Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - SANTARUS INC | c19024e8vk.htm |
Exhibit 99.1
| NasdaqGS: SNTSJune 22, 2011 |
| 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 generate sales of Glumetza(r) and Cycloset(r) brand products; risks related to Santarus' product development programs; Santarus' ability to generate revenue under its strategic alliances with Merck, GSK and Norgine; Santarus' ability to continue to generate revenues from branded and authorized generic Zegerid(r) prescription products; Santarus' ability to maintain patent protection and data exclusivity for its products and product candidates; other difficulties or delays in the 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 1995. Santarus(r), Zegerid(r) and Zegerid OTC(r) are trademarks of Santarus, Inc. MMX(r) is a trademark of Cosmo Technologies Limited. Glumetza(r) is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the U.S. to Depomed, Inc. Rhucin(r) and RuconestTM are trademarks of Pharming Group NV. Cycloset(r) is a trademark of VeroScience LLC. All other trademarks appearing in this presentation are the property of their respective owners. June 22, 2011 2 |
| Santarus - Investment Rationale 2 differentiated commercial products for adults with type 2 diabetes - combined peak sales potential of $300M to $400M (Glumetza(r) and Cycloset(r))2 late-stage development products (budesonide MMX(r) and Rhucin(r)) with combined peak sales potential of ~$500 millionConfirming plans to submit budesonide MMX NDA by year-end following recent pre-NDA meetingTwo placebo-controlled studies completed with Rhucin and a confirmatory Phase III study has been initiated2 additional development products (Rifamycin SV MMX(r) and SAN- 300) in clinical testingFocus on proprietary products for physician specialists and balancing investments in R&D and SG&A to achieve meaningful, sustainable growth in revenues and profits June 22, 2011 3 |
| Santarus Offers Attractive Mix of Commercial & Development Opportunities Development Opportunities Development Opportunities *Zegerid(r) is a non-promoted prescription product that continues to generate revenue. In addition, Zegerid OTC(r) is promotedby Merck Consumer Care. GlaxoSmithKline and Norgine have rights to Zegerid in certain territories outside the U.S. Plan to submit NDA by end of 2011 Phase III study (TD ) in progress Phase III in progress Phase II to begin in 2011 Phase I started in March 2011 - RA is first targeted indication June 22, 2011 4 |
| Specialty Focus - Leverage Commercial Investment Sales Reps Physician Specialist Today Near Term Long Term Products & Product Candidates 110 Endocrinologists X Glumetza(r)Cycloset(r) +80 Gastroenterologists X Budesonide MMX(r)Rifamycin SV MMX(r)SAN-300 +25 Allergists/Immunologists X Rhucin(r)SAN-300 +30 Rheumatologists X SAN-300 June 22, 2011 5 |
| Financial Focus - Increase Shareholder Value Sales per Rep Revenue SG&A as % RevenueR&D as % Revenue Profits & Cash Flow June 22, 2011 6 |
| Glumetza(r) (metformin hydrochloride extended release tablets)* Once-daily, extended-release metformin 500 mg & 1000 mg tabletsIndicated for adults with type 2 diabetesAdjunct to diet and exercise to improve glycemic controlDesigned to reduce GI side effects1Q 2011 promotion revenue of $10.3 million ($15.3 million net product sales)Five U.S. patents expire in 2016, 2020, 2021 & 2025Depomed has patent infringement litigation ongoing against Lupin Limited and Sun Pharmaceutical Industries * Please see www.Glumetzaxr.com for full prescribing and safety information including a Black Box warning. * Please see www.Glumetzaxr.com for full prescribing and safety information including a Black Box warning. June 22, 2011 7 |
| Weekly Glumetza(r) Script Performance Source: IMS NPA Weekly (NGPS) 8 June 22, 2011 (CHART) Through week ending June 10, 2011 |
| Cycloset(r) (bromocriptine mesylate) Tablets* Cycloset(r) (bromocriptine mesylate) Tablets* First and only centrally acting dopamine agonist oral antidiabeticQuick-release formulation of bromocriptine mesylateIndicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetesDemonstrated in Cycloset clinical program:Consistent glycemic controlCardiovascular safety profileOverall safety profileFive Orange Book listed patents expire in 2012, 2014 and 2015 * Please see www.Cycloset.com for full prescribing and safety information Commercial launch in November 2010 June 22, 2011 9 |
| Cycloset(r) Prescriber and Prescription Trends June 22, 2011 10 Prescriptions normalized to 120 pills per Rx Source: IMS Health, Weekly NPA and Xponent Weekly Through week ending June 10, 2011 |
| Cycloset(r) Improves HbA1c When Added to Other Agents HbA1c changes from baseline to week 24 0.6% to 0.9% HbA1c reductions when added to other oral antidiabetics* Efficacy data in combination with thiazolidinediones (TZDs) are limited. Efficacy has not been confirmed in combination with insulin. *Findings from a 52-week, randomized controlled trial to evaluate the safety and efficacy of Cycloset. Data shown are from a prospective 24-week assessment for treatment differences from baseline to week 24 in HbA1c . June 22, 2011 11 |
| Cycloset(r) Controls Glucose Throughout the Day 2-hour postprandial plasma glucose (PPG) levels at week 24: change vs. placebo* All PPG levels (mg/dL) were significantly lower vs placebo (p<.05)* Findings from a 24-week, placebo-controlled, monotherapy trial that evaluated the efficacy and safety of Cycloset as an adjunct to diet and exercise in 159 overweight adults with type 2 diabetes and inadequate glycemic control Once-daily dosing of Cycloset provided significant PPG reductions - without increasing plasma insulin concentrations* June 22, 2011 12 |
| Cycloset(r) Demonstrated Cardiovascular Safety Profile Cycloset(r) Demonstrated Cardiovascular Safety Profile In a 3,070 patient, 52-week safety study, Cycloset use was not associated with an increased risk for adverse cardiovascular events 55% relative risk reduction for MACE* endpoint vs placebo. Hazard ratio=0.45 (95% CI, 0.205-0.9996); p=0.0459 There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Cycloset or any other antidiabetic drug. Cycloset does not increase the risk of macrovascular events. *MACE (major adverse cardiovascular events): supplementary analysis of composite endpoint of time to first MI, stroke or CV death. June 22, 2011 13 |
| Attractive Late-stage Product Candidates Budesonide MMX(r)Two Phase III studies completed for the induction of remission of mild or moderate active ulcerative colitis Extended use study completed (last patient last visit) in May 2011; top- line data in 2H 2011Plan to submit NDA by end of 2011 following recent pre-NDA meeting with FDARhucin(r) (recombinant human C1 inhibitor)Two placebo-controlled studies completed in hereditary angioedema (HAE)Phase III clinical study in HAE required for BLA submission initiated in 1Q 2011Phase II proof-of-concept in solid organ transplantation to begin in 2011 Combined peak sales potential of ~$500 million June 22, 2011 14 |
| Selected IBD Branded Promoted Products - US TRx Growth and IMS Sales GrowthMay '10 - April '11 LTM Total TRx = 3.7 million LTM Total IMS Sales = $1.9 billion (CHART) (CHART) June 22, 2011 15 |
| IBD Therapy - Pill Burden Asacol(r)/ Asacol(r) HD (TID) + +Entocort(r) EC (QD) Lialda(r) (QD) Pentasa(r) (QID) + + + Budesonide MMX(r)* (QD) Product Pills Per Day(induction of remission) *Budesonide MMX is an investigational product and is not FDA approved June 22, 2011 16 |
| Budesonide MMX(r) Phase III Clinical Studies Over 1000 patients enrolled across four treatment arms in two Phase III clinical studies for the induction of remission in mild or moderate active ulcerative colitis12-month extension study completed (last patient last visit) in May 2011; top-line data 2H 2011Pre-NDA meeting has been heldPlan to submit NDA at end of 2011Patent expiry in 2020~$300 million U.S. peak sales estimated June 22, 2011 17 |
| (CHART) (CHART) Budesonide MMX(r) 9 mg - Positive Results in Induction of Remission of Active Ulcerative Colitis U.S. Phase III Clinical Study E.U. Phase III Clinical Study 7.4% 13.2% 12.1% 4.5% 17.4%+ 8.3% 12.6%+- Placebon=121 PlaceboN=89 Bud MMX(r) 9mgn=123 Bud MMX(r) 9mgN=109 Bud MMX(r) 6mgn=121 Bud MMX(r) 6mgN=109 Asacol(r)(a)n=124 Entocort(r) EC(a)n=103 Statistical analysis plan intent to treat population excludes patients who had normal histology at baseline, GCP violations or major entry criteria violations. A total of 20 patients in US study and 101 patients in EU study were excluded. *Statistically significant vs placebo at p=0.0143 +Statistically significant vs placebo at p=0.0047 +-Statistically significant vs placebo at p=0.05a) Not powered to show a statistical difference between budesonide MMX(r) treatment arms and Asacol and Entocort reference arms 17.9%* Remission rates after 8 weeks of treatment June 22, 2011 18 |
| Budesonide MMX(r) Generally Well Tolerated Budesonide MMX(r) Generally Well Tolerated Treatment related AE data from U.S. and E.U. studies Top-line study results indicate that budesonide MMX(r) 9 mg and 6 mg were generally well tolerated and the frequency of treatment related adverse events was similar across all treatment groups. June 22, 2011 19 |
| Extension Study with Budesonide MMX(r) 6 mg Completed May 2011 12-month, double-blind, placebo-controlled extended use study (extension of 8 week induction studies) with 123 patients enrolledPrimary objectivesEvaluate long-term safety and tolerability of budesonide MMX 6 mgCollect data on the efficacy of budesonide MMX 6 mg in the maintenance of remission of ulcerative colitis vs placeboExtension study is exploratory and not powered to demonstrate a statistically significant difference between budesonide MMX 6 mg and placeboTop-line data in 2H 2011Confirmed in pre-NDA meeting that the FDA wants data from the extension study in the budesonide MMX NDA submission June 22, 2011 20 |
| Rhucin(r) (recombinant human C1 inhibitor) U.S. regulatory statusOrphan drug designation in U.S. for treatment of acute attacks of HAEPhase III study initiated in February with dosing regimen at 50 U/kgExpect to complete Phase III study by 3Q 2012Promoted in E.U. as Ruconest(tm) by Swedish Orphan Biovitrum for treatment of acute attacks of HAEPotential in other indicationsAntibody-mediated rejection or delayed graft function following solid organ transplantationTwo U.S. patents expire in 2020 and 2022Expect to have 12 years of data exclusivity for biologic product upon FDA approval~$200 million estimated peak sales potential in U.S. in HAE June 22, 2011 21 |
| U.S. HAE Treatments Expected to Evolve to Acute Therapies Cinryze(r)10-15% of patientsMost severe casesVery frequent attacksHistory of life- threatening or intense pain Significant impact on QOL Berinert(r), Kalbitor(r), Others60-70% of patientsMild/moderate casesMore frequent attacksPeripheral locationsGenerally no history of life threatening attacks Traditional Prophylaxis New Therapy for Prophylaxis Acute Treatments Androgens**20-25% of patientsMilder casesInfrequent attacksGenerally stable/well controlledCost/coverage issuesSkews male *Based on qualitative market research conducted by Santarus with physicians treating HAE patients. Patient preference will also influence treatment choice.**Anabolic steroids Physicians' views of future distribution of treatments for HAE patients with introduction of additional acute therapies* June 22, 2011 22 |
| Rhucin(r) - Two Placebo-Controlled Studies Completed in Treating Acute Attacks of HAE Primary Endpoint (minutes) Primary Endpoint (minutes) Primary Endpoint (minutes) Primary Endpoint (minutes) Primary Endpoint (minutes) 100 U/kg N =13 50 U/kg N =12 Placebo N =13 p-values Time to the beginning of relief(VAS decrease from baseline ^ 20mm) 68 122 258 0.001* <0.001** Primary Endpoint (minutes) Primary Endpoint (minutes) Primary Endpoint (minutes) Primary Endpoint (minutes) 100 U/kg N =16 Placebo N =16 p-value Time to the beginning of relief(VAS decrease from baseline ^ 20mm) 62 508 0.003 North America Europe *p=0.001 for 100 U/kg vs. Placebo **p<0.001 for 50 U/kg vs. Placebo (100 U/kg vs. 50 U/kg p = NS ) All times are reported as median values June 22, 2011 23 |
| Rifamycin SV MMX(r) - Phase III Study in TD Broad-spectrum in vitro antibacterial activity, including C. difficile20 year history of use of rifamycin SV in Europe in IV/IM formsMMX is an oral tablet form that selectively delivers to the colon Negligible systemic absorption (<1%)Good safety & tolerability profile (from 400 mg to 1200 mg daily)Clinical activity in infectious diarrhea appears comparable to Xifaxan(r) (rifaximin)No clinically relevant bacterial resistance observedNo known drug interactionsCurrently enrolling patients in a Phase III study testing b.i.d. dosing for 3 days in Travelers' DiarrheaExpect to complete enrollment in 1H 2012 June 22, 2011 24 |
| Early-Stage Product Candidate: SAN-300 (Anti-VLA-1 Antibody) SAN-300 has potentially broad clinical applications in autoimmune and inflammatory diseasesEfficacy in multiple preclinical models of inflammation, such as rheumatoid arthritis, inflammatory bowel disease, psoriasis and organ transplantHumanized antibody created by Biogen Idec, which has extensive biologic experiencePreclinical package provided foundation to proceed into Phase I clinical studyFormulated GMP drug is availablePhase I clinical study initiated in March 2011SAN-300 (anti-VLA-1 antibody) covered by five U.S. patents, including composition of matter patent expiring in 2022Biologic qualifies for 12 years data exclusivity upon FDA approval June 22, 2011 25 |
| Historical Financial Performance 2006 - 2010 Total Revenue Net Income (Loss)(CHART) 2006 2007 2009 2008 2010 $ Millions (CHART) $49 June 22, 2011 26 |
| 3 Months Ended March 31, Cash, cash equivalents & short-term investments: $54.8 million at March 31, 2011 Notes:Generic competition for Zegerid(r) started in June 2010Fiscal 2010 expenses included $7.1 million in restructuring costs, $15 million upfront for Rhucin agreement and $5.4 million in success-based milestone expense 1Q 2011 and 2010 Full Year Financial Results (Unaudited) ($ Millions)Except per share amounts 2011 2010 2010 Total revenues $ 22.8 $ 39.7 $ 125.4 Total costs & expenses $ 23.2 $ 36.1 $ 143.4 Net income (loss) $ (0.5) $ 3.3 $ (18.5) Net income (loss)/share $ (0.01) $ 0.05 $ (0.31) 12 Months Ended Dec 31, June 22, 2011 27 |
| Near Term Value Drivers for Santarus Glumetza(r) - expect significant revenue growthCycloset(r) - educate endocrinologists and establish sales momentumBudesonide MMX(r) - NDA submission planned for end of 2011Advance clinical programsRhucin Phase III study in HAE (paid for by Pharming) Rifamycin SV MMX(r) Phase III clinical study in Travelers' DiarrheaSAN-300 (anti-VLA-1 antibody) Phase I studySolid financial management June 22, 2011 28 |