FULLTEXT DEL 1 AV 1

Kvartalsrapport Q3 2024

Dokumentindex

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First 9 Months Earnings 
and Business Update
November 14, 2024

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Disclaimer
2
This presentation (“Presentation”) does not contain or 
constitute an offer to sell, a solicitation of an offer to buy, or a 
recommendation to purchase any security of Alvotech (the 
“Company”) to any person in the United States or in any 
jurisdiction to whom or in which such offer or solicitation is 
unlawful.  Any trademarks, servicemarks, trade names and 
copyrights of the Company and other companies contained in 
this Presentation are the property of their respective owners.
Forward-Looking Statements
This Presentation contains forward-looking statements within 
the meaning of the Private Securities Litigation Reform Act of 
1995, as amended. Forward-looking statements generally relate 
to future events or future financial or operating performance of 
the Company and may include, for example, the Company’s 
expectations regarding capitalization through equity or debt 
financing, Alvotech’s ability to maintain listing requirements, 
future growth, results of operations, performance, projections 
of future revenue and cash runway, competitive advantages, 
business prospects and opportunities including pipeline product 
development, future plans and intentions, results, level of 
activities, performance, goals or achievements or other future 
events, the re-inspection of the Company’s manufacturing site 
by the FDA, the expectation that the FDA’s facility inspection in 
March 2023 will also serve as the pre-license inspection for 
AVT04,  potential approval, including for AVT02 and AVT04, by 
the FDA and other regulatory agencies, commercial launch of 
the Company’s products and product candidates, including 
AVT02 in the U.S., the timing and progress of the 
announcement of clinical study results, the commencement of 
patient studies, regulatory approvals and market launches, the 
Company’s partnerships, including with Teva and information 
about the market opportunity of the Company’s pipeline 
products. In some cases, you can identify forward-looking 
statements by terminology such as “may”, “should”, “expect”, 
“intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, 
“potential” or “continue”, or the negatives of these terms or 
variations of them or similar terminology. Such forward-looking 
statements are subject to risks, uncertainties, and other factors 
which could cause actual results to differ materially from those 
expressed or implied by such forward-looking statements. 
These forward-looking statements are based upon estimates 
and assumptions that, while considered reasonable by the 
Company and its management, are inherently uncertain and 
are inherently subject to risks, variability and contingencies, 
many of which are beyond the Company’s control. Factors that 
may cause actual results to differ materially from current 
expectations include, but are not limited to: (1) the outcome of 
any legal proceedings that may be instituted against the 
Company or others following the business combination 
between Alvotech Holdings S.A., Oaktree Acquisition Corp. II 
and Alvotech; (2) the ability to maintain stock exchange listing 
standards; (3) changes in applicable laws or regulations; (4) the 
possibility that the Company may be adversely affected by 
other economic, business, and/or competitive factors; (5) the 
Company’s estimates of expenses and profitability; (6) the 
Company’s ability to develop, manufacture and commercialize 
the products and product candidates in its pipeline; (7) the 
ability of Alvotech or its partners to respond to inspection 
findings and resolve deficiencies to the satisfaction of the 
regulators; (8) actions of regulatory authorities, which may 
affect the initiation, timing and progress of clinical studies or 
future regulatory approvals or marketing authorizations; (9) the 
ability of the Company or its partners to enroll and retain 
patients in clinical studies; (10) the ability of the Company or its 
partners to gain approval from regulators for planned clinical 
studies, study plans or sites; (11) the ability of the Company’s 
partners to conduct, supervise and monitor existing and 
potential future clinical studies, which may impact 
development timelines and plans; (12) the Company’s ability to 
obtain and maintain regulatory approval or authorizations of its 
products, including the timing or likelihood of expansion into 
additional markets or geographies; (13) the success of the 
Company’s current and future collaborations, joint ventures, 
partnerships or licensing arrangements; (14) the Company’s 
ability, and that of its commercial partners, to execute their 
commercialization strategy for approved products; (15) the 
Company’s ability to manufacture sufficient commercial supply 
of its approved products; (16) the outcome of ongoing and 
future litigation regarding the Company’s products and product 
candidates; (17) the potential impact of the ongoing COVID-19 
pandemic on the FDA’s review timelines, including its ability to 
complete timely inspection of manufacturing sites; and (18) the 
impact of worsening macroeconomic conditions, including 
rising inflation and interest rates and general market 
conditions, war in Ukraine and global geopolitical tension, and 
the ongoing and evolving COVID-19 pandemic on the 
Company’s business, financial position, strategy and anticipated 
milestones; and (19) other risks and uncertainties set forth in 
the sections entitled “Risk Factors” and “Cautionary Note 
Regarding Forward-Looking Statements” in documents that the 
Company may from time to time file or furnish with the SEC. 
There may be additional risks that the Company does not 
presently know or that the Company currently believes are 
immaterial that could also cause actual results to differ from 
those contained in the forward-looking statements. This 
presentation also contains estimates and other statistical data 
made by independent parties and by the Company relating to 
market size and growth and other data about the Company’s 
industry. This data involves a number of assumptions and 
limitations, and you are cautioned not to give undue weight to 
such estimates. In addition, projections, assumptions, and 
estimates of the future performance of the markets in which 
the Company operates are necessarily subject to a high degree 
of uncertainty and risk. Nothing in this Presentation should be 
regarded as a representation by any person that the forward-
looking statements set forth herein will be achieved or that any 
of the contemplated results of such forward-looking statements 
will be achieved. You should not place undue reliance on 
forward-looking statements, which speak only as of the date 
they are made. The Company does not undertake any duty to 
update these forward-looking statements or to inform the 
recipient of any matters of which any of them becomes aware 
of which may affect any matter referred to in this Presentation.
Non-IFRS Financial Measures
This Presentation may include projections of certain financial 
measures not presented in accordance with International 
Financial Reporting Standards (“IFRS”) including, but not limited 
to, Adjusted EBITDA and certain ratios and other metrics 
derived therefrom. These non-IFRS financial measures are not 
measures of financial performance in accordance with IFRS and 
may exclude items that are significant in understanding and 
assessing the Company’s financial results. Therefore, these 
measures should not be considered in isolation or as an 
alternative to net income, cash flows from operations or other 
measures of profitability, liquidity or performance under IFRS. 
You should be aware that the Company’s presentation of these 
measures may not be comparable to similarly-titled measures 
used by other companies. The Company believes these non-
IFRS measures of financial results provide useful information to 
management and investors regarding certain financial and 
business trends relating to the Company’s financial condition 
and results of operations. The Company believes that the use of 
these non-IFRS financial measures provide an additional tool for 
investors to use in evaluating ongoing operating results and 
trends and in comparing the Company’s financial measures 
with other similar companies, many of which present similar 
non-IFRS financial measures to investors. These non-IFRS 
financial measures are subject to inherent limitations as they 
reflect the exercise of judgments by management about which 
expense and income are excluded or included in determining 
these non-IFRS financial measures. Due to the high variability 
and difficulty in making accurate forecasts and projections of 
some of the information excluded from these projected 
measures, together with some of the excluded information not 
being ascertainable or accessible, the Company is unable to 
quantify certain amounts that would be required to be included 
in the most directly comparable IFRS financial measures 
without unreasonable effort. Consequently, no disclosure of 
estimated comparable IFRS measures is included and no 
reconciliation of the forward-looking non-IFRS financial 
measures is included. For the same reasons, the Company is 
unable to address the probable significance of the unavailable 
information, which could be material to future results.

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Agenda ROBERT WESSMAN
Chairman and Chief Executive Officer
ANIL OKAY
Chief Commercial Officer
JOEL MORALES
Chief Financial Officer
MING LI
Chief Strategy Officer
BENEDIKT STEFÁNSSON
VP of IR and Global Communication
1
2
3
4
OVERVIEW
COMMERCIAL and R&D UPDATE
FINANCIAL UPDATE
Q&A

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Robert
Wessman
Chairman and 
Chief Executive Officer

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Continued Growth for 2024
5
Key Financial 
Highlights 9M-2024
Positive Adjusted EBITDA for the 2nd 
consecutive quarter, resulting in a total 
of $86.6mn for 9M-24
→ ~9x increase in revenues vs. prior year
→ Step up product gross margin in Q3 (37%) 
vs. Q2 (17%)1
→ Pipeline progression and new deals resulted 
in increased milestone revenue recognition
Product 
Revenues
9M - 2024 
Performance
Total 
Revenues
Milestone
Revenues
Adjusted
EBITDA
$338.6mn $128.0mn
$86.6mn $210.5mn
vs. $38.1mn in 9M-23 vs. $29.8mn in 9M-23
vs. ($225.3mn) loss in 9M-23 vs. 8.2mn in 9M-23
1Excludes margin contribution from milestone revenues

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Key Recent Highlights
6
EMA acceptance of marketing application 
for AVT03, biosimilar to Prolia® and Xgeva®
SELARSDI® full label and additional 
presentation approved
Patient Study for AVT16, proposed 
biosimilar to Entyvio® , has been initiated
EMA acceptance of marketing application 
for AVT05, biosimilar to Simponi®
U.S. FDA concluded 
a successful general 
GMP inspection in 
September of 
Alvotech’s Reykjavik 
manufacturing site
→ 2 FDA 483 observations 
were noted; company 
has provided robust 
responses

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Launch of 
UZPRUVO®
Approval of
UZPRUVO®
Positive clinical 
study results for
AVT06
Initial launch of
SIMLANDI® 
Approval of 
SIMLANDI® 
Approval of 
SELARSDI®
US Commercial 
agreement with
QUALLENT 
Collaboration 
with STADA for 
AVT03
Collaboration 
with Advanz for 
AVT06
Launch of 
JAMTEKI 
7
Continued Progress and Execution (2024)
Clarity for market 
entry dates for 
AVT04 
Positive clinical 
study results for 
AVT05
Launch of
USTEKINUMAB
Positive PK Study for 
AVT03
Collaboration with 
Dr. Reddy’s for 
AVT03
Closing of private 
debt financing
ALVOTECH
7
JANUARY MARCH APRILFEBRUARY JUNEMAY
Positive clinical 
study results for
AVT03
EMA filing 
acceptance of
AVT06
Successful GMP 
Inspection
FDA
Confirmatory 
Patient Study for
AVT16
EMA MA 
Acceptance
AVT03
Positive clinical 
study results for
AVT03
Full label and additional 
presentation approved on
SELARSDI® 
JULY SEPTEMBER OCTOBERAUGUST NOVEMBER DECEMBER
EMA MA 
Acceptance
AVT05

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Anil Okay
Chief Commercial Officer

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U.S. Commercialization Update
9
Biosimilar 
to Stelara®
SELARSDI® approved in the U.S. for all associated 
indications
Product launch expected to be February 21, 2025
February 19th, 2025, BSUFA date to determine 
interchangeability
Provisional approval is expected with final approval given 
upon exclusivity expiry on April 30, 2025
Ongoing discussions for formulary access through 
commercial partner Teva
Ongoing discussions for private label business
Biosimilar 
to Humira®
SIMLANDI® and unbranded form are interchangeable to the 
reference product
SIMLANDI® is listed as preferred on Express Scripts (part of 
CIGNA), CarelonRx, Navitus, Blue Cross Blue Shield of MA 
and LA; expect expansion in 2025
Commercialization agreement with Quallent; part of the 
Cigna network
~1.3 million units of binding purchase orders for 2024 across 
both channels (US only)
>40% of orders delivered through Q3

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Ex-US Commercialization Update
10
AVT02, biosimilar to Humira® , has been launched in 26 markets outside the U.S.
•  Inclusive of Canada (SIMLANDI®) and many markets across Europe (HUKYNDRA®)
AVT04, biosimilar to Stelara, has been launched in 23 markets
• Inclusive of Canada (JAMTEKI
 ), Japan, and across Europe (UZPRUVO®)
UZPRUVO® launched in ~20 markets across Europe with further expansion 
expected in the coming months
• Strong partner sales in EU4 plus UK
Up to 1/3 of product revenue in 20241 expected to come from ex-US markets 
Growth in product revenue expected in 2025 from ex-US markets from both new 
and existing launches
1Inclusive of both AVT02 and AVT04

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Near Term Pipeline Update
11
Biosimilar candidate to Eylea®
Developing for both vial and pre-filled syringe
Seeking interchangeability designation
Partnerships include Teva (US), Advanz (EU)
Marketing application accepted by EMA
IP strategy integrated with product 
development
AVT29
Biosimilar candidate to Eylea® HD
Commercial partnerships consistent with 
low-dose
Formulation and process have been 
developed and program currently in scale-
up phase
IP strategy integrated with product 
development
AVT06
11

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Near Term Pipeline Update
12
Targeting both Simponi® (pharmacy benefit) 
and Simponi Aria® (medical benefit)
Established anti-TNF with SP2/0 technology 
barrier
Only one other company has completed a 
clinical trial utilizing a biosimilar candidate
Marketing application accepted by EMA; the 
first and currently only filing1
US filing expected in 20242 via 2 separate 
submissions
12
AVT05
 AVT03
Biosimilar candidate to Prolia® and Xgeva®
Both a Medical benefit and pharmacy benefit 
product in the U.S.
US Partnership with Dr. Reddy’s Laboratories 
Semi-exclusive partnership in EU with Dr. 
Reddy’s and STADA
Marketing application accepted by EMA
US filing expected in 20241
1EMA Oct 2024 list of medicines under evaluation
2Announcements are made upon filing acceptance

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Portfolio
13
BIOSIMILAR 
CANDIDATE
REFERENCE 
BIOLOGIC
THERAPEUTIC 
AREA
EARLY
PHASE
PRE-
CLINICAL
CLINICAL TRIAL(S) FILING2 APPROVAL LAUNCH
PK STUDY PATIENT TRIAL
AVT02 adalimumab HUMIRA® Immunology
AVT04 ustekinumab STELARA® Immunology
AVT05 golimumab
SIMPONI®/
SIMPONI ARIA® Ophthalmology
AVT03 denosumab PROLIA®/ 
XGEVA® Bone Disease
AVT061 aflibercept EYLEA® Immunology
AVT29 aflibercept EYLEA® HD Ophthalmology
AVT233 omalizumab XOLAIR® Respiratory
AVT16 vedolizumab ENTYVIO® Immunology
AVT33 pembrolizumab KEYTRUDA® Oncology
AVT28 Not disclosed Not disclosed Immunology
AVT41 Not disclosed Not disclosed Immunology
AVT19 Not disclosed Not disclosed Immunology
27 Markets
23 Markets
58 Markets
42 Markets
73 Markets
52 Markets
1Separate PK studies are not required for proposed biosimilars to Eylea®
2Filing status reflects filing acceptance in at least one major market 
3AVT23 rights are licensed from Kashiv BioSciences and refer specifically to European Union member states, the UK, Australia, Canada, and New Zealand.
Positive Results
Ongoing
Ongoing
Positive Results
Positive Results
Positive Results
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.
HUMIRA is a registered trademark of AbbVie Inc.
STELARA, SIMPONI and SIMPONI ARIA are 
registered trademarks of Johnson & Johnson Inc.
XOLAIR is a registered trademark of Novartis AG
PROLIA AND XGEVA are registered trademarks 
of Amgen, Inc.

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Joel 
Morales
Chief Financial Officer

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Q3 2024 YTD Financial Highlights
15
CASH AND 
LIQUIDITY
OPERATING 
PERFORMANCE
SHARES 
OUTSTANDING
Finalized financing facilities in 
Q3, simplifying overall capital 
structure – as of 30 September, 
~$1B of outstanding 
borrowings.
$118 million of cash on hand 
as of 30 September. 
Based on current operating 
plans, the Company believes it 
has sufficient cash runway to 
free cash flow positive. 
301.7 million shares 
outstanding as of 30 
September.
Includes 39.6 million of 
earnout shares, of which 19.2 
million not currently vested.
Excludes shares to be issued 
for certain programs and 
arrangements that are not yet 
settled as of 30 September.
Total revenue of $339 million, ~ 
9x increase versus prior year.
$128 million of product revenues 
primarily driven by Humira 
biosimilar launch in US and 
Stelara biosimilar launch in ex-
US markets.
$211 million of milestone 
revenue, primarily due to 
advancement of the pipeline and 
new product launches. 
Adjusted EBITDA of $87 million, 
versus negative ($225) million in 
prior year.

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Appendix

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Reported to Adjusted Reconciliation
17
9M 2024 Adjustment Entries
Cost of Product Revenue − $1.2m charge related to long-term incentive plan 
R&D
− $1.9m charge related to long-term incentive plan (non-cash)
− ($1.3m) IP litigation costs attributable to programs - reclassified from G&A
− ($1.1m) partial reversal of one-time AR reserve pertaining to the termination of 
AVT23 licensing agreement with Biosana (non -cash)
G&A
− $4.8m charge related to long-term incentive plan (non-cash)
− $1.3m IP litigation costs attributable to programs - reclassified to R&D
− $0.5m one-time transaction cost
Impairment loss on inv. in JV − $3.0m from sales of China JV
Finance Income − ($75.5m) fair value adjustment on derivatives (non-cash)
Finance Costs − $117.5m fair value adjustment on derivatives (non-cash)
(Loss) Gain on exting. of fin. liab. − $69.4m loss on extinguishment of bonds and borrowings (non-cash)
Exchange Rate Differences − ($1.7m) impact of exchange rate fluctuations (non-cash)
Income Tax − ($0.8m) tax impact of discrete adj. in jurisdictions where tax benefits are available
9M 2023 Adjustment Entries
Cost of Product Revenue − $2.3m charge related to long-term incentive plan 
− $0.3m loss on disposal of PPE (non -cash)
R&D
− $18.5m of one-time, Biosana accounts receivables reserve pertaining to the 
termination of AVT-23 (non-cash)
− $3.5m charge related to long-term incentive plan (non-cash)
− ($1.9m) IP litigation costs attributable to programs - reclassified from G&A
G&A
− $0.9m of one-time costs in connection with the Iceland main board listing
− $9.4m charge related to long-term incentive plan (non-cash)
− $1.9m IP litigation costs attributable to programs – reclassified to R&D 
Finance Income − ($42.5m) fair value adjustment on derivatives (non-cash)
Finance Cost − $14.1m fair value adjustment on derivatives (non-cash)
Exchange Rate Differences − ($0.9m) impact of exchange rate fluctuations (non-cash)
Income Tax − ($3.7m) tax impact of discrete adj. in jurisdictions where tax benefits are available

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Capital Structure as of September 30, 2024
18
1 Using the Company's average stock price of $11.07 and calculated in accordance with the Warrant Agreement dated September 21, 2020.

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Additional 
information
investors.alvotech.com
investors.alvotech.com
alvotech.com
alvotech.com
alvotech.is
alvotech.is
alvotech.ir@alvotech.com
alvotech.ir@alvotech.com