Sun Pharma Advanced Research Co. Ltd. · NSE:SPARC
Sun Pharma Advanced Research — Investor Presentation (August 2017)
52 slides from Sun Pharma Advanced Research's investor presentation, Aug 24, 2017
Slide 1: Investor Update on R&D Pipeline
Investor Update on R&D Pipeline 24th August 2017 BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837 © 2017 - Sun Pharma Advanced Research Company Limited (SPARC). All Rights Reserved
Slide 2: Disclaimer
Disclaimer Except for the historical information contained herein, statements in this presentation and the subsequent discussions, which include words or phrases such as “will”, “aim”, “will likely result”,“would”, “believe”, “may”, “expect”, “will continue”, “anticipate”, “estimate”, “intend”, “pla
Slide 3: Agenda
Agenda SPARC Strategy & Market Opportunity – Key 1 Upcoming Milestones Anil Raghavan – CEO 5 Programs Narendra Lakkad – V.P. Business Development 2 Key Clinical Programs SiuLong Yao – Sr. V.P. Clinical Development & Operations 6 Financial Update Chetan Rajpara – CFO 3 Drug Discovery Programs Nitin D
Slide 4: Agenda
Agenda SPARC Strategy & Market Opportunity – Key 1 Upcoming Milestones Anil Raghavan – CEO 5 Programs Narendra Lakkad – V.P. Business Development 2 Key Clinical Programs SiuLong Yao – Sr. V.P. Clinical Development & Operations 6 Financial Update Chetan Rajpara – CFO 3 Drug Discovery Programs Nitin D
Slide 5: SPARC's R&D strategy: Innovation with balanced risk
SPARC’s R&D strategy Innovation with balanced risk 2007 – 2013 2014 – onwards Delivery Systems Innovation v Validated Biology/Novel Chemistry New Targets Oncology | CNS | Inflammation | Ophthalmology | Dermatology Leverage Formulation Development capabilities to pursue low hanging 505(b)(2) opportun
Slide 6: Our short to medium term focus
Our short to medium term focus Execute well while building competencies for the future Conclude late stage clinical programs to enhance revenue visibility Accelerate early stage clinical proof-of-concept Continue to build our operating model and partnerships Augment our early stage pipeline © 2017 S
Slide 7: Focus on near term priorities
Focus on near term priorities SPARC portfolio is gathering momentum Key Milestones Initiated: Tech transfer of ElepsiaTM XR and XelprosTM to ElepsiaTM XR and XelprosTM alternate manufacturing sites Completed: Salmeterol – Fluticasone DPI pivotal program, Execution of pivotal studies Baclofen GRS pat
Slide 8: Our operating model is evolving
Our operating model is evolving Substantial investments to make SPARC future ready Key Priorities Talent acquisition in Discovery Biology, Clinical Development and Regulatory Affairs Capability Development Investments in upgrading the laboratory infrastructure and enabling technologies Computational
Slide 9: Long-term portfolio strategy
Long-term portfolio strategy Focused approach and translational discipline Highly focused program selection Treatment resistance in select cancers Neurodegenerative conditions with clear molecular bases Inflammation/Auto-immune disorders Abuse deterrence Drug Delivery Platform development Selective
Slide 10: Setting expectations: Upcoming milestones for SPARC
Setting expectations Upcoming milestones for SPARC Brimonidine OD SDP – 037 Pivotal study initiation Pivotal study initiation Baclofen GRS Salmeterol – IND Filings Study Fluticasone DPI 4 INDs completion, European MAA NDA filing & filing & Out- Out-licensing licensing SDN – 021 Taclantis™ Pilot HAL
Slide 11: Agenda
Agenda SPARC Strategy & Market Opportunity – Key 1 Upcoming Milestones Anil Raghavan – CEO 5 Programs Narendra Lakkad – V.P. Business Development 2 Key Clinical Programs SiuLong Yao – Sr. V.P. Clinical Development & Operations 6 Financial Update Chetan Rajpara – CFO 3 Drug Discovery Programs Nitin D
Slide 12: Baclofen GRS: Development on track as planned
Baclofen GRS Development on track as planned Recruitment completed for all Phase 3 studies Duration of Action Efficacy Study Safety Study Study Number of 285 135 375 Subjects Status • Recruitment • Studies completed completed • Data under review • LPO – Aug’17 Data read-out in Oct’17 Planned NDA fil
Slide 13: Salmeterol-Fluticasone DPI: Summary of pivotal studies results
Salmeterol – Fluticasone Dry Powder Inhaler Summary of pivotal studies results Peak Inspiratory Flow (PIF) study Mean PIF values well within the required range All subject groups successfully able to use SPARC device High Dose Pharmacokinetic (PK) study Fluticasone and salmeterol PK comparable to Se
Slide 14: Salmeterol-Fluticasone DPI: Next steps
Salmeterol – Fluticasone Dry Powder Inhaler Next steps Based on PIF study, High dose and Low dose PK study data, SPARC is consulting EU regulatory agencies to understand path forward for approval of all 3 strengths EU = European Union © 2017 SPARC 14
Slide 15: Taclantis: Pursuing BE strategy for USA registration
TaclantisTM Pursuing BE strategy for USA registration Novel formulation of paclitaxel using SPARC’s proprietary Nanotecton™ platform technology 100000 Mean Plasma Concentration Completed pilot BA/BE studies 10000 Data suggest possibility of BE in a Total Paclitaxel fully powered PK study 1000 ng/ml
Slide 16: SUN-K0706 CML: Highly selective BCR-ABL inhibitor
SUN – K0706 CML Highly selective BCR–ABL Inhibitor Potent and orally bioavailable SUN – K0706 Plasma Profile Effective against BCR-ABL and its 1000 mutants, including T315I mutation Plasma concentration (ng/mL) Completed Single Ascending Dose 100 (SAD) study in healthy volunteers Orally bioavailable
Slide 17: SUN-K0706 CML: Development status update
SUN – K0706 CML Development status update Plan to complete the MAD study by Q4FY18 Initiation of pivotal efficacy study by Q2FY19 © 2017 SPARC 17
Slide 18: Brimonidine OD: Improving glaucoma patient compliance
Brimonidine OD Improving Glaucoma patient compliance and adherence Brimonidine is a commonly used second line drug to treat Glaucoma Treatment adherence with Brimonidine is highly variable* Patients on Brimonidine TID achieve significantly lower adherence rates* SPARC is developing a novel once-a-da
Slide 19: Brimonidine OD: Similar IOP reduction as Alphagan P TID
Brimonidine OD Achieves similar IOP reduction as Alphagan® P TID Proof-of-concept established in Phase 2 study in 140 Glaucoma patients Met pre-specified clinical equivalence efficacy criteria compared to Alphagan® P TID at all time points No new adverse events reported Brimonidine OD Vs Alphagan® P
Slide 20: Brimonidine OD: Development status update
Brimonidine OD Development status update EoP2 meeting with US FDA & IND filing by Q3FY18 Phase 3 initiation by Q4FY18 EoP2 = End of Phase 2 © 2017 SPARC 20
Slide 21: SUN-597 Topical: Development status update
SUN – 597 Topical Development status update Novel topical steroid for steroid responsive dermatoses IND opened in USA Phase 1 vasoconstrictor assay study completed Initiating pilot study in psoriasis patients, topline data expected by Q3FY18 Phase 1 healthy volunteer safety/tolerability study planne
Slide 22: Agenda
Agenda SPARC Strategy & Market Opportunity – Key 1 Upcoming Milestones Anil Raghavan – CEO 5 Programs Narendra Lakkad – V.P. Business Development 2 Key Clinical Programs SiuLong Yao – Sr. V.P. Clinical Development & Operations 6 Financial Update Chetan Rajpara – CFO 3 Drug Discovery Programs Nitin D
Slide 23: Parkinson's Disease: Growing evidence of c-Abl kinase involvement
Parkinson’s Disease Growing evidence of c-Abl kinase involvement 10 mn people worldwide living with Parkinson’s Disease^ Currently available therapies provide symptomatic relief only No disease modifying therapy available Expression and activation of c-Abl kinase is observed in neuronal cells overex
Slide 24: SUN-K0706 PD: Neuroprotective activity in mouse model
SUN – K0706 PD Promising neuroprotective activity in mouse model of PD Representative photomicrographs showing TH-immunoreactive neurons in SNPc 14 Integrated Density of TH-Immunoreactivity 25 % Area of TH-Positive Neurons 12 10 20 Int Density 8 15 % Area 6 10 4 5 2 0 0 Naïve Placebo of K0706 (1 mpk
Slide 25: SUN-K0706 PD: Initiated Phase 1 study
SUN – K0706 PD Initiated phase 1 study in Parkinson’s Disease patients Phase 1 Assessment of PK, safety and tolerability in patients Study ongoing; 2 cohorts completed Phase 2 Proof of efficacy study in Parkinson’s Disease patients to be initiated © 2017 SPARC 25
Slide 26: SCD-044: Selective S1P Receptor 1 agonist
SCD – 044 Novel highly selective S1P Receptor 1 agonist for auto-immune disorders Project under collaboration with Bioprojet, France Fingolimod is the 1st in class S1P receptor agonist approved for Multiple Sclerosis US$ 3.1 bn global sales in 2016* Being non-selective modulator, Fingolimod is assoc
Slide 27: SCD-044: Comparable pre-clinical efficacy to Fingolimod
SCD – 044 Comparable pre-clinical efficacy to Fingolimod Achieves comparable lymphopenia, a marker of efficacy, across different species Drug Lymphopenia SCD – 044 is efficacious in animal models of autoimmune inflammation Rat, 0.3 mg/kg Dog, 0.3 mg/kg Desirable oral bioavailability and PK profile 2
Slide 28: SCD-044: Development status update
SCD – 044 Development status update Completed 13 week toxicity studies in rodents and primates Completed safety pharmacology and preclinical efficacy studies IMPD filed in Europe Phase 1 initiation by Q3FY18 IMPD = Investigational Medicinal Product Dossier © 2017 SPARC 28
Slide 29: Agenda
Agenda SPARC Strategy & Market Opportunity – Key 1 Upcoming Milestones Anil Raghavan – CEO 5 Programs Narendra Lakkad – V.P. Business Development 2 Key Clinical Programs SiuLong Yao – Sr. V.P. Clinical Development & Operations 6 Financial Update Chetan Rajpara – CFO 3 Drug Discovery Programs Nitin D
Slide 30: Prescription Opioids Abuse
Prescription Opioids Abuse IR opioids are most vulnerable >20,000 deaths occurred in 2015 due to prescription opioid overdose* Common routes of IR opioid abuse 100% 66% of abusers prefer IR 90% formulations# 80% 70% • Ease of manipulation drives 60% % abusers preference for IR dosage forms 50% Oral
Slide 31: SDN-021: Designed to deter multi-pill oral abuse
SDN – 021 Designed to deter multi-pill oral abuse Delivers clinically effective dose if used as Schematic representation of prescribed technology Upon ingestion of multiple pills, the technology reduces peak drug levels and slows down the release Deprives abuser of the desired “high” with multiple p
Slide 32: SDN-021: Lead formulation demonstrated acceptable PK
SDN – 021 Lead formulation demonstrated acceptable PK characteristics Single tablet PK data Multiple tablet PK data Cmax blunted by ~30% Tmax delayed Cmax blunted by ~50% SDN-021 fasted Ref fasted SDN-021fed Ref fed Ref fasted SDN-021 fed SDN-021 fasted Fed state – Potential to meet BE in Ingestion
Slide 33: SDN-021: Development status update
SDN – 021 Development status update In-vitro Category I Abuse Deterrence studies and Pilot Human Abuse Liability (HAL) studies planned in Q3FY18 Consultation with USFDA planned to discuss registration pathway and Abuse Deterrence label for oral multi-pill abuse © 2017 SPARC 33
Slide 34: Minocycline Topical: Development status update
Minocycline Topical Development status update Preclinical PoC in Acne model Novel safer and efficacious formulation of 1.9 minocycline for Acne 1.8 Placebo Formulation optimized based on successful rabbit 1.7 Right Ear Thickness (mm) toxicity study outcome Disease Control Minipig toxicity study Mean
Slide 35: SDP-037: Novel BID steroid for ocular pain and inflammation
SDP – 037 Novel BID steroid for Ocular pain and inflammation Steroids are mainstay treatment for ocular pain SDP – 037 Reference & inflammation Steroid US$ 750 mn sales in USA* Currently approved steroid eye drops are administered 3 to 4 times per day Marketed eye drops have hazy/milky appearance wh
Slide 36: SDP-037: Designed with novel Micellar Technology
SDP – 037 Designed with novel Micellar Technology Uses proprietary composition of non-ionic, cationic and anionic solubilizers to produce unique micelles Solubilization of steroid provides clear colorless appearance Polymeric stabilizer provides longer retention and bio-adhesion Helps retain efficac
Slide 37: SDP-037: Comparable pre-clinical efficacy at BID dosing
SDP – 037 Comparable pre-clinical efficacy at BID dosing and lower drug concentration Efficacy of SDP-037 vs. Reference Efficacy of SDP-037 vs. Reference Steroid in rabbit model of acute uveitis Steroid in rabbit model of paracentesis 70 3 60 2.5 Total Cell count 50 PGE2 (ng/ml) 2 40 1.5 30 20 1 ***
Slide 38: SDP-037: Development status update
SDP – 037 Development status update Pre-IND meeting with USFDA completed IND submission by Q4FY18 Phase 3 pivotal study initiation by Q1FY19 © 2017 SPARC 38
Slide 39: Agenda
Agenda SPARC Strategy & Market Opportunity – Key 1 Upcoming Milestones Anil Raghavan – CEO 5 Programs Narendra Lakkad – V.P. Business Development 2 Key Clinical Programs SiuLong Yao – Sr. V.P. Clinical Development & Operations 6 Financial Update Chetan Rajpara – CFO 3 Drug Discovery Programs Nitin D
Slide 40: Baclofen GRS: Significant commercial opportunity
Baclofen GRS Significant commercial opportunity for once-a-day formulation 16 USA Baclofen Solid Oral Market* 900 789 Majority of physicians believe that 14 713 800 664 steady blood levels and once-a-day 12 628 700 dosing are key benefits over IR 10 495 535 600 Baclofen^ 8 9 10 500 8 400 6 7 IR Bacl
Slide 41: Taclantis: Cremophor and Albumin free paclitaxel formulation
TaclantisTM Cremophor® and Albumin free paclitaxel formulation Cremophor® based paclitaxel Percentage of Patients with Documented Hypersensitivity formulations are associated with Reactions to Paclitaxel* hypersensitivity reactions ~12% of patients have documented hypersensitivity reactions* Taclant
Slide 42: Taclantis: Market Opportunity
TaclantisTM Market Opportunity Overall paclitaxel volume sales stagnated USA patient share* over last 2 years nab-paclitaxel Conventional Paclitaxel • Increasing penetration of novel agents may limit the use of paclitaxel No. of patients 37000 ~ 65% paclitaxel treated patients prescribed Cremophor®
Slide 43: Salmeterol-Fluticasone DPI: ICS/LABA DPI market dynamics in Europe
Salmeterol – Fluticasone Dry Powder Inhaler ICS/LABA DPI market dynamics in Europe Total ICS/LABA Dry Powder Inhaler ICS+LABA DPI sales (US$Mn) in Europe* market in Europe is estimated to be ~ US$ 2.5 bn* 199 133 Seretide® Accuhaler® has market share of 34% in ICS/LABA market 830 977 New once-a-day
Slide 44: Brimonidine OD: USA Glaucoma market healthy growth trend
Brimonidine OD USA Glaucoma market – Healthy growth trend USA Glaucoma Market, (US$ Mn)* Over 2.7 mn glaucoma patients in the USA; expected to reach 4.3 mn 135 29 by 2030** 196 Glaucoma market in USA estimated 430 at US$ 2.7 bn with 35 mn 1,374 prescriptions dispensed in last year* Rx volume growth
Slide 45: Brimonidine OD: Market acceptance of improved Brimonidine products
Brimonidine OD Market acceptance of improved Brimonidine products Brimonidine USA Sales (Mn)* $500 $15 $422 $400 $13 $374 $400 Brimonidine initially approved as $301 $333 $8 $11 $8 Brimonidie 0.2% eye drops $300 $7 $7 $7 $9 $7 $200 Tolerability issues with 0.2% strength $5 $3 led to development of 0
Slide 46: SUN-K0706 CML: Addressing unmet need in treatment resistant CML
SUN – K0706 CML Addressing high unmet need in treatment resistant CML Estimated 50,000 patients are living 300 USA Prescription Volume* with CML in USA^ 253 241 234 250 ~15% patients discontinue 2nd line therapy due to adverse events# 200 196 200 Limited treatment options for ` 000 150 patients who
Slide 47: Agenda
Agenda SPARC Strategy & Market Opportunity – Key 1 Upcoming Milestones Anil Raghavan – CEO 5 Programs Narendra Lakkad – V.P. Business Development 2 Key Clinical Programs SiuLong Yao – Sr. V.P. Clinical Development & Operations 6 Financial Update Chetan Rajpara – CFO 3 Drug Discovery Programs Nitin D
Slide 48: Financial Summary
Financial Summary (INR Mn) FY17 FY16 FY15 FY14 FY13 Total Income 1,946 1,642 1,588 1,770 889 Total Expenses 3,149 2,342 1,983 1,427 1,114 Profit / (Loss) after tax (1,203) (700) (395) 303 (225) Liquidity Status Cash and equivalents INR 282 mn as on 30th June ‘17 Delay in commercialization of Xelpros
Slide 49: Financial Summary
Financial Summary Expected cash outflows • Increased number of clinical programs • Higher operating expenses • Acquisition & refurbishing cost of new facility at Savli Expected cash inflows • Raised INR 5,000 Mn through Preferential Issue of Warrants (25% received) • Out-licensing of Baclofen GRS if
Slide 50: Agenda
Agenda SPARC Strategy & Market Opportunity – Key 1 Upcoming Milestones Anil Raghavan – CEO 5 Programs Narendra Lakkad – V.P. Business Development 2 Key Clinical Programs SiuLong Yao – Sr. V.P. Clinical Development & Operations 6 Financial Update Chetan Rajpara – CFO 3 Drug Discovery Programs Nitin D
Slide 51: R&D Pipeline
R&D Pipeline Pre- Approved Product Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 registration / Market ElepsiaTM XR Epilepsy (Levetiracetam ER) XelprosTM Glaucoma (Latanoprost BAK Free) Salmeterol-Fluticasone Asthma / COPD DPI Baclofen GRS Spasticity TaclantisTM Cancer (PICN) Brimonidine
Slide 52: For updates and specific queries, please visit www.sparc.life
For updates and specific queries, please visit www.sparc.life or contact Narendra Lakkad Tel : +91 22 6645 5645, Ext 5607 Tel Direct : +91 22 66455607 Mobile : +91 9821510498 narendra.lakkad@sparcmail.com © 2017 Sun Pharma Advanced Research Company Limited., All Rights Reserved. The SPARC Logo is a
Sun Pharma Advanced Research Company Limited (SPARC) — Investor Presentation (August 2017) on 6ix