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Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
Cipher Pharmaceuticals (DND) Presentation 2011
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Cipher Pharmaceuticals (DND) Presentation 2011

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  • 1. October 2011
  • 2. Forward-looking StatementsThis presentation may contain forward-looking statements within the meaning of certain securities laws, including the “safeharbour” provisions of the Securities Act (Ontario) and other provincial securities law in Canada. These forward-lookingstatements include, among others, statements with respect to our objectives, goals and strategies to achieve those objectivesand goals, as well as statements with respect to our beliefs, plans, objectives, expectations, anticipations, estimates andintentions. The words “may”, “will”, “could”, “should”, “would”, “suspect”, “outlook”, “believe”, “plan”, “anticipate”, “estimate”,“expect”, “intend”, “forecast”, “objective” and “continue” (or the negative thereof), and words and expressions of similar import,are intended to identify forward-looking statements.By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, whichgive rise to the possibility that predictions, forecasts, projections and other forward-looking statements will not be achieved.Certain material factors or assumptions are applied in making forward-looking statements and actual results may differmaterially from those expressed or implied in such statements. We caution readers not to place undue reliance on thesestatements as a number of important factors, many of which are beyond our control, could cause our actual results to differmaterially from the beliefs, plans, objectives, expectations, anticipations, estimates and intentions expressed in such forward-looking statements. These factors include, but are not limited to, the applicability of patents and proprietary technology;possible patent litigation; regulatory approval of products in the Company’s pipeline; changes in government regulation orregulatory approval processes; government and third-party payer reimbursement; dependence on strategic partnerships forproduct candidates and technologies, marketing and R&D services; meeting projected drug development timelines and goals;intensifying competition; rapid technological change in the pharmaceutical industry; anticipated future losses; the ability toaccess capital to fund R&D; and the ability to attract and retain key personnel.We caution that the foregoing list of important factors that may affect future results is not exhaustive. When reviewing ourforward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties andpotential events. Additional information about factors that may cause actual results to differ materially from expectations, andabout material factors or assumptions applied in making forward-looking statements, may be found in the body of thispresentation, in the “Risk Factors” section of our Annual Information Form, under “Business Risks” and elsewhere in theManagement’s Discussion and Analysis of Operating Results and Financial Position in our most recent annual and quarterlyfinancial statements and elsewhere in our filings with Canadian securities regulators, except as required by Canadiansecurities laws, the Company does not undertake to update any forward-looking statements; such statements speak only as ofthe date made. We do not undertake to update any forward-looking statements, whether written or oral, that may be madefrom time to time by us or on our behalf; such statements speak only as of the date made. The forward-looking statementsincluded herein are expressly qualified in their entirety by this cautionary language. 2
  • 3. Cipher Pharmaceuticals (TSX:DND) 54 clinical trials Commercial-stage 5 specialty pharma new drug applicationscompany focused on 4improving drugs for Distributor partnerships better results 2 final FDA approvals 2 growing revenue streams 3
  • 4. Pipeline Market / Phase Phase Regulatory Indication I/II III approval Commercial Launched Q4 2007Lipofen® Hyperlipidemia (Kowa Pharma) Moderate to moderately Launched Q3 2011CIP-Tramadol ER severe chronic pain (Vertical Pharma) Launch expected Q4CIP-Isotretinoin Severe acne 2012 (Ranbaxy Pharma) 4
  • 5. Lipofen® Status Report • Kowa Pharmaceuticals - U.S. Distributor • Strong presence in lipid management market with Lipofen and Livalo (pitavastatin) • Expanded to 250 reps in the field in 2010 • Lipofen in P2 position on each call • Patent-protected until 2015 5
  • 6. Thousands Ja $50 $100 $150 $200 $250 $300 $350 $400 $0 n- 0 M 9 ar -0 M 9 ay -0 9 Ju l-0 Se 9 p- 0 No 9 v- 09 Ja n- 1 M 0 ar -1 M 0 ay -1 0 Ju Lipofen® Royalty Growth l-1 Se 0 p- 1 No 0 Monthly Royalties (US$) v- 1 Ja 0 n- 1 M 1 ar -1 M 1 ay -1 1 Ju l-1 16
  • 7. U.S. Fenofibrate Opportunity US$2.0 Billion Market 1,800 1,600 1,400 1,200 1,000Thousands 800 600 400 200 0 4 5 6 7 8 Ja 9 0 1 05 06 07 08 09 10 11 l-0 l-0 l-0 l-0 l-0 l-0 l-1 l-1 n- n- n- n- n- n- n- Ju Ju Ju Ju Ju Ju Ju Ju Ja Ja Ja Ja Ja Ja TRx NRx Source: IMS Health 7
  • 8. Pipeline Market / Phase Phase Regulatory Indication I/II III approval CommercialLipofen® Hyperlipidemia Launched Q4 2007 (Kowa Pharma)CIP- Moderate to moderately Launched Q3 2011Tramadol ER severe chronic pain (Vertical Pharma) Launch expected Q4CIP-Isotretinoin Severe acne 2012 (Ranbaxy Pharma) 8
  • 9. CIP-TRAMADOL ER: Best in Class Profile Ultram ER® RyzoltTM CIP-Tramadol ER Time to reach therapeutic levels (100ng/ml plasma levels) 240 minutes 60 minutes 60 minutes Food Effect Yes Yes No Therapeutically Active Dosages 100 mg Yes No Yes 200 mg Yes Yes Yes 300 mg Yes Yes Yes Dosage Format Tablets Tablets Capsules Significant differentiation to drive promotional success 9
  • 10. CIP-TRAMADOL ER: Fast OnsetConcentration Bioequivalence 200 mg multi-dose (fasted)(ng/mL) Mean Plasma Concentration (0-24 hours) Tramadol N=38300200100 CIP-TRAMADOL ER ULTRAM ER 4 8 12 16 20 24 Time (hours) 10
  • 11. CIP-TRAMADOL ER: Status ReportU.S. Canada• Final FDA approval May 2010 • Final TPD approval Sept 2011• U.S. patent issued Dec 2010 • Patent issued July 2011• Completed licensing agreement • Completed licensing agreement with Vertical Pharmaceuticals with Medical Futures • US$1.5 million upfront, potential for • US$0.3 million upfront, additional US$5.5 million in pre- and post- cumulative sales milestones commercial milestones • Double-digit royalty • Royalty in mid-teens • ~22 reps for launch, plans for • ~60 reps currently, plans for further expansion further expansion in H1 2012 • Launching in Q1 2012 as Durela™ • Launched in Q3 2011 as ConZip™ 11
  • 12. U.S. Tramadol Opportunity ~US$160 Million Extended-Release Market Total Tramadol TRx vs. ER TRx 3,500 3,000 2,500Thousands 2,000 1,500 1,000 500 0 Feb-06 Sep-06 Apr-07 Nov-07 Jun-08 Jan-09 Aug-09 Mar-10 Oct-10 May-11 ER TRx Total Tramadol TRx Source: IMS Health 12
  • 13. Pipeline Market / Phase Phase Regulatory Indication I/II III approval CommercialLipofen® Hyperlipidemia Launched Q4 2007 (Kowa Pharma)CIP- Moderate to moderately severe Launched Q3 2011Tramadol ER chronic pain (Vertical Pharma)CIP- Severe acne Launch expected Q4Isotretinoin 2012 (Ranbaxy Pharma) 13
  • 14. CIP-ISOTRETINOIN: OpportunityBest in Class Formulation and First to Market• Effective treatment requires reaching 120 to 150 mg per kg over a 5-6 month course of treatment• Current products have 70% variability in absorption depending on dietary intake causing inconsistency in getting drug on board• Demonstrated much greater absorption consistency with or without food, giving physicians assurance that target accumulative dose will be achieved regardless of diet• Expected to be the only promoted isotretinoin product in U.S. 14
  • 15. CIP-ISOTRETINOIN: ProfileMean Plasma Isotretinoin Conc. AUC: 252.60(ng/mL) Phase I: Study No. 2003-627 Cmax: 267.53 Single dose study of Accutane 40mg Fed vs. Fast Condition Accutane® 40mg (Fed) Accutane® 40mg (Fast) Time (hours) 15
  • 16. CIP-ISOTRETINOIN: ProfileMean Plasma Isotretinoin Conc. AUC: 106.0(ng/mL) Phase I: Study No. 2003-627 Cmax: 100.6 Single dose study Accutane 40mg vs. CIP-Isotretinoin (20mg X 2) Fed Condition Accutane® 40mg CIP-Isotretinoin 2 x 20mg Time (hours) 16
  • 17. CIP-ISOTRETINOIN: ProfileMean Plasma Isotretinoin Conc. AUC: 178.8(ng/mL) Phase I: Study No. 2003-627 Cmax: 200.2 Single dose study Accutane 40mg vs. CIP-Isotretinoin (20mg X 2) Fast Condition CIP-Isotretinoin 2 x 20mg Accutane® 40mg Time (hours) 17
  • 18. U.S. Isotretinoin Opportunity US$0.5 Billion Market (Generic) Total Isotretinoin Market140,000120,000100,000 80,000 60,000 40,000 20,000 0 Jun-04 Feb-05 Oct-05 Jun-06 Feb-07 Oct-07 Jun-08 Feb-09 Oct-09 Jun-10 Feb-11 Source: IMS Health 18
  • 19. CIP-ISOTRETINOIN: Status ReportClinical – Phase III Safety Study• 900+ patients in the U.S. and Canada• Approved under SPA• Top-line results released in Q3 2011 • Positive safety data: both drugs showed similar adverse event profiles • Efficacy data: • Under PP analysis, both efficacy endpoints met non-inferiority margins • In mixed LOCF analysis of ITT population, both efficacy endpoints met non-inferiority margins • In the LOCF analysis of the ITT population, the first primary endpoint was achieved while the second fell slightly outside non-inferiority targetRegulatory/Commercial• FDA and Health Canada submissions planned for Q4 2011• Pre-commercial preparation has commenced 19
  • 20. CIP-ISOTRETINOIN: U.S. DistributionRanbaxy Pharmaceuticals (owned by Daiichi Sankyo)• Subsidiary of global pharmaceutical company• Dermatology sales presence in U.S. isotretinoin market• Funded majority of Phase III study• Up to $24M in pre- and post-commercial milestones• Royalty in the mid-teens on net sales• P1 detail position in Year 1 and primarily P1 in Years 2 and 3 20
  • 21. What’s Next?Lipofen® • Continued royalty revenue • Initial royalty revenue from U.S. agreementCIP-TRAMADOL ER • Canadian launch: Q1 2012 • FDA submission: Q4 2011CIP-ISOTRETINOIN • Health Canada submission: Q4 2011 • Additional $1.0 million milestone payment: Q4 2011 • Canadian commercialization opportunitiesNew opportunities • Out-license current products in other markets • Product portfolio expansion 21
  • 22. Growing Portfolio Value Q3 2011 Q1 2012 U.S. launch Cdn launch Q4 2011 FDA Q4 2012 Submission U.S. launchRevenue ($) Q3 2011 Health Canada Q2 2012 FDA approval Response CIP-Isotretinoin CIP-Tramadol Lipofen 2011 2012 2013 2014
  • 23. Financial Review(In 000’s of CDN$ H1 2011 H1 2010 2010 2009Royalty Revenue 1,114 981 2,067 1,107Milestone Revenue 287 2,155 3,318 2,072R&D Expenses 1,125 523 743 956OG&A Expenses 1,774 1,941 3,895 4,252Income / (loss) (1,594) 310 172 (2,715)Income / (loss) per (0.07) 0.01 0.00 (0.11)shareSolid financial position• No debt, cash at June 30, 2011: $8.6 million• Shares outstanding: Approx 24.2 million (basic), 26 million (fully diluted) 23
  • 24. Summary• Steady revenue stream from Lipofen®• ConZip™ / Durela™ provide second royalty revenue stream• CIP-ISOTRETINOIN offers significant financial upside• Solid financial position• Strong core management team 24
  • 25. Questions

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