Building $Billion Specialty Vaccine Company Phase 3 Vaccine and Pending Acquisition of Marketed Vaccines

Transcription

1 Building $Billion Specialty Vaccine Company Phase 3 Vaccine and Pending Acquisition of ed Vaccines Ken Kelley, CEO Linda Rubinstein, CFO Nima Farzan, COO Jefferies Global Healthcare Conference, June 3, 2014

2 Disclaimers THIS INFORMATION HEREIN CONTAINS FORWARD-LOOKING STATEMENTS. PAXVAX BELIEVES THAT THE EXPECTATIONS REFLECTED ARE REASONABLE, BUT IT CAN GIVE NO ASSURANCE THAT SUCH EXPECTATIONS WILL PROVE CORRECT. CERTAIN ECONOMIC AND MARKET INFORMATION CONTAINED HEREIN HAS BEEN OBTAINED FROM PUBLISHED SOURCES PREPARED BY OTHER PARTIES. WHILE SUCH SOURCES ARE BELIEVED TO BE RELIABLE, NEITHER PAXVAX NOR ANY OF ITS AGENTS OR AFFILIATES ASSUME ANY RESPONSIBILITY FOR THE ACCURACY OR COMPLETENESS OF SUCH INFORMATION. INVESTORS SHOULD MAKE THEIR OWN INVESTIGATIONS AND EVALUATIONS OF PAXVAX, INCLUDING THE MERITS AND RISKS INVOLVED IN AN INVESTMENT THEREIN. PRIOR TO ANY INVESTMENT, PAXVAX WILL GIVE INVESTORS THE OPPORTUNITY TO ASK QUESTIONS OF AND RECEIVE ANSWERS AND ADDITIONAL INFORMATION FROM IT CONCERNING THE TERMS AND CONDITIONS OF THIS OFFERING AND OTHER RELEVANT MATTERS. INVESTORS SHOULD INFORM THEMSELVES AS TO THE LEGAL REQUIREMENTS APPLICABLE TO THEM IN RESPECT OF THE ACQUISITION, HOLDING AND DISPOSITION OF SHARES OF PAXVAX, AND AS TO THE INCOME AND OTHER TAX CONSEQUENCES TO THEM OF SUCH ACQUISITION, HOLDING AND DISPOSITION. June 3, 2014 Jefferies Global Healthcare Conference 2

3 Exceptional - Rationale Focus on Specialty Travel Vaccines $5B TAM, 50M travelers, high gross margins Easy market access; no payers or formulary issues Use of Key Account Managers; concentrated market Low Risk High Reward Plan in Place Acquired previously marketed cholera vaccine Bring it to market quickly, replicating past data Pending acquisition of marketed travel vaccine(s) Proprietary Platform and Pipeline Oral Adenovirus 4 live virus as vector for many vaccines Proof of concept in H5 flu; anthrax now in Phase 1/2 Third technology platform: Dengue vaccine breakthrough Nearing Inflection Point for Value Creation Cholera vaccine revenues in 2015, +EBITDA by 2017 Acquisition accelerates time to +EBITDA to 2016 Business model supports multi-$b market cap in 5 years June 3, 2014 Jefferies Global Healthcare Conference 3

4 Unique Opportunity to Build An Independent Vaccine Company High Gross Margins (Low COGS) & High Operating Margins (Low Cost of Sales) Travelers Pediatrics/ Seasonal Flu Low Development Costs Or Acquisition Costs June 3, 2014 Jefferies Global Healthcare Conference 4

5 Capable Team to Execute Specialty Vaccine Strategy Ken Kelley, CEO/Founder PaxVax, IntraBiotics; K2 BioVentures, Latterell, IVP; McKinsey Nima Farzan, COO Novartis Vaccines, DoubleTwist, BCG Linda Rubinstein, CFO Ingenuity, Solexa, ChemoCentryx, Lehman Piers Whitehead, Chief Corp Dev Officer NeoVacs, VaxGen, Mercer Marc Gurwith, MD, CMO VaxGen, Wyeth Jon Smith, PhD, CSO Liquidia, AlphaVax, USAMRIID Tom Monath, MD, CTO Acambis, KPCB, USAMRIID Howie Rosen, Chairman of Board Gilead, Alza, J&J, McKinsey Phil Russell, MD, Board Member Maj.Gen-Ret; USAMRIID, BARDA; IAVI, IVI, Aeras, Sabin Jim Connolly, Board Member Aeras, Wyeth Vaccines, Wyeth; Vaxess Acquired Orchol/Voyapak Identified additional product acquisitions Launched 5 vaccines: Menveo, Ixiaro, smallpox, H1N1, YF Ran American Society of Tropical Medicine & Hygiene (Tom Monath) Built pipeline from technology platform Ran 36 vaccine clinical trials Manufactured GMP biologicals in-house June 3, 2014 Jefferies Global Healthcare Conference 5

6 Travel Vaccines: $5 Billion TAM 50 million travelers per year Workers, students, families, soldiers Travel from developed to developing countries Unmet needs: cholera, typhoid, malaria, dengue June 3, 2014 Jefferies Global Healthcare Conference 6

7 Travel Vaccines: GM and Access (Akin to Derm Sales of Botox) Travelers Vaccine US Wholesale Price Regimen Rabies $225 x 3 3 injections Japanese Encephalitis $250 x 2 2 injections Cholera $200 x 1 1 oral dose Yellow Fever $75 x1 1 injection Typhoid $60 1 injection or 4 oral doses Easy access, no formulary issue Cash pay, little insurance concerns Doctors push, 25-50% mark up Doctors want convenience, easy regimen wins Doctors stock one brand, most useful wins Travelers show up late, fast acting wins June 3, 2014 Jefferies Global Healthcare Conference 7

8 Concentrated U.S. : Use Key Account Manager Model 7 Key Account Managers Cover 5,000 Clinics in US 1. Wholesalers 2. Distributors Low cost of sales 3. DoD 4. Retail 5. Universities 6. Integrated Health Networks 7. Big Clinics Easy to scale with additional vaccines Similar models in Canada, UK, Australia Partner where large sales force needed Leisure/Business Travelers Employers Soldiers Students June 3, 2014 Jefferies Global Healthcare Conference 8

9 Started with Previously ed Cholera Vaccine Low Clinical Risk Successful single oral dose cholera vaccine >12 clinical studies; >80,000 subjects Orochol approved 1999 Sold in 6 countries for 3 years Berna shuts down cholera to make typhoid Taken off market by 2004 PaxVax licenses strain from University of Maryland 2009 Simply repeating what Berna did 5 years and $40M program Written guidance from FDA, EMA Brand name: Voyapak June 3, 2014 Jefferies Global Healthcare Conference 9

10 Inflection Point of Value Creation: Positive Phase 3 Data in Hand Phase 1 safety/immune efficacy (66 subjects) - 89% seroconversion Phase 3 efficacy 10 day challenge (68 subjects) - 91% vaccine efficacy H H H H CTM mfg Stability ongoing 3,000 subject 28 day safety 60 subject 90 day challenge efficacy BLA filings Priority Review US approval & launch EU, CA, ANZ approvals Upcoming milestones: Jun 14: 90 day challenge data Sep 14: Safety, Lot-to-Lot, Older Adult datas Q1 15: BLA filing Q4 15: US FDA approval, PRV issued, launch June 3, 2014 Jefferies Global Healthcare Conference 10

11 Voyapak Should be Leader for the Very Long Term No cholera vaccine exists in U.S. today 100% share; no competition uptake like other travel vaccines (e.g. typhoid) Outside US; one competitor 40% share; single dose is superior Dukoral with 2 dose regimen is inferior Assume price partiy No competitive product in sight No vaccine generics June 3, 2014 Jefferies Global Healthcare Conference 11

12 Revenue in $M Voyapak Contribution Leads to Profits in Near Term ROW US Contribution $91M $63M 50 $38M 25 0 $4M $18M Assumptions US 4M travelers, 5% immunization rate, $200 price; plus DOD ROW 40% share of Dukoral market at parity pricing Annual increase in travelers, price June 3, 2014 Jefferies Global Healthcare Conference 12

13 Pipeline from Proprietary Platforms RICH PIPELINE FUNDED BY $50M AWARDS, GRANTS AND CONTRACTS Preclinical Phase 1 Phase 2 Phase 3 TAM Platform Travel Biodefense Cholera $250M Bacteria Dengue $2B Virus Malaria $1B Rabies $100M H5 Flu $250M Anthrax $400M Ad 4/7 $35M Live Ad4/7 Oral Vector June 3, 2014 Jefferies Global Healthcare Conference 13

14 Millions Long Term Model > $2.5B Value Other (Grants, Ad4/7, Pandemic Flu, Malaria, Dengue,...) Anthrax Cholera EBITDA (excluding PRV sale) 20x Trailing EBITDA = $2.5B Valuation 6x Trailing Revenue = $2.5B Valuation June 3, 2014 Jefferies Global Healthcare Conference 14

15 Priority Review Voucher Legislated in 2007 to reward new products for 16 named neglected tropical disease including cholera; later addition of rare pediatric disease voucher program Priority Review Voucher (PRV) granted upon BLA approval PRV can be used for any drug application PRV can be sold Estimated value $100-$500M from industry surveys System is working; fiveissued to date; FDA honored Novartis (for Coartem malaria); honored by FDA (for canakinumab gout) J&J (for Sirturo tuberculosis); not yet used or sold Biomarin (for VIMIZIM MPS IVA); not yet used or sold Knight (for Impavido leishmaniasis); not yet used or sold PaxVax (for Voyapak cholera); expected in 2015 June 3, 2014 Jefferies Global Healthcare Conference 15

16 Recent IPO s and Vaccine Acquisitions Support Valuation 2013 & 2014 IPOs At Phase 3 15 Companies Mean $508M Median $301M 2014 Companies Positive Phase 3 Data 9 Companies Mean $1,078M Median $826M Excludes public vaccine companies: NVAX $1B, EBS $0.8B, INO $0.5B DVAX $0.4B, GNCA $0.3B Acquirer Company Price Lead Product Year $60m Phase private $250m Phase private $325m Phase private $357m Phase private $546m x sales $2900m x sales June 3, 2014 Jefferies Global Healthcare Conference 16

17 Exceptional - Summary Focus on Specialty Travel Vaccines $5B TAM, 50M travelers, high gross margins Easy market access; no payers or formulary issues Use of Key Account Managers; concentrated market Low Risk High Reward Plan in Place Acquired previously marketed cholera vaccine Bring it to market quickly, replicating past data Acquire marketed travel vaccines (not yet closed) Proprietary Platform and Pipeline Oral Adenovirus 4 live virus as vector for many vaccines Proof of concept in H5 flu; anthrax now in Phase ½ Third technology platform: Dengue vaccine breakthrough Nearing Inflection Point for Value Creation Cholera vaccine revenues in 2015, +EBITDA by 2017 Acquisition accelerates time to +EBITDA to 2016 Business model supports multi-$b market cap in 5 years June 3, 2014 Jefferies Global Healthcare Conference 17

18 The Specialty Travel Vaccine Company