Eagle Pharmaceuticals, Inc. · OTC:EGRX
Eagle Pharmaceuticals — Investor Presentation (May 2014)
14 slides from Eagle Pharmaceuticals's investor presentation, May 8, 2014
Slide 1: May 2014
May 2014
Slide 2: Forward Looking Statements
Forward Looking Statements 2 This presentation contains certain forward-looking information about Eagle Pharmaceuticals that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking sta
Slide 3: About Eagle Pharmaceuticals
Specialty pharmaceutical company focused on developing and commercializing injectable products Differentiated commercialization strategy utilizing the FDA's 505(b)(2) regulatory pathway Addresses shortcomings of existing, FDA-approved, commercially successful injectable products Focused on critical
Slide 4: A New Paradigm in Specialty Injectables
EAGLE 505(b)(2) – PDUFA Dates New IP (11 patents) Leverage existing brand Low operating cost Specialty Pharma Premium pricing Long commercial duration Injectable Generics Low R&D cost High barrier dosage form A New Paradigm in Specialty Injectables 505(b)(2) = Early Access & Differentiation
Slide 5: Clear Benefits of 505(b)(2) Pathway
Clear Benefits of 505(b)(2) Pathway Strict product specifications More difficult to circumvent patents Subject to 180-day exclusivity period Altered formulations allow for: Strengthened assertions of non infringement Improved product profile New patentable compositions Not blocked by ANDA holder’s 1
Slide 6: Late Stage: Disclosed Portfolio
Late Stage: Disclosed Portfolio Product Active Ingredient 2013 US Branded Sales (mm)1 Upcoming Milestone Ryanodex dantrolene $20 NDA Fast-Tracked PDUFA 7-22-14 EP-4104 (heat stroke) dantrolene N/A Start clinical trial mid-2014 EP-3101 (ready to dilute) bendamustine $709 Tentative approval 7-6-14 EP-
Slide 7: Ryanodex: Malignant Hyperthermia
Rapid reconstitution: administered in <1 minute ~$20 million US market (upside with premium pricing) Requires only small external sales force to call on stakeholders CLINICAL TIMELINE Ryanodex: Malignant Hyperthermia (MH) 1. Retrospective study conducted by the Malignant Hyperthermia Association of
Slide 8: EP-4104: Exertional Heat Stroke (EHS)
EP-4104: Exertional Heat Stroke (EHS) Leverages similarities to malignant hyperthermia Product Profile: Management of EHS as an emergency treatment Single IV bolus plus standard care (cooling and IV rehydration) Target Population: Athletes (leading cause of student athlete death in the US), workers
Slide 9: Bendamustine Portfolio
Bendamustine Portfolio Two bendamustine products with significant near-term potential for treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) EP-3101 (ready to dilute) No reconstitution and better stability versus current branded product EP-3102 (shorter in
Slide 10: Bendamustine Market Opportunity
Bendamustine Market Opportunity Eagle Launch Window Estimated US branded sales of Treanda1 exceed $800 million at launch of EP-3101/EP-31022 1) Bendamustine is currently marketed by Teva Pharmaceuticals under the brand name Treanda 2) Based on publicly filed reports with the SEC, independent market
Slide 11: Bendamustine Commercialization Strategy
Expect to launch prior to generics or other 505(b)(2) entrants Switch to superior product One patent issued and 4 filed with expiry expected 2031-2033 Market with small specialty sales force to cover both corporate accounts and infusion centers Bendamustine Commercialization Strategy 2014 2017 2015
Slide 12: Looking Ahead to EP-6101 & EP-5101
Looking Ahead to EP-6101 & EP-5101 EP-6101 (bivalirudin) Enhanced version of the anti-coagulant Angiomax No reconstitution & dilution Less time consuming Complies with regulations such as USP (797) Reduces dosing errors More efficient work flow EP-5101 (pemetrexed) Primarily used as a treatment for
Slide 13: Investment Considerations
Investment Considerations Expansive market opportunity in injectable products space Extensive pipeline of product candidates with near term commercialization potential Differentiated commercialization strategy utilizing the FDA's 505(b)(2) regulatory pathway Strong IP portfolio to protect market pos
Slide 14: May 2014
May 2014
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