<SEC-DOCUMENT>0000000000-22-003447.txt : 20220615
<SEC-HEADER>0000000000-22-003447.hdr.sgml : 20220615
<ACCEPTANCE-DATETIME>20220330133006
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-22-003447
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20220330

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Alvotech
		CENTRAL INDEX KEY:			0001898416
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				981629342
		STATE OF INCORPORATION:			N4
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD

	BUSINESS ADDRESS:	
		STREET 1:		9, RUE DE BITBOURG
		CITY:			LUXEMBOURG
		STATE:			N4
		ZIP:			L-1273
		BUSINESS PHONE:		354 422-4500

	MAIL ADDRESS:	
		STREET 1:		9, RUE DE BITBOURG
		CITY:			LUXEMBOURG
		STATE:			N4
		ZIP:			L-1273

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Alvotech Lux Holdings S.A.S.
		DATE OF NAME CHANGE:	20211209
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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<FILENAME>filename2.txt
<TEXT>
United States securities and exchange commission logo





                              March 30, 2022

       Robert Wessman
       Executive Chairman
       Alvotech Lux Holdings S.A.S.
       9, Rue de Bitbourg
       L-1273 Luxembourg
       Grand Duchy of Luxembourg

                                                        Re: Alvotech Lux
Holdings S.A.S.
                                                            Amendment No. 2 to
Registration Statement on Form F-4
                                                            Filed March 14,
2022
                                                            File No. 333-261773

       Dear Mr. Wessman:

             We have reviewed your amended registration statement and have the
following
       comments. In some of our comments, we may ask you to provide us with
information so we
       may better understand your disclosure.

              Please respond to this letter by amending your registration
statement and providing the
       requested information. If you do not believe our comments apply to your
facts and
       circumstances or do not believe an amendment is appropriate, please tell
us why in your
       response.

              After reviewing any amendment to your registration statement and
the information you
       provide in response to these comments, we may have additional comments.
Unless we note
       otherwise, our references to prior comments are to comments in our
February 25, 2022 letter.

       Amendment No. 2 to Registration Statement on Form F-4

       Risk Factors
       Clinical drug development involves a lengthy and expensive process and
Alvotech may
       encounter substantial delays in its clinical studies , page 60

   1.                                                   We note your revised
disclosure here relating to the Russian invasion of Ukraine, your
                                                        ongoing clinical trial
for AVT04 and the collection of safety data from trial participants in
                                                        Ukraine and your plans
to conduct additional trials in Ukraine in 2022. Please disclose
                                                        whether and how AVT04
is currently materially impacted, including, but not limited to:
                                                            whether you are
able to communicate with those patients you are still in the process
                                                            of collecting
safety data from;
 Robert Wessman
Alvotech Lux Holdings S.A.S.
March 30, 2022
Page 2
            the percentage of your enrollment that may be impacted (out of 581
patients);
            whether you still expect to report topline results in the second
half of 2022;
            potential impacts on the AVT04 trial;
            where you plan to initiate the    other clinical trials    that
were previously planned for
          Ukraine; and
          clarification as to your planned development timeline for AVT04.
      Please also revise your Business section accordingly and explain whether
and how you
      have undertaken efforts to mitigate the impact and where possible
quantify the impact to
      your business, if material.
Comparable Public Companies, page 166

2.    We acknowledge the additional information provided in response to prior
comment 3,
      which addresses the "TAM-Current Pipeline" for Alvotech of $82.2 billion
and the
      corresponding discussion of the $85 billion originator market on page
233. However, the
      market opportunities for your current product candidates as of March 2022
on page 233
      aggregate to only $56.3 billion. Please explain the $28.7 billion
difference between these
      amounts and revise your presentations accordingly. Also, provide an
appropriate
      linkage between the amounts for Alvotech's "TAM-Current Pipeline" on page
166 and the
      potential originator market on page 233.
Business of Alvotech
Commercial Partnerships, page 225

3.    We note that you have revised your disclosure on pages 225-232 and
284-287 in response
      to our prior comment 8 to reflect additional detail concerning each of
your commercial
      partnerships and we reissue the comment in part. For each of your
partnership agreements,
      please expand your disclosure to ensure that you are disclosing all
material terms,
      including the quantification of any royalty rate, or a range no greater
than 10 percentage
      points per tier. For example, with respect to multiple agreements, you
currently state that
      the partner "will exclusively buy the relevant biosimilar candidate from
[you] at a royalty
      or the applicable floor price, whichever is higher, for the duration of
the agreement."
        You may contact Franklin Wyman at 202-551-3660 or Vanessa Robertson at
202-551-
3649 if you have questions regarding comments on the financial statements and
related
matters. Please contact Jessica Ansart at 202-551-4511 or Jeffrey Gabor at
202-551-2544 with
any other questions.



                                                            Sincerely,
FirstName LastNameRobert Wessman
Comapany NameAlvotech Lux Holdings S.A.S.                   Division of
Corporation Finance
                                                            Office of Life
Sciences
March 30, 2022 Page 2
cc:
FirstName Nicolas Dumont
          LastName
</TEXT>
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