SPARCNSE19 September 2019

Sun Pharma Advanced Research Company Limited has informed the Exchange regarding Investor Presentation

Sun Pharma Advanced Research Company Limited

SPARC/Sec/SE/2019-20/032

19th September 2019

To National Stock Exchange of India Ltd. Exchange Plaza, Plot No. C/1, G Block, Bandra Kurla Complex, Bandra (East), Mumbai – 400 051.

Ref: Scrip Code: NSE: SPARC; BSE: 532872

Sub: Investor Presentation – Update on R&D Pipeline.

Dear Sir/Madam,

BSE Limited P J Towers, Dalal street, Mumbai - 400001

Further to our letter No. SPARC/Sec/SE/2019-20/028 dated 22nd August 2019 on the subject, please find enclosed a copy of the presentation by the Company providing update on R&D Pipeline, which is self-explanatory.

You are requested to kindly take the same on your record & disseminate the information through your website.

Yours faithfully,

For Sun Pharma Advanced Research Company Limited

Debashis Dey Company Secretary

Encls: A/a.

Update on R&D Pipeline

19 Sep, 2019

BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837

Disclaimer

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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. Accordingly, any persons in possession of this presentation should inform themselves about and observe any such restrictions. This presentation may include statements which may constitute forward-looking statements. All statements that address expectations or projections about the future, including, but not limited to, statements about the strategy for growth, business development, market position, expenditures, and financial results, are forward looking statements. Forward looking statements are based on certain assumptions and expectations of future events. This presentation should not be relied upon as a recommendation or forecast by Sun Pharma Advanced Research Company Limited (“Company"). Please note that the past performance of the Company is not, and should not be considered as, indicative of future results. The Company cannot guarantee that these assumptions and expectations are accurate or will be realized. The actual results, performance or achievements, could thus differ materially from those projected in any such forward-looking statements. The Company does not undertake to revise any forward-looking statement that may be made from time to time by or on behalf of the Company. Given these risks, uncertainties and other factors, viewers of this presentation are cautioned not to place undue reliance on these forward looking statements. The information contained in these materials has not been independently verified. None of the Company, its Directors, Promoters or affiliates, nor any of its or their respective employees, advisers or representatives or any other person accepts any responsibility or liability whatsoever, whether arising in tort, contract or otherwise, for any errors, omissions or inaccuracies in such information or opinions or for any loss, cost or damage suffered or incurred howsoever arising, directly or indirectly, from any use of this document or its contents or otherwise in connection with this document, and makes no representation or warranty, express or implied, for the contents of this document including its accuracy, fairness, completeness or verification or for any other statement made or purported to be made by any of them, or on behalf of them, and nothing in this presentation shall be relied upon as a promise or representation in this respect, whether as to the past or the future. The information and opinions contained in this presentation are current, and if not stated otherwise, as of the date of this presentation. The Company undertakes no obligation to update or revise any information or the opinions expressed in this presentation as a result of new information, future events or otherwise. Any opinions or information expressed in this presentation are subject to change without notice. This presentation does not constitute or form part of any offer or invitation or inducement to sell or issue, or any solicitation of any offer to purchase or subscribe for, any securities of the Company, nor shall it or any part of it or the fact of its distribution form the basis of, or be relied on in connection with, any contract or commitment therefor. No person is authorized to give any information or to make any representation not contained in or inconsistent with this presentation and if given or made, such information or representation must not be relied upon as having been authorized by any person. By participating in this presentation or by accepting any copy of the slides presented, you agree to be bound by the foregoing limitations.

Fourth level

The slide set contains unpublished data, should not be replicated without prior consent from SPARC

1. 6.

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Agenda

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Strategy & Growth Drivers Anil Raghavan – CEO

Update on Clinical Programs SiuLong Yao – Sr. V.P. Clinical Development & Operations

Early Stage Program Update Vikram Ramanathan – V.P. Translational Development

Collaborations & Partnerships Nitin Damle – Sr. V.P. Innovation

Financial Summary Chetan Rajpara – CFO

Q&A

1. 6.1.

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Agenda

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Fourth level

Strategy & Growth Drivers Anil Raghavan – CEO

Update on Clinical Programs SiuLong Yao – Sr. V.P. Clinical Development & Operations

Early Stage Program Update Vikram Ramanathan – V.P. Translational Development

Collaborations & Partnerships Nitin Damle – Sr. V.P. Innovation

Financial Summary Chetan Rajpara – CFO

Q&A

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Strategy & Growth Drivers

Early programs reach the finish line ...offering validation and key lessons for the future

SPARC received USFDA approvals for Xelpros® and Elepsia® XR

Click to edit Master text styles USFDA accepted SPARC’s NDA for Taclantis® (PICS)

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Third level

Xelpros® BAK Free

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Elepsia® XR 1/1.5g

Taclantis®

Xelpros® was launched in the US by Sun Pharma in Q4 FY19

Early days yet, product gaining prescription share

USFDA approved 1000 mg and 1500 mg strengths of Elepsia® XR

Expect to finalize commercial partner for US in H2 FY20

NDA accepted in Q1 FY20. PDUFA date set for Feb. 2020

SPARC is reviewing Celgene infringement challenge

USFDA = United States Food and Drug Administration; NDA = New Drug Application; PDUFA = Prescription Drug User Fee Act

Our external environment is reshaping our strategy

Forces redefining the reimbursement environment are real and here to stay

Click to edit Master text styles Society and regulatory agencies continue to encourage breakthrough innovation

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Third level Artificial Intelligence and Digitalization Fourth level are finally adding real value

Innovation is moving beyond the traditional realms of Big Pharma, Small Molecule & Biologics Domain

Virtualization and strategic partnering are rewriting the value propositions and operating models

Companies need to adapt smartly to survive

First in class, Multiple modalities, Complex delivery solutions

Focus away from incremental innovation and follow-on products

Key strategic priorities

Accelerate prioritized clinical programs

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SCO-088 registration study and SCC-138 PoCs

SCD-044 Phase 2 study for Psoriasis

SCO-120 in ER+, HER2- metastatic Breast Cancer

Obtain PoC for novel targets & complex platforms

Build depth and diversity of pipeline

Fourth level

Grow novel Biologics pipeline

Continue to scale up external collaborations

Streamline operating model

Exit programs early–clinical PoC vs Market Authorization

Increase externalization of non-core activities

Continue to invest in Digital and AI

PoC = Proof of Concept; AI = Artificial Intelligence; ER = Estrogen Receptor; HER 2 = Human Epidermal Growth Factor Receptor 2

Key portfolio reprioritizations

SPARC is committed to rigorous gating for resource allocations

We have reprioritized the following programs after successful completion of early proof of concept studies

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ADF Platform

Second level

SDE-124

SDD-098

Third level

Pilot HAL trial completed successfully

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Fast evolving market environment requires a committed development partner

PoC study for an overdose prevention variant of the platform ongoing

Preclinical proof-of- concept and manufacturing viability established

Oral GLP-1 analogues resets the standard of care

Need to streamline therapeutic area focus

Preclinical proof-of- concept established

Commercial potential does not fit into current portfolio expectations

Reimbursement challenges add additional layer of risk to the program

ADF = Abuse Deterrent Formulation; HAL = Human Abuse Liability; PoC = Proof of Concept; GLP-1 = Glucagon-Like Peptide 1

Setting expectations for 2020-21

Ensure US commercial launch of Elepsia® XR and Taclantis®

Stay on track for FY23 NDA submission for SCO-088 and FY22 Clinical PoCs for SCC-138 and SCD-044

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Second level

Complete the Phase 1 trials of SCO-120, initiate patient trial

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Complete NDA submissions for PDP-716 and SDN-037 on positive data readouts

Fourth level Transition of one more NCE to IND

Continue to tighten the portfolio while staying open to opportunistic exits from clinical assets; and

Continue SPARC’s transition to an increasingly first-in-class, multi-modal portfolio, enabled by a digital and data driven execution engine

PoC = Proof of Concept; NDA = New Drug Application; NCE = New Chemical Entity; IND = Investigational New Drug

1. 6.

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Second level

Agenda

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Fourth level

Strategy & Growth Drivers Anil Raghavan – CEO

Update on Clinical Programs SiuLong Yao – Sr. V.P. Clinical Development & Operations

Early Stage Program Update Vikram Ramanathan – V.P. Translational Development

Collaborations & Partnerships Nitin Damle – Sr. V.P. Innovation

Financial Summary Chetan Rajpara – CFO

Q&A

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Fourth level

PDP-716 Once-a-day formulation of Brimonidine for treatment of Glaucoma

PDP-716 Development status update

Phase 2 completed with IOP reduction equivalent to Alphagan® P Click to edit Master text styles

Phase 3 study initiated in Q1 FY19

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PDP-716 OD vs Alphagan® P TID

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Primary endpoint of mean IOP at 8 a.m., 10 a.m., 4 p.m.

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Number of sites recruiting ~20

Last subject out Q1 FY21

Futility analysis Q3 FY20

Pediatric waiver granted

NDA filing Q4 FY21

Patient recruitment status

45%

52%

To be enrolled

Enrolled

In-screening

NDA = New Drug Application;

IOP = Intra-ocular Pressure; OD = Once–a–day

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SDN-037 Novel formulation for Ocular Pain and Inflammation

SDN-037 Development status update

Vehicle controlled single Phase 3 study to support NDA submission initiated in Click to edit Master text styles Q1 FY19

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Number of sites recruiting ~15

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Last subject out planned by Q4 FY21 Fourth level

Futility analysis outcome expected in Q3 FY20

NDA filing planned by Q2 FY22

Patient recruitment status

21%

79%

To be enrolled

Enrolled

NDA = New Drug Application

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SCO-088 Highly selective BCR-ABL inhibitor for treatment resistant Chronic Myeloid Leukemia

SCO-088 Clinical development plan: Umbrella protocol

Orphan Drug Designation approved Click to edit Master text styles 7 years US market exclusivity

Second level USFDA user fee waiver

Completing Part B, starting Part C

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Part A

Single Ascending Dose study (SAD) in volunteers

Waiver of user fee by US FDA

Part B

Multiple Ascending Dose study (MAD) in patients

3 0 _ 5 1 _ R L C

Part C

Pivotal efficacy study in refractory patients

USFDA = United States Food and Drug Administration

SCO-088 Promising clinical activity - Phase 1b study

Heterogeneous population

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80% failed ≥ 3 TKI therapies

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32% had at least 1 baseline mutation

Third level 56% had refractory disease

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Early anti-leukemic efficacy

81% hematological response rate

52% major cytogenetic response rate

Hematological response

P C -

L M C

30 40

90 100

% of patients with haematological response

Maintained CHR

Achieved CHR

Cytogenetic response

13/37 subjects on treatment for >12 months

P C -

L M C

CML = Chronic Myeloid Leukemia; CCyR = Complete Cytogenetic Response; CyR= Cytogenetic Response; TKI = Tyrosine Kinase Inhibitor; MaCyR = Major Cytogenetic Response; CP = Chronic Phase; Unpublished data – Not to be replicated

100

% of patients with MaCyR

Maintained CCyR

Achieved CCyR

Partial CyR

SCO-088 Durable responses with about 70% patients continuing on treatment

6 months

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18 months

2 years

s t c e b u s

f o r e b m u N

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* Fourth level

Duration in months

Discontinued study drug; Unpublished data – Not to be replicated

SCO-088 Promising activity in accelerated approval population

Dosing Cohort (mg)

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126

174

204

240

Total

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Subjects refractory to ≥3 TKIs including Ponatinib

Fourth level 0

Responders on SCO-088

50% response rate following last line of therapy

Consistent with USFDA expectations for accelerated approval

USFDA = United States Food and Drug Administration; TKI = Tyrosine Kinase Inhibitor; Unpublished Data – Not to be replicated

SCO-088 Well tolerated in heavily pre-treated population with refractory disease

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Second level

2 serious adverse events related to use of SCO-088

Third level

Mild to moderate GI disturbances and complaints of the musculoskeletal system were most commonly observed

Fourth level

SAE = Serious Adverse Event GI = Gastro-intestinal; Unpublished data – Not to be replicated

SCO-088 Development status update

End of Phase 1 meeting with USFDA completed

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Agreement on study design and approval requirements

Second level

Single arm study in refractory subjects

Third level

Site startup in progress

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FPI Q4 FY20

USFDA = United States Food and Drug Administration; FPI = First Patient In

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SCC-138 For treatment of Parkinson’s disease

SCC-138 1st in class disease modifying treatment

Potent, orally active, brain-penetrating, small molecule inhibitor of c-Abl with potential for neuroprotection

Click to edit Master text styles Pre-clinical development Second level Role of SCC-138 in in human iPSC- derived neurons

Third level

1) Preserves Parkin activity Fourth level

2) Modulating autophagic flux

3) Altering α-synuclein inclusions

PoC demonstrated in α-synuclein PFF induced mice model

PoC demonstrated in AAV1/2 α- synuclein rat model

Clinical development

Phase 1

1) Human PK established

2) Food effect study completed

3) Single Ascending Dose study completed

4) Multiple Ascending Dose study

completed

Phase 2

Proof of Concept study initiated

Favorable safety profile

No treatment related serious adverse events reported

PFF = Pre-formed Fibrils; AAV = Adreno Adenosine Vector; iPSC = Induced Pluripotent Stem cell; PK = Pharmacokinetic; PoC = Proof of Concept; Unpublished data – Not to be replicated

SCC-138 Augmented autophagic flux in human iPSC-derived neurons*

Autophagy markers

Augments autophagic flux

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Can remove endogenous cABL-mediated interference in autophagy and augment autophagic flux in a sustained manner Third level

Sustained autophagy is therapeutically meaningful and beneficial

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Reduces α-synuclein inclusions

Inhibits cABL and prevents accumulation of potentially toxic proteins such as α-synuclein, Tau, Aβ42 in the microenvironment

An important observation in support of a broader application of SCC-138 in various neurodegenerative diseases such as AD, ALD, DLB, HD, and PD

I I 3 C L

O S M D /

F A B

2 6 p

O S M D /

t n e m t a e r T

0.5 nM

1 nM

10 nM

* Study conducted at Brigham and Women’s Hospital Inc Boston MA

K0706 = SCC-138; AD = Alzheimer’s Disease; ALD = Adrenoleukodystrophy; DLB = Dementia with Lewy Bodies; HD = Huntington’s Disease; PD = Parkinson’s Disease; iPSC = Induced Pluripotent Stem cell; Unpublished Data - Not to be replicated

0.5 nM

1 nM

10 nM

SCC-138 Dose dependent improvement in behavioral assessment in the PFF-induced mouse model*

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Improves PFF-induced deficits in behavioral parameters; maximum improvement at 45 mg/kg dose

Turning time and Descending time in pole test and grip strength evaluated

* Study conducted at Johns Hopkins University Baltimore MD

PFF = Pre-formed Fibrils; PBS = Phosphate-buffered Saline; Unpublished Data - Not to be replicated

SCC-138 Neuroprotective effect in the PFF-induced mouse model*

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PFF synuclein model experiment completed.

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Result confirms that SCC-138 shows a dose-dependent reduction in synuclein-mediated death of dopaminergic neurons

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c p N S n

s n o r u e n e v i t i s o p f o r e b m u N

12000

PBS + Placebo

α-Syn PFF + Placebo

10000

α-Syn PFF + SCC-138 (45 mg/kg)

8000

6000

4000

2000

PFF Synuclein

SCC-138 Dose mg/kg

* Study conducted at Johns Hopkins University, Baltimore MD

Unpublished Data - Not to be replicated ; K0706 = SCC-138; PFF = Pre-formed Fibrils; PBS = Phosphate-buffered saline

SCC-138 Neuroprotective effect in the AAV driven rat A53T α-synuclein model*

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8000

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r e b m u n

l l

e c e v + H T

a r g N

Third level 6000

Fourth level

4000

2000

1-way-RM-ANOVA with Fisher’s LSD test NS / * / ** / *** represents P>0.05, P<0.05 P<0.01 or P<0.001 cf. EV

* Study conducted by an external CRO

Unpublished Data - Not to be replicated; AAV = Adreno Adenosine Vector; α-Syn = α-Synuclein; K0706 = SCC-138 EV = Empty Vector TH= Thyrosine Hydroxylase

SCC-138 Phase 1 study update

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Phase 1 trial (14 Day study) in Parkinson’s subjects completed

Second level

Doses up to 384 mg studied

Third level

Well tolerated-no severe adverse events.

Fourth level

Phase 1 trial in healthy controls completed up to 384 mg x 7 days.

CSF collected for 24 hours in each subject.

Confirmed adequate levels in CSF

CSF = Cerebrospinal Fluid; MAD = Multiple Ascending Dose; Unpublished data – Not to be replicated

Phase 2 study of Abl tyrosine kinase inhibition with K0706 (SCC-138)

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Screening

Randomization

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Fourth level

Placebo

(N=168)

SCC–138

96 mg (N=168)

SCC–138

192 mg (N=168)

Follow up

504 subjects randomized to placebo, 96 mg or 192 mg

Early stage subjects not on dopaminergic medication other than MAO-B inhibitors

Primary endpoint is change in MDS-UPDRS Part 2 & 3

Study initiated in Feb 2019. Last subject out expected Q4 FY22

MDS-UPDRS = Movement Disorder Society – Unified Parkinson’s Disease Rating Scale; MAO-B = Monoamine oxidase B

SCC-138 Broader application in other synucleinopathies – Dementia with Lewy Bodies (DLB)

DLB, a neurodegenerative condition with progressive cognitive impairment, hallucinations and Parkinsonism

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Estimated to affect about 1.4 million people in the USA*

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2nd most common cause of dementia in the elderly

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Strong overlap with Parkinson’s Disease

Synucleinopathies with Lewy Bodies seen on autopsy, and similar genetic risks suggesting potential efficacy in DLB

Investigator-initiated trial in collaboration with Georgetown University, Washington on-going in subjects with DLB

Expected completion of study by early 2021

* https://ghr.nlm.nih.gov/condition/dementia-with-lewy-bodies; Image courtesy: Lewy Body Dementia Association. Org

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SCD-044 For treatment of Autoimmune disorders

SCD-044 Selective S1PR1 modulator for autoimmune diseases

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SPARC is developing a novel orally bioavailable, potent and selective S1PR1 modulator in collaboration with Bioprojet, France

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Preclinical studies completed with promising results in various animal models of autoimmune diseases, including psoriasis

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Phase 1 study completed in healthy volunteers

S1PR1 = Sphingosine-1–Phosphate Receptor 1

SCD-044 Safety established in Phase 1 study

Multi-part Phase 1 study completed in healthy volunteers

Part 1: Single ascending dose

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Six dose levels in males and one dose level in females

Second level

~55% lymphocyte count decrease following 1 mg dose

Third level

Part 2: Food effect

Fourth level

No significant food effect

Part 3: Multiple Ascending Dose

Four dose levels including two up-titration scheme in males and one up-titration scheme dose level in females

~60% lymphocyte count reduction observed at 1 mg dose with asymptomatic bradycardia

Unpublished data – Not to be replicated

SCD-044 Heart rate and lymphocyte count relationship

Lymphocyte reduction Vs Heart Rate (HR)

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t n u o c

e t y c o h p m y l

e s a e r c e d %

Second level 57

Third level

Fourth level

10.4

13.0

8.33

2-4-6

0.3-0.6-1

Dose/Regimen; mg

)

m p b (

e n

i l

e s a b m o r f

e g n a h c

e t a r

t r a e H

Max drop in Mean HR (bpm)

Lymphopenia

Decrease in lymphocyte count

Escalation scheme of 0.3-0.6-1 results in target decrease in lymphocyte count with less effect on heart rate

Data readout based on top line data; Unpublished Data – Not be replicated; bpm = Beats per minute

SCD-044 Development status update

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Second level

IND filing by Q3 FY20 Third level

Phase 2 study initiation by H2 FY20

Fourth level

IND = Investigational New Drug

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Third level

Fourth level

SDN-021 For prevention of multi pill oral abuse

SDN-021 Abuse deterrent opioid

Designed to deliver clinically effective dose at prescribed dose

Click to edit Master text styles Upon ingestion of multiple pills the Second level technology reduces peak drug levels and slows down the release

Third level

Ability to deter abuse by other prevalent Fourth level routes – injection and snorting

Includes presence of an aversive agent to further deter abuse if tampered

Significant reduction in Cmax and partial AUC for initial 2 hours compared to Reference in both fasted and fed conditions; prolonged Tmax in fed condition

Drug plasma profile in recreational, oral multi-pill abusers

Norco Ref

SDN Fasted

SDN-021 Fasted

SDN Fed

SDN-021 Fed

160

140

120

100

) l

m / g n (

c n o c

a m s a l p n a e M

-20

Time (Hours)

AUC = Area Under the Curve; Cmax = Maximum Concentration; Tmax = Time required to reach Cmax ; Unpublished data – Not to be replicated

SDN-021 Trend indicating potential to deter oral multi-pill abuse

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Encouraging results in Category 1 in Second level vitro tamperability evaluation

Third level

Fourth level

Reduction in drug liking was observed in favour of SDN-021 implied by lower Emax compared to Reference

Recreational, oral multi-pill abusers experienced significantly less “Drug High” measured on visual analogue scale

Drug Liking Emax (linear model)*

88.38

81.03

Least square mean

Reference

SDN-021

* Pilot HAL study Cohort A: Participants able to differentiate between two doses of Reference and Placebo

Unpublished data – Not to be replicated; HAL = Human Abuse Liability

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Third level

Fourth level

SDN-118 Overdose prevention

SDN-118 Addressing intentional / accidental drug overdose

Targets the population at risk of suicidal ideation Click to edit Master text styles

Second level

Multi-component system employs pH dependent solubility of existing anti- depressant

Third level

Fourth level

Changes the pH of stomach micro environment upon ingestion of multiple pills

Restricts the rate and extent of drug release, thereby reducing the potential harm due to overdose

Encouraging results in single unit PK study; multiple unit PoC PK study underway

Single capsule PK, SDN-118 Vs Reference

Test A

SDN-118

Reference B

) l

m / g n (

n o i t a r t n e c n o c

a m s a l P

Time (hours)

PK = Pharmacokinetic; PoC = Proof of Concept; Unpublished data – Not to be replicated

1. 6.1.

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Second level

Agenda

Third level

Fourth level

SPARC Strategy & Growth Drivers Anil Raghavan – CEO

Update on Clinical Programs SiuLong Yao– Sr. V.P. Clinical Development & Operations

Early Stage Program Update Vikram Ramanathan – V.P. Translational Development

Collaborations & Partnerships Nitin Damle– Sr. V.P. Innovation

Financial Summary Chetan Rajpara- CFO

Q&A

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Second level

Third level

Fourth level

SCO-120 Targeting ESR1 mutations

SCO-120 Orally bioavailable SERD

Anti-estrogen therapy is mainstay of treatment for women with breast cancer whose tumors express ERα

Click to edit Master text styles Degradation of ERα is deemed a superior therapeutic approach in the treatment of Second level ER +ve breast cancer Third level

20-50% of patients with metastatic breast Fourth level cancer develop resistance to anti- estrogen therapies due to emergence of mutations in the ERα

Currently, fulvestrant is the only approved SERD. However, it is an intramuscular injection and low levels are achievable in vivo

SCO-120 is a novel, orally-active, selective ER degrader targeting both wild type and mutant forms of ER

SERD = Selective Estrogen Receptor Degrader; ERα = Estrogen Receptor Alpha Image courtesy: Ma C, et.al., Mechanisms of aromatase inhibitors resistance. Nat Rev Cancer (2015) 15:261–75.

SCO-120 Efficacy established in preclinical assessments*

Tumor Growth Inhibition – MCF-7 cell xenografts expressing mutant ERα Y537S

Click to edit Master text styles Potent in vitro SERD activity in breast cancer MCF-7 cells expressing ERα wild type (WT) and its mutants, including Y537S and D538G mutations

Second level

Third level

Fourth level

SCO-120 shows robust tumor growth inhibition of WT as well as Y537S and D538G xenografts

Superior efficacy in comparison to fulvestrant against Y537S and D538G mutant xenografts

)

m m

( e m u o v r o m u T

800

700

600

500

400

300

200

Vehicle SCO-120 (5 mg/kg) SCO-120 (12.5 mg/kg) SCO-120 (25 mg/kg) SCO-120 (50 mg/kg) SCO-120 (100 mg/kg) SCO-120 (300 mg/kg)

Fulvestrant (50 mg/kg) Fulvestrant (100 mg/kg)

n.s.

*** ** ** ****

**** ****

14 Days post treatment initiation

* Study conducted using cells developed at The Institute of Cancer Research, London

SERD = Selective Estrogen Receptor Degrader; ERα = Estrogen Receptor Alpha; Unpublished data, not to be replicated

SCO-120 Combination with CDK 4/6 inhibitor: xenograft studies*

Wild Type

1400

1200

Vehicle Palbociclib (45 mg/kg) Click to edit Master text styles SCO-120 (25 mg/kg) + Palbociclib (45 mg/kg) Fulvestrant (50 & 25 mg/kg) + Palbociclib (45 mg/kg) Second level

SCO-120 (25 mg/kg) Fulvestrant (50 & 25 mg/kg)

1000

)

m m

( e m u o v r o m u T

800

600

400

200

Third level

Fourth level

****

**** ****

****

14 Days post treatment initiation

1100

1000

)

m m

( e m u o v r o m u T

900

800

700

600

500

400

300

200

100

Y537S mutant

Vehicle SCO-120 (25 mg/kg) Palbociclib (45 mg/kg) Fulvestrant (100 mg/kg) SCO-120 (25 mg/kg) + Palbociclib (45 mg/kg) Fulvestrant (100 mg/kg) + Palbociclib (45 mg/kg)

**** **** ********

****

14 Days post treatment initiation

SCO-120 shows promising activity against resistant mutants alone, and the effect is further enhanced in combination with Palbociclib

* Study conducted using cells developed at The Institute of Cancer Research, London

Fulvestrant group received 50 mg/kg as loading dose thrice- weekly for first week, followed by 25 mg/kg twice-weekly for remaining 3 weeks; Unpublished data – Not to be replicated

SCO-120 Encouraging preclinical toxicity results

IND enabling toxicity studies have been completed

Click to edit Master text styles Acute and sub-chronic toxicity evaluated in mice, rats, dogs and monkeys. No Observed Adverse Effect Levels (NOAEL) established

Second level

Non-mutagenic and non-genotoxic

Third level

Battery of in vivo safety pharmacology studies completed - No adverse effects on CNS, respiratory and CVS parameters

Fourth level

Generally clean in vitro off-target profile vs 87 targets. Low liability for uterotrophic effect

IND = Investigational New Drug; CNS = Central Nervous System; CVS = Cardio Vascular System; Unpublished data – Not to be replicated

SCO-120 Development status update

Completed pre-IND meeting with USFDA Click to edit Master text styles

Phase 1 study will be initiated in Q4 FY20

Second level

Third level

Fourth level

USFDA = United States Food and Drug Administration; IND = Investigational New Drug

1. 6.1.

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Second level

Agenda

Third level

Fourth level

SPARC Strategy & Growth Drivers Anil Raghavan – CEO

Update on Clinical Programs SiuLong Yao– Sr. V.P. Clinical Development & Operations

Early Stage Program Update Vikram Ramanathan – V.P. Translational Development

Collaborations & Partnerships Nitin Damle– Sr. V.P. Innovation

Financial Summary Chetan Rajpara- CFO

Q&A

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Second level

Third level

Fourth level

Collaborations & Partnerships

Build diversified drug pipeline …by complementing in-house expertise with strategic external partnerships

Collaborations with external innovators

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Oncology

Second level

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Immuno-inflammation

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Partnerships with leading global researchers to source promising early stage innovative science/biology

Focus continues to be on novel first-in-class or best- in-class opportunities as well as complex drug delivery platforms to address high unmet clinical needs

Internal ideation

Therapeutic focus

Neuro-degeneration

Chase validated as wells as first-in-class drug targets in select therapeutic areas

Ophthalmology

Complex drug delivery systems

SPARC continues to pursue novel 505(b)(2) opportunities with high commercial potential

Exploratory programs

Augment capabilities to pursue new treatment modalities like novel biologics that may offer significant value proposition versus existing therapies

Developing external innovation network …to tap novel science early on

Scale-up strategic partnerships with global academic centres as well as leading Click to edit Master text styles research service providers

SPARC – Washington University collaboration

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SPARC is evaluating and considering few unique research opportunities for providing grant funding

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Additionally, SPARC has been expanding tie-ups with other leading academic institutes in the US

University of Arizona, Tucson

Update on external innovation SPARC–HitGen collaboration

SPARC and HitGen have entered in to a research collaboration to identify novel small molecule leads for targets of interest to SPARC

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Under this collaboration, HitGen will apply its proprietary technology platform, based on DNA-encoded library design, synthesis and screening; to discover novel leads for SPARC Second level

HitGen shall be eligible to receive upfront payment and certain success based Third level milestone payments Fourth level

HitGen has initiated screening of its DNA-encoded compound library against a drug target of interest to SPARC in Q2 FY20

DNA Encoded Library Screening*

*Image courtesy: HitGen

Update on external innovation SPARC–University of Arizona collaboration

SPARC has collaborated with University of Arizona, Tucson to develop novel molecule(s) derived from natural sources for treatment resistant cancer

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SPARC is currently conducting in vitro and in vivo studies to establish proof-of- concept

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SPARC has the option to exclusively license the molecule(s) on worldwide basis

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SPARC shall be responsible for further development & commercialization of the drug

1. 6.1.

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Agenda

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SPARC Strategy & Growth Drivers Anil Raghavan – CEO

Update on Clinical Programs SiuLong Yao– Sr. V.P. Clinical Development & Operations

Early Stage Program Update Vikram Ramanathan – V.P. Translational Development

Collaborations & Partnerships Nitin Damle– Sr. V.P. Innovation

Financial Summary Chetan Rajpara- CFO

Q&A

SPARC

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Financial Summary

(INR mn)

FY19

Total Income

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1,964

FY18

832

FY17

1,947

FY16

1,642

FY15

1,588

Total Expenses

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Third level

Exceptional Item

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3,418

3,292

3,137

2,342

1,983

490

Profit / (Loss) after Tax

(1,454)

(1,970)

(1,190)

(700)

(395)

Total Comprehensive Income (Net of tax)

Liquidity Status

(1,447)

(1,984)

(1,195)

N.A.

Cash and cash equivalents INR 788 Mn as on 31-Aug-19

INR = Indian Rupees

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Pipeline

R&D Pipeline

Product

Indication

Discovery

Preclinical

Phase 1

Phase 2

Phase 3

Pre- registration

Approved / Market

Elepsia® XR

Xelpros®

Epilepsy

Glaucoma

Taclantis®

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Baclofen GRS

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Spasticity

PDP–716

SDN–037

SCO–088

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Glaucoma Fourth level Ocular Pain & Inflammation

CML

SCC–138

Parkinson’s Disease

SDN–021

Pain

SCD–044

Autoimmune Disorders

SDN–118

Depression

SCO–120

Breast Cancer

CML = Chronic Myeloid Leukemia

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THANK YOU

Fourth level For updates and specific queries, please visit www.sparc.life or write to us at bus.dev@sparcmail.com

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 presentation. This material is for use during an oral presentation; it is not a complete record of the discussion. This work may not be used, sold, transferred, adapted, abridged, copied or reproduced in whole on or in part in any manner or form or in any media without the prior written consent. All product names and company names and logos mentioned herein are the trademarks or registered trademarks of respective owners

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