Sun Pharma Advanced Research Co. Ltd. · NSE:SPARC

Sun Pharma Advanced Research — Investor Presentation (September 2018)

60 slides from Sun Pharma Advanced Research's investor presentation, Sep 4, 2018

  1. Slide 1: Update on R&D Pipeline

    Update on R&D Pipeline 4th September 2018 BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837 © 2018 - Sun Pharma Advanced Research Company Limited (SPARC). All Rights Reserved

  2. Slide 2: 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.

  3. Slide 3: Agenda

    Agenda SPARC Strategy & Key Nanoformulations & Long 1 Growth Drivers 6 Acting Depots Anil Raghavan – CEO Ajay Khopade – V.P. Formulation Development Yashoraj Zala – V.P. Formulation Development Financial Highlights Abuse & Overdose Deterrent 2 Chetan Rajpara – CFO 7 Platform Yashoraj Zala – V.P. For

  4. Slide 4: Agenda

    Agenda SPARC Strategy & Key Nanoformulations & Long 1 Growth Drivers 6 Acting Depots Anil Raghavan – CEO Ajay Khopade – V.P. Formulation Development Yashoraj Zala – V.P. Formulation Development Financial Highlights Abuse & Overdose Deterrent 2 Chetan Rajpara – CFO 7 Platform Yashoraj Zala – V.P. For

  5. Slide 5: SPARC's Journey: Poised to reach important milestones

    SPARC’s Journey Poised to reach important milestones…. SPARC responded to US FDA CRLs indicating facility compliance and readiness, resetting the regulatory clock for approval  XelprosTM : PDUFA date – Nov’18  ElepsiaTM XR : PDUFA date – Jan’19 CRL = Complete Response Letter, PDUFA = Prescription

  6. Slide 6: Marking the conclusion of our initial set of delivery solutions

    …marking the conclusion of our initial set of delivery solutions Baclofen GRS  Pivotal studies did not meet the primary end point  Met several clinically significant secondary end-points (E.g.: Spasm Frequency, SGIC, etc.)  Plan to submit additional registration studies while exploring opportunit

  7. Slide 7: Key takeaways from our initial programs

    Key takeaways from our initial programs  SCO – 088: Chronic Myeloid Leukemia Abl kinase  SCC – 138: Parkinson's Disease Need for enhanced inhibitors  SCO – 125: Chronic Myeloid Leukemia translational rigor S1PR1 agonist  SCD – 044: Autoimmune disorders Challenging reimbursement environment – Nee

  8. Slide 8: Possible value inflection points & resource allocation

    Possible value inflection points & resource allocation A snapshot of next 24 months Platform Program Development Plan | Short to Medium Term MAD (Cont. To MTD) SCO – 088 Pivotal efficacy Front line CML Abl kinase inhibitors P2 PoC SCC – 138 SCO – 125 MAD (Cont. To MTD) P2 PoC MAD S1PR1 agonist SCD –

  9. Slide 9: We will continue to be in the investment mode in the medium term

    We will continue to be in the investment mode in the medium term Platform Program Development Plan | Short to Medium Term Cost Early Trend Exit MAD (Cont. To MTD) Pivotal efficacy SCO – 088 +++ Front line CML Abl kinase inhibitors P2 PoC SCC – 138 +++ MAD (Cont. To MTD) P2 PoC SCO – 125 + MAD S1PR1

  10. Slide 10: SPARC R&D priorities

    SPARC R&D priorities Execute on SPARC clinical portfolio on schedule and budget to achieve financial sustainability Increase the rigor of portfolio decision making to ensure quality of assets transitioning from pre-clinical to clinical development Leverage computational capabilities and external str

  11. Slide 11: Dedicated research facility at Savli, Vadodara

    Dedicated research facility at Savli, Vadodara Dedicated, modern campus with world class infrastructure Augmenting research capabilities with state of the art technology and equipment Plan to shift to new facility by Q4 FY19 © 2018 SPARC 11

  12. Slide 12: Agenda

    Agenda SPARC Strategy & Key Nanoformulations & Long 1 Growth Drivers 6 Acting Depots Anil Raghavan – CEO Ajay Khopade – V.P. Formulation Development Yashoraj Zala – V.P. Formulation Development Financial Highlights Abuse & Overdose Deterrent 2 Chetan Rajpara – CFO 7 Platform Yashoraj Zala – V.P. For

  13. Slide 13: Financial summary

    Financial summary (INR mn) FY18 FY17 FY16 FY15 FY14 Total Income 832 1,947 1,642 1,588 1,770 Total Expenses 3,292 3,137 2,342 1,983 1,427 Exceptional Item 490 - - - - Profit (Loss) after Tax (1,970) (1,190) (700) (395) 303 Total Comprehensive (1,984) (1,195) N.A. N.A. N.A. Income (Net of tax) Liquid

  14. Slide 14: Financial Summary

    Financial Summary Expected cash outflows  Increased number of clinical programs  Higher operating expenses  Refurbishing cost of new facility at Savli Expected cash inflows  Raised INR 5,000 mn through Preferential Issue of Warrants (70% received, INR 1,500 mn to be received in Jan-19)  Milesto

  15. Slide 15: Agenda

    Agenda SPARC Strategy & Key Nanoformulations & Long 1 Growth Drivers 6 Acting Depots Anil Raghavan – CEO Ajay Khopade – V.P. Formulation Development Yashoraj Zala – V.P. Formulation Development Financial Highlights Abuse & Overdose Deterrent 2 Chetan Rajpara – CFO 7 Platform Yashoraj Zala – V.P. For

  16. Slide 16: SCO-088 Encouraging preliminary efficacy and safety observed

    SCO – 088 Encouraging preliminary efficacy and safety observed Effective against BCR-ABL and its %Subjects by disease status mutants, including T315I mutation Ph+ALL Multiple Ascending Dose (MAD) study 7% ongoing in CML patients CML BP 13%  Completed 5 dose escalations  PK supports once-a-day dosi

  17. Slide 17: SCO-088 Haematological response in CML patients

    SCO – 088 Haematological response in CML patients Haematological response 15000 # # WBC counts (cell/µL) 12500 10000 7500 5000 2500 0 * * * * SCREENING C3D28/C4D1 C6D28/C7D1 # Values above scale of this graph Subjects * NA as subject was discontinued from study Normal WBC count range Haematological

  18. Slide 18: SCO-088 Development status update

    SCO – 088 Development status update Plan to complete MAD study by Q4 FY19 Phase 2 pivotal efficacy study  Single arm, open label, efficacy study in 150 subjects failed on ≥ 3 TKIs  Protocol submission to US FDA by Q2 FY19  Study initiation by Q3 FY19 SCO – 088 = K0706 CML, CML = Chronic Myeloid L

  19. Slide 19: Parkinson's Disease: Increasing incidence due to the aging population

    Parkinson’s Disease Increasing incidence due to the aging population Anti-Parkinson's market ($ mn)* Over 1 mn people living with 16 Parkinson’s Disease in the US^ Dopamine Agonists 74 31 MAO-B Inhibitors Expected to grow to ~1.35 mn by 2022 with about 60,000 new patients 307 Antiparkinson's diagnos

  20. Slide 20: SCC-138 Supporting pre-clinical data in Parkinson's Disease

    SCC – 138 Supporting pre-clinical data in Parkinson’s Disease Effect of 3-day vs. 14-day treatment of the SPARC c-Abl Pre-clinical development inhibitors on the autophagic flux. Therapeutic potential in α-synuclein PFF induced model Role of SCC – 138 in human IPSC- derived neurons 1) Augmenting Park

  21. Slide 21: SCC-138 1st in class disease modifying treatment

    SCC – 138 1st in class disease modifying treatment Orally active, disease modifying treatment 700 SCC – 138 serum levels in PD patients* with potential neuro-protective activity 600 Inhibits Abl and Fyn kinase – relevant to neurodegeneration 500 Cavg (ng/mL) Completed 6 dose cohorts in Phase 1 PD 40

  22. Slide 22: SCC-138 Development status update

    SCC – 138 Development status update MAD study on-going; plan to add higher dose levels Phase 2 PoC to be initiated in PD patients by Q3 FY19 at multiple centres across North America, Asia and Europe SCC – 138 = K0706 Parkinson’s Disease, PoC = Proof of Concept MAD = Multiple ascending dose PD = Park

  23. Slide 23: Agenda

    Agenda SPARC Strategy & Key Nanoformulations & Long 1 Growth Drivers 6 Acting Depots Anil Raghavan – CEO Ajay Khopade – V.P. Formulation Development Yashoraj Zala – V.P. Formulation Development Financial Highlights Abuse & Overdose Deterrent 2 Chetan Rajpara – CFO 7 Platform Yashoraj Zala – V.P. For

  24. Slide 24: SCD-044 Selective S1PR1 agonist for autoimmune diseases

    SCD – 044 Selective S1PR1 agonist for autoimmune diseases SPARC is developing a novel orally bioavailable, potent and selective S1PR1 agonist in collaboration with Bioprojet, France S1PR1 agonists cause diminished migration of lymphocytes out of lymphoid tissues leading to decrease in circulating ly

  25. Slide 25: SCD-044 First-in-Human Study is well underway

    SCD – 044 First-in-Human Study is well underway Lymphocyte count reduction* 0% D1, 2h D1, 4h D1, 8h D1, 12h D2, 24h D3, 48h Multi-part study in healthy volunteers -10% %Change from Baseline  Part 1: Single ascending dose study completed -20% -21% • 6 dose groups evaluated compared to placebo -30% -

  26. Slide 26: SCD-044 Development status update

    SCD – 044 Development status update Planned completion of Phase 1 study by Q1 FY20 Phase 2 study initiation anticipated by Q1 FY20  Indications under consideration include Psoriasis, Inflammatory Bowel Diseases, Atopic Dermatitis & others © 2018 SPARC 26

  27. Slide 27: Agenda

    Agenda SPARC Strategy & Key Nanoformulations & Long 1 Growth Drivers 6 Acting Depots Anil Raghavan – CEO Ajay Khopade – V.P. Formulation Development Yashoraj Zala – V.P. Formulation Development Financial Highlights Abuse & Overdose Deterrent 2 Chetan Rajpara – CFO 7 Platform Yashoraj Zala – V.P. For

  28. Slide 28: PDP-716 Novel once-a-day eye drops for Glaucoma

    PDP – 716 Novel once-a-day eye drops for Glaucoma TearActTM technology Existing formulations of Brimonidine, an α2 adrenergic agonist, are administered TID in the second line treatment of Glaucoma TID dosing often results in lower treatment adherence rates in patients* SPARC is developing improved f

  29. Slide 29: PDP-716 Phase 2 data supports once-a-day dosing

    PDP – 716 Phase 2 data supports once-a-day dosing Proof of concept demonstrating equivalence to Alphagan® P dosed TID was completed in human trial Met pre-specified clinical equivalence efficacy criteria compared to Alphagan® P TID at all time points No new adverse events reported PDP – 716 vs Alpha

  30. Slide 30: PDP-716 Development status update

    PDP – 716 Development status update IND submitted in Q4 FY18 US FDA alignment on single, active controlled Phase 3 study with Alphagan® P as a comparator to support NDA submission Phase 3 study initiated in Q1 FY19  Target enrolment of 666 subjects  Recruitment at ~27 sites across the US NDA submi

  31. Slide 31: SDN-037 Improved ocular steroid with reduced dosing frequency

    SDN – 037 Improved ocular steroid with reduced dosing frequency Currently marketed steroid eye drops are Micellar technology approved for QID dosing Additionally, marketed products have hazy/milky appearance which may blur the vision upon administration SPARC is developing novel formulation of an ex

  32. Slide 32: SDN-037 Development status update

    SDN – 037 Development status update US FDA alignment on single, vehicle controlled Phase 3 study to support NDA submission Phase 3 study initiated in Q1 FY19  Target enrolment of 386 subjects  Recruitment at ~15 sites across US NDA submission planned by Q2 FY20 IND = Investigational New Drug, US F

  33. Slide 33: Agenda

    Agenda SPARC Strategy & Key Nanoformulations & Long 1 Growth Drivers 6 Acting Depots Anil Raghavan – CEO Ajay Khopade – V.P. Formulation Development Yashoraj Zala – V.P. Formulation Development Financial Highlights Abuse & Overdose Deterrent 2 Chetan Rajpara – CFO 7 Platform Yashoraj Zala – V.P. For

  34. Slide 34: Taclantis: Establishing bio-equivalence to Abraxane

    TaclantisTM Establishing bio-equivalence to Abraxane® Novel formulation of paclitaxel using SPARC’s proprietary Nanotecton™ platform technology Pivotal BE study fully enrolled  142 patients randomized  99 evaluable patients  No hypersensitivity reactions observed Data read out expected by Q3 FY19

  35. Slide 35: SDE-124 Long acting formulation of GLP-1 receptor agonist

    SDE – 124 Long acting formulation of GLP–1 receptor agonist 21 mn diagnosed cases of type 2 diabetes in the US#; estimated 1.5 mn new cases diagnosed annually^ US GLP-1 receptor agonists market value ($ mn)* 59 GLP-1 receptor agonists reported 1,197 131 annual sales of ~$9 bn with 39% YoY growth* 3,

  36. Slide 36: SDE-124 Encouraging efficacy in pre-clinical setting

    SDE – 124 Encouraging efficacy in pre-clinical setting Comparative PK profile in SD rats Comparative HbA1C profile in Fatty-Zucker rats 7 10000 Test Gelpeak* Test gel peak* 6.5 Test Geltrough* Test gel trough* Reference peak Plasma Concentration, ng/ml Reference peak Reference trough 6 Plasma concen

  37. Slide 37: SDE-124 Development status update

    SDE – 124 Development status update Prototype formulation ready; short term stability study ongoing Pre-IND meeting with US FDA completed IND enabling toxicology studies planned to be initiated by Q3 FY19 IND submission by Q3 FY20 Phase 1 human PoC study initiation by Q4 FY20 US FDA = United States

  38. Slide 38: SDD-098 Development status update

    SDD – 098 Development status update According to AAD, more than 5 mn people seek medical treatment for acne and has significant impact on productivity for affected individuals SPARC is developing novel topical formulation of Minocycline designed to reduce systemic side- effects associated with oral

  39. Slide 39: Agenda

    Agenda SPARC Strategy & Key Nanoformulations & Long 1 Growth Drivers 6 Acting Depots Anil Raghavan – CEO Ajay Khopade – V.P. Formulation Development Yashoraj Zala – V.P. Formulation Development Financial Highlights Abuse & Overdose Deterrent 2 Chetan Rajpara – CFO 7 Platform Yashoraj Zala – V.P. For

  40. Slide 40: SDN-021 Potential to deter oral multiple pill abuse

    SDN – 021 Potential to deter oral multiple pill abuse US IR opioid market value ($ Mn)* 187 mn prescriptions generated for IR opioids with estimated value of ~$2 bn* 578 600 524 66% of the abusers prefer IR formulations 500 due to ease of manipulation^ 440 SPARC developed IR opioid formulation 400 w

  41. Slide 41: SDN-021 Multiple pill abuse deterrence: main driver to adoption

    SDN – 021 Multiple pill abuse deterrence – main driver to adoption* SDN – 021 Adoption drivers* SDN – 021 Perceived key benefit * Multi-pill abuse 87% deterrence 25% Nasal route abuse deterrence 29% Injection route 75% abuse deterrence 22% 87% of physicians see oral multi-pill abuse 75% of payers vi

  42. Slide 42: SDN-021 Development status update

    SDN – 021 Development status update Pilot Human Abuse Liability (HAL) study ongoing  Primary endpoint: Drug Liking – Emax  Cohort A recruitment completed  Cohort B recruitment ongoing  Topline data expected by Q3 FY19 Phase 3 clinical study planned in concurrence with US FDA guidance; planned in

  43. Slide 43: SDN-118 Addressing prescription drug overdose

    SDN – 118 Addressing prescription drug overdose Suicide, one of the top 10 leading Cause of suicide death (%) causes of death in the US n = 38,364 SPARC has developed an anti- 23% depressant product based on overdose 33% prevention technology platform 21% Technology works to curb release on 23% inge

  44. Slide 44: SDN-118 Overdose prevention technology

    SDN – 118 Overdose prevention technology API Reverse Enteric Polymer pH Modulator Mechanism of release from one pill Mechanism of release from multiple pills  Quantity of pH modulator released  Quantity of pH modulator released from from 1 pill does not affect the multiple pills changes the microe

  45. Slide 45: SDN-118 Development status update

    SDN – 118 Development status update Pre-IND advice received from the US FDA IND filing planned in Q3 FY19 Overdose PoC PK studies planned in Q4 FY19 IND = Investigational New Drug NDA = New Drug Application US FDA = United States Food & Drug Administration PoC = Proof of Concept © 2018 SPARC 45

  46. Slide 46: Agenda

    Agenda SPARC Strategy & Key Nanoformulations & Long 1 Growth Drivers 6 Acting Depots Anil Raghavan – CEO Ajay Khopade – V.P. Formulation Development Yashoraj Zala – V.P. Formulation Development Financial Highlights Abuse & Overdose Deterrent 2 Chetan Rajpara – CFO 7 Platform Yashoraj Zala – V.P. For

  47. Slide 47: Early stage pipeline building strategy

    Early stage pipeline building strategy Internal ideation  Chase validated drug targets in select therapeutic areas  Leverage capabilities in complex drug delivery Oncology Narrow therapeutic focus systems to pursue commercially attractive Treatment resistance 505(b)(2) opportunities External innov

  48. Slide 48: Attacking treatment resistance in cancer

    Attacking treatment resistance in cancer Fast follower approach in a clinically and commercially validated space A number of molecularly targeted therapies against the indications of interest Emerging evidence of the development of resistance to targeted therapies  Resistance often attributed to mu

  49. Slide 49: Neurodegeneration

    Neurodegeneration A common pathway of neuronal death irrespective of disease-specific misfolded protein inclusions in distinct neurodegenerative diseases Chronic inflammation Functional Degeneration neurons of neurons Accumulation of misfolded protein inclusions as disease‐specific biomarkers α‐Synu

  50. Slide 50: Update on collaborations

    Update on collaborations Pursue active collaborations with global academic centres and research institutes Unique academic partnering proposition for significant value creation  Cash investment  In-kind contribution leveraging internal infrastructure in preclinical & clinical development Flexible

  51. Slide 51: SPARC – Washington University Collaboration

    SPARC – Washington University Collaboration SPARC partnered with Skandalaris Center of Washington University, St. Louis, US  Identifying translational inventions and advancing them towards commercialisation SPARC supported Skandalaris Center’s LEAP (Leadership in Entrepreneurial Acceleration Progra

  52. Slide 52: Agenda

    Agenda SPARC Strategy & Key Nanoformulations & Long 1 Growth Drivers 6 Acting Depots Anil Raghavan – CEO Ajay Khopade – V.P. Formulation Development Yashoraj Zala – V.P. Formulation Development Financial Highlights Abuse & Overdose Deterrent 2 Chetan Rajpara – CFO 7 Platform Yashoraj Zala – V.P. For

  53. Slide 53: Taclantis: Albumin free nanoformulation of Paclitaxel

    TaclantisTM Albumin free nanoformulation of Paclitaxel Over 45% of US clinicians documented hypersensitivity reactions in more than 10% patients treated with Cremophor ® based paclitaxel* US unit sales^ 2000 More than 60% of US physicians view risk of hypersensitivity and ease of administration 1500

  54. Slide 54: PDP-716 US market opportunity

    PDP – 716 US market opportunity Brimonidine US sales ($ mn)* 450 400 350 $406 Mn US Glaucoma market is estimated at $ 3.0 300 Sales ($ mn) bn in 2017* 250 200 Brimonidine is one of the most widely 150 prescribed anti-glaucoma drug with sales 100 $10.7 Mn 50 of $ 417 mn and 3.7 mn prescriptions 0 dis

  55. Slide 55: PDP-716 Once-a-day eye drops perceived favourably by physicians

    PDP – 716 Once-a-day eye drops perceived favourably by physicians Preference in treatment Percentage of ophthalmologists Product X Continue to use Clear preference of physicians for Alphagan® P TID PDP – 716* 93% of physicians would prefer to prescribe once a day eye drops 93% Novel once-a-day Brimo

  56. Slide 56: SDN-037 US market opportunity

    SDN – 037 US market opportunity Cataract causes half of all cases of blindness and affects more than 24 mn Topical ophthalmic steroid US market* people in US with age 40 and older 800 750 9.5 Topical steroids are standard of care for 700 the treatment of pain & inflammation 9.2 9.0 600 associated wi

  57. Slide 57: SCO-088 Targeting treatment intolerance and resistance in CML

    SCO – 088 Targeting treatment intolerance and resistance in CML 300 US prescription volume* Increasing usage of 2nd and 3rd generation TKIs 253 250 241 234 230 217 Limited treatment options for 3rd line 205 and beyond 200 Prescriptions (` 000) Physicians believe, the currently 150 available therapie

  58. Slide 58: Agenda

    Agenda SPARC Strategy & Key Nanoformulations & Long 1 Growth Drivers 6 Acting Depots Anil Raghavan – CEO Ajay Khopade – V.P. Formulation Development Yashoraj Zala – V.P. Formulation Development Financial Highlights Abuse & Overdose Deterrent 2 Chetan Rajpara – CFO 7 Platform Yashoraj Zala – V.P. For

  59. Slide 59: R&D Pipeline

    R&D Pipeline Pre- Approved Product Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 registration / Market ElepsiaTM XR (Levetiracetam ER) Epilepsy XelprosTM (Latanoprost BAK Free) Glaucoma TaclantisTM Cancer (PICS) Salmeterol-Fluticasone Asthma / COPD DPI Baclofen GRS Spasticity PDP - 716 Gl

  60. Slide 60: Thank You

    Thank You © 2018 Sun Pharma Advanced Research Company Limited., All Rights Reserved. The SPARC Logo is a trademarks 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 presenta

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