SEC Company Response from PROTHENA CORP PUBLIC LTD (PRTA) — Feb 28, 2019
PROTHENA CORP PUBLIC LTD CO
Date: Feb. 28, 2019 · CIK: 0001559053 · Accession: 0001193125-19-058884
AI Filing Summary & Sentiment
File numbers found in text: 001-35676
Referenced dates: December 19, 2018, January 22, 2019
Letter
FOIA CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO RULE 83
Prothena Corporation plc
77 Sir John Rogerson’s Quay, Block C
Grand Canal Docklands
Dublin 2, D02 T804, Ireland
February 28,
Via EDGAR Transmission and Overnight Delivery
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Healthcare & Insurance
100 F Street, N.E.
Washington, DC 20549
Attention:
Frank Wyman
Tabatha McCullom
Re:
Prothena Corporation plc
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed February 26, 2018
Form 10-Q for the Quarterly Period Ended September 30, 2018
Filed November 6, 2018
File No. 001-35676
Ladies and Gentlemen:
Prothena Corporation plc (the “Company” or “Prothena”) submits this addendum to its letter dated January 22, 2019, in response to comments received by letter dated December 19, 2018 from the Staff of the Securities and Exchange Commission (the “Staff”). A courtesy copy of this letter is being submitted to the Staff by overnight delivery.
Capitalized terms used but not defined herein have the meanings ascribed to them in the Master Collaboration Agreement by and between Prothena Biosciences Limited and Celgene Switzerland LLC (“Celgene”) dated March 20, 2018 (the “Agreement”), to which the Staff’s comments relate.
The information provided below is in response to requests communicated by the Staff in telephone conversations with Prothena representatives on February 22 and 23, 2019. We hope this information is responsive to the Staff’s requests, and would be pleased to reconvene again by telephone if it would helpful to explain any of the responses below or answer any further questions.
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.
Confidential Treatment Requested by Prothena Corporation plc
PRTA-1
Transaction Overview
At a fundamental level, the transaction reflected in the Agreement is [***].
Prothena has a long history and deep expertise in neuroscience. Its scientific legacy began with Athena Neurosciences (“Athena”), which was founded in 1986. Athena scientists made significant discoveries that advanced the understanding of the biology of Alzheimer’s disease. Their findings led to the development of a drug discovery and development organization that generated multiple clinical candidates that have been, and continue to be, tested in Alzheimer’s disease. These scientists also pioneered significant scientific discoveries with cell adhesion molecules, leading to the discovery, development and commercialization of Tysabri® (natalizumab), which is approved for the treatment of relapsing forms of multiple sclerosis and marketed by Biogen Inc. Athena was acquired by Elan Corporation, plc (“Elan”) in 1996, and its discovery and development activities continued within Elan until 2012, when Prothena separated (“spun-out”) from Elan with a substantial portion of Elan’s drug discovery platform. Today, Prothena is drawing on its deep expertise in neuroscience to build a pipeline of investigational compounds that could deliver innovative therapies for patients. That pipeline includes prasinezumab (previously referred to as PRX002), an antibody for the potential treatment of Parkinson’s disease which is currently in a Phase 2 clinical study being conducted by Roche, with whom Prothena has a worldwide collaboration for that potential therapy. [***]
[***]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.
Confidential Treatment Requested by Prothena Corporation plc
PRTA-2
For Celgene, the transaction with Prothena provided Celgene with options to obtain exclusive rights to Prothena’s research and development on three potential programs that target deadly, incurable neurodegenerative diseases, including:
•
[***] the Tau program), which [***];
•
[***] the TDP-43 program), which [***]; and
•
[***] the TDP-43 program [***].
[***]
All three of the programs that are the subject of the Agreement [***]. Prothena [***], and [***].
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.
Confidential Treatment Requested by Prothena Corporation plc
PRTA-3
To illustrate the potential timelines for research and development in neurodegenerative diseases: [***]. Prothena applied for IND approval of that antibody in 2014 and initiated its first Phase 1 clinical trial later that year. The second Phase 1 trial for PRX002 was completed in 2016. A Phase 2 clinical trial of PRX002 was initiated in 2017 [***].
The Two Licenses
The licenses granted under Sections 7.1.1 and 7.1.2 of the Agreement are extremely limited, and do not constitute distinct or material performance obligations under the Agreement. [***]
License under Section 7.1.1: The license granted under this section expressly limits Celgene’s use of Prothena IP (as defined in the Agreement) to that which is necessary for Celgene to conduct its activities and perform its obligations under the Agreement. The referenced Sections 2.4 and 2.9 confirm that the purpose of this limited license is [***]. This license [***]. [***] Moreover, this license will terminate in any event upon termination of the Agreement for whatever reason.
License under Section 7.1.2: The license granted under this section [***].
[***]
Although this license would continue beyond the termination of the Agreement, Prothena [***]. However, because the limited license granted to Celgene in Section 7.1.2 [***].
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.
Confidential Treatment Requested by Prothena Corporation plc
PRTA-4
[***]
Prothena’s Accounting under ASC 606
Prothena’s determination to defer revenue recognition of the entire nonrefundable upfront payment by Celgene was based on the following analyses applying Accounting Standards Codification Topic 606 (“ASC 606”) to the transaction.
1. Prothena concluded that the Agreement is [***].
2. Evaluation of Prothena’s performance obligations in Agreement:
Prothena Obligation
Distinct Performance Obligation under ASC 606?
[***]
1. [***]
[***]
2. [***]
[***]
[***]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.
Confidential Treatment Requested by Prothena Corporation plc
PRTA-5
3. [***]
[***]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.
Confidential Treatment Requested by Prothena Corporation plc
PRTA-6
4. [***].
[***]1
5. [***]
[***]
6. [***]
[***]
7. [***]
[***]
8. [***]
[***]
As described above, early-stage discovery research for potential immunotherapies for Parkinson’s disease [***].
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.
Confidential Treatment Requested by Prothena Corporation plc
PRTA-7
9. [***].
[***]
3. Determination of transaction price
[***]
The Agreement includes the following consideration:
Consideration
Type
Consideration per the
Agreement
Included in the Initial Transaction Price?
[***]
[***]
[***]
[***]
[***]
[***]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.
Confidential Treatment Requested by Prothena Corporation plc
PRTA-8
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
4. Allocation of transaction price to performance obligations
[***]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.
Confidential Treatment Requested by Prothena Corporation plc
PRTA-9
5. Recognition of revenue
[***]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.
Confidential Treatment Requested by Prothena Corporation plc
PRTA-10
[***]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.
Confidential Treatment Requested by Prothena Corporation plc
PRTA-11
6. Evaluation of significant financing component
[***]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.
Confidential Treatment Requested by Prothena Corporation plc
PRTA-12
7. Evaluation of stand ready considerations
[***]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.
Confidential Treatment Requested by Prothena Corporation plc
PRTA-13
* * * * *
Please contact Bill Homan (at 650-615-2113 or bill.homan@prothena.com) or John C. Williams of Latham & Watkins LLP (at 650-470-4887 or john.williams@lw.com) if you have questions regarding the foregoing responses to the Staff’s comments.
Sincerely,
/s/ Tran B. Nguyen
Show Raw Text
CORRESP 1 filename1.htm CORRESP FOIA CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO RULE 83 Prothena Corporation plc 77 Sir John Rogerson’s Quay, Block C Grand Canal Docklands Dublin 2, D02 T804, Ireland February 28, 2019 Via EDGAR Transmission and Overnight Delivery U.S. Securities and Exchange Commission Division of Corporation Finance Office of Healthcare & Insurance 100 F Street, N.E. Washington, DC 20549 Attention: Frank Wyman Tabatha McCullom Re: Prothena Corporation plc Form 10-K for the Fiscal Year Ended December 31, 2017 Filed February 26, 2018 Form 10-Q for the Quarterly Period Ended September 30, 2018 Filed November 6, 2018 File No. 001-35676 Ladies and Gentlemen: Prothena Corporation plc (the “Company” or “Prothena”) submits this addendum to its letter dated January 22, 2019, in response to comments received by letter dated December 19, 2018 from the Staff of the Securities and Exchange Commission (the “Staff”). A courtesy copy of this letter is being submitted to the Staff by overnight delivery. Capitalized terms used but not defined herein have the meanings ascribed to them in the Master Collaboration Agreement by and between Prothena Biosciences Limited and Celgene Switzerland LLC (“Celgene”) dated March 20, 2018 (the “Agreement”), to which the Staff’s comments relate. The information provided below is in response to requests communicated by the Staff in telephone conversations with Prothena representatives on February 22 and 23, 2019. We hope this information is responsive to the Staff’s requests, and would be pleased to reconvene again by telephone if it would helpful to explain any of the responses below or answer any further questions. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-1 Transaction Overview At a fundamental level, the transaction reflected in the Agreement is [***]. Prothena has a long history and deep expertise in neuroscience. Its scientific legacy began with Athena Neurosciences (“Athena”), which was founded in 1986. Athena scientists made significant discoveries that advanced the understanding of the biology of Alzheimer’s disease. Their findings led to the development of a drug discovery and development organization that generated multiple clinical candidates that have been, and continue to be, tested in Alzheimer’s disease. These scientists also pioneered significant scientific discoveries with cell adhesion molecules, leading to the discovery, development and commercialization of Tysabri® (natalizumab), which is approved for the treatment of relapsing forms of multiple sclerosis and marketed by Biogen Inc. Athena was acquired by Elan Corporation, plc (“Elan”) in 1996, and its discovery and development activities continued within Elan until 2012, when Prothena separated (“spun-out”) from Elan with a substantial portion of Elan’s drug discovery platform. Today, Prothena is drawing on its deep expertise in neuroscience to build a pipeline of investigational compounds that could deliver innovative therapies for patients. That pipeline includes prasinezumab (previously referred to as PRX002), an antibody for the potential treatment of Parkinson’s disease which is currently in a Phase 2 clinical study being conducted by Roche, with whom Prothena has a worldwide collaboration for that potential therapy. [***] [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-2 For Celgene, the transaction with Prothena provided Celgene with options to obtain exclusive rights to Prothena’s research and development on three potential programs that target deadly, incurable neurodegenerative diseases, including: • [***] the Tau program), which [***]; • [***] the TDP-43 program), which [***]; and • [***] the TDP-43 program [***]. [***] All three of the programs that are the subject of the Agreement [***]. Prothena [***], and [***]. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-3 To illustrate the potential timelines for research and development in neurodegenerative diseases: [***]. Prothena applied for IND approval of that antibody in 2014 and initiated its first Phase 1 clinical trial later that year. The second Phase 1 trial for PRX002 was completed in 2016. A Phase 2 clinical trial of PRX002 was initiated in 2017 [***]. The Two Licenses The licenses granted under Sections 7.1.1 and 7.1.2 of the Agreement are extremely limited, and do not constitute distinct or material performance obligations under the Agreement. [***] License under Section 7.1.1: The license granted under this section expressly limits Celgene’s use of Prothena IP (as defined in the Agreement) to that which is necessary for Celgene to conduct its activities and perform its obligations under the Agreement. The referenced Sections 2.4 and 2.9 confirm that the purpose of this limited license is [***]. This license [***]. [***] Moreover, this license will terminate in any event upon termination of the Agreement for whatever reason. License under Section 7.1.2: The license granted under this section [***]. [***] Although this license would continue beyond the termination of the Agreement, Prothena [***]. However, because the limited license granted to Celgene in Section 7.1.2 [***]. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-4 [***] Prothena’s Accounting under ASC 606 Prothena’s determination to defer revenue recognition of the entire nonrefundable upfront payment by Celgene was based on the following analyses applying Accounting Standards Codification Topic 606 (“ASC 606”) to the transaction. 1. Prothena concluded that the Agreement is [***]. 2. Evaluation of Prothena’s performance obligations in Agreement: Prothena Obligation Distinct Performance Obligation under ASC 606? [***] 1. [***] [***] 2. [***] [***] [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-5 3. [***] [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-6 4. [***]. [***]1 5. [***] [***] 6. [***] [***] 7. [***] [***] 8. [***] [***] 1 As described above, early-stage discovery research for potential immunotherapies for Parkinson’s disease [***]. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-7 9. [***]. [***] 3. Determination of transaction price [***] The Agreement includes the following consideration: Consideration Type Consideration per the Agreement Included in the Initial Transaction Price? [***] [***] [***] [***] [***] [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-8 [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] 4. Allocation of transaction price to performance obligations [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-9 5. Recognition of revenue [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-10 [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-11 6. Evaluation of significant financing component [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-12 7. Evaluation of stand ready considerations [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-13 * * * * * Please contact Bill Homan (at 650-615-2113 or bill.homan@prothena.com) or John C. Williams of Latham & Watkins LLP (at 650-470-4887 or john.williams@lw.com) if you have questions regarding the foregoing responses to the Staff’s comments. Sincerely, /s/ Tran B. Nguyen Tran B. Nguyen Chief Operating Officer and Chief Financial Officer cc: Karin L. Walker, Chief Accounting Officer and Controller Bill Homan, Chief Legal Officer and Company Secretary David Rae, KPMG LLP Brian Fields, KPMG LLP Kathleen Wells, Latham & Watkins LLP John Williams, Latham & Watkin LLP [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter. Confidential Treatment Requested by Prothena Corporation plc PRTA-14