatory approval and the process of initiating trials at, and
enrolling patients at, clinical sites; the effect of changes in its practices and policies
related to the Companys compliance programs and SciClones ability to attract and retain
key personnel. SciClone cannot predict the timing or outcome of the SEC and DOJ investigations, or of
the level of its efforts required to cooperate with those investigations, however the Company
has incurred substantial expenses in connection with the investigations and related litigation
and expects to incur additional expense and the investigations could result in fines and
further changes in its internal control or other remediation measures that could adversely
affect its business. Please also refer to other risks and uncertainties described in SciClones
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. |
SciClone
Today:
Earnings-Driven
Specialty
Pharma
Company with Growing China Commercial Business
Revenue & Profitability
Growth Track Record
Successful Products,
Pipeline, Partnerships
Established Multinational
Company
Solid well-established business
fundamentals
Continued top-
and bottom-line
growth potential
Strong cash balance: est.
>105MM at 12/31/13
Excellent investment
opportunity to participate
in fast-growing China
pharma market
Large marketed portfolio
of in-licensed and proprietary
products; well-stocked
development pipeline
Spans high growth markets:
CV, CNS, ID, oncology
Lead
product
ZADAXIN
®
exceeding $100MM in sales
Success in managing Chinese
regulatory and commercial
processes
Focus on high quality
compliance and controls in US
and China
Experienced, high caliber US
and China management teams
Reputation for high quality
products compliant with
Western manufacturing
standards
Strong market presence in
China since 1996
3 |
4
Positive Revenue and EPS Trends
2012
Guidance
2013
Guidance
2011
2010
2009
2008
($0.20)
($0.10)
$0.00
$0.10
$0.20
$0.30
$0.40
$0.50
$0.60
$0.70
$0.80
$0.90
$1.00
$0MM
$20MM
$40MM
$60MM
$80MM
$100MM
$120MM
$140MM
$160MM
$180MM
Non-GAAP Basic EPS
Revenue |
5
*Basic
**Non-GAAP
***Excludes effect of share repurchases
Consistently Growing Profits and Cash Flow
FY 2013
Guidance
FY2012
Guidance
FY
2011
FY 2010
FY 2009
Revenue
$150
-$155MM
$152
-$157MM
$134MM
$85MM
$72MM
EPS*
$0.66
-$0.72**
$0.62
-$0.68**
$0.62**
$0.44
$0.26
Cash &
Investments
>$105MM***
$87MM
$67MM
$57MM
$32MM |
6
Creating Shareholder Value through Share
Repurchases and Cash Balances
2013 Estimate
FY2012
FY
2011
Shares
Repurchased
2.5MM
4.7MM
0.8MM
Cash used in
Repurchases
$12.4MM
$24.8MM
$3.5MM |
7
Partnering Strategy to Drive Top Line
and Profitability
Partner of choice positioning,
leveraging commercial and regulatory
expertise
Renegotiating promotion agreements
to achieve more favorable terms and
increased profitability
Sanofi: potential 1-year contract
extension being finalized; negotiation
of multi-year extension anticipated
in 2013
Baxter: multi-year contract renewal
being finalized
Pfizer: multi-year contract renewal
up for negotiation in 1Q13
Xatral
Urology
Depakine
CNS
Stilnox
CNS
Tritace
Cardiovascular
Holoxan
Oncology
Mesna
Cancer
Supportive Care
Endoxan
Oncology
Farlutal
Oncology
Methotrexate
Oncology
Daunoblastina
Oncology
Estracyt
Oncology
Leucovorin
Oncology
Aggrastat
Cardiovascular |
8
Strategy for Continued Sales and Profit Growth
Build momentum for high-margin marketed portfolio in China
Increase profitability
Structure licensing and promotion agreements at favorable terms
Careful expense management to generate profits from promotion model
Opportunistic acquisition/in-licensing of branded products at profitable
terms Advance late-stage pipeline to fuel long-term growth
Tramadol approved for pain 1Q12
DC Bead approvalexpected for liver cancer
Optimize commercial operations and strategies
Recent high-caliber senior executive hires with multinational
credentials Search underway for new China CEO
Drive ZADAXIN growth
Develop future market leaders: Aggrastat, Stillnox
Build on the solid base for established products: Depakine
® |
Product Portfolio:
Current and Future
Market Leaders
9 |
10
Product and Development Portfolios Span Large,
Growing Commercial Markets
Marketed Products
Development Products
Immunostimulant for HBV, HCV, cancer, vaccine adjuvant; proprietary product Broad-spectrum
anti-convulsant for epilepsy; bipolar disorder; exclusively promoted for Sanofi
Non-benzodiazepine hypnotic for sleep disorders; exclusively promoted for Sanofi Intervention cardiology
product; licensed from Iroko exclusively for China
Tramadol sustained release capsule for moderate to severe pain; licensed from Meda; approved 1Q12 Embolic drug-eluting bead
for targeted delivery of cancer chemo; licensed from BTG/Biocompatibles
Miconazolelauriadmucoadhesivetablet for oropharyngeal candidiasis; licensed from BioAlliance Fentanyl sublingual tablet for
breakthrough cancer pain; licensed from Orexo
Oral film formulation of ondansetron for chemo-induced nausea; licensed from Applied Pharma
Research |
11
Indications: HBV, HCV, certain cancers; vaccine
adjuvant
Proprietary to SciClone: registered in China 1996
High quality imported premium brand thymalfasin
Award-winning anti-counterfeiting label to protect
patient safety and security
Acts through TLR9 pathway
Effective in immune system compromised patients
Clinical demonstration of quality-of-life benefits
Immune stimulator for treatment in severe hepatitis
and oncology
|
12
ZADAXIN
(
)
in
China
Commercial
Growth Opportunity
Thymosins(ZADAXIN category) top 5 category
product in China
Key advantage: high-quality Western manufacturing
Highly differentiated: no imported competitors
Sales reaching more than $100M
40%+ of RMB value share, 13% of volume share
despite heavy local generic competition
Potential year-over-year growth 15-20%
Penetrate deeper and wider into more departments
within hospitals in markets that can support premium
pricing
Target tier 1 and 2 cities and smaller, rural areas
where market demand is growing
Cross-sell with oncology sales force
Growth strategy: |
13
Market Advantages Potentially Driving
Increased Demand for ZADAXIN
Recent price reductions likely to increase volume and market
penetration
Increased affordability for broader range of hospitals and patients
Strengthen provincial tendering strategies
Independent listing from generics supports premium pricing
Leverage expanding indications for ZADAXIN: sepsis and
general surgery
Take advantage of governments imposition of limitations on
antibiotic overuse
Thymalfasin recently confirmed in treatment guidelines for
hepatocellular carcinoma |
14
Description
Commercial
Opportunity
Broad spectrum treatment for epileptic
attacks and syndromes; bipolar disorder
Licensed from Sanofi-Aventis; exclusive
China promotion rights
Year of China registration: 2008
Depakine
®
CNS Market Leader
SciClones 2
nd
largest product:
sales grew ~28% CAGR over last 3years
Most widely prescribed broad-spectrum
anticonvulsant in China
Large underserved market in 2nd tier cities
Market share: 40%+
30% potential year-over-year market growth |
Description
Intervention cardiology product
Fast acting, reversible IIb/IIIa inhibitor that disaggregates
platelet thrombi and improves myocardial perfusion
Improves results of those at high risk of MI 3-4 days post-
acute angina (including patients facing early PTCA)
Licensed from Iroko; exclusive China distribution rights
Year of China registration: 2009
Aggrastat
®
Future Cardiovascular Market Leader
Commercial
Opportunity
15
Significant long-term growth potential in fast-
growing stent market
>150,000 angioplasty procedures in China
per year
Competition: 1st and only imported, China-
approved IIb/IIIainhibitor
ReoPro, Integrilin
at least 5-7 years behind
Plans to re-launch, accelerate provincial tendering
Potential year-over-year market growth: 20%+ |
16
Description
Stillnox
®
Market Leader in Sleep Disorders
Commercial
Opportunity
Non-benzodiazepine hypnotic
Exclusively promoted for Sanofi-Aventis
Year of China registration: 2008
High growth potential in tier 1
cities and large institutions; strong
efficacy, favorable side-effect profile
Market share 35%
Potential year-over-year
growth:15% |
Path to Continued
Earnings Growth and
Value Creation
17 |
18
Predicted to grow at least 15-20% compared to essentially
flat US, EU markets
Increased consumer demand
Broader access to health care services
Current and future growth largely located in second-tier and
rural areas
Growing demand for imported pharmaceutical brands, which are
widely favored by patients and physicians over locally
manufactured generic products
SciClonesuccessfully expanding market access throughout
China
with
successful
wider/deeper
strategy
China Pharma Market is Major Growth
Opportunity for SciClone |
19
Established Multinational Company Ranking in
Top Tier in China Market
US corporate headquarters: China operations report into US
Experienced international management teams in US and China
Attracting leading local management talent in China
Strong commercial, regulatory, reimbursement capabilities
Compliance and financial controls policies are top-tier
SEC-regulated, Sarbanes-Oxley compliance
US GAAP accounting standards
Continually improving policies, training and practices company-wide
Business practices and standards similar to multinational peers;
superior to local companies
Excellent reputation for high quality products compliant with
Western manufacturing standards
Focus on strict FCPA compliance |
20
Build on our well established commercial, regulatory management
strengths
Take advantage of growth trends in the China pharmaceutical market
Deploying experienced sales and marketing teams to key geographies
Further capitalize on our reputation as a provider of high quality,
premium brands
Continue to deliver shareholder value by
Returning to high sales growth rates
Building earnings per share
Achieving strong positive cash flows
Increasing China product pipeline
Strategy to Leverage China Pharma Market
Growth Opportunties |
21
SciClone: Unique Investment Opportunity to
Participate in Growing China Pharma Market
US-based,
China-focused
Profitable
with
Significant
Growth
Potential
Broad
Portfolio of
Marketed
Products
Promising
Late-Stage
Pipeline
A Partner
of
Choice
for
In-Licensing
Strong
Balance Sheet
|
SciClone
Pharmaceuticals |