Bahaa Rashad

BD Director

SAJA Pharmaceuticals

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London, 25th, 2020

HOLIDAY INN LONDON24-25 FEBRUARY 202

Global forecasted CAGR 19-23 is 5.6%, ME 7.7% and Saudi Arabia the largest market in ME is 5.7%

Source: IQVIA Market Prognosis May 2019 (Un audited data)2

In MEA region, Saudi Arabia is the largest, while Algeria, UAE and Egypt are key countries driving the growth of the region

Source: IQIVA Audited Data MAT Q1 2019 private, LPO, institutional data where available; Value sales at ex-factory price level without discount; Egypt sales at constant exchange rate and don’t account for any currency fluctuation or devaluation 3

KSA is expected to lose rank in 2023 but will continue to head all MEA markets.

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➢ KSA Retail and Inst. market is

valued at $8.2 B growing at 6%

PPG and 4% CAGR accounting

for 32% share in total MEA sales

➢ Retail channel covers 44% share

sales however it has lost ~$70 Mn

over last MAT. Institutional and

LPO channels have grown at 13%

PPG each

➢ Egypt Total market is valued at $4

B and 3.4 B in volume growing at

24% PPG in value

➢ Alimentary TA leads the market

with 20% share growing at 29%

PPG and 61 new launches in

2019

Among the MEA key markets, Saudi is the biggest with 32% share but Egypt saw highest growth at 24%.

Source: IQVIA Audited Data, MAT Q1 2019, includes IQVIA private, LPO, institutional data where available; Value sales at ex-factory price level without discount; Egypt sales at constant exchange rate and don’t account for any currency fluctuation or devaluation, however real growth at variable exchange rate is -4%

Ref: Strategic market review report, IQVIA, Feb 2019

KSA market overview- growth drivers and barriers

55Source: Strategic market review report, IQVIA, Feb 2019NCD: No-Communicable Disease

GCC market growthFuture forecasted growth rate is expected to be 5.9% to reach more than 7 billion USD

Source : IQVIA market prognosis report 2019 6

Egypt pharma market is expected to grow at double digits as a result of rise in health awareness causing a shift to innovative medicines & price growth

Source: IQVIA Market Prognosis™, Industry reports 7

TransformationHyperloop system is coming to Saudi Arabia

https://www.techjuice.pk/hyperloop-system-is-coming-saudi-arabia/

Saudi Arabia Granted Women the Right to Drive

https://www.expatwoman.com/saudi-arabia/home-car/women-in-saudi-arabia-overseas-licences-can-now-apply-for-their-saudi-driving

http://www.valorealestate.com/dubai-expo-2020-what-will-be-the-impact-on-dubais-real-estate-market/

New Grand Egyptian Museum

https://egyptindependent.com/egypt-govt-prepares-ceremony-for-grand-egyptian-museum-opening/

8Egypt will be the 6th largest economy by 2030

Transformation – key words ➢Unification : pricing unification in all GCC markets.

➢Universal insurance coverage: Egypt is embarking on a big change with the universal healthcare coverage, this is a game changer in Egypt

➢Harmonization: of the regulatory procedures The effort is taking place specially in GCC region.

➢United purchase: The establishment of NUPCO in Saudi Arabia and the unified purchasing agency in Egypt.

➢Localization : of the pharmaceutical industry, and the local content & launch mechanism

➢Privatization: of the healthcare services in Saudi Arabia

Launch of Universal healthcare coverage systemIn Egypt

http://en.wataninet.com/features/health/new-healthcare-insurance-system-covers-egyptians-one-and-all/29989/

SAUDI ARABIA LAUNCHES HEALTHCARE PRIVATISATION PROGRAMME

https://www.imtj.com/news/saudi-arabia-launches-healthcare-privatisation-programme/

Imp

act

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Transformation – Regulatory & IP

➢The establishment & empowerment of the NFSA and the Egyptian Drug Authority (EDA).They are directly reporting to both the Prime Minister & the President.➢ Saudi FDA launches the electronic gate, and the new

registration guidelines.➢Fast track registration adopted by several authorities.➢Reliance mechanisms is adopted in both Egypt, UAE, Jordan

and Saudi Arabia. (Bridging and Verification)➢The change of the box system in Egypt.➢Implementation of the track and Trace.➢Submission for registration before approval in the Country of

Origin ➢Pricing based on form 30 and the price in the country of origin.➢The establishment of Saudi patent authority.

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Multiple initiatives have been implemented by authorities to reduce the registration and access to pharmaceutical products

Source: IQVIA expertisePhRMA | Assessment of access to medicine timelines in selected countries in Middle East and Africa | Project Report | April 2019

Abridged & verification

Electronic Gate submission

eCTD verification checklist

Abridged & verification

Fast track registration

EDA and NFS

Initiatives to reduce theRegistration time

Example: Egypt initiatives

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Stability study of the pharmaceutical drug s should be done according to the climatic conditions of Saudi Arabia

Zone II could be accepted but withProper justifications

SOURCE: SFDA; team analysis12

Usually, SFDA sets retail prices based on lowest benchmark

Saudi Arabia relies on 30 reference countries to establish pricing during the drug approval process and revises price every three years. Typically, lowest prices among reference countries and country of origin is used to determine the price.Reference countries include low income countries such as Algeria and Egypt.Prices in Saudi Arabia affect prices in Kuwait, Qatar, Jordan, Bahrain, Oman, and the United Arab Emirates

SOURCE: SFDA; team analysis13

5th generic and beyond maintains same price point as 4th genericPrices are revised every three years and in revision:Therapeutic significance and availability of alternatives.Whether the product’s price has changed in the country of origin and other countries taken into consideration

Access to ME market depends on multiple dimensions which are complex across countries

Source: IQVIA expertisePhRMA | Assessment of access to medicine timelines in selected countries in Middle East and Africa | Project Report | April 2019

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Market Access success criteria is different for each ME market

The ME markets are different: each market has it unique characteristics which affect the market access model, regulatory pathway, supply and the marketing

approach

https://www.reinsurancene.ws/mena-re-insurance-markets-face-short-term-volatility-a-m-best/

•Egypt - Egyptian Drug Authority•Jordan - Jordan Food and Drug Administration•Oman - Ministry of Health•Saudi Arabia - Saudi Food and Drug Authority•Turkey - Ministry of Health•United Arab Emirates -Ministry of Health•Yemen - Supreme Commission for Drugs and Medical Appliances

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Company Location Key Information

Jeddah • Joint Venture with Banaja Holdings – Glaxo Saudi Arabia Limited.• 75,000-square-meter facility with a yearly production capacity of 12 million tubes,

3.5 million bottles, 4 million inhalers and 15 million tablet packs.• Produced drugs include Glaxo’s anti-ulcerant Zantac and its anti-asthmatic Ventolin.

Jeddah • Joint venture with Tamer – SAJA• 30,000-square-meter facility producing Sankyo and Yamanouchi products as well as

contract bulk production for other Japanese drug companies.

King Abdullah Economic City, Rabigh

• 32,000-sqauer-meter planned facility with a yearly production capacity of 18 million packs.

• Planned packaging and warehousing of several Pfizer solid dose medicines currently supplied to the KSA market.

King Abdullah Economic City, Rabigh

• 35,000-square-meter facility with planned production spanning up to 20 products including oral anti-diabetics and cardiovascular drugs.

• Research activities to be conducted in coordination with KAUST.

Source: MENA Pharmaceutical Review Strategies & Outlook pdf

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Go to Market Approaches

Go to market approaches adopted by Global pharma

Localization of the Manufacturing has been implemented by different Global pharma like Novartis, J&J, Roche, AstraZeneca, etc.

✓ Examples : ✓ Sanofi and SAJA (Second brand for

Lantus (Glargine) solo star✓ Novartis and SAJA ( Second brand for

Galvus and Galvus met (Vildagliptin)

Second brand / Co-marketing

✓ Examples : ✓ Pfenex licensed Teriparatide (PF708) in the

MENA region to Alvogen and SAJA.

Licensing and Supply agreement

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Go to Market Approaches

Different Go to market approaches adopted by Global pharma

Usual Market access Business model

✓ Agency Agreement ✓ Limited market presence.✓ Less investment needed✓ Control (Scientific office?)✓ Best model for smaller markets

(Yemen, Lebanon)✓ Applicable mostly for big pharma

Local Distributor / Agent model

✓ Licensing agreement / Partial manufacturing / JV

✓ Faster access / Business protection.✓ Price protection / Tender privileges.✓ Less profit / Higher volumes.✓ Best model for big market due to

new localization attitude (Saudi Arabia, Egypt)

Partnering with a Local manufacturer

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➢ MAH➢ Trade Mark➢ Pharmacovigilance➢ Product liability insurance➢ Upfront investment➢ Registration/Actual launch➢ Submission before

registration in CoO

Initiatives to reduce theRegistration time

✓ Examples : ✓ Sanofi and SAJA (Second brand for

Lantus (Glargine) solo star✓ Novartis and SAJA ( Second brand for

Galvus and Galvus met (Vildagliptin)

Second brand / Co-marketing

✓ Examples : ✓ Pfenex licensed Teriparatide (PF708) in the

MENA region to Alvogen and SAJA.

Licensing and Supply agreement

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Go to Market Approaches

Different Go to market approaches adopted by Global pharma

✓ UAE allows access to 43 countries worldwide so many foreign pharmaceuticals companies see potential in the Middle East as they can have a very light legal and physical footprint in the region.

✓ Establishment of Soft legal entity in the main land or free zone is allowed

UAE

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Go to Market Approaches

Example of the market access - Legal forms - ME

✓ To tape into the largestpharma market in MEA,and produce at low cost.

✓ Foreign companies can own 100%, repatriate the money and collect royalties with favorable tax

✓ Example GSK, Novartis, etc.

Egypt

✓ JV manufacturing : SAJA and GSK

✓ JV Distributions✓ Establishment of local

subsidiaries : SAFAD (Novartis), Pfizer Saudi, Sanofi Saudi

Saudi Arabia

https://www.reinsurancene.ws/mena-re-insurance-markets-face-short-term-volatility-a-m-best/

•Egypt - Egyptian Drug Authority•Jordan - Jordan Food and Drug Administration•Oman - Ministry of Health•Saudi Arabia - Saudi Food and Drug Authority•Turkey - Ministry of Health•United Arab Emirates -Ministry of Health•Yemen - Supreme Commission for Drugs and Medical Appliances

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Potential and growing but Challenging and Transforming,

Coutnry Population 2019

Bahrain 1,641

Egypt 100,388

Iraq 39,310

Jordan 10,102

Kuwait 4,207

Lebanon 6,856

Oman 4,975

Palestine 4,981

Qatar 2,832

Saudi Arabia 34,269

Syria 17,070

Yemen 29,162

SAJA is a joint-venture between the premier Saudi

Health care company TAMER and two of the leading Japanese Companies, Astellas Pharma Inc., and Daiichi-Sankyo Co. Ltd.

SAJA operates in 15 countries in MENA region with full sales and marketing teams and we are actively pursuing strengthen our geographical foot print in the region through resources acquisition and capital investments. “ The most important element is bringing together the right people who will be responsible to bring all of this together, SAJA has been very keen on diversifying & building its Human Resources to integrate all of the different cross border experiences & to share them cross functionally to simply be the best in what we do” In addition to our current facility Saudi Arabia, SAJA have acquired a new facility in Egypt and moving forward to establish a green field facility in Algeria to enhance our market access to the African countries. Our solid infrastructure and strong financial and commercial capabilities render SAJA as a key Player in MENA Market.

Currently SAJA is the GCC region Market Leader in Urology therapeutic field and our portfolio includes strong candidates in the Cardio-Metabolic, Antibacterial, and Primary Care fields, while Oncology, Biosimilars, and Hospital products are the key strategic Business Development areas for SAJA in 2017 - 2023 plan.

SAJA is an example of a one-stop-shop and platform for any company looking to access to ME and North Africa

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Trusted Partner

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Right Business Model

Right Partner