BIO CEO & Investor Conference February 2006

Transcription

1 BIO CEO & Investor Conference February 2006

2 Safe Harbor Statements made in this press release that state Novavax's or its management's intentions, hopes, beliefs, expectations, or predictions are forward-looking statements. Forward-looking statements include but are not limited to statements regarding usage of cash, product sales, future product development and related clinical trials and future research and development, including FDA approval. Novavax's actual results could differ materially from those expressed in such forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from those expressed or implied by such forward-looking statements. Such factors include, among other things, the following: general economic and business conditions; ability to enter into future collaborations with industry partners; competition; unexpected changes in technologies and technological advances; ability to obtain rights to technology; ability to obtain and enforce patents; ability to commercialize and manufacture products; ability to maintain commercial-scale manufacturing capabilities; results of clinical studies; progress of research and development activities; business abilities and judgment of personnel; availability of qualified personnel; changes in, or failure to comply with, governmental regulations; the ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity financing or otherwise; and other factors referenced herein. Additional information is contained in Novavax's annual report on Form 10-K for the year ended December 31, 2004 and quarterly reports on Form 10-Q for the quarters ended March 31, 2005, June 30, 2005 and September 30, 2005, incorporated herein by reference. Statements made herein should be read in conjunction with Novavax's annual and quarterly reports filed with the SEC. Copies of these filings may be obtained by contacting Novavax at 508 Lapp Road, Malvern, PA 19355, Tel or the SEC at 2

3 Agenda Corporate Strategy Novavax Vaccines Drug Delivery Products Strategy Execution 3

4 Novavax: A Unique Capability Blend Formulation Science Adjuvants Vaccine Technologies Flu Vaccine Products Drug Development & Manufacturing Infrastructure 4

5 Novavax Strategy Shareholder Value Vaccines (growth) Drug Delivery Products (harvest) Time 5

6 Market Validation Share Price $5.00 $4.50 $4.00 $3.50 $3.00 $2.50 $2.00 $1.50 $1.00 $0.50 Aug 2005 Nov

7 Vaccines (Growth Strategy) Technology Overview Pandemic Flu Vaccine Seasonal Flu Vaccine Pipeline beyond Flu 7

8 Antigen: Virus-Like Particles (VLPs) Influenza Virus Purified Flu VLPs M1 HA NA Hemagglutinin (HA) Neuraminidase (NA) Core (M1) 100 nm 8

9 Adjuvant: Novasomes Novasome + Influenza virus = Virusome 9

10 Vaccines Technology Overview Pandemic Flu Vaccine Seasonal Flu Vaccine Product Pipeline 10

11 Pandemic Flu Vaccine: Challenges Emerging Strain Immunogenicity Surge Capacity Lead Time Strain Match Dose, schedule Adjuvants Limited capacity Cost 11

12 Pandemic Flu Vaccine: Solutions rdna VLP, Adjuvants Redefine Surge Capacity 12

13 Recombinant Virus-Like Particle (VLP) Vaccine ppolh N2 ppolh H9 ppolh M1 HA NA M1 100 nm Exact genetic match Right 3D configuration of HA protein Efficient insect cell-based production Allows surge capacity 13

14 VLPs Mimic Whole Influenza Virus Influenza Virus Purified VLPs HA NA M1 100 nm 14

15 rdna VLPs Reduce Lead Time NA HA M pfu influenza virus HA, NA, and M1 baculovirus vector rtpcr cloning HA, NA, and M1 genes Master and Working Seed stocks Day 1 Day 3 Day 7 Day 21 Day 30 Day 40 Day 45 15

16 rdna VLPs Reduce Lead Time VLP Production HA/NA/M1 VLPs Secreted Bulk VLPs Potentially Unlimited Supply of Vaccine Day Day Day 60 16

17 Pandemic Flu Vaccine: Solutions rdna VLP, Adjuvants Redefine Surge Capacity 17

18 VLPs Increase Immunogenicity µg HA subunit (soluble protein) 10 µg HA subunit + Novasomes Serum HAI antibody titer (log 2 ) µg HA in VLPs 1 µg HA in VLPs + Novasomes Protective HAI levels 6 4 Protective HAI levels 2 primary boost primary boost 18 *Source: Center for Disease Control

19 Novasomes : A Proprietary Adjuvant For use with vaccines for the prevention of infectious diseases [USPTO # 6,387,373 B1, Date of issue: May 14, 2002] Novasome + Influenza virus = Virusome 19

20 Novasomes Improve Immunogenicity of Flu Vaccines (Protective ferret model with H3N2) Week Inactivated Flu Vaccine (Serum HAI Titers, 1/dilution) Virusome * * * Post Challenge * * Statistically significant (ANOVA) 20

21 Pandemic Flu Vaccine: Solutions rdna VLP Adjuvants Redefined Surge Capacity 21

22 Traditional Cell Culture Limitations Stainless-steel tanks Difficult to clean, sterilize, operate $ MM/facility Difficult to expand No surge capacity months to commission 14 22

23 Disposable Cell Culture Inflated plastic bag Disposable cultivation chamber Wave action Large turbulent surface Good oxygen transfer Prevents cell settling 15 23

24 Proven Scale-Up to 500 Liters Wave Bioreactor System500/1000 Ideal for insect cell/vlp vaccine process Completely closed system No biosafety/containment issues High productivity. Quick turnaround. Easy cultivation process Low cost medium Potential Influenza vaccine output per 500L batch = MM eggs 16 24

25 Minimal Infrastructure, Low Cost Disposable Tank-based Construction time 5 months months Cost $ 1 million $ 3-5 million GMP cell culture capability to 500L PacificGMP, San Diego CA 17 25

26 Pandemic Flu Vaccine: Solutions rdna VLP, Adjuvants Disposable Mfg Reduced Lead Time Exact Strain Match Single dose Novasome Large capacity Low cost 26

27 Vaccines Technology Overview Pandemic Flu Vaccine Seasonal Flu Vaccine Product Pipeline 27

28 Potential Seasonal Flu Vaccine Candidate Broader Coverage Better immunogenicity: Adult & Pediatric populations Better Efficacy Higher fidelity with HA Lower Cost Amenable to Combination Therapy 28

29 Vaccine Product Pipeline Avian Flu HIV E-Selectin Seasonal Flu 29

30 Drug Delivery Products (Harvest Strategy) 30

31 Drug Delivery Technology Platforms Micellar Nanoparticles (MNP) Focus Novasomes Sterisomes TM 31

32 MNP Drug Delivery in Skin 1. Skin layers allow drug reservoir 2. MNP deposits drug in skin 3. Reservoir releases drug to blood Sustained delivery of drug at steady therapeutic levels 32

33 Benefits of MNP Delivery System Avoid GI side-effects Eliminates adhesive & unsightly patch Avoid first-pass hepatic effect Moisturizes skin High drug concentration in application area Non-invasive Lotion enlarges application site vs. patches Once daily dosing 33

34 Estrasorb FDA approved October st and only estrogen topical emulsion Licensed to Esprit Pharma, October 2005 (North America) Licensing discussions underway for other geographies Indication: moderate-to-severe vasomotor symptoms associated with menopause 34

35 Harvest Strategy Beyond Estrasorb Develop New Products Using Proprietary Technologies Cash Identify Compounds With Unique Formulation Needs New Various stages of Development Business Development Harvest product by Licensing/partnering/ Co-development Business Development Leverage Formulation Dev And Mfg Move select products Further Along Business Development Development Value Chain 35

36 Value Proposition Opportunity Example Value Proposition Resources Deployed Private Speciality Pharma Esprit Basket of products, IPO Commercial Focus Big Pharma Consumer Div Unnamed Differentiation, Market Share for Existing Product Generic Ranbaxy Branded Generics Biotech Start Up with NCE Unnamed Speed to market Formulation Technology Development Experience Production Facilities 36

37 MNP Product Development Hormone Products Improved High Value Oral Products Available Topicals APIs Application Androsorb In Patches Acyclovir Raloxifene Sirolimus Norethindrone Nicotine Antifungals Alendronate Estradiol/ Fentanyl Loratadine Naltrexone Norethindrone Oxybutinin Higher Risk, Higher Value 37

38 Strategy Execution Who? Novavax Team With What? Novavax Resources How? Business Model When? Milestones 38

39 Management Team Rahul Singhvi, ScD President & CEO 10 years with Merck & Co. Ray Hage, SVP & COO Various Sales & Marketing positions at Lilly & Cephalon Dennis Genge, VP & CFO Various Acctg & Finance positions at Ligand, Picxus Steve Bandak, MD VP Medical Affairs 26 Years at Lilly in Clinical Research Robert Lee, PhD, VP Pharmaceutical Development Co-founder Nanosystems, VP at Lyotropics, Imcor Gale Smith, PhD, VP Vaccine Development Inventor Baculovirus system insect cells, CSO Protein Sciences D. Craig Wright, MD Chief Scientific Officer Co-founder of Novavax, prolific inventor, infectious disease expert 39

40 Novavax Resources Experience w/ Drug Development thru FDA Approval GMP drug manufacturing facility in PA GMP biological clinical facility in Rockville, MD Financial stability - $32MM cash (12/31/06) Relationships: US Congress, NIH, CDC 40

41 Milestones Exit pharmaceutical sales & reduce burn Monetize legacy products Address cash position Refocus on product development Sign MNP licensing deal(s) Start Phase I Avian Flu vaccine trials Conduct MNP Product Proof of Concept Studies in Man 41

42 Participate in the Novavax Opportunity! Formulation Science Adjuvants Vaccine Technologies Flu Vac. Products Drug Development & Manufacturing Infrastructure 42