Nexvet Biopharma — Investor Presentation (June 2016)
48 slides from Nexvet Biopharma's investor presentation, Jun 3, 2016
Slide 1: Investor update
Investor update 3 June 2016 Nexvet*TM Transforming animal medicine
Slide 2: Forward-looking statements
Forward-looking statements This presentation and other presentations given today contain forward-looking statements. All statements, other than statements of historical facts, contained in these slides and the accompanying oral presentation, including statements regarding our future results of opera
Slide 3: Our vision
Our vision “The Genentech” of animal health A company born from a novel platform technology dedicated to market disruption via the superiority of biopharmaceuticals
Slide 4: Animal health fundamentals: U.S. market
Animal health fundamentals: U.S. market Increasing importance of pets as members of the family $60.3B Increasing total spend on +6% 2015 pets Pet adoption up 11% 1 11% Feb 2014- Feb 2015 86m 78m U.S. dog and cat populations Veterinary services $15.4B in 2015 Prescriptions historic annual growth: 8%1
Slide 5: The human biologics revolution
The human biologics revolution Human mAb sales per annum 40 35 30 (billions) 20 $ US 15 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Year Oncology Autoimmune/inflammatory Other mAbs: a leap forward Safety Specificity Injectable Monthly dosing Of 2015’s 10 best-selling h
Slide 6: Animal health fundamentals: innovation vacuum
Animal health fundamentals: innovation vacuum Innovation ‘traditionally’ focused on livestock Products gradually migrated to pets (e.g. parasiticides) Generics now widespread in pet therapeutics Pet therapeutics innovation lags market need Industry leaders hungry for novel blockbusters Nexvet: posit
Slide 7: Delivering the vision
Delivering the vision Validated platform Broad IP portfolio Novel pipeline Global partnerships Vertically integrated team technology 9 patent families >85 patents pending >15 granted
Slide 8: PETization: a platform for rapid mAb design
PETization: a platform for rapid mAb design 1. All our biologics programs have originated from PETization 2. An algorithm-based approach that converts mAbs from one species to another 3. Proprietary, patent-protected, and clinically validated in three species 4. The key advantages of PETization are:
Slide 9: Pipeline
Pipeline Therapeutic Research AND Est. Target Pilot study Pivotal studies area POC approval Ranevetmab ~2019 Chronic pain NGF NV-02 ~2019 Chronic Dog Multiple TNF Further studies to commence when POC complete inflammation Cat in progress Dog Allergy Undisclosed Cat Multiple Dog in progress Cat Immun
Slide 10: Partners
Partners Research and development Distribution and development The Zenoaq collaboration provides: Novel starting mAbs and IP to targets North American and ROW rights (excl. Asia and Europe) to resulting products The Virbac collaboration provides: Distribution channels ROW development and regulatory
Slide 11: Our global expertise
Our global expertise
Slide 12: Agenda
Agenda Dr. Juergen Horn, CPDO: Clinical programs Ray O’Connor, VP Technical Operations: BioNua Damian Lismore, CFO: Financials and strategy
Slide 13: Development update
Development update Juergen Horn | Chief Product Development Officer June 2016
Slide 14: Overview: organisation & expertise
Overview: organisation & expertise Highly experienced team in all relevant areas Network of industry proven CROs/CMOs and industry and academic consultants Integrated biopharmaceutical manufacturing facility Nexvet internal New Product Development resources and expertise Clinical Regulatory Manufact
Slide 15: BioNua: achievements since purchase
BioNua: achievements since purchase Recruitment of expert staff and update/refurbishment of facility Installation of state-of-the-art disposable biopharmaceutical equipment Transfer of licenses from previous owner Successful production of first 200L demo batch Drug product manufacturing site selecte
Slide 16: Chronic pain in dogs: first-in-class opportunity
Chronic pain in dogs: first-in-class opportunity >140m pet dogs in U.S. and EU U.S. small animal $284m pain drug sales 83% 2015 Daily pills: • poor compliance ~95% 60% owners would pay for more convenient dosing Dog population is aging: ~20% will get osteoarthritis (OA) NSAIDs dominate despite: • la
Slide 17: Ranevetmab: target product profile unique to dog market
Ranevetmab: target product profile unique to dog market Parameter Nexvet’s ranevetmab 100% Control of pain associated Lead indication canine mAb with osteoarthritis Dosing Subcutaneous injection once every 4 weeks Safety Safe and well-tolerated Ex-U.S. & CAN Pivotal study met primary profit share Ef
Slide 18: Ranevetmab: achievements in 2015/2016
Ranevetmab: achievements in 2015/2016 Successful completion of pivotal OA study TAS protocol concurred Meetings with regulators (U.S., EU): clarity on requirements Successful introduction of new purification step to improve yield even further Successful transfer from CMOs for process development: ro
Slide 19: Chronic pain in cats: a major first-mover opportunity
Chronic pain in cats: a major first-mover opportunity Medical and commercial need for a Majority of older cats show long-acting, convenient, safe evidence of arthritis treatment option No pain drugs approved for Veterinarians concerned about long-chronic use in U.S. term safety of NSAIDs given: Maxi
Slide 20: NV-02: clinical data supports target product profile
NV-02: clinical data supports target product profile 100% feline mAb Pilot safety study: successful Proof-of-concept efficacy: successful P <0.05 Score CSOM at 3 weeks post- N=32 treatment (Client Specific Outcome Improvement Median Measures) Cat pilot safety and efficacy (126 enrolled): positive to
Slide 21: NV-02: achievements 2015/16
NV-02: achievements 2015/16 Successful completion of pilot OA study TAS protocol submitted to FDA-CVM for concurrence Regulatory confirmation that NV-02 follows same principles as NV-01 Successful transfer from CMOs to BioNua: first 200L demo batch successfully produced Next Steps: Protocol concurre
Slide 22: Anti-PD-1: first-in-class opportunity
Anti-PD-1: first-in-class opportunity ` Blocking PD-1 activity exposes tumor cells to immune attack PD-1 in humans Cancer in dogs First approval: late 2014 Between 14% and 27% of Trials: Hundreds dogs die of cancer Trial patients: Current standards-of-care Thousands 2020 sales: $14B (E) have signifi
Slide 23: USDA: achievements 2015/16
USDA: achievements 2015/16 Candidate anti-PD-1 PETized mAbs identified USDA jurisdiction granted for anti-PD1 mAbs Identified experienced regulatory and manufacturing partner for USDA programs Product Development Plan established for first USDA development program Next Steps: Initiate PKPD/safety an
Slide 24: Anticipated value drivers: target time windows
Anticipated value drivers: target time windows Pivotal safety completion Ranevetmab FDA CMC – manufacturing process validation & stability approval US Last Technical Section US & EU dossier Submission Ranevetmab & Approval Process Pivotal efficacy completion NV-02 FDA approval Pivotal safety complet
Slide 25: Establishment of internal drug substance manufacturing capabilities: BioNua
Establishment of internal drug substance manufacturing capabilities: BioNua Ray O’Connor | VP Technical Operations June 2016
Slide 26: Strategic importance of BioNua
Strategic importance of BioNua 1. Dedicated CMOs for veterinary mAbs do not exist 2. There are substantial challenges with sharing veterinary and human manufacturing space 3. There is currently shortage of global biopharma manufacturing capacity 4. Regulators require strong linkage between clinical
Slide 27: Development and commercialization strategy
Development and commercialization strategy Nexvet Australia CMO 1. PETization 1. Clonal cell line 1. Process development 2. Generation of development and scale-up PoC material 2. Generation of 2. Manufacture of drug 3. Biological + Master Cell substance for clinical analytical Bank supply assay 3. P
Slide 28: Development and commercialization strategy
Development and commercialization strategy Nexvet U.S. Drug product CMO 1. Pivotal studies 1. Fill & finish of drug 1. Commercial 2. Management of CRO manufacture of drug substance into vials 3. Regulatory affairs substance 2. Labelling and 2. Continuous Process packaging of product Improvement for
Slide 29: Facility overview: a unique opportunity
Facility overview: a unique opportunity • 20,000 square feet • Previously licensed by Health Products Regulatory Authority for commercial and clinical manufacture of API. • Development and analytical laboratories • Key utilities include purified water, water for injection (WFI), clean steam, waste t
Slide 30: Acquisition process
Acquisition process Full due diligence was performed from May to September 2015 Engineering review determined that facility was well maintained and utilities were in good working order A review of the quality systems indicated that the facility had a good track record with the HPRA (Irish Regulators
Slide 31: Manufacturing and development capabilities
Manufacturing and development capabilities Current capacity is approximately 30 x 200L batches per year Facility is capable of scaling up to 1,000L disposable bioreactor The bridge between research to development and onto commercial-scale manufacturing has been established using 250mL and 10L biorea
Slide 32: BioNua: organization chart
BioNua: organization chart 25 FTEs 18 with college degrees 3 PhDs, 7 MScs, 8 BSc or equivalent
Slide 33: Accelerated start-up schedule delivered
Accelerated start-up schedule delivered A traditional start-up schedule 0 month 18 months Delivered BioNua start-up schedule 0 month 9 months Start-up strategy Experienced team Leveraged the previous operator’s infrastructure Purchased high quality disposable equipment: similar to previous CMO Keepi
Slide 34: Typical production process flow: upstream
Typical production process flow: upstream Day 0 Cell expansion Wave bioreactor Incubator N-2 wave bioreactor N-1 wave bioreactor 200L production bioreactor Day 39 200L bioreactor
Slide 35: Typical production process flow: downstream
Typical production process flow: downstream Cell harvest and cell culture Day 39 Chromatography supernatant conditioning skid Capture chromatography Harvest skid UF/DF1 Viral inactivation Anion exchange chromatography Viral filtration UF/DF2 Day 46 UF/DF skid
Slide 36: 200L cell growth in BioNua exceed benchmark
200L cell growth in BioNua exceed benchmark 30 BioNua 6 10 CMO x 25 growth 20 Cell 15 10 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Time (days) Cell growth from first NV-02 BioNua 200L bioreactor greater than previous batches produced by CMOs Technology transfer from established CMO to a new facility
Slide 37: Summary
Summary 1. Facility became available April 2015, and was a highly attractive acquisition 2. It became clear that securing this facility for Nexvet would ensure: A smoother regulatory approval process for our products Continuity of supply Lower COGs Lower development costs for future products 3. Proc
Slide 38: Financing and corporate structure
Financing and corporate structure Damian Lismore | Chief Financial Officer June 2016
Slide 39: Financial overview
Financial overview Q3 F2016 (June 30 balance date) Other R&D credit o Cash at March 31, 2016: $37.2m Australia - Received $3.1m re: F2015 - Receivable $1.4m Q3 YTD Net loss 5.7 15.4 Ireland Disclosed $0.2m R&D income 0.4 1.4 (not booked to income) Operating expenses • Secured dedicated - R&D 4.3 11.
Slide 40: BioNua snapshot
BioNua snapshot Overview of transaction o Facility historically operated under Investigational Medicines Product License and a cGMP Manufacturing License o Paid €1.75m ($2.0m) o Entered a 10 year lease—$118k p.a. initially, market assessments, with purchase option after 5 years o Initial capex requi
Slide 41: IDA grant overview
IDA grant overview Overview o IDA Ireland support of over $2m cash grant over 4 years o Support for equipment, people and project-specific manufacturing o Payments contingent on milestone achievements o IDA Ireland retains re-imbursement rights in all agreements Cash flow and reporting o Cash: norma
Slide 42: Efficient global structure
Efficient global structure Clinical Sales & Marketing U.S. HQ U.S. corporate base Clinical & regulatory Tax Rate ~40% Commercialization & Manufacturing ` Global HQ Tullamore, Ireland Manufacturing base Tax Rate 12.5% Incentives – IDA cash grant support – R&D cash incentives from F2016 Operations, R&
Slide 43: Leveraging the corporate structure
Leveraging the corporate structure Australia Ireland USA CMC Standard Research project Clinical 45% cash refund Australia if >50% of relevant spend in Australia IDA grant Ireland 25% R&D incentive $2.3m in F2014 Cash flow Yes Yes (over 3 years) $3.1m in F2015 March 10-Q Disclosure $1.4m $0.4m $0.2m
Slide 44: Summary
Summary Strong cash position as of March 31, 2016: Nexvet has gained a quality manufacturing facility $37.2m Internalizing manufacturing reduces development costs and COGS Leveraging skillsets, favorable tax incentives and Nexvet positioned for non-dilutive grants pipeline growth in cost-effective m
Slide 45: Summary
Summary Dr. Mark Heffernan | CEO June 2016
Slide 46: Consistent execution to-date
Consistent execution to-date Series B Irish domiciling IPO Corporate Virbac Zenoaq Partnering agreement agreement POC Pivotal efficacy Complementary Ranevetmab completion completion pilot completion POC Pilot Clinical NV-02 completion completion batch ready Manufacturing BioNua facility BioNua facil
Slide 47: Upcoming catalysts
Upcoming catalysts NV-02 pilot study completion (Q2): DELIVERED Bionua operational (Q2): DELIVERED Ranevetmab pivotal data presentation (Q2) Ranevetmab TAE submission (Q2) Anticipated NV-02 pivotal safety and efficacy study initiation (2H) Manufacture clinical material and initiate pivotal TAS study
Slide 48: Nexvet: Transforming animal medicine
Nexvet*TM Transforming animal medicine