(NASDAQ: AUXL) February 2008 Exhibit 99.1 |
2 (NASDAQ: AUXL) Safe Harbor Statement Safe Harbor Statement We will make various remarks during this presentation that constitute “forward-looking statements” for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995, including statements regarding the pricing, time to market, size of market, growth potential and therapeutic benefits of the Company’s product candidates, including those for the treatment of Dupuytren’s contracture, Peyronie’s disease, and Frozen Shoulder syndrome; interpretation of market research data; competition within certain markets relevant to the Company’s product candidates; interpretation of clinical results, including the efficacy and tolerability of the Company’s product candidates; the timing of the commencement and completion of clinical trials and the timing of reporting of results therefrom; the timing of manufacturing scale up for the Company’s product candidates; the Company’s ability to manufacture XIAFLEX™ (clostridial collagenase for injection – formerly referred to as AA4500) at the Company’s Horsham facility; the timing of the completion of phase III trials for XIAFLEX for the treatment of Dupuytren’s contracture and the reporting of results therefrom; the timing of the filing of the Biologics License Application for approval of XIAFLEX for the treatment of Dupuytren’s contracture and the approval thereof; the timing of the phase IIb trials for XIAFLEX for the treatment of Peyronie’s disease; competitive developments affecting the Company’s products and product candidates, including generic competition; the success of the Company’s development activities; future Testim market share, prescriptions and sales growth and factors that may drive such growth; size and growth potential of the testosterone replacement therapy market and the gel segment thereof and factors that may drive such growth; the effect of the Company’s expansion of its field force; the protection for Testim afforded by U.S. Patent No. 7,320,968, the value of extending patent protection for Testim through January 2025, the value and likelihood that patents will be granted from the continuation and divisional applications filed by Bentley Pharmaceuticals, Inc.; the Company’s development and operational goals for fiscal 2008; the ability to fund future operations; and the Company’s expected financial performance during 2008 and financial milestones that it may achieve for 2008, including 2008 net revenues, research and development spending, selling, general and administrative expenses, and net loss. All remarks other than statements of historical facts made during this presentation, including but not limited to, statements regarding future expectations, plans and prospects for the Company, statements regarding forward-looking financial information and other statements containing the words “believe,” “may,” “could,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” and similar expressions, as they relate to the Company, constitute forward-looking statements. Actual results may differ materially from those reflected in these forward- looking statements due to various factors, including general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries and those discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2006 and the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2007 under the heading “Risk Factors”, which is on file with the Securities and Exchange Commission (the “SEC”) and may be accessed electronically by means of the SEC’s home page on the Internet at http://www.sec.gov or by means of the Company’s home page on the Internet at http://www.auxilium.com under the heading “Investor Relations - SEC Filings.” There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. In addition, forward-looking statements provide the Company’s expectations, plans or forecasts of future events and views as of the date of this presentation. The Company anticipates that subsequent events and developments will cause the Company’s assessments to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s assessments as of any date subsequent to the date of this presentation. |
Fastest Growing TRT product in the U.S. Late Stage Company Transforming Product Poised for Growth + = |
4 (NASDAQ: AUXL) Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) • Specialty biopharmaceutical company focused on Urologists, Endocrinologists, Orthopedists and certain PCPs • Founded in 1999 • Headquarters in Malvern, Pa. – Manufacturing in Horsham, Pa. – Approximately 290 employees (~190 commercial) • I.P.O in July 2004 – Currently approximately 40.0 million shares issued & outstanding – Additional 7 million shares subject to issuance from stock options & warrants • A component of the NASDAQ BIOTECH INDEX |
5 (NASDAQ: AUXL) Broad Pipeline Maturing in Coming Years Broad Pipeline Maturing in Coming Years Note: Worldwide rights for all products available, except Testim where ex -U.S. rights have been licensed. XIAFLEX™ (clostridial collagenase for injection) was formally referred to as AA4500 6 Product Testim® gel Approved in U.S. Europe & Canada XIAFLEX™ XIAFLEX™ XIAFLEX™ Transmucosal Film AA4010 Transmucosal Film Transmucosal Film Market Phase III Phase II Phase I Pre-clinical Late Research Hypogonadism Dupuytren’s Contracture Peyronie’s Disease Frozen Shoulder Syndrome Overactive Bladder Hormones and Urology Pain |
6 (NASDAQ: AUXL) Anticipated News Flow Events Anticipated News Flow Events 5 Jan 22: • Testim-Patent Issued Q108/Q208: • XIAFLEX-Complete Peyronie's Animal Study • XIAFLEX-Initiate Peyronie's Phase IIb Studies Q208: • XIAFLEX-Top- line Phase III (Double Blind) Data H109: • XIAFLEX-Open Label Safety Data Early 2009: • XIAFLEX-File BLA for Dupuytren's Contracture 6 6 Q409 Q309 Q209 Q109 Q408 Q308 Q208 Q108 Early 2010 • XIAFLEX – FDA Approval In Dupuytren’s Contracture Early 2010 |
XIAFLEX™ (clostridial collagenase for injection) A Company Transforming Opportunity |
8 (NASDAQ: AUXL) XIAFLEX – XIAFLEX – Company Transforming Opportunity Company Transforming Opportunity • Potential to replace surgery in certain indications • Great fit for Specialty Biopharmaceutical Company • Worldwide rights offer options to build company or generate cash – exploring partnering opportunities now • We believe there are approximately 450,000 potential patients annually in U.S. and EU for Dupuytren’s & Peyronie’s indications - > $1 Billion opportunity, based on market research and analysis • BLA for Dupuytren’s Contracture expected to file in early 2009 |
9 (NASDAQ: AUXL) XIAFLEX for Dupuytren’s XIAFLEX for Dupuytren’s Contracture Contracture • Collagen accumulation in hand causes affected fingers to become permanently flexed Disease description • Patented through 2014; Orphan Drug Exclusivity for 7 years post approval I.P. position • Surgery is only approved treatment - expensive and characterized by numerous complications Current treatment • Enrollment in CORD I and CORD II completed in December 2007 • Last injections in CORD I and double blind portion of Cord II expected in March 2008 – Top line results in Q2 2008 Clinical status • Prevalence estimated at 3-6% of Caucasian populations - highest among people of northern European descent Target population Source: Badalamente, M. et al. J. Hand Surgery, September 2002 |
10 (NASDAQ: AUXL) Potential to Revolutionize Treatment for Dupuytren’s Potential to Revolutionize Treatment for Dupuytren’s Contracture Contracture Current Treatment XIAFLEX Treatment |
11 (NASDAQ: AUXL) Journal Journal of of Hand Hand Surgery, Surgery, July/Aug July/Aug 2007- 2007- Methods Methods • Randomized, double-blind, placebo controlled • 35 Patients (28 men, 7 women) • Mean Age was 61 ± 8.5 years • XIAFLEX Injections: – 10,000 units dosing – Maximum 3 injections per joint at 4-6 week intervals – 2:1 randomization vs. placebo • Primary Endpoint: – Contracture within 0 to 5° of normal – Measured 30 days after last injection |
12 (NASDAQ: AUXL) Pivotal Phase III Study – Pivotal Phase III Study – Results Results XIAFLEX Placebo P-value Primary End Point 21/23 (91%)* 0/12 < .001 - MP Joint 12/14 (86%) 0/7 < .001 - PIP Joint 9/9 (100%) 0/5 < .001 Secondary Joint 5/6 (83%) 0/3 .035 Median Time to Success 8 Days N/A Mean # Injections For Success 1.4 N/A * Success rates were 70% after a single injection |
13 (NASDAQ: AUXL) Pivotal Phase III Study – Pivotal Phase III Study – Other Findings Other Findings • Adverse Events: – No Serious Adverse Events reported – Adverse events were mild to moderate, mostly local reactions. Resolved within a mean of 3 weeks – No reports of loss of sensation or infections, and no skin grafts required • In total, 54 / 62 (87%) joints achieved clinical success in the study and its open label extension • Recurrence Rates: – 3 of 54 joints followed for 12 months – 5 of 27 joints followed for 24 months |
14 (NASDAQ: AUXL) Dupuytren’s Clinical Plan ~ 725 total patients Dupuytren’s Clinical Plan ~ 725 total patients • CORD I Study: – 216 patients in at least 15 sites in the U.S. – Double blind placebo controlled, randomized in 2:1 ratio of active to placebo – Primary endpoint is reduction in contracture to within 0 - 5º of normal – Secondary endpoints to measure clinical improvement and time to success – Top Line data expected to be available Q2 2008 • CORD II Study: – 60 patients, following protocol similar to U.S. trial – Top Line data expected to be available Q2 2008 – Five Australian sites • JOINT I (open label in U.S.) completed enrollment • JOINT II (open label ex-U.S.) will complete enrollment in Q1 2008 • As of Feb. 15, 2008, over approx. 840 patients have received in excess of 1,800 injections |
15 (NASDAQ: AUXL) We believe: • There is a pent-up demand for non-surgical therapy • Surgeons and patients prefer non-invasive treatment • Each patient on average has 2.2 joints which will require treatment; 49% have contractures in both hands • Early data indicates on average 1.4 vials of XIAFLEX required per joint 2.2 joints per patient x 1.4 vials per joint = 3.1 vials per patient on average • We believe XIAFLEX treatment can be priced competitively to cost of surgery (~$5,000 in the U.S.) Dupuytren’s Commercial Opportunity Dupuytren’s Commercial Opportunity |
16 (NASDAQ: AUXL) Market Research Performed – Market Research Performed – Dupuytren’s Dupuytren’s • Multiple prevalence data sets proved to be highly variable in numbers of patients • Two rounds of quantitative primary research have been commissioned by Auxilium on XIAFLEX for Dupuytren’s contracture • A combined 571 Orthopedic Surgeons have been interviewed to estimate market size (401 in U.S.; 170 in Europe) and 391 have given feedback on potential usage of XIAFLEX (221 U.S.; 170 Europe) • Second study (n=444 total & 340 in depth) was designed to provide 95% confidence level and 7.5% margin of error |
17 (NASDAQ: AUXL) Patients Seeking Treatment ~1,030,000 No Prior Surgery ~540,000 Had Surgery Previously ~490,000 Watchful Waiting ~270,000 Medical/ Surgical Treatment ~270,000 Medical/ Surgical Treatment ~125,000 Watchful Wait/ In Follow Up ~365,000 XIAFLEX Potential Candidates ~240,000 240,000 Dupuytren’s Candidates In U.S. & Europe 240,000 Dupuytren’s Candidates In U.S. & Europe Annually Annually Source: Auxilium research and analysis ~150,000 in U.S. ~ 90,000 in Europe Prevalence 3 – 6% of Population ~13,500,000 to 27,000,000 |
18 (NASDAQ: AUXL) XIAFLEX for Peyronie’s Disease XIAFLEX for Peyronie’s Disease • Patented through 2019 • Orphan Drug exclusivity for 7 years post approval I.P. position • Treated by urologists • Lacks good treatment options – PABA, Vitamin E, Verapamil ineffective – Surgery may shorten penis; cause scarring • Unmet need for non-surgical treatment Current treatment • Promising efficacy data from open label phase II studies. Statistically significant improvement vs. baseline was achieved in: –Correction of penile deviation (> 25% reduction in angle) –In sexual functioning Clinical status • Affects men predominantly over 50 Target population • Plaque or hard scar area on the penis • Deformity of the penis during erection precludes intercourse Disease description Source: Mulhall, J. et al, June 2004 |
19 (NASDAQ: AUXL) Peyronie’s Clinical Plan Peyronie’s Clinical Plan • Local effects / tolerability pre-clinical study outside of plaque requested by FDA. In life stage of animal study completed 4Q 2007. Expect to send final report to FDA in 1H 2008. • Phase IIb dose ranging study expected to begin in Q2 2008, pending FDA review of animal study results • Patient Reported Outcome Survey likely to be primary endpoint. We plan to validate of the Survey during a phase IIb study. • File as a Supplemental BLA for Peyronie’s indication. Will not be filed before Dupuytren’s BLA approved. |
20 (NASDAQ: AUXL) Market Research Performed – Market Research Performed – Peyronie’s Peyronie’s • Two rounds of quantitative primary research have been commissioned by Auxilium on XIAFLEX for Peyronie’s disease • A combined 575 Urologists have been interviewed to estimate market size (415 in U.S.; 160 in Europe) and 383 have given feedback on potential usage of XIAFLEX (223 U.S.; 160 Europe) • Second study (n=472 total & 333 in depth) was designed to provide 95% confidence level and 7.5% margin of error |
21 (NASDAQ: AUXL) Patients Seeking Treatment ~475,000 Surgery Not Recommended ~365,000 Watchful Waiting ~160,000 Medical or Intralesional Therapy ~205,000 Surgery Recommended ~110,000 XIAFLEX Potential Candidates ~210,000 210,000 Peyronie’s Candidates In U.S. and Europe 210,000 Peyronie’s Candidates In U.S. and Europe Annually Annually Source: Auxilium research ~135,000 in U.S. ~ 75,000 in Europe |
22 (NASDAQ: AUXL) XIAFLEX for Frozen Shoulder Syndrome XIAFLEX for Frozen Shoulder Syndrome • Arthroscopic procedure or surgery Current treatment • Early studies showed trend to efficacy and tolerability at highest dose (10,000 units) • Additional phase II studies needed to assess optimal dose, primary endpoints and dosing regimen Clinical status • Estimated 3% of people develop frozen shoulder syndrome over their lifetime – Higher incidence among patients with diabetes (10- 20%) vs general population (2-5%) – Higher incidence among patients with insulin- dependent diabetes (36%), with increased frequency of bilateral shoulder involvement – Market research indicates ~700,000 patients visit doctors in the U.S. every year • Most common in patients between 45 – 70 yrs Target population • Diminished shoulder motion, characterized by restriction in active and passive range of motion Disease description Source: Pearsall, A. Adhesive capsulitis. eMedicine. 2005 http://www.emedicine.com/pmr/topics372.htm |
Testim ® 1% Testosterone Gel: Near-Term Growth Driver Executing on Opportunities |
24 (NASDAQ: AUXL) Testim® Testim® is the Fastest Growing Testosterone is the Fastest Growing Testosterone Replacement Therapy Gel Replacement Therapy Gel • Proprietary, topical 1% testosterone gel – Once-a-day application – Favorable clinical and commercial profile • Comparative studies support advantages • Non-substitutable with Androgel • Broad prescription coverage • Growing prescriber loyalty |
25 (NASDAQ: AUXL) Male Hypogonadism (Testosterone Deficiency) Overview Male Hypogonadism (Testosterone Deficiency) Overview • Recent study indicates 39% of U.S. males over 45 yrs are hypogonadal – We estimate that less than 10% of affected population receives treatment • Diagnosis increasing through education and awareness Signs/symptoms – Brain Function Libido and erections Energy and vigor Cognitive function Sleep quality Irritability and depressed mood Signs/symptoms – Body Composition Muscle mass and strength Bone mineral density Male hair density and skin thickness Fat mass – abdominal obesity Source: Mulligan T. et al. Int J. Clin Pract 2006 |
26 (NASDAQ: AUXL) Clinical Results Show Testim Clinical Results Show Testim ® ® Changes Body Composition Improves Sexual Activity • Sexual Activity 59% • Statistically significant increases in sexual desire • Lean Body Mass 4.8 lbs • Fat Mass 4.0 lbs • Bone Mineral Density 2.6 % 12-month study Placebo-controlled study, 90-day results Source: Auxilium studies published in Journal of Clinical Metabolism & Review of Urology |
27 (NASDAQ: AUXL) Patient Benefits are Clinically Proven Patient Benefits are Clinically Proven Note: Adjusted geometric means (CV b %) of a single-dose (50 mg testosterone), randomized, complete crossover study of 29 hypogonadal men. Total Testosterone 2,000 3,000 4,000 5,000 6,000 Mean AUC 0-24 (ng*h/dL) Testim AndroGel Free Testosterone 0 50 100 150 200 250 Mean AUC 0-24 (ng*h/dL) Testim AndroGel • 16 clinical studies involving approx. 1,800 patients – largest placebo-controlled study ever conducted • Clinical trial of Testim ® vs. AndroGel ® – Testim provides 30% higher testosterone absorption (p<0.001) |
28 (NASDAQ: AUXL) Gels Fastest Growing TRT Segment Gels Fastest Growing TRT Segment Source: IMS data ($ in millions) Gel Patch Oral Injectables $35 $117 $200 $287 $340 $383 $449 0 100 200 300 400 500 600 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 $459 $399 $302 $210 $77 $59 $49 $499 $118 $568 Gel Segment Growth ($) Dec 2007 L12M: +25% Gel Segment Growth ($) Gel Segment Growth ($) Dec 2007 L12M: Dec 2007 L12M: +25% 2007 700 $685 $563 |
29 (NASDAQ: AUXL) $- $5 $10 $15 $20 $25 $30 0 20 40 60 80 100 120 Net Revs TRX Testim ® ® quarterly net revenues and scripts ($ in millions) Established Track Record of Consistent Growth Established Track Record of Consistent Growth Q4 2007 Net Revenues Y/Y Growth: +40% Q4 2007 Net Q4 2007 Net Revenues Revenues Y/Y Growth: Y/Y Growth: +40% Q4 2007 TRX Y/Y Growth: +32.4% Q4 2007 TRX Q4 2007 TRX Y/Y Growth: Y/Y Growth: +32.4% Source: Auxilium and IMS data |
30 (NASDAQ: AUXL) Testim Testim ® ® Driving Growth in Market Driving Growth in Market Source: IMS data Testim ® Share of TRx of Gel Market Strong market share with high-prescribing urologists & PCP’s; 39.2% gel market share of decile 8-10 Urologists and 29% share with decile 8 – 10 PCP’s in December 2007 1.0% 21.5% 0% 5% 10% 15% 20% 25% Mar-03 Dec-07 |
31 (NASDAQ: AUXL) • U.S. Testim ® patent (covering Hsieh Enhancers) expires in June 2008 • U.S. Patent # 7,320,968 covering method of use claims for Testim issued January 22, 2008; expires 2025 • Divisional application and continuations filed with USPTO in late 2007 with a plan to protect additional inventions and seek additional claims • New patent issued in Canada; expires 2023 • New patent issued in Europe; expires 2023 Note: The referenced Testim patents are owned by Bentley Pharmaceuticals, Inc. Testim Patent Coverage |
Financials / Strategic Priorities |
33 (NASDAQ: AUXL) YTD 2008 Q4 ’07 Dec ’07 Guidance Revenues $27.7 $95.7 $120-125 R&D Expense $14.5 $42.8 $52-56 SG&A Expense $18.9 $72.8 $88-92 Net Loss $11.9 $40.7 $44-48 Stock – Based Comp Expense $1.8 $6.0 $9-11 Cash & short term investments $76.1 2007 Financial Results and 2008 Guidance 2007 Financial Results and 2008 Guidance ($ Millions) ($ Millions) |
34 (NASDAQ: AUXL) Strategic Priorities Strategic Priorities • Continue Development of XIAFLEX with a plan to: – Complete dosing in CORD I and double blind portion of CORD II in Q1 2008, allowing for top line results to be announced in Q2 2008 & be prepared to file BLA in early 2009 – Initiate Phase IIb in Peyronie’s Disease in Q2 2008 – Continue market research activities; prepare commercial team – Continue development of XIAFLEX in Peyronie’s Disease and Frozen Shoulder Syndrome indications • Continue Driving Testim Growth |
35 (NASDAQ: AUXL) Fastest Growing TRT product in the U.S. Late Stage Company Transforming Product Poised for Growth + = |