Submitted confidentially to the Securities and Exchange Commission on May 8, 2020

  

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM F-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

AMRYT PHARMA PLC
(Exact name of Registrant as specified in its charter)

Not Applicable
(Translation of Registrant’s name into English)

England and Wales
(State or other jurisdiction of
incorporation or organization) 2834
(Primary Standard Industrial
Classification Code Number) Not Applicable
(I.R.S. Employer
Identification Number)

Dept 920a 196 High Road, Wood Green,
London, United Kingdom, N22 8HH
Tel: +44 (0)20 3026 7257
(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

Puglisi & Associates
850 Library Avenue, Suite 204
Newark, Delaware 19711
Tel: (302) 738-6680

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Boris Dolgonos
Andrew L. Fabens
Gibson, Dunn & Crutcher LLP
200 Park Avenue
New York, NY 10166
Tel: (212) 351-4000 Christopher Haynes
Gibson, Dunn & Crutcher
UK LLP
Telephone House 2-4
Temple Avenue
London, EC4Y 0HB
United Kingdom
Tel: +44 (0) 20-7071 4000 Brian K. Rosenzweig
Lilit Kazangyan
Covington & Burling LLP
The New York Times Building
620 Eighth Avenue
New York, NY 10018-1405
Tel: (212) 841-1000 Paul Claydon
Simon Amies
Covington & Burling LLP
265 Strand London WC2R
1BH United Kingdom
Tel: +44 (0) 20-7067 2000

Approximate date of commencement of proposed sale to the public:
As soon as practicable after the effective date of this Registration Statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.  ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933.

Emerging Growth Company ☒

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 7(a)(2)(B) of the Securities Act.  ☐

† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

CALCULATION OF REGISTRATION FEE

Title of Each Class of Securities To Be Registered	Proposed Maximum Aggregate Offering Price(1)	Amount of Registration Fee(2)
Ordinary shares, nominal value £0.06 per share(3)	$	$

(1)
Estimated solely for the purpose of calculating the amount of the registration fee in accordance with Rule 457(o) under the Securities Act of 1933, as amended. Includes the    additional ordinary shares represented by   American Depositary Shares, or ADSs, that the underwriters have the option to purchase.

(2)
Calculated pursuant to Rule 457(o) based on an estimate of the proposed maximum aggregate offering price.

(3)
ADSs issuable upon deposit of the ordinary shares registered hereby will be registered pursuant to an amendment to a registration statement on Form F-6 (registration number 333-233844). Each ADS represents five ordinary shares.

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

EXPLANATORY NOTE

Amryt Pharma plc is submitting this Draft Registration Statement on Form F-1 as an exhibit-only submission. This Draft Registration Statement does not modify any provision of the prospectus that forms a part of the Draft Registration Statement. Accordingly, Part I, the form of prospectus, has been omitted from this submission.

PART II — INFORMATION NOT REQUIRED IN PROSPECTUS

Item 6.
Indemnification of Directors and Officers.

Subject to the Companies Act, pursuant to the articles of association, current and former members of the Company’s board of directors and its current and former officers (excluding auditors) may at the discretion of the Company be indemnified by the Company against all liabilities, costs, charges and expenses incurred by him in the execution and discharge of his duties to the Company and any Associated Company (as defined in the Companies Act) of the Company, including any liability incurred in defending any proceedings, civil or criminal, that relate to anything done or omitted by him as an officer or employee of the Company or an Associated Company provided that no such indemnity shall extend to any liability arising out of the fraud or dishonesty of the relevant director or officer or the obtaining by such person of any personal profit or advantage to which such person was not entitled.

However, no current or former members of the Company’s board of directors nor its current or former officers (excluding auditors) shall be entitled to be indemnified for:

(i)
any liability incurred by him to the Company or any Associated Company of the Company;

(ii)
any fine imposed in any criminal proceedings;

(iii)
any sum payable to a regulatory authority by way of a penalty in respect of non-compliance with any requirement of a regulatory nature howsoever arising;

(iv)
any amount for which he has become liable in defending any criminal proceedings in which he is convicted and such conviction has become final;

(v)
any amount for which he has become liable in defending any civil proceedings brought by the Company or any Associated Company of the Company in which a final judgment has been given against him; and

(vi)
any amount for which he has become liable in connection with any application under certain provisions of the Companies Act in which the court refuses to grant him relief and such refusal has become final.

The Company may provide funds (either directly or indirectly) to any current or former director or officer to meet expenditure incurred or to be incurred by him in any proceedings (whether civil or criminal) brought by any person or in relation to any investigation or action to be taken by a regulatory authority that relate to anything done or omitted or alleged to have been done or omitted by him as an officer or employee of the Company or any Associated Company of the Company in respect of which it is alleged he has been guilty of negligence, default, breach of duty or breach of trust, provided that he will be obliged to repay any such amount no later than:

(i)
in the event that he is convicted in proceedings, the date when the conviction becomes final;

(ii)
in the event that judgment is given against him in proceedings, the date when the judgment becomes final; or

(iii)
in the event that the court refuses to grant him relief on any application under certain provisions of the Companies Act, the date when the refusal becomes final.

In the underwriting agreement, the form of which is filed as Exhibit 1.1 to this registration statement, the underwriters will agree to indemnify, under certain conditions, us, our directors, our officers and persons who control our company within the meaning of the Securities Act, against certain liabilities, but only to the extent that such liabilities are caused by information relating to the underwriters furnished to us in writing expressly for use in this registration statement and certain other disclosure documents.

Insofar as indemnification of liabilities arising under the Securities Act may be permitted to our board, executive officers, or persons controlling us pursuant to the foregoing provisions, we have been informed that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.

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Item 7.
Recent Sales of Unregistered Securities.

Issuances of Capital Stock

• On October 9, 2017, the registrant issued 66,477,651 ordinary shares (11,079,608 equivalent ordinary shares post the six for one share consolidation in July 2019) to certain new and existing investors for aggregate consideration of £13.3 million; and

• On August 27, 2019, the registrant's predecessor agreed to issue 7,346,189 ordinary shares to certain new and existing investors for aggregate consideration of $8 million.

Options

Since May 1, 2017, the registrant (or its predecessor) has granted stock options to purchase an aggregate of 12,324,310 ordinary shares with exercise prices ranging from £0.7584 to £1.5528 per share, to certain employees, contractors and directors in connection with services provided to the registrant by such parties, as follows:

Grant Date	Number of options	Exercise price per share
May 25, 2017	55,572	£1.5528
July 12, 2017	98,563	£1.3500
September 12, 2017	31,909	£1.4250
September 19, 2017	88,210	£1.5000
November 28, 2017	719,415	£1.2072
May 21, 2019	1,115,241	£0.7584
November 5, 2019	10,215,400	£1.2150

Certain of these options have since lapsed. The number of options and exercise price per share in the table above have been adjusted to reflect the six-for-one share consolidation in July 2019.

Acquisition of Aegerion

On September 24, 2019, in connection with its acquisition (the “Acquisition”) of Aegerion Pharmaceuticals, Inc. (“Aegerion”), the registrant issued the following securities:

• 77,027,423 ordinary shares (including 48,739,975 ordinary shares represented by 9,747,995 American Depositary Shares) and 8,065,000 zero cost warrants to former creditors of Aegerion as consideration for the Acquisition;

• 345,542 warrants to purchase an equal number of ordinary shares with a weighted average exercise price of £1.44 per ordinary share, which were issued in exchange for warrants that had been issued in 2016 in connection with the registrant’s predecessor’s admission to the AIM in 2016;

• 27,541,944 ordinary shares (including 1,693,275 ordinary shares represented by 338,655) American Depositary Shares) and 5,911,722 zero cost warrants in connection with a $60 million equity offering to new and existing investors and former creditors of Aegerion;

• $125 million aggregate principal amount of Convertible Notes due 2025 (convertible at initial rate of 386.75 ordinary shares for each $1,000 principal amount, which is subject to customary anti-dilution adjustments as well as adjustments following certain fundamental changes); and

• Contingent Value Rights to holders of the registrant's ordinary shares and to employee option holders entitling them to proceeds of up to $85 million upon the occurrence of specified milestones related to the regulatory approval and commercialization of AP101.

On November 14, 2019, the registrant issued 4,864,656 zero cost warrants in exchange for an equivalent number of ordinary shares, which remain held in treasury.

All of the foregoing issuances were made pursuant to exemptions from the registration requirements of the Securities Act, namely, outside of the United States pursuant to Regulation S, to U.S. entities pursuant to Section 4(a)(2) of the Securities Act or pursuant to Section 1145 of the Bankruptcy Reform Act of 1978.

Item 8.
Exhibits and Financial Statements.

(a)
Exhibits. The exhibits to this registration statement are listed in the Exhibit Index to this registration statement and incorporated herein by reference.

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(b)
Financial Statement Schedules. Schedules not listed above have been omitted because the information required to be set forth therein is not applicable or is shown in the consolidated financial statements or notes thereto.

Item 9.
Undertakings.

The undersigned registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreement, certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the provisions described in Item 6 hereof, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

The undersigned registrant hereby undertakes that:

(1)
For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.

(2)
For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

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EXHIBIT INDEX

Exhibit Number	Exhibit Description
1.1*	Form of Underwriting Agreement
2.1*	Plan Funding Agreement, dated May 20, 2019, between Amryt Pharma plc and Aegerion Pharmaceuticals, Inc.
2.2*	Share Purchase and Transfer Agreement, dated October 16, 2015, among Amryt Pharmaceuticals DAC, Software AG – Stiftung, Dr. Armin Schiffler and Birken AG
3.1*	Articles of Association of Amryt Pharma plc
4.1*	Deposit Agreement
4.2*	Form of American Depositary Receipt (included in Exhibit 4.1)
5.1	Opinion of Gibson, Dunn & Crutcher UK LLP
8.1	Opinion of Gibson, Dunn & Crutcher UK LLP regarding tax matters
10.1*	Debtor’s Modified First Amended Joint Chapter 11 Plan, dated August 29, 2019, of Aegerion Pharmaceuticals, Inc., et al.
10.2	Restructuring Support Agreement, dated May 20, 2019, among Aegerion Pharmaceuticals, Inc. and each of its subsidiaries party thereto, Amryt Pharma plc, as plan investor, and Athyrium Opportunities II Acquisition LP, Athyrium Opportunities III Acquisition LP, Highbridge MSF International Ltd., 1992 Tactical Credit Master Fund, L.P., Highbridge SCF Special Situations SPV, L.P., Highbridge SCF Loan SPV, L.P., Whitebox Relative Value Partners, LP, Whitebox GT Fund, LP, Whitebox Multi-Strategy Partners, LP, Pandora Select Partners, LP, Nineteen77 Global Multi-Strategy Alpha Master Limited and Nineteen77 Global Convertible Bond Master Limited, as consenting lenders
10.3	Backstop Agreement, dated July 10, 2019, among Amryt Pharma plc and Highbridge MSF International Ltd., Highbridge SCF Special Situations SPV, L.P., 1992 Tactical Credit Master Fund, L.P., Athyrium Opportunities II Acquisition, 2 LP, Athyrium Opportunities III Acquisition 2 LP, Whitebox Relative Value Partners, LP, Whitebox GT Fund, LP, Whitebox Multi-Strategy Partners, LP, Pandora Select Partners, LP, Nineteen77 Global Multi-Strategy Alpha Master Limited and Nineteen77 Global Convertible Bond Master Limited, as backstop parties
10.4†	Registration Rights Agreement, dated September 25, 2019, among Amryt Pharma Holdings plc, Highbridge MSF International Ltd., Highbridge Tactical Credit Master Fund, L.P., Highbridge SCF Special Situations SPV, L.P., Athyrium Opportunities II Acquisition 2 LP and Athyrium Opportunities III Acquisition 2 LP
10.5†	Senior Secured Credit Agreement, dated September 24, 2019, among Aegerion Pharmaceuticals, Inc., as borrower, Amryt Pharma Holdings plc, the lenders party thereto and Cantor Fitzgerald Securities as administrative agent and collateral agent for the lenders
10.6†	Indenture, dated September 24, 2019, among Aegerion Pharmaceuticals, Inc., as issuer, Amryt Pharma Holdings plc, Amryt Pharma plc and the additional guarantors party thereto and GLAS Trust Company LLC, as the trustee, relating to the issuer’s 5.00% Convertible Senior Notes due 2025
10.7†	License Agreement, effective as of March 14, 2018, between Amryt Genetics Limited and University College Dublin, National University of Ireland
10.8.1	Patent License Agreement, effective as of May 19, 2006, between Aegerion Pharmaceuticals, Inc. and The Trustees of the University of Pennsylvania (incorporated by reference to Exhibit 10.6 to Aegerion Pharmaceutical Inc.’s Registration Statement on Form S-1, as amended, filed with the SEC on August 10, 2010)
10.8.2	First Amendment to Patent License Agreement, effective as of September 27, 2006, between Aegerion Pharmaceuticals, Inc. and The Trustees of the University of Pennsylvania (included in Exhibit 10.8.1)
10.9.1	Asset Purchase Agreement, dated November 5, 2014, by and among Aegerion Pharmaceuticals, Inc., Amylin Pharmaceuticals, LLC and AstraZeneca Pharmaceuticals LP (incorporated by reference to Exhibit 10.29 to Aegerion Pharmaceuticals, Inc.’s Amendment No. 1 to the Annual Report on Form 10-K, filed with the SEC on July 7, 2015)

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Exhibit Number	Exhibit Description
10.9.2	First Amendment to Asset Purchase Agreement, dated January 9, 2015, by and among Aegerion Pharmaceuticals, Inc., Amylin Pharmaceuticals, LLC and AstraZeneca Pharmaceuticals LP (incorporated by reference to Exhibit 10.30 to Aegerion Pharmaceuticals, Inc.’s Annual Report on Form 10-K, filed with the SEC on March 2, 2015)
10.10	License Agreement, dated February 7, 2006, by and between Amgen Inc. and Amylin Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.32 to Aegerion Pharmaceuticals, Inc.’s Annual Report on Form 10-K, filed with the SEC on March 2, 2015).
10.11.1†	Contract Manufacturing Agreement, dated September 30, 2010, by and between Amylin Pharmaceuticals, Inc. and Sandoz GmbH
10.11.2†	First Amendment, dated September 1, 2011, to Contract Manufacturing Agreement, dated September 30, 2010, by and between Amylin Pharmaceuticals, Inc. and Sandoz GmbH
10.11.3†	Amendment No. 2, dated December 18, 2012, to Contract Manufacturing Agreement, dated September 30, 2010, by and between Amylin Pharmaceuticals, Inc. and Sandoz GmbH
10.11.4	Amendment No. 3, dated July 8, 2013, to Contract Manufacturing Agreement, dated September 30, 2010, by and between Amylin Pharmaceuticals, Inc. and Sandoz GmbH
10.11.5	Amendment No. 4, dated June 23, 2014, to Contract Manufacturing Agreement, dated September 30, 2010, by and between Amylin Pharmaceuticals, Inc. and Sandoz GmbH
10.11.6†	Amendment No. 5, dated October 13, 2014, to Contract Manufacturing Agreement, dated September 30, 2010, by and between Amylin Pharmaceuticals, Inc. and Sandoz GmbH
10.11.7†	6th Amendment, dated June 1, 2017, to Contract Manufacturing Agreement, dated September 30, 2010, by and between Aegerion Pharmaceuticals, Inc. and Sandoz GmbH
10.11.8†	7th Amendment, dated August 1, 2017, to Contract Manufacturing Agreement, dated September 30, 2010, by and between Aegerion Pharmaceuticals, Inc. and Sandoz GmbH
10.12.1†	Master Services Agreement, dated as of December 6, 2013 between Bristol-Meyers Squibb Company and Accredo Health Group, Inc.
10.12.2	1st Amendment, dated January 9, 2014, to Master Services Agreement, dated as of December 6, 2013 between Bristol-Meyers Squibb Company and Accredo Health Group, Inc.
10.12.3†	Second Amendment, dated June 1, 2014, to Master Services Agreement, dated as of December 6, 2013 between Astrazeneca Pharmaceuticals LP and Accredo Health Group, Inc.
10.12.4	Third Amendment, dated June 20, 2016, to Master Services Agreement, dated as of December 6, 2013 between Aegerion Pharmaceuticals, Inc. and Accredo Health Group, Inc.
10.12.5†	Fourth Amendment, dated October 19, 2017, to Master Services Agreement, dated as of December 6, 2013 between Aegerion Pharmaceuticals, Inc. and Accredo Health Group, Inc.
10.13#	Amryt Pharma plc Employee Share Option Plan 2019
16.1*	Letter from BDO LLP
21.1*	List of Subsidiaries
23.1*	Consent of Grant Thornton with respect to financial statements of Amryt Pharma plc
23.2*	Consent of Deloitte & Touche, LLP with respect to financial statements of Aegerion Pharmaceuticals, Inc.
23.3	Consent of Gibson, Dunn & Crutcher UK LLP (included in Exhibits 5.1 & 8.1)
24.1*	Powers of Attorney (included on signature page to the registration statement)

*
To be filed by amendment.

†
Portions of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation S-K Item 601(b)(10)(iv).

#
Indicates senior management contract or compensatory plan.

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SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form F-1 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in London, the United Kingdom on      , 2020.

AMRYT PHARMA PLC
By:
	Name:	Dr. Joseph A. Wiley
	Title:	Chief Executive Officer

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We, the undersigned directors, officers and/or authorized representative in the United States of Amryt, hereby severally constitute and appoint Joseph Wiley and Rory Nealon, and each of them singly, our true and lawful attorneys, with full power to any of them, and to each of them singly, to sign for us and in our names in the capacities indicated below the registration statement on Form F-1 filed herewith, and any and all pre-effective and post-effective amendments to said registration statement, and any registration statement filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, in connection with the registration under the Securities Act of 1933, as amended, of equity securities of Amryt Pharma plc, and to file or cause to be filed the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as each of them might or could do in person, and hereby ratifying and confirming all that said attorneys, and each of them, or their substitute or substitutes, shall do or cause to be done by virtue of this Power of Attorney.

Pursuant to the requirements of the Securities Act of 1933, as amended, this registration statement has been signed by the following persons on      , 2020 in the capacities indicated:

Name	Title
	Chief Executive Officer and Director (Principal Executive Officer)
Dr. Joseph A. Wiley
	Chief Financial Officer and Chief Operating Officer (Principal Financial and Accounting Officer)
Rory P. Nealon
	Chairman of the Board
Raymond T. Stratford
	Director
Donald K. Stern
	Director
Dr. Alain H. Munoz
	Director
Dr. Patrick V.J.J. Vink
	Director
Stephen T. Wills
	Director
George P. Hampton, Jr.

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SIGNATURE OF AUTHORIZED US REPRESENTATIVE OF REGISTRANT

Pursuant to the requirements of the Securities Act of 1933, as amended, the undersigned, the duly authorized representative in the United States of Amryt Pharma plc has signed this registration statement on      , 2020.

By:
	Name:	Donald Puglisi
	Title:	Authorized Representative in the United States

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