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2025-08-25
ARGENX SE
Filing - SEC Comment Letter to ARGENX SE
UPLOAD · 2025-08-25
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2025-09-25
ARGENX SE
References: August 25, 2025
Filing - Correspondence from ARGENX SE
CORRESP · 2025-09-25
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ARGENX SE
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2017-11-14
ARGENX SE
Filing - SEC Comment Letter to ARGENX SE
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2017-12-11
ARGENX SE
Filing - Correspondence from ARGENX SE
CORRESP · 2017-12-11
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2017-12-11
ARGENX SE
Filing - Correspondence from ARGENX SE
CORRESP · 2017-12-11
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ARGENX SE
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2017-05-03
ARGENX SE
Filing - SEC Comment Letter to ARGENX SE
UPLOAD · 2017-05-03
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2017-05-03
ARGENX SE
References: May 2, 2017
Filing - Correspondence from ARGENX SE
CORRESP · 2017-05-03
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2017-05-08
ARGENX SE
References: May 5, 2017
Filing - Correspondence from ARGENX SE
CORRESP · 2017-05-08
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2017-05-16
ARGENX SE
References: May 12, 2017
Filing - Correspondence from ARGENX SE
CORRESP · 2017-05-16
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2017-05-16
ARGENX SE
Filing - Correspondence from ARGENX SE
CORRESP · 2017-05-16
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2017-05-16
ARGENX SE
Filing - Correspondence from ARGENX SE
CORRESP · 2017-05-16
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2017-05-17
ARGENX SE
References: May 16, 2017
Filing - Correspondence from ARGENX SE
CORRESP · 2017-05-17
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ARGENX SE
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2017-05-17
ARGENX SE
Filing - SEC Comment Letter to ARGENX SE
UPLOAD · 2017-05-17
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ARGENX SE
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2017-05-15
ARGENX SE
Filing - SEC Comment Letter to ARGENX SE
UPLOAD · 2017-05-15
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ARGENX SE
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2017-05-05
ARGENX SE
Filing - SEC Comment Letter to ARGENX SE
UPLOAD · 2017-05-05
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2017-04-19
ARGENX SE
Filing - SEC Comment Letter to ARGENX SE
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2017-04-21
ARGENX SE
References: April 19, 2017
Filing - Correspondence from ARGENX SE
CORRESP · 2017-04-21
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ARGENX SE
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SEC wrote to company
2017-03-29
ARGENX SE
Filing - SEC Comment Letter to ARGENX SE
UPLOAD · 2017-03-29
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-18 | SEC Comment Letter | ARGENX SE | Netherlands | 001-38097 | Read Filing View |
| 2025-09-25 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2025-08-25 | SEC Comment Letter | ARGENX SE | Netherlands | 001-38097 | Read Filing View |
| 2017-12-11 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-12-11 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-11-14 | SEC Comment Letter | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-17 | SEC Comment Letter | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-17 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-16 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-16 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-16 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-15 | SEC Comment Letter | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-08 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-05 | SEC Comment Letter | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-03 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-03 | SEC Comment Letter | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-04-21 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-04-19 | SEC Comment Letter | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-03-29 | SEC Comment Letter | ARGENX SE | Netherlands | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-18 | SEC Comment Letter | ARGENX SE | Netherlands | 001-38097 | Read Filing View |
| 2025-08-25 | SEC Comment Letter | ARGENX SE | Netherlands | 001-38097 | Read Filing View |
| 2017-11-14 | SEC Comment Letter | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-17 | SEC Comment Letter | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-15 | SEC Comment Letter | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-05 | SEC Comment Letter | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-03 | SEC Comment Letter | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-04-19 | SEC Comment Letter | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-03-29 | SEC Comment Letter | ARGENX SE | Netherlands | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-25 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-12-11 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-12-11 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-17 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-16 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-16 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-16 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-08 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-05-03 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
| 2017-04-21 | Company Response | ARGENX SE | Netherlands | N/A | Read Filing View |
2025-12-18 - UPLOAD - ARGENX SE File: 001-38097
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> December 18, 2025 Karl Gubitz Chief Financial Officer argenx SE Laarderhoogtweg 25 1101 EB Amsterdam Re: argenx SE Form 20-F for Fiscal Year Ended December 31, 2024 File No. 001-38097 Dear Karl Gubitz: 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>
2025-09-25 - CORRESP - ARGENX SE
CORRESP
1
filename1.htm
September 25, 2025
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
Attention: Bonnie Baynes
Daniel Gordon
Lauren Sprague Hamill
Alan Campbell
RE: argenx
SE
Form 20-F for Fiscal Year Ended December 31, 2024
Filed March 20, 2025
File No. 001-38097
Dear Ms. Baynes, Mr. Gordon, Ms. Hamill
and Mr. Campbell,
argenx SE (“argenx” or the
“Company”) is submitting this letter in response to comments from the staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) contained in its letter dated August 25, 2025, relating
to the above referenced Annual Report on Form 20-F for the year ended December 31, 2024 filed with the Commission on March 20,
2025 (the “Form 20-F”).
For your convenience, we have reproduced the
Staff’s comments preceding the Company’s responses below. All capitalized and uncapitalized (but defined) terms used and
not defined herein shall have the meaning given to them in the Form 20-F.
Form 20-F for Fiscal Year Ended December 31, 2024
Item 4.B Business Overview
Intellectual Property, page 55
1. Based on your patent disclosures on page 56,
it appears that two U.S. patents related to composition of matter claims pertaining to the
NHANCE platform will expire earliest in 2027 to 2028. In this regard, we note your disclosure
on page 55 that the Company is “materially dependent” on regulatory, patent
and other proprietary protection related to its core platform technologies, including NHANCE.
As appropriate in future filings, please provide risk factor disclosure discussing the extent
to which you face material risk stemming from the expiration of these patents, or otherwise
advise.
Response: The Company respectfully
submits that the expiration of the NHANCE patents in 2027 or 2028 does not currently present a material risk to the Company. Materiality
arises in this instance if these patents cover third-party activities and these third parties would be liable for infringement.
Based on publicly available information on current clinical development timelines, the Company does not believe this to be the case.
argenx
SE
Laarderhoogtweg
25
1101,
EB, Amsterdam
The Netherlands
T: +32
9 310 34 00 BTW BE 0818.292.196 IBAN: BE46 7370 2845 9126 info@argenx.com www.argenx.com
In consideration of the Staff’s comment,
the Company expects to include a clarification in its Annual Report on Form 20-F for the year ended December 31, 2025 substantially
as set forth below.
Specifically,
we are materially dependent on elements of our regulatory, patent and other proprietary protection, including certain of those related
to our core platform technologies, described in Section 1.6.2 “Platform Technologies” below and our product
candidates, as described in Section 1.6.3 “Our Internal Programs” below and Section 1.6.4 “Our Partnered
Programs” below.
2. We note that you do not include discussion
of any patent rights directed to efgartigimod on page 56. To the extent any patent rights
that you own or license with respect to this program are material to your business, please
revise future filings to include disclosure that describes such patents or patent applications
on an individual or patent family basis, or otherwise advise.
Response: The Company respectfully refers the
Staff to the section titled “Platform Technologies” on page 56 of the Form 20-F, which includes disclosure on the
patent portfolio used for the Company’s ABDEGTM platform. As disclosed, for the Company’s ABDEGTM platform,
which is incorporated in efgartigimod, the Company has a broad patent portfolio with multiple patent families that cover, or are intended
to cover, the composition of matter and/or uses of certain FcRn antagonists to achieve disease-modifying effects. The composition of
matter and other relevant patents arising from the same patent family in the U.S. are set to expire in 2036 while in many other countries
the base expiry date is 2034. The Company anticipates several more patient innovations to evolve during development for which it intends
to seek additional patent protection with later expiration dates.
In consideration of the Staff’s comment,
the Company expects to include a clarification in its Annual Report on Form 20-F for the year ended December 31, 2025 substantially
as set forth below.
Our Internal Programs
efgartigimod
efgartigimod
incorporates the ABDEG™ platform technology, for which we co-own the technology with the University of Texas Southwestern Medical
Center and enjoy certain exclusive license rights. We have a broad patent portfolio with multiple patent families covering the composition
of matter and uses of certain FcRn antagonists to achieve disease-modifying effects. The composition of matter and other relevant patents
arising from the same patent family in the U.S. expire in 2036 whereas in many other countries the base expiry date is 2034. We anticipate
several more patient innovations to evolve during development for which we intend to seek additional patent protection with later expiration
dates.
2 |
ITEM 5.A. Operating and Financial Review
and Prospects - Operating Results
Results of Operations - Product Net Sales,
page 87
3. We note your disclosures on pages 87
and F-2 of operating results and the notes to the financial statement that your principal
source of revenue is product net sales, specifically from sales of VYVGART and VYVGART SC.
We also note your disaggregation of product net sales by geography on pages 87 and F-34.
Please tell us how you considered further disaggregating your product net sales revenue in
accordance with paragraph 114 of IFRS 15 and paragraph 32 of IFRS 8, specifically whether
you considered disaggregating by product categories including VYVGART and VYVGART SC.
Response: The Company respectfully acknowledges
the Staff’s comment and the requirements of (i) paragraph 114 of IFRS 15 regarding the disaggregation of revenue into categories,
and (ii) paragraph 32 of IFRS 8 concerning the disclosure of revenue by product or group of similar products.
The Company’s principal source of revenue
consists of product net sales of VYVGART (efgartigimod alpha). As defined in the Form 20-F, VYVGART should be read as references
to VYVGART IV and/or VYVGART SC, including VYVGART HYTRULO in relation to the U.S. and China, VYVGART in relation to the EU and the UK
and VYVDURA in relation to Japan.
VYVGART IV and VYVGART SC are two formulations
of the same primary biologic active substance, efgartigimod alfa (referred to as VYVGART). VYVGART IV is administered intravenously,
while VYVGART SC is delivered subcutaneously. Although the method of administration (‘‘MoA’’) differ,
both formulations are designed to achieve the same therapeutic objective. The availability of both options provides flexibility and interchangeability
in treatment administration, allowing physicians to tailor therapy based on individual patient needs and preferences. The Company submits
that this supports the conclusion that the products are similar for disclosure purposes. In reaching this view, the Company has considered
the similarities in production and distribution processes, customer base, applicable regulatory frameworks across jurisdictions, and
the underlying economic characteristics of the products, notwithstanding an alternative method of administration.
As part of the Company’s periodic internal
controls over financial reporting, the Company assesses whether the level of revenue disaggregation is appropriate and sufficient pursuant
to the IFRS requirements mentioned above. As disclosed in the Form 20-F, the Company disaggregates total revenues by jurisdiction/countries
to comply with the requirements of IFRS 8.33, which requires disclosure of separate revenues from external customers attributed to an
individual foreign country, where those revenues are material.
3 |
Based on the Company’s assessment performed
prior to the filing referred to herein, the Company concluded that additional disaggregation is not required under IFRS 15.114 and IFRS
8.32 for the following reasons.
IFRS 15 Considerations
Paragraph 114 of IFRS 15 requires an entity to
disaggregate revenue from contracts with customers into categories that depict how the nature, amount, timing and uncertainty of revenue
and cash flows are affected by economic factors. A patient and their physician’s choice between VYVGART IV and VYVGART SC does
not result in a material difference in the amount, the timing and the uncertainty of revenue and cash flows. As detailed above, the nature
of both MoAs delivers the same therapeutic value.
Additionally, paragraph B88 of IFRS 15 requires
entities to consider how the information about the entity’s revenue is presented for other purposes including:
· disclosures
presented outside of the financial statements,
· information
regularly reviewed by the chief operating decision maker (“CODM”) for
evaluating the financial performance of operating segments, and
· other
information that is similarly used by an entity or users of an entity’s financial statements
to evaluate the entity’s financial performance or make resource allocation decisions.
The Company respectfully advises the Staff of
the following:
· It
has not publicly disclosed, nor otherwise presented, a disaggregation of revenues by MoA.
Any internal analyses or assessments, to the extent they exist, have not been shared with
external stakeholders for investment-related purposes and are not considered part of the
Company’s public disclosures. This is applicable to quarterly investor presentations,
press releases or other publicly available disclosures.
· The
CODM regularly reviews the Company’s aggregated product net sales (consisting of sales
of both VYVGART IV and VYVGART SC) to evaluate the financial performance of
its commercial function.
· Revenue
by MoA is internally available for operational planning purposes, however, the Company’s
financial performance and resource allocation is primarily based on aggregated sales of VYVGART
IV and VYVGART SC. The commercialization of the Company’s products is managed as a
single reporting function which is consistent with its organizational structure.
In addition, considering
factors in paragraph B89 of IFRS 15, the choice between VYVGART IV and VYVGART SC does not affect the type of customer.
The Company’s customers under IFRS 15 consist mainly of the distributor and/or the wholesaler who carry both MoAs. The contract
type or duration, sales channel, and timing of revenue recognition or cash flows are the same or similar under both MoAs. Each MoA must
be approved in each geography based on local laws and regulations under the same or similar process for each MoA.
The Company therefore concludes that under IFRS,
VYVGART encompasses both MoAs as a single group of similar products.
4 |
IFRS 8 Considerations
Paragraph 32 of IFRS 8 requires entities to report revenues from external
customers for each product and service, or each group of similar products and services.
The Company believes that VYVGART IV and VYVGART
SC constitute a single group of similar products due to their shared molecule, therapeutic purpose, integrated commercial strategy, and
similar economic and revenue recognition characteristics. The Company’s presentation of product net sales (including sales of both
VYVGART IV and VYVGART SC) is consistent with how the Company’s CODM reviews the Company’s financial performance and consistent
with disclosures about its products outside of the financial statements.
As such, the Company believes that its current
disclosure complies with the requirements of paragraph 114 of IFRS 15 and paragraph 32 of IFRS 8, and that further disaggregation is
not necessary or appropriate.
The Company continues to monitor its internal
reporting structure and external regulatory developments to evaluate whether changes to revenue disaggregation or segment disclosures
are warranted. This evaluation is performed at each reporting period in accordance with IFRS 15 and IFRS 8.
Note 27. Contingencies, page F-46
4. We note your disclosures that as of December 31,
2024 you had no outstanding claims or litigation that may have a significant adverse impact
to you, and your risk factor on page 9 that your products and product candidates may
have serious adverse, undesirable or unacceptable side effects. We also note the FDA’s
June 30, 2025 FAERS report of Vyvgart Hytrulo’s potential serious risk where the
FDA is evaluation the need for regulatory action and the related Pomerantz LLP law firm July 1,
2025 investigation regarding whether the Company and its directors and officers have engaged
in securities fraud or other unlawful business practices. Please tell us, with a view toward
future disclosure, your consideration of disclosing this information that appears may be
material to understanding or assessing your business, financial condition and results of
operations.
Response: The Company respectfully submits that
the FDA’s FAERS report dated June 30, 2025 (the “Report”) does not require any update to the risk
disclosures on page 9 of the Form 20-F. The Company believes those disclosures remain accurate in all material respects.
The Company notes that the Report does not indicate
any causality between Vyvgart Hytrulo and reported adverse events and does not reflect a benefit-risk statement on the use of Vyvgart
Hytrulo in the treatment of chronic inflammatory demyelinating polyneuropathy (“CIDP”). The Company continues
to monitor the reporting of any adverse effects of Vyvgart Hytrulo in the treatment of CIDP and is following the normal comment procedure
with the FDA regarding the Report.
5 |
With respect to attorney advertising soliciting
clients, such solicitations do not constitute an “outstanding c
2025-08-25 - UPLOAD - ARGENX SE File: 001-38097
August 25, 2025
Karl Gubitz
Chief Financial Officer
ARGENX SE
Laarderhoogtweg 25
1101 EB Amsterdam
Re:ARGENX SE
Form 20-F for Fiscal Year Ended December 31, 2024
File No. 001-38097
Dear Karl Gubitz:
We have reviewed your filing and have the following comments.
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
Item 4.B Business Overview
Intellectual Property, page 55
1.Based on your patent disclosures on page 56, it appears that two U.S. patents related
to composition of matter claims pertaining to the NHANCE platform will expire
earliest in 2027 to 2028. In this regard, we note your disclosure on page 55 that the
Company is "materially dependent" on regulatory, patent and other proprietary
protection related to its core platform technologies, including NHANCE. As
appropriate in future filings, please provide risk factor disclosure discussing the extent
to which you face material risk stemming from the expiration of these patents, or
otherwise advise.
2.We note that you do not include discussion of any patent rights directed to
efgartigimod on page 56. To the extent any patent rights that you own or license with
respect to this program are material to your business, please revise future filings to
include disclosure that describes such patents or patent applications on an individual
or patent family basis, or otherwise advise.
August 25, 2025
Page 2
ITEM 5.A. Operating and Financial Review and Prospects - Operating Results
Results of Operations - Product Net Sales, page 87
3.We note your disclosures on pages 87 and F-2 of operating results and the notes to the
financial statement that your principal source of revenue is product net sales,
specifically from sales of VYVGART and VYVGART SC. We also note your
disaggregation of product net sales by geography on pages 87 and F-34. Please tell us
how you considered further disaggregating your product net sales revenue in
accordance with paragraph 114 of IFRS 15 and paragraph 32 of IFRS 8,
specifically whether you considered disaggregating by product categories including
VYVGART and VYVGART SC.
Note 27. Contingencies, page F-46
4.We note your disclosures that as of December 31, 2024 you had no outstanding claims
or litigation that may have a significant adverse impact to you, and your risk factor on
page 9 that your products and product candidates may have serious adverse,
undesirable or unacceptable side effects. We also note the FDA's June 30,
2025 FAERS report of Vyvgart Hytrulo's potential serious risk where the FDA is
evaluation the need for regulatory action and the related Pomerantz LLP law firm July
1, 2025 investigation regarding whether the Company and its directors and officers
have engaged in securities fraud or other unlawful business practices. Please tell us,
with a view toward future disclosure, your consideration of disclosing this information
that appears may be material to understanding or assessing your business, financial
condition and results of operations.
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 Bonnie Baynes at 202-551-4924 or Daniel Gordon at 202-551-3486 if
you have questions regarding comments on the financial statements and related
matters. Please contact Lauren Sprague Hamill at 303-844-1008 or Alan Campbell at 202-
551-4224 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2017-12-11 - CORRESP - ARGENX SE
CORRESP 1 filename1.htm December 11, 2017 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4561 100 F Street, N.E. Washington, D.C. 20549 Attention: Jeffrey Gabor Re: argenx SE Acceleration Request for Registration Statement on Form F-1 File No. 333-221984 Ladies and Gentlemen: Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended, please be advised that we will take reasonable steps to secure adequate distribution of the preliminary prospectus to underwriters, dealers, institutions and others, prior to the requested effective time of the Registration Statement. We wish to advise you that the participating underwriters have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. We hereby join in the request of the registrant that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated to 4:00 p.m., Eastern Time, on December 13, 2017, or as soon thereafter as practicable. [Signature Page Follows] Very truly yours, COWEN AND COMPANY, LLC PIPER JAFFRAY & CO. As representatives of the Underwriters By: COWEN AND COMPANY, LLC By: /s/ Bill Follis Name: Bill Follis Title: Managing Director By: PIPER JAFFRAY & CO. By: /s/ Christie L. Christina Name: Christie L. Christina Title: Managing Director
2017-12-11 - CORRESP - ARGENX SE
CORRESP 1 filename1.htm December 11, 2017 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4561 100 F Street, N.E. Washington, D.C. 20549 Attention: Jeffrey Gabor Re: argenx SE Acceleration Request for Registration Statement on Form F-1 File No. 333-221984 Dear Mr. Gabor: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), argenx SE (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to December 13, 2017 at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP, by calling Edwin M. O’Connor at (212) 813-8853. We also respectfully request that a copy of the written order from the U.S. Securities and Exchange Commission verifying the effective time and date of the Registration Statement be sent to our counsel, Goodwin Procter LLP, Attention: Edwin M. O’Connor, by facsimile to (212) 937-3476. If you have any questions regarding this request, please contact Edwin M. O’Connor of Goodwin Procter LLP at (212) 813-8853. Sincerely, ARGENX SE /s/ Tim Van Hauwermeiren Tim Van Hauwermeiren Chief Executive Officer cc: Eric Castaldi, Chief Financial Officer, argenx SE Michael H. Bison, Goodwin Procter LLP Edwin O’ Connor, Goodwin Procter LLP
2017-11-14 - UPLOAD - ARGENX SE
November 13, 2017
Tim Van Hauwermeiren
Chief Executive Officer
argenx SE
Willemstraat 5
4811 AH, Breda, the Netherlands
argenx SE
Draft Registration Statement on Form F-1
Filed November 6, 2017
File No. 377-01775Re:
Dear Mr. Van Hauwermeiren:
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 Jeffrey Gabor at 202-551-2544 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Michael Bison
2017-05-17 - UPLOAD - ARGENX SE
Mail Stop 4546
May 16, 2017
Tim Van Hauwermeiren
Chief Executive Officer
argenx SE
Willemstraat 5
4811 AH, Breda, the Netherlands
Re: argenx SE
Amendment No. 3 to
Registration Statement on Form F -1
Filed May 16, 2017
File No. 333-217417
Dear Mr. Van Hauwermeiren:
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 bel ieve 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.
Exhibit 5.1
1. Please rem ove the limitation in Section 3(o): Jurisdiction on page 4 of the opinion . In the
alternative, please explain how the limitation is consistent with Section 14 of the
Securities Act.
Tim Van Hauwermeiren
argenx SE
May 16, 2017
Page 2
You may contact Sasha Parikh at (202) 551 -3627 or Kevin Vaughn, Accounting Branch
Chief, at (202) 551 -3494 if you have questions regarding comments on the financial statements
and related matters. Please contact Ada D. Sarmento at (202) 551 -3798 or Erin Jaskot, Special
Counsel, at (202) 551 -3442 with any other questio ns.
Sincerely,
/s/ Erin K. Jaskot, for
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Edwin O’Connor
Goodwin Procter LLP
2017-05-17 - CORRESP - ARGENX SE
CORRESP 1 filename1.htm Michael H. Bison 617.570.1933 mbison@goodwinlaw.com Goodwin Procter LLP Counselors at Law 100 Northern Avenue Boston, MA 02210 T: 617.570.1000 F: 617.523.1231 May 17, 2017 VIA EDGAR AND FEDERAL EXPRESS U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Re: argenx SE Amendment No. 3 to Registration Statement on Form F-1 Filed May 16, 2017 File No. 333-217417 Dear Ms. Hayes: This letter is being submitted on behalf of argenx SE (the “Company”) in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to Amendment No. 3 to the Company’s Registration Statement on Form F-1 filed on May 16, 2017 ( “Amendment No. 3”), as set forth in your letter dated May 16, 2017 addressed to Mr. Van Hauwermeiren, Chief Executive Officer of the Company (the “Comment Letter”). The Company is concurrently filing Amendment No. 4 to the Company’s Registration Statement on Form F-1 (“Amendment No. 4”), which includes changes to reflect responses to the Staff’s comments. For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. The responses provided herein are based upon information provided to Goodwin Procter LLP by the Company. In addition to submitting this letter via EDGAR, we are sending via Federal Express two copies of each of this letter and Amendment No. 4. Exhibit 5.1 1. Please remove the limitation in Section 3(o): Jurisdiction on page 4 of the opinion. In the alternative, please explain how the limitation is consistent with Section 14 of the Securities Act. RESPONSE: In response to the Staff’s comment, the Company’s counsel has removed the exclusive jurisdiction clause from Exhibit 5.1. If you should have any questions concerning the enclosed matters, please contact the undersigned at (617) 570-1933. Sincerely, /s/ Michael H. Bison Michael H. Bison Enclosures cc: Tim Van Hauwermeiren, Chief Executive Officer, argenx SE Eric Castaldi, Chief Financial Officer, argenx SE Edwin M. O’Connor, Goodwin Procter LLP 2
2017-05-16 - CORRESP - ARGENX SE
CORRESP 1 filename1.htm Michael H. Bison 617.570.1933 mbison@goodwinlaw.com Goodwin Procter LLP Counselors at Law 100 Northern Avenue Boston, MA 02210 T: 617.570.1000 F: 617.523.1231 May 16, 2017 VIA EDGAR AND FEDERAL EXPRESS U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Re: argenx SE Amendment No. 2 to Registration Statement on Form F-1 Filed May 8, 2017 File No. 333-217417 Dear Ms. Hayes: This letter is being submitted on behalf of argenx SE (the “Company”) in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to Amendment No. 2 to the Company’s Registration Statement on Form F-1 filed on May 8, 2017 ( “Amendment No. 2”), as set forth in your letter dated May 12, 2017 addressed to Mr. Van Hauwermeiren, Chief Executive Officer of the Company (the “Comment Letter”). The Company is concurrently filing Amendment No. 3 to the Company’s Registration Statement on Form F-1 ( “Amendment No. 3”), which includes changes to reflect responses to the Staff’s comments. For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the Staff’s comments refer to Amendment No. 2, and page references in the responses refer to Amendment No. 3. The responses provided herein are based upon information provided to Goodwin Procter LLP by the Company. In addition to submitting this letter via EDGAR, we are sending via Federal Express two copies of each of this letter and Amendment No. 3 (marked to show changes from Amendment No. 2). Registration Statement Cover Page 1. Please confirm whether your U.S. IPO price will be substantially the same as the home market trading price. You may use the most recent home market trading price, converted to U.S. dollars at the most recent exchange rate, only if the U.S. IPO price will be largely based on the home market trading price. If you expect that the U.S. IPO price will not be substantially the same as the home market trading price (i.e., the U.S. IPO price will be sold at a substantial discount), please disclose on the cover page of the preliminary prospectus a bona fide price range of the offered securities. If you intend to price the securities based on the home market price, you may disclose a percentage range based on that price (for example, 10% of the home market price) within which you intend to price the securities. See Item 501(b)(3) of Regulation S-K. RESPONSE: In response to the Staff’s comment, the Company has revised the cover page to disclose that the Company expects the initial public offering price to be not more than 10% below the closing price of its ordinary shares on its home market on the day the Company prices the offering. Dutch Tax Consequences Prior To Our Redomiciliation, page 266 Dutch Tax Consequences Upon Completion of Our Redomiciliation, page 273 We note your response to our prior comment 1, however, you have not revised these sections to provide a firm opinion for each material tax consequence. As the tax disclosure in these sections serves as the tax opinion, please further revise to clearly identify and articulate the opinions being rendered by counsel and express a firm opinion for each material tax consequence, or explain why such an opinion cannot be given. Please remove portions of the current disclosure stating that “generally” a certain tax consequence will apply, as this does not express a firm opinion. Further, please remove the term “certain” in the heading “Certain Material United States, Dutch and Belgian Tax Consideration,” and throughout the disclosure in this section to clarify that this section addresses all material tax consequences. For guidance consider Section III of Staff Legal Bulletin No. 19. RESPONSE: In response to the Staff’s comment, the Company has removed the tax opinion from the registration statement and revised the disclosures on pages 267 and 273. If you should have any questions concerning the enclosed matters, please contact the undersigned at (617) 570-1933. 2 Sincerely, /s/ Michael H. Bison Michael H. Bison Enclosures cc: Tim Van Hauwermeiren, Chief Executive Officer, argenx SE Eric Castaldi, Chief Financial Officer, argenx SE Edwin M. O’Connor, Goodwin Procter LLP 3
2017-05-16 - CORRESP - ARGENX SE
CORRESP 1 filename1.htm May 16, 2017 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Suzanne Hayes Re: argenx SE Registration Statement on Form F-1 (File No. 333-217417) Ladies and Gentlemen: Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended, we wish to advise that between May 8, 2017 and the date hereof, approximately 574 copies of the Preliminary Prospectus dated May 8, 2017 were distributed to prospective underwriters, institutional investors and prospective dealers in connection with the above-captioned Registration Statement. We wish to advise you that the participating underwriters have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. We hereby join in the request of the registrant that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated to 4:00 p.m. Eastern Time, on Wednesday, May 17, 2017 or as soon thereafter as practicable. [signature page follows] Very truly yours, COWEN AND COMPANY, LLC PIPER JAFFRAY & CO. As representatives of the Underwriters By: Cowen and Company, LLC By: /s/ Jason Fenton Name: Jason Fenton Title: Managing Director By: Piper Jaffray & Co. By: /s/ Christie L. Christina Name: Christie L. Christina Title: Managing Director
2017-05-16 - CORRESP - ARGENX SE
CORRESP 1 filename1.htm May 16, 2017 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4561 100 F Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Re: argenx SE Acceleration Request for Registration Statement on Form F-1 File No. 333-217417 Dear Ms. Hayes: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), argenx SE (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to May 17, 2017 at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP, by calling Michael H. Bison at (617) 570-1933. We also respectfully request that a copy of the written order from the Securities and Exchange Commission verifying the effective time and date of the Registration Statement be sent to our counsel, Goodwin Procter LLP, Attention: Michael H. Bison, by facsimile to (617) 321-4370. If you have any questions regarding this request, please contact Michael H. Bison of Goodwin Procter LLP at (617) 570-1933. Sincerely, ARGENX SE /s/ Tim Van Hauwermeiren Tim Van Hauwermeiren Chief Executive Officer cc: Eric Castaldi, Chief Financial Officer, argenx SE Michael H. Bison, Goodwin Procter LLP Edwin O’ Connor, Goodwin Procter LLP
2017-05-15 - UPLOAD - ARGENX SE
Mail Stop 4546
May 12, 2017
Tim Van Hauwermeiren
Chief Executive Officer
argenx SE
Willemstraat 5
4811 AH, Breda, the Netherlands
Re: argenx SE
Amendment No. 2 to
Registration Statement on Form F -1
Filed May 8, 2017
File No. 333-217417
Dear Mr. Van Hauwermeiren:
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 bel ieve 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 May 5, 2017 letter .
Registration Statement Cover Page
1. Please confirm whether your U.S. IPO price will be substantially the same as the home
market trading price. You may use the most recent home ma rket trading price, converted
to U.S. dollars at the most recent exchange rate , only if the U.S. IPO price will be largely
based on the home market trading price. If you expect that the U.S. IPO price will not be
substantially the same as the home market trading price (i.e., the U.S. IPO price will be
sold at a substantial discount), please disclose on the cover page of the preliminary
prospectus a bona fide price range of the offered securities. If you intend to price the
securities based on the home mar ket price, you may disclose a percentage range based on
Tim Van Hauwermeiren
argenx SE
May 12, 2017
Page 2
that price (for example, 10% of the home market price) within which you intend to price
the securities. See Item 501(b)(3) of Regulation S -K.
Dutch Tax Consequences Prior To Our Redomiciliation, page 266
Dutch Tax Consequences Upon Completion of Our Redomiciliation, page 273
2. We note your response to our prior comment 1 , however, you have not revised these
section s to provide a firm opinion for each material tax consequence. As the tax
disclosure in these sections serves as the tax opinion, please further revise to clearly
identify and articulate the opinions being rendered by counsel and express a firm opinion
for each material tax consequence, or explain why such an opinion cannot be given .
Please rem ove portion s of the current disclosure sta ting that “generally” a certain tax
consequence will apply , as this does not express a firm opinion . Further, please remove
the term “certain” in the heading “ Certain Material United States, Dutch and Belgian Tax
Consideration,” and throughout the disclosure in this section to clarify that this section
addresses all material tax consequences. For guidance consider Section III of Staff Legal
Bulletin No. 19.
You may contact Sasha Parikh at (202) 551 -3627 or Kevin V aughn, Accounting Branch
Chief, at (202) 551 -3494 if you have questions regarding comments on the financial statements
and related matters. Please contact Ada D. Sarmento at (202) 551 -3798 or Erin Jaskot, Special
Counsel, at (202) 551 -3442 with any other questions.
Sincerely,
/s/ Erin K. Jaskot, for
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Edwin O’Connor
Goodwin Procter LLP
2017-05-08 - CORRESP - ARGENX SE
CORRESP 1 filename1.htm Michael H. Bison Goodwin Procter LLP 617.570.1933 Counselors at Law mbison@goodwinlaw.com 100 Northern Avenue Boston, MA 02210 T: 617.570.1000 F: 617.523.1231 May 8, 2017 VIA EDGAR AND FEDERAL EXPRESS U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Re: argenx SE Amendment No. 1 to Registration Statement on Form F-1 Filed May 4, 2017 File No. 333-217417 Dear Ms. Hayes: This letter is being submitted on behalf of argenx SE (the “Company”) in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to Amendment No. 1 to the Company’s Registration Statement on Form F-1 filed on May 4, 2017 (the “Registration Statement”), as set forth in your letter dated May 5, 2017 addressed to Mr. Van Hauwermeiren, Chief Executive Officer of the Company (the “Comment Letter”). The Company is concurrently filing Amendment No. 2 to the Company’s Registration Statement on Form F-1 (“Amendment No. 2”), which includes changes to reflect responses to the Staff’s comments. For reference purposes, the text of the Comment Letter has been reproduced herein with a response below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the Staff’s comments refer to the Registration Statement, and page references in the responses refer to Amendment No. 2. The response provided herein is based upon information provided to Goodwin Procter LLP by the Company. In addition to submitting this letter via EDGAR, we are sending via Federal Express two <May 8, 2017> Page 2 copies of each of this letter and Amendment No. 2 (marked to show changes from the Registration Statement). Exhibit 8.1 1. It appears that you intend to use a short-form tax opinion. Please have counsel revise Section 3. Opinion to clearly state that the disclosure under the headings “Dutch Tax Consequences Prior To Our Redomiciliation” and “Dutch Tax Consequences Upon Completion of Our Redomiciliation” is the opinion of counsel. Please also revise the disclosure under these headings in the prospectus to clearly state that it is the opinion of counsel and to identify and articulate the opinions being rendered by counsel. Please ensure that you provide a firm opinion for each material tax consequence or explain why such an opinion cannot be given. Please also remove the language throughout stating that these sections are summaries. Refer to Section III of Staff Legal Bulletin No. 19 for guidance. RESPONSE: In response to the Staff’s comment, the Company has revised the disclosure on pages 266, 267 and 273 of Amendment No. 2 and the Company advises the Staff that it will file a revised opinion in a subsequent amendment to the Registration Statement. If you should have any questions concerning the enclosed matters, please contact the undersigned at (617) 570-1933. Sincerely, /s/ Michael H. Bison Michael H. Bison Enclosures cc: Tim Van Hauwermeiren, Chief Executive Officer, argenx SE Eric Castaldi, Chief Financial Officer, argenx SE Edwin M. O’Connor, Goodwin Procter LLP 2
2017-05-05 - UPLOAD - ARGENX SE
Mail Stop 4546
May 5, 2017
Tim Van Hauwermeiren
Chief Executive Officer
argenx SE
Willemstraat 5
4811 AH, Breda, the Netherlands
Re: argenx SE
Amendment No. 1 to
Registration Statement on Form F -1
Filed May 4, 2017
File No. 333-217417
Dear Mr. Van Hauwermeiren:
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 amendme nt 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.
Exhibit 8 .1
1. It appears that you inte nd to use a short -form tax opinion. Please have counsel revise
Section 3. Opinion to clearly state that the disclosure under the headings “ Dutch Tax
Consequences Prior To Our Redomiciliation ” and “ Dutch Tax Consequences Upon
Completion of Our Redomiciliati on” is the opinion of counsel. Please also revise the
disclosure under these headings in the prospectus to clearly state that it is the opinion of
counsel and to identify and articulate the opinions be ing rendered by counsel . Please
ensure that you provid e a firm opinion for each material tax consequence or explain why
such an opinion cannot be given. Please also remove the language throughout stating that
Tim Van Hauwermeiren
argenx SE
May 5, 2017
Page 2
these sections are summaries. Refer to Section I II of Staff Legal Bulletin No. 19 for
guidance.
You may contact Sasha Parikh at (202) 551 -3627 or Kevin Vaughn, Accounting Branch
Chief, at (202) 551 -3494 if you have questions regarding comments on the financial statements
and related matters. Please contact Ada D. Sarmento at (202) 551 -3798 or Erin J askot, Special
Counsel, at (202) 551 -3442 with any other questions.
Sincerely,
/s/ Erin K. Jaskot, for
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Edwin O’Connor
Goodwin Procter LLP
2017-05-03 - CORRESP - ARGENX SE
CORRESP 1 filename1.htm Michael H. Bison 617.570.1933 mbison@goodwinlaw.com Goodwin Procter LLP Counselors at Law 100 Northern Avenue Boston, MA 02210 T: 617.570.1000 F: 617.523.1231 May 3, 2017 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Re: argenx SE Registration Statement on Form F-1 Filed April 21, 2017 File No. 333-217417 Dear Ms. Hayes: This letter is being submitted on behalf of argenx SE, formerly argenx N.V. (the “Company”) in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s Registration Statement on Form F-1 submitted on April 21, 2017 (the “Registration Statement”), as set forth in your letter dated May 2, 2017 addressed to Mr. Van Hauwermeiren, Chief Executive Officer of the Company (the “Comment Letter”). The Company is concurrently filing Amendment No. 1 to the Company’s Registration Statement on Form F-1 (the “Amendment No. 1”), which includes changes to reflect responses to the Staff’s comments. For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the Staff’s comments refer to the Registration Statement, and page references in the responses refer to Amendment No. 1. The responses provided herein are based upon information provided to Goodwin Procter LLP by the Company. In addition to submitting this letter via EDGAR, we are sending via Federal Express two copies of each of this letter and Amendment No. 1 (marked to show changes from the Registration May 3, 2017 Page 2 Statement). Overview of Our Anticipated Restructuring and Redomiciliation, page 161 1. We note your response to our prior comment 1, but we are unable to agree with your analysis with respect to the proposed redomiciliation from the Netherlands to Belgium following completion of the offering. Please confirm to us that you intend to register the offer of securities in the redomiciliation under the Securities Act of 1933 or seek no-action relief. RESPONSE: In response to the Staff’s comment, the Company confirms that it intends to register the offer of securities in the redomiciliation under the Securities Act of 1933 or seek no-action relief. Risks Related to Our Organization and Operations, page 58 We are exposed to unanticipated changes in tax laws and regulations, page 62 2. We note your disclosure that some of your tax loss carry forwards may be forfeited as a result of transactions in the third sentence in the last paragraph of this risk factor. Please clarify whether the transactions you are referring to are the proposed redomiciliation and restructuring. RESPONSE: In response to the Staff’s comment, the Company has revised the disclosure on pages 62–63 of Amendment No. 1. Collaborations, page 136 3. We note your response to our prior comment 4. Please provide us with additional analysis as to why you believe that your agreement with AbbVie is not a material contract pursuant to Item 601(b)(10) of Regulation S-K. Please address the past and potential payments under the AbbVie agreement and their contribution to revenue in your response. RESPONSE: In response to the Staff’s comment, the Company respectfully advises the Staff that it does not believe that the AbbVie agreement is a material contract under Item 601(b)(10) of Regulation S-K. The Company’s consideration of Item 601(b)(10) of Regulation S-K is summarized below. As noted in the Company’s previous response letter, the AbbVie agreement was entered into in the ordinary course of business, thus 601(b)(10)(ii) of Regulation S-K is the relevant test. Item 601(b)(10)(ii) of states that “[i]f the contract is such as ordinarily accompanies the kind of business conducted by the registrant and its subsidiaries, it will be deemed to have been made in the ordinary course of business and need not be filed unless it falls within one or more of the following categories, in which case it shall be filed except where immaterial in amount or significance.” It is clear that none of the categories set forth in subparts (ii)(A), (ii)(C) or (ii)(D) of Item 601(b)(10) apply to the AbbVie agreement. Subsection (B) states that a contract entered into in the ordinary course of business would be a “material contract” if such contract is a “contract upon which the registrant’s business is substantially dependent, as in the case of continuing contracts to sell the major part of registrant’s products or services or to purchase the major part of registrant’s requirements of goods, services or raw materials or any franchise or license or other agreement to use a patent, formula, trade secret, process or trade name upon which registrant’s business depends to a material extent.” The Company respectfully advises the Staff that it is not substantially dependent on the AbbVie agreement, for the following reasons: · Product diversification. The AbbVie agreement is one of the Company’s six collaboration agreements and relates to one of the Company’s ten product candidates disclosed in the Registration Statement, reflecting the Company’s portfolio approach to product development and collaborations. That is, the Company has a strategy to develop multiple product candidates such that it is not substantially dependent on any one product candidate or collaboration. · Payments are non-refundable. The upfront and milestone payments received to date are non-refundable and non-creditable. Thus, regardless of whether the investigational new drug application (“IND”) enabling work is successful, AbbVie cannot reclaim this money. · Pre-clinical asset. ARGX-115, the product candidate covered by the AbbVie agreement, is a pre-clinical asset. As noted in the Company’s previous response letter and in the Registration Statement, there is significant risk associated with drug development generally, especially pre-clinical assets that have not yet demonstrated safety and efficacy in human subjects. Importantly, the Company has not completed the necessary pre-clinical work necessary to enable the filing of an IND for the commencement of clinical trials, and even then this product candidate would need to complete multiple rounds of clinical trials before regulatory approval and commercialization occurs. As disclosed in the Registration Statement, most of the milestones ($325 million out of $625 million maximum) are commercial milestones, and $190 million of the milestone payments are tied to regulatory filings and approval. Royalties under the agreement would only be payable to the Company upon commercialization of ARGX-115. 2 May 3, 2017 Page 3 · Commercial license not exercised. As disclosed in the Registration Statement, once IND-enabling studies are completed, AbbVie has the option (but not the obligation) to exercise a commercial license and assume responsibility for advancing ARGX-115 into the clinic and, pending success in the clinic, seeking regulatory approval. This option has not yet been exercised. If exercised, the Company would have no responsibility for advancing this product candidate on its own. · Current business is not dependent on future payments under this agreement. In response to the Staff’s comment, the Company advises the Staff that, as disclosed in the Registration Statement, the Company accounts for cash received under its collaboration agreement with AbbVie on a deferred basis, because the Company is responsible for performing the development work until the IND-enabling work is completed and AbbVie exercises its option, if at all. However, while the Company has derived a significant amount of its revenue from the AbbVie agreement (50.5% for the year ended December 31, 2016 and 58.4% for the three months ended March 31, 2017), the Company is not dependent on future payments under the AbbVie agreement to perform its obligations under the agreement or otherwise run its business. The Company advises the Staff that the payments received to-date from AbbVie are sufficient to cover the Company’s expected expenses to complete its development work under the agreement. As noted above, if the Company’s development work is successful, and AbbVie exercises its option, AbbVie will assume sole responsibility for future development work for ARGX-115, as a result of which the Company will have no further obligations under the AbbVie agreement. The Company has not built its business around an internal assumption that additional payments will occur under the AbbVie agreement. As mentioned in the Company’s previous response letter, available cash plus the proceeds from the proposed offering are sufficient to fund the Company’s operations and its current development activities and thus the Company is not dependent upon the receipt of any contingent payments under the AbbVie agreement. The Company acknowledges that the AbbVie agreement is referenced more than once in the Registration Statement, including the Prospectus Summary and the Company’s product candidate pipeline chart. The Company has included this disclosure because it considers its collaboration agreement with AbbVie to be evidence of third-party validation of the Company’s technology platform and approach. Collaboration agreements like the Company’s collaboration agreement with AbbVie are typically only entered into after extensive due diligence of the applicable technology platform, evaluation of relevant pre-clinical and clinical data, a review of the relevant intellectual property portfolio and related matters. In drafting its disclosure, the Company concluded that the fact that a large, sophisticated, well-funded and well-known biopharmaceutical company like AbbVie would enter into a collaboration agreement with the Company is a relevant consideration for investors when considering an investment in the Company. However, it does not necessarily follow that the Company is “substantially dependent” on the collaboration agreement for purposes of Item 601(b)(10)(ii). As noted above, the Company is not “substantially dependent” on the AbbVie agreement and the agreement does not relate to a “major part” of the Company’s product candidate pipeline or business and the Company’s business is not dependent on future payments under this agreement. The Company advises the Staff that, notwithstanding its consideration of the Item 601(b)(10) “material contract” test, it did consider whether additional disclosure concerning the nature and material terms of the AbbVie agreement would benefit investors in making an informed investment decision concerning the Company. Although the Company did not conclude it was “substantially dependent” on the AbbVie agreement for the reasons cited above, it did elect to provide disclosure related to the agreement, including the material terms of the agreement, in the Registration Statement in order to enable investors to form a better view of the Company and its business as a whole. The Company respectfully advises the Staff that it does not believe filing the AbbVie agreement as an exhibit would provide meaningful information to investors beyond that which has already been summarized in the Registration Statement. Finally, the Company advises the Staff that it will continue to evaluate in future periods whether the AbbVie agreement rises to the level of substantial dependence or otherwise satisfies the definition of a “material contract” under Item 601(b)(10) of Regulation S-K. For example, the agreement might satisfy the Item 601(b)(10) test in the event that AbbVie exercises a commercial license for ARGX-115, or if ARGX-115 advances into the clinic or into later-stage clinical trials or achieves regulatory approval, as a result of which the Company would be entitled to receive more significant payments (and upon commercialization, royalties), upon which the Company may become substantially dependent depending on the facts and circumstances applicable to the Company at that time. Description of Share Capital, page 189 Preemptive Rights, page 190 4. We note your response to our prior comment 5. Please disclose whether the limitation or restriction of preemption rights could be used as a potential anti-takeover measure. RESPONSE: In response to the Staff’s comment, the Company has revised the disclosure on page 200 of Amendment No. 1. 3 May 3, 2017 Page 4 If you should have any questions concerning the enclosed matters, please contact the undersigned at (617) 570-1933. Sincerely, /s/ Michael H. Bison Michael H. Bison Enclosures cc: Tim Van Hauwermeiren, Chief Executive Officer, argenx SE Eric Castaldi, Chief Financial Officer, argenx SE Edwin M. O’Connor, Goodwin Procter LLP 4
2017-05-03 - UPLOAD - ARGENX SE
Mail Stop 4546
May 2, 2017
Tim Van Hauwermeiren
Chief Executive Officer
argenx N.V.
Willemstraat 5
4811 AH, Breda, the Netherlands
Re: argenx N.V.
Registration Statement on Form F -1
Filed April 21, 2017
File No. 333-217417
Dear Mr. Van Hauwermeiren :
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 respon se to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our April 19, 2017 letter .
Overview of Our Anticipated Restructuring and Redomiciliation, page 161
1. We note your response to our prior comment 1 , but we are unable to agree with your
analysis with respect to the proposed redomiciliation from the Netherlands to Belgium
following completion of the offering . Please confirm to us that you intend to register the
offer of securities in the redomiciliation under the Securities Act of 1933 or seek no -
action relief .
Tim Van Hauwermeiren
argenx N.V.
May 2, 2017
Page 2
Risks Related to Our Organization and Operations, page 58
We are exposed to unanticipated changes in tax laws and regulations, page 62
2. We note your disclosure that some of your tax loss carry forwards may be forfeited as a
result of transactions in the third sentence in the last paragraph of this risk factor . Please
clarify whether the transactions you are referring to are the proposed redomiciliation and
restructuring .
Collaborations, page 136
3. We note your response to our prior comment 4. Please provide us with additional
analysis as to why you believe that your agreement with AbbVie is not a material
contract pursuant to Item 601(b)(10) of Regulation S -K. Please address the past and
potential pa yments under the AbbVie agreement and their contribution to revenue in your
response.
Description of Sha re Capital, page 189
Preemptive Rights, page 190
4. We note your response to our prior comment 5. Please disclose whether the limitation or
restriction of preemption rights could be used as a potential anti -takeover measure.
We remind you that the compan y 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 statement.
You may contact Sasha Parikh at (202) 551 -3627 or Kevin Vaughn, Accounting Branch
Chief, at (202) 551 -3494 if you have questions regarding comments on the financial statements
and related matters. Please contact Ada D. Sarmento at (202) 551 -3798 or Erin Jaskot, Special
Counsel, at (202) 551 -3442 with any other questions.
Sincerely,
/s/ Erin K. Jaskot, for
Suzanne Hayes
Assis tant Director
Office of Healthcare and Insurance
cc: Edwin O’Connor
Goodwin Procter LLP
2017-04-21 - CORRESP - ARGENX SE
CORRESP 1 filename1.htm Michael H. Bison 617.570.1933 mbison@goodwinlaw.com Goodwin Procter LLP Counselors at Law 100 Northern Avenue Boston, MA 02210 T: 617.570.1000 F: 617.523.1231 April 21, 2017 VIA EDGAR AND FEDERAL EXPRESS U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Re: argenx N.V. Amendment No. 1 to Draft Registration Statement on Form F-1 Confidentially Submitted April 5, 2017 CIK No. 0001697862 Dear Ms. Hayes: This letter is being submitted on behalf of argenx N.V. (the “Company”) in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to Amendment No. 1 to the Company’s Confidential Draft Registration Statement on Form F-1 submitted on April 5, 2017 (the “Draft Registration Statement”), as set forth in your letter dated April 19, 2017 addressed to Mr. Van Hauwermeiren, Chief Executive Officer of the Company (the “Comment Letter”). The Company is concurrently filing the Company’s Registration Statement on Form F-1 (the “Registration Statement”), which includes changes to reflect responses to the Staff’s comments. For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the Staff’s comments refer to the Draft Registration Statement, and page references in the responses refer to Registration Statement. The responses provided herein are based upon information provided to Goodwin Procter LLP by the Company. Overview of Our Anticipated Restructuring and Redomiciliation, page 161 1. We note your plans to redomicile from the Netherlands to Belgium following completion of the offering. Please tell us whether you intend to register the offer of securities in the redomiciliation under the Securities Act of 1933. If you do not intend to register the transaction, please tell us the exemption(s) from registration upon which you intend to rely, including the facts supporting your reliance on such exemption(s). Please also provide us with your analysis as to whether the tender offer rules will apply to this transaction. RESPONSE: The Company advises the Staff that the sole purpose of the potential redomiciliation transaction is to change the Company’s domicile from the Netherlands to Belgium. As such, the transaction is akin to a migratory merger for a domestic corporation, which is expressly deemed not to be an offer or sale within the meaning of Section 2(3) of the Securities Act by virtue of Rule 145(a)(2). Indeed, the proposed transaction would seem to be of a similar nature to the type of transaction contemplated by Securities Act Sections, Compliance and Disclosure Interpretations (C&DIs) 203.06 and 239.04, which state that transactions to change a foreign issuer’s domicile from one political subdivision of a country to another (such as reincorporation from one Canadian province to another) likewise should not be treated as a sale. Similar to a migratory merger from one state to another state within the United States, or from one political subdivision of a country to another, the potential redomiciliation transaction involves a change of the Company’s domicile from one country to another country within the European Union. As such, the Company is of the view that the potential redomiciliation transaction does not involve an offer or sale of its securities. As with domestic migratory mergers, corporate requirements in the Netherlands do require shareholder approval for the potential redomiciliation transaction. However, the Company advises the Staff that it does not consider the shareholder vote to constitute an “investment decision” for purposes of Section 2(3) of the Securities Act. The Preliminary Note of Rule 145 is instructive in this regard; it reads in part: “The thrust of the rule is that an offer, offer to sell, offer for sale, or sale occurs when there is submitted to security holders a plan or agreement pursuant to which such holders are required to elect, on the basis of what is in substance a new investment decision, whether to accept a new or different security in exchange for their existing security.” The Company advises the Staff that the potential redomiciliation transaction will not involve the exchange of one security for another security. Rather, subject to board and shareholder approval, the redomiciliation would only result in the transfer of the registered seat of the Company from the Netherlands to Belgium. The Company will remain the same legal entity before and after the redomiciliation, and the underlying ordinary shares will remain unchanged and continue to be held by the same shareholders. Importantly, there would be no change in the Company’s 2 business or operations, its results of operations or financial position, or its senior managers or board of directors, such that it would require a new investment decision with respect to the Company’s securities. In connection with the proposed shareholder meeting, the Company will deliver notice of the general meeting to its shareholders, together with disclosures describing the material terms of the redomiciliation. The Registration Statement similarly includes a summary of the material terms of the redomiciliation transaction. From a disclosure standpoint, the Company respectfully advises the Staff that it does not believe registration of the redomiciliation transaction on Form S-4 would provide investors with any additional information beyond what is proposed to be included in the proxy statement for the shareholder meeting. Because the potential redomiciliation transaction will not involve the exchange of one security for another security, or any of the eight-factors set forth in Wellman v. Dickinson, 475 F. Supp. 783 (S.D.N.Y. 1979), aff’d, 682 F.2d 355 (2d Cir. 1982), the tender offer rules are not implicated. 2. We note that your purpose for the redomiciliation is that value creation is not properly aligned with your intellectual property ownership structures as required under the Base Erosion and Profit Shifting project of the Organization for Economic Co-operation and Development, and that you face a compliance burden as a company existing under Dutch law with shares listed on Euronext Brussels. Please disclose the potential risks or costs to the company that may occur if you are unable to complete the redomiciliation. RESPONSE: In response to the Staff’s comment, the Company respectfully advises the Staff that the restructuring that will result in the transfer of intellectual property (and the aligning of value creation and intellectual property ownership structures as required under the Base Erosion and Profit Shifting project of the Organization for Economic Co-operation and Development) is expected to occur prior to the launch of this offering and will no longer be subject to any completion risk. With respect to other risks or costs to the Company if it is unable to complete the redomiciliation, the Company has revised the disclosure on page 63 in response to the Staff’s comment. Phase 1 Part of Phase 1/2 Clinical Trial in Patients with Advanced Malignancies Expressing CD70, page 122 3. We note your response to our prior comment 13. Please disclose the definitions used for Grade 3 and Grade 4 drug-related adverse events. RESPONSE: In response to the Staff’s comment, the Company has revised the disclosure on 3 pages 126–128 of the Registration Statement. Collaborations, page 132 License Agreements, page 136 4. We note your discussion in these sections of several collaboration and license agreements. However, you have only filed the patent license agreement with The Board of Regents of the University of Texas System as an exhibit. Please file these agreements as exhibits to the registration statement or tell us why you believe that you are not required to file such agreements pursuant to Item 601(b)(10) of Regulation S-K. RESPONSE: In response to the Staff’s comment, the Company respectfully advises the Staff that it does not believe these agreements are material contracts under Item 601(b)(10) of Regulation S-K. The Company’s consideration of Item 601(b)(10) of Regulation S-K is summarized below. Background Item 601(b)(10)(i) of Regulation S-K defines a “material contract” as a contract made outside of the ordinary course of business which is material to the registrant. Item 601(b)(10)(ii) of Regulation S-K states that “[I]f the contract is such as ordinarily accompanies the kind of business conducted by the registrant and its subsidiaries, it will be deemed to have been made in the ordinary course of business and need not be filed unless it falls within one or more of the following categories, in which case it shall be filed except where immaterial in amount or significance.” It is clear that none of the categories set forth in Item 601(b)(10)(ii), subsections (A) (concerning officers and directors), (C) (concerning acquisitions or sale of property) or (D) (concerning material leases) apply to any of the agreements at issue. Subsection (B) states that a contract entered into in the ordinary course of business would be a “material contract” if such contract is a “contract upon which the registrant’s business is substantially dependent, as in the case of continuing contracts to sell the major part of registrant’s products or services or to purchase the major part of registrant’s requirements of goods, services or raw materials or any franchise or license or other agreement to use a patent, formula, trade secret, process or trade name upon which registrant’s business depends to a material extent.” Contracts Not Made Outside of the Ordinary Course of Business The Company advises the Staff that none of the referenced collaboration agreements or license agreements were entered into outside the ordinary course of business. As described in the Registration Statement, the Company is a pre-commercial biotechnology company focused on the development of antibody-based therapies for the treatment of severe autoimmune diseases 4 and cancer. As such, it would be expected to enter into license agreements from time to time in order to secure certain intellectual property rights necessary or advisable for the commercialization of its product candidates, and collaboration agreements with larger biopharmaceutical companies for the development and/or commercialization of its product candidates. Indeed, such agreements ordinarily accompany the business of identifying and developing therapeutic products. Accordingly, the Company respectfully advises the Staff that it does not consider these agreements to satisfy the definition of a “material contract” under Item 601(b)(10)(i) of Regulation S-K. The Company’s Business is not Substantially Dependent on the Contracts The Company advises the Staff that it is not substantially dependent on any of the collaboration agreements, nor do the license agreements concern the right to use a patent, formula, trade secret, process or trade name upon which the Company’s business depends to a material extent, for purposes of Item 601(b)(10)(ii) of Regulation S-K. The reasons for this conclusion vary based on the nature of the agreement, so the discussion that follows is organized by category of agreement. (i) Collaboration Agreements As disclosed in the Registration Statement, the Company is focused on the development of antibody-based therapies for the treatment of severe autoimmune diseases and cancer, with the strategy of retaining development and commercialization rights to those product candidates it believes it can ultimately commercialize successfully on its own, if approved. Where the Company believes a product candidate might be better served by a larger biopharmaceutical company with greater resources, it intends to enter into customary collaboration agreements. Such agreements enable the Company to more broadly diversify is pipeline of product candidates, and largely offload the product development and commercialization of these product candidates to third parties, thus enabling the Company to primarily focus its product development efforts on its wholly-owned programs. The Company advises the Staff that it would not have pursued development of any of the partnered product candidates in the absence of a collaboration agreement. In accordance with this strategy, the Company has entered into a number of customary collaboration agreements for the selection and development of defined product candidates and, if these product candidates are successful in the clinic, ultimately the commercialization of these product candidates. The Company advises the Staff that it does not consider itself to be substantially dependent on any of these collaboration agreements, for the following reasons. · Large number of collaborations and large number of product candidates within those collaborations. The five collaboration agreements described in the Registration Statement 5 contemplate the development of multiple product candidates, many of which have not even been identified yet. Because drug development is uncertain, the Company and its collaboration partners have intentionally undertaken a portfolio approach to identification, selection and development of product candidates, such that the failure of no one product candidate or no one collaboration would have a material adverse on the Company’s business. The Company advises the Staff that it considers the large number of collaborations to be evidence of large biopharmaceutical companies’ confidence in the potential of the Company’s technology platform and approach. It has not, however, built its core business on the assumption that any one of these programs will be successful. · Selected product candidates are in the earliest stages of development. Each of the Company’s collaborations are in the earliest stages. In some cases (e.g., Shire), the collaboration continues to focus on target screening with no product candidates identified. Where product candidates have been identified, all but one remain in the pre-clinical phase of development. As is typical of drug development, whether or not these product candidates ever advance to early-stage clinical trials, late-stage clinical trials, regulatory approval or commercialization is uncertain. As would be expected, the Company’s right to receive future payments under these collaboration agreements are more heavily weighted towards regulatory approval and commercial success. · Commercial licenses not yet exercised. Given the early stage of these collaborations, as noted above, in many cases the collaboration partner has not yet exercised its option to secure commercial rights to these product candidates (e.g., AbbVie, LEO Pharma and Shire). As disclosed in the Registration Statement, these agreements include customary provisions that permit the collaboration partner to secure commercial rights to a product candidate after the product candidate has achieved a pre-defined development milestone. Given the early-stage nature of these programs, such options have not been exercised. · The Company is not substantially dependent upon future payments under the collaboration agreements. As disclosed in the Registration Statement, the collaboration agreements typically provide for a non-refundable upfront payment to the Company, with the right to receive milestones upon the achievement of defined development, regulatory or commercial milestones. As disclos
2017-04-19 - UPLOAD - ARGENX SE
Mail Stop 4546
April 19, 2017
Tim Van Hauwermeiren
Chief Executive Officer
argenx N.V.
Willemstraat 5
4811 AH, Breda, the Netherlands
Re: argenx N.V.
Amendment No. 1 to
Draft Registration Statement on Form F -1
Submitted April 5, 2017
CIK No. 0001697862
Dear Mr. Van Hauwermeiren :
We have reviewed your amended draft 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 providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. 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 the information you provide in response to these comments and your
amende d draft registration statement or filed registration statement, we may have additional
comments.
Overview of Our Anticipated Restructuring and Redomiciliation, page 161
1. We note your plans to redomicile from the Netherlands to Belgium following completi on
of the offering. Please tell us whether you intend to register the offer of securities in the
redomiciliation under the Securities Act of 1933. If you do not intend to register the
transaction, please tell us the exemption(s) from registration upon wh ich you intend to
rely, including the facts supporting your reliance on such exemption(s). Please also
provide us with your analysis as to whether the tender offer rules will apply to this
transaction.
Tim Van Hauwermeiren
Argenx N.V.
April 19, 2017
Page 2
2. We note that your purpose for the redomiciliation i s that value creation is not properly
aligned with your intellectual property ownership structures as required under the Base
Erosion and Profit Shifting project of the Organization for Economic Co -operation and
Development, and that you face a compliance burden as a company existing under Dutch
law with shares listed on Euronext Brussels. Please disclose the potential risks or costs to
the company that may occur if you are unable to complete the redomiciliation .
Phase 1 Part of Phase 1/2 Clinical Trial in Patients with Advanced Malignancies Expressing
CD70, page 122
3. We note your response to our prior comment 13 . Please disclose the definitions used for
Grade 3 and Grade 4 drug -related adverse events.
Collaborations, page 132
License Agreements, pag e 136
4. We note your discussion in these sections of several colla boration and license
agreements . However, you have only filed the patent license agreement with The Board
of Regents of the University of Texas System as an exhibit. Please file these agreements
as exhibits to the registration statement or tell us why you believe that you are not
required to file such agreements pursuant to Item 601(b)(10) of Regulation S -K.
Description of Share Capital, page 189
Preemptive Rights, page 190
5. We note your disclosure that the shareholders at the General Meeting on April 26, 2017
will be asked to designate the board of directors to issue additional shares and grant rights
to subscribe for shares and to limit or exclud e preemption rights of shareholders for such
shares for a period starting on April 26, 2017 and ending on December 31, 2017 and for a
period of 18 months from the day of the meeting. We also note that the first
authorization is for the purpose of admissio n to listing and trading of the new ordinary
shares on NASDAQ while the second authorization can also be used for such purpose.
Please disclose the main purpose for the limitation or exclusion of the preemptive rights
for the second authorization for 18 m onths and whether such limitation or exclusion is
intended to benefit specific persons. Refer to Form 9.A.3 of Form 20 -F.
Tim Van Hauwermeiren
Argenx N.V.
April 19, 2017
Page 3
You may contact Sasha Parikh at (202) 551 -3627 or Kevin Vaughn, Accounting Branch
Chief, at (202) 551 -3494 if you have questio ns regarding comments on the financial statements
and related matters. Please contact Ada D. Sarmento at (202) 551 -3798 or Erin Jaskot, Special
Counsel, at (202) 551 -3442 with any other questions.
Sincerely,
/s/ Erin K. Jaskot, for
Suzanne Hayes
Assistant Director
Offic e of Healthcare and Insurance
cc: Edwin O’Connor
Goodwin Procter LLP
2017-03-29 - UPLOAD - ARGENX SE
Mail Stop 4546
March 28 , 2017
Tim Van Hauwermeiren
Chief Executive Officer
argenx N.V.
Willemstraat 5
4811 AH, Breda, the Netherlands
Re: argenx N.V.
Draft Registration Statement on Form F -1
Submitted March 1, 2017
CIK No. 0001697862
Dear Mr. Van Hauwermeiren :
We have reviewed your draft 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 providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. 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 the information you provide in response to these comments and your
amended draft registra tion statement or filed registration statement, we may have additional
comments.
Cover Page
1. We note your statement that the last reported sale price of your ordinary shares on
Euronext Brussels was €__, equivalent to $__ per share . You may present the most recent
home market trading price, converted to U.S. dollars at the most recent exchange rate ,
assuming the U.S. IPO price will be largely based on the home market trading price.
However, b ased on your disclosure on page 215, it appears that the IPO price will be
determined by negotiations between you and the representatives of the underwriters using
many factors and that the U.S. IPO price will not be substantially the same as the home
market trading price. Please revise yo ur cover page to provide bona fide pricing
information. See Item 501(b)(3) of Regulation S -K.
Tim Van Hauwermeiren
Argenx N.V.
March 28 , 2017
Page 2
Summary
Overview, page 1
2. We note your disclosure that you commenced a Phase 1/2 clinical trial of ARGX -110 in
combination with azacitidine for the treatment of n ewly diagnose d AML or high -risk
MDS patients in December 2016 and that you expect to initiate the Phase 2 part of a
Phase 1/2 clinical trial of ARGX -110 for the treatment of cutaneous TCL in March 2017.
Please disclose the requirements for a clinical tria l to be considered a Phase 1/2.
3. Please revise your product pipeline table here and in the Business section to remove
programs that are in the discovery phase. Because you have not identified a product
candidate for these programs, it is premature to inc lude them in a product pipeline table.
4. Please include a column for Phase 3 in your product pipeline table.
5. We note your disclosure on page 5 that no significant trends in terms of safety were
observed between the dose groups for ARGX -110. However, we no te that there were
seven patient deaths in the Phase 1 trials and there was one drug -related patient death
attributed to sepsis in the Phase 1 safety -expansion . Please balance your disclosure in
this section so that it does not imply that there are no par ticular safety risks related to
ARGX -110.
Implications of Being an Emerging Growth Company, page 8
6. Please supplementally provide us with copies of all written communications, as defined
in Rule 405 under the Securities Act, that you , or anyone authorized to do so on your
behalf , present to potential investors in reliance on Section 5(d) of the Securities Act,
whether or not they retain copies of the communications.
Risk Factors
We rely on third parties to supply and manufacture our p roduct candidates . . ., page 43
7. We note that you rely primarily on Lonza Sales AG for the manufacturing of the drug
substance of all your products. We further note that you do not have alternative
production plans in place, and in case of a disruption y ou would have to establish
alternative plans which would require substantial capital and you would likely experience
months or years of manufacturing delays. Please file your manufacturing agreement with
Lonza as an exhibit to the registration statement, or, in the alternative, please tell us why
you do not believe you are required to do so.
Intellectual property rights of third parties . . ., page 47
8. We note that you are aware of certain issued patents held by third parties that may cover
certain aspect s of your pro duct candidates and if these patents have not expired at the
Tim Van Hauwermeiren
Argenx N.V.
March 28 , 2017
Page 3
time of approval of your product candidates you may be subject to an infringement
action. Please disclose the expiration date(s) for the patents at issue.
We have obtained signific ant funding from agencies of the government of the Flemish region . .
., page 57
9. Please revise to disclose what is considered a “fundamental change” to your shareholding
base that could cause Flemish agencies to re -evaluate subsidies granted to you.
Use of Proceeds, page 72
10. We note your disclosure regarding the intended use of funds to expand applications of
ARGX -113 to develop a subcutaneous formulation, including a Phase 1 clinical trial in
healthy volunteers and explore additional indications. If the anticipated proceeds will not
be sufficient to fund this use, please disclose the amount and sources of other funds
needed. Refer to Item 3.C.1 of Form 20 -F.
Management ’s Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Significant Judgments and Estimates
Measurement of Share -Based Payments, page 94
11. Please address the following regarding your disclosure that for grants beginning in 2016,
you only considered the historical volatility of your stock price calculated since your
initial public offering.
Given the ten year option life and the fact that yo u have been a public company for
approximately two years, please tell us your consideration of B25(b) and B26 in IFRS 2.
It appears that by limiting your consideration solely to your own share price volatility
data, the volatility assumption used in your computations dropped to 40% on page F -10
for the options granted during 2016 from 59% as reported on page F -41 for the options
granted during 2015 using peer data. To the extent you continue to believe that excluding
peer data which would cover a longer historical time period is appropriate, revise your
disclosure here to more clearly discuss the impact of that decision and provide
quantification to the extent possible.
Business , page 98
12. We note your disclosure on page 18 that you do not have any active INDs for your
proposed indications at this time nor have you conducted any of your clinical
development to date in the United States . Please also disclose this in the Business
section .
Tim Van Hauwermeiren
Argenx N.V.
March 28 , 2017
Page 4
Phase 1/2 Clinical Trial in Patients with Advanced Malignan cies Expressing CD70, page 118
13. Please disclose the definitions used for Grade 3 and Grade 4 drug -related adverse events.
Please also explain the types of serious adverse events that make up the 20 reported
serious adverse events, the number of patients w ho experienced these events and at which
does levels, and what is meant by “heavily pre -treated.” Please also disclose the dose
levels for the seven patient deaths.
Collaborations, page 126
License Agreements, page 130
14. For each collaboration agreement discussed, please present the amount of milestone
payments that the company may receive for each of development, regulatory and
commercial milestones.
15. Please present the royalty amount for the license agreement with Bird Rock Bio., Inc. in a
range t hat does not exceed ten percent and disclos e the royalty term.
16. Please disclose the following for each of the license agreements, to the extent not already
disclosed:
Nature and scope of intellectual property transferred;
Duration of agreement and royalty term; and
Payment provisions, including total up front or execution payments received or paid,
aggregate amounts paid or received to date, the annual license maintenance fees,
aggregate future milestone payments , and profit or revenue sharing provisions.
Principal Shareholders, page 170
17. Please revise your disclosure to identify the natural person or persons who hav e voting
and investment control of the shares held by LSP IV Management B.V., Forbion Capital
Fund II Cooperatief U.A., Federated Equity Management Company of Pennsylvania and
Perceptive Advisors LLC.
18. Please include the information required by Item 7.A.2 of Form 20 -F.
Comparison of Dutch Corporate Law, our Articles of Association and Board By -Laws and U.S.
Corporate Law, page 185
19. We note your disclosure that the summary is subject to Dutch law, including Book 2 of
the Dutch Civil Code and Delaware corporation law, including the Delaware General
Corporation Law. It is not appropriate to qualify your disclosure by reference to
infor mation that is not included in the prospectus or filed as an exhibit to the registration
statement. Please revise accordingly.
Tim Van Hauwermeiren
Argenx N.V.
March 28 , 2017
Page 5
General
20. Please provide us proofs of all graphics, visual, or photographic information you will
provide in the printed prospectus prior to its use, for example in a preliminary prospectus.
Please note that we may have comments regarding this material.
You may contact Sasha Parikh at (202) 551 -3627 or Kevin Vaughn, Accounting Branch
Chief, at (202) 551 -3494 if you have qu estions regarding comments on the financial statements
and related matters. Please contact Ada D. Sarmento at (202) 551 -3798 or Erin Jaskot, Special
Counsel, at (202) 551 -3442 with any other questions.
Sincerely,
/s/ Erin K. Jaskot, for
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Edwin O’Connor
Goodwin Procter LLP
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