Title: Unlocking the Potential
1Unlocking the Potential
- Aspreva Pharmaceuticals Corporation
- (NASDAQ ASPV TSX ASV)
- Annual and Special General Meeting
- May 31, 2007 at the Four Seasons Hotel
- Richard Glickman
- Chairman CEO
2Disclaimer
- Certain statements in this presentation contain
forward-looking statements within the meaning of
the Private Securities Litigation Act of 1995.
Words such as "anticipates," "believes,"
"estimates," "expects," "intends," "may,"
"plans," "projects," "will," "would" and similar
expressions are intended to identify
forward-looking statements, although not all
forward-looking statements contain these
identifying words. Forward looking statements
include, but are not limited to, those with
respect to future profits, product revenues, the
use of net proceeds from our initial public
offering, the timing of clinical trials and the
completion date for clinical trials and
additional collaborations and their timing. These
forward-looking statements are only predictions
based upon our current expectations, and actual
events or results may differ materially. We may
not actually achieve the plans, intentions or
expectations disclosed in our forward-looking
statements. Forward-looking statements involve
risks and uncertainties. Our actual results and
the timing of events could differ materially from
those anticipated in such forward-looking
statements as a result of these risks and
uncertainties, which include, without limitation,
the risk that we may not sustain our
profitability future sales of CellCept may be
less than expected our future operating results
are uncertain and likely to fluctuate we may not
be able to develop and obtain regulatory approval
for CellCept in the treatment of autoimmune
indications and any future products in our
targeted indications we may not be able to
establish marketing and sales capabilities and
the costs of launching CellCept in the treatment
of autoimmune indications and any future products
for our targeting indications may be greater than
anticipated we may not be successful in
establishing additional collaborations we may
face unknown risks related to intellectual
property matters we may face increased
competition from other pharmaceutical or
biotechnology companies, and other risks and
uncertainties detailed in our filings with the
Securities and Exchange Commission and Canadian
securities regulatory authorities. You are
cautioned not to place undue reliance on these
forward-looking statements, which speak only as
of the date of this presentation. All
forward-looking statements are qualified in their
entirety by this cautionary statement, and
Aspreva undertakes no obligation to revise or
update any forward-looking statements as a result
of new information, future events or otherwise
after the date hereof.
3Agenda
- Highlights of the Past 6 Years
- Richard Glickman Chairman CEO
- Financial Highlights
- Bruce Cousins EVP CFO
- Clinical Highlights
- Dr. Usman (Oz) Azam EVP Chief Medical Officer
- Business Development Highlights
- Noel Hall, President Co-Founder
- Closing
- Richard Glickman Chairman CEO
4Looking Back
- Vision To change the treatment landscape for
people with less common - diseases by increasing the pool of
evidence-based medicines - Aspreva Aspirations, Hopes (reves) Dreams
(spero) - 2001 Incorporated
- 2003 Signed collaborative agreement with Roche
- 2004 Raised 57M USD in Series A financing
- 2004 2005 Initiated 3 phase III clinical
trials - 2005 IPO raising 91M USD
- 2006 Completed MG trial
- 2006 Completed enrollment in LN trial
- 2007 Completed enrollment in PV trial
5Moving Forward
- Strong platform to support continued growth
- Global reach across 4 geographic offices
- Talent pool with established clinical and
regulatory expertise - Solid financial position
- Culture of innovation and entrepreneurship
- Strong and capable management team
- Noel Hall, President Co-Founder
- Bruce Cousins, EVP CFO
- Dr. Usman (Oz) Azam, EVP Chief Medical Advisor
- Rick Goulburn, EVP Global Pharmaceutical
Operations - Paul Brennan, SVP Business Development
- Dr. Richard Jones, SVP and Chief Scientific
Officer - Darcy OGrady, VP Global Human Resources
6Agenda
- Highlights of the Past 6 Years
- Richard Glickman Chairman CEO
- Financial Highlights
- Bruce Cousins EVP CFO
- Clinical Highlights
- Dr. Usman (Oz) Azam EVP Chief Medical Officer
- Business Development Highlights
- Noel Hall, President Co-Founder
- Closing
- Richard Glickman Chairman CEO
7Financial Progress 2004- 2006
8Financial Highlights 2007 and Beyond
- Q1 2007
- Revenue 59.3 M
- Net income 36.4 M
- Diluted earnings per share (EPS)
1.03 - Cash and equivalents 277.2 M
- Operating cash flow 20.5 M
- Shares outstanding (diluted)
35,406,138 - Market Cap 763 million (March 31, 2007)
- Essentially debt-free
- Competitive global tax rate - lt15
- Revenue guidance for 2007 in excess of 245M
USD - Strong operating margins supported by 133 FTEs
9Agenda
- Highlights of the Past 6 Years
- Richard Glickman Chairman CEO
- Financial Highlights
- Bruce Cousins EVP CFO
- Clinical Highlights
- Dr. Usman (Oz) Azam EVP Chief Medical Officer
- Business Development Highlights
- Noel Hall, President Co-Founder
- Closing
- Richard Glickman Chairman CEO
10CellCept Overview (Mycophenolate Mofetil or MMF)
- Leading branded transplant medicine in the world
- 1.5 billion USD worldwide sales in 2006
- Small molecule immunosuppressant
- Approved for renal, heart and liver transplant
- 11 years of clinical practice, over 600,000
patient years of experience - Significantly improved graft patient survival
- This drug has largely replaced azathioprine
and is widely used because it is effective in
combination with many other agents, simple to use
without monitoring, and free from organ toxicity
and cardiovascular risk. -
- Dr. Philip F. Halloran, NEJM December 23, 2004
CellCept transformed transplant medicine
11Clinical Highlights
Under Partnership Agreement with Roche
Market Size (patients worldwide)
Submissions Expected
Regulatory Route
Status
Completion of Trial
Indication
Completion of induction Q2 2007
Lupus Nephritis
US sNDA (Type 2 - Europe)
600,000
Phase 3
Myasthenia Gravis
Complete/ Not filing
US sNDA (Type 2 - Europe)
100,000
Phase 3
Pemphigus Vulgaris
US sNDA (Type 2 - Europe)
40,000
Phase 3
2008
12Systemic Lupus Erythematosus (SLE)
- Life threatening disease
- Chronic inflammatory autoimmune disorder
- US prevalence 500,000 to 1.5M
- Current therapies inadequate highly toxic
- No new medications approved in 30 years
Lupus Nephritis the most common serious
manifestation of SLE
- Inflammatory kidney disease affecting 30 50
of SLE patients - Intense disease activity (flares) followed by
periods of remission - Patient population 600,000 worldwide
- Current treatment
- Steroids and anti-cancer drugs
13Aspreva Lupus Management Study (ALMS)
- Clinical Regulatory Plan
- Global phase III trial underway
- Induction - Open label comparison of MMF vs. IVC
- Key Endpoints
- Decrease in proteinuria
- Stabilization (to within 25 of baseline) or
improvement of serum creatinine - Maintenance - Blinded comparison of MMF vs. AZA
in maintenance of remission - Recruitment of 371 patients completed in
September 2006 - SPA process completed in September 2005
- Induction phase now complete awaiting
preliminary data (Q2 2007) - Targeting sNDA filing with FDA in Q4 2007 with
Type II Variation submission to follow based on
preliminary results
14Pemphigus Vulgaris
- Painful, life-threatening chronic AI disease
- Patient population 40,000 worldwide
- Current treatment
- High dose steroids and immunosuppressants
- CellCept clinical evidence establishes proof of
concept - Clinical Regulatory Plan
- Global phase III trial underway
- Recruitment of 77 patients completed in March
2006 - Secondary patient enrollment to 96 patients
completed May 2007 - Trial completion expected in 2008
Toxicity of current treatments limits their
efficacy
15Agenda
- Highlights of the Past 6 Years
- Richard Glickman Chairman CEO
- Financial Highlights
- Bruce Cousins EVP CFO
- Clinical Highlights
- Dr. Usman (Oz) Azam EVP Chief Medical Officer
- Business Development Highlights
- Noel Hall, President Co-Founder
- Closing
- Richard Glickman Chairman CEO
16Aspreva Business Development Process Focus
Alliance Mgmt
Signing
Strategy
BD Operations Business Intelligence,
Competitive Intelligence, Research, Reporting
- Processes led by BD department with reviews and
assessments shared by relevant functional
areas in Aspreva - Autoimmune and Renal focus
- Evaluating partnerships, licensing agreements,
acquisitions
17Asprevas Strengths Solid Foundation to support
growth
- Talent pool
- Recognized for our expertise in less common
disease targets - New members to continue to increase the strength
of our management team - Dr. Usman (Oz) Azam, Executive Vice President
Chief Medical Officer - Paul Brennan, Senior Vice President, Business
Development - Relationships
- Solid relationship with Roche (granted Preferred
Partner status from Roche) - Key medical specialists (nephrologists and
rheumatologists) - Global reach
- Headquartered in BC, Canada with offices in New
Jersey, Switzerland, and the UK - 133 full-time employees
- ALMS trial 371 patients at 88 sites in 21
countries - Beyond Compliance
- Met requirements for Sarbanes Oxley Act in 2006
- Continually working to surpass regulatory
requirements highest standards of corporate
governance and health care compliance
18Agenda
- Highlights of the Past 6 Years
- Richard Glickman Chairman CEO
- Financial Highlights
- Bruce Cousins EVP CFO
- Clinical Highlights
- Dr. Usman (Oz) Azam EVP Chief Medical Officer
- Business Development Highlights
- Noel Hall, President Co-Founder
- Closing
- Richard Glickman Chairman CEO
19(No Transcript)