
The remaining 23.5% ownership interest was held by various entities, with no single shareholder holding more than
2.4% ownership interest as of 31 December 2022.
1.4 Going concern
The Group has primarily funded its operations with proceeds from the issuance of ordinary shares 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 $551.7 million, $513.6 million, and $101.5 million for the years ended
31 December 2023, 2022, and 2021, respectively, and had an accumulated deficit of $2,205.8 millions as of
31 December 2023. The Group has not generated positive operational cash flow, largely due to the continued focus
on biosimilar product development and expansion efforts.
As of 31 December 2023, the Group had cash and cash equivalents, excluding restricted cash, of $11.2 millions and
current assets less current liabilities of ($66.1) million.
The Group devotes substantially all of its efforts towards obtaining regulatory approval and raising capital necessary
to fund its operations and it is subject to a number of risks associated with clinical research and development, the
development of and regulatory approval of commercially viable biosimilar products, the need to raise adequate
additional financing necessary to fund the development and commercialization of its biosimilar products.
The Company announced in February 2024 that the U.S. Food and Drug Administration ("FDA") has approved
SIMLANDI (adalimumab, referred to as AVT02 in Alvotech's biosimilar pipeline) injection, as an interchangeable
biosimilar to Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic
arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult
hidradenitis suppurativa and adult uveitis. Teva is Alvotech’s strategic partner for the exclusive commercialization
of SIMLANDI in the United States. SIMLANDI is the first high-concentration, citrate-free biosimilar to Humira that
has been granted an interchangeability status by the FDA, and will qualify for interchangeable exclusivity for the
40mg/0.4ml injection. This approval is an important milestone for the Company to access the U.S. market with a
unique positioning. The Company expects to launch AVT02 with its partner Teva in the United States during the
first half of 2024.
Additionally, in February 2024, the Company announced it has reached settlement agreements with Johnson &
Johnson in Japan, Canada and in the European Economic Area (EEA) for AVT04, a biosimilar to Stelara
(ustekinumab). Regulatory approval for AVT04 in these markets has already been granted. Market applications for
AVT04 are currently pending in additional global markets, including in the U.S. Market entry of AVT04 in Canada
started in Q1 2024. Launch of AVT04 in Japan is anticipated after the upcoming round of National Health Insurance
reimbursement price listings, in May 2024. Entry to the first European markets is expected as soon as possible after
the expiration date of the European Supplementary Protection Certificate for Stelara, which is in late July 2024.
These approvals represent another significant milestone for the Company to tap into the Stelara market.
The closing of the private placement equity offering in February 2024 provided the Group with gross proceeds of
$166 million (net proceeds of $160 million) that is expected to be used to finance general corporate purposes and
working capital, to strengthen its production capacity, and to support expected biosimilars launches. As part of the
transaction, the Group sold 10,127,132 Ordinary Shares, par value USD 0.01 per share, at a purchase price of $16.41
per share, or ISK 2,250 per share, at foreign exchange rates on 23 February 2024.
Additionally, the Group expects to continue to source its financing during the development of its biosimilar products
from existing out-license contracts with commercial partners. In light of these conditions and events management
evaluated whether there is substantial doubt about the Group’s ability to continue as a going concern for at least one
year after the date that the consolidated financial statements are issued. Based on the cash on hand, funding received,
and projected future cash flows, management concluded that the Group has the ability to continue as a going
concern for at least one year after the date that the consolidated financial statements are issued. As such, the
consolidated financial statements have been prepared on a going concern basis
However, although management continues to pursue these plans, 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.
.
Notes to the Consolidated Financial Statements
20