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Investor PresentationJune 2012
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Forward-looking Statements
This presentation may contain forward-looking statements within the meaning of certain securities laws, including the “safe harbour” provisions of the Securities Act (Ontario) and other provincial securities law in Canada. These forward-looking statements include, among others, statements with respect to our objectives, goals and strategies to achieve those objectives and goals, as well as statements with respect to our beliefs, plans, objectives, expectations, anticipations, estimates and intentions. 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, which give 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 differ materially from those expressed or implied in such statements. We caution readers not to place undue reliance on these statements as a number of important factors, many of which are beyond our control, could cause our actual results to differ materially 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 or regulatory approval processes; government and third-party payer reimbursement; dependence on strategic partnerships for product 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 to access 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 our forward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Additional information about factors that may cause actual results to differ materially from expectations, and about material factors or assumptions applied in making forward-looking statements, may be found in the body of this presentation, in the “Risk Factors” section of our Annual Information Form, under “Business Risks” and elsewhere in the Management’s Discussion and Analysis of Operating Results and Financial Position in our most recent annual and quarterly financial statements and elsewhere in our filings with Canadian securities regulators, except as required by Canadian securities laws, the Company does not undertake to update any forward-looking statements; such statements speak only as of the date made. We do not undertake to update any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf; such statements speak only as of the date made. The forward-looking statements included herein are expressly qualified in their entirety by this cautionary language.
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Commercial-stage specialty pharma
company focused on improving drugs for
better results
Cipher Pharmaceuticals (TSX:DND; OTC: CPHMF)
54 clinical trials
6 new drug applications
4 Distributor partnerships
5final FDA & HC approvals
3 growing revenue streams
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Senior Management & Board
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Management Board of Directors
Larry Andrews• President and CEO
Norman Evans, C.A.• Chief Financial Officer
Jason A. Gross, Pharm.D.• Vice President, Scientific Affairs
William Garriock (Chair)
Stefan Aigner
Larry Andrews
William Claypool
Gerald McDole
John Mull
Stephen Wiseman
Market / Indication
Phase I/II
Phase III
Regulatory approval Commercial
Lipofen®
CIP-Isotretinoin
CIP-Tramadol ER
Severe acne
Launched Q4 2007 (Kowa Pharma)
Launched Q3 2011(Vertical Pharma)
Moderate to moderately severe chronic pain
Hyperlipidemia
Product Portfolio
Launch expected Q4 2012 (Ranbaxy Pharma)
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• U.S. distributor: Kowa Pharmaceuticals
• Strong presence in lipid management market with Lipofen and Livalo (pitavastatin)
• 250 primary care representatives
• Enhanced promotional effort in the latter half of 2011 has been rewarded with increased Rx penetration in the $2 billion fenofibrate market.
• Lipofen patent-protected until 2015
Lipofen® Status Report
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U.S. Fenofibrate Opportunity
Source: IMS Health
US$2.0 Billion Market
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Lipofen® Monthly Prescription Performance
Source: IMS HealthSource: IMS Health
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Lipofen® Quarterly Royalty Revenue
Market / Indication
Phase I/II
Phase III
Regulatory approval Commercial
Lipofen®
CIP-Isotretinoin Severe acne
Launched Q4 2007 (Kowa Pharma)
Launched Q3 2011(Vertical Pharma)
Moderate to moderately severe chronic pain
Hyperlipidemia
Product Portfolio
Launch expected Q4 2012 (Ranbaxy Pharma)
CIP-Tramadol ER
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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
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CIP-TRAMADOL ER: Status Report
U.S.• Final FDA approval May 2010• U.S. patent issued Dec 2010• Completed licensing agreement
with Vertical Pharmaceuticals• US$1.5 million upfront, potential for
US$5.5 million in pre- and post-commercial milestones
• Royalty in mid-teens• ~60 reps currently, plans for
further expansion in H1 2012
• Launched in Q3 2011 as ConZip™
Canada• Final TPD approval Sept 2011• Patent issued July 2011• Completed licensing agreement
with Medical Futures• US$0.3 million upfront, additional
cumulative sales milestones• Double-digit royalty• ~22 reps for launch, plans for
further expansion
• Launched in Q1 2012 as Durela™
U.S. Tramadol Opportunity
Source: IMS Health
~US$130 Million Extended-Release Market
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Total ER Segment
Total Tramadol Market
U.S. Tramadol Opportunity: ConZipTM
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Market / Indication
Phase I/II
Phase III
Regulatory approval Commercial
Lipofen®
CIP-Isotretinoin
Severe acne
Launched Q4 2007 (Kowa Pharma)
Launched Q3 2011(Vertical Pharma)
Moderate to moderately severe chronic pain
Hyperlipidemia
Product Portfolio
Launch expected Q4 2012 (Ranbaxy Pharma)
CIP-Tramadol ER
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CIP-ISOTRETINOIN: Opportunity
• 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 under different dietary conditions causing inconsistency in getting drug on board
• CIP-Isotretinoin has demonstrated much greater absorption consistency with or without food, giving physicians assurance that target accumulative dose will be achieved regardless of diet
• Currently available isotretinoin products are not promoted to Dermatologists –a monopoly on promotion!
CIP-ISOTRETINOIN: ProfileAUC: 252.60
Cmax: 267.53Phase I: Study No. 2003-627Single dose study of Accutane 40mg
Fed vs. Fast Condition
Time (hours)
Accutane® 40mg (Fed)
Accutane® 40mg (Fast)
Mean Plasma Isotretinoin Conc. (ng/mL)
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CIP-ISOTRETINOIN: Opportunity
• FDA Approval May 25, 2012
• To be marketed as Absorica™
• Package Insert Highlights
• While “Bioequivalent with Accutane when both drugs are taken with a high fat meal”
• “83% greater absorption than Accutane under fasted conditions”
• Therefore “Not Interchangeable with generic products of Accutane”
• Therefore “dosed Without Regard to Meals”
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US$0.4+ Billion Market (Generic)
Source: IMS Health
CIP-ISOTRETINOIN: U.S. Market
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CIP-ISOTRETINOIN: U.S. Distribution Partner
Ranbaxy Pharmaceuticals (owned by Daiichi Sankyo)• Subsidiary of a global pharmaceutical company• Existing sales force presence in U.S. isotretinoin market• FDA approval triggers a $9 million milestone payment • Royalty in the mid-teens on net sales + additional $10
million sales milestone (cumulative sales post launch )• Minimum commitment of 50 dermatology representatives• P1 detail position in Year 1 and P1/P2 in Years 2 and 3
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CIP-ISOTRETINOIN: U.S. Distribution Partner
“We are thrilled to make Absorica available as a valuable option for the dermatologist and patients who need treatment for severe recalcitrant nodular acne”
“Absorica is a critical milestone in our commitment to serve the dermatology community and will be theflagship brand for Ranbaxy’s specialized dermatology sales force,” said Venkat Krishnan, Senior Vice President and Regional Director, Americas”
Source: Ranbaxy Press Release
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CIP-ISOTRETINOIN: Canadian Opportunity
Regulatory• New Drug Submission in Q4 2011• Health Canada response expected in Q1 2013
Commercial• Plan to establish commercial footprint to market the product• Plan to license in complementary late-stage products
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CIP-Isotretinoin
CIP-Tramadol
Lipofen
Tramadol‐Q3 2011 Health Canada
approval
Tramadol‐Q3 2011 U.S. launch
Iso‐Q4 2011 FDA Submission
Tramadol‐Q1 2012 Cdn launch
Iso‐Q2 2012 FDA Response
Iso‐Q4 2012 U.S. Launch
Growing Portfolio Value
Potential Reven
ue ($)
Note: This is intended to illustrate market opportunity; this is not a forecast
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(In 000’s of CDN$)Q1
2012Q4
2011Q3
2011Q2
2011Q1
2011
Net Revenue/Gross Margin 1,811 1,047 1,120 727 675
R&D Expenses 471 612 468 578 547
OG&A Expenses 1,016 724 667 618 1,177
Income / (loss) 125 (490) (227) (509) (1,085)
Income / (loss) per share 0.01 (0.02) (0.01) (0.02) (0.05)
Cash at quarter end 10,113 9,636 9,235 8,573 9,147
Financial Review
• Shares outstanding: Approx 24.3 million (basic), 26 million (fully diluted)
• Over $90 million in loss carry forwards
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Lipofen®
CIP-ISOTRETINOIN
CIP-TRAMADOL ER
New opportunities
• Continued royalty revenue growth
• New revenue streams from U.S. and Canadian distribution partners
• Product portfolio expansion – primary focus on later stage products for North American market
• Establish commercial footprint in Canada anchored by CIP-ISOTRETINOIN
• Out-license current products in other international markets
• $9 million milestone payment
• Commercial batch manufacturing: Q3 2012
• Absorica™ U.S. launch: Q4 2012
• Health Canada approval: Q1 2013
• Canadian commercial launch: Q2 2013
What’s Next?