Zegerid Capsules 20 mg and 40 mg Zegerid Powder for Oral Suspension 20 mg and 40 mg
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1 Nasdaq: SNTS
2 Safe Harbor This presentation may include forward-looking statements that are based on our management s beliefs and assumptions and on information currently available to our management. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans will be achieved. Actual results may differ materially from those set forth in this presentation due to the risks and uncertainties inherent in Santarus business, including, without limitation: Santarus ability to increase market demand for, and sales of, its Zegerid products; Santarus dependence on a number of third parties, such as Schering-Plough under the OTC license agreement, Otsuka America under the co-promotion agreement and inventiv under the contract sales agreement; Santarus ability to maintain patent protection for its products and to commercialize its products without infringing the patent rights of others, including the results of any proceedings related to the Paragraph IV certification by Par Pharmaceutical, Inc.; other difficulties or delays in development, testing, manufacturing and marketing of, and maintaining regulatory approvals for, Santarus products; Santarus ability to obtain additional financing as needed to support its operations; Santarus ability to generate revenues under its co-promotion agreements for Naprelan and Fleet Phospho-soda EZ-Prep products; and other risks detailed in Santarus public filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Santarus undertakes no obligation to revise or update this presentation. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of Santarus and Zegerid are registered trademarks of Santarus, Inc. Naprelan is a registered trademark of Elan Corporation, plc. Fleet is a trademark of C.B. Fleet Company, Incorporated and Phospho-soda, and EZ-Prep are trademarks of C.B. Fleet Inv estment Corporation. All other trademarks appearing in this presentation are the property of their respectiv e owners.
3 Santarus Highlights Developed and currently marketing Zegerid novel immediate-release omeprazole proton pump inhibitor (PPI) products for U.S. upper GI Rx market Zegerid Capsules 20 mg and 40 mg Zegerid Powder for Oral Suspension 20 mg and 40 mg Commercial expansion in 1Q 2007 to >500 sales representatives detailing Zegerid in primary detail sales position Concentrated commercial target of 26,000 gastroenterologists and primary care physicians who prescribed approximately one-third of the value of PPIs in 2006, or approximately $4.5 billion Co-promotion agreements to leverage sales organization Fleet Phospho-soda EZ-Prep Bowel Cleansing System signed in late August 2007 for GI market Naprelan Controlled Release Tablets launched in 3Q 2007 for primary care market Santarus sales representatives promoting Zegerid in first detail sales position and copromoted products in second detail sales position
4 Santarus Highlights Continued License agreement with Schering-Plough to leverage low dosage (20 mg) omeprazole products using Santarus patented PPI technology into $1+ billion OTC market $5 million milestone received in August 2007 for progress on clinical development strategy Strong intellectual property position for immediate-release PPI technology under license from U of Missouri Five issued U.S. patents expire in 2016 European patent granted in August 2007 with expiry in January 2021 Other patents issued in Australia, Mexico, New Zealand, Russia, Singapore, South Africa and South Korea Paragraph IV certification by Par Pharmaceutical on Zegerid Capsule Orange Book patents received in August 2007 Santarus has 45 days to commence patent infringement lawsuit that would result in stay of FDA approval of Par ANDA filing until the earlier of 30 months or a district court decision adverse to Santarus Santarus evaluating details of Paragraph IV certification
5 US PPI Prescription Market Delayed Release Brands $13.7 Billion LTM ending June 2007 (Delayed-Release Brands) AstraZeneca Prilosec $0.2B AstraZeneca Nexium $5.3B J&J Aciphex $1.3B Generic Omeprazole $0.6B TAP Prevacid $3.8B Wyeth Protonix $2.5B Source: IMS Health, National Sales Perspective Audit
6 US Monthly PPI Prescriptions 3,000,000 LTM Rx Growth for the Prescription PPI Market = 10.6%* 2,500,000 Nexium Generic Omeprazole TRx 2,000,000 1,500,000 Prevacid Protonix 1,000, ,000 Aciphex Prilosec OTC 0 Jun-05 Aug-05 Oct- 05 Dec-05 Feb-06 Apr-06 Jun-06 Aug-06 Oct- 06 Dec-06 Feb-07 Apr-07 Jun-07 Prilosec *Includes prescriptions for Prilosec OTC. LTM growth for branded, marketed prescription PPIs through 7/31/07 was 1.1%. Source: IMS Health, NPA Monthly (NGPS)
7 PPI Market Rolling 8-Week Comparison 8 Weeks Ending 8/17/07 Over Prior 8 Weeks 8.0% 6.0% 5.8% NRx TRx 4.0% 2.0% 1.6% 0.0% -2.0% -4.0% -3.8% -2.8% -1.5% -2.1% -4.1% -3.0% -3.8% -1.8% -3.2% -2.1% -6.0% Source: IMS NPA Weekly (NGPS) Aciphex Nexium Prevacid Protonix Zegerid DR Branded Rx PPI
8 PPI Market --Rolling 4-Week Growth 6.0% 4 Weeks Ending 8/17/07 Over Prior 4 Weeks 5.0% 4.7% 4.0% NRx TRx 4.1% 3.0% 2.0% 1.0% 0.0% -1.0% 0.0% -0.8% 0.0% -1.1% -0.1% -1.1% -0.2% -1.1% -2.0% -1.7% -1.9% -3.0% Source: IMS NPA Weekly (NGPS) Aciphex Nexium Prevacid Protonix Zegerid DR Branded Rx PPI
9 Unmet Clinical Needs Create Market Opportunities Zegerid Capsules First line therapy Unmet Clinical Needs Breakthrough heartburn 50% of GERD patients Nocturnal heartburn 79% of GERD patients Other Market Opportunities 1/3 of GERD visits are first-time visits PPI switching rate ~15-20%
10 Zegerid Marketed Products Products Indications Est. U.S. Prevalence Zegerid Capsules* Heartburn/GERD 54 million adults Erosive esophagitis Duodenal & gastric ulcers 16 million adults (~30% of GERD patients) 14 million adults Zegerid Powder for Oral Suspension* Reduction of risk of upper GI bleeding in critically ill patients (powder for oral suspension only) 1.5 million high-risk, critically ill ventilated patients *Zegerid Capsules and Powder for Oral Suspension are available in 20 mg and 40 mg dosage strengths
11 Effect of of Zegerid Antacid on ph Antacid buffer raises ph to >7 within 1 minute ph kinetic (acid infusion) in vitro model: Effect of 20 meq sodium bicarbonate ph ph 6.5 ph 6.0 ph 5.0 ph Time (minutes) Rapidly increases ph to 6.5 and maintains it for about 30 minutes 38
12 Zegerid Immediate-Release Profile Mean Plasma Omeprazole Concentrations Following a Morning Dose of Zegerid Powder for Oral Suspension and Prilosec on Day 1* Plasma Omep razole (ng/ml Zegerid Immediate-Release 20 mg Prilosec Delayed-Release 20 mg Plasma Omeprazole (ng/ml) Zegerid Immediate-Release 40 mg Prilosec Delayed-Release 40 mg mg: n=35 40 mg: n= Hours Hou rs *Peak blood levels reached in 30 minutes vs. 1½ - 2 hours Zegerid Capsules show similar effects in general as the powder for oral suspension Castell D., Expert Opin Pharmacother, 2005; 6:
13 Upper GI GI Products/Mechanisms ANTACIDS Neutralize existing acid Work quickly but produce only short term relief STOMACH ACID (HCL) Parietal Cell PROTON PUMP INHIBITORS Irreversibly bind to acid producing proton pumps and inhibit acid production regardless of pathway PROTON PUMPS ACETYLCHOLINE H 2 RECEPTOR ANTAGONISTS Block only 1 of 3 acid stimulating pathways HISTAMINE GASTRIN
14 Zegerid Suspension Duration of of Effect Time Gastric ph > 4 Over 24 Hours Product Zegerid Suspension Nexium Prevacid Aciphex Protonix Time Gastric ph > hrs (40 mg) 16.8 hrs (40 mg) 15.8 hrs (30 mg) N/A N/A Time Gastric ph > hrs (20 mg) 12.7 hrs (20 mg) 11.7 hrs (15 mg) 14.4 hrs (20 mg) N/A Zegerid Capsules show similar effects in general as the powder for oral suspension Source: Zegerid Package Insert, Nexium Package Insert, Prevacid Package Insert, Aciphex Package Insert, Protonix Package Insert
15 Zegerid Suspension Positive Data in in Nighttime Acid Control Positive data in controlling nighttime acid differentiates Zegerid from delayed-release PPIs One trial included Zegerid, Prevacid and Nexium dosed at bedtime and evaluated control of nighttime acid A second trial included Zegerid and Protonix in nighttime acid control using different dosing regimens Data from both trials were presented at medical meetings and have been published in peer-reviewed journals
16 Zegerid Suspension Rapid Control of of Acid with Bedtime Dosing Rapid Release Zegerid ph>4 within 15 Minutes 10:15 PM Bedtime dosing at 10 pm for all 3 PPIs Zegerid reached ph>4 1:15 AM Nexium reached ph>4 3:15 AM Prevacid reached ph>4 10 PM 11 PM 12 AM 1 AM 2 AM 3 AM 4 AM Time at which the median number of subjects first reached gastric ph>4 (measured from 10 pm to 4 am) after daily bedtime dosing at steady state on Day 7 Katz et al, Gastroenterology 2006;130(2):A175
17 Zegerid Suspension -- Control of of Nighttime Acid Median Percentage of Time with Gastric ph>4 Percentage of time ph> Zegerid 40 mg Powder for Oral Suspension P = NS 47 Nexium 40 mg Capsule P < vs Prevacid 27 Prevacid 30 mg Capsule Measured from 10 pm to 4 am after daily bedtime dosing (10 pm) at steady state on Day 7 Katz et al, Gastroenterology 2006;130(2):A175
18 Nighttime Cumulative Integrated Gastric Acidity (IGA) in in NAB Study days of once-daily dosing at 10:00 pm Cumulative IGA (mmol*hr/l) 242.2* 215.1* 182.0* Prevacid 30 mg * 85.5* 103.9* 134.6* 135.0* Nexium 40 mg Zegerid (SUSP) 40 mg *p<0.05 All pairwise comparisons vs Zegerid (n=49) Katz et al, Gastroenterology 2006;130(2):A175
19 Zegerid Suspension Nighttime Acid Control Under Different Dosing Regimens Nighttime Median Gastric ph for 8 Hours Measured on Day 6 or Day Zegerid Protonix 4.7 * Dosing Regimen 1: Zegerid at bedtime Protonix pre-dinner Gastric ph * 1.5* 1.7* Regimen 1 Regimen 2 Regimen 3 (n=32) (n=17) (n=32) Dosing Regimen 2: Zegerid & Protonix in morning and at bedtime Dosing Regimen 3: Zegerid at bedtime Protonix in morning and at bedtime *p<0.001 when compared with Zegerid Castell et al, Aliment Pharmacol Ther 2005; 21;
20 Zegerid Marketing Message Rapid Release. Continued Control. Zegerid is the only oral PPI that combines immediate release with the power of continued acid control Zegerid s distinct drug profile Maximal plasma levels in ~30 minutes Median gastric ph>4 ranging from 12.2 to 18.6 hours depending on dose and formulation Nighttime and daytime acid control Extensive managed care coverage
21 Zegerid Commercial Team 2007 Santarus Commercial Organization 210 sales reps internally Experienced national and regional account managers call on managed care >250 in commercial organization Otsuka America Co-promotion Agreement 170 experienced sales reps On board since November 2004 inventiv CSO Agreement Adds 140 sales reps Trained and in territories 1Q 2007 Santarus sales management provides sales direction to inventiv reps Allows for increased frequency of Zegerid calls on targeted physicians
22 Commercial Managed Care Preferred Formulary Status July % 70% 60% 50% 40% 30% 20% 10% Percent of ~197 Million Formulary Lives Zegerid Capsule WAC Price = $3.58* per dose, 18% less than Nexium 0% Zegerid Aciphex Nexium Prevacid Protonix Source: MediMedia July 2007 Data *WAC price effective
23 Weekly Prescribers of of Zegerid 40 mg Suspension Capsule Number of MDs 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1,000 - Dec- 04 Feb- 05 Apr- 05 Jun-05 Aug- 05 Oct - 05 Dec -05 Feb- 06 Apr- 06 J un- 06 Aug- 06 Oct -06 Dec- 06 Feb- 07 Apr- 07 Jun- 07 Aug- 07 Source: WKHealth
24 Zegerid Capsules Monthly NRx and TRx Zegerid Capsules Monthly NRx and TRx TRx NRx Mar-06 Apr-06 May-06 Jun-06 Jul-06 Aug-06 Sep-06 Oct-06 Nov-06 Dec-06 Jan-07 Feb-07 Mar-07 Apr-07 May-07 Jun-07 Jul-07 Source: IMS NPA/NGPS TRx (Retail & Mail Order) Number of Prescriptions
25 Zegerid Brand -- Total Monthly Prescriptions 80,000 70,000 Capsule Suspension Number of Prescriptions 60,000 50,000 40,000 30,000 20,000 10,000 0 Jan- 05 Mar- 05 M ay- 05 Jul- 05 Sep- 05 Nov- 05 Jan- 06 Mar- 06 M ay- 06 Jul- 06 Sep- 06 Nov- 06 Jan- 07 Mar- 07 May- 07 Jul- 07 Source: IMS NPA/NGPS TRx (Retail & Mail Order)
26 Commercialization of of Zegerid Brand PPI market has evolved into higher dose Rx and lower dose OTC markets 96% of Zegerid Capsule prescriptions are at the 40 mg dosage strength and majority of other branded PPI Rx business is at higher dosage strength Nexium Capsules 40 mg Prevacid Capsules 30 mg Protonix Tablets 40 mg 96% of scripts 94% of scripts 99% of scripts Lower dosage strength business is shifting to OTC market where Zegerid does not currently participate Entry into the OTC market may leverage Zegerid brand and gives Santarus access to new, growing low dosage market
27 OTC License Agreement with Schering-Plough Santarus granted rights to Schering-Plough to develop, manufacture and commercialize low-dose (20 mg) omeprazole products using Santarus patented PPI technology for OTC market in U.S. and Canada $15 million upfront fee to Santarus in 4Q 2006 $5 million milestone received in August 2007 Potential for additional $60 million in milestone payments Low double-digit royalty on net sales* Santarus continues to promote Zegerid 20 mg and 40 mg in U.S. prescription market * Santarus is obligated to pay royalties to U of Missouri on net sales of licensed OTC products
28 Fleet Phospho-soda EZ-Prep Co-promotion Agreement Signed co-promotion agreement with C.B. Fleet in late August 2007 for Fleet Phospho-soda EZ-Prep Bowel Cleansing System Fleet Phospho-soda EZ-Prep is an OTC product for bowel preparation for GI procedures Santarus sales representatives will commence promoting Fleet Phospho-soda EZ-Prep to targeted GI physicians and medical staff in second detail sales position in 4Q 2007 Zegerid continues to be promoted in primary detail sales position Santarus eligible for co-promotion fees of up to approximately $3 million over one-year term Santarus receives a set fee per call, subject to minimum and maximum number of calls Opportunity to earn bonus payments if unit sales exceed predetermined baselines Sampling and sales promotion expenses for Fleet Phosphosoda EZ-Prep to be borne by Fleet
29 Naprelan Co-promotion Agreement Signed co-promotion agreement with Victory Pharma in late June 2007 for Naprelan (naproxen sodium) Controlled Release Tablets Naprelan is a once-daily NSAID indicated for treatment of a number of conditions including arthritis and relief of mild to moderate pain Santarus sales representatives commenced promoting Naprelan to targeted primary care physicians in second detail sales position in 3Q 2007 Zegerid continues to be promoted in primary detail sales position Santarus will receive a percentage of the net sales value of prescriptions generated by Santarus targeted physicians Sampling and sales promotion expenses for Naprelan to be borne by Santarus
30 Financial Highlights (unaudited) Three Months Ended June 30, Six Months Ended June 30, ($ millions) Except per share amounts Product sales, net $ 18.8 $ 8.7 $ 35.8 $ 14.5 Total revenues Total costs & expenses Net loss $ (12.9) $ (16.7) $ (29.4) $ (36.6) Net loss/share $ (0.25) $ (0.36) $ (0.58) $ (0.80) Cash, cash equivalents & short-term investments: $52.4 million at June 30, 2007 Committed equity financing facility of up to additional 3.5 million shares (subject to certain conditions) and $20.0 million revolving line of credit Santarus plans to continue to invest in activities to build the Zegerid brand
31 Future Milestones Working with recently expanded sales team to promote Zegerid brand as the only immediate-release oral PPI in $13+ billion U.S. PPI market Continue to focus on gaining key managed care formulary wins for Zegerid brand Execute on two co-promotion agreements to generate incremental revenue and contribute to bottom line Seek additional product opportunities to leverage commercial organization Evaluate opportunities to license immediate-release PPI technology for ex-u.s. markets
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