Edastuskiri

Ministry of Health Suur-Ameerika 1 10122 Tallinn Estonia To: Birgit Lao, General Director of Estonian Health Board Per Email: [email protected] Pandemic Preparedness for Rapid Availability of Vaccines Halle, 08/15/24 Dear Mrs. Lao, With Wacker Biotech GmbH, Germany has a pioneer in mRNA technology that is decisively strengthening Germany's pandemic preparedness*. In just two years, WACKER Biotech has built one of Europe's largest and most modern mRNA production centres in Halle, which has been in operation since June 2024. The production facility in Halle can produce over 200 mil- lion vaccine doses per year and is ready to quickly supply Germany and Europe with life-sav- ing vaccines in the event of an emergency. WACKER Biotech would now like to make this unique expertise available to other countries. Estonia in particular has the opportunity to benefit from this expertise through pandemic pre- paredness contracts with WACKER and to strengthen their own health security. WACKER Biotech has established itself as a microbial CDMO (Contract Development and Manufacturing Organisation), specialising in the production of therapeutic proteins, vaccines and products with live bacteria. WACKER Biotech has a network of closely interlinked pro- duction sites in Europe and the USA. This allows flexible transfer of production processes between the sites and provides solutions for potential bottlenecks. Let's work together to utilize this technology leadership to strengthen Estonia's health secu- rity. We look forward to a timely exchange. Yours sincerely Dr. Andreas Anton Senior Project Lead Pandemic Preparedness Wacker Biotech GmbH

Who we are? – www.wacker.com/mRNA Engage the Experts - pDNA, mRNA, and LNP Solutions from Research to Commerciali- zation Wacker Biotech is your CDMO partner for the entire manufacturing chain of plasmid DNA (pDNA) and messenger RNA (mRNA) to lipid nanoparticle (LNP) formulations. We leverage our global team of development, process engineering, and manufacturing experts and a net- work of state-of-the-art facilities to accelerate our partners’ programs from research phase to the market.

* https://www.pei.de/EN/newsroom/press-releases/year/2022/07-pandemic-preparedness-contracts-signed-rapid-availability- vaccines.html?nn=406136

Ministry of Health Suur-Ameerika 1 10122 Tallinn Estonia To: Birgit Lao, General Director of Estonian Health Board Per Email: [email protected] Pandemic Preparedness for Rapid Availability of Vaccines Halle, 08/15/24 Dear Mrs. Lao, With Wacker Biotech GmbH, Germany has a pioneer in mRNA technology that is decisively strengthening Germany's pandemic preparedness*. In just two years, WACKER Biotech has built one of Europe's largest and most modern mRNA production centres in Halle, which has been in operation since June 2024. The production facility in Halle can produce over 200 mil- lion vaccine doses per year and is ready to quickly supply Germany and Europe with life-sav- ing vaccines in the event of an emergency. WACKER Biotech would now like to make this unique expertise available to other countries. Estonia in particular has the opportunity to benefit from this expertise through pandemic pre- paredness contracts with WACKER and to strengthen their own health security. WACKER Biotech has established itself as a microbial CDMO (Contract Development and Manufacturing Organisation), specialising in the production of therapeutic proteins, vaccines and products with live bacteria. WACKER Biotech has a network of closely interlinked pro- duction sites in Europe and the USA. This allows flexible transfer of production processes between the sites and provides solutions for potential bottlenecks. Let's work together to utilize this technology leadership to strengthen Estonia's health secu- rity. We look forward to a timely exchange. Yours sincerely Dr. Andreas Anton Senior Project Lead Pandemic Preparedness Wacker Biotech GmbH

Who we are? – www.wacker.com/mRNA Engage the Experts - pDNA, mRNA, and LNP Solutions from Research to Commerciali- zation Wacker Biotech is your CDMO partner for the entire manufacturing chain of plasmid DNA (pDNA) and messenger RNA (mRNA) to lipid nanoparticle (LNP) formulations. We leverage our global team of development, process engineering, and manufacturing experts and a net- work of state-of-the-art facilities to accelerate our partners’ programs from research phase to the market.

* https://www.pei.de/EN/newsroom/press-releases/year/2022/07-pandemic-preparedness-contracts-signed-rapid-availability- vaccines.html?nn=406136

Wacker Biotech: ENGAGE THE EXPERTS IN ADVANCED THERAPIES Copyright Wacker Chemie AG 2024 0

CREATING TOMORROW’S SOLUTIONS

Fast-Tracking an Estonian National Pandemic Preparedness Program - Be ready in 2025

Wacker Biotech - A Business Unit of Wacker Chemie AG

[email protected]

1

PANDEMIC - A serious cross-border threat to national health, society and economy

50.000.000

50.000.000

32.000.000

25.000.000

15.000.000

8.000.000

6.900.000

5.000.000

4.800.000

3.000.000

2.500.000

2.000.000

1.000.000

500.000

575.400

150.000

Worldwide Smallpox Epidemic 1877-1977

Spanish Flu 1918-1919

Plaque of Justitian 483-565

HIV/AIDS 1981-present

Bubonic Plaque (Black death) 1347-1351

Cocolitzli 1545-1547

Mexico Smallpox Epidemic 1519-1520

Covid-19 2019-present

Antonine Plague 165-180

Cholera 1817-1975

The Great Plaques 1348-1665

Russia Typhus Epidemic 1918-1922

Japanese Smallpox Epidemic 735-737

Hon Kong Flu 1968-1970

Europe Smallpox Epidemic 1870-1875

Swine Flu 2009-2010

Yellow Fever 1800-1802

500.000.000

 COVID-19  First pandemic in the globalized modern world

 Fast global spread (first case: 30.12.19 China  21.01.20 USA, 24.01.20 Germany, 27.02.20 Estonia)

 1st wave with high lethality of > 6 % (comparable to Spanish Flu)

 Partial loss of governmental control and/or disturbing interventions: Medical triage, state of emergency, commercial shutdown, translocation restriction, supply chain breakdown, social distancing, unemployment/unpaid leave

 Deepest dive in economics since the Big Depression of 1929  Global GDP 2020: -3,4 % [2 trillion US$]

 Game Changer: Exceptional fast counteraction by providing a 1st vaccine in US 326 days / EU 333 days after first infection (11. & 21.12.2020 Comirnaty)[cases of death]

2

Strengthen resilience by preventive countermeasures - Pandemic Preparedness

Lessons learned: Speed does matter!

 Several national vaccination programs (e.g. Israel) enabled maximum speed in counteracting

 Providing a fast and proactive disease control by early availability of vaccines and launching one of the first nationwide immunization programs

Consequence: Be prepared!

 Ensure timely and adequate access to vaccines by reservation of manufacturing capacity

 Strengthen national independency from supply chain restrictions

 Prevent loss of governmental control over health, society and economy in case of anew pandemic

 Enable efficient vaccination of the Estonian population as early as possible.

Wacker Biotech offers:

 A strategy for immediate and fast vaccine production within 4 months (1.4 m doses)

 Validated by the German Pandemic Preparedness Program

Wacker Biotech ensures:

 Availability of manufacturing capacities

 Independence from supply chain restrictions

 Flexibility of vaccine to be produced (CDMO approach)

Wacker Biotech enables:

 Efficient protection of the Estonian population and economy

 Autonomous governance of pandemic event and self- determined action facing threats to health

Further information: Press Release: Paul Ehrlich Institute - Pandemic Preparedness Contracts Press Release: Wacker Chemie AG - Pandemic Readiness

3

Estonia‘s way to a National Pandemic Preparedness Program!

Experienced manufacturer for mRNA vaccines [under pandemic conditions]

Certified by German Pandemic Preparedness Program

20+ years experience in early-stage projects and contract manufacturing

Adaptation of existing concept to national requirements within 2 months

Fast track stockpiling of material based on established contracts within 3 - 5 months

Staffing of additional personnel within 6 - 9 month possible

Reliable long-term partner backed by corporate structure (Wacker Chemie AG, DAX listed)

Wacker Biotech’s capabilities:

01 02 03 04 05 06 07 08 09 10 11 12 01 02 03

Preparedness PhaseQualification Phase

Adaptation of Concept

Month

Stand-by active

Stockpilling Material

Recruiting & Training

Readiness

Overall concept:

 Capacity reservation contracts for flexible mRNA- manufacturing

 Including stockpiling of material, (human) resources and logistics management, regulatory affairs

 Active program management during stand-by phase

4

Facility: Multiple lines for in vitro transcription and LNP formulation up to 30 L start volume, permanent qualified state (“warm base”)

Manufacturing concept: Generic but flexible process approach enabling tailor-made manufacturing in a single-use setup (“ball room concept”)

Emergency change over: Process transfer and start of production within a 10-week period after call off

Logistics & Material Management: 1000 + palette places available to store and restock critical material up to 8 years

Supply chain: Contractual commitment of qualified suppliers for critical material

Staffing: 100 head count team dedicated to mRNA manufacturing with 200 nearby backup employees

Risk management: Multiple concepts to assure pandemic business continuity incl. contract templates

Cornerstones of a Pandemic Preparedness Program offered by Wacker Biotech

5

At a glance: Wacker Biotech’s production site in Halle/Saale (Germany) - one of the most modern RNA-manufacturing facilities in the world

New facility (opening in 06/24)

 Certified by the German Government for Pandemic Readiness  provide 80 m doses vaccine p.a. in case of emergency

 Multiple parallel programs possible

Capex: By Wacker Chemie AG: triple digit million €

Cornerstones: Multipurpose facility

~ 3.000 m² on brown field ~ 8.000 m² facility space on 5 floors

Capacity: >200 batches and >>700 m doses mRNA vaccine p. a. on 4 manufacturing lines (0.5 - 30 L IVT)

Capabilities: Currently 100 highly educated staff (up to 200 possible)

Expertise: pDNA manufacturing, mRNA as well as LNP formulation, protein vaccines

Technology: Multiple application in infectious diseases as well as cancer or gene therapy/enzyme replacement

6

The next Pandemic may be just a footstep away…

…we are prepared and ready to support!

7

Contact

Please contact

Andreas Anton PhD

Senior Project Lead Pandemic Preparedness

[email protected]

+49 345 44511 474

Wacker Biotech: ENGAGE THE EXPERTS IN ADVANCED THERAPIES Copyright Wacker Chemie AG 2024 8

CREATING TOMORROW’S SOLUTIONS

Wacker Biotech: ENGAGE THE EXPERTS

[email protected]

Wacker Biotech: ENGAGE THE EXPERTS IN ADVANCED THERAPIES Copyright Wacker Chemie AG 2024 0

CREATING TOMORROW’S SOLUTIONS

Fast-Tracking an Estonian National Pandemic Preparedness Program - Be ready in 2025

Wacker Biotech - A Business Unit of Wacker Chemie AG

[email protected]

1

PANDEMIC - A serious cross-border threat to national health, society and economy

50.000.000

50.000.000

32.000.000

25.000.000

15.000.000

8.000.000

6.900.000

5.000.000

4.800.000

3.000.000

2.500.000

2.000.000

1.000.000

500.000

575.400

150.000

Worldwide Smallpox Epidemic 1877-1977

Spanish Flu 1918-1919

Plaque of Justitian 483-565

HIV/AIDS 1981-present

Bubonic Plaque (Black death) 1347-1351

Cocolitzli 1545-1547

Mexico Smallpox Epidemic 1519-1520

Covid-19 2019-present

Antonine Plague 165-180

Cholera 1817-1975

The Great Plaques 1348-1665

Russia Typhus Epidemic 1918-1922

Japanese Smallpox Epidemic 735-737

Hon Kong Flu 1968-1970

Europe Smallpox Epidemic 1870-1875

Swine Flu 2009-2010

Yellow Fever 1800-1802

500.000.000

 COVID-19  First pandemic in the globalized modern world

 Fast global spread (first case: 30.12.19 China  21.01.20 USA, 24.01.20 Germany, 27.02.20 Estonia)

 1st wave with high lethality of > 6 % (comparable to Spanish Flu)

 Partial loss of governmental control and/or disturbing interventions: Medical triage, state of emergency, commercial shutdown, translocation restriction, supply chain breakdown, social distancing, unemployment/unpaid leave

 Deepest dive in economics since the Big Depression of 1929  Global GDP 2020: -3,4 % [2 trillion US$]

 Game Changer: Exceptional fast counteraction by providing a 1st vaccine in US 326 days / EU 333 days after first infection (11. & 21.12.2020 Comirnaty)[cases of death]

2

Strengthen resilience by preventive countermeasures - Pandemic Preparedness

Lessons learned: Speed does matter!

 Several national vaccination programs (e.g. Israel) enabled maximum speed in counteracting

 Providing a fast and proactive disease control by early availability of vaccines and launching one of the first nationwide immunization programs

Consequence: Be prepared!

 Ensure timely and adequate access to vaccines by reservation of manufacturing capacity

 Strengthen national independency from supply chain restrictions

 Prevent loss of governmental control over health, society and economy in case of anew pandemic

 Enable efficient vaccination of the Estonian population as early as possible.

Wacker Biotech offers:

 A strategy for immediate and fast vaccine production within 4 months (1.4 m doses)

 Validated by the German Pandemic Preparedness Program

Wacker Biotech ensures:

 Availability of manufacturing capacities

 Independence from supply chain restrictions

 Flexibility of vaccine to be produced (CDMO approach)

Wacker Biotech enables:

 Efficient protection of the Estonian population and economy

 Autonomous governance of pandemic event and self- determined action facing threats to health

Further information: Press Release: Paul Ehrlich Institute - Pandemic Preparedness Contracts Press Release: Wacker Chemie AG - Pandemic Readiness

3

Estonia‘s way to a National Pandemic Preparedness Program!

Experienced manufacturer for mRNA vaccines [under pandemic conditions]

Certified by German Pandemic Preparedness Program

20+ years experience in early-stage projects and contract manufacturing

Adaptation of existing concept to national requirements within 2 months

Fast track stockpiling of material based on established contracts within 3 - 5 months

Staffing of additional personnel within 6 - 9 month possible

Reliable long-term partner backed by corporate structure (Wacker Chemie AG, DAX listed)

Wacker Biotech’s capabilities:

01 02 03 04 05 06 07 08 09 10 11 12 01 02 03

Preparedness PhaseQualification Phase

Adaptation of Concept

Month

Stand-by active

Stockpilling Material

Recruiting & Training

Readiness

Overall concept:

 Capacity reservation contracts for flexible mRNA- manufacturing

 Including stockpiling of material, (human) resources and logistics management, regulatory affairs

 Active program management during stand-by phase

4

Facility: Multiple lines for in vitro transcription and LNP formulation up to 30 L start volume, permanent qualified state (“warm base”)

Manufacturing concept: Generic but flexible process approach enabling tailor-made manufacturing in a single-use setup (“ball room concept”)

Emergency change over: Process transfer and start of production within a 10-week period after call off

Logistics & Material Management: 1000 + palette places available to store and restock critical material up to 8 years

Supply chain: Contractual commitment of qualified suppliers for critical material

Staffing: 100 head count team dedicated to mRNA manufacturing with 200 nearby backup employees

Risk management: Multiple concepts to assure pandemic business continuity incl. contract templates

Cornerstones of a Pandemic Preparedness Program offered by Wacker Biotech

5

At a glance: Wacker Biotech’s production site in Halle/Saale (Germany) - one of the most modern RNA-manufacturing facilities in the world

New facility (opening in 06/24)

 Certified by the German Government for Pandemic Readiness  provide 80 m doses vaccine p.a. in case of emergency

 Multiple parallel programs possible

Capex: By Wacker Chemie AG: triple digit million €

Cornerstones: Multipurpose facility

~ 3.000 m² on brown field ~ 8.000 m² facility space on 5 floors

Capacity: >200 batches and >>700 m doses mRNA vaccine p. a. on 4 manufacturing lines (0.5 - 30 L IVT)

Capabilities: Currently 100 highly educated staff (up to 200 possible)

Expertise: pDNA manufacturing, mRNA as well as LNP formulation, protein vaccines

Technology: Multiple application in infectious diseases as well as cancer or gene therapy/enzyme replacement

6

The next Pandemic may be just a footstep away…

…we are prepared and ready to support!

7

Contact

Please contact

Andreas Anton PhD

Senior Project Lead Pandemic Preparedness

[email protected]

+49 345 44511 474

Wacker Biotech: ENGAGE THE EXPERTS IN ADVANCED THERAPIES Copyright Wacker Chemie AG 2024 8

CREATING TOMORROW’S SOLUTIONS

Wacker Biotech: ENGAGE THE EXPERTS

[email protected]