Cipla: Transforming for a new horizon Transforming for a new horizon Cipla Corporate Presentation...

ConfidentialCorporate Presentation 2017-18

Cipla: Transforming for a new horizon

Cipla Corporate Presentation


Disclaimer

Except for the historical information contained herein, statements in this presentation and the subsequent discussions may constitute "forward-

looking statements". These forward-looking statements involve a number of risks, uncertainties and other factors that could cause actual results to

differ materially from those suggested by the forward-looking statements. These risks and uncertainties include, but are not limited to our ability to

successfully implement our strategy, our growth and expansion plans, our ability to obtain regulatory approvals, technological changes, fluctuation

in earnings, foreign exchange rates, our ability to manage international operations and exports, our exposure to market risks as well as other risks.

Cipla Limited does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date thereof.

Information relating to any medical products or medical devices contained herein is provided by Cipla for general information purposes only.

Information on any of the medical products or medical devices may vary from country-to-country. A reference to a medical product or a medical

device does not imply that such medical product or medical device is available in your country. The commercial availability of the medical products

or medical devices listed herein in your country is dependent on the validity and status of existing patents and/or marketing authorizations related

to each. An independent enquiry regarding the availability of each medical products or medical device should be made for each individual country

The product information contained herein is not intended to provide complete medical information, and is not intended to be used as an alternative

to consulting with qualified doctors or health care professionals.

Nothing contained herein should be construed as giving of advice or the making of a recommendation and it should not be relied on as the basisfor any decision or action. It is important to only rely on the advice of a health care professional

2


Established in 1935, Cipla is a pioneer in the Indian pharmaceutical industry

Cipla started as a small Indian enterprise, committed to the nation's quest for self-sufficiency – today it has transformed into a world-class global pharmaceutical player

3rd largest in India4 3rd largest in South

Africa5

Among top 10 most

dispensed generic

companies in US6

Cipla Today8

Markets 80+

Revenue ~ $2.2bn

R&D

investment~ 7%

EBITDA

margin~ 18%

Among the top 5 in

some of the key

emerging

economies7

1 in 3 HIV* patients

take Cipla ARVs# 1

One of the world’s

largest inhalation

portfolios

One of the world’s

largest suppliers of

anti-malarials

Partner of choice for

Donor Funded /

Tender Agencies

1. Based on combined sales in the generic accessible market | 2. Rx + Gx business, as per IMS MAT Nov ‘17 + business estimates | 3. As per IMS MAT Nov ‘17 |4. By market share, India sales, IMS MAT Nov ’17 | 5. As per IMS MAT

Nov ’17, including tender business | 6. As per IMS MAT Nov ‘17 – by TRx | 7. As per IMS MAT Sept ’17 | 8. Trailing 12 months (TTM) – H2 FY’17 + H1 FY’18 | * HIV - Human Immunodeficiency Virus | # ARV – Anti Retrovirals

Amongst the top 2

largest dispensed

companies in India2

8 out of every 10

doctors in India

prescribe at least 1

Cipla medicine3

3rd most dispensed

company in South

Africa3

Patient access at the center of Cipla’s success

Healthy business performance in key markets

YEARS

OF CARING82

3


Scorecard - Cipla has made significant achievements against its key strategic objectives (1/2)

Grow US towards a billion dollar enterprise with focus on Specialty

95 ANDAs* pending for approval including 25

tentative approvals

20+ annual filing run rate since FY ’17 - to be

maintained in the coming years

Approvals for differentiated products such as

Budesonide, Decitabine and Sevelamer demonstrate

capability in niche areas

Committed to build a Specialty franchise in the US.

Multiple assets under evaluation for partnership

Drive growth in markets like India, South Africa and other key markets

Healthy growth rates last year for India (~10%1) as well as

South Africa (~17%2)

Multiple in-licensing deals in India and South Africa to

strengthen key therapies like Diabetes, Cardiology, Respiratory,

and CNS#

Artesunate Rectocaps (paediatric Anti-Malarial) and Q-Tib (TB

in HIV Patients) launched during the year under Cipla Global

Access

Biosimilars - partnerships in emerging markets and South

Africa

*ANDA – Abbreviated New Drug Application | # CNS – Central Nervous System

1. Rx + Gx, FY ‘17 | 2. FY ‘17

4


23 successful audits1 this year

across our facilities including 7

USFDA audits

Manufacturing and R&D sites

remain in a state of compliance

Fresh talent onboarding and

continuous skill upgradation at

manufacturing sites

Maintaining high standards of quality & compliance

`MDI – Metered Dose Inhaler | ^^ FPSM - Fluticasone Propionate/Salmeterol | *DTM – Direct-To-Market | # B2B – Business-To-Business | ^ SA – South Africa | ~ SSA – Sub-Saharan Africa | ** CGA – Cipla Global Access

1. Including Invagen facility audits

Scorecard - Cipla has made significant achievements against its key strategic objectives (2/2)

Expanding Respiratory franchise

Respiratory in India: shaping the

ecosystem – over 2Mn patients

counselled over the last year

Synchrobreathe (breath-actuated MDI`)

successfully launched in South Africa

FPSM^^ launched in Australia and 8

European markets this year

FPSM now sold in 40+ countries

Leadership position in Respiratory in

markets like India and Sri Lanka

Business optimization to bring focus and drive synergy

25+ markets optimized in the last 2

years in emerging markets

Strategic divestitures executed to

increase focus on core business

5+ markets converted from DTM* to

B2B# model in Europe

African footprint consolidated by

merging SA^, SSA~ and CGA** into

SAGA

5


20%

23%25%

FY '16 FY '17 H1 FY '18

Optimization efforts have led to increased margins, as well as synergies and efficiencies in the system

• Cost containment initiatives in direct and indirect spends have resulted in significant margin improvement and driven

synergy, simplification and efficiency

• Supply chain optimization efforts have led to an increase in OTIF* and reduction in stock-outs

1. Margins exclude one-offs (like Esomeprazole, accounting based reclassifications, restructuring cost and Indigo), Cipla Health and Biotech business | * On Time In Full

Generics base business EBITDA margin (ex-R&D)1 has shown considerable improvement in the last few years

~

~~

+ 3% + 2%

6

R&D expected to grow in the near

future

Fuel for further innovation and for

pursuing other growth opportunities


Upcoming growth opportunities for Cipla are predicated around multiple levers across geographies

7

India:

• Portfolio strengthening

• Patient engagement

North America:

• Commercial strength

• Differentiated pipeline

• Specialty focus

SAGA:

• Market expansion

• Partnerships

• Tender business

Other Key Markets:

• Strengthen DTMs

• Expand in newer markets

Diversified portfolio

& pipeline in

regulated markets

High standards of

manufacturing,

regulatory and

compliance

Cipla’s core

principles – guiding

its culture of

excellence

Share of revenue1

1. Revenue share as per H1 FY’18 | 2. SAGA includes South Africa, Cipla Global Access and Sub-Saharan Africa | 3. Includes vet, India API and others

# EM – Emerging Markets | ^ EU – Europe | * API – Active Pharmaceutical Ingredient

*

2

3

#

^

Others

2%API

4%


India will continue to be a key component of Cipla’s growth story, providing a strong base for global expansion

Rx therapy share and market performance1

1. As per IMS sales data Nov‘17 | 2. As per overall therapy ranking in IMS as on Nov’17 |

* SGLT-2 - Sodium-Glucose Co-Transporter 2 | # OTC – Over-The-Counter | ^ BPH - Benign Prostatic Hyperplasia

Growth outlook for India business

Therapy Strengthening:

• Cardio-Metabolic: Focus on progressive products like betablockers and

SGLT-2* Inhibitors

• Dermatology: Expand in topical segments – 10+ upcoming launches including

topicals and emollients

• Urology: Strengthen prescriber base with focus on BPH^, build Uro-Oncology

Portfolio

Acceleration through inorganic initiatives:

• Executed partnerships with MNCs for Respiratory, Cardiology, and Diabetes

segments

• Advanced discussions underway for partnerships in Oncology, Dermatology

and Vaccines

Respiratory30%

Anti-infectives

21%

Cardio-Metabolic

13%

Gastro Intestinal

6%

Urology5%

Neuro / CNS4%

Ophthal / Oto3%

Anti-virals5%

Others13%

#1

#3

#1

#5

#5

#1

4 therapies ranked amongst top 32 – contributing to

61% of Cipla’s revenue share

Ranked 3rd in chronic segment and 2nd in acute

17 first-to market brands in inhalation market

8


Driving volume growth in India by increasing the patient funnel - Cipla is running various initiatives and programs to expand awareness and improve diagnosis & compliance

Over 80 Mn Asthma and COPD patients in India

Of the diagnosed

population, 20%

are still untreated

Only 24% of

patients on

treatment are on

inhalation therapy

<10% of the total population is on

inhalation therapy and of those,

only ~40% are compliant

BEROKZINDAGI

BEROKZINDAGI

Note: Nebules not included | Source: Cipla estimates basis market studies

1

2

3

~8 Mn patients on inhalation

therapy

~30 Mn patients on treatment

BerokZindagi aims for conversion from oral to inhalation therapy + targeting diagnosed patients not on treatment

• Campaign targeting

asthma awareness and

management

• Over 11 million people so

far have come in touch

with the campaign through

digital mediums

Breathefree addresses patients not on treatment as well as undiagnosed patients

Cipla’s innovative handheld Spirometer helps in diagnosing & educating patients

Partnered with a large diagnostic chain to

provide Spirometry test to all patients –

pilot with 5 centres & 40 doctors

Breathefree reached 2Mn

patient touchpoints through

~640 educators and 4000

Breathefree chemists

9

Undiagnosed

51%

Diagnosed

49%

On

treatment

80%

Not on

treatment

20%

Oral

76%

Inhalation

24%


North America, with its current low base, is set to grow disproportionately and have a higher contribution to Cipla’s top-line

10

Amongst top 3 in 32 out of 47 products; market leader in 121

Launched limited competition products like gPulmicort and

gDacogen

On track for 20+ filings this year

* FY ‘18 onwards, for illustrative purposes only - not to scale | 1. Market statistics as per IMS MAT Nov ’17

Grow the US business to contribute ~30% towards Cipla’s revenues

18%

30%

FY '17 FY '18 FY '19 FY '20 FY '21 FY '22

US

Co

ntr

ibu

tion

*

Portfolio Expansion and Diversification:

• Build differentiated pipeline with focus on HIV, Respiratory

& Oncology

• Accelerate growth through in-licensing and multi-product

partnerships to diversify risk (5 partnerships executed)

Focus on Specialty (Respiratory and CNS):

• Use Tizanidine patch (Phase 1A study completed, results

under analysis) as a launchpad for Specialty business

• Multiple assets at an advanced stage of evaluation for

Respiratory and CNS

CNS, Oncology

CNS, Respiratory

RespiratoryGrowth

PortfolioOncology,

CNS

~

ConfidentialCorporate Presentation 2017-18 11

Focus on innovative platform technologies to build a robust pipeline which will drive future growth in North America

Innovative

technology

platforms

No of pipeline

products

Market size

(US$)

Inhalation

technology

15

14Bn

Suspension based

liquids

12

3.7Bn

Liposome

injections

2

308Mn

Nanotechnology

1

656Mn

1

2

Over 100 patents granted,

including respiratory

Patent filing includes drug

substances & products, platform

technologies, polymorphs &

crystals, and medical devices

Over 1500 dedicated and

talented scientists

Developing proprietary medical

devices for respiratory

medicinesMDIs, nasal

sprays, respules

Pipeline

snapshot

Anti-

inflammatory,

ophthalmic, CNS

Anti-fungal,

oncology

Technologically

complex nano-

paclitaxel


Filings for under-development products in the US will bolster future growthSplit of top 50 projects

6

8

104

22

16

15

6

9

4

11

22

17

18

28 4

Of the 200+ development projects, top 50 have market size of > US$ 35bn

RespiratoryTherapy Dosage form

Dermatology

Oncology

CNS

Others

Orals

Solids

Injectables

Inhalation

Others

Simple

Medium

Complex

Complexity Market potential (innovator sales)

> $ 500mn$100-500mn

< $100mn

Topicals

16 Para IV Filings primarily in Respiratory,

Oncology and Dermatology

15+ limited

competition products

CNS, Respiratory and

Oncology pipeline has a

brand market size of

>US$ 25bn

12

FPSM DPI under

development for regulated

markets

~80%

~40%

Limited competition products – indicative only1

~50%

~80%

~30%

~30%~40%

1. Competition stats are Cipla estimates


SAGA will continue to advance through private market expansion and institutional partnerships

SAGA to continue being a key business contributor, as well as home to first-of-its-kind initiatives by Cipla

13

4th largest in South Africa in the private market1

Leading position in 5 out of the 14 therapies in South Africa2 in

which we have a presence

Market expansion:

• 6 new first-to-market products to be launched over the next few

months addressing a brand market of > US$ 30Mn

• Target tenders in ARVs, malaria, tuberculosis, hepatitis-C &

reproductive health

In-licensing and partnerships:

• ~10 partnerships executed for biosimilars, OTC and other select

molecules. Further tie-ups being evaluated.

1. As per IMS MAT Nov ‘17, by value | 2. As per IMS MAT Nov ’17 & WWP

After providing ‘dollar-a-day’ HIV drugs in Africa, Cipla now partners with Clinton Health to provide access to

affordable cancer treatment in Africa

• American Cancer Society & Clinton Health Access Initiative announced collaboration with Cipla to increase access to lifesaving cancer treatment in Africa

• Cipla has pledged to make select common cancer medicines available at agreed upon affordable prices


Cipla’s presence in other key markets will serve as our demographic dividend by bringing in high volumes and cushioning against market volatility

Increased focus on going deeper in certain chosen markets and strengthening current portfolio

14

Strengthened front ends in Australia and UK

Executed biosimilar partnerships in several emerging markets

Build and deepen newer markets for incremental volume growth:

• Australia, Colombia – Expand presence through Respiratory portfolio

• Brazil & China – Develop presence through Oncology and Respiratory

pipeline

Strengthen DTM Markets to build base for growth:

• Strengthen key DTM markets like Sri Lanka and UK through new

Respiratory launches (MDIs and DPIs*)

• Build biosimilar partnerships across marketsStrengthen

existing DTMs

New markets +

new molecules

Volume growth across other key

markets

* DPI – Dry powder inhaler


Cipla continues to maintain quality and compliance standards across manufacturing locations

15

521 successful audits conducted by global regulatory bodies across our facilities2

17 12 6 4 3 3 2 1 1 1

53 2 1

5

25 1

1 2 1 1

7

7

1

12 1

1 2 1

USFDA PIC/S WHO(Geneva)

TGA(Australia)

MHRA (UK) APVMA(Australia)

INVIMA(Colombia)

ANVISA(Brazil)

EMA EDQM(Europe)

PMDA(Japan)

2015 2016 2017

2

23 successful audits in

2017 alone including 7

USFDA audits

Finished

formulations

▪ 30+ formulations facilities

▪ 50+ dosage forms

▪ 1500+ products

1. Total of 2015,2016 and 2017; includes Invagen facility audits for 2016 & 20172. Select sites also have approvals from Denmark, France, Uganda, Singapore, Latvia, Tanzania, Kenya and various other countries

Increased automation to further strengthen quality and control processes

APIs▪ 5+ API facilities

▪ 1000+ tons capacity


Cipla intends to achieve its key strategic goals in order to grow sustainably with a better overall financial profile

16

1

Grow US towards a ~30% contribution to Cipla’s revenues via continued traction on filings & launches;

ramp up Specialty through in-house capabilities and partnerships

3Leverage existing Respiratory capabilities globally to expand our footprint, both in emerging and

developed markets

5 Continue momentum on ambitious cost optimization programs in order to boost margin profile and future growth

2

Bolster growth and leadership position in India, South Africa and key emerging markets through consumer

access programs, inorganic partnerships and therapy shaping initiatives

4 Build a leaner operating model and continue our focus on excellence in quality, compliance, patient

access and talent pool


Cipla’s Credo – The center of Cipla’s culture of excellence

17

Unveiled earlier this year, Cipla’s credo is being embodied everyday by its 23000+ employees as the base principles for guiding life at Cipla


Thank You

18


Contact Details

Registered Office :

Cipla Limited, Cipla House, Peninsula

Business Park, Ganpatrao Kadam

Marg, Lower Parel, Mumbai 400 013

For any general queries, Reach us at:

[email protected]

[email protected]

For more information please visit

www.cipla.com

19

mailto:[email protected]

mailto:[email protected]

http://www.cipla.com/

Cipla: Transforming for a new horizon Transforming for a new horizon Cipla Corporate Presentation...

Documents

Transcript of Cipla: Transforming for a new horizon Transforming for a new horizon Cipla Corporate Presentation...