Sun Pharma Advanced Research Co. Ltd. · NSE:SPARC
Sun Pharma Advanced Research — Investor Presentation (September 2020)
60 slides from Sun Pharma Advanced Research's investor presentation, Sep 10, 2020
Slide 1: Exchange cover letter: Investor Presentation—Update on R&D Pipeline
SPARC/Sec/SE/2019-20/022 10th September 2020 To The National Stock Exchange of India Ltd. BSE Limited Exchange Plaza, 5th Floor, P J Towers, Plot No. C/1, G Block, Dalal street, Bandra Kurla Complex, Mumbai - 400001 Bandra (East), Mumbai – 400 051. Ref: Scrip Code: NSE: SPARC; BSE: 532872 Sub: Inves
Slide 2: Update on R&D pipeline
Update on R&D pipeline 10th September 2020 BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837 1 SPARC @ 2020
Slide 3: Disclaimer
Disclaimer This presentation and its contents are confidential and should not be distributed, published or reproduced, in whole or part, or disclosed by recipients directly or indirectly to any other person. Any failure to comply with these restrictions may constitute a violation of applicable laws.
Slide 4: Presentation agenda
Presentation agenda Strategy overview Clinical NCE assets Clinical NDDS assets 01 Anil Raghavan, CEO 02 SiuLong Yao, Head Clinical 03 Nitin Dharmadhikari, Head Development & Operations Drug Delivery System Licensing update & Academic Pre-clinical NCE 04 competitive landscape 05 collaborations 06 ass
Slide 5: Strategy overview
Strategy overview Anil Raghavan BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837 4 SPARC @ 2020
Slide 6: On the hard road, together
On the hard road, together Let’s take a moment to reflect Broad Portfolio Global Organization Upcoming Catalysts 2 USFDA approved 3 offices in two continents Approvals from late stage drugs (Xelpros, Elepsia) pipeline 160 labs; 120,000 sq. ft. 3 NCEs in Vodobatinib CML 350+ scientists clinical devel
Slide 7: Our operating model is fully built-up
Our operating model is fully built-up Discovery Development Commercialization INTERNAL IDEATION PRE-CLINICAL Target selection Formulation development STRATEGIC Pharmacology PARTNERSHIPS Medicinal chemistry DMPK In-vitro biology Toxicology Biologics CMC scale-up CLINICAL COMPANY INCUBATION Clinical s
Slide 8: First wave of innovation is nearing completion
First wave of innovation is nearing completion Novel delivery systems through the 505(b)(2) pathway Technology Liposomal Drug Oral Delivery Liposomal Drug Delivery Technology - Licensing Delivery Technology Technologies Sun Pharma (USA) Oral Delivery Technologies - Sun Pharma (India) Approved Xelpro
Slide 9: Market shifts towards real-value
Market shifts towards real-value Early movers garner a lion’s share of value 4 20 316 524 241 116 235 155 111 347 100 92 26 15 101 9 12 61 8 2652 3325 3784 1594 3170 2559 3307 1290 245 3714 1916 635 182 374 741 24 12 8 4 7 FY15 FY16 FY17 FY18 FY19 FY20 FY15 FY16 FY17 FY18 FY19 FY20 FY15 FY16 FY17 FY
Slide 10: SPARC responded with a hard pivot
SPARC responded with a hard pivot To a mix of new biology and complex modalities New Targets Investing Best-in-Class for Validated SPARC is now focused on new Targets targets and modalities: Partnering Cancer metabolism, Precision oncology, Neurodegeneration, Bi-specific antibodies, Building on chem
Slide 11: Setting up several near term catalysts
Setting up several near term catalysts Neuro- Vodobatinib PD – Clinical proof-of-concept (PoC) by 2022 in Parkinson’s degenerative Disease, first-in-class disease modifying opportunity. Diseases Pilot study in Lewy Body Dementia in collaboration with Georgetown University is expected to be read out
Slide 12: Building long term value
Building long term value SPARC’s early stage portfolio is being transformed Development Development Asset Distribution Pipeline 2014 (n=31) Pipeline 2020 (n=19) 2020 (n=19) 19% 19% 32% 19% 62% 68% 81% NDDS NCE NDDS NCE NBE First-in-class Best-in-class Aggressive pruning to weed-out potentially unvia
Slide 13: Taking stock of COVID-19
Taking stock of COVID-19 Eco-system is impacted significantly Delayed Initiation 255 263 271 Enrollment Suspension 202 224 151 169 Slow Enrollment 121 110 105 102 82 90 785 790 790 784 785 76 750 772 672 701 56 592 518 372 401 420 14 299 159 131 145 154 172 182 190 62 81 88 98 105 108 110 111 123 25
Slide 14: Expectations for next year
Expectations for next year What to look for in the next 12 months Conclude and partner for commercialization first wave programs (PDP-716, SDN-037 & Taclantis) Aggressive accrual for on-going clinical studies Continued pre-clinical prioritization and build-up for additional INDs in FY22 Build on the
Slide 15: Clinical NCE assets
Clinical NCE assets SiuLong Yao BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837 14 SPARC @ 2020
Slide 16: Vodobatinib
Vodobatinib Highly selective ABL inhibitor with multiple applications Potent and highly selective BCR ABL TKI Kinome analysis revealing very limited off-target activity Good oral bioavailability in humans, crosses blood brain barrier Human PK established, moderate food effect No QT prolongation or o
Slide 17: Vodobatinib for CML (SCO-088): current clinical plan
Vodobatinib for CML (SCO-088) Current clinical plan PART A PART B PART C Single ascending Multiple Pivotal efficacy dose (SAD) ascending dose study in refractory study in healthy (MAD) study in patients volunteers patients Completed Enrollment near Enrollment initiated completion 16 SPARC @ 2020
Slide 18: Vodobatinib for CML (SCO-088): promising initial data
Vodobatinib for CML (SCO-088) Promising initial data persisting Phase 1 dose escalation study completed Hematological Response Anti-leukemic activity in CP-CML patients 2020 87% hematological response rate CP-CML 68% major cytogenetic response rate 2019 58% major cytogenetic response in 0 10 20 30 4
Slide 19: Vodobatinib for CML (SCO-088): generally safe and well tolerated
Vodobatinib for CML (SCO-088) Generally safe and well tolerated 2 serious adverse events related to Vodobatinib Mild to moderate GI disturbances and complaints of the musculo-skeletal system were most commonly observed No drug associated cardiac events reported GI = Gastrointestinal 18 SPARC @ 2020
Slide 20: Vodobatinib for CML (SCO-088): pivotal study plan
Vodobatinib for CML (SCO-088) Pivotal study plan Single arm study (Part C) PART C Ph+ CML patients refractory and/or intolerant to ≥3 TKIs including ponatinib CP-CML FPI Q4 FY20 59 subjects Participating countries USA, Belgium, France, Italy, Spain, Romania, Hungary, Singapore, UK, Korea Topline res
Slide 21: Vodobatinib for PD (SCC-138)
Vodobatinib for PD (SCC-138) First-in-class neuroprotective agent Pre-clinical Enhances autophagic flux Decreases α-synuclein inclusions Efficacy against neurodegeneration demonstrated in multiple animal models Clinical Human PK established Food effect study completed Single and multiple ascending d
Slide 22: Current status
Current status RANDOMIZATION Early stage subjects not on dopaminergic medication other than MAO-B inhibitors PLACEBO 88 sites in USA, Spain, Poland, Hungary, (N=168) Slovakia, India Regulatory approval in all countries VODOBATINIB FPI 192mg (N=168) February, 2019 for USA November, 2019 for EU Septem
Slide 23: Enrollment campaign
Enrollment campaign Advertising campaign Patient website Plan to extend pilot campaign to all sites Search Engine Optimization Traditional media (News papers, Radio, etc.) Complimentary approaches Additional regions Australia UK and other European sites Increase protocol user-friendliness PROSEEK =
Slide 24: Vodobatinib in Lewy Body Dementia
Vodobatinib in Lewy Body Dementia RANDOMIZATION PLACEBO (N=15) Ongoing investigator-initiated trial in collaboration with Georgetown University 12 week study with primary outcome measure of safety Secondary outcome of CSF and blood- VODOBATINIB based biomarkers 96mg (N=15) Expected study completi
Slide 25: SCD-044
SCD-044 Selective S1PR1 modulator for autoimmune diseases Novel, orally bioavailable, potent and selective S1PR1 agonist Fingolimod (first-in-class S1P receptor agonist) approved for multiple sclerosis is associated with serious bradycardia SCD-044 appears to have good balance between potentially ef
Slide 26: SCD-044 therapeutic index
SCD-044 therapeutic index Efficacy and safety established in Phase 1 study Heart Rate & Lymphocyte Counts following Multiple Doses 100 1 mg 2 mg 2-4-6 mg 0.3-0.6-1 mg 0.2-0.6-1 mg 80 81 80 75 70 68 68 66 63 HR Decrease (bmp)/ALC drop;% 60 55 51 40 20 0 -5.4 -11.6 -11.4 -12.7 -12.1 -20 Does in mg Max
Slide 27: SCO-120: Breast cancer SERD
SCO-120 Breast cancer SERD Hormonal therapy is SoC for ~70% of Breast cancer subtypes2 HR+/HER2- metastatic breast cancer patients1 ERα mutations develop in 20-50% of ~15% patients with metastatic disease IM fulvestrant is the only approved ~15% SERD but it is poorly active against mutations SCO-120
Slide 28: SCO-120: Oral SERD
SCO-120 Oral SERD US IND filed January, 2020 SAD in healthy volunteers ongoing 50 mg & 100 mg cohort dosing completed Generally safe and well tolerated, no significant AEs Future studies MAD in healthy volunteers, FPI Q4 FY21 Phase 2 PoC in patients, FPI Q2 FY23 SERD = selective estrogen receptor de
Slide 29: SCO-120 Preliminary pharmacokinetics
SCO-120 Preliminary pharmacokinetics SCO-120 AUC24 (h*ng/ml) Mouse WT Mouse 50 mg 100 mg 200 mg 400 mg 800 mg 1600 mg Mutant Efficacious Concentrations in Mice Concentrations in Humans Projected Concentrations in Humans Current exposures near those required for efficacy in preclinical studies WT = w
Slide 30: Clinical NDDS assets
Clinical NDDS assets Nitin Dharmadhikari BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837 29 SPARC @ 2020
Slide 31: Ophthalmology programs
Ophthalmology programs Reaching the finish line SDN-037 PDP-716 Management of inflammation and pain post Treatment of glaucoma cataract surgery Futility analysis conducted October, 2019 Phase 3 study completed 245 subjects Last patient out March, 2020 Exceeded statistical criteria to continue Toplin
Slide 32: Phenobarbital injection
Phenobarbital injection Preservative-free injection for neonatal seizure Current standard of care for treatment of neonatal seizure Phenobarbital is an “unapproved drug” in USA; Approved before 1938 which did not require proof for safety and / or efficacy Existing marketed product is not approved by
Slide 33: Licensing update & competitive landscape
Licensing update & competitive landscape Michael Choi BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837 32 SPARC @ 2020
Slide 34: Commercial partnerships
Commercial partnerships NOVEMBER 2019 DECEMBER 2019 MAY 2020 License deal with a subsidiary of License Agreement with Bioprojet Worldwide license agreement China Medical System Holdings to acquire exclusive rights for with Sun Pharma for SCD-044, Limited (CMS) to develop and Investigational Medicina
Slide 35: Epidemiology of Parkinson's Disease
Epidemiology of Parkinson’s Disease PD affects ~7M people globally; expected to grow above 14M by 2040* ~1 million PD patients in the US ~1.4 million PD patients in Europe ~256k PD patients in Japan ~60k new diagnoses each year ~110k new diagnoses each year Chronic and progressive nature of disease
Slide 36: Economic burden of PD
Economic burden of PD MJFF study estimates total direct and indirect cost at $52 billion in the USA alone Physician office, 1.23 Medical equipment, 0.15 Other expenses, 0.53 Prescription Hospital Motor vehicle Paid daily non medication, 4.14 inpatient, 7.19 modification, 0.93 medical care, 3.85 Outp
Slide 37: Vodobatinib is a game changer in PD
Vodobatinib is a game changer in PD As the 1st disease modifying therapy (DMT), Vodobatinib has the potential to address the enormous unmet need in PD ~70% of the PD patients to eligible to receive a Key unmet needs* DMT at diagnosis to delay the need of symptomatic Lack of disease-modifying High tr
Slide 38: Vodobatinib commercial potential
Vodobatinib commercial potential With successful development in PD, Vodobatinib has the potential to be SPARC’s first blockbuster drug All CNS indications PD is the lead indication and current forecast in high single digit ($B) validated by external third party research LBD indication has ~1.5x more
Slide 39: CML market opportunity
CML market opportunity Long lifespan of patients have turned CML into a chronic relapsing disease With the advent of the Tyrosine Kinase Inhibitors New cases N E W C A Sand E S A Ndeaths D D E A T H S per P E R 1 100,000 0 0 , 0 0 0 ( U S A )(USA) # (TKIs): 22 The annual mortality rate in CML has de
Slide 40: CML market opportunity
CML market opportunity 2nd and 3rd line agents have been successful even with generic Imatinib available The current TKI global market is approximately worth TKI Global Sales Data ($M USD)* 6 billion USD $220 $6,000 $233 $257 $272 Despite genericization of Gleevec, branded 2nd and 3rd $296 $365 gen
Slide 41: SCO-120 market opportunity
SCO-120 market opportunity A superior oral SERD which can address ERα mutations is much needed The HR+/ HER2- breast cancer affects over 230k All Cases patients per year# The current market value of the SoC is estimated to be $5B in 2020* HR- HR+ CDK4/6 inhibitors has emerged as the new gold standar
Slide 42: Academic collaborations
Academic collaborations Rajesh Ranganathan BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837 41 SPARC @ 2020
Slide 43: Diversify drug portfolio
Diversify drug portfolio By augmenting in-house expertise with strategic external partnerships Oncology Internal Strengths Ideation: Nominate first-in-class drug targets in select therapeutic areas and engage in Immuno-inflammation Exploratory programs Augment capabilities to pursue new treatment mo
Slide 44: Expanding academic partnerships
Expanding academic partnerships …to tap novel biology early on Novel drug delivery platform technology for targeted Multi-year partnership to accelerate the discovery & delivery of drugs for cancer and autoimmune development of new drugs disorders SPARC shall provide up to a total of US$ 10 Mn. in S
Slide 45: Pre-clinical NCE assets
Pre-clinical NCE assets Vikram Ramanathan BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837 44 SPARC @ 2020
Slide 46: Pre-clinical NCE overview
Pre-clinical NCE overview The preclinical NCE programs represent SPARC’s transition to a truly innovative biopharma company with novel drugs for novel targets Neurodegeneration – Inflammatory Oncology protein aggregates diseases Nanotechnology Cancer metabolism Parkinson’s Disease approaches for sit
Slide 47: Targeting cancer metabolism
Targeting cancer metabolism Identifying the right molecular targets Normal cells have a complex network of pathways and cycles to produce the required raw material for their growth (glucose, amino acids and proteins, lipids, nucleotides) Cancer cells grow fast by upregulating several metabolic pathw
Slide 48: Targeting of driver mutations in cancer
Targeting of driver mutations in cancer Dominant mutations that drive cancer cell growth Only few of the many mutations that randomly occur First-generation and early therapies lose efficacy in a patient are the drivers of the cellular changes over time. The cancers develop resistance by that actual
Slide 49: Targeting of driver mutations in cancer
Targeting of driver mutations in cancer Example from our clinical portfolio and area of continued focus SCO-120 (ER-α Degrader) Mechanisms that can enable drug resistance in human cancer cells Drug for resistant breast cancer where estrogen receptor target which drives cell proliferation (ER+) in tu
Slide 50: Neurodegenerative diseases
Neurodegenerative diseases Different diseases manifest at different locations Different neurodegenerative diseases Anatomical location of neurodegenerative diseases show abnormal brain pathology and atrophy of different regions of the brain, each disease with a specific regional pattern Accumulation
Slide 51: Neurodegenerative diseases
Neurodegenerative diseases Cellular processes related to misfolded proteins Choking of normal pathways to clear Pathways involved in neurodegenerative diseases misfolded proteins results in neuronal death and progressive brain atrophy which can manifest at some stage as dementia. Examples of such mi
Slide 52: Inflammatory diseases
Inflammatory diseases Using platform technologies to address unmet medical needs Nanotechnology approach for site-directed mAb therapy Collaboration with US academic who has world-class expertise in nanotechnology to deliver protein Using “molecular velcro” to localise to specific target organs and
Slide 53: Biologics
Biologics Nitin Damle BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837 52 SPARC @ 2020
Slide 54: SPARC biologics
SPARC biologics Target exposure to Current emphasis on bi-specific Target biology and antibody MoA Target biochemistry active antibody or multi-specific biologics Ideally suited for various disease indications in oncology and inflammation therapeutic areas High-hanging fruit Ease of combination wi
Slide 55: SPARC biologics
SPARC biologics Capabilities established in-house Molecular biology / Recombinant DNA technology Purification and structural & functional characterization of recombinant proteins Antibody development and engineering Multifunctional immunofusion therapeutic proteins Antibody modifications for site-sp
Slide 56: Financial update
Financial update Chetan Rajpara BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837 55 SPARC @ 2020
Slide 57: Financial summary
Financial summary INR Mn FY16 FY17 FY18 FY19 FY20 QI FY20 QI FY21 Total Income 1,642 1,947 832 1,964 866 210 1,861 Total Expenses 2,342 3,137 3,292 3,418 3,990 1,152 1,294 Exceptional Item - - 490 - - - - Profit (Loss) after Tax -700 -1,190 -1,970 -1,454 -3,124 -942 567 USD Mn Total Income 25.1 29.0
Slide 58: Cash & liquidity
Cash & liquidity Cash on hand INR 240 Mn ($3.3 Mn) as on Plans to raise ~$125-150 Mn by way of fresh equity 7-Sep-20 issuance to meet expenses over next 3 years FY21 Budget ~60% spend for clinical expenses Line of Credit up to INR 2,000 Mn (~$27.2 Mn) from holding company, of which INR 400 Mn (~$5.4
Slide 59: Clinical pipeline
Clinical pipeline NCE/NDDS Asset Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 Registration Vodobatinib Parkinson’s Disease Lewy Body Dementia Vodobatinib Refractory CML NCE SCO-120 Metastatic Breast Cancer SCD-044 Atopic Dermatitis Psoriasis Taclantis Cancer PDP-716 Glaucoma NDDS SDN-037
Slide 60: Thank You
Thank You The SPARC Logo is a trademark of Sun Pharma Advanced Research Company Ltd . In addition to Company data, data from market research agencies, Stock Exchanges and industry publications has been used for this presentation. This material is for use during an oral presentation; it is not a comp
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