Investor Presentaiton

Made public by

sourced by PitchSend

5 of 22

Creator

PitchSend logo
PitchSend

Category

Pending

Published

Unknown

Slides

Transcriptions

#1alvotech Alvotech OVERVIEW AND UPDATE June 2023 O ALVOTECH. ALL RIGHTS RESERVED#22 Content alvotech 1 Alvotech Overview Partnership and BD Update 2 3 AVTO2 Update 4 Portfolio 5 ESG © ALVOTECH. ALL RIGHTS RESERVED#3alvotech Alvotech Overview#44 Founded in 2013 by Róbert Wessman Overview >1000 employees Vertically integrated with in-house R&D, Drug Substance and Drug Product Manufacturing Global market access through top-tier strategic commercial partners in over 90 markets globally 11 biosimilars or biosimilar candidates in the portfolio Dual listed (NASDAQ) in both U.S. and Iceland Pure Play Biosimilar Company OLYMPUS alvotech#5Timeline Since Public Listing alvotech STADA launches AVTO2 in EU ESG reporting portal launched JAMP Pharma Partnership Expansion Listing on Iceland Main Market Listing on Nasdaq US and First North Iceland Patient study for AVT03 initiated Fuji submits AVT04 marketing application AVTO2 IC¹ deemed approvable by FDA AVTO4 filing accepted in Europe CRL received for AVTO2 in US (1st BLA) Jun2 2 32 Jul 22 Aug 22 Sep 22 Oct 22 Nov 22 Dec 22 Jan 23 Feb 23 Mar 23 Apr 23 May 23 Patient study for AVT06 initiated STADA launches AVTO2 in Switzerland New $136 m financing facilities AVT04 filing accepted in US 2022 ESG disclosures updated PK study for AVT03 initiated AVTO2 approved in Australia BoD expansion CRL received for AVTO2 in US 5 1. IC Interchangeability; CRL was received noting site inspection requirement $137 Private Share Placement Fuji and Alvotech expand partnership PK study for AVT05 initated AVTO2 Approved in Saudi Arabia Patient study for AVT05 initiated Advanz Partnership Expansion for EU Legend Portfolio Commercial Corporate © ALVOTECH. ALL RIGHTS RESERVED#6Biologic medicines have revolutionized treatment across numerous disease states Biologic medicines (biologics) are large complex molecules derived from living organisms and have been found to be effective treatments for many difficult-to- treat conditions Due to the high cost of treatment, biologics remain unavailable to a majority of the global population² 6 Sources: 1 Fierce Pharma 2 - Medicine in Drug Discovery 3 - IQVIA Institute alvotech Biologics are among the most expensive medications on the market; 9 of the top 15 selling medications are biologics¹ 59% of novel active substances launched in 2022 were biologics³ © ALVOTECH. ALL RIGHTS RESERVED#7Biosimilars can lower cost and increase access to biologics, globally Biosimilars in the U.S. alone are expected to result in $42Bn of savings over the next 5 years1 Biosimilars are therapeutically equivalent to biologics and provide a more cost-effective alternative to health systems, payers and patients; And can encourage innovation through competition Europe is the most mature biosimilar market reaching €9.7Bn in 2021 generating €30Bn of savings across Europe² Global Savings from biosimilars are expected to exceed $290Bn in cumulative spending through 20272 7 Sources: 1 IQVIA Institute 2- IQVIA Institute alvotech © ALVOTECH. ALL RIGHTS RESERVED#88 00 Our leadership team encompasses decades of collective experience and a common commitment to biosimilars 24 28 ROBERT WESSMAN Chief Executive Officer HAFRUN FRIDRIKSDOTTIR Chief Operating Officer M gsk Alvogen teva Actavis Allergan M Actavis 20 A AZTIQ Lotus ADALVO teva 20 JOSEPH E. MCCLELLAN Chief Scientific Officer Wyeth Pfizer 20 17 JOEL MORALES ANIL OKAY Chief Financial Officer Chief Commercial Officer alvotech 20 TANYA ZHAROV General Counsel & Head of Legal MERCK KPMG A AZTIQ ABDIIBRAHIM deCODE genetics PAR PHARMACEUTICAL SANOFI RICHTER-HELM) Alvogen ADALVO pwc GIEDRIUS ZUNDA Chief Technical Officer 25 SANDRA CASACA Chief Quality Officer 20 PHILIP CARAMANICA Chief IP Counsel, Deputy General Counsel Z-Biotech Consulting AMGEN abbvie ll Bristol Myers Squibb NORTHWAY® BIOTECH ATARA BIO SANDOZA Novartis Division Synthon CardinalHealth 20 30 MING LI Chief Strategy Officer ROSE-MARIE OHLSSON Chief Information Officer ALPHARMA. M Actavis Alvogen A AZTIQ ●sobi SEB rare strength © ALVOTECH. ALL RIGHTS RESERVED#99 Our strategically located global footprint supports R&D and Manufacturing alvotech We bring together the brightest minds to deliver to our partners, customers and patients around the world from our international sites Reykjavík, Iceland: Corporate Operations Pharmaceutical Sciences Manufacturing Jülich and Hannover, Germany: Pharmaceutical Sciences Zürich, Switzerland: Clinical Regulatory Affairs Bangalore, India: . Technical Operations Research & Development Arlington, USA: Corporate Operations Regulatory Affairs © ALVOTECH. ALL RIGHTS RESERVED#1010 1. Extensive Manufacturing Facility Located in Iceland Key Features Capacity and Scalability Flexible Capabilities Externally Validated Quality alvotech Technology & Capabilities Approximately ~280,000ft² facility (inclusive of ongoing expansion) with existing 4-wall drug substance capacity expected to support pipeline through 2030 (1) • Commercial product manufacturing initiated, with inventory build underway Differentiated capabilities including CHO and SP2/0 host cell lines Single use bioreactors for use with fed batch or perfusion processes Aseptic fill/finish capabilities 3 successful IMA/EMA inspections with clinical and commercial licenses issued 4 commercial partner audits successfully completed Conveniently situated between the U.S. and Europe Intentionally Located Powered by renewable energy with access to abundant clean and hot water Operates in a "patent-light" zone Includes 140,000ft² ongoing capacity expansion projects expected to be completed in early 2024 - costs for this are included in Alvotech's financial guidance © ALVOTECH. ALL RIGHTS RESERVED#11alvotech Partnership and BD Update#1212 Advanz Partnership/BD Update 1 Expands partnership with Advanz Pharma to include 5 additional biosimilar candidates including proposed biosimilars to Simponi (golimumab) and Entyvio (vedolizumab) and 3 early-stage, undisclosed biosimilars 2 Up-front payment of $60 million 3 Additional payments of up to ~$280 million based on achievement of certain development and commercial milestones in addition to the customary revenue share of ~40% 4 Demonstrates the ability of a business-to-business (B2B) platform to monetize early-stage assets 5 Alvotech's Business Development (BD) pipeline remains active; Key activities going forward focus on oncology and oncology related assets with AVTO3 and AVT33 with rights available in U.S. and Europe alvotech O ALVOTECH. ALL RIGHTS RESERVED#1313 Strategic Partnerships Allowing for Broad Reach to >90 Markets Worldwide Partner Geographic Rights USA teva US EU STADA ADVANZ EU PHARMA Fuji Pharma Japan JAPAN CHINA 扬子江④业集团 Yangtze River Pharmaceutical Group ترو CANADA JAMP APAC GROUPE & PHARMA Cipla DKSH KAMADA High Quality Pharmaceuticals MENA YAS HOLDING ياس القابضة 佑 ABDIIBRAHIM A POLIFARMA TTUTEUR Megalabs S. AM. Libbs LS SAVAL STEINCARES SPECIALTY DIVISION China Canada Australia, New Zealand, South Africa Taiwan, Malaysia, Singapore, Cambodia & Indonesia Israel Various Turkey "We stand by life" Argentina Various Brazil Chile LatAm Our partnerships enable reach to patients in >90 markets worldwide alvotech © ALVOTECH. ALL RIGHTS RESERVED#14alvotech AVTO2 Update#1515 AVTO2 Status in the U.S. 1 June 28th, 2023 is the BSUFA goal date for the AVTO2 BLA (interchangeability and biosimilarity) 2 3 Upcoming meeting with Office of Pharmaceutical Manufacturing Assessment scheduled for mid-June to discuss inspection status of the Reykjavik facility alvotech Company has followed up on manufacturing and supply related commitments on June 1st to the biosimilar BLA (currently under CRL) as communicated during the Q1 call 4 Company prepared for resubmission, if needed; satisfactory inspection status remains the outstanding requirement to gain approval for AVTO2 in the U.S. 5 Ongoing and transparent discussions continue with customers to ensure parties are aware of approval status on a proposed high-concentration, interchangeable biosimilar to HumiraⓇ (adalimumab) O ALVOTECH. ALL RIGHTS RESERVED#16alvotech Portfolio#1717 Alvotech is pursuing a strategically selected biosimilar portfolio of attractive molecules Biosimilar Candidate Reference Biologic Therapeutic Area Early Phase Pre-clinical Clinical Trial(s) Filing Approval Approved by: AVTO2 high-concentration adalimumab AVTO4 ustekinumab AVTO3 denosumab AVTO6 aflibercept AVT23* omalizumab AVTO5 golimumab AVT16 vedolizumab EYLEAⓇ XOLAIR SIMPONIⓇ/ Immunology SIMPONI ARIA® ENTYVIOⓇ HUMIRA® Immunology EC, Health Canada MHRA, TGA STELARAⓇ Immunology PROLIAⓇ/XGEVAⓇ Immunology/ Oncology Filed in Major Markets PK and Patient Study Initiated Patient Study Ophthalmology Respiratory Initiated PK Study Completed PK and Patient Study Initiated Immunology AVT33 KEYTRUDAⓇ® Oncology pembrolizumab AVT19 Undisclosed Undisclosed AVT21 Undisclosed Undisclosed AVT41 Undisclosed Undisclosed alvotech Launch Launched in: Canada Europe (16) HUMIRA is a registered trademark of AbbVie Inc. STELARA, SIMPONI and SIMPONI ARIA are registered trademarks of Janssen Biotech, Inc. XOLAIR is a registered trademark of Novartis AG PROLIA AND XGEVA are registered trademarks of Amgen, Inc. EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc. ENTYVIO is a registered trademark of Millennium Pharmaceuticals, Inc. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp. © ALVOTECH. ALL RIGHTS RESERVED#18alvotech ESG#1919 Corporate Sustainability and ESG at Alvotech alvotech Strong Thematic Basis Biosimilars promote the sustainability of healthcare systems by improving patient access: providing lower cost alternatives to higher priced biologics Biologics are a growing class of medicines that account for almost one third of the global market for pharmaceuticals by value(1) Limited public comps for global pure play model provides investors exposure to the social and economic benefits of biosimilars • Strong Intrinsic Qualities Scope 1 and 2 carbon neutral for 2020 and 2021 Manufacturing utilizes nearly 100% of electricity from renewable energy sources Located in Iceland which is an isolated energy system based on hydro and geothermal resources Limited water scarcity and wildfire risks Biologics are biodegradable: limits exposure to Pharmaceuticals in Environment (PIE) issues • R&D driven business model Strong Commitment to ESG о о Materiality assessment performed ESG Portal to be made available to stakeholders with metrics consistent with NASDAQ and/or GRI frameworks Key policies implemented in connection with business combination Governance, code of ethics, whistleblower, anti-harassment, and data privacy protection Annual equal pay audits, equality and diversity assessments, and employee engagement survey Joined UN Global Compact 1.IQVIA INSTITUTE; Spotlight on Biosimilars, Optimizing The Sustainability of Healthcare Systems, June 2021 - Data refers to 2021 © ALVOTECH. ALL RIGHTS RESERVED#2020 20 ESG Portal @ http://alvotech.com/corporate-sustainability alvotech Company Biosimilars Svestors Partnerships Contact us a Corporate Sustainability Careers News alvotech CORPORATE SUSTAINABILITY ESG Portal Alvotech is committed to the promise of biosimilars, which we believe can directly expand patient access to medicines globally and contribute to the overall sustainability of healthcare systems by providing lower cost alternatives to high-priced biologic medicines. This mission driven focus provides a strong basis for Our corporate sustainability initiatives. We are committed to implementing a strong Environmental, Social, and Governance framework at Alvotech. we aim to bring our portfolio and pipeline of biosimilars and biosimilar candidates to the global marketplace through our commercial partners around the world. Alvotech is in the process of transitioning from an R&D-only company into an integrated commercial stage enterprise. As we scale our production and DOWNLOADS Environmental We are committed to u environment From our ge the count supplies local indu pections and group audainability Az a global company angly with our o minimizing the impec that this commitments and CO2 emissions Emissions and Energy Use Water Consumption Weste > ESG data (XLS) ESG data (PDF) salvotech Alvotech ESG Data 2020-2021 Company Scamilars Social Our dom tives by respomi Diversity and laclusion Health and safety Equal Pay Certificati 2020 2021 NASDAQ GRI Notes CHC Emissions and Emissions intensity Scope1&2 emissions 218 219 El 305-1305-2 cope, 2 & 3 emissions 100209 670 513 Et 305-1305-2305-3 Scopel emissions 1002ea 16 12 306 Scope) emissions from fuel use 1C0200 12 E 306- Scopel emissions from refrigerants 14 E 305- Scope 2 emissions rcope 206 306- Scope 2 emissions from electricity use 10026q 177 Et 305-2 Scap a from thermal energy use CO2ea 25 B 305-21 Scope Scope Semissions from tights 1C0269 CO264 261 294 305-3 192 207 E 305-3 Scope 3 emissions from waste 69 85 B 305-3 Scopes emissions from fuel and energy use Scopel&2 emissions intensity per employe F 305-3 63 308-4 +CcQeleme 06 Company Biosimilars Alvotech ESG Dara 2020-2021 alvotech 1 alvotech Social Ratio of pay of man to women Growth of total headcount Women in Management Women in the company excluding management Ratio of temporary workers to total headcount Existence of a sexual harassment and/or non-discrimination policy? sabor policy? Frequency of injury events relative to total workforce Existence of an occupational health and/or global health & safety policy? es your company follow a child and/or forced Does y If yes, does your child and/or forced labor policy See also: cover suppliers and ver Does your company follow a human rights policy? If yes, does your human rights policy cover suppliers and vendors? Company Ber Governance Alvotech is committed to strong and transparent corporate governance Dur corporate governance mamewod-along with our internal contride and poffce-intended support sustainable nancial performance and long-term value creation for dil of our statholders including sitanenchors patients, employees and chher desireho The of rectors E and Bain Co Whistleblowing Policy © ALVOTECH. ALL RIGHTS RESERVED#2121 For additional information https://alvotech.com/ Lalvotech

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Q4 & FY22 - Investor Presentation image

Q4 & FY22 - Investor Presentation

Financial Services

FY23 Results - Investor Presentation image

FY23 Results - Investor Presentation

Financial Services

Ferocious - Plant Growth Optimizer image

Ferocious - Plant Growth Optimizer

Agriculture

Market Outlook and Operational Insights image

Market Outlook and Operational Insights

Metals and Mining

2023 Investor Presentation image

2023 Investor Presentation

Financial

Leveraging EdTech Across 3 Verticals image

Leveraging EdTech Across 3 Verticals

Technology

Axis 2.0 Digital Banking image

Axis 2.0 Digital Banking

Sustainability & Digital Solutions

Capital One’s acquisition of Discover image

Capital One’s acquisition of Discover

Mergers and Acquisitions