FULLTEXT DEL 1 AV 1
Kvartalsrapport Q2 2023
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Alvotech
9, rue de Bitbourg
L-1273 Luxembourg
Grand Duchy of Luxembourg
RCS Luxembourg B 258.884
Alvotech
Unaudited Condensed Consolidated
Interim Financial Statements as of
30 June 2023 and for the six
months ended 30 June 2023 and 30
June 2022
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Table of Contents
Endorsement by the Board of Directors 2-6
Unaudited Condensed Consolidated Interim Statements of Profit or Loss and
Other Comprehensive Income or Loss 7
Unaudited Condensed Consolidated Interim Statements of Financial Position 8-9
Unaudited Condensed Consolidated Interim Statements of Cash Flows 10-11
Unaudited Condensed Consolidated Interim Statements of Changes in Equity 12
Notes to the Unaudited Condensed Consolidated Interim Financial Statements 13-33
Alvotech
Unaudited Condensed
Consolidated Interim Financial
Statements as of 30 June 2023 and
for the six months ended 30 June
2023 and 30 June 2022
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Endorsement by the Board of Directors and the CEO
Unless otherwise indicated or the context otherwise requires, all references to “Alvotech,” the “Company,” the “Group,” “we,” “our,” “us”
or similar terms refer to Alvotech and its consolidated subsidiaries.
Alvotech is a highly integrated biotech company focused solely on th e development and manufacture of biosimilar medicines for patients
worldwide. Our purpose is to improve the health and quality of life of patients around the world by improving access to proven treatments
for various diseases. Since our inception, we have built our company with key characteristics we believe will help us capture the substantial
global market opportunity in biosimilars: a leadership team that has brought numerous successful biologics and biosimilars to market
around the world; a purpose-built biosimilars research and development and manufacturing platform; top commercial partnerships in
global markets; and a diverse, expanding pipeline addressing many of the biggest disease areas and health challenges globally. Alvotech is a
company committed to constant innovation: we focus our platform, people, and partnerships on finding new ways to drive access to more
affordable biologic medicines. Alvotech, which was founded in 2013, is led by specialists in biopharmaceutical product creation from
around the world that bring extensive combined knowledge and expertise to its mission.
Alvotech currently has eleven product candidates in its pipeline f or serious diseases with unmet patients and market need. Product
candidates in our pipeline address reference products treating autoimmune, eye, and bone disorders, as well as cancer.
The Unaudited Condensed Consolidated Interi m Financial Statements for the six-month period ended 30 June 2023 comprise the financial
statements of Alvotech and its subsidiaries (together “the Group” or “Alvotech”).
The Unaudited Condensed Consolidated Interim Financial Statements are prepared in accordance with IAS 34 'Interim financial reporting'
and should be read in conjunction with the Group’s ConsolidatedFinancial Statements as at and for the year ended 31 December 2022.
These Unaudited Condensed Consolidated Interim Financial Statements for the six-month period ended 30 June 2023 have not been
audited by an external auditor.
Financial results for the six months ended 30 June 2023
As of 30 June 2023, the Company had $60.5 million in cash and cash equivale nts, excluding restricted cash. In addition, the Company had
borrowings of $808.6 million, including $22.5 million of current portion of borrowings, as of 30 June 2023.
Product revenue: The Company successfully launched the AVT02 product in Canada and select European countries during the second
quarter of 2022 and increased sales volume in these countries resulted in $3.9 million and $22.7 million of product revenue recognized
during the six months ended 30 June 2022 and 2023, respectively.
License and other revenue: License and other revenue decreased by $38.6 million, from $36.2 million for the six months ended 30 June
2022, to $(2.5) million for the six months ended 30 June 2023. The decrease in license and other revenue was primarily driven by the
recognition of $34.7 million research and development milestone during the same period in the prior year, due to the completion of the
AVT04 main clinical program. The remainder of the decrease is mainly due to the net impact of the changes in licensing arrangements
during the six months ended 30 June 2023.
Cost of product revenue: The Company successfully launched AVT02 in select European countries and Canada during the six months
ended 30 June 2022. As a result, the Company recognized cost of product revenue in the amount of $17.8 million and $67.9 million during
the six months ended 30 June 2022 and 2023, respectively. Cost of product revenue includes both variable and fixed manufacturing costs
associated with commercial manufacturing. Cost of product revenue for the period is disproportionate relative to product revenue due to
the timing of new launches and elevated product ion-related charges, resulting in higher costs than revenues recognized for the period. The
Company expects this relationship to normalize with increased production from the scaling and expansion of new or recent launches. The
Company estimates that the anticipated increase in sales volumes will result in a greater absorption of fixed manufacturing costs. Prior to
the recognition of cost of product revenues, costs from pre-comme rcial manufacturing activities were reported as research and
development expenses. 2
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Endorsement by the Board of Directors and the CEO
Research and development expenses: Research and development expenses increased by $12.7 million, or 14.6%, from $86.9 million for the
six months ended 30 June 2022, to $99.6 million for the six months ended 30 June 2023. The increase was primarily driven by a one-time
charge of $18.5 million relating to the termination of the co-development agreement with Biosana for AVT23, and a $24.6 million increase
in direct program expenses mainly from three biosimilar candidates, AVT03, AVT05 and AVT06, that entered clinical development in
2022. These increases were partially offset by a decrease of $21.0 million primarily related to programs which have completed clinical phase
(i.e., AVT02 and AVT04 programs). In addition, upon the launc h of AVT02 during the second quarter of 2022, the Company commenced
recognizing pre-commercial manufacturing activities as cost of product revenue. As a result, research and development expenses during the
six months ended 30 June 2022 included $12.3 million of costs relating to AVT02 which have since been recognized as cost of product
revenue.
General and administrative expenses: General and administrative expenses decreased by $97.2 million, or 69.9%, from $139.1 million for
the six months ended 30 June 2022, to $41.9 million for the six month s ended 30 June 2023. The decrease in general and administrative
expenses was primarily attributable to a $83.4 million non-cash share listing expense and $21.0 million of transaction costs recorded as a
result of the Business Combination recognized as of 30 June 2022. The Company also incurred $10.6 million of IP-related legal expenses
during the six months ended 30 June 2022, compared to $1.3 million during the 6 months ended 30 June 2023. This decrease was partially
offset by a $7.7 million net increase in other general administrative expenses due to incremental costs from operating as a public company
in both the U.S. and Iceland. Lastly, the Company recognized $7.5 m illion of general and administrative expenses for share-based
payments, resulting from the granting of RSUs during the six months ended 30 June 2023, against $0.1 million during the six months ended
30 June 2022.
Net Loss: Net loss was $86.9 million, or $(0.39) per share on a basic and diluted basis, for the six months ended 30 June 2023 as compared
to net loss of $184.5 million, or $(1.02) on a basic and diluted basis, for the same six months of 2022.
Pipeline highlights
In April 2023, Alvotech received from the FDA a complete response l etter (CRL) for the Company’s BLA. The CRL noted that certain
deficiencies conveyed following the FDA’s recent reinspection of the Co mpany’s Reykjavik facility must be satisfactorily resolved before
the application may be approved.
On 28 June 2023, the FDA issued a CRL for Alvotech’s 2nd BLA, which contained data to support approval as a high-concentration
biosimilar and additional information to support the interchangeability designation. The CRL noted that certain deficiencies, which were
conveyed following the FDA’s reinspection of the Company’s Reykja vik facility that concluded in March 2023, must be satisfactorily
resolved before the application can be approved.
Alvotech’s next three most advanced product candidates, AVT06, AVT03, and AVT05, are proposed biosimilars to Eylea ® (aflibercept),
Prolia®/Xgeva® (denosumab) and Simponi ®/Simponi Aria ® (golimumab), respectively. Alvotech announced that the AVT04 filing was
accepted in the U.S. in January 2023, and in Europe in February 2023.
In March 2023, Alvotech provided Biosana a notice of termination for the global licensing agreement between the two companies
covering the co-development of AVT23, a proposed biosimilar to Xolair® (omalizumab).
On 19 May 2023, Alvotech entered into termination agreements with STADA to terminate the license and supply agreements between
Alvotech and STADA pertaining to Alvotech’s product candidates AVT03, a biosimilar candidate to Prolia® / Xgeva® (denosumab),
AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab) and AVT16, a proposed biosimilar to Entyvio®
(vedolizumab). Pursuant to the terms of the termination agreemen ts, Alvotech repaid the aggregate amount of $18.9 million in July 2023
that Alvotech had previously received from STADA under the terminated agreements.
On 22 May 2023, Alvotech entered into a master license and supply a greement with Mercury Pharma Gro up Limited (trading as Advanz
Pharma Holdings) (“Advanz”) with respect to the supply and commercialization in Europe of AVT05, a biosimilar candidate to Simponi®
and Simponi Aria® (golimumab), AVT16, a proposed biosimilar to Entyvio® (vedolizumab), and three additional early-stage, undisclosed
biosimilar candidates (each, a "Product Schedule"). Under the terms of the agreements with Advanz, Alvotech will develop the product
candidates and provide the dossier of data, information and know-how relating to the relevant product candidate to Advanz. Alvotech
retains full ownership of all intellectual property rights in the product candidates and the dossiers. Advanz has an exclusive right to use the
dossiers to apply for, and, subject to grant, maintain regulatory approvals for the products and to commercialize them in the European
Economic Area, the United Kingdom and Switzerland. Advanz made upfront
3
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Endorsement by the Board of Directors and the CEO
payments in the aggregate amount of $61.0 million at signing of the Product Schedules and agreed to make additional payments for an
aggregate amount of up to $287.5 million upon the achievement of ce rtain development and commerci al milestones. Alvotech will
manufacture, supply and deliver the product to Advanz and Advanz will exclusively buy the relevant biosimilar candidate from Alvotech at
a royalty of approximately 40% of the estimated net selling price or an agreed-upon applicable floor price, whichever is higher, for the
duration of the relevant Product Schedule.
On 12 June 2023, Alvotech announced a settlement and license agreement with Johnson & Johnson concerning AVT04, Alvotech’s
proposed biosimilar to Stelara® (ustekinumab) in the United States. The settlement grants a license entry date for AVT04 in the United
States no later than 21 February 2025.
On 24 July 2023, Alvotech announced that Teva Pharmaceuticals, Inc. (“Teva”) and Alvotech have agreed to expand their existing
strategic partnership agreement. As part of the agreement, Teva will acquire subordinated convertible bond instruments, dated 20
December 2022, for $40 million. The expansion to th e existing strategic partnership agreement p ertains to exclusive commercialization in
the U.S. by Teva of two new biosimilar candidates (adding to the five products in the current partnership agreement, AVT02, AVT04,
AVT05, AVT06 and AVT16) and line extensions of two current biosimilar candidates in the partnership, to be developed, and
manufactured by Alvotech. The agreement includes milestone payments, the majority paid following product approvals and upon
achieving significant sales milestones. Teva and Alvotech will share profit from the commercialization of the biosimilars. The agreement
also includes increased involvement by Teva regarding manufacturing and quality at Alvotech’s manufacturing facility. Teva is actively
supporting Alvotech on-site in Iceland to be fully ready for an FDA inspection.
Alvotech also has a number of other programs in earlier phases of development that it plans to advance over the coming years. The two
most advanced of these, AVT16 and AVT33, are in early development and with immunology and oncology reference products that have
estimated combined global peak sales of approximately $30 billion.
Corporate highlights
On 25 January 2023, the Company issued an additional $10.0 million in Tranche B Convertible Bonds. Holders of the Tranche B
Convertible Bonds may elect, at their sole discretion, to convert all or part of the principal amount and accrued interest into Alvotech
ordinary shares at a conversion price of $10.00 per share on 31 December 2023, or 30 June 2024. The conversion feature was accounted
for as an embedded derivative and classified as equity.
On 10 February 2023, the Company completed a private placement equity offering of $137.0 million, at current ISK exchange rates, of its
ordinary shares, par value $0.01 per share, at a purchase price of $11.57 per share. The shares were delivered from previously issued
ordinary shares held by Alvotech’s subsidiary, Alvotech Manco ehf. As a result of the proceeds raised from the private placement offering,
the Company extinguished the derivative financial liability related to the Senior Bond Warrants resulting in the potential issuance of penny
warrants representing 1.0% of the fully diluted ordinary share capital. This was accounted for as an extinguishment of a derivative
financial liability in the consolidated statement of profit or loss and other comprehensive income or loss.
On 17 February 2023, the first tranche of OACB Earn Out Shares vested resulting in the issuance of 625,000 ordinary shares. The
issuance of ordinary shares for the first tranche was accounted for as an extinguishment of a derivative financial liability in the
consolidated statement of profit or loss and other comprehensive income or loss.
In January and February 2023, the Senior Bond Warrant holders (penny warrant holders) elected to exercise their warrants. As a result,
2,479,962 ordinary shares were issued in exchange for the exercising of the penny warrants. The Company received an immaterial amount
of cash and recognized the transaction as an extinguishment of the derivative financial liabilities. The difference between the fair value of
the equity issued and the carrying value of the derivative financial liab ilities was recognized in the consolidated statement of profit or loss
and other comprehensive income or loss.
From January through March 2023, holders of the OACB Warrants exercised their warrant rights for an exercise price of $11.50 for the
rights to one ordinary share per warrant. The exercises resulted in the issuance of 551,261 ordinary shares and cash proceeds of $6.3
million. The difference between the fair value of the equity issued and the carrying value of the derivative financial liabilities was
recognized in the consolidated statement of profit or loss and other comprehensive income or loss.
4
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Endorsement by the Board of Directors and the CEO
Future developments and uncertainties
As mentioned above, in July 2023, the Company expanded its exist ing strategic partnership agreement with Teva who will acquire
subordinated convertible bonds in principal amount of $40 million.
Also in July 2023, the Company secured a private placement of subordinated convertible bonds denominated in Icelandic krona and US
dollar for a principal amount of $100 million. ATP Holdings ehf., a subsidiary of Aztiq, the largest shareholder of Alvotech, committed to
acquiring any of the bonds which have not been sold to other investors.
In addition to the cash received, the Company expects to continue to source its cash flows during the development of its biosimilar
product candidates from new and existing out-license contracts wit h commercial partners and financing through shareholder equity and
related party and third-party debt financing.
Statement by the Board of Directors and the CEO
According to the Board of Directors’ and CEO’s best knowledge, the Unaudited Condensed Consolidated Interim Financial Statements
are prepared in accordance with IAS 34 'Interim financial reporting' and give a true and fair view of the consolidated financial
performance of the Group for the six-month period ended 30 June 2023, its a ssets, liabilities and consolidated financial position as at 30
June 2023 and its consolidated cash flows for the six-month period ended 30 June 2023. Furthermore, in our opinion the Unaudited
Condensed Consolidated Interim Financial Statements and the endorsement of the Board of Directors and the CEO give a fair view of
the development and performance of the Group's operations and its position and describe the principal risks and uncertainties faced by
the Group.
The Board of Directors and CEO of Alvotech hereby endorse the Unaudited Condensed Consolidated Interim Financial Statements of
Alvotech for the six-month period ended 30 June 2023 with their signatures.
For the foreseeable future, Alvotech’s Board o f Directors will maintain a capita l structure that supports Alvotech’s strategic objectives
through managing the budgeting process, maintaining strong investor relations, and managing financial risks. Consequently, if it is
successful in these plans, management and the Board of Directors believe that Alvotech will have sufficient funds, and access to sufficient
funds, to continue in operation for at least the next 12 months and w ill be able to realize its assets and discharge its liabilities and
commitments in the normal course of business. However, although management continues to pursue these plans, there is no assurance
that Alvotech will be successful in obtaining sufficient funding on terms acceptable to Alvotech management to fund continuing
operations, if at all. Alvotech’s future capital requirements will depend on many factors, including the following:
• the progress, results, and costs of preclinical studies for any programs that Alvotech may develop;
• the costs, timing, and outcome of regulatory review of program candidates;
• Alvotech’s ability to establish and maintain collaborations, licensing, and other agreements with partners on favorable terms, if at all;
• the achievement of milestones or occurrence of other developments that trigger payments under the agreements that Alvotech has
entered into or may enter into with third parties or related parties;
• the extent to which Alvotech is obligated to reimburse clinical trial costs under collaboration agreements, if any;
• the costs of preparing, filing and prosecuting patent applications and maintaining, defending and enforcing Alvotech’s intellectual
property rights;
• the extent to which Alvotech acquires or invests in businesses, products, technologies, or other joint ventures;
• the costs of performing commercial-scale manufacturing in-house and, if needed, securing manufacturing arrangements for commercial
production of its program candidates; and
• the costs of establishing or contracting for sales and marketing capabilities if Alvotech obtains regulatory approvals to market program
candidates.
5
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Endorsement by the Board of Directors and the CEO
Done in Luxembourg on 30 August 2023,
For the Board of Directors and CEO:
Robert Wessman
Title: Director and authorized signatory
6
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USD in thousands, except for per share amounts Notes
5 22,715 3,932
5 (2,460) 36,186
45 142
(67,909) (17,813)
(99,582) (86,884)
1.1 (41,910) (139,147)
Operating loss (189,101) (203,584)
21 (2,706) (1,266)
6 122,480 50,968
6 (64,300) (52,406)
(3,081) 4,744
Non-operating profit 52,393 2,040
Loss before taxes (136,708) (201,544)
7 49,854 17,073
Loss for the period (86,854) (184,471)
Other comprehensive loss
Item that will be reclassified to profit or loss in subsequent periods:
(1,523) (4,243)
Total comprehensive loss (88,377) (188,714)
Loss per share
8 (0.39) (1.02)
Income tax benefit .................................................................................................................
Exchange rate differences on translation of foreign operations .....................................
General and administrative expenses ..................................................................................
Share of net loss of joint venture ........................................................................................
Finance income ......................................................................................................................
Finance costs ..........................................................................................................................
Exchange rate difference ......................................................................................................
Research and development expenses ..................................................................................
Cost of product revenue .......................................................................................................
Basic and diluted loss for the period per share .................................................................
Unaudited Condensed Consolidated Interim Statements of Profit or Loss
and Other Comprehensive Income or Loss
License and other revenue ....................................................................................................
Other income ..........................................................................................................................
Product revenue .....................................................................................................................
Six months
ended
30 June
2023
Six months
ended
30 June
2022
The accompanying notes are an integral part of these Unaudited Condensed Consolidated Interim Financial Statements
7
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USD in thousands
Notes
Non-current assets
9 231,989 220,594
10 101,402 47,501
11,886 11,643
11 14,007 25,652
5 8,312 3,286
21 43,613 48,568
2,053 5,780
25,187 25,187
7 260,301 209,496
698,750 597,707
Current assets
13 79,366 71,470
16,307 32,972
5 19,129 25,370
14 34,988 32,949
19 1,656 1,548
12 60,466 66,427
211,912 230,736
910,662 828,443
31 December
2022
Other long-term assets ................................................................................................
Contract assets .............................................................................................................
Cash and cash equivalents ..........................................................................................
Goodwill .......................................................................................................................
Contract assets .............................................................................................................
Inventories ....................................................................................................................
Unaudited Condensed Consolidated Interim Statements of Financial Position
Right-of-use assets .......................................................................................................
Investment in joint venture ........................................................................................
Restricted cash .............................................................................................................
Total non-current assets
Deferred tax assets .......................................................................................................
Total assets
Property, plant and equipment ..................................................................................
Total current assets
Other intangible assets ................................................................................................
Receivables from related parties ................................................................................
30 June
2023
Trade receivables .........................................................................................................
Other current assets ....................................................................................................
The accompanying notes are an integral part of these Unaudited Condensed Consolidated Interim Financial Statements
8
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USD in thousands
Notes
Equity
15 2,271 2,126
15 1,224,814 1,058,432
38,308 30,582
(2,965) (1,442)
(1,740,968) (1,654,114)
Total equity (478,540) (564,416)
Non-current liabilities
16 786,175 744,654
22 229,046 380,232
19 7,440 7,440
10 87,416 35,369
- 544
5 57,387 57,017
45 309
Total non-current liabilities 1,167,509 1,225,565
Current liabilities
43,931 49,188
10 7,983 5,163
16 22,463 19,916
19 1,137 1,131
5 58,978 36,915
1,520 934
20 85,681 54,047
Total current liabilities 221,693 167,294
Total liabilities 1,389,202 1,392,859
Total equity and liabilities 910,662 828,443
Accumulated deficit .....................................................................................................
Borrowings ...................................................................................................................
Other long-term liability to related party .................................................................
Derivative financial liabilities .....................................................................................
Current maturities of borrowings ..............................................................................
Deferred tax liability ....................................................................................................
Contract liabilities ........................................................................................................
Trade and other payables ............................................................................................
31 December
2022
Share premium .............................................................................................................
Unaudited Condensed Consolidated Interim Statements of Financial Position
Share capital ..................................................................................................................
Taxes payable ...............................................................................................................
Other reserves ..............................................................................................................
Lease liabilities ..............................................................................................................
Long-term incentive plan ...........................................................................................
Other current liabilities ...............................................................................................
Translation reserve ......................................................................................................
Lease liabilities ..............................................................................................................
Liabilities to related parties .........................................................................................
30 June
2023
Contract liabilities ........................................................................................................
The accompanying notes are an integral part of these Unaudited Condensed Consolidated Interim Financial Statements
9
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USD in thousands
Notes
Cash flows from operating activities
(86,854) (184,471)
Adjustments for non-cash items:
- (4,803)
1.1 - 83,411
17 11,911 5,555
10,934 9,977
9 323 -
18,500 -
21 2,706 1,266
6 (122,480) (50,968)
6 64,300 52,406
3,081 (4,744)
7 (49,854) (17,073)
Operating cash flow before movement in working capital (147,433) (109,444)
13 (7,896) (15,606)
16,665 24,092
(102) 2,825
5 1,215 (20,398)
3,711 (11,384)
(6,182) 17,408
37,679 (12,226)
4,395 (6,963)
Cash used in operations (97,948) (131,696)
25 8
(29,427) (9,220)
(652) (248)
Net cash used in operating activities (128,002) (141,156)
Cash flows from investing activities
(22,594) (17,660)
133 379
11 (2,764) (9,309)
- (14,914)
Net cash used in investing activities (25,225) (41,504)
Disposal of property, plant and equipment .......................................................................
Restricted cash in connection with the amended bond agreement ................................
Loss for the period ................................................................................................................
Share of net loss of joint venture ........................................................................................
Loss on disposal of property, plant and equipment .........................................................
Income tax benefit .................................................................................................................
(Increase) in inventories ........................................................................................................
Gain on extinguishment of SARs liability ..........................................................................
Increase / (decrease) in trade and other payables .............................................................
Increase / (decrease) in liabilities with related parties ......................................................
Interest paid ............................................................................................................................
Share-based payment expense ..............................................................................................
Finance costs ..........................................................................................................................
Decrease in trade receivables ...............................................................................................
Depreciation and amortization ............................................................................................
Acquisition of intangible assets ............................................................................................
Unaudited Condensed Consolidated Interim Statements of Cash Flows
Six months
ended
30 June
2023
Six months
ended
30 June
2022
Exchange rate difference ......................................................................................................
Change in allowance for receivables ...................................................................................
Finance income ......................................................................................................................
Share listing expense ..............................................................................................................
Increase / (decrease) in contract liabilities .........................................................................
Increase / (decrease) in other liabilities ..............................................................................
Interest received .....................................................................................................................
(Increase) / decrease in contract assets ..............................................................................
(Increase) / decrease in other assets ...................................................................................
Income tax paid ......................................................................................................................
Acquisition of property, plant and equipment ..................................................................
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Cash flows from financing activities
16 (84,507) (1,414)
10 (3,700) (5,033)
16 93,561 10,786
15 136,877
-
15 (4,141) -
22 6,365 -
1.1 - 174,930
1.1 - (5,561)
1.1 - 9,827
- 110,000
Net cash generated from financing activities 144,455 293,535
(8,772) 110,875
66,427 17,556
2,811 7
60,466 128,438
Supplemental cash flow disclosures (Note 23)
Proceeds from loans from related parties ..........................................................................
Gross private placement equity offering fee paid .............................................................
Repayments of principal portion of lease liabilities ..........................................................
Repayments of borrowings ...................................................................................................
Proceeds from new borrowings ...........................................................................................
Effect of movements in exchange rates on cash held ......................................................
Gross proceeds from the private placement equity offering fee ....................................
Cash and cash equivalents at the end of the period ...........................................
Gross proceeds from the PIPE Financing .........................................................................
Cash and cash equivalents at the beginning of the period ...............................................
(Decrease) increase in cash and cash equivalents ..............................................................
Gross PIPE Financing fees paid ..........................................................................................
Proceeds from the Capital Reorganization ........................................................................
Proceeds from warrants ........................................................................................................
The accompanying notes are an integral part of these Unaudited Condensed Consolidated Interim Financial Statements
11
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Share Other Accumulated Total
USD in thousands Share capital premium reserves deficit equity
135 1,000,118 - 4,669 (1,140,534) (135,612)
- - - - (184,471) (184,471)
- - - (4,243) - (4,243)
- - - (4,243) (184,471) (188,714)
175 169,193 - - - 169,368
35 30,267 - - - 30,302
1,731 (173,296) - - - (171,565)
2,076 1,026,282 - 426 (1,325,005) (296,221)
2,126 1,058,432 30,582 (1,442) (1,654,114) (564,416)
- - - - (86,854) (86,854)
- - - (1,523) - (1,523)
- - - (1,523) (86,854) (88,377)
118 132,618 - - - 132,736
6 8,300 - - - 8,306
25 27,159 - - - 27,184
6 7,582 - - - 7,588
- - 10,909 - - 10,909
0 249 (333) - - (84)
(10) (9,526) (4,231) - - (13,767)
- - 1,381 - - 1,381
2,271 1,224,814 38,308 (2,965) (1,740,968) (478,540)
Settlement of SARs with shares................................................................................
PIPE Financing............................................................................................................
Loss for the period......................................................................................................
Foreign currency translation differences..................................................................
Unaudited Condensed Consolidated Interim Statements of Changes in Equity
Translation
reserve
At 1 January 2022.........................................................................................
Recognition of equity component of convertible bonds.......................................
Vested earn-out shares................................................................................................
Recognition of share-based payments expense.......................................................
Public warrants excercised.........................................................................................
Capital Reorganization................................................................................................
Settlement of SARs with shares................................................................................
Settlement of RSUs with shares................................................................................
At 30 June 2023............................................................................................
Capital contribution....................................................................................................
At 30 June 2022............................................................................................
Loss for the period......................................................................................................
Penny warrants excercised.........................................................................................
Foreign currency translation differences..................................................................
Total comprehensive loss...........................................................................................
At 1 January 2023.........................................................................................
Total comprehensive loss...........................................................................................
The accompanying notes are an integral part of these Unaudited Condensed Consolidated Interim Financial Statements
===== SIDA 14 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
1. General information
1.1 Capital Reorganization
● The Predecessor merged with and into the Parent, whereby all outstanding ordinary shares of the Predecessor (“Predecessor
Ordinary Shares”) were exchanged for Ordinary Shares, pursuant to a share capital increase of Alvotech, with Alvotech as the
surviving company in the merger.
Concurrently with the execution of the Business Combination Agreement, OACB and Alvotech entered into subscription
agreements (“Subscription Agreements”) with certain investors (the “PIPE Financing”). On 15 June 2022, immediately prior to
the closing of the Business Combination, the PIPE Financing was closed, pursuant to the Subscription Agreements, in which
subscribers collectively subscribed for 17,493,000 Ordinary Shares at $10.00 per share for an aggregate subscription price equal to
$174.9 million.
The Business Combination was accounted for as a capital reorganization. Under this method of accounting, OACB was treated as
the “acquired” company for financial reporting purposes, with Alvotech Holdings S.A. being the accounting acquirer and
accounting predecessor. Accordingly, the capital reorganization was treated as the equivalent of Alvotech issuing shares at the
closing of the Business Combination for the net assets of OACB as of the Closing Date, accompanied by a recapitalization. The
capital reorganization, which was not within the scope of IFRS 3 since OACB did not meet the definition of a business in
accordance with that guidance, was accounted for within the scope of IFRS 2. In accordance with IFRS 2, Alvotech recorded a
one-time non-cash share listing expense of $83.4 million, recognized as a general and administrative expense, based on the excess
of the fair value of Alvotech shares issued, at the Closing Date, over the fair value of OACB's identifiable net assets acquired. The
fair value of shares issued was estimated based on a market price of $9.38 per share as of 15 June 2022.
Alvotech (the “Parent” or the “Company” or “Alvotech”), previously known as Alvotech Lux Holdings S.A.S., the surviving
company after the Business Combination (as defined below) with, among other parties, Alvotech Holdings S.A. (the
“Predecessor”), is a Luxembourg public limited company (société anonyme) incorporated and existing under the laws of the Grand
Duchy of Luxembourg, having its registered office at 9, rue de Bitbourg, L-1273 Luxembourg, Grand Duchy of Luxembourg and
is registered with the Luxembourg Trade and Companies’ Register under number B 258884. The Company was incorporated on
23 August 2021. These unaudited condensed consolidated interim financial statements were approved by the Group’s Board of
Directors, and authorized for issue, on 30 August 2023.
The Company and its subsidiaries (collectively referred to as the “Group”) are a global biotech company specialized in the
development and manufacture of biosimilar medicines for patients worldwide. The Group has commercialized a biosimilar
product and has multiple biosimilar molecules.
On 15 June 2022 (the “Closing Date”), the Company consummated the capital reorganization with Alvotech Holdings and OACB
(the “Business Combination” or “Capital Reorganization”) pu rsuant to the business combination agreement, dated as of 7
December 2021, as amended by an amendment agreement dated 18 April 2022 and 7 June 2022 (the “Business Combination
Agreement”), by and among the Company, Oaktree Acquisition Corp. II (“OACB”) and the Predecessor. The closing of the
Business Combination resulted in the following transactions:
●
OACB merged with and into the Company, whereby (i) all of t he outstanding ordinary shares of OACB (“OACB Ordinary
Shares”) were exchanged for ordinary shares of Alvotech (“Ordina ry Shares”) on a one-for-one basis, pursuant to a share capital
increase of Alvotech and (ii) all of the outstanding warrants of OACB ceased to represent a right to acquire OACB Ordinary
Shares and now represent a right to be issued one Ordinary Share, with Alvotech as the surviving company in the merger;
●
Alvotech redeemed and canceled the initial shares held by the initial sole shareholder of Alvotech pursuant to a share capital
reduction of Alvotech;
● The legal form of Alvotech changed from a simplified joint stock company (société par actions simplifiée) to a public limited
liability company (société anonyme) under Luxembourg law; and
13 All amounts are in USD
===== SIDA 15 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
Shares (in 000s)
OACB Shareholders
976,505
5,000,000
1,250,000
7,226,505
56,060$
9,100
65,160
(18,251)
83,411
1.2 Information a
bout shareholders
1.3 The impact of Russia and Ukraine Conflict and Economic Conditions
Global economic and business activities continue to face widespread macroeconomic uncertainties, including health epidemics,
labor shortages, bank failures, inflation and monetary supply sh ifts, recession risks and potential disruptions from the Russia-
Ukraine conflict. The Company continues to actively monitor the impact of these macroeconomic factors on its financial
condition, liquidity, operations, and workforce. We are unable to predict the effect that geopolitical events, including the conflict in
Ukraine, global inflation and rising interest rates, may have on our operations. To the extent that geopolitical events adversely
affect our business prospects, financial condition, and results of operations, they may also have the effect of exacerbating many of
the other risks described or referenced in the section titled “Risk Factors” of our Annual Report on Form 20-F for the year ended
31 December 2022, filed with the SEC on 1 March 2023.
The Company believes that inflation will have a general impact on the business in line with overall price increases, increases in the
cost of borrowing, and operating in an inflationary economy. We cannot predict the timing, strength, or duration of any
inflationary period or economic slowdown or its ultimate impact on the Company. If the conditions in the general economy
significantly deviate from present levels and continue to deteriorate it could have a material adverse effect on the Group’s business,
financial condition, results of operations and growth prospects.
As of 30 June 2023, the conflict in Ukraine has not had a material impact on the Group’s financial condition, results of operations,
the timelines for biosimilar product development, expansion efforts or the Group’s operations as a whole.
Adjusted net liabilities of OACB as of 15 June 2022.......................................................................
Difference - being the share listing expense................................................................................... .......
In connection with the Business Combination and PIPE Financing, the Company incurred $26.6 million of transaction costs,
which represent legal, financial advisory, and other professional fees, during the six months ended 30 June 2022. Of this amount,
$5.6 million represented equity issuance costs related to PIPE Financing that were capitalized in share premium. The remaining
$21.0 million was recognized as general and administrative expense.
Significant shareholders of the Company are Aztiq Pharma Partners S.à r.l. (“Aztiq”) and Alvogen Lux Holdings S.à r.l.
(“Alvogen”), with 38.0% and 33.4% ownership interest as of 30 June 2023, respectively. The remaining 28.6% ownership interest
is held by various shareholders, with no single shareholder holding more than 3.0% ownership interest as of 30 June 2023.
OACB Earn Out Shares....................................................................................................... ...............
Total Alvotech Shares issued to OACB shareholders.....................................................................
Fair value of Shares issued to OACB as of 15 June 2022...............................................................
Fair value of OACB Earn Out Shares issued to OACB as of 15 June 2022................................
Estimated fair market value................................................................................................ ................
Class A Shareholders....................................................................................................... ....................
Class B Shareholders....................................................................................................... ....................
14 All amounts are in USD
===== SIDA 16 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
1.4 Going concern
2. Basis of preparation
In July 2023, the Company expanded its existing strategic partnership agreement with Teva Pharmaceuticals, Inc. (“Teva”) who
will acquire subordinated convertible bonds for $40 million (see Not e 24 for further information). The Group expects to continue
to source its cash flow during the development of its biosimilar products from new and existing out-license contracts with
customers.
As such, the unaudited condensed consolidated interim financial statements have been prepared on a going concern basis.
Management continues to pursue the funding plans as described above, however there is no assurance that the Group will be
successful in obtaining sufficient funding on terms acceptable to the Group to fund continuing operations, if at all. If financing is
obtained, the terms of such financing may adversely affect the holdings or the rights of the Group’s shareholders. The ability to
obtain funding, therefore, is outside of management’s control and is a material uncertainty that may cast significant doubt upon the
Group’s ability to continue as a going concern.
The unaudited condensed consolidated interim financial statements of the Group as of and for the six months ended 30 June 2023
have been prepared in accordance and in compliance with International Accounting Standard 34 Interim Financial Reporting (IAS
34) as issued by the International Accounting Standards Board (IASB).
The accounting policies and basis of preparation adopted in the pre paration of these unaudited condensed consolidated interim
financial statements are consistent with those followed in the pr eparation of the Group’s consolidated financial statements issued
for the year ended 31 December 2022, except for the adoption of new and amended accounting standards effective as of 1 January
2023 set out below. The Group has not early adopted any other standards, interpretations or amendments that have been issued
but are not yet effective. The unaudited condensed consolidated interim financial statements are presented in US dollars and all
values are rounded to the nearest thousand unless otherwise indicated.
During the same month, the Company also secured a private placement of subordinated convertible bonds denominated in
Icelandic krona (ISK) and US dollar (USD) for a principal amount of $100 million. ATP Holdings ehf., a subsidiary of Aztiq, the
largest shareholder of Alvotech, committed to acquiring any of the bonds which have not been sold to other investors (see Note
24 for further information).
The Group has primarily funded its operations with proceeds from the issuance of equity and the issuance of loans and
borrowings to both related parties and third parties. The Group has also incurred recurring losses since its inception, including net
losses of $86.9 million and $ 184.5 million for the six months ended 30 June 2023 and 2022, respectively, and had an accumulated
deficit of $1,741.0 million as of 30 June 2023 and $1,654.1 m illion as of 31 December 2022. The Group has not generated positive
operational cash flow, largely due to the continued focus on biosimilar product development and expansion efforts.
As of 30 June 2023, the Group has cash and cash equivalents, excluding restricted cash, of $60.5 m illion and net current assets less
current liabilities of $(9.8) million. The closing of the private placement equity offering in January 2023 provided the Group with
gross proceeds of $ 137.0 million that is expected to be used to finance the continuing development and commercialization of its
biosimilar products. As described in Note 3, the Company extended strategic partnership with Mercury Pharma Group Limited
(trading as Advanz Pharma Holdings) (“Advanz”) to commerc ialize five proposed biosilimar s in Europe, yielding upfront
payments from Advanz in the aggregate amount of $61.0 million at signing of the agreement.
15 All amounts are in USD
===== SIDA 17 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
3. Significant changes in the current reporting period
From January through March 2023, holders of the OACB Warrants exercised their warrant rights for an exercise price of $11.50
for the rights to one ordinary share per warrant. The exercises resulted in the issuance of 551,261 ordinary shares and cash
proceeds of $6.3 million. The Company recognized the transaction as an extinguishment of the derivative financial liabilities. The
difference between the fair value of the equity issued and the carrying value of the derivative financial liabilities was recognized in
the consolidated statements of profit or loss and other comprehensive income or loss. See Note 22 for further information.
On 25 January 2023, the Company issued an additional $10.0 m illion in Tranche B Convertible Bonds. Holders of the Tranche B
Convertible Bonds may elect, at their sole discretion, to convert all or part of the principal amount and accrued interest into
Alvotech ordinary shares at a conversion price of $10.00 per share on 31 December 2023, or 30 June 2024. The conversion
feature was accounted for as an embedded derivative, that is bifurcated and classified as equity. See Note 16 for further
information.
On 10 February 2023, the Company completed a private placement equity offering of $137.0 m illion, at current ISK exchange
rates, of its ordinary shares, par value $0.01 per share, at a purchase price of $11.57 per share. The shares were delivered from
previously issued ordinary shares held by Alvotech’s subsidiary, Alvotech Manco ehf. As a result of proceeds raised from the
private placement offering, the Company extinguished the derivative financial liability related to the Senior Bond Warrants
resulting in the potential issuance of penny warrants representing 1.0% of the fully diluted ordinary share capital (the "1.0% Senior
Bond Warrants"). This was accounted for as an extinguishment of a derivative financial liability in the consolidated statement of
profit or loss and other comprehensive income or loss. See Notes 15 and 16 for further information.
On 17 February 2023, the first tranche of OACB Earn Out Shares vested resulting in the issuance of 625,000 ordinary shares. The
issuance of ordinary shares for the first tranche was accounted for as an extinguishment of a derivative financial liability. The
difference between the fair value of the equity issued and the carrying value of the derivative financial liabilities was recognized in
the consolidated statement of profit or loss and other comprehensive income or loss. See Note 22 for further information.
On 27 February 2023, the Group and Teva signed an amendment to the license and development agreement. As part of that
amendment, the Group agreed to provide future financial consideration to Teva to assist with the cost of launching and marketing
the licensed biosimilar products.
In January and February 2023, the Senior Bond Warrant (i.e., penny warrants) holders elected to exercise their warrants. As a
result, 2,479,962 ordinary shares were issued in exchange for the exercising of the penny warrants. The Company r eceived an
immaterial amount of cash and recognized the transaction as an extinguishment of the derivative financial liabilities. The difference
between the fair value of the equity issued and the carrying value of the derivative financial liabilities was recognized in the
consolidated statement of profit or loss and other comprehensive income or loss.
The financial position and performance of the Group was impacted by the following events and transactions during the six
months ended 30 June 2023:
In preparing these unaudited condensed consolidated interim financial statements, management has made judgements and
estimates that affect the application of accounting policies and the reported amounts of assets and liabilities, income and expense.
Actual results may differ from these estimates. The significant judgements made by management in applying the Group’s
accounting policies and the key sources of estimation uncertainty were the same as those described in the Group´s consolidated
financial statements issued for the year ended 31 December 2022.
In the opinion of the Group’s management, these unaudited condensed consolidated interim financial statements contain all
normal recurring adjustments necessary to present fairly the financial position and results of operations of the Group for each of
the periods presented. The unaudited condensed consolidated interim financial statements do not include all the notes and other
information required in an annual financial report. Accordingly, these unaudited condensed consolidated interim financial
statements should be read in conjunction with the Group’s c onsolidated financial statements issued for the year ended 31
December 2022. The condensed consolidated statement of financial position as of 31 D ecember 2022 was derived from the
consolidated financial statements at that date.
16 All amounts are in USD
===== SIDA 18 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
In April 2023, Alvotech r eceived from the US Food and Drug Administratio n (FDA) a complete respons e letter (CRL) for the
Company’s Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira®
(adalimumab). On 28 June 2023, Alvotech announced that the FDA has issued a CRL for Alvotech’s BLA for AVT02, which
contained data to support approval as a high-c oncentration biosimilar and additional information to support the interchangeability
designation. The CRLs noted that certain deficiencies, which were conveyed following the FDA’s reinspection of the company’s
Reykjavik facility that concluded in March 2023, must be satisfactorily resolved before the application can be approved.
On 19 May 2023, Alvotech entered into termination agreements with STADA Arzneimittel AG (“STADA”) to terminate the
license and supply agreements between Alvotech and STADA pertaining to Alvotech’s product candidates AVT03, a biosimilar
candidate to Prolia® / Xgeva® (denosumab), AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab) and
AVT16, a proposed biosimilar to Entyvio® (ve dolizumab). Pursuant to the terms of the termination agreements, Alvotech repaid
the aggregate amount of $18.9 million in July 2023 that Alvotech had previously r eceived from STADA under the terminated
agreements.
On 22 May 2023, Alvotech entered into a master license and supply agreement with Advanz with respect to the supply and
commercialization in Europe of AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab), AVT16, a
proposed biosimilar to Entyvio® (vedolizumab), and three additi onal early-stage, undisclosed biosimilar candidates (each, a
"Product Schedule"). Under the terms of the agreements with Adva nz, Alvotech will develop the product candidates and provide
the dossier of data, information and know-how relating to the relevant product candidate to Advanz. Alvotech retains full
ownership of all intellectual property rights in the product candi dates and the dossiers. Advanz has an exclusive right to use the
dossiers to apply for, and, subject to grant, maintain regulatory approvals for the products and to commercialize them in the
European Economic Area, the United Kingdom and Switzerland. Advanz made upfront payments in the aggregate amount of
$61.0 million at signing of the Product Schedules and agreed to make additional payments for an aggregate amount of up to $ 287.5
million upon the achievement of certain development and commercial milestones. Alvotech will manufacture, supply and deliver
the product to Advanz and Advanz will exclusively buy the relevant biosimilar candidate from Alvotech at a royalty of
approximately 40% of the estimated net selling price or an agreed-upon applicable floor price, whichever is higher, for the
duration of the relevant Product Schedule.
On 12 June 2023, Alvotech announced a settlement and license agreement with Johnson & Johnson concerning AVT04,
Alvotech’s proposed biosimilar to Stelara® (ustekinumab) in the United States. The settlement grants a license entry date for
AVT04 in the United States no later than 21 February 2025.
In March 2023, Alvotech provided BiosanaPharma ("Biosana") a notice of termination for the global licensing agreement between
the two companies covering the co-development of AVT23, a proposed biosimilar to Xolair® (omalizumab). See Note 11 for
further information.
17 All amounts are in USD
===== SIDA 19 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
4. New accounting policy and standards
IFRS 17 - Insurance Contracts
IAS 1 (Amendment) - Disclosure of Accounting Policies
The IASB issued amendments on IFRS 8 to help entities to distinguish between accounting policies and accounting estimates. The
amendments clarify how companies distinguish changes in accounting policies from changes in accounting estimates, with a
primary focus on the definition of and clarifications on accounting estimates. The distinction between the two is important
because changes in accounting policies are applied retrospectively, while changes in accounting estimates are applied prospectively.
The amendments further clarify that accounting estimates are monetary amounts in the financial statements and are subject to
measurement uncertainty. The amendments also clarify the relationship between accounting policies and accounting estimates by
specifying that a company develops accounting estimates to achieve the objective set out by an accounting policy. The
amendments are applied to all financial statements and disclosures of the Group effective 1 January 2023. The adoption of the
amendments did not have a material impact on the unaudited condensed consolidated interim financial statements of the Group.
IAS 12 (Amendments) - Deferred Tax Related to Assets and Liabilities Arising from a Single Transaction
The IASB issued amendments on IAS 12, which clarifies how companies shall account for deferred tax on transactions such as
leases and decommissioning obligations, with a focus on reducing diversity in practice. The amendments narrow the scope of the
initial recognition exemption in paragraphs 15 and 24 of IAS 12 so that it does not apply to transactions that give rise to equal and
offsetting temporary differences. As a result, companies will need to recognize deferred tax assets and a deferred tax liability for
temporary differences arising on initial recognition of a lease and a decommissioning provision. The amendments are applied to all
financial statements and disclosures of the Group effective 1 January 2023. The adoption of the amendments did not have a
material impact on the unaudited condensed consolidated interim financial statements of the Group.
In May 2017, the IASB issued IFRS 17, Insurance Contracts, which replaces IFRS 4, Insurance Contracts. This standard sets out
principles for the recognition, measurement, presentation and disclosure of insurance contracts that are within the scope of IFRS
17. In June 2020, the IASB issued Amendments to IFRS 17, which addresses concerns and implementation challenges that were
identified after IFRS 17, Insurance Contracts, was published in 2017. The amendments are effective for annual periods beginning
on or after 1 January 2023. IFRS 17 requires fundamental accounting changes to how insurance contracts are measured and
accounted for. It introduces the general measurement model, based on a risk-adjusted present value of future cash flows that will
arise as the insurance contract is fulfilled. This new measurement model aims to provide relevant information of the future cash
flows. The general measurement model is modified for the measurement of reinsurance contracts held, direct participating
contracts, and investment contracts with discretionary participation features. Also, while the general measurement model applies to
all groups of insurance contracts in scope of IFRS 17, a simplified approach (a premium allocation approach) may be used to
measure contracts that meet certain criteria. IFRS 17 also includes new disclosure requirements, providing more clarity and
transparency for users of financial statements. The adoption of the standard did not have a material impact on the unaudited
condensed consolidated interim financial statements of the Group.
The IASB issued Disclosure of Accounting Policies (Amendments to IAS 1) and IFRS Practice Statement 2 Making Materiality
Judgements. The amendments replace the requirement for entities to disclose their significant accounting policies with the
requirement to disclose their material accounting policy information. The amendments also include guidance to help entities apply
the definition of material in making decisions about accounting policy disclosures. These amendments are effective for annual
periods beginning on or after 1 January 2023. The adoption of these amendments did not have a material impact on the unaudited
condensed consolidated interim financial statements of the Group.
IFRS 8 (Amendments) - Accounting Policies, Changes in Accounting Estimates and Errors
In the six months ended 30 June 2023, the Group has applied, for the first time, the following new or revised international
financial reporting standards (IFRS) issued by the IASB that are mandatorily effective for the period:
18 All amounts are in USD
===== SIDA 20 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
5. Revenue
Disaggregated revenue
2023 2022
22,715 3,932
7,635 424
(10,095) 35,762
20,255 40,118
Contract assets and liabilities
28,656 93,932
(83) -
(1,232) (7,545)
- (34,194)
- 60,543
- 2,377
100 1,252
27,441 116,365
The decrease in contract assets as of 30 June 2023 is primarily due to reclassification from contract assets to trade r eceivables when
the Group has the right to invoice the customer and the receipt of consideration is only conditional upon the passage of time. The
net increase in contract liabilities as of 30 June 2023 is mainly due to prepayment from customers as the Group entered into new
commercial agreements during the period, offset by termination of agreements which resulted in reclassification to other current
liabilities (see Note 3 for further information).
As of 30 June 2023, $8.3 m illion and $19.1 million are recorded as non-current contract assets and current contract assets,
respectively. Non-current contract assets will materialize over the next 2 to 4 years. As of 30 June 2023, $57.4 m illion and $59.0
million are recorded as non-current contract liab ilities and current contract liabilities, resp ectively. Non-current contract liabilities
will be recognized as revenue over the next 2 to 7 years as either services are rendered or contractual milestones are achieved,
depending on the performance obligation to which the payment relates.
Contract assets and contract liabilities as of 30 June 2022 were $39.8 million and $62.3 million, respectively. The Group recognized
$35.1 million of revenue during the six months ended 30 June 2022.
Contract asset additions ...................................................................................................... ....................
Amounts transferred to trade receivables ...................................................................................... .......
Customer prepayments .......................................................................................................... .................
Revenue recognized ............................................................................................................ ....................
Foreign currency ad
justment ..................................................................................................................
30 June 2023 .................................................................................................................. ..........................
Amounts transferred to other current liabilities ...................................................................................
1 January 2023 ................................................................................................................ .........................
Increase in license revenue is mainly due to signing of new commercial contracts with new partners. Decrease in research and
development and other service revenue is due to no milestones achieved in the period and termination of commercial contracts
(see Note 3 for further information).
A reconciliation of the beginning and ending balances of contract assets and contract liabilities related to Alvotech’s out-license
contracts is shown in the table below (in thousands):
Contract assets
Contract
liabilities
The following table summarizes the Group’s revenue from contracts with customers, disaggregated by the type of good or service
and timing of transfer of control of such goods and services to customers during the six months ended 30 June 2023 and 2022 (in
thousands):
30 June
Product revenue (point in time revenue recognition)..........................................................................
License revenue (point in time revenue recognition)...........................................................................
Research and development and other service revenue (over time revenue recognition).................
19 All amounts are in USD
===== SIDA 21 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
6. Finance income and finance costs
Finance income earned during the six months ended 30 June 2023 and 2022 is as follows (in thousands):
2023 2022
119,528 50,920
2,927 40
25 8
122,480 50,968
Finance costs incurred during the six months ended 30 June 2023 and 2022 are as follows (in thousands):
2023 2022
(5,906) -
(56,631) (35,153)
- (7,430)
- (6,511)
(1,362) (3,312)
(401) -
(64,300) (52,406)
7.
Income tax
8. Loss per share
2023 2022
(86,854) (184,471)
Number of shares
225,523,805 181,695,118
(0.39) (1.02)
During the six months ended 30 June 2023 and 2022, the calculation of diluted loss per share did not differ from the calculation of
basic loss per share since the inclusion of potential Ordinary Shares pursuant to the Group’s earn out agreements, warrant
agreements, former convertible loan agreements and convertible bond agreements would have been antidilutive. As such,
72,888,953 and 50,496,647 potential Ordinary Shares were excluded from the calculation of diluted loss per share for the six
months ended 30 June 2023 and 2022, respectively.
30 June
Earnings
Loss for the period ..................................................................................................... ......................
Weighted average number of ordinary shares outstanding .............................................................
Basic and diluted loss per share .............................................................................................. ...............
The calculation of basic and diluted loss per share for the six months ended 30 June 2023 and 2022 is as follows (in thousands,
except for share and per share amounts):
The Group’s effective tax rate for the six months ended 30 June 2023 and 30 June 2022 was 36.47% and 8.47%, respectively,
resulting in a tax benefit in both periods. The effective tax rate for both periods is influenced by losses and non-deductible interest
incurred in Luxembourg for which no deferred tax asset is recognized and IFRS fair value adjustments which are not tax effected.
The tax benefit booked for the current period is driven by operational losses in Iceland and the favorable foreign currency impact
arising from the strengthening of the Icelandic krona against the US dollar which increased the US dollar value of tax loss carry-
forward.
Amortization of deferred debt issue costs...................................................................................... .......
30 June
Changes in the fair value of derivative financial liabilities...................................................................
Interest on debt and borrowings................................................................................................ ............
Special put option and consenting fee.......................................................................................... .........
Loss on remeasurement of bonds................................................................................................. .........
Interest on lease liabilities (see Note 10)................................................................................................
30 June
Changes in the fair value of derivative financial liabilities...................................................................
Interest income from cash and cash equivalents................................................................................. .
Other interest income.......................................................................................................... ....................
20 All amounts are in USD
===== SIDA 22 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
9. Property, plant and equipment
10. Leases
2023
Right-of-use assets
47,501
2,780
54,846
(258)
(3,742)
275
101,402
Lease liabilities 2023
40,532
2,780
53,920
(2,889)
(266)
(16)
1,338
95,399
(7,983)
87,416
Balance at 30 June ............................................................................................................ ......................................................
Current liabilities ............................................................................................................................... .....................................
Non-current liabilities ............................................................................................................................... .............................
Adjustments for indexed leases ................................................................................................... .........................................
New or renewed leases ......................................................................................................... .................................................
Installment payments .......................................................................................................... ..................................................
Cancelled leases .............................................................................................................. ........................................................
Foreign currency adjustment ....................................................................................................................... .........................
Translation difference ......................................................................................................... ..................................................
At the commencement date of the lease, the Group recognizes lease liabilities measured at the present value of lease payments to
be made over the lease term. The Group’s lease liabilities and the movements during the six months ended 30 June 2023 are as
follows (in thousands):
Balance at 1 January .......................................................................................................... ....................................................
Adjustments for indexed leases ................................................................................................... .........................................
New or renewed leases ......................................................................................................... .................................................
Cancelled leases .............................................................................................................. ........................................................
Depreciation .................................................................................................................. .........................................................
Translation difference ......................................................................................................... ..................................................
During the six months ended 30 June 2023, the Group acquired items of property, plant and equipment with a cost of $19.5
million, primarily consisting of facility equipment. The Group recognized $6.8 million and $4.9 million of depreciation expense for
the six months ended 30 June 2023 and 2022, respectively. Disposal of assets in the six months ended 30 June 2023 amounted to
$0.4 million.
The Group pledged $119.4 m illion and $ 122.4 m illion of property, plant and equipment as collateral to secure bank loans with
third parties as of 30 June 2023 and 31 December 2022, respectively.
The Group’s leased assets consist of facilities, fleet and equipment pursuant to both arrangements with third parties and related
parties. In April 2023 the Group started to lease a new building in Reykjavik from Fasteignafélagið Eyjólfur ehf. a related party,
(see Note 19). At the commencement of the lease the carrying value of the asset was $51.7 million. The carrying amounts of the
Group’s right-of-use assets and the movements during the six months ended 30 June 2023 are as follows (in thousands):
Balance at 1 January .......................................................................................................... ....................................................
During the six months ended 30 June 2023 and 2022, the Group recognized no impairments of property, plant and equipment.
Balance at 30 June ............................................................................................................ ......................................................
21 All amounts are in USD
===== SIDA 23 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
2023 2022
(3,742) (4,641)
(1,362) (3,312)
1,338 3,526
Loss of cancelled leases ...................................................................................................... ....................... (8) -
(3,774) (4,427)
11,961
41,257
69,807
123,025
11.
Other intangible assets
12. Cash and cash equivalents
30 June
2023
31 December
2022
9,609 10,377
50,857 56,050
60,466 66,427
Cash and cash equivalents include both cash in banks and on hand. Cash and cash equivalents as of 30 June 2023 and 31
December 2022 are as follows (in thousands):
Cash and cash equivalents denominated in US dollars .......................................................................
Cash and cash equivalents denominated in other currencies .............................................................
During the six months ended 30 June 2023, the Group acquired $2.9 m illion of software assets. The Group recognized $0.4
million and $0.4 million of amortization expense for the six months ended 30 June 2023 and 2022, respectively.
During the six months ended 30 June 2023, following the termination of the agreement with Biosana, the Group derecognized
$15.0 million of other intangible assets relating to intellectual property rights for the co-development and commercialization of
AVT23. A corresponding receivable was recognized to reflect the claim against Biosana for full reimbursement.
Total amount recognized in profit or loss ...................................................................................... ......
The maturity analysis of undiscounted lease payments as of 30 June 2023 is as follows (in thousands):
30 June
2023
Total depreciation expense from right-of-use assets ...........................................................................
Interest expense on lease liabilities ........................................................................................................
Foreign currency difference on lease liability .......................................................................................
The amounts recognized in the unaudited condensed consolidated interim statements of profit or loss and other comprehensive
income or loss during the six months ended 30 June 2023 and 2022 in relation to the Group’s lease arrangements are as follows (in
thousands):
30 June
Less than one year ............................................................................................................ .....................................................
One to five years ............................................................................................................. .......................................................
Thereafter ..................................................................................................................... ..........................................................
22 All amounts are in USD
===== SIDA 24 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
13. Inventories
The Group’s inventory balances as of 30 June 2023 and 31 December 2022 are as follows (in thousands):
30 June
2023
31 December
2022
47,835 41,961
31,806 29,450
1,514 2,121
(1,789) (2,062)
79,366 71,470
14. Other current assets
The composition of other current assets as of 30 June 2023 and 31 D ecember 2022 is as follows (in thousands):
30 June
2023
31 December
2022
22,630 20,601
7,691 6,468
- 3,520
- 851
4,667 1,509
34,988 32,949
15.
Share capital
252,160,087 2,126 1,058,432 1,060,558
11,834,061 118 132,618 132,736
0 6 8,300 8,306
2,479,962 25 27,159 27,184
551,300 6 7,582 7,588
42,328 - 249 249
(1,044,737) (10) (9,526) (9,536)
266,023,001 2,271 1,224,814 1,227,085
No dividends were paid or declared during the six month periods ended 30 June 2023 and 2022.
Share capital Share premium Total
Balance at 1 January 2023...........................................................
Balance at 30 June 2023..............................................................
Capital contribution (Note 3).....................................................
Vested earn-out shares (Note 3)................................................
Penny warrants (Note 3).............................................................
Finished goods................................................................................................................. .........................
Inventory reserves............................................................................................................. .......................
The increase in inventory from 31 December 2022 to 30 June 2023 is due to ongoing preparation for commercial launch of certain
of the Group’s biosimilar product candidates.
Prepaid expenses............................................................................................................... .......................
Proceeds receivable from Convertible Bonds..................................................................................... ..
Value-added tax................................................................................................................ ........................
Raw materials and supplies..................................................................................................... .................
Work in progress............................................................................................................... .......................
Public warrants (Note 3).............................................................
Settlement of RSUs with shares.................................................
Settlement of SARs with shares.................................................
Derivative asset............................................................................................................... ..........................
Ordinary
shares
Other short-term receivables................................................................................................... ...............
Movements in the Group’s Ordinary Shares, share capital and share premium during the six months ended 30 June 2023 are as
follows (in thousands, except for share amounts):
23 All amounts are in USD
===== SIDA 25 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
16. Borrowings
30 June
2023
31 December
2022
540,189 530,506
51,211 32,441
13,798 65,793
54,134 -
5,026 -
70,271 64,588
74,009 71,242
808,638 764,570
(22,463) (19,916)
786,175 744,654
Senior Bonds
Convertible Bonds
As of 30 June 2023, the carrying amount, including accrued interest, of the Tranche A and Tranche B Convertible Bonds was
$41.3 million and $9.9 million, respectively.
As of 30 June 2023, the carrying amount, including accrued interest, of the Senior Bonds was $540.2 m illion. The Group has the
option, at any time, to prepay all or any part of the outstanding bonds in exchange for the payment of the redemption premium
pursuant to the terms of the agreement.
As a result of proceeds raised from the private placement offering executed in February 2023, the Company extinguished the
liability related to the senior bond warrants resulting in the potential issuance of the 1.0% Senior Bond Warrants (see Note 22 for
further information).
The Group has pledged its property, plant and equipment, intellectual property and trademarks as collateral for the Senior Bonds.
On 25 January 2023, the Company issued an additional $10.0 m illion in Tranche B convertible bonds (the "Convertible Bonds").
Holders of the Tranche B Convertible Bonds may elect, at their sole discretion, to convert all or part of the principal amount and
accrued interest into Alvotech ordinary shares at a conversion price of $10.00 per share on December 31, 2023, or June 30, 2024.
The conversion feature associated with the Tranche B Convertible Bonds was determined to be an embedded derivative as the
economic characteristics and risks are not closely related to the debt host. The Tranche B conversion feature was bifurcated and
classified as equity due to the conversion price having preservation and passage of time adjustments that meet the fixed-for-fixed
criteria.
The weighted-average interest rates of outstanding borrowings for the six months ended 30 June 2023 and the twelve months
ended 31 December 2022 are 12.52% and 12.41%, respectively.
Aztiq Convertible Bond......................................................................................................... ..................
Alvogen Facility............................................................................................................................... .........
Total outstanding borrowings, net of debt issue costs.........................................................................
Less: current portion of borrowings............................................................................................ ..........
Total non-current borrowings.................................................................................................... ............
Other borrowings............................................................................................................... ......................
The Group’s debt consists of interest-bearing borrowings from financial institutions, related parties and third parties. Outstanding
borrowings, net of net debt issue costs, are as follows (in thousands):
Senior Bonds................................................................................................................... ..........................
Convertible Bonds.............................................................................................................. ......................
Mitsui Convertible Bond........................................................................................................ .................
Shinhan Convertible Bond....................................................................................................... ...............
24 All amounts are in USD
===== SIDA 26 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
Aztiq Convertible Bond and Other Bonds
Alvogen Facility
Other borrowings
764,570
(81,554)
(2,954)
96,450
25,203
(1,381)
5,434
401
2,4
69
Borrowings, net at end of period 808,638
In December 2022 the Group refinanced its manufacturing facility in Reykjavik with two Landsbankinn hf. loans. Those two loans
were denominated in ISK and included a conversion clause to convert them into USD. The conversion of these two loans took
place in March 2023.
Under the terms of the loan agreements after conversion, the first loan includes annuity payments that are due monthly with a final
maturity in December 2029 and a variable interest rate of USD SOFR plus a margin of 4.75%. The second loan is a bullet loan
with a final maturity in December 2027 and a variable interest rate of USD SOFR plus a margin of 3.75%
The Group determined that conversion to USD of the two loans was a substantial modification to loan agreements and accounted
for the transaction as an extinguishment. No gain or loss was recognized as part of the extinguishment.
Movements in the Group’s outstanding borrowings during the six months ended 30 June 2023 are as follows (in thousands):
As of 30 June 2023, the outstanding balance on the two loans was $17.1 m illion and $32.7 million, respectively.
30 June
2023
In Apri
l 2023, ATP Holdings ehf., an aff iliate of Aztiq, a related party, sold a portion o f the Aztiq Convertible Bond to Mitsui &
Co., Ltd. ("Mitsui"), a global trading and investment compa ny headquartered in Japan, and Shinhan Healthcare fund 5
("Shinhan"), a fund established under the laws of the Republic of Korea.
In connection with the 16 November 2022 Senior Bond amendment, Alvotech entered into a subordinated loan agreemen t with
Alvogen (the “Alvogen Facility”).
As of 30 June 2023, the carrying amount, including accrued interest, of the Alvogen Fac ility was $70.3 million.
As of 30 June 2023, the carrying amount, including accrued interest, o f the Aztiq Convertible Bond, the Mitsui Convertible Bond
and the Shinhan Convertible Bond was $13.8 million, $54.1 million, and $5.0 million, respectively. Fair value measurements of the
derivative financial liabilities are set out in Note 22.
Accretion/derecognition of borrowing discount.................................................................................. ..............................
Amortization of deferred debt issue cost....................................................................................... ......................................
Foreign currency exchange difference........................................................................................... .......................................
Borrowings, net at 1 January................................................................................................... ..............................................
Extinguishment of borrowings................................................................................................... ..........................................
Repayments of borrowings....................................................................................................... .............................................
Proceeds from new borrowings................................................................................................... .........................................
Accrued interest............................................................................................................... .......................................................
Recognition of new borrowing discount.......................................................................................... ....................................
25 All amounts are in USD
===== SIDA 27 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
30 June
2023
22,463
543,530
197,841
3,468
41,336
808,638
17.
Share-based payments
2023
6,979,486
326,123
(597,421)
(633,020)
(656,086)
5,419,082
RSUs
6,731,665 $6.83
(1,312,583) $6.33
5,419,082 $6.95
2023 2022
1,769 -
2,625 -
7,517 -
11,911 -
18.
Litigation
Research and development expenses.............................................................................................. .......
General and administrative expenses............................................................................................ .........
Outstanding at 1 January....................................................................................................... ................................................
Maturities of the Group’s outstanding borrowings as of 30 June 2023 are as follows (in thousands):
Vested during the period....................................................................................................... .................................................
Outstanding at 30 June......................................................................................................... ...................
The Group recognized the following share-based payment expense during the periods ended 30 June 2023 and 2022 (in
thousands):
The Company is involved in legal proceedings and litigation in the ordinary course of business. In the opinion of management, the
outcome of such matters will not have a material adverse effect on the Company’s combined financial position, results of
operations, or liquidity.
On 1 December 2022, the Renumeration Committee authorized, and the Group granted restricted stock units (“RSUs”) to
employees, executives, and directors granting rights to Ordinary Shares once vesting conditions are met. Compensation expense
for RSUs is determined based upon the fair value of the Ordinary Shares underlying the awards on the date of grant and expensed
over the vesting period, which is generally a one to four-year period, with a 1-year cliff vesting period and subsequent monthly
vesting, resulting from participates completing a service condition. Movements in RSUs during the period ended 30 June 2023 are
as follows:
Weighted
Average Fair
value
Granted........................................................................................................................ ..............................
Vested......................................................................................................................... ...............................
Shares delivered during the period............................................................................................. ...........................................
Outstanding at 30 June......................................................................................................... ..................................................
Forfeited during the period.................................................................................................... ................................................
New grants during the period................................................................................................... .............................................
Cost of product revenue........................................................................................................ ..................
The Group’s indebtedness also includes interest-bearing loans from related parties, Alvogen and Aztiq. The Group’s outstanding
borrowings from such related party loans are $84.1 million as of 30 June 2023. See Note 19 for further information.
Within one year................................................................................................................ .......................................................
Within two years............................................................................................................... ......................................................
Within three years............................................................................................................. ......................................................
Within four years.............................................................................................................. ......................................................
Thereafter...................................................................................................................... ..........................................................
26 All amounts are in USD
===== SIDA 28 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
19. Related parties
Purchased Sold Receivables Payables /
service / interest Service Loans
5,683 - - 70,271
3,138 - 766 15,843
-5 5 -
100 55 - 17
50 - - -
24 - - 484
- 73 1 -
31 - - 12
194 - - 194
- - - 7,440
-2 - -
102 - - -
159 - 12 144
- - 758 -
30 103 103 32
- 49 - -
319 - - 84
-- 7 -
257 - - 93
1,636 - - 52,454
947 - 4 9,012
12,670 287 1,656 156,080
Fasteignafélagið Eyjólfur ehf - Sister company .......................
FLÓKI fasteignir ehf. - Sister company .................................
(a) The full amount of purchased service relates to interest expenses from long-term liabilities and the full amount of payables /
loans are interest-bearing long-term liabilities (see Note 16).
(b) Payables to Lotus Pharmaceuticals Co. Ltd. is presented as “Other long-term liability to related party” on the unaudited
condensed consolidated interim statements of financial position.
(c) The amount receivable from Alvotech and CCHT Biopharmaceutical Co., Ltd. relates to amounts due for reference drugs used
in research and development studies and certain consulting fees incurred by the Group.
Alvogen Malta Sh. Services - Sister company ..........................
Norwich Clinical Services Ltd - Sister company .....................
Alvotech and CCHT Biopharmaceutical Co., Ltd. (c) ...........
Adalvo Limited - Sister company .............................................
Flóki Invest ehf - Sister company .............................................
Adalvo UK - Sister company ....................................................
Alvogen ehf. - Sister company ................................................
Alvogen UK - Sister company .................................................
Lotus Pharmaceuticals Co. Ltd. - Sister company (b) ............
Lotus International Pte. Ltd. - Sister company .......................
Alvogen Emerging Markets - Sister company .........................
Alvogen Inc. - Sister company .................................................
Alvogen Finance B.V. - Sister Company .................................
Related party transactions as of and for the six months ended 30 June 2023 are as follows (in thousands):
Alvogen Lux Holdings S.à r.l. – Sister company (a) ...............
Alvogen Iceland ehf. - Sister company ..................................
ATP Holdings ehf. - Sister company (a) ..................................
Aztiq Fjárfestingar ehf. – Sister company ................................
Aztiq Consulting ehf. – Sister company ...................................
Flóki-Art ehf. - Sister company .................................................
27 All amounts are in USD
===== SIDA 29 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
Purchased Sold Receivables Payables /
service / interest Service Loans
889 - - 64,588
- - 765 81,254
--- 2 5
--- 2 0
3,987 - - -
470 180 - 484
-- 1 -
- - 2 7,440
-2 3 -
98 - - -
89 303 12 222
- - 758 -
545 215 - 349
786 - - -
96 - - -
26 - - -
522 - 7 -
97 - - -
134 - - 31
539 - - -
- 196 - -
734 - - 8,876
9,012 895 1,548 163,289
(a) The full amount of purchased service relates to interest expenses from long-term liabilities and the full amount of payables /
loans are interest-bearing long-term liabilities (see Note 16).
(b) Payables to Lotus Pharmaceuticals Co. Ltd. is presented as “Other long-term liability to related party” on the unaudited
condensed consolidated interim statements of financial position.
(c) The amount receivable from Alvotech and CCHT Biopharmaceutical Co., Ltd. relates to amounts due for reference drugs used
in research and development studies and certain consulting fees incurred by the Group.
(d) Lambhagavegur is no longer a related party as it was sold during the year ended 31 December 2022.
(e) Fasteignafélagið Sæmundur hf. was acquired as part of the Share Purchase Agreement, with ATP Holdings ehf., on 16
November 2022. The related party transactions reflect activity until the acquisition date.
Alvogen Spain SL - Sister company .........................................
Norwich Clinical Services Ltd - Sister company .....................
Lambhagavegur 7 ehf - Sister company (d) .............................
Fasteignafélagið Eyjólfur ehf - Sister company .......................
Flóki fasteignir ehf. - Sister company ......................................
Alvogen Malta Sh. Services - Sister company ..........................
Alvogen Pharma India Ltd. - Sister company .........................
Flóki Invest ehf - Sister company .............................................
L41 ehf. - Sister company ..........................................................
Lotus Pharmaceuticals Co. Ltd. - Sister company (b) ............
Lotus International Pte. Ltd. - Sister company .......................
Alvogen Emerging Markets - Sister company .........................
Alvogen Inc. - Sister company .................................................
Alvotech and CCHT Biopharmaceutical Co., Ltd. (c) ...........
Adalvo Limited - Sister company .............................................
Alvogen Lux Holdings S.à r.l. – Sister company (a) ...............
ATP Holdings ehf. - Sister company (a) ..................................
Aztiq Consulting ehf. - Sister company ...................................
Alvogen Iceland ehf. - Sister company ..................................
Alvogen ehf. - Sister company ................................................
Fasteignafélagið Sæmundur hf. - Sister company (e) ..............
Aztiq Fjárfestingar ehf. – Sister company ................................
Related party transactions as of and for the six months ended 30 June 2022 and as of 31 D ecember 2022 are as follows (in
thousands):
30 June 2022 31 D ecember 2022
28 All amounts are in USD
===== SIDA 30 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
20. Other current liabilities
The composition of other current liabilities as of 30 June 2023 and 31 December 2022 is as follows (in thousands):
30 June
2023
31 December
2022
12,077 15,620
13,080 -
2,264 2,249
34,194 -
5,327 5,025
4,220 12,433
14,519 18,720
85,681 54,047
21.
Interests in joint ventures
30 June
2023
48,568
(2,706)
(2,249)
43,613
Unpaid tax relating to SARs settlements........................................................................................ .......
The Group did not receive any dividends from JVCO during the six months ended 30 June 2023 and 2022. Furthermore, there
were no commitments or contingencies outstanding with JVCO as of 30 June 2023. While there are no significant restrictions
resulting from contractual arrangements with JVCO, entities in China are subject to local exchange control regulations. These
regulations provide for restrictions on exporting capital from those countries, other than dividends.
The following table provides the change in the Group’s investment in joint venture for its 50% ownership of Alvotech & CCHT
Biopharmaceutical Co., Ltd. (the “joint venture” or “JVCO”) during the six months ended 30 June 2023 (in thousands):
Balance at 1 January........................................................................................................... .....................................................
Share in losses................................................................................................................ .........................................................
Translation difference.......................................................................................................... ..................................................
Accrued payables to commercial partners........................................................................................ .....
Accrued vacation leave......................................................................................................... ...................
Employee incentive plan........................................................................................................ ..................
Accrued expenses............................................................................................................... ......................
Unpaid salary and salary related expenses...................................................................................... .......
Accrued interest and financial fees............................................................................................ .............
29 All amounts are in USD
===== SIDA 31 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
22. Financial instruments
540,189 546,510
13,798 14,721
54,134 57,755
5,026 5,362
51,211 73,822
664,358 698,170
530,506 535,167
65,793 65,772
32,441 52,463
628,740 653,402
31 December 2022
Carrying
amount Fair value
Senior Bonds................................................................................................................... ..........................
Convertible Bonds.............................................................................................................. ......................
Aztiq Convertible Bond......................................................................................................... ..................
Senior Bonds................................................................................................................... ..........................
Mitsui Convertible Bond........................................................................................................ .................
Aztiq Convertible Bond......................................................................................................... ..................
Shinhan Convertible Bond....................................................................................................... ...............
Convertible Bonds.............................................................................................................. ......................
As part of the Business Combination, Predecessor shareholders were granted a total of 38,330,000 Ordinary Shares subject to
certain vesting conditions (“Predecessor Earn Out Shares”). One half of the Predecessor Earn Out Shares will vest if, at any time
during the five years following the closing of the Business Combination, the Alvotech ordinary share price is at or above a volume
weighted average price (“VWAP”) of $15.00 per share for any ten trading days within any twenty-trading day period, with the
other half vesting at a VWAP of $20.00 per share for any ten trading days within any twenty-trading day period. The Predecessor
Earn Out Shares are accounted for as derivative financial liabilities in accordance with IAS 32 and will be subject to ongoing mark-
to-market adjustments through the statement of profit or loss and other comprehensive income or loss. The Predecessor Earn
Out Shares had a fair value of $176.7 million as of 30 June 2023 and $276.2 million as of 31 December 2022.
Former OACB shareholders were granted a total of 1,250,000 Ordinary Shares subject to certain vesting conditions (“OACB Earn
Out Shares”). One half of the OACB Earn Out Shares will vest if, a t any time during the five years following the closing of the
Business Combination, the Alvotech ordinary share price is at or above a VWAP of $12.50 per share for any ten trading days
within any twenty-trading day period, with the other half vesting at a VWAP of $15.00 per share. On 17 February 2023, the first
half of OACB Earn Out Shares vested resulting in the issuance of 625,000 ordinary shares by the Company. The OACB Earn Out
Shares are accounted for as derivative financial liabilities in accordance with IAS 32 and will be subject to ongoing mark-to-market
ad
justments through the statement of profit or loss and other comprehensive income or loss. The difference between the fair value
of the equity issued and the carrying value of the derivative financial liabilities was recognized in the consolidated statement of
profit or loss and other comprehensive income or loss. The OACB Earn Out Shares had a fair value of $3.3 million as of 30 June
2023 and $10.5 million as of 31 December 2022.
Additionally, as part of the Business Combination the Company assumed the 10,916,647 outstanding OACB warrants, on
substantially the same contractual terms and conditions as were in effect immediately prior to the Business Combination. Each
warrant entitles the holder to purchase one Alvotech ordinary share. From January through March 2023, holders of the OACB
warrants exercised their warrant rights for an exercise price of $11.50 for the rights to one ordinary share per warrant. The
exercises resulted in the issuance of 551,261 ordinary shares and cash proceeds of approximately $6.3 million. The OACB warrants
are accounted for as derivative financial liabilities in accordance with IAS 32 and will be subject to ongoing mark-to-market
adjustments through the consolidated statement of profit or loss and other comprehensive income or loss. The OACB warrants
had a fair value of $12.9 million as of 30 June 2023 and $10.2 m illion at 31 December 2022. The fair value of the warrants was
derived from the publicly quoted trading price at the valuation date.
It is management’s estimate that the carrying amounts of financial assets and financial liabilities carried at amortized cost
approximate their fair value, with the exception of the Senior B onds, Aztiq Convertible Bond, Mitsui Convertible Bond, Shinhan
Convertible Bond and other Convertible Bonds, since any applicable interest receivable or payable is either close to current market
rates or the instruments are short-term in nature. Differences between the fair values and carrying amounts of these borrowings as
of 30 June 2023 and 31 December 2022 are identified as follows:
30 June 2023
Carrying
amount Fair value
30 All amounts are in USD
===== SIDA 32 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
Fair value measurements
Level 1 Level 2 Level 3 Total
- - 12,838 12,838
- - 23,355 23,355
- 176,700 - 176,700
- 3,300 - 3,300
12,853 - - 12,853
12,853 180,000 36,193 229,046
Senior Bond Warrants
Tranche A Conversion Feature
$7.74 $10.00
$10.00 $10.00
52.5% 45.0%
4.7% 4.2%
0.0% 0.0%
16.5% 19.3%
Stock Price.................................................................................................................... .............................
Conversion Price............................................................................................................... .......................
Volatility rate............................................................................................................................... ..............
31 December
2022
30 June
2023
Risk-free interest rate........................................................................................................ .......................
Dividend yield................................................................................................................. ..........................
Risk yield..................................................................................................................... ...............................
On 16 November 2022, the Group amended and upsized the outstanding bonds by $70.0 m illion. The amended bond agreement
of the Senior Bonds resulted in, among other things, an increase in the interest rate, resulting in a range from 10.75% to 12.0%
depending on the occurrence of certain events, as defined by the terms of the agreement. The Group accounted for this interest
rate feature (the “Senior Bond Interest Rate Feature”) as an embedded derivative, classified as an other current asset in the
consolidated statement of financial position as of 31 December 2022. Since the conditions to adjust the coupon rate have not been
met as of 31 March 2023 per the terms of the agreement, the interest rate on the Senior Bonds is now fixed and the embedded
derivative previously recorded has been extinguished during the six-month period ended 30 June 2023, resulting in a loss on
extinguishment of $0.9 million recorded in finance costs.
The fair value of the Senior Bond Warrants was determined using the Finnerty model along with the publicly quoted trading price
of Ordinary Shares and probability of the contingent events occurring at the valuation date. Probabilities associated with the
instruments are determined based on all relevant internal and ext ernal information available and are reviewed and reassessed at
each reporting date. As of 30 June 2023, the Company had 1,718,845 warrants with an exercise price of $0.01, representing the
1.5% tranche of Senior Bond Warrants (see Note 16 for further information).
The fair value of the Tranche A Conversion Feature was determined using a lattice model that incorporated inputs and
assumptions as further described below. The inputs and assumptions associated with the valuation of the instruments are
determined based on all relevant internal and external information available and are reviewed and reassessed at each reporting date.
The following table presents the assumptions and inputs that were used for the model in valuing the Tranche A Conversion
Feature:
The Group did not recognize any transfers of assets or liabilities between levels of the fair value hierarchy during the six-month
period ended 30 June 2023.
The following tables illustrate the fair value measurement hierarchy of the Group’s financial instruments measured to fair value on
a recurring basis as of 30 June 2023 (in thousands):
30 June 2023
Senior Bond Warrant liabilities..................................................
OACB Earn Out Shares.............................................................
OACB Warrant liabilities............................................................
Tranche A Conversion Feature..................................................
Predecessor Earn Out Shares.....................................................
31 All amounts are in USD
===== SIDA 33 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
Predecessor Earn Out Shares
38,330,000 38,330,000
$7.74 $10.00
50.0% 45.0%
4.32% 4.05%
OACB Earn Out Shares
625,000 1,250,000
$7.74 $10.00
50.0% 45.0%
4.32% 4.05%
OACB Warrants
23. Supplemental cash flow information
Supplement cash flow information for the periods ended 30 June 2023 and 2022 is included below (in thousands):
2023 2022
Non-cash investing and financing activities
1,082 998
4,201 -
53,920 1,592
- 9,100
- 227,500
13,768 30,302
84 -
The fair value of the OACB Earn Out Shares was determined using a Monte Carlo analysis that incorporated inputs and
assumptions as further described below. Assumptions and inputs associated with the valuation of the instruments are determined
based on all relevant internal and external information available and are reviewed and reassessed at each reporting date.
30 June
2023
31 December
2022
Risk-free interest rate........................................................................................................ .......................
Number of shares............................................................................................................... ......................
Share price.................................................................................................................... .............................
Volatility rate............................................................................................................................... ..............
The following table presents the assumptions and inputs that were used for the model in valuing the OACB Earn Out Shares:
The fair value of the Predecessor Earn Out Shares was determined using Monte Carlo analysis that incorporated inputs and
assumptions as further described below. The inputs and assumptions associated with the valuation of the instruments are
determined based on all relevant internal and external information available and are reviewed and reassessed at each reporting date.
The following table presents the assumptions and inputs that were used for the model in valuing the Predecessor Earn Out Shares:
Risk-free interest rate........................................................................................................ .......................
31 December
2022
Volatility rate............................................................................................................................... ..............
30 June
2023
Number of shares............................................................................................................... ......................
Share price.................................................................................................................... .............................
Acquisition of intangibles through in trade payables and current liabilities .....................................
The number of shares is based on the shares granted as part of th e Business Combination Agreement. The stock price is based on
Company’s stock price at the valuation date. The volatility rate is based on historical data from a peer group of public companies
with an enterprise value between $500 million and $5 billion. The risk-free interest rate is based on U.S. treasury yields
corresponding to the expected life input into the pricing model.
Right-of-use assets obtained through new operating leases ...............................................................
The fair value of the warrant liabilities was determined using the public trading price of the warrants. The public trading price of
the warrants was $1.24 at 30 June 2023.
30 June
Acquisition of property, plant and equipment in trade payables and current liabilities ..................
OACB Earn Out Shares recognized ............................................................................................... ......
Predecessor Earn Out Shares recognized ........................................................................................ .....
Settlement of SARs with shares ................................................................................................ .............
Settlement of RSUs with shares ................................................................................................ .............
32 All amounts are in USD
===== SIDA 34 =====
Notes to the Unaudited Condensed Consolidated Interim Financial Statement
24. Subsequent events
The Group evaluated subsequent events through 30 August 2023, the date these unaudited condensed consolidated interim
financial statements were available to be issued.
On 24 July 2023, Alvotech announced that Teva and Alvotech have agreed to expand their existing strategic partnership
agreement. As part of the agreement, Teva will acquire subordinated convertible bond instruments, dated 20 December 2022, in
principal amount of $40 million. The expansion to the existing strategic partnership agreement pertains to exclusive
commercialization in the U.S. by Teva of two new biosimilar candidates (adding to the five products in the current partnership
agreement, AVT02, AVT04, AVT05, AVT06 and AVT16) and line extensions of two current biosimilar candidates in the
partnership, to be developed, and manufactured by Alvotech. The agreement includes milestone payments, the majority paid
following product approvals and upon achieving significant sales milestones. Teva and Alvotech will share profit from the
commercialization of the biosimilars.
On 31 July 2023, Alvotech completed a private placement of subordinated convertible bonds denominated in Icelandic krona and
US dollar for a principal amount of $100 million, or approximately ISK 13 billion at current exchange rates, in an overseas
offering directed solely at qualified investors in Iceland. ATP Holdings ehf., which is affiliated with Aztiq Pharma Partners S.à r.l.,
the largest shareholder of Alvotech, has entered into an agreement with Alvotech under which ATP Holdings ehf. committed to
acquiring any of the bonds which have not been sold to other investors, after all binding offers from qualified professional
investors in the private placement have been submitted, up to the principal amount of $100 million.
33 All amounts are in USD