Nexvet Biopharma — Investor Day (November 2015)
54 slides from Nexvet Biopharma's investor day presentation, Nov 23, 2015
Slide 1: Welcome to our Animal Health Symposium
To our Animal Health Symposium Welcome! 23 November 2015 NASDAQ: NVET Exhibit 99.1
Slide 2: Disclaimer
Disclaimer statements. All statements, other than statements of historical facts, contained in and our drug ability di ir duct timing 10K, statements. These statements relate to future events or to our future financial i SEC’). factors y pl by the forward-looking statements. The words “anticipate,”
Slide 3: Overview of the symposium
The animal health industry and opportunities for innovation: Dr George Gunn An overview of Nexvet: Details of the successful NV-01 pivotal study Next steps for Nexvet’s development programs PETization and Nexvet’s R&D Finances and corporate structure Partnerships, market opportunities and near-term
Slide 4: Overview of Nexvet
Overview of Nexvet Dr. Mark Heffernan Chief Executive Officer 23 November 2015
Slide 5: Nexvet: leadership in veterinary biologic therapies
Nexvet: leadership in veterinary biologic therapies Focused: Biopharmaceuticals for companion animals in major indications Platform: Proprietary PETization™ enables rapid monoclonal mAb design Expanding biologics pipeline: Validated Approach:Taking successful mAb targets and making available for com
Slide 6: Building a fully integrated veterinary biopharma
Building a fully integrated veterinary biopharma PETization Platform company >10 programs in drug discovery/ PoC phase Commercialization Prep for NV-01 next phase USDA programs emerging Commercial partnerships: Manufacturing Facility Supplying: Clinical Commercial Clinical & regulatory NV-01: pivota
Slide 7: Today's Nexvet insights: overview
Today’s Nexvet insights: overview NV-01 clinical studies – Dr. Colin Giles: Overview of NV-01 Successful pivotal study overview: protocol and results Upcoming development milestones – Dr. Juergen Horn: NV-01 and NV-02: Next steps BioNua: Nexvet’s manufacturing facility PETization and R&D strategy –
Slide 8: NV-01 study outline and results
NV-01 study outline and results Dr. Colin Giles Vice President of Clinical and Regulatory Affairs 23 November 2015
Slide 9: Nerve growth factor (NGF): an important pain pathway
Nerve growth factor (NGF): an important pain pathway NGF is involved in nerve growth and pain signaling and highly conserved across species Anti-NGF mAbs have demonstrated significant potency in rodent and human trials (Phase II/III) e.g. PFE/LLY studies of Tanezumab Strong human Phase II clinical d
Slide 10: NV-01: canine chronic pain
NV-01: canine chronic pain A “100% dog” anti-NGF mAb with a superior target product profile to NSAIDs on multiple parameters Nexvet’s NV-01 Chronic pain associated with osteoarthritis Subcutaneous injection once every 4 weeks NV-01 safe and well-tolerated in pivotal and POC studies Pivotal study met
Slide 11: Osteoarthritis and pain in dogs
Osteoarthritis and pain in dogs Osteoarthritis (OA) is a painful condition that affects many dogs NV-01 is being developed as a once monthly treatment for the control of pain associated with OA in dogs To gain regulatory approval of a new veterinary medicine, the FDA and other Regulatory Agencies re
Slide 12: Pivotal study design
Pivotal study design A study to compare NV-01 administered by subcutaneous injection in comparison to placebo, for the control of pain associated with OA in dogs. Final evaluable case number. Total enrollment was 262. 246 6 study sites in U.S., 3 in France, 3 in Germany Treatment Number of dogs (fin
Slide 13: Treatments and assessments
Treatments and assessments 3 treatments (NV-01 or placebo), are given at days 0, 28 and 56 1 vial per 10 kg of dog body weight, given subcutaneously Assessments are made at days 0,14, 28, 56, and 84 Day 112 final telephone check Efficacy variables: Primary: Clinical success as determined by CSOM (to
Slide 14: Results of study
Results of study 262 dogs were enrolled in the study, and there were 246 evaluable cases. The primary endpoint was achieved with a statistically significant improvement over placebo in clinical success rate as determined by changes in Client-Specific Outcome Measures (CSOM) score between enrollment
Slide 15: NV-01 pivotal study: overall summary
NV-01 pivotal study: overall summary Treatment Days Assessment Day 0 14 28 56 84 112 CSOM success ✔ CSOM group medians ✔ CBPI success ✔ CBPI group medians ✔ CSOM global assessment Significantly different Very close to significance Not significant Final check of dog ✔ P=0.0046 P=0.038 P=0.0268 P=0.04
Slide 16: Other ongoing study
Other ongoing study Additional study in client-owned dogs is ongoing This study is investigating different dosage regimens and treatment options The study is still in progress; dogs have been recruited from 15 veterinary clinics across the USA Study expected to be complete in Q1 2016 We also plan to
Slide 17: What does all this mean?
What does all this mean? This pivotal study success is a major advance for the NV-01 program It provides a substantial basis for planned submissions for marketing authorization in the U.S., EU, and the rest of the world It also provides strong evidence on multiple efficacy endpoints which is very en
Slide 18: Lead program development
Lead program development Dr. Juergen Horn Chief Product Development Officer 23 November 2015
Slide 19: NV-01: First mover mAb in chronic canine pain
NV-01: First mover mAb in chronic canine pain Efficacy confirmed Substantial body of evidence as basis for planned submissions for marketing authorizations in both the U.S. and Europe Submission of Effectiveness technical section to FDA (US) planned in Q2 2016 2016: Next steps FDA feedback on CMC st
Slide 20: NV-02: a fully felinized anti-NGF mAb
NV-02: a fully felinized anti-NGF mAb Parameter Lead indication Dosing Safety Efficacy Nexvet’s NV-02 Chronic pain associated with degenerative joint disease Subcutaneous injection once every 4-6 weeks No safety issues seen to-date Seen in acute pain model equivalent to meloxicam Positive top-line d
Slide 21: NV-02: strong supportive data to-date
NV-02: strong supportive data to-date P < 0.05 Median Score Improvement Multiple studies in Proof-of-Concept (PoC) phase show positive safety, PK and efficacy potential 32 cat efficacy study completed successfully PoC in client owned cats Statistically significant top-line results seen in 3 week CSO
Slide 22: NV-02: ongoing pilot study
NV-02: ongoing pilot study Anticipated study completion in Q2 2016 Positive outcome = initiate pivotal program in 2016 15 Investigator sites in the United States Cats with naturally occurring osteoarthritis, a common form of degenerative joint disease Placebo-controlled blinded pilot field safety an
Slide 23: BioNua: integrated manufacturing
BioNua: integrated manufacturing Our plan: Equipment: Investment in state-of-the-art disposable bioprocessing technology Manufacturing: Production site for clinical trial material and commercial product for NV-01 and NV-02 and other Nexvet products People: Experienced and highly motivated staff Time
Slide 24: BioNua: opportunities
BioNua: opportunities Full control of manufacturing from discovery to the market Independence from CMOs - Priorities set according to Nexvet strategy - Addresses issues with CMO ANVISA restrictions Improved cost-efficiency of development & commercial cost of goods
Slide 25: Conclusions
Conclusions NV-01 on track toward submission for marketing approval NV-02 in large multi-center pilot client-owned cat study BioNua: number of strategic advantages through integrated manufacturing
Slide 26: PETization platform and R&D strategy
PETization platform and R&D strategy Dr. David Gearing Chief Scientific Officer 23 November 2015
Slide 27: Background
Background Nexvet is committed to producing truly innovative biopharmaceuticals for animal health We have a team of scientists dedicated to biopharmaceutical drug discovery We have pioneered and patented a novel platform technology, PETizationTM, which enables rapid and effective inter-species trans
Slide 28: The R&D team
The R&D team Director of Research Dr. Sam Busfield Director of Development Dr. Dallas Hartman Key achievements At CSL Ltd: Developed world-class analytical biochemistry capabilities to support global research and development projects Led delivery of comprehensive analytical characterization packages
Slide 29: The R&D team
The R&D team Core function and capabilities Large-scale production of therapeutic proteins Development of purification processes Characterization and identification of stable drug formulations Core function and capabilities PETizing and designing antibodies Laboratory validation of candidates Potenc
Slide 30: The R&D facility: our "Labradory"
The R&D facility: our “Labradory” Origin of the company and PETization platform Strong R&D/biopharma talent Culture based on innovation Supportive R&D tax environment Outstanding Infrastructure: Intending to move to new location within the prestigious Walter & Eliza Hall Institute (WEHI) Our core R&
Slide 31: PETization: a platform technology for rapid discovery
PETization: a platform technology for rapid discovery Many of our programs have originated from PETization PETization: Algorithm-based approach that converts mAbs from one species to another Proprietary and patent protected The key advantages of PETization are: Rapid Retention of the affinity of the
Slide 32: Conventional antibody conversion: competitor methods
Conventional antibody conversion: competitor methods Conventional or ‘traditional’ CDR-grafting and affinity maturation is slow Process is inefficient: affinity of resulting mAb often lower than parent antibody Results in less than 100% species-specific antibody sequence: chance of immune reaction i
Slide 33: PETization: the Nexvet method
PETization: the Nexvet method Leverages the diversity in expressed IgG variable domain framework sequences (captured in proprietary Nexvet databases) Rapid and robust: an in silico algorithm Complete species conversion with maintenance of parent antibody affinity Results in 100% species-specific ant
Slide 34: Safety by design
Safety by design PETization process designs 100% species compatibility IgG isotypes used in NV-01 and NV-02 do not recruit complement or activate ADCC Synthetic genes: no dog or cat DNA used in making antibodies Impeccable host CHO-SK1 cell line provenance: as used for human mAbs CHO cell lines nega
Slide 35: Areas of product development
Areas of product development We are focused on therapeutic proteins in four areas for new development: Focus on conditions with significant unmet medical need >10 active programs, many progressing into POC over next 12 months USDA-regulated products will allow for faster commercialization Pain Infla
Slide 36: Active Programs
Active Programs Stage of Development Therapeutic Area Indications Species Lead identification Proof-of-concept* PETization and in vitro work pk s i e Inflammation OA (dog/cat), chronic kidney disease (cat), Inflammatory bowel disease Our research pipeline of biologic therapies *Includes pharmacokine
Slide 37: Conclusions
Conclusions In-house drug discovery capabilities leveraging R&D incentives Proprietary and clinically proven platform technology Robust pipeline: programs progressing towards and through exploratory PoC studies Products regulated by USDA will enable accelerated commercialization in the US Our biothe
Slide 38: Financing and Corporate Structure
Financing and Corporate Structure Damian Lismore Chief Financial Officer 23 November 2015
Slide 39: Financial overview Q1 F2016
Financial overview Q1 F2016 (June 30 balance date) Cash at September 30, 2015: $47.7m Operating loss of $4.0m in first quarter. Includes an exchange gain of $1.0m $0.6m income under Australian R&D incentive program Operating expenses: R&D $3.7m G&A $1.9m Other Received $3.1m cash under Australian R&
Slide 40: Effective corporate structure
Global HQ Dublin, Ireland Manufacturing base Commercialization IP base Tax offset for R&D Melbourne, Australia U.S. HQ U.S. corporate base Clinical & regulatory Marketing & sales Effective corporate structure Operations, R&D Manufacturing Clinical Sales & Marketing Incentives – IDA Grant support – R
Slide 41: Leveraging the corporate structure
Leveraging the corporate structure Standard project Australia Ireland Cash flow 45% cash refund if >50% of relevant spend in Australia IDA grant 25% R&D incentive $2.3m in F2014 $3.1m in F2015 Yes Yes (over 3 years) CMC Clinical Australia Ireland USA Research
Slide 42: BioNua snapshot
BioNua snapshot Overview of transaction Facility historically operated under Investigational Medicines Product License and a cGMP Manufacturing License Paid 1.75m ($2.0m) Entered a 10 year lease - $118K p.a. initially, market assessments, with purchase option after 5 years Initial capex requirement
Slide 43: IDA grant overview
IDA grant overview Overview IDA Ireland support of over $2m cash grant over 4 years Support for equipment, people and project-specific manufacturing Payments contingent on milestone achievements IDA Ireland retains re-imbursement rights in all agreements Cash flow and reporting Cash: normally paid a
Slide 44: Summary
Summary Strong cash position as of September 30, 2015: Internalizing manufacturing reduces development costs and COGS Nexvet positioned for pipeline growth in cost-effective manner Leveraging skillsets, favorable tax incentives and non-dilutive grants $47.7m
Slide 45: Partnerships and value catalysts
Partnerships and value catalysts Dr. Mark Heffernan Chief Executive Officer 23 November 2015
Slide 46: Corporate partnerships: accelerating commercialization
Corporate partnerships: accelerating commercialization Nexvet has entered two major collaboration arrangements in the last year Our collaborators are attracted to: Differentiated target product profiles (dosing, efficacy, safety potential) Our ability to produce 100% species-specific products, rapid
Slide 47: Corporate partnerships: Virbac and Zenoaq
Corporate partnerships: accelerating commercialization Collaboration and distribution agreement for NV-01 First option to negotiate other PETization-derived products Virbac has EU and ROW rights, Nexvet retains U.S./Canadian rights Milestone payments on regulatory approval, profit share agreement Ne
Slide 48: Dog pain opportunity (NV-01)
Dog pain opportunity (NV-01) Commercial need for a long-acting, safe treatment option May Increased diagnosis of dog osteoarthritis since 2007 38% U.S. small animal pain market, dominated by canine NSAIDs (from ~ $10m before NSAIDs hit market in 1996) $272M of 2014 U.S. sales were NSAIDs despite kno
Slide 49: Cat pain opportunity (NV-02)
Cat pain opportunity (NV-02) Medical and commercial need for a long-acting, convenient, safe treatment option May Of U.S. NSAIDs sales only ~$8m are for cats because of known limitations: Side effects particular concern with cats Short half-life ~$8M Majority of cats show evidence of arthritis Major
Slide 50: Allergy and inflammation; immuno-oncology
Allergy and inflammation Allergy and inflammation are often linked Multiple organ systems affected by chronic inflammatory conditions: Dogs: Atopic dermatitis, arthritis, inflammatory bowel disease, diabetes Cats: Dermatitis, arthritis, chronic kidney disease Atopic dermatitis affects ~10% dogs New
Slide 51: New opportunities: horse pain
New opportunities Pain (horses) Up to 60% of horse lameness is due to osteoarthritis (OA) 50% of horse operations in the USA reported at least one case of lameness in the prior year Surveyed veterinarians said 15% of horses they see every month had chronic OA pain1 Horse populations: ~8.3m U.S ~6m E
Slide 52: Pipeline of biologic therapies
Active Programs Stage of Development Therapeutic Area Species Lead Identification Proof-of-concept* Pilot Pivotal Indicative Approval Pain OA pain ~2018/2019 ~2019/2020 Inflammation OA, IBD, CKD Allergy Pruritis/Atopic Dermatitis Pipeline of biologic therapies NGF = Nerve Growth Factor; TNF = Tumor
Slide 53: 2016: Major value catalysts
2016: Major value catalysts NV-01: Positive pivotal safety and efficacy study results received (Q4 2015) Receipt of pilot study data (Q1 2016) Submission of technical effectiveness section to FDA (Q2 2016) Initiation of pivotal safety study (2016) Transfer of process to BioNua (2016) NV-02: Pilot st
Slide 54: Nexvet: Transforming animal medicine
Nexvet” Transforming animal medicine vista sion eK