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2022-07-27
Alvotech
References: July 22, 2022
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Alvotech
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Alvotech
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2022-02-04
Alvotech
References: January 18, 2022
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2022-03-14
Alvotech
References: February 25, 2022
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2022-04-04
Alvotech
References: March 30, 2022
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2022-04-19
Alvotech
References: April 12, 2022
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2022-05-02
Alvotech
References: April 28, 2022
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2022-05-02
Alvotech
References: April 28, 2022
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2022-05-10
Alvotech
References: May 9, 2022
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-07 | SEC Comment Letter | Alvotech | Luxembourg | 001-41421 | Read Filing View |
| 2025-07-31 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2025-07-21 | SEC Comment Letter | Alvotech | Luxembourg | 001-41421 | Read Filing View |
| 2024-08-27 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2024-08-23 | SEC Comment Letter | Alvotech | Luxembourg | 333-281684 | Read Filing View |
| 2023-10-27 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2023-10-26 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2023-07-20 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2023-07-20 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-09-19 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-09-19 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-07-27 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-07-27 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-07-22 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-05-10 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-05-10 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-05-09 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-05-02 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-05-02 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-04-28 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-04-19 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-04-12 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-04-04 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-03-30 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-03-14 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-02-25 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-02-04 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-01-18 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-07 | SEC Comment Letter | Alvotech | Luxembourg | 001-41421 | Read Filing View |
| 2025-07-21 | SEC Comment Letter | Alvotech | Luxembourg | 001-41421 | Read Filing View |
| 2024-08-23 | SEC Comment Letter | Alvotech | Luxembourg | 333-281684 | Read Filing View |
| 2023-10-26 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2023-07-20 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-07-27 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-07-22 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-05-09 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-04-28 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-04-12 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-03-30 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-02-25 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-01-18 | SEC Comment Letter | Alvotech | Luxembourg | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-31 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2024-08-27 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2023-10-27 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2023-07-20 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-09-19 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-09-19 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-07-27 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-05-10 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-05-10 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-05-02 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-05-02 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-04-19 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-04-04 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-03-14 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
| 2022-02-04 | Company Response | Alvotech | Luxembourg | N/A | Read Filing View |
2025-08-07 - UPLOAD - Alvotech File: 001-41421
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 7, 2025 Linda Jonsdottir Chief Financial Officer Alvotech 9, Rue de Bitbourg L- 1273 Luxembourg Grand Duchy of Luxembourg Re: Alvotech Form 20-F for Fiscal Year Ended December 31, 2024 File No. 001-41421 Dear Linda Jonsdottir: We have completed our review of your filing. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-07-31 - CORRESP - Alvotech
<DOCUMENT> <TYPE>CORRESP <SEQUENCE>1 <FILENAME>filename1.txt <TEXT> July 31, 2025 Via EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Tara Harkins Lynn Dicker Re: Alvotech Form 20-F for Fiscal Year Ended December 31, 2024 File No. 001-41421 Ladies and Gentlemen: This letter provides the response to the comment provided by the staff (the Staff) of the Securities and Exchange Commission in its comment letter dated July 21, 2025 (the Comment Letter) with respect to Form 20-F for Fiscal Year Ended December 31, 2024, filed on March 27, 2025, of Alvotech (the Company). The Staffs comment is repeated in bold and italics and is followed by the Companys response. Form 20-F for Fiscal Year Ended December 31, 2024 Note 2.6 Revenue recognition, page F-14 We note your disclosure on pages 74-79 of your commercial partnerships that include licensing and other components. Please revise the notes to your financial statements in future filings to disclose the material terms of each of these arrangements, including your obligations under the agreements in accordance with IFRS 15. Response: The Company acknowledges the Staffs comment and will revise the notes to its financial statements in future filings to disclose the material terms of each of its material commercial partnership agreements, including the Companys obligations under these agreements, in accordance with IFRS 15. * * * * Please do not hesitate to contact me at +354 825 8464 or via e-mail at lindaj@alvotech.com if you have any questions. Very truly yours, _/s/__Linda Jonsdottir_____________ Linda Jonsdottir Chief Financial Officer cc: Robert Wessman, Alvotech Tanya Zharov, Alvotech Divakar Gupta, Cooley LLP Katie Kazem, Cooley LLP </TEXT> </DOCUMENT>
2025-07-21 - UPLOAD - Alvotech File: 001-41421
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 21, 2025 Linda Jonsdottir Chief Financial Officer Alvotech 9, Rue de Bitbourg L- 1273 Luxembourg Grand Duchy of Luxembourg Re: Alvotech Form 20-F for Fiscal Year Ended December 31, 2024 File No. 001-41421 Dear Linda Jonsdottir: We have limited our review of your filing to the financial statements and related disclosures and have the following comment. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 20-F for Fiscal Year Ended December 31, 2024 Note 2.6 Revenue recognition, page F-14 1. We note your disclosure on pages 74-79 of your commercial partnerships that include licensing and other components. Please revise the notes to your financial statements in future filings to disclose the material terms of each of these arrangements, including your obligations under the agreements in accordance with IFRS 15. July 21, 2025 Page 2 In closing, we remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Tara Harkins at 202-551-3639 or Lynn Dicker at 202-551-3616 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2024-08-27 - CORRESP - Alvotech
CORRESP
1
filename1.htm
August 27, 2024
Via EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Tim Buchmiller
Re:
Alvotech
Registration Statement on Form F-3
Filed August 21, 2024
File No. 333-281684
Acceleration Request
Requested Date: August 29, 2024
Requested Time: 4:00 p.m. Eastern Time
Dear Mr. Buchmiller:
In accordance with Rule 461 under the Securities Act of 1933, as amended,
the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the
“Commission”) take appropriate action to cause the above-referenced Registration Statement on Form F-3 (File
No. 333-281684) (the “Registration Statement”), to become effective on August 29, 2024, at 4:00 p.m. Eastern
Time, or as soon thereafter as is practicable, or at such later time as the Registrant may orally request via telephone call to the Commission’s
staff. The Registrant hereby authorizes Katie A. Kazem of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once
the Registration Statement has been declared effective, please orally confirm that event with Katie A. Kazem of Cooley LLP at (703) 456
8043.
[Signature page follows]
Very truly yours,
Alvotech
By: /s/ Tanya Zharov
Tanya Zharov
General Counsel
cc:
Divakar Gupta, Cooley LLP
Katie A. Kazem, Cooley LLP
2024-08-23 - UPLOAD - Alvotech File: 333-281684
August 23, 2024
Tanya Zharov, Esq.
General Counsel
Alvotech
9, Rue de Bitbourg,
L-1273 Luxembourg,
Grand Duchy of Luxembourg
R.C.S. Luxembourg : B258884
Re:Alvotech
Registration Statement on Form F-3
Filed August 21, 2024
File No. 333-281684
Dear Tanya Zharov Esq.:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that
the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tim Buchmiller at 202-551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Katie A. Kazem, Esq.
2023-10-27 - CORRESP - Alvotech
CORRESP 1 filename1.htm October 27, 2023 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Tamika N. Sheppard Re: Alvotech Registration Statement on Form F-3 Filed October 20, 2023 File No. 333-275111 Acceleration Request Requested Date: October 30, 2023 Requested Time: 4:00 p.m. Eastern Time Dear Ms. Sheppard: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form F-3 (File No. 333-275111) (the “Registration Statement”), to become effective on October 30, 2023, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable, or at such later time as the Registrant may orally request via telephone call to the Commission’s staff. The Registrant hereby authorizes Nicolas H.R. Dumont of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Nicolas H.R. Dumont of Cooley LLP at (212) 479-6446. [Signature page follows] Very truly yours, Alvotech By: /s/ Tanya Zharov Tanya Zharov General Counsel cc: Michal Berkner, Cooley LLP Nicolas H.R. Dumont, Cooley LLP
2023-10-26 - UPLOAD - Alvotech
United States securities and exchange commission logo
October 26, 2023
Tanya Zharov
General Counsel
Alvotech
1201 Wilson Blvd., Ste. 2130
Arlington, Virginia 22209
Re:Alvotech
Registration Statement on Form F-3
Filed October 20, 2023
File No. 333-275111
Dear Tanya Zharov:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tamika Sheppard at 202-551-8346 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Nicolas H.R. Dumont
2023-07-20 - CORRESP - Alvotech
CORRESP
1
filename1.htm
July 20, 2023
Via EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Dillon Hagius
Re:
Alvotech
Registration Statement on Form F-3
Filed July 14, 2023
File No. 333-273262
Acceleration Request
Requested Date: July 21, 2023
Requested Time: 4:00 p.m. Eastern Time
Dear Sir:
In accordance with Rule 461 under the Securities Act of 1933, as amended,
the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the
“Commission”) take appropriate action to cause the above-referenced Registration Statement on Form F-3 (File
No. 333-273262) (the “Registration Statement”), to become effective on July 21, 2023, at 4:00 p.m. Eastern Time,
or as soon thereafter as is practicable, or at such later time as the Registrant may orally request via telephone call to the Commission’s
staff. The Registrant hereby authorizes Nicolas H.R. Dumont of Cooley LLP, counsel to the Registrant, to make such request on its behalf.
Once the Registration Statement has been declared effective, please orally confirm that event with Nicolas H.R. Dumont of Cooley LLP at
(212) 479-6446.
[Signature page follows]
Very truly yours,
Alvotech
By: /s/ Tanya Zharov
Tanya Zharov
General Counsel
cc:
Michal Berkner, Cooley LLP
Katie Kazem, Cooley LLP
2023-07-20 - UPLOAD - Alvotech
United States securities and exchange commission logo
July 20, 2023
Joel Morales
Chief Executive Officer
Alvotech
9, Rue de Bitbourg
L-1273 Luxembourg
Grand Duchy of Luxembourg
Re:Alvotech
Registration Statement on Form F-3
Filed July 14, 2023
File No. 333-273262
Dear Joel Morales:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Dillon Hagius at 202-551-7967 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Nicolas H.R. Dumont
2022-09-19 - CORRESP - Alvotech
CORRESP 1 filename1.htm CORRESP Alvotech Société Anonyme (Public Limited Company) 9, Rue de Bitbourg L-1273 Luxembourg Grand Duchy of Luxembourg R.C.S. Luxembourg: B258884 September 19, 2022 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Re: Alvotech Registration Statement on Form F-1 File No. 333-266294 Request for Acceleration of Effective Date Requested Date: September 21, 2022 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form F-1 (File No. 333-266294) (the “Registration Statement”) to become effective on September 21, 2022, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Nicolas H.R. Dumont of Cooley LLP, counsel to the Registrant, at (212) 479-6446, or in his absence, Michal Berkner of Cooley LLP at +44 (0) 20 7556 4321 or Divakar Gupta of Cooley LLP at (212) 479-6474. * * * * Very truly yours, /s/ Tanya Zharov Name: Tanya Zharov Title: Deputy Chief Executive Officer cc: Robert Wessman, Alvotech Nicolas H.R. Dumont, Cooley LLP Divakar Gupta, Cooley LLP Michal Berkner, Cooley LLP
2022-09-19 - CORRESP - Alvotech
CORRESP 1 filename1.htm CORRESP Alvotech Société Anonyme (Public Limited Company) 9, Rue de Bitbourg L-1273 Luxembourg Grand Duchy of Luxembourg R.C.S. Luxembourg: B258884 September 19, 2022 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Re: Alvotech Registration Statement on Form F-1 File No. 333-266136 Request for Acceleration of Effective Date Requested Date: September 21, 2022 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form F-1 (File No. 333-266136) (the “Registration Statement”) to become effective on September 21, 2022, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Nicolas H.R. Dumont of Cooley LLP, counsel to the Registrant, at (212) 479-6446, or in his absence, Michal Berkner of Cooley LLP at +44 (0) 20 7556 4321 or Divakar Gupta of Cooley LLP at (212) 479-6474. * * * * Very truly yours, /s/ Tanya Zharov Name: Tanya Zharov Title: Deputy Chief Executive Officer cc: Robert Wessman, Alvotech Nicolas H.R. Dumont, Cooley LLP Divakar Gupta, Cooley LLP Michal Berkner, Cooley LLP
2022-07-27 - UPLOAD - Alvotech
United States securities and exchange commission logo
July 27, 2022
Mark Levick
Chief Executive Officer
Alvotech
9, Rue de Bitbourg
L-1273 Luxembourg
Grand Duchy of Luxembourg
Re:Alvotech
Registration Statement on Form F-1
Filed July 22, 2022
File No. 333-266294
Dear Mr. Levick:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Nicolas H.R. Dumont, Esq.
2022-07-27 - CORRESP - Alvotech
CORRESP
1
filename1.htm
CORRESP
Alvotech
Société Anonyme (Public Limited Company)
9, Rue de Bitbourg
L-1273 Luxembourg
Grand Duchy of Luxembourg
R.C.S. Luxembourg: B258884
July 27, 2022
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3628
Attention: Daniel Crawford
Tim Buchmiller
Re:
Alvotech
Registration Statement on Form F-1
Filed on July 14, 2022
File No. 333-266136
Ladies and Gentlemen:
On behalf of Alvotech
(the “Company”), we are providing this letter in response to the comments provided by the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in its
comment letter dated July 22, 2022 (the “Comment Letter”) with respect to the Company’s Registration Statement on Form F-1 (“Registration Statement”)
filed on July 14, 2022.
Concurrently with the submission of this response letter, the Company is filing, through EDGAR, Amendment
No. 1 to the Registration Statement (“Amendment No. 1”).
The numbering of
the paragraphs below corresponds to the numbering of the comments contained in the Comment Letter, which, for your convenience, we have incorporated into this response letter in bold and italics. Page references in the text of this response letter
correspond to the page numbers of Amendment No. 1. Capitalized terms used but not otherwise defined in this letter shall have the meanings set forth in Amendment No. 1.
Registration Statement on Form F-1 filed July 14, 2022
Cover Page
1.
For each of the founder shares and the public warrants, disclose the price that the selling
securityholders paid for such shares and units overlying such securities.
Response: The Company
acknowledges the Staff’s comment and has revised its disclosure on the cover page and pages v and vi.
2.
We note your disclosure that you will receive proceeds from the exercise of the Warrants and that the
exercise price of your Warrants is $11.50 per warrant. Please include disclosure that compares the market price of the ordinary shares underlying the Warrants to the exercise price of the Warrants. Please also describe the impact on your liquidity
and update your disclosure to address your ability to fund your operations on a prospective basis with your current cash on hand.
Response: The Company acknowledges the Staff’s comment and respectfully advises the Staff that the Company believes the exercise
of the Warrants is not material to the Company’s liquidity position since it has not relied upon, and is not dependent upon, the receipt of the cash proceeds from the exercise of the Warrants offered in the prospectus as a source of liquidity
to fund its operations in the next twelve months. For purposes of clarity, the Company has revised its disclosure on page 154 to that effect. The Company has also revised its disclosure on page 6 to compare the market price of the ordinary shares
underlying the Warrants to the exercise price of the Warrants.
3.
We note your disclosure that based on the closing price of your Ordinary Shares of $7.00 as of
July 11, 2022, the Sponsor and other holders of the Founder Shares would experience a potential profit of up to approximately $5.88 per share, or up to approximately $36.73 million in
the aggregate. Please also indicate that the public securityholders may not experience a similar rate of return on the securities they purchased due to differences in the purchase prices and the current trading price. Please also include appropriate
risk factor disclosure.
Response: The Company acknowledges the Staff’s comment and has revised its
disclosure on the cover page and page 68.
Risk Factors
Risks Related to Ownership of our Ordinary Shares and our Status as Public Company Sales of Ordinary Shares, or the perception of such sales, by us or the
Selling Securityholders pursuant to this prospectus…, page 67.
4.
We note your disclosure on page 68 that the Ordinary Shares being offered for resale pursuant to this
prospectus by the Selling Securityholders represent approximately 6.87% of Alvotech’s outstanding shares as of June 15, 2022. This appears to conflict with your disclosure on the cover page which states the
percentage is 84.31%. Please reconcile your disclosure or otherwise advise. Also, to illustrate this risk, revise to disclose the purchase price of the securities being registered for resale.
Response: The Company acknowledges the Staff’s comment and has revised its disclosure on the cover page and on page 68.
Management’s Discussion and Analysis of Financial Condition and Results of Operations Company Overview, page 139.
5.
In light of the significant number of redemptions and the likelihood that the company will not receive
significant proceeds from exercises of the warrants because of the disparity between the exercise price of the warrants and the current trading price of the ordinary shares, expand your discussion of capital resources to address any changes in the
company’s liquidity position since the business combination. If the company is likely to have to seek additional capital, discuss the effect of this offering on the company’s ability to raise additional capital.
2
Response: The Company acknowledges the Staff’s comments and respectfully advises
the Staff that the Company believes there have not been any material changes in the Company’s liquidity position since the business combination. The Company has revised its disclosure on page 154 to elaborate on the expected effect of this
offering on the Company’s ability to raise additional capital.
6.
Please expand your discussion here to reflect the fact that this offering involves the potential sale of
a substantial portion of shares for resale and discuss how such sales could impact the market price of the company’s ordinary shares. Your discussion should highlight the fact that Alvogen Lux Holdings and Aztiq Pharma Partners, beneficial
owners of 35% and 40% of your outstanding shares, respectively will be able to sell all of their shares for so long as the registration statement of which this prospectus forms a part is available for use.
Response: The Company acknowledges the Staff’s comments and has revised its disclosure of page 154.
* * * *
3
Please direct any questions or comments regarding the foregoing or with respect to Amendment
No. 1 to the undersigned at (212) 479-6446, Michal Berkner of Cooley LLP at +44 (0) 20 7556 4321 or Divakar Gupta of Cooley LLP at (212) 479-6474.
Very truly yours,
/s/ Nicolas H.R. Dumont
Nicolas H.R. Dumont
cc:
Robert Wessman, Alvotech
Tanya Zharov, Alvotech
Michal
Berkner, Cooley LLP
Divakar Gupta, Cooley LLP
2022-07-22 - UPLOAD - Alvotech
United States securities and exchange commission logo
July 22, 2022
Philip Caramanica
Secretary & Treasurer
Alvotech
1201 Wilson Blvd., Ste. 2130
Arlington, Virginia 22209
Re:Alvotech
Registration Statement on Form F-1
Filed July 14, 2022
File No. 333-266136
Dear Mr. Caramanica:
We have limited our review of your registration statement to those issues we have
addressed in our 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.
Registration Statement on Form F-1 filed July 14, 2022
Cover Page
1.For each of the founder shares and the public warrants, disclose the price that the selling
securityholders paid for such shares and units overlying such securities.
2.We note your disclosure that you will receive proceeds from the exercise of the Warrants
and that the exercise price of your Warrants is $11.50 per warrant. Please include
disclosure that compares the market price of the ordinary shares underlying the Warrants
to the exercise price of the Warrants. Please also describe the impact on your liquidity
and update your disclosure to address your ability to fund your operations on a
prospective basis with your current cash on hand.
FirstName LastNamePhilip Caramanica
Comapany NameAlvotech
July 22, 2022 Page 2
FirstName LastName
Philip Caramanica
Alvotech
July 22, 2022
Page 2
3.We note your disclosure that based on the closing price of your Ordinary Shares of $7.00
as of July 11, 2022, the Sponsor and other holders of the Founder Shares would
experience a potential profit of up to approximately $5.88 per share, or up to
approximately $36.73 million in the aggregate. Please also indicate that the public
securityholders may not experience a similar rate of return on the securities they
purchased due to differences in the purchase prices and the current trading price. Please
also include appropriate risk factor disclosure.
Risk Factors
Risks Related to Ownership of our Ordinary Shares and our Status as a Public Company
Sales of Ordinary Shares, or the perception of such sales, by us or the Selling Securityholders
pursuant to this prospectus . . . ., page 67
4.We note your disclosure on page 68 that the Ordinary Shares being offered for resale
pursuant to this prospectus by the Selling Securityholders represent approximately
6.87% of Alvotech’s outstanding shares as of June 15, 2022. This appears to conflict with
your disclosure on the cover page which states the percentage is 84.31%. Please reconcile
your disclosure or otherwise advise. Also, to illustrate this risk, revise to disclose the
purchase price of the securities being registered for resale.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Company Overview, page 139
5.In light of the significant number of redemptions and the likelihood that the company will
not receive significant proceeds from exercises of the warrants because of the disparity
between the exercise price of the warrants and the current trading price of the ordinary
shares, expand your discussion of capital resources to address any changes in the
company’s liquidity position since the business combination. If the company is likely to
have to seek additional capital, discuss the effect of this offering on the company’s ability
to raise additional capital.
6.Please expand your discussion here to reflect the fact that this offering involves the
potential sale of a substantial portion of shares for resale and discuss how such sales could
impact the market price of the company’s ordinary shares. Your discussion should
highlight the fact that Alvogen Lux Holdings and Aztiq Pharma Partners, beneficial
owners of 35% and 40% of your outstanding shares, respectively, will be able to sell all of
their shares for so long as the registration statement of which this prospectus forms a part
is available for use.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
FirstName LastNamePhilip Caramanica
Comapany NameAlvotech
July 22, 2022 Page 3
FirstName LastName
Philip Caramanica
Alvotech
July 22, 2022
Page 3
statement.
You may contact Daniel Crawford at 202-551-7767 or Tim Buchmiller at 202-551-
3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Nicolas H.R. Dumont, Esq.
2022-05-10 - CORRESP - Alvotech
CORRESP
1
filename1.htm
CORRESP
Alvotech
9, Rue de Bitbourg
L-1273
Luxembourg
Grand Duchy of Luxembourg
May 10, 2022
Via EDGAR
Securities and Exchange Commission
Division of Corporation
Finance
100 F Street, N.E.
Washington, D.C. 20549-3628
Attention: Franklin
Wyman
Vanessa Robertson
Jessica Ansart
Jeffrey Gabor
Re:
Alvotech
Registration Statement on Form F-4 (File No. 333-261773)
Request for Acceleration of Effective Date
Ladies and Gentlemen:
In accordance with Rule
461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration
Statement on Form F-4 (File No. 333-261773) (the “Registration Statement”) to become effective on May 10, 2022, at 4:00 p.m. Eastern
Time, or as soon thereafter as is practicable.
Once the Registration Statement has been declared effective, please orally confirm that
event with Nicolas H.R. Dumont of Cooley LLP, counsel to the Registrant, at (212) 479-6446, or in his absence, Michal Berkner of Cooley LLP at +44 (0) 20 7556 4321 or Divakar Gupta of Cooley LLP at (212) 479-6474.
[Signature page follows]
Very truly yours,
/s/ Helga Tatjana Zharov
Name: Helga Tatjana Zharov
Title: Chairperson (Président)
cc:
Robert Wessman, Alvotech
Nicolas H.R. Dumont, Cooley LLP
Michal Berkner, Cooley LLP
Divakar Gupta, Cooley LLP
Christian O. Nagler, Kirkland & Ellis LLP
Peter Seligson, Kirkland & Ellis LLP
Allison Gallagher, Kirkland & Ellis LLP
2022-05-10 - CORRESP - Alvotech
CORRESP 1 filename1.htm CORRESP Alvotech 9, Rue de Bitbourg L-1273 Luxembourg Grand Duchy of Luxembourg May 10, 2022 Via EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Franklin Wyman Vanessa Robertson Jessica Ansart Jeffrey Gabor Re: Alvotech Amendment No. 5 to Registration Statement on Form F-4 Filed on May 2, 2022 File No. 333-261773 Ladies and Gentlemen: On behalf of Alvotech (the “Company”), we are providing this letter in response to the comments provided by the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in its comment letter dated May 9, 2022 (the “Comment Letter”) with respect to the Company’s Amendment No. 5 to Registration Statement on Form F-4 (“Amendment No. 5”) filed on May 2, 2022. Concurrently with the submission of this response letter, the Company is filing, through EDGAR, Amendment No. 6 to the Registration Statement (“Amendment No. 6”). The numbering of the paragraphs below corresponds to the numbering of the comments contained in the Comment Letter, which, for your convenience, we have incorporated into this response letter in bold and italics. Page references in the text of this response letter correspond to the page numbers of Amendment No. 6. Capitalized terms used but not otherwise defined in this letter shall have the meanings set forth in Amendment No. 6. Amendment No. 5 to Registration Statement on Form F-4 Questions and Answers about the Business Combination Q: Will OACB, TopCo and Alvotech be obtaining new financing in connection with the Business Combination?, page 9 1. We note your response to prior comment 1. Please also disclose here that the new financing is needed for additional liquidity in the event of high redemptions, consistent with your disclosure on page 160. Response: The Company acknowledges the Staff’s comment and has revised its disclosure on page 11. Summary of the Proxy Statement/Prospectus The Business Combination Conditions to Closing, page 30 2. We note your revised disclosure here in response to our prior comment 1 to further clarify amendments to the minimum cash condition and aggregate transaction proceeds that were made in the BCA Amendment. We also note your revised disclosure on page 189 where you state that “[t]he $90,000,000 refers to the Loan Advances with Alvogen and Aztiq for an amount of $50.0 million and the Alvogen Bridge Loan for up to $40.0 million” and that “[a]ny debt financing funded to Alvotech or available to be funded in addition to these facilities, whether from shareholders or third parties, will count towards the $250,000,000 Minimum Cash Condition.” Please revise your disclosure here to provide similar clarification regarding to what the $90.0 million refers and which of your debt facilities may count towards the minimum cash condition. Response: The Company acknowledges the Staff’s comment and has revised its disclosure on page 30. * * * * 2 Please direct any questions or comments regarding the foregoing or with respect to Amendment No. 6 to the undersigned at (212) 479-6446, Michal Berkner of Cooley LLP at +44 (0) 20 7556 4321 or Divakar Gupta of Cooley LLP at (212) 479-6474. Very truly yours, /s/ Nicolas H.R. Dumont Nicolas H.R. Dumont cc: Robert Wessman, Alvotech Tanya Zharov, Alvotech Michal Berkner, Cooley LLP Divakar Gupta, Cooley LLP Christian O. Nagler, Kirkland & Ellis LLP Peter Seligson, Kirkland & Ellis LLP Allison Gallagher, Kirkland & Ellis LLP
2022-05-09 - UPLOAD - Alvotech
United States securities and exchange commission logo
May 9, 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. 5 to Registration Statement on Form F-4
Filed May 2, 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 April 28, 2022 letter.
Amendment No. 5 to Registration Statement on Form F-4
Questions and Answers About the Business Combination
Q: Will OACB, TopCo and Alvotech be obtaining new financing in connection with the
Business Combination?, page 9
1.We note your response to prior comment 1. Please also disclose here that the new
financing is needed for additional liquidity in the event of high redemptions, consistent
with your disclosure on page 160.
FirstName LastNameRobert Wessman
Comapany NameAlvotech Lux Holdings S.A.S.
May 9, 2022 Page 2
FirstName LastName
Robert Wessman
Alvotech Lux Holdings S.A.S.
May 9, 2022
Page 2
Summary of the Proxy Statement/Prospectus
The Business Combination
Conditions to Closing, page 30
2.We note your revised disclosure here in response to our prior comment 1 to further clarify
amendments to the minimum cash condition and aggregate transaction proceeds that were
made in the BCA Amendment. We also note your revised disclosure on page 189 where
you state that "[t]he $90,000,000 refers to the Loan Advances with Alvogen and Aztiq for
an amount of $50.0 million and the Alvogen Bridge Loan for up to $40.0 million" and
that "[a]ny debt financing funded to Alvotech or available to be funded in addition to
these aforementioned facilities, including the Sculptor facility and potential other debt
facilities, whether from shareholders or third parties, will count towards the $250,000,000
Minimum Cash Condition." Please revise your disclosure here to provide similar
clarification regarding to what the $90.0 million refers and which of your debt facilities
may count towards the minimum cash condition.
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,
Division of Corporation Finance
Office of Life Sciences
cc: Nicolas Dumont
2022-05-02 - CORRESP - Alvotech
CORRESP 1 filename1.htm CORRESP Alvotech 9, Rue de Bitbourg L-1273 Luxembourg Grand Duchy of Luxembourg May 2, 2022 Via EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Franklin Wyman Vanessa Robertson Jessica Ansart Jeffrey Gabor Re: Alvotech Amendment No. 4 to Registration Statement on Form F-4 Filed on April 19, 2022 File No. 333-261773 Ladies and Gentlemen: On behalf of Alvotech (the “Company”), we are providing this letter in response to the comments provided by the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in its comment letter dated April 28, 2022 (the “Comment Letter”) with respect to the Company’s Amendment No. 4 to Registration Statement on Form F-4 (“Amendment No. 4”) filed on April 19, 2022. This letter is intended to replace previously provided correspondence of even date herewith, which inadvertently omitted page number references in the response to comment 1. Accordingly, please disregard such earlier correspondence and refer to this letter instead. Concurrently with the submission of this response letter, the Company is filing, through EDGAR, Amendment No. 5 to the Registration Statement (“Amendment No. 5”). The numbering of the paragraphs below corresponds to the numbering of the comments contained in the Comment Letter, which, for your convenience, we have incorporated into this response letter in bold and italics. Page references in the text of this response letter correspond to the page numbers of Amendment No. 5. Capitalized terms used but not otherwise defined in this letter shall have the meanings set forth in Amendment No. 5. Amendment No. 4 to Registration Statement on Form F-4 Risk Factors Prior to the consummation of the Business Combination, and even after…, page 55 1. We note your disclosure that you have entered into three new financing arrangements in connection with the Business Combination, including your loan agreement with Alvogen, your debt facility with Sculptor and your Standby Equity Purchase Agreement (SEPA) with Yorkville. We also note that you have revised the minimum cash requirement to include cash proceeds from the trust account (after redemptions), together with the proceeds of the PIPE Financing “and the aggregate proceeds in excess of $90,000,000 (representing financing advanced, or expected to be advanced, to Alvotech by certain of its existing shareholders) of any debt financing funded or available to be funded to Alvotech from prior to the Closing (and, for the avoidance of doubt, after December 7, 2021), at or following the closing.” With respect to these new financing arrangements, please revise your disclosure throughout the registration statement as follows: • Please revise your discussion of the minimum cash requirement as noted above to specify how the financing arrangements with Alvogen, Sculptor and Yorkville may contribute to meeting this requirement. • Please revise your disclosure, as appropriate, to disclose whether and to what extent any of these new financing arrangements may be a possible source of dilution shareholders who elect not to redeem their shares in connection with the business combination. To the extent that any of the arrangements may be a significant source of dilution, please provide disclosure of the impact of that significant source of dilution at each of the redemption levels detailed in your sensitivity analysis, including any needed assumptions. • Please revise your Questions and Answers about the Business Combination section starting on page 7 to include a discussion of new financing you are obtaining in connection with the Business Combination, including the PIPE financing as well as the loan agreement with Alvogen, the debt facility with Sculptor and the SEPA with Yorkville. • Please revise the Background of the Business Combination section beginning on page 149 to include a discussion of the negotiations of these various agreements including background on when and why it was decided to pursue these additional financing arrangements. • Please revise the Certain Agreements related to the Business Combination to include a summary of the material terms of each of these agreements, including, where applicable, a description of any consideration provided in exchange for the agreement. • Please file the binding term sheet for the debt facility agreement with Sculptor as well as the SEPA with Yorkville as exhibits or provide an analysis supporting your determination that the agreements are not required to be filed. Response: The Company acknowledges the Staff’s comment and has revised its disclosure on pages 10 through 13, 21 through 23, 159 through 160, 189 and 193. The Company also filed the binding offer letter and term sheet, and the SEPA as exhibits 10.33 and 10.34. * * * * Please direct any questions or comments regarding the foregoing or with respect to Amendment No. 5 to the undersigned at (212) 479-6446, Michal Berkner of Cooley LLP at +44 (0) 20 7556 4321 or Divakar Gupta of Cooley LLP at (212) 479-6474. Very truly yours, /s/ Nicolas H.R. Dumont Nicolas H.R. Dumont cc: Robert Wessman, Alvotech Tanya Zharov, Alvotech Michal Berkner, Cooley LLP Divakar Gupta, Cooley LLP Christian O. Nagler, Kirkland & Ellis LLP Peter Seligson, Kirkland & Ellis LLP Allison Gallagher, Kirkland & Ellis LLP
2022-05-02 - CORRESP - Alvotech
CORRESP 1 filename1.htm CORRESP Alvotech 9, Rue de Bitbourg L-1273 Luxembourg Grand Duchy of Luxembourg May 2, 2022 Via EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Franklin Wyman Vanessa Robertson Jessica Ansart Jeffrey Gabor Re: Alvotech Amendment No. 4 to Registration Statement on Form F-4 Filed on April 19, 2022 File No. 333-261773 Ladies and Gentlemen: On behalf of Alvotech (the “Company”), we are providing this letter in response to the comments provided by the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in its comment letter dated April 28, 2022 (the “Comment Letter”) with respect to the Company’s Amendment No. 4 to Registration Statement on Form F-4 (“Amendment No. 4”) filed on April 19, 2022. Concurrently with the submission of this response letter, the Company is filing, through EDGAR, Amendment No. 5 to the Registration Statement (“Amendment No. 5”). The numbering of the paragraphs below corresponds to the numbering of the comments contained in the Comment Letter, which, for your convenience, we have incorporated into this response letter in bold and italics. Page references in the text of this response letter correspond to the page numbers of Amendment No. 5. Capitalized terms used but not otherwise defined in this letter shall have the meanings set forth in Amendment No. 5. Amendment No. 4 to Registration Statement on Form F-4 Risk Factors Prior to the consummation of the Business Combination, and even after…, page 55 1. We note your disclosure that you have entered into three new financing arrangements in connection with the Business Combination, including your loan agreement with Alvogen, your debt facility with Sculptor and your Standby Equity Purchase Agreement (SEPA) with Yorkville. We also note that you have revised the minimum cash requirement to include cash proceeds from the trust account (after redemptions), together with the proceeds of the PIPE Financing “and the aggregate proceeds in excess of $90,000,000 (representing financing advanced, or expected to be advanced, to Alvotech by certain of its existing shareholders) of any debt financing funded or available to be funded to Alvotech from prior to the Closing (and, for the avoidance of doubt, after December 7, 2021), at or following the closing.” With respect to these new financing arrangements, please revise your disclosure throughout the registration statement as follows: • Please revise your discussion of the minimum cash requirement as noted above to specify how the financing arrangements with Alvogen, Sculptor and Yorkville may contribute to meeting this requirement. • Please revise your disclosure, as appropriate, to disclose whether and to what extent any of these new financing arrangements may be a possible source of dilution shareholders who elect not to redeem their shares in connection with the business combination. To the extent that any of the arrangements may be a significant source of dilution, please provide disclosure of the impact of that significant source of dilution at each of the redemption levels detailed in your sensitivity analysis, including any needed assumptions. • Please revise your Questions and Answers about the Business Combination section starting on page 7 to include a discussion of new financing you are obtaining in connection with the Business Combination, including the PIPE financing as well as the loan agreement with Alvogen, the debt facility with Sculptor and the SEPA with Yorkville. • Please revise the Background of the Business Combination section beginning on page 149 to include a discussion of the negotiations of these various agreements including background on when and why it was decided to pursue these additional financing arrangements. • Please revise the Certain Agreements related to the Business Combination to include a summary of the material terms of each of these agreements, including, where applicable, a description of any consideration provided in exchange for the agreement. • Please file the binding term sheet for the debt facility agreement with Sculptor as well as the SEPA with Yorkville as exhibits or provide an analysis supporting your determination that the agreements are not required to be filed. Response: The Company acknowledges the Staff’s comment and has revised its disclosure on pages [_]. The Company also filed the binding offer letter and term sheet, and the SEPA as exhibits 10.33 and 10.34. * * * * Please direct any questions or comments regarding the foregoing or with respect to Amendment No. 5 to the undersigned at (212) 479-6446, Michal Berkner of Cooley LLP at +44 (0) 20 7556 4321 or Divakar Gupta of Cooley LLP at (212) 479-6474. Very truly yours, /s/ Nicolas H.R. Dumont Nicolas H.R. Dumont cc: Robert Wessman, Alvotech Tanya Zharov, Alvotech Michal Berkner, Cooley LLP Divakar Gupta, Cooley LLP Christian O. Nagler, Kirkland & Ellis LLP Peter Seligson, Kirkland & Ellis LLP Allison Gallagher, Kirkland & Ellis LLP
2022-04-28 - UPLOAD - Alvotech
United States securities and exchange commission logo
April 28, 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. 4 to Registration Statement on Form F-4
Filed April 19, 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 April 12, 2022 letter.
Amendment No. 4 to Registration Statement on Form F-4
Risk Factors
Prior to the consummation of the Business Combination, and even after..., page 55
1.We note your disclosure that you have entered into three new financing arrangements in
connection with the Business Combination, including your loan agreement with Alvogen,
your debt facility with Sculptor and your Standby Equity Purchase Agreement (SEPA)
with Yorkville. We also note that you have revised the minimum cash requirement to
include cash proceeds from the trust account (after redemptions), together with the
proceeds of the PIPE Financing "and the aggregate proceeds in excess of $90,000,000
(representing financing advanced, or expected to be advanced, to Alvotech by certain of
FirstName LastNameRobert Wessman
Comapany NameAlvotech Lux Holdings S.A.S.
April 28, 2022 Page 2
FirstName LastName
Robert Wessman
Alvotech Lux Holdings S.A.S.
April 28, 2022
Page 2
its existing shareholders) of any debt financing funded or available to be funded to
Alvotech from prior to the Closing (and, for the avoidance of doubt, after December 7,
2021), at or following the closing." With respect to these new financing arrangements,
please revise your disclosure throughout the registration statement as follows:
•Please revise your discussion of the minimum cash requirement as noted above to
specify how the financing arrangements with Alvogen, Sculptor and Yorkville may
contribute to meeting this requirement.
•Please revise your disclosure, as appropriate, to disclose whether and to what extent
any of these new financing arrangements may be a possible source of dilution
shareholders who elect not to redeem their shares in connection with the business
combination. To the extent that any of the arrangements may be a significant source
of dilution, please provide disclosure of the impact of that significant source of
dilution at each of the redemption levels detailed in your sensitivity analysis,
including any needed assumptions.
•Please revise your Questions and Answers about the Business Combination section
starting on page 7 to include a discussion of new financing you are obtaining in
connection with the Business Combination, including the PIPE financing as well as
the loan agreement with Alvogen, the debt facility with Sculptor and the SEPA with
Yorkville.
•Please revise the Background of the Business Combination section beginning on page
149 to include a discussion of the negotiations of these various agreements including
background on when and why it was decided to pursue these additional financing
arrangements.
•Please revise the Certain Agreements related to the Business Combination to include
a summary of the material terms of each of these agreements, including, where
applicable, a description of any consideration provided in exchange for the
agreement.
•Please file the binding term sheet for the debt facility agreement with Sculptor as well
as the SEPA with Yorkville as exhibits or provide an analysis supporting your
determination that the agreements are not required to be filed.
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,
Division of Corporation Finance
Office of Life Sciences
cc: Nicolas Dumont
2022-04-19 - CORRESP - Alvotech
CORRESP 1 filename1.htm CORRESP Alvotech 9, Rue de Bitbourg L-1273 Luxembourg Grand Duchy of Luxembourg April 19, 2022 Via EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Franklin Wyman Vanessa Robertson Jessica Ansart Jeffrey Gabor Re: Alvotech Amendment No. 3 to Registration Statement on Form F-4 Filed on March 14, 2022 File No. 333-261773 Ladies and Gentlemen: On behalf of Alvotech (the “Company”), we are providing this letter in response to the comments provided by the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in its comment letter dated April 12, 2022 (the “Comment Letter”) with respect to the Company’s Amendment No. 3 to Registration Statement on Form F-4 (“Amendment No. 3”) filed on April 4, 2022. Concurrently with the submission of this response letter, the Company is filing, through EDGAR, Amendment No. 4 to the Registration Statement (“Amendment No. 4”). The numbering of the paragraphs below corresponds to the numbering of the comments contained in the Comment Letter, which, for your convenience, we have incorporated into this response letter in bold and italics. Page references in the text of this response letter correspond to the page numbers of Amendment No. 4. Capitalized terms used but not otherwise defined in this letter shall have the meanings set forth in Amendment No. 4. Amendment No. 3 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 58 1. We note your response to prior comment 1 and reissue in part. We note your statement in your response letter indicating that you had originally planned clinical trial sites in Russia in addition to Ukraine and that you are now considering alternative trial sites, including in South Africa and Poland. Please revise your disclosure here and in your Business section to state your original plans for your clinical trial sites in Russia as well as to disclose that you are currently considering initiating clinical trials previously planned for Ukraine and Russia in alternative locations, including South Africa and Poland. Response: The Company acknowledges the Staff’s comment and has revised its disclosure on pages 62, 234 and 235. * * * * Please direct any questions or comments regarding the foregoing or with respect to Amendment No. 4 to the undersigned at (212) 479-6446, Michal Berkner of Cooley LLP at +44 (0) 20 7556 4321 or Divakar Gupta of Cooley LLP at (212) 479-6474. Very truly yours, /s/ Nicolas H.R. Dumont Nicolas H.R. Dumont cc: Robert Wessman, Alvotech Tanya Zharov, Alvotech Michal Berkner, Cooley LLP Divakar Gupta, Cooley LLP Christian O. Nagler, Kirkland & Ellis LLP Peter Seligson, Kirkland & Ellis LLP Allison Gallagher, Kirkland & Ellis LLP
2022-04-12 - UPLOAD - Alvotech
United States securities and exchange commission logo
April 12, 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. 3 to Registration Statement on Form F-4
Filed April 4, 2022
File No. 333-261773
Dear Mr. Wessman:
We have reviewed your amended registration statement and have the following
comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies 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 this comment, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our March 30, 2022 letter.
Amendment No. 3 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 58
1.We note your response to prior comment 1 and reissue in part. We note your statement in
your response letter indicating that you had originally planned clinical trial sites in Russia
in addition to Ukraine and that you are now considering alternative trial sites, including in
South Africa and Poland. Please revise your disclosure here and in your Business
section to state your original plans for your clinical trial sites in Russia as well as to
disclose that you are currently considering initiating clinical trials previously planned for
Ukraine and Russia in alternative locations, including South Africa and Poland.
FirstName LastNameRobert Wessman
Comapany NameAlvotech Lux Holdings S.A.S.
April 12, 2022 Page 2
FirstName LastName
Robert Wessman
Alvotech Lux Holdings S.A.S.
April 12, 2022
Page 2
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,
Division of Corporation Finance
Office of Life Sciences
cc: Nicolas Dumont
2022-04-04 - CORRESP - Alvotech
CORRESP
1
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CORRESP
Alvotech Lux Holdings S.A.S.
9, Rue de Bitbourg
L-1273 Luxembourg
Grand Duchy of Luxembourg
April 4, 2022
Via EDGAR
Securities and Exchange Commission
Division of Corporation
Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549-3628
Attention: Franklin
Wyman
Vanessa Robertson
Jessica Ansart
Jeffrey Gabor
Re:
Alvotech Lux Holdings S.A.S.
Amendment No. 2 to Registration Statement on Form F-4
Filed on March 14, 2022
File No. 333-261773
Ladies and Gentlemen:
On behalf of Alvotech Lux
Holdings S.A.S. (the “Company”), we are providing this letter in response to the comments provided by the staff (the “Staff”) of the Securities and Exchange Commission (the
“Commission”) in its comment letter dated March 30, 2022 (the “Comment Letter”) with respect to the Company’s Amendment No. 2 to Registration Statement on Form F-4 (“Amendment No. 2”) filed on March 14, 2022.
Concurrently with the submission of this response letter, the Company is filing, through EDGAR, Amendment No. 3 to the Registration
Statement (“Amendment No. 3”).
The numbering of the paragraphs below corresponds
to the numbering of the comments contained in the Comment Letter, which, for your convenience, we have incorporated into this response letter in bold and italics. Page references in the text of this response letter correspond to the page numbers of
Amendment No. 3. Capitalized terms used but not otherwise defined in this letter shall have the meanings set forth in Amendment No. 3.
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;
•
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.
Response: The Company acknowledges the Staff’s
comment and has revised its disclosure on pages 60 and 233 to provide more detail around the impact of the Russian invasion in Ukraine on Alvotech’s ongoing AVT04 clinical trial and its planned trials.
Due to an increase in patient enrollment by approximately 10%, the original sample size of patients is larger than originally planned. The 188
patients in Ukraine make up approximately 32% of the total patient population of 581. The Company does not consider its AVT04 trial to be materially impacted and still expects to report topline results in the second half of 2022, principally
because:
•
all patients, including those located in Ukraine, have completed the study primary endpoint assessment (at week
12);
•
approximately 70% of the patients worldwide (408/581) and 69% of the patients in Ukraine (130/188) have reached
the end of stage-1 (at week 28); and
•
in a worst-case scenario where patients in Ukraine are not able to continue beyond
stage-1, there is a sufficiently large patient population to ensure an acceptable and robust safety assessment by the end of the study (at week 52).
With respect to the other planned trials, the Company respectfully informs the Staff that it had originally planned clinical trial sites for
its AVT03 and AVT06 studies in Ukraine and Russia. Due to the conflict, the Company is now considering alternative trial sites, including in South Africa and Poland. The Company does not expect these relocations to impact the timelines of the
programs.
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.
2
Response: The Company acknowledges the Staff’s comment and has revised its
disclosure on page 230 to clarify that the difference between the $56.3 billion aggregate market opportunity of its current product candidates and the over $85 billion of its aggregate market opportunity is due to two undisclosed product
candidates whose aggregate market opportunity is approximately $30 billion. In addition, the Company has clarified its disclosures with respect to “TAM—Current Pipeline” to indicate that the figure with respect to Alvotech does
not take into account AVT23, a product candidate that was not under development when its projections were initially made to the OACB Board and management, but that now is part of its current pipeline. Finally, the Company has further enhanced its
disclosures to make clear that originator market opportunities do not account for price erosion.
Business of Alvotech
Commercial Partnerships, page 255
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.”
Response: The Company acknowledges the Staff’s comment and has revised its
disclosure on page 222 to further clarify that, unless otherwise indicated, each commercial partnership described pays a royalty of approximately 40% (within the 10 percentage point range of 35% to 45%) or the applicable floor price, whichever price
is higher. The Company further explained that a floor price is a minimum price per unit specific to each presentation to be paid by the commercial partner for the product, and is determined per each presentation and product taking into consideration
Cost of Goods of manufacturing, supply and commercial market environment.
* * * *
3
Please direct any questions or comments regarding the foregoing or with respect to Amendment
No. 3 to the undersigned at (212) 479-6446, Michal Berkner of Cooley LLP at +44 (0) 20 7556 4321 or Divakar Gupta of Cooley LLP at (212) 479-6474.
Very truly yours,
/s/ Nicolas H.R. Dumont
Nicolas H.R. Dumont
cc:
Robert Wessman, Alvotech Lux Holdings S.A.S.
Tanya Zharov, Alvotech Lux Holdings S.A.S.
Michal Berkner, Cooley LLP
Divakar Gupta, Cooley LLP
Christian O. Nagler, Kirkland & Ellis LLP
Peter Seligson, Kirkland & Ellis LLP
Allison Gallagher, Kirkland & Ellis LLP
2022-03-30 - UPLOAD - Alvotech
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;
FirstName LastNameRobert Wessman
Comapany NameAlvotech Lux Holdings S.A.S.
March 30, 2022 Page 2
FirstName LastName
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,
Division of Corporation Finance
Office of Life Sciences
cc: Nicolas Dumont
2022-03-14 - CORRESP - Alvotech
CORRESP 1 filename1.htm CORRESP Alvotech Lux Holdings S.A.S. 9, Rue de Bitbourg L-1273 Luxembourg Grand Duchy of Luxembourg March 14, 2022 Via EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Franklin Wyman Vanessa Robertson Jessica Ansart Jeffrey Gabor Re: Alvotech Lux Holdings S.A.S. Amendment No. 1 to Registration Statement on Form F-4 Filed on February 4, 2022 File No. 333-261773 Ladies and Gentlemen: On behalf of Alvotech Lux Holdings S.A.S. (the “Company”), we are providing this letter in response to the comments provided by the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in its comment letter dated February 25, 2022 (the “Comment Letter”) with respect to the Company’s Amendment No. 1 to Registration Statement on Form F-4 (“Amendment No. 1”) filed on February 4, 2022. Concurrently with the submission of this response letter, the Company is filing, through EDGAR, Amendment No. 2 to the Registration Statement (“Amendment No. 2”). The numbering of the paragraphs below corresponds to the numbering of the comments contained in the Comment Letter, which, for your convenience, we have incorporated into this response letter in bold and italics. Page references in the text of this response letter correspond to the page numbers of Amendment No. 2. Capitalized terms used but not otherwise defined in this letter shall have the meanings set forth in Amendment No. 2. Amendment No. 1 to Registration Statement on Form F-4 The Business Combination The Background of the Business Combination, page 151 1. We note your response to our prior comment 16 and reissue the comment in part. We note that you have substantially revised this section to include further detail on the negotiations, including reference to certain proposals and responses concerning material terms of the transaction. For example, on page 153 you state that “OACB returned comments to the Term Sheet to Alvotech, including with respect to certain binding provisions, the amount of contemplated PIPE financing, exclusivity terms, the Sponsor earn-out terms, transaction approvals and registration rights,” however, you do not describe the proposals concerning these terms. Please revise your disclosure throughout this section to describe each proposal (preliminary or otherwise) and counterproposal concerning a material transaction term and to identify the party putting it forward. In this regard, we continue to note that the Background section as written discusses in general terms the topical areas discussed by the parties during the eight month negotiations and some of the final terms they mutually agreed upon but does so with little indication of how those terms evolved during the course of the discussions/negotiations. Response: The Company acknowledges the Staff’s comment and has revised the disclosures on pages 153 through 159 in response thereto. 2. We note your revised disclosure on page 158 where you discuss the subsequent PIPE financing arrangement and related subscription agreements that you entered into on January 18, 2022. Please expand your discussion in the background section to provide detail on the negotiation and marketing processes for this subsequent PIPE transaction. Response: The Company acknowledges the Staff’s comment and has revised the disclosures on page 159 in response thereto. Comparable Public Companies, page 164 3. We acknowledge the additional information provided in your response to prior comment 24 but continue to have difficulty in understanding the relevance of the “TAM—Current Pipeline” (market opportunity) for Alvotech. Please quantify the estimate of peak WW sales from 2021-2026 for each of your biosimilar products, as assumed in your forecast on page 168, and the estimate of peak WW sales from 2021-2026 for each of the corresponding reference products. Also, on page 169 you state that global markets for biologic and biosimilar medicines are forecasted to grow to approximately $555 billion and $80 billion by 2026, respectively. It is not clear how the combined estimated peak global sales of the product candidates in your pipeline could be $85.5 billion when the global market for biosimilar medicines is forecasted to reach $80 billion by 2026. Explain the relationship between these amounts. Revise your presentation accordingly. Response: The Company acknowledges the Staff’s comment about the relevance of the “TAM – Current Pipeline” figures on page 166 and has revised its disclosure to explain how and why target markets for products in the biosimilar industry are described in relation to estimated peak sales of corresponding originator products. The Company further notes the Staff’s request to quantify peak worldwide sales from 2021-2026 for each of its biosimilar products, and the estimate of peak worldwide sales from 2021-2026 for each corresponding reference originator product. In response thereto, the Company has revised the disclosure on pages 170 through 171 to include tabular disclosure of peak actual and estimated revenues for the originator medicines addressed by the Company’s development pipeline in each year from 2021-2026, as provided by Evaluate Pharma. Nevertheless, the Company respectfully advises the Staff that it is unable for competitive reasons to disclose estimated peak worldwide sales of each of its biosimilar products from 2021-2026. 2 As described elsewhere in Amendment No. 2, much like generic drugs, biosimilars offer a lower cost alternative to their name-brand reference products. Unlike developers of originator products that quite often are creating their own market with no existing competition, the Company is not developing a new innovative product. Instead, biosimilars enter into direct competition with what is typically a large-scale incumbent producer. This results in the biosimilar market being characterized by fundamentally different development, regulatory, legal and commercial attributes as compared to originator businesses where a brand new, intellectual property protected, pharmaceutical product is being developed. Estimates of peak sales of the Company’s biosimilar medicines, as with all biosimilars, depend on several factors, including (1) peak sales of the relevant originator medicine, as adjusted for the proposed discounted price of the biosimilar medicine; (2) the market share ultimately achieved by the biosimilar medicine; (3) Alvotech’s share of in-market sales from its commercial partners; (4) estimated launch date; and (5) the product’s probability of success (“POS”). As discussed in turn below (with the exception of POS, which is discussed in the Company’s response to Comment 6), each of these elements are highly confidential elements of the Company’s commercial strategy that the Company believes would be harmful to its business interests and therefore also harmful to its future public company investors if disclosed publicly. Within the biosimilars industry, pricing is a key element of commercial strategy and assumptions around pricing are therefore confidential and highly sensitive information until a biosimilar medicine has launched and a price for the medicine has been publicly announced. As a result, we believe that such pricing information should not be disclosed as competitors could use that information to undercut the Company’s products on the basis of price. Nevertheless, in response to the Staff’s comment, the Company has disclosed expected originator market size by year as measured by peak sales of those products, with a sensitivity analysis using different pricing erosion assumptions. In addition, the Company has provided historical pricing data for biosimilar launches to contextualize this presentation and indicated that that the biosimilar price discounts assumed in the Company’s forecasts are greater than the average historical market examples provided. The Company believes that investors can assess expected pricing and resulting biosimilar market size based on these disclosures. The pricing of a biosimilar medicine is also a major determinant of the market share that the biosimilar medicine achieves, which also renders assumptions regarding market share highly confidential and competitively sensitive. While the Company believes it would be harmful to the Company and its investors and is therefore not in a position to provide precise assumptions for competitive reasons, the Company has disclosed in response to the Staff’s comment that its projections assume market share ranging from high-single digits to 20% in certain cases. With respect to its share of revenue, the Company has also disclosed that it receives on average 40% of in-market sales from its commercial partners. The other significant factor in determining peak sales of biosimilar medicines is the date of commercial launch of the biosimilar product. The date of estimated launch of a biosimilar product is also competitively sensitive that the Company must protect. Because biosimilars enter into direct competition with what is typically a large-scale incumbent producer, that is, the originator product company, a sensitive legal pathway must typically be successfully traversed in order to launch a biosimilar, much like in the generic space. Alvotech may need to, from time to time, engage in patent litigation (e.g. under the Biologics Price Competition and Innovation Act in the United States) with the originator before launching a biosimilar. Other IP litigation is also 3 possible, including those adverse to non-originator third-party competitors that may hold patents allegedly infringed by Alvotech. These legal considerations are typically less relevant in the originator market, but are characteristic of the biosimilar industry where originators routinely seek to prevent more cost-effective biosimilar products from coming to market through such patent claims. The timing of any particular biosimilar launch depends largely on the Company’s ability to navigate the patent landscape, which may be achieved by litigation, settlement, or expiration of the patent exclusivity of the reference products, among other methods. The Company’s recent litigation with AbbVie is a direct example of the dynamics articulated in this paragraph. As a result, the Company devotes significant resources to understanding when and under what circumstances a given biologic patent expires, and then the Company must establish a development, regulatory, and legal strategy contingent on that analysis. Such legal considerations are discussed elsewhere in Amendment No. 2. In response to the Staff’s comment and to assist investors in assessing the reasonableness of the projections provided to the OACB board of directors and management, the Company has revised its disclosure to provide launch date ranges between 12 and 24 months between anticipated timing between regulatory filing and product launch for each product. As disclosed elsewhere in the registration statement, the Company has a relatively short timeframe for its expected launches as it has disclosed that it plans to launch its first five product candidates by 2025. Further, the Company is committed to informing investors promptly when launch dates become certain as regulatory and legal pathways are clarified. The recent settlement agreement with AbbVie is again a compelling example, where the Company announced that it planned to enter the US market on July 1, 2023 following announcement of the settlement agreement. In contrast to the biosimilars market, developers of originator products can publish estimates of the market size for each of the products they are developing and expected revenues based on announced estimated launch dates, but those estimates rarely make a difference to competitors as the originator is often times creating its own new market. However, in contrast and much like the generics market, each one of Alvotech’s products is designed to take market share away from a product, the originator of which will be determined to maintain their market share. If the Company were to announce when it planned on launching a product, what it expected revenues to be in future years for those products and its contemplated pricing, market incumbents would triangulate their own competitive strategy against the Company on the basis of price or other factors. Further, developers and manufacturers of corresponding originator products would, in substance, be granted a roadmap as to when and how to enjoin future development of the Company’s products, perhaps even years in advance. Such litigation or legal action could imperil the development of the Company’s biosimilar products and would result in a material competitive disadvantage to the Company. As a result, the Company believes that the specific disclosure the Company is being asked to provide, would, if provided, undermine the information itself and invalidate the Company’s assumptions and therefore not be in the best interests of the Company or its investors. Due to these competitive concerns, the Company believes it would be detrimental to the interests of the Company and its investors to publicly quantify peak sales for each of its anticipated biosimilar product to the extent requested by the Staff as these disclosures could provide insight to competitors around highly sensitive elements of the Company’s commercial strategy, including anticipated pricing and launch timing. Further, the Company believes that these unique legal and commercial dynamics of the biosimilar industry are very well understood by investors in the generics and biosimilars space, and thus this information would be beneficial mostly to the Company’s competitors and not to its public investors. 4 The Company further acknowledges the Staff’s comment regarding the estimated total biosimilars market size of approximately $80 billion in 2026 relative to the total peak originator sales of $85.5 billion that is addressed by the Company’s current development pipeline. The Company respectfully advises the Staff that it believes that these figures are not directly comparable. Firstly, and most significantly, the $80 billion of biosimilar market sales in 2026 represents the expected sales of biosimilar medicines in that year rather than peak originator sales for all biosimilars that are commercially available in 2026, which is expected to be significantly higher. Secondly, the peak originator sales figure is based on the pricing of the branded originator medicines, whereas the 2026 biosimilars market revenues reflects the pricing of the biosimilars that are commercially available at that point, which are typically priced at a discount to originator medicine prices. Where applicable, the Company has clarified that the $85 billion figure relates to originator sales. 4. Please explain and quantify the expected impact of price erosion on “originator” branded biologic products as biosimilar products are introduced in these markets in each year over the next 3 years and your consideration of these market dynamics in determining “our product candidates’ market opportunity” as you quantified on page 223. Also, describe and quantify the “historical market examples for biosimilars” that you reference on page 169. Revise your presentation accordingly. Response: The Company acknowledges the Staff’s comment and, as described further in its response to Comment 3, has revised the disclosures on pages 171 through 173 to provide a price erosion sensitivity analysis by reference to corresponding originator product and to describe in general terms anticipated timing between regulatory filing and product launch. The Company has included a sensitivity analysis illustrating the potential impact on total biosimilar revenues for each of its pipeline candidates with
2022-02-25 - UPLOAD - Alvotech
United States securities and exchange commission logo
February 25, 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. 1 to Registration Statement on Form F-4
Filed February 4, 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 January 18, 2022 letter.
Amendment No. 1 to Registration Statement on Form F-4
The Business Combination
The Background of the Business Combination, page 151
1.We note your response to our prior comment 16 and reissue the comment in part. We note
that you have substantially revised this section to include further detail on the
negotiations, including reference to certain proposals and responses concerning material
terms of the transaction. For example, on page 153 you state that "OACB returned
comments to the Term Sheet to Alvotech, including with respect to certain binding
provisions, the amount of contemplated PIPE financing, exclusivity terms, the Sponsor
earn-out terms, transaction approvals and registration rights," however, you do not
FirstName LastNameRobert Wessman
Comapany NameAlvotech Lux Holdings S.A.S.
February 25, 2022 Page 2
FirstName LastNameRobert Wessman
Alvotech Lux Holdings S.A.S.
February 25, 2022
Page 2
describe the proposals concerning these terms. Please revise your disclosure throughout
this section to describe each proposal (preliminary or otherwise) and counterproposal
concerning a material transaction term and to identify the party putting it forward. In this
regard, we continue to note that the Background section as written discusses in general
terms the topical areas discussed by the parties during the eight month negotiations and
some of the final terms they mutually agreed upon but does so with little indication of
how those terms evolved during the course of the discussions/negotiations.
2.We note your revised disclosure on page 158 where you discuss the subsequent PIPE
financing arrangement and related subscription agreements that you entered into on
January 18, 2022. Please expand your discussion in the background section to provide
detail on the negotiation and marketing processes for this subsequent PIPE transaction.
Comparable Public Companies, page 164
3.We acknowledge the additional information provided in your response to prior comment
24 but continue to have difficulty in understanding the relevance of the “TAM--Current
Pipeline” (market opportunity) for Alvotech. Please quantify the estimate of peak WW
sales from 2021-2026 for each of your biosimilar products, as assumed in your forecast on
page 168, and the estimate of peak WW sales from 2021-2026 for each of the
corresponding reference products. Also, on page 169 you state that global markets for
biologic and biosimilar medicines are forecasted to grow to approximately $555 billion
and $80 billion by 2026, respectively. It is not clear how the combined estimated peak
global sales of the product candidates in your pipeline could be $85.5 billion when the
global market for biosimilar medicines is forecasted to reach $80 billion by 2026.
Explain the relationship between these amounts. Revise your presentation accordingly.
4.Please explain and quantify the expected impact of price erosion on "originator" branded
biologic products as biosimilar products are introduced in these markets in each year over
the next 3 years and your consideration of these market dynamics in determining “our
product candidates’ market opportunity” as you quantified on page 223. Also, describe
and quantify the “historical market examples for biosimilars” that you reference on page
169. Revise your presentation accordingly.
Certain Unaudited Alvotech Prospective Financial Information , page 166
5.We acknowledge the additional information provided in your response to prior comment
25 but continue to believe that your presentation does not provide investors with sufficient
information to evaluate the reasonableness of your financial projections. Please provide
additional discussion that facilitates an understanding of the risk that estimates underlying
your forecasted market share, revenue and adjusted EBITDA are sensitive to changes in
underlying assumptions and quantify the impact on your forecast, resulting from likely
variability in these assumptions. Also, provide additional discussion that facilitates an
understanding of the progression in each year over the period 2022 through 2025 of
growth in market share, revenue and adjusted EBITDA, including underlying changes in
FirstName LastNameRobert Wessman
Comapany NameAlvotech Lux Holdings S.A.S.
February 25, 2022 Page 3
FirstName LastNameRobert Wessman
Alvotech Lux Holdings S.A.S.
February 25, 2022
Page 3
percentages for cost of goods sold and operating costs. In addition, provide us the
following information and revise your presentation accordingly.
•Identify the principal target markets and quantify estimated revenues for each market
by 2025.
•Describe the expected timing for regulatory approval of your seven pipeline products
and subsequent commercialization activities in each of the principal target markets.
•Provide a breakdown of forecasted 2025 revenues by product for each market.
•Discuss the key market dynamics underlying price erosion affecting reference
products associated with your biosimilar products during the period 2022 through
2025 and quantify the degree of price erosion by product and principal market that is
expected by 2025.
•Provide a breakdown of future milestone payments aggregating $916 million by type
and year.
•Explain whether alternate financial projections were prepared, acknowledging your
statement that “no alternative financial projections were considered by OACB’s
Board.”
6.We acknowledge the additional information provided in your response to prior comment
28 but continue to have difficulty in understanding how you determined probability of
technical success (“POS”).” Please describe and quantify the methods and key
assumptions underlying your POS estimates for each development phase. In addition,
expand your presentation as follows:
•Identify the “over a dozen biosimilars” developed by your management team in the
past, describe the development time frame for each biosimilar product and quantify
associated revenues generated upon its commercialization.
•Describe your experience with development of biosimilar products from each of your
"host cell lines (CHO and SP2/0) and processes (Fed batch and
perfusion)," identifying those products that did or did not achieve regulatory approval
and commercialization.
•Describe the expected timing for pre-clinical, clinical and submission phase
development, as well as regulatory approval and commercialization for each of your
five pipeline products to be launched in more than 50 markets by 2025.
•Describe the significant risks associated with your planned development and
regulatory approval processes, described on pages 215- 216, and provide data
supporting your assertion that these processes for biosimilar products are “less
uncertain relative to originator biologics."
•Describe the significant risks governing successful future commercialization for your
five biosimilar products, given the level of apparent competition described on pages
229-230, and explain how these risks were considered in determining your forecasts
of Alvotech Revenue and Adjusted EBITDA on page 168.
FirstName LastNameRobert Wessman
Comapany NameAlvotech Lux Holdings S.A.S.
February 25, 2022 Page 4
FirstName LastNameRobert Wessman
Alvotech Lux Holdings S.A.S.
February 25, 2022
Page 4
Business of Alvotech
Third Party Suppliers and Manufacturers, page 217
7.We note your revised disclosure in response to our prior comment 31. You state that "[t]he
availability of master cell banks is critical to [y]our ability to manufacture products for the
commercial market" and that "[s]hould [y]our cell banks (despite any redundancies) be
compromised, [you] would be unable to produce usable products for patients in any
market." Please expand your disclosure to explain what "master cell banks" are and to
describe why they are critical to your operations. Please also revise your risk factor
disclosure to cover the particular risk posed to your business by your dependence on
master cell banks.
Commercial Partnerships, page 219
8.We note your response to our prior comment 32 and reissue the comment in part. For each
of your partnership agreements as described on pages 219-222 and 274-275, please
expand your disclosure to ensure that you are disclosing all material terms, including the
following:
•the nature and scope of any intellectual property transferred;
•each parties' rights and obligations;
•quantification of all up-front or execution payments received or paid to date;
•aggregate amounts paid or received to date under the agreement;
•aggregate amounts of all potential development, regulatory and commercial
milestone payments;
•quantification of the royalty rate, or a range no greater than 10 percentage points per
tier;
•disclosure of the duration of the agreement and when royalty provisions expire; and
•disclosure of termination provisions.
For example, we note your description of your agreement with Fuji Pharma where you
state that "Fuji Pharma agreed to make certain payments to Alvotech upon the
achievement of certain milestones [...]," and your description of your partnership with
Biosana where you state that "[you] have agreed to make certain tiered royalty payments
to Biosana," however, you do not quantify the aggregate amount of these potential
milestone payments or royalty rates.
Our Pipeline, page 222
9.We note your response to our prior comment 34 and reissue the comment in part. To the
extent that all 8 of your product candidates are material, please revise your pipeline table
to identify all 8 candidates. Alternatively, revise your summary to indicate you have
6 material product candidates in development and remove these two undisclosed programs
from your pipeline table.
FirstName LastNameRobert Wessman
Comapany NameAlvotech Lux Holdings S.A.S.
February 25, 2022 Page 5
FirstName LastName
Robert Wessman
Alvotech Lux Holdings S.A.S.
February 25, 2022
Page 5
Our Programs, page 223
10.We note your response to our prior comment 35. For each serious treatment-emergent
adverse event, clearly describe the event including whether it was assessed as drug-
related.
AVT02, our high-concentration biosimilar to Humira, page 224
11.We note your response to our prior comment 36 and reissue the comment. In particular,
please revise the text of the legend contained in the bottom left of the graphic as it does
not currently appear to be legible.
Material Agreements, Partnerships and Suppliers, page 227
12.We note your response to our prior comment 37 and reissue the comment in part. We also
note your disclosure with respect to your agreements with STADA and Teva where you
state that you have received $32.8 million and $75 million, respectively, in upfront and
milestone payments combined. Please revise your disclosure to distinguish between
aggregate amounts received to date for upfront payments and for milestone payments,
providing separate amounts for each.
Intellectual Property , page 230
13.We note your response to our prior comment 39 and reissue the comment in part. With
respect to the two categories of patent applications that you have pending related to you
AVT02 product, please also disclose the type of patent protection for which you are
applying such as composition of matter, use or process.
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,
Division of Corporation Finance
Office of Life Sciences
cc: Nicolas Dumont
2022-02-04 - CORRESP - Alvotech
CORRESP 1 filename1.htm CORRESP Alvotech Lux Holdings S.A.S. 9, Rue de Bitbourg L-1273 Luxembourg Grand Duchy of Luxembourg February 4, 2022 Via EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Franklin Wyman Vanessa Robertson Jessica Ansart Jeffrey Gabor Re: Alvotech Lux Holdings S.A.S. Registration Statement on Form F-4 Filed on December 20, 2021 File No. 333-261773 Ladies and Gentlemen: On behalf of Alvotech Lux Holdings S.A.S. (the “Company”), we are providing this letter in response to the comments provided by the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in its comment letter dated January 18, 2022 (the “Comment Letter”) with respect to the Company’s Registration Statement on Form F-4 (the “Registration Statement”) filed on December 20, 2021. Concurrently with the submission of this response letter, the Company is filing, through EDGAR, Amendment No. 1 to the Registration Statement (“Amendment No. 1”). The numbering of the paragraphs below corresponds to the numbering of the comments contained in the Comment Letter, which, for your convenience, we have incorporated into this response letter in bold and italics. Page references in the text of this response letter correspond to the page numbers of Amendment No. 1. Capitalized terms used but not otherwise defined in this letter shall have the meanings set forth in Amendment No. 1. Registration Statement on Form F-4 filed on December 20, 2021 Cover Page 1. Disclose if the SPAC’s sponsors, directors, officers or their affiliates will participate in the PIPE Financing. Response: The Company acknowledges the Staff’s comment and has revised the disclosures on the cover page to note that none of the SPAC’s sponsor, directors, officers or their affiliates will participate in the PIPE Financing. 2. We note your disclosure here that the Sponsor has agreed to, among other things, waive its anti-dilution rights with respect to its OACB Class B Ordinary Shares in connection with the consummation of the Business Combination. We also note a reference on page F-47 to an anti-dilution adjustment with respect to the OACB private placement warrants, which are also held by the Sponsor. Please clarify whether the sponsor also has anti-dilution rights with respect to its OACB private placement warrants and whether any financing affiliated with the business combination would trigger this anti-dilution adjustment for the benefit of the sponsor. Response: The Company acknowledges the Staff’s comment and has revised the disclosures on the cover page to clarify that the Sponsor has anti-dilution rights with respect to its OACB Private Placement Warrants and that there is no proposed financing in connection with the Business Combination that would trigger an anti-dilution adjustment for the OACB Private Placement Warrants. Questions and Answers about the Business Combination What equity stake will current OACB shareholders and Alvotech Shareholders have in TopCo after the Closing, page 10 3. We note that the table illustrating the ownership levels in TopCo excludes the impact of the shares underlying the TopCo warrants. Please disclose the sponsor and its affiliates’ total potential ownership interest in the combined company, assuming exercise and conversion of all securities. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 9 through 11 to include the impact of the shares underlying the TopCo warrants and clarify the sponsor and its affiliates’ total potential ownership in the combined company. 4. Revise your disclosure here and throughout the prospectus to show the potential impact of redemptions on the per share value of the shares owned by non-redeeming shareholders by including a tabular presentation in relation to redemptions showing a range of redemption scenarios, including an interim redemption level in addition to the minimum and maximum interim redemption levels that you currently present. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 9 through 11 to present a tabular presentation of the range redemption scenarios and the potential impact of redemptions on the per share value of the shares owned by the non-redeeming shareholders. 5. Please revise to disclose all possible sources and extent of dilution that shareholders who elect not to redeem their shares may experience in connection with the business combination. Provide disclosure of the impact of each significant source of dilution, including the amount of equity held by founders, convertible securities, including warrants retained by redeeming shareholders, at each of the redemption levels detailed in your sensitivity analysis, including any needed assumptions. Response: The Company acknowledges the Staff’s comment and has revised the disclosure in the tabular presentation referred to in the response to Comment 4 to disclose all possible sources and extent of dilution that shareholders who elect not to redeem their shares may experience in connection with the Business Combination. 2 What interests do OACB’s current officers and directors have in the Business Combination, page 12 6. We note your disclosure here and on page 25 concerning the interests of the sponsor and OACB’s officers and directors in the business combination. Please expand your disclosure to quantify the aggregate dollar amount of what the sponsor, the company’s officers and directors or any of their affiliates have at risk that depends on completion of a business combination. Include the current value of securities held, loans extended, fees due, and out-of-pocket expenses for which the sponsor, OACB’s officers and directors or any of their respective affiliates are awaiting reimbursement. For example, we note your disclosure in a risk factor on page 112 stating that at the close of the business combination, the sponsor and OACB’s executive officers and directors, and any of their respective affiliates, will be reimbursed for out-of-pocket expenses. Response: The Company acknowledges the Staff’s comment and has revised the disclosures on pages 14, 32, 117,118, 146, 163 and 164 to quantify the aggregate dollar amount and describe the nature of what the sponsor and the Company’s officers and directors have at risk that depends on the completion of a business combination. 7. Please also clarify in your discussion of the interests of the sponsor and OACB’s officers and directors whether the sponsor and its affiliates can earn a positive rate of return on their investment, even if other SPAC shareholders experience a negative rate of return in the post-business combination company. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 14, 21, 117, 118, 163 and 164 to disclose that the sponsor and its affiliates can earn a positive rate of return on their investment, even if other SPAC shareholders experience a negative rate of return in the post-business combination company. 8. We note your disclosure that certain affiliates of the sponsor have an ownership interest in the target company. Please provide that interest as an approximate dollar value based on the transaction value and recent trading prices as compared to the price paid. Response: The Company acknowledges the Staff’s comment and has revised the disclosures on pages 14, 32, 117, 146 and 163 accordingly. 9. It appears that OACB’s articles of association waived the corporate opportunities doctrine. Please address this potential conflict of interest and whether it impacted your search for an acquisition target. Response: The Company acknowledges the Staff’s comment and confirms that the potential conflict of interest relating to the waiver of the corporate opportunities’ doctrine in OACB’s articles of association did not impact OACB’s search for an acquisition target. OACB further confirms for the Staff that OACB was not prevented from reviewing any opportunities as a result of such waiver. The disclosure on page 292 of the Registration Statement has been revised in response to the Staff’s comment. 3 10. We note your disclosure here and elsewhere throughout the prospectus, including on page 261, that certain shareholders agreed to waive their redemption rights. Please describe any consideration provided in exchange for this agreement. Please also revise your disclosure summarizing the background of the business combination beginning on page 143 to discuss the negotiation of this agreement. Response: The Company acknowledges the Staff’s comment and has revised the disclosures on pages 13, 32, 117, 145 and 163 to note that no consideration was received in exchange for entering into the agreement and the disclosure on page 151 to summarize the background of the agreement between the SPAC and the shareholders to waive their respective redemption rights. Do I have redemption rights, page 13 11. We note your disclosure here that holders of public warrants do not have redemption rights with respect to such warrants in connection with the business combination. Quantify the value of warrants, based on recent trading prices, that may be retained by redeeming stockholders assuming maximum redemptions and identify any material resulting risks. Response: The Company acknowledges the Staff’s comment and has revised the disclosures on pages 19 through 21 to quantify the value of the warrants, based on recent trading prices, that may be retained by redeeming stockholders assuming maximum redemptions and identify any material resulting risks. 12. It appears that underwriting fees remain constant and are not adjusted based on redemptions. Revise your disclosure to disclose the effective underwriting fee on a percentage basis for shares at each redemption level presented in your sensitivity analysis related to dilution. Response: The Company acknowledges the Staff’s comment and has revised the disclosure in the tabular presentation referred to in the response to Comment 3 to disclose the effective underwriting fee on a percentage basis for shares at each redemption level. Risk Factors Risks Related to OACB and the Business Combination, page 104 13. Please include risk factor disclosure that highlights the material risks to public warrant holders, including those arising from differences between private and public warrants. Clarify whether recent common stock trading prices exceed the threshold that would allow the company to redeem public warrants. Clearly explain the steps, if any, the company will take to notify all shareholders, including beneficial owners, regarding when the warrants become eligible for redemption. Response: The Company acknowledges the Staff’s comment and has included disclosure on pages 15, 16, 119 and 120 to highlight the material risks to public warrant holders, clarify whether recent common stock trading prices exceed the threshold that would allow the Company to redeem public warrants and clearly explain the steps the Company will take to notify all shareholders of when the warrants become eligible for redemption. 4 14. Disclose the material risks to unaffiliated investors presented by taking the company public through a merger rather than an underwritten offering. These risks could include the absence of due diligence conducted by an underwriter that would be subject to liability for any material misstatements or omissions in a registration statement. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page 113 to disclose the material risks to unaffiliated investors presented by taking the Company public through a merger rather than an underwritten offering. Since Sponsor and OACB executive officers and directors will not be eligible to be reimbursed for their out-of-pocket expenses, page 112 15. Please revise this risk factor to more clearly state that because the sponsor will benefit from the completion of a business combination and may be incentivized to complete an acquisition of a less favorable target company or on terms less favorable to shareholders rather than liquidate. Please also highlight this risk in the Summary of the Proxy Statement/Prospectus. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 14, 32, 118, 122, 146 and 164 to highlight the risk that the sponsor will benefit from the completion of a business combination and may be incentivized to complete an acquisition of a less favorable target company or on terms less favorable to shareholders rather than liquidate. The Business Combination The Background of the Business Combination, page 143 16. Substantially revise the Background section to detail the negotiations concerning key aspects of the Business Combination and related transactions, including without limitation, the scope and valuation of the target’s business, the merger consideration, and the structure of the transaction (including the negotiation and marketing processes for the PIPE transaction). Each proposal (preliminary or otherwise) and counterproposal concerning a material transaction term made between April 9 and December 7 should be described and the proposing party identified. In this regard, we note that the Background section as written discusses in general terms the topical areas discussed by the parties during the eight month negotiations and some of the final terms they mutually agreed upon but does so without any indication of how those terms evolved during the course of the discussions/negotiations. Response: The Company acknowledges the Staff’s comment and has revised the disclosures on pages 151 through 158. 5 17. Please expand your disclosure on page 143 to describe how Alvotech was identified as a target and by whom. Response: The Company acknowledges the Staff’s comment and has revised the disclosures on page 152. 18. We note that Deutsche Bank Securities Inc. and Citibank Global Markets Inc. are serving as financial and capital markets advisors to you and also served as underwriters in the IPO and are eligible to receive deferred underwriting compensation. Please revise to disclose these conflicts of interest in the Summary and throughout your registration statement, as appropriate. Response: The Company acknowledges the Staff’s comment and has revised the disclosures on page 153. 19. Please clarify whether any discussions took place with the target about the potential loss of clients in the near future or other events that may materially affect the target’s prospects or its financial projections for future performance of the business. Response: The Company acknowledges the Staff’s comment and respectfully advises the Staff that no specific discussions took place with the target regarding potential client loss or material deviations from its financial projections. OACB considered these topics in discussions surrounding valuation of the target. Regulatory approval for its near term products, which OACB viewed as the most significant factor affecting future projections, was then incorporated in the valuation. 20. Please clarify whether there were any valuations or other material information about the SPAC, the target, or the de-SPAC transaction provided to potential PIPE investors that have not been disclosed publicly. Response: The Company acknowledges the Staff’s comment and respectfully advises the Staff that all material valuations or other transaction information about OACB, Alvotech or the de-SPAC transaction provided to PIPE investors has been disclosed publicly. However, certain prospective and actual PIPE investors received certain more detailed non-public information about OACB, Alvotech and the proposed business combination. Al
2022-01-18 - UPLOAD - Alvotech
United States securities and exchange commission logo
January 18, 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.
Registration Statement on Form F-4
Filed December 20, 2021
File No. 333-261773
Dear Mr. Wessman:
We have reviewed your 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.
Registration Statement on Form F-4 filed December 20, 2021
Cover Page
1.Disclose if the SPAC’s sponsors, directors, officers or their affiliates will participate in the
PIPE Financing.
2.We note your disclosure here that the Sponsor has agreed to, among other things, waive its
anti-dilution rights with respect to its OACB Class B Ordinary Shares in connection with
the consummation of the Business Combination. We also note a reference on page F-47 to
an anti-dilution adjustment with respect to the OACB private placement warrants, which
are also held by the Sponsor. Please clarify whether the sponsor also has anti-dilution
rights with respect to its OACB private placement warrants and whether any financing
FirstName LastNameRobert Wessman
Comapany NameAlvotech Lux Holdings S.A.S.
January 18, 2022 Page 2
FirstName LastName
Robert Wessman
Alvotech Lux Holdings S.A.S.
January 18, 2022
Page 2
affiliated with the business combination would trigger this anti-dilution adjustment for the
benefit of the sponsor.
Questions and Answers about the Business Combination
What equity stake will current OACB shareholders and Alvotech Shareholders have in TopCo
after the Closing, page 10
3.We note that the table illustrating the ownership levels in TopCo excludes the impact of
the shares underlying the TopCo warrants. Please disclose the sponsor and its affiliates'
total potential ownership interest in the combined company, assuming exercise and
conversion of all securities.
4.Revise your disclosure here and throughout the prospectus to show the potential impact of
redemptions on the per share value of the shares owned by non-redeeming shareholders by
including a tabular presentation in relation to redemptions showing a range of redemption
scenarios, including an interim redemption level in addition to the minimum and
maximum interim redemption levels that you currently present.
5.Please revise to disclose all possible sources and extent of dilution that shareholders who
elect not to redeem their shares may experience in connection with the business
combination. Provide disclosure of the impact of each significant source of dilution,
including the amount of equity held by founders, convertible securities, including warrants
retained by redeeming shareholders, at each of the redemption levels detailed in your
sensitivity analysis, including any needed assumptions.
What interests do OACB’s current officers and directors have in the Business Combination, page
12
6.We note your disclosure here and on page 25 concerning the interests of the sponsor and
OACB's officers and directors in the business combination. Please expand your disclosure
to quantify the aggregate dollar amount of what the sponsor, the company's officers and
directors or any of their affiliates have at risk that depends on completion of a business
combination. Include the current value of securities held, loans extended, fees due, and
out-of-pocket expenses for which the sponsor, OACB's officers and directors or any of
their respective affiliates are awaiting reimbursement. For example, we note your
disclosure in a risk factor on page 112 stating that at the close of the business
combination, the sponsor and OACB's executive officers and directors, and any of their
respective affiliates, will be reimbursed for out-of-pocket expenses.
7.Please also clarify in your discussion of the interests of the sponsor and OACB's officers
and directors whether the sponsor and its affiliates can earn a positive rate of return on
their investment, even if other SPAC shareholders experience a negative rate of return in
the post-business combination company.
FirstName LastNameRobert Wessman
Comapany NameAlvotech Lux Holdings S.A.S.
January 18, 2022 Page 3
FirstName LastName
Robert Wessman
Alvotech Lux Holdings S.A.S.
January 18, 2022
Page 3
8.We note your disclosure that certain affiliates of the sponsor have an ownership interest in
the target company. Please provide that interest as an approximate dollar value based on
the transaction value and recent trading prices as compared to the price paid.
9.It appears that OACB's articles of association waived the corporate opportunities doctrine.
Please address this potential conflict of interest and whether it impacted your search for an
acquisition target.
10.We note your disclosure here and elsewhere throughout the prospectus, including on page
261, that certain shareholders agreed to waive their redemption rights. Please describe any
consideration provided in exchange for this agreement. Please also revise your disclosure
summarizing the background of the business combination beginning on page 143 to
discuss the negotiation of this agreement.
Do I have redemption rights, page 13
11.We note your disclosure here that holders of public warrants do not have redemption
rights with respect to such warrants in connection with the business combination. Quantify
the value of warrants, based on recent trading prices, that may be retained by redeeming
stockholders assuming maximum redemptions and identify any material resulting risks.
12.It appears that underwriting fees remain constant and are not adjusted based on
redemptions. Revise your disclosure to disclose the effective underwriting fee on a
percentage basis for shares at each redemption level presented in your sensitivity analysis
related to dilution.
Risk Factors
Risks Related to OACB and the Business Combination, page 104
13.Please include risk factor disclosure that highlights the material risks to public warrant
holders, including those arising from differences between private and public warrants.
Clarify whether recent common stock trading prices exceed the threshold that would allow
the company to redeem public warrants. Clearly explain the steps, if any, the company
will take to notify all shareholders, including beneficial owners, regarding when the
warrants become eligible for redemption.
14.Disclose the material risks to unaffiliated investors presented by taking the company
public through a merger rather than an underwritten offering. These risks could include
the absence of due diligence conducted by an underwriter that would be subject to liability
for any material misstatements or omissions in a registration statement.
Since Sponsor and OACB executive officers and directors will not be eligible to be reimbursed
for their out-of-pocket expenses, page 112
15.Please revise this risk factor to more clearly state that because the sponsor will benefit
from the completion of a business combination and may be incentivized to complete an
acquisition of a less favorable target company or on terms less favorable to shareholders
FirstName LastNameRobert Wessman
Comapany NameAlvotech Lux Holdings S.A.S.
January 18, 2022 Page 4
FirstName LastNameRobert Wessman
Alvotech Lux Holdings S.A.S.
January 18, 2022
Page 4
rather than liquidate. Please also highlight this risk in the Summary of the Proxy
Statement/Prospectus.
The Business Combination
The Background of the Business Combination, page 143
16.Substantially revise the Background section to detail the negotiations concerning key
aspects of the Business Combination and related transactions, including without
limitation, the scope and valuation of the target's business, the merger
consideration, and the structure of the transaction (including the negotiation and
marketing processes for the PIPE transaction). Each proposal (preliminary or otherwise)
and counterproposal concerning a material transaction term made between April 9 and
December 7 should be described and the proposing party identified. In this regard, we
note that the Background section as written discusses in general terms the topical areas
discussed by the parties during the eight month negotiations and some of the final terms
they mutually agreed upon but does so without any indication of how those terms evolved
during the course of the discussions/negotiations.
17.Please expand your disclosure on page 143 to describe how Alvotech was identified as a
target and by whom.
18.We note that Deutsche Bank Securities Inc. and Citibank Global Markets Inc. are serving
as financial and capital markets advisors to you and also served as underwriters in the IPO
and are eligible to receive deferred underwriting compensation. Please revise to disclose
these conflicts of interest in the Summary and throughout your registration statement, as
appropriate.
19.Please clarify whether any discussions took place with the target about the potential loss
of clients in the near future or other events that may materially affect the target’s prospects
or its financial projections for future performance of the business.
20.Please clarify whether there were any valuations or other material information about the
SPAC, the target, or the de-SPAC transaction provided to potential PIPE investors that
have not been disclosed publicly.
21.Please revise your disclosure to include any discussions about continuing employment or
involvement for any persons affiliated with the SPAC before the merger, any formal or
informal commitment to retain the financial advisors after the merger, and any pre-
existing relationships between SPAC sponsors and additional investors.
Certain Engagements in Connection with the Business Combination and Related Transactions,
page 152
22.We note your disclosure that with respect to the transaction, Morgan Stanley and Credit
Suisse were engaged as financial advisors to Alvotech and Deutsche Bank was engaged as
a financial advisor and capital markets advisor to OACB. We also note your disclosure on
FirstName LastNameRobert Wessman
Comapany NameAlvotech Lux Holdings S.A.S.
January 18, 2022 Page 5
FirstName LastNameRobert Wessman
Alvotech Lux Holdings S.A.S.
January 18, 2022
Page 5
page 144 that Citibank was also involved in discussions with the other three banks as early
as May 11, 2021. Please expand your disclosure in the Background section to further
describe the role of these financial advisors in the transaction. In particular, please
disclose when each financial advisor was engaged and the level of diligence they
performed in connection with the transaction.
The Business Combination
Comparable Public Companies, page 152
23.Please revise to explain the basis for including each of the comparable public companies
shown or excluding any public companies.
24.Please explain how you determined Alvotech’s “TAM--Current Pipeline” as based on
reports provided by Evaluate Pharma and the following Alvotech growth projections as
based on reports provided by CapIQ and Refinitiv: “2021-2025 Revenue CAGR,” “2025E
Gross Margin” and “2025E Adj. EBITDA Margin.” If these reports were not used, explain
how you determined these amounts. Revise your presentation accordingly.
Certain Unaudited Alvotech Prospective Financial Information, page 154
25.Please provide us an analysis by year demonstrating the growth in total Alvotech revenue
from $30 to $60 million for FY 2021 to an amount greater than $800 million for FY 2025
and the improvement in Adjusted EBITDA from ($150) million to ($200) million for FY
2021 to an amount greater than $460 million for FY 2025 and revise your presentation
accordingly. In this regard, quantify EBITDA and reconcile it to Adjusted EBITDA for
each year. Also, provide us the following information.
•Describe and quantify the key assumptions underlying these financial
projections, how they were developed and the factors considered by OACB's Board
in concluding that they were reasonable.
•Describe alternative financial projections that were considered and (if any) and the
basis for their rejection.
•Describe how these financial projections were used in your $2.3 billion valuation of
Alvotech, as indicated on page 153.
•Provide a breakdown of future revenue by commercialization partner and type of
payment for each year during 2021-2025.
•Provide a breakdown of Adjusted EBITDA by source for each year during 2021-
2025.
•Describe and quantify the key factors underlying significant year-to-year changes in
revenues by partner and Adjusted EBITDA by source during 2021-2025.
26.Please provide a list of your “strategic commercialization partnerships” with leading
pharmaceutical companies, as discussed in the sixth bullet on page 156, and summarize
key terms governing each partnership. In this regard, demonstrate how you determined
their future remittances under these partnerships is expected to be “on average
approximately 40% of in-market sales" and provide a milestone breakdown by partner and
FirstName LastNameRobert Wessman
Comapany NameAlvotech Lux Holdings S.A.S.
January 18, 2022 Page 6
FirstName LastNameRobert Wessman
Alvotech Lux Holdings S.A.S.
January 18, 2022
Page 6
year for the $150 million received to date and the $950 million to be received in the
future.
27.Please explain the likely impact on the future prospects of AVT02 resulting from the
recent FDA deferral of approval, as discussed on page 230, and associated litigation
initiated by AbbVie, as discussed on pages F-125 to F-127. Revise the third bullet on page
156 accordingly.
28.Please explain the qualitative and quantitative factors that you considered in establishing a
75% or higher probability of success for your clinical and pre-clinical programs and the
related launch of 5 products in more than 50 markets by 2025. Revise the seventh bullet
on page 156 accordingly.
The Business Combination Agreement
Conditions to Closing the Business Combination, page 164
29.Please clarify which conditions are subject to waiver.
U.S. Federal Income Tax Considerations, page 176
30.We note your disclosure that the transaction "generally should qualify as an F
Reorganization" and that a U.S. Holder should not recognize any gain or loss. A tax
opinion must be filed whenever the tax consequences of a transaction are material to an
investor and a representation as to tax consequences is set forth in the filing. Please file a
tax opinion as an exhibit to the filing or provide us your analysis as to why you do not
believe such an opinion is required. Refer to Item 601(b)(8) of Regulation S-K and, for
guidance, Section III.A.2 of Staff Legal Bulletin No. 19. Additionally, please also refer to
Sections III.C.3 and 4 of Staff Legal Bulletin No. 19 concerning assumptions and opinions
subject to uncertainty. In this regard, we note the disclosure that the transaction "generally
should qualify as an F Reorganization." If there is uncertainty regarding the tax treatment,
counsel’s opinion should discuss the degree of uncertainty.
Business of Alvotech
Third Party Suppliers and Manufacturers, page 201
31.Please expand your disclosure to include a description of the sources and availability of
your raw materials, including a description of whether prices of principal raw materials
are volatile. Refer to Item 4.B.4. of Form 20-F.
Commercial partnerships, page 202
32.We note your disclosure here concerning your principal partners and partnerships by