Nasdaq: SNTS. January 11, 2010

Transcription

1 Nasdaq: SNTS January 11, 2010

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, Zegerid and Glumetza brand products; Santarus ability to maintain patent protection for its products, including the timing and outcome of the Zegerid and Glumetza patent infringement lawsuits; risks related to the development programs for budesonide MMX and rifamycin SV MMX ; Santarus ability to generate revenue under its strategic alliances with Schering-Plough HealthCare Products, GlaxoSmithKline and Norgine; other difficulties or delays in development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus 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, Zegerid and Zegerid OTC are trademarks of Santarus, Inc. MMX is a trademark of Cosmo Technologies Limited. Glumetza is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the U.S. to Depomed, Inc. All other trademarks appearing in this presentation are the property of their respective owners. January 11,

3 Santarus Overview Specialty biopharmaceutical company Acquiring, developing and commercializing proprietary products Focus on needs of patients treated by gastroenterologists and other selected physicians 2 marketed products Zegerid & Glumetza Leveraging our immediate-release PPI technology Schering-Plough HealthCare Products Zegerid OTC in North America GlaxoSmithKline - Ex-U.S. license (>100 countries) for Rx and OTC Norgine - Ex-U.S. license in Europe for Rx 2 late-stage product candidates focused on lower GI - budesonide MMX and rifamycin SV MMX 70% 3-year revenue CAGR ( ) January 11,

4 Milestones Achieved in 2009 Zegerid OTC NDA approved; $20 million milestone earned from Schering-Plough Immediate-release omeprazole Rx tablet NDA approved Completed patient enrollment in European Phase III clinical study and 80% enrolled in U.S. Phase III clinical study for budesonide MMX Submitted IND to begin Phase III clinical study for rifamycin SV MMX Reported 36% product-related revenue growth YTD September 2009 Achieved three consecutive profitable quarters; $7.6 million net income YTD September 2009 Licensed Zegerid immediate-release PPI technology for Europe Ranked number 23 fastest growing company in North America on Deloitte 2009 Technology Fast 500 January 11,

5 Santarus Portfolio and Pipeline Drug Partner Ph I Ph II Ph III NDA Marketed Zegerid Capsules & Powder for Oral Susp. (Rx - US) Glumetza (Rx - US) Zegerid OTC TM (US) IR omeprazole tablet (Rx - US) Zegerid Rx & OTC (Rights in 114 countries)*** Zegerid RX (Europe) Depomed Schering-Plough GSK Norgine * ** Budesonide MMX (US) Cosmo Rifamycin SV MMX (US) Cosmo *NDA approved December 1, 2009 **NDA approved December 4, 2009 ***GSK currently promotes Zegerid Rx products in Puerto Rico and USVI. January 11,

6 Key Elements of Santarus Business Strategy Increasing sales of Zegerid and Glumetza brand prescription products Maximizing the value of our proprietary proton pump inhibitor (PPI) technology Advancing development of our lower GI product candidates Expanding our product portfolio to further leverage our commercial capabilities Through internal development or co-promotion, in-licensing or acquisition of proprietary marketed or development-stage products January 11,

7 Zegerid (omeprazole/sodium bicarbonate) First and only immediate-release oral PPI Zegerid * differentiation demonstrated in daytime and nighttime acid control in pharmacodynamic clinical studies: was significantly faster and significantly better in controlling gastric acidity than Prevacid and Protonix with 7 continuous days of dosing (n=51) had more rapid control of nighttime acid vs Nexium and Prevacid on day 7 (n=49) had fewer episodes of nocturnal acid breakthrough vs Protonix on day 6/7 (n=32) $31.5 million net sales in 3Q 2009, up 12% over 3Q 2008 Prescription growth of 6% in 3Q 2009 over 3Q 2008 Improvement in average selling price vs prior year New immediate-release tablet formulation approved on 12/4/09 PDUFA date 6 issued U.S. patents expire in mid-2016 Patent infringement litigation ongoing against Par Pharmaceutical *Please see for full prescribing and safety information January 11,

8 Branded PPI Market Rolling 12-Month Comparison 15% 10% 12 Months Ending 11/30/09 Over Prior 12 Months NRx TRx 9.2% 5% 3.0% 1.4% 4.9% 0% -5% -10% -15% -20% -9.0% -11.6% -14.7% -16.8% Aciphex Nexium Prevacid * Zegerid Source: IMS NPA Weekly (NGPS) January 11, 2010 *Prevacid lost patent exclusivity as of November 10,

9 Glumetza (metformin hydrochloride extended release tablets) Once-daily, extended-release metformin 500 mg & 1000 mg tablets Indicated for adults with type 2 diabetes Adjunct to diet and exercise to improve glycemic control Designed to reduce GI side effects Potential to achieve optimal level of glycemic control with fewer discontinuations of therapy Titration to 2000 mg/day with fewer GI side effects than immediate-release metformin $6.8 million promotion revenue in 3Q 2009, up 20% over 2Q % quarterly sequential growth in 3Q 2009 for total prescriptions in 500 mg equivalents Four U.S. patents expire in 2016, 2020 & 2021 Depomed has patent infringement litigation ongoing against Lupin Limited *Please see for full prescribing and safety information including a Black Box warning. January 11,

10 Glumetza - Santarus Promotional Effect 2,600 Glumetza Weekly NRx Trends 2,400 2,200 2,000 1,800 Thanksgiving 1,600 Christmas 1,400 1,200 1, Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec-09 NRx Glumetza NRx (Pre-Santarus Promotion) Glumetza NRx (With Santarus Promotion) Source: IMS NPA Weekly through December 25, 2009 January 11,

11 Glumetza Current Market Share Trends Glumetza Branded Metformin Weekly Market Share Trends 40.0% 35.0% 30.0% 25.0% 20.0% 15.0% 10.0% 25.1% 22.8% 5.0% 0.0% Aug-06 Oct-06 Dec-06 Feb-07 Apr-07 Jun-07 Aug-07 Oct-07 Dec-07 Feb-08 Apr-08 Jun-08 Aug-08 Oct-08 Dec-08 Feb-09 Apr-09 Jun-09 Branded Metformin Market Share Aug-09 Oct-09 Dec-09 TRX Share - Branded Met NRX Share - Branded Met Source: IMS NPA weekly through December 25, 2009 January 11, % 34.7%

12 Glumetza - Source of New Business Rolling 3 months through October 2009 Switch to 43% Add on 14% New therapy starts 43% Source: IMS Market Dynamics January 11,

13 Santarus Field Organization Field Organization 200 Santarus sales reps 100 inventiv sales reps Regional/District sales management Account managers Scientific affairs liaisons Trade relations Customers Gastroenterologists Endocrinologists Selected Primary Care Physicians MCOs, PBMs, Gov t National & Regional KOLs Wholesalers, Chains Capacity available for additional marketed products January 11,

14 Santarus Strategy Maximizing PPI Technology Schering-Plough HealthCare Products license agreement for 20 mg Zegerid OTC in North America December 1, 2009 FDA approval received - $20 million milestone earned Potential for $37.5 million in sales milestones and low double-digit royalty GSK license agreement for Rx and OTC in >100 countries Submission of NDAs commenced in 2009; Clinical Trial Application submitted in China More submissions expected in 2010 Tiered royalties from mid-teens to mid-twenties PPI sales of $2.6 billion growing at ~20% in covered territories Norgine license agreement for Rx Zegerid in Europe $2.5 million upfront upon signing in October 2009 Up to $10 million in regulatory milestones and tiered royalties in mid- to high-teens Regulatory pathway in Europe to be determined January 11,

15 Santarus Strategy Advancing Lower GI Pipeline Strategic collaboration with Cosmo for late-stage lower GI product candidates using MMX, a proprietary drug delivery technology Budesonide MMX - Phase III studies ongoing in ulcerative colitis Rifamycin SV MMX - Expect to start first Phase III study in 1H 2010 MMX technology delivers drugs directly to colon, offering potential for efficacy with fewer side-effects typically associated with systemic absorption Budesonide MMX and rifamycin SV MMX are GI products with attractive commercial potential and focused promotional efforts January 11,

16 Late-stage Development Pipeline Budesonide MMX In Phase III development for induction of remission for mild or moderate active ulcerative colitis January 11,

17 Budesonide MMX Budesonide Non-halogenated glucocorticoid Greater topical anti-inflammatory activity with less systemic absorption versus other glucocorticoids due to high first pass metabolism Budesonide MMX Extended release formulation that releases budesonide throughout the entire colon at a controlled rate utilizing the MMX delivery system technology Clinical program includes two Phase III clinical studies to support European and U.S. regulatory submissions for induction of remission for mild or moderate active ulcerative colitis plus a 12-month extended use study Top-line data expected in 1H 2010 for European study and in 2H 2010 for U.S. study Completion of extended use study expected in 1H 2011 Santarus has license for U.S. rights January 11,

18 MMX Technology Targets Entire Colon 1h 30m duodenum 4h 30m ascending colon 7h 30m transverse colon 10h transverse colon 16h descending colon 24h rectum Pharmaco-Scintigraphy Using Isotopes January 11,

19 Inflammatory Bowel Disease An estimated 1.2 million people in U.S. have IBD ~730,000 with ulcerative colitis ~480,000 with Crohn s disease There is no known cure for ulcerative colitis Symptoms include rectal bleeding, abdominal pain, increased stool frequency, loss of appetite, fever and weight loss Goal is to manage symptoms 5-ASAs are currently used as first-line treatment Patients may be in remission and then will flare, requiring additional therapy to induce remission again Up to 30% of ulcerative colitis patients require treatment with steroids Duration of steroid therapy currently limited due to systemic side effects January 11,

20 Selected Treatments for IBD in the U.S. $1.6 billion IMS Sales (12 months through 11/30/09) Generics and other 5-ASAs $114M Prometheus Entocort EC $221M P&G Asacol $665M Shire Pentasa $230M Shire Lialda $233M Axcan Canasa $94M Source: IMS Health, National Sales Perspective Audit January 11,

21 Budesonide MMX vs. Entocort EC Delivery Mechanism Both are non-systemic corticosteroid oral formulations; Budesonide MMX is targeted to the colon Budesonide MMX MMX delivery engineered for release throughout entire colon Entocort EC Enteric-coated granules dissolve in the intestine Patients 730,000 (Ulcerative Colitis) 480,000 (Crohn s Disease) Dose / Indication Sales / Potential Patent Expiry mg tablet once daily for induction* $150MM-$250MM (Estimated peak sales) 3 x 3 mg capsule once daily for induction, 2 x 3 mg once daily for maintenance $221MM (IMS - MAT 11/30/09) 2011/2015 *Subject to FDA approval January 11,

22 Budesonide MMX Phase III Clinical Program Initial indication: induction of remission for mild or moderate active ulcerative colitis Two Phase III studies being conducted under Special Protocol Assessments approved by the FDA Enrolling ~1,000 patients overall in U.S. and European clinical studies Each induction clinical study has four arms and 8-week course of treatment Budesonide MMX at 6 mg once-daily Budesonide MMX at 9 mg once-daily Placebo Reference arm with comparator drugs (Asacol in U.S. and Entocort EC in Europe) Up to 150 patients in a 12-month extended use study requested by FDA Top line data expected: 1H 2010 European induction study (Enrollment completed in December) 2H 2010 U.S. induction study (~ 80% enrolled) 1H 2011 Extended use study (Enrollment ongoing) Assuming successful completion of Phase III studies and extended use study, plan to submit NDA in 2H 2011 January 11,

23 Late-stage Development Pipeline Rifamycin SV MMX Expect to begin Phase III study in patients with travelers diarrhea in 1H 2010 January 11,

24 Rifamycin SV MMX Profile Broad-spectrum antibacterial activity, including C. difficile 20 year history of use of rifamycin SV in Europe in IV/IM forms MMX is an oral tablet form that selectively delivers to the colon Negligible systemic absorption (<1%) Good safety & tolerability profile (from 400mg to 1200mg daily) Clinical activity in infectious diarrhea appears comparable to Xifaxan No clinically relevant bacterial resistance observed No known drug interactions Easy to use (b.i.d. for 3 days in Travelers Diarrhea)* *Subject to FDA approval January 11,

25 Travelers Diarrhea An estimated million people each year are affected by Travelers Diarrhea (TD) 40%-60% of travelers from developed countries visiting developing countries for a period of 2-3 weeks will be affected by TD 100% of travelers living with locals: Peace Corps volunteers, students High risk areas include Latin America, Africa, Southeast Asia TD is characterized by three or more loose stools over a 24-hour period TD may also be associated with fever, abdominal cramping, nausea and vomiting Roughly 80% of TD cases are caused by bacterial enteropathogens January 11,

26 Phase III Clinical Development Plan Clinical Studies Phase III US First of two randomized, double-blind, multicenter, parallel group clinical studies to assess the efficacy and safety of Rifamycin SV MMX 800 mg vs. placebo in the treatment of patients with travelers diarrhea Approximately 300 patients per study Phase III EU (Dr. Falk Pharma) Randomized, double-blind, multicenter, parallel group clinical study to assess the efficacy and safety of Rifamycin SV MMX 800 mg vs. Ciprofloxacin 1000 mg in the treatment of patients with travelers diarrhea >700 patients Status IND submitted Anticipate 1H 2010 start for first clinical study Anticipate 1H 2010 start January 11,

27 Rifamycin SV MMX vs. Xifaxan Delivery Mechanism Both are non-systemic antibiotic oral formulations initially targeted for treatment of Travelers Diarrhea (TD), with potential for other indications Rifamycin SV MMX Xifaxan MMX delivery engineered for release in the colon Film-coated tablet; no specific delivery system TD Patients 10MM-16MM 10MM-16MM Dose / Indication 2x 200 mg tablet b.i.d. for TD* 200 mg tablet t.i.d. for TD Sales / Potential Patent Expiry Potential Indications $50MM-$150MM (Est. peak sales) 2020/2025 (application pending) Diverticulitis, HE, IBD, CDAD *Subject to FDA approval $106MM (IMS MAT 11/30/09) 2024 HE, IBS, CD, CDAD January 11,

28 Continued Improvement in Financial Results Total Revenue Net Loss $140 $120 $100 License & royalty revenue Promotion revenue Product sales, net $94 $130 $90 $80 $70 $60 $83 $65 $56 $ Millio ns $80 $60 $40 $27 $49 $ Millions $50 $40 $30 $20 $44 $19 $20 $10 $0 $ $ January 11,

29 Third Sequential Profitable Quarter in 2009 (Unaudited) ($ millions) Except per share amounts Three Months Ended Sept 30, Product-related revenue $ 38.3 $ 29.5 $ $ 76.3 Total revenues * Total costs & expenses Net income (loss) $ 5.3 $ (4.0) $ 7.6 $ (8.4)* Net income (loss)/ share $ 0.09 $ (0.08) $ 0.13 $ (0.16) Cash, cash equivalents & short-term investments: $61.8 million at September 30, 2009 Positive cash flow from operations of $4.3 million in 3Q09 and $5.3 million for the nine months ended September 30, 2009 $20 million milestone received in 4Q09 for approval of Zegerid OTC January 11, Nine Months Ended Sept 30, *Included $2.5 million milestone and $5.7 million of amortization of deferred revenue associated with termination of a co-promotion agreement, with no offsetting expense, that positively impacted net income

30 Future Milestones Continue to grow sales of the Zegerid brand as the only immediaterelease oral PPI in $14 billion U.S. PPI prescription market Work to increase Glumetza prescription demand Seek to diversify sources of revenue through strategic relationships Schering-Plough s Zegerid OTC approved in December 2009; launch anticipated 1H 2010 Advance the development of pipeline product candidates Complete budesonide MMX Phase III clinical program; assuming successful completion of clinical program, plan to submit NDA in 2H 2011 IND filed - expect to initiate first Phase III clinical study for rifamycin SV MMX in 1H 2010 Maintain focus on managing our business Control costs and preserve capital while pursuing growth initiatives January 11,

31 Execution of Strategies Revenue Growth Drivers Glumetza Zegerid Budesonide MMX * Rifamycin SV MMX * Ex-US Zegerid* Zegerid OTC Glumetza Zegerid MMX product candidates focused on gastroenterologists, a relatively small specialty group OTC and ex-us royalties and milestones diversify and grow revenue without adding infrastructure Zegerid and Glumetza revenue covers infrastructure costs *Subject to regulatory approval January 11,