Furiex Pharmaceuticals

Transcription

1 Furiex Pharmaceuticals NASDAQ: FURX June Almenoff MD, PhD President & Chief Medical Officer Bio CEO & Investor Conference February 2011

2 Forward-Looking Statements This presentation includes forward-looking statements. All statements other than statements of historical facts are forward-looking statements for purposes of these provisions, including any projections of financial results, clinical trial and other research and development activities, regulatory agency reviews or approvals, potential market sizes, milestones, royalties or other financial items, any statements of the plans and objectives of management for future operations, any statements concerning proposed new products or licensing or collaborative arrangements, any statements concerning the technical basis for pipeline products, any statements regarding future economic conditions or performance, and any statement of assumptions underlying any of the foregoing. Actual results could differ materially from those projected or assumed in the forward-looking statements. Our future financial condition and results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties, including the risk factors set forth in the Information Statement attached to our Form 10 and other SEC filings. 2

3 Company Overview Spin-off from Pharmaceutical Product Development (NASDAQ: PPDI) Headquarters: Morrisville, NC Employees: ~ 25 Key Facts Cash Balance end Q3 2010: $92 million Marketed Products NESINA Furiex Revenues Pipeline Products $18.0 $8.7 $ Q32010YTD 2008: $18mm in development milestones for Alogliptin 2009: $5.9mm in revenues from milestones and royalties 2010: $8.7mm in revenues from milestones and royalties Fluoroquinolone (JNJ Q-2) (Phase II) MuDelta (Phase II) PPD (Phase II) 3

4 Differentiated Risk-Sharing Business Model Discovery Research Pharma / Biotech Partner Furiex partners early stage assets from innovators CRO Services Pre-clinical and Proof of Concept (through PII/PIIb) Furiex Pharmaceuticals Furiex funds early development, creating value by de-risking and accelerating programs Late Stage Development (Phase III) Commercialization Pharma / Biotech Partner or Third Party Partner Partner progresses assets to commercialization Furiex receives regulatory and sales-based milestone payments plus royalties 4

5 NOW Is The Right Time for Furiex Facing patent cliffs Seeking efficient, EXTERNALLY-FOCUSED models to bolster pipelines Willing to pay premium for later stage assets Differentiated Business Model

6 Deep Experience in Drug Development Dr. Fred Eshelman, Chairman Dr. June Almenoff, President and Chief Medical Officer Dr. Gail McIntyre, SVP, Research Dr. Paul Covington, SVP, Clinical Operations Years in Industry

7 Diverse Portfolio in Multiple Therapeutic Areas Phase of Development Program Indication Preclinical PI PII PIII Marketing Application Submission Market Licensor Collaborator 1 Priligy Premature Ejaculation US EU/ex-US Eli Lilly & Co. 2 Janssen-Cilag Alogliptin Type 2 Diabetes EU US JP Syrrx, Inc. Takeda Aloglitpin / Actos Combination Type 2 Diabetes EU US JP Syrrx, Inc. Takeda Alogliptin / Metformin Combination Type 2 Diabetes Syrrx, Inc. Takeda Fluoroquinol one Antibiotic Complicated Skin Infections Bacterial Pneumonia Janssen Pharmaceutica N.V Janssen Pharmaceutica N.V. 3 Mu Delta IBS-diarrheal Janssen Pharmaceutica N.V Janssen Pharmaceutica N.V. 3 PPD Cholesterol Lowering Ranbaxy Laboratories 1 Refers to late-stage development and commercialization collaborator. 2 Furiex originally licensed compound from Eli Lilly. 3 At the completion of Phase II, Janssen will have the option to continue development and commercialization of each compound. 7

8 Pipeline - Fluoroquinolone (JNJ-Q2) Indication: Complicated skin-skin structure infections (ABSSSI) Community acquired bacterial pneumonia (CABP) Market: WW antibiotic market estimated at $42 billion 1 Fluoroquinolone class generated $7 billion in sales in Methicillin-resistant Staph aureus (MRSA) accounts for >50% of Staph infections in the US 2 Key Differentiators: Status: Commercial Partner: Broad-spectrum antibiotic with low propensity for resistance Excellent MRSA coverage including quinolone-resistant MRSA Excellent coverage of resistant pneumococcal pneumonia Positive Phase II data for complicated skin infections (ABSSSI) Phase II study in CABP initiated Johnson & Johnson (option to take back in-house) Furiex responsible for Phase II studies Up to $90 million in regulatory milestones Up to $75 million in sales based milestones Sales-based royalties ranging mid-single to low-initial double digit 1 Hamad_Nature Reviews Drug Discovery Sep Emerging Infectious Diseases 2009; 15(12): Photo credit: 8

9 Positive Phase II study for skin infections Non-inferior on new draft FDA endpoint of early clinical response (62.7% JNJ-Q2 vs. 57.7% linezolid) Outstanding coverage of all bacteria isolated from clinical trial subjects including MRSA, FQ-resistant Staph Excellent clinical cure rates (traditional FDA endpoint) JNJ-Q2 may fill a significant unmet need for oral antibiotics to treat severe skin infections, particularly MRSA.

10 Pipeline - MuDelta Indication: Diarrhea-predominant irritable bowel syndrome Market: IBS-d affects ~12 million Americans 1 Key Differentiators: Underserved market with limited treatment options Combination of agonist/ opioid receptor antagonist activities expected to address both diarrhea and abdominal pain, without constipating effects Locally acting in the gut - low potential for side-effects Status: Phase II studies ongoing, expect topline data late 2011 Commercial Partner: Extracellular Intracellular mu ()-opioid delta (δ)-opioid receptor receptor kappa (κ)-opioid receptor mu ()-opioid receptor Granted Fast Track Status From FDA (Jan 2010) Johnson & Johnson (option to take back in-house) Furiex responsible for Phase II study Up to $90 million in regulatory milestones Up to $75 million in sales based milestones Sales-based royalties ranging mid-single to low-initial double digit 1 International Foundation For Functional Gastrointestinal Diseases 10

11 Pipeline PPD

12 PPD 10558: Muscle-Sparing Statin, With Efficacy Similar to Best-In-Class Statin Indication: Lipid lowering in statin intolerance due to muscle pain (10% users)1 Clinical efficacy is similar to atorvastatin, a best-in-class statin Outstanding preclinical muscle tox, negligible muscle penetration vs other statins Favorable metabolic profile prevents toxic interactions common to other statins Lowest systemic exposure vs. other statins minimizes muscle toxicity risk Seeking a Phase IIb-III development partner PPD 10558: Other Statins: Drug stays localized to the site of action (liver) Higher exposure increases muscle toxicity risk Images from MedicalRF.com/Visuals Unlimited Inc; K. Hann at ShutterStock.com 1 Sathasivam, S, Lecky, B. (2008) British Medical Journal: 337: ; WW dyslipidemia market estimated at $35 billion (IMS Health Midas, 2009)) 12 12

13 Two Marketed Products Nesina Regulatory and Sales Milestones, Royalties Revenue With Growth Potential No Further Development Costs 13

14 Marketed - PRILIGY (Dapoxetine) Indication: Market: Premature Ejaculation (PE) ~30% of males experience PE compared to 10-20% for erectile dysfunction (ED) 1 Key Differentiators: First approved oral medication for PE Rapid onset of action makes it well suited for on-demand use 2 Status: Marketed in 14 countries in EU, Asia and Latin America Phase IIIb clinical trials ongoing in US; Phase IV ongoing in ROW Commercial Partner: Johnson & Johnson Up to $15 million in regulatory milestones Up to $50 million in sales based milestones Sales-based royalties ranging from 10% to 20% No remaining R&D commitments 14 1 J Sex Med 2205; Supplement 2 Lancet (2006) 368:

15 Marketed - NESINA (Alogliptin) Indication: Type II Diabetes (DPPIV inhibitor) Market: 2009 WW anti-diabetics market $30 billion 1 Current DPPIV inhibitor sales ~$3 billion and growing 2 Key Differentiators: Improves glycemic control without causing weight gain or hypoglycemia Status: Launched in Japan in mid-2010 CV safety trial on-going Alogliptin, Alogliptin/Actos and Alogliptin/Metformin approval anticipated in 2012 for US and for EU 3 Commercial Partner: Takeda Up to $45 million in regulatory milestones Up to $33 million in sales based milestones Sales-based royalties ranging from 7% to 12% in the US, 4% to 8% in Europe and Japan, and 3% to 7% in ROW* No remaining R&D commitments * Subject to 0.5% reduction for portion of royalties and up to 0.5% for milestone payments by Takeda to a licensor for IP related to Nesina 15 1 IMS Health Midas, December Company Reports. 3 Takeda FY 2009 Full Year Results Earnings Release Presentation

16 Well Capitalized Well capitalized with cash to fund operations through at least end of 2011 Additional cash inflows should support the business going forward Royalties from Priligy and Alogliptin Milestones on various programs 3Q2010 Financial Metrics ($ in mm) Cash $92.0 Debt $ Revenue (nine months ending Sept 30 th ) $8.7 We cannot assure you that our current funds will meet our working capital and operational needs or that our working capital requirements will not increase beyond our current expectations. We might need to obtain additional financing from banks or other lenders, or through public offerings or private placements of debt or equity securities, strategic relationships or other arrangements to fully execute our business strategy. 16

17 Investment Highlights Well-capitalized balance sheet Potential to be cash flow positive in 2012 Strong diversified pipeline with multiple therapeutic candidates Two marketed products with significant growth potential Track record of advancing clinical candidates with speed and expertise makes Furiex the preferred development partner for biopharma 17