SEC Comment Letter for PROTHENA CORP PUBLIC LTD (PRTA) — Oct 29, 2012
PROTHENA CORP PUBLIC LTD CO
Date: Oct. 29, 2012 · CIK: 0001559053 · Accession: 0000000000-12-059441
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File numbers found in text: 001-35676
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October 28, 2012 Via E -mail Dale Schenk, PhD President and Chief Executive Officer Neotope Corporation Limited 650 Gateway Boulevard San Francisco, CA 94080 Re: Neotope Corporation Limited Registration S tatement on Form 10 Filed October 1, 2012 File No. 001-35676 Dear Dr. Schenk : We have reviewed your registration statement on Form 10 filed on October 1, 2012 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 amend ing your registration statement and providing the requested information . If you do not believe our comments apply to your facts and circumstances or do not belie ve 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. General 1. We note that there are a number of additional exhibits that still need to be filed. Please provide these exhibits as promptly as possible. Please note that we may have comments on these materials once they are provided. 2. Unless otherwise ind icated, references to p age references and captions in this letter are to the information statement filed as exhibit 99.1 . EXHIBIT 99.1 Information Statement General 3. It appears that the sale of shares by Neotope to Elan is one of the trans actions included in the series of transactions by which Elan will separate its Neotope Business from Elan’s other business es. Accordingly, it appears that this sale of shares to Elan is part of the Dale Schenk, PhD Neotope Corporation Limited October 28, 2012 Page 2 spin-off transaction. As described in the informat ion statement, after the sale of shares by Neotope, t he Elan shareholders will directly own a reduced percentage of equity securities and voting power in Neotope as compared to their percentage of equity securities and voting power in Elan . Please provide us with a detailed analysis which supports your conclusion that this is consistent with Staff Legal Bulletin No. 4, including support for your conclusion that the transaction is pro rata. Alternatively, please withdraw this registration statement and fil e a Securities Act registration statement to register this offering prior to seeking shareholder approval for the distribution . 4. We note that the issuance of 99.99% of Neotope’s shares will constitute a deemed “in specie” distribution by Elan to holders of record of Elan ordinary shares and Elan ADSs. Please briefly describe the meaning and significance of an “in specie” distribution the first time you use the term. 5. We note that immediately following the separation and distribution, Elan will purchase and acquire 18% of the outstanding ordinary shares of Neotope, consisting of (1) the purchase and acquisition (by way of “share subscription”) of newly issued shares of Neotope for cash and (2) the purchase of all Neoto pe incorporator shares. Please clarify the actions Elan will take to acquire 18% of the outstanding ordinary shares of Neotope . Please also clarify when this will occur. For example, we note that you state on page 15 that it will take the distribution agent up to two week s to issue the spin -off shares, will the purchase occur during this period? 6. You disclose throughout the information statement that f or U.S. federal income tax purposes, Elan expects that, while the matter is not free from doubt, the separation and distribution should qualify as a reorganization under section 368(a)(1)(D) of the Code, and the distribution, as such, should qualify as a distribution of our ordinary shares to Elan shareholders under section 355 of the Code. Please expand your disclosure to disclose the basis for your statement that the matter is not free from doubt. Please include in this discussion when the doubt may rise to the point where the distribution would not qualify as a reorganization. Summary Our Company Overview, page 3 7. Please briefly explain the meaning and significance of being granted “orphan drug designation” and filing an “Investigational New Drug Application” the f irst time you use such terms. 8. We note that Neotope US will provide research and development services to Elan for a limited time following the separation and distribution. Please revise your disclosure to quantify this length of time. Dale Schenk, PhD Neotope Corporation Limited October 28, 2012 Page 3 9. You disclose that r esearch and development services will be provided by Neotope US to Neotope Biosciences and Elan at “arm’s length rates.” Given that these transactions are related party transactions, this term does not appear appropriate. Please revise to delete the refe rence to “arm’s length rates.” In addition, please revise your disclosure on pages 31, 57 and 58 to remove the same reference and expand your disclosure on pages 57 and 58 to describe the payment terms. Risk Factors, page 4 10. Please expand your disclosure to describe the most sig nificant risks that are associated with each item listed in the bullet points in this section. Questions and Answers About the Separation and Distribution Q: Why is the separation of Ne otope structured as a distribution and not a sale?, page 7 11. Please revise your disclosure to explain how a distribution will “create long term value” for Elan Shareholders and why it will “provide greater assurance that decisions regarding Neotope’s capita l structure support future financial stability” compared to a sale. Q: How will Elan vote our ordinary shares that it acquires immediately following the separation and distribution? , page 8 12. You disclose here that Elan has agreed to vote the ordinary shares that it acquires immediately following the separation and distribution in proportion to the votes cast by your other sharehol ders and will grant you a proxy with respect to such shares. You reference the section “Arrangements between Elan and Neotope ” for more information, however, you do not disclose any information regarding this matter in the referenced section. Please expan d your disclosure on pages 55, 94 and 99 to disclose the mat erial terms of this agreement. In addition, please file a copy of the document or agreement that memorializes the terms of this agreement. Terms of the Separation and Distribution and Related Transactions, page 15 13. Please expand your disclosure to disclose the holder(s) of the incorporator shares. Risk Factors , page 18 14. You d isclose that yo ur business may be adversely affected by risks and uncertainties not known to you or risks that you currently believe to be immaterial. Please delete this statement as it is not appropriate to warn investors about risks which you are not currently aware or believe to be immaterial. Dale Schenk, PhD Neotope Corporation Limited October 28, 2012 Page 4 We will require additional capital to fund our operations, and if we are unable to obtain…, page 18 15. We note that following your separation from Elan, you believe that your existing cash and cash equivalents, will be sufficient to support you through approximately June 30, 2015 and that any future capital requirements will depend on many factors that are current ly unknown. Please revise your disclosure in this section to quantify the amount of your cash and cash equivalents, working capital and your rate of negative cash flow per month. In addition, we also note that you plan to initiate a Phase 1 clinical trial for NEOD001 in late 2012. To the extent practicable, please quantify the amount of funds you will need to complete this Phase 1 trial. Our collaborators, prospective collaborators, and suppliers will need assurances…, page 19 16. You disclose that some of your collaborators, prosp ective collaborators and suppliers will need assurances that your financial resources and stability on a stand -alone basis is sufficient to satisfy their requirements for doing or continuing to do business with you. Please expand this risk factor to discl ose each collaborator, prospective collaborator or supplier that you have not yet satisfied their requirements for doing or continuing to do business with you. We will rely on third parties to conduct our clinical trials, and those third parties…, page 25 17. We note that you have entered into agreements with third parties, and to date, you believe your consultants, contract research organization an d other similar entities with which you are working have performed well. Please expand your disclosure in this section and throughout your filing, as appropriate, to discuss the current third parties that are material to your business, if any. Also, if y ou have entered into any agreements with these third parties, please expand your disclosure in the Business section to disclose the material terms of these agreements and file the agreements as exhibits pursuant to Item 601(b)(10) of Regulation S -K. Simil arly, in the your risk factors following this risk factor, please expand your disclosure concerning your collaborators, manufacturers, and suppliers. If we are unable to adequately pr otect the intellectual property …, page 27 18. Please expand your disclosure in this risk factor to discuss any material patents , whether owned or licensed, and the expiration date of such p atents. Litigation regarding patents, patent applications and other proprietary rights may be expensive and time consuming …., page 28 19. You disclose that if you become entangled in the matter between AIA and Elan, you expect Elan to reimburse you for your expenses and indemnify you for any damages. Dale Schenk, PhD Neotope Corporation Limited October 28, 2012 Page 5 Please expand your disclosure here and on page 56 to clarify if this is a contractual obligation and if there are any limits or caps on the expense reimbursement or indemnity. We may be subject to claims that our empl oyees have wrongfully used or disclosed…, page 29 20. To the extent that you have received notice of any claims that your employees have wrongfully used or disclosed trade secrets of their former employers, please revise your disclosure to discuss such claims and the potential consequences. We may not realize some or all of the potential benefits we expect from our separation…, page 29 21. We note your one example why you may not be able to achieve some or al l of the benefits that you expect to achieve as a result of your separation from Elan. Please expand your disclosure to describe the other reasons why you may not realize the benefits you anticipate. Our historical and pro forma fi nancial information is not necessaril y representative of the results…, page 31 22. Please expand your disclosure to provide a quantified estimate of the additional costs that you disclose in this section. We expect that we will be treated as a p assive foreign investment company, which…, page 32 23. Please revise your disclosure to describe the meaning and significance of the terms “passive foreign investment company” and “qualified electing fund” the first time you use them. After the distribution, certain of our executive officers and directors may have actual…, page 33 24. We note that certain persons you expect will be your executive officer and directors will be former officers and employees of Elan. Please revise your disclosure to include the names of these individuals, their current positions with Elan and their financial interest in Elan. The Separation and Distribution and Related Transactions Reasons for the Separation and Distributi on and Related Transactions , page 40 25. We note that you have provided a description of the key benefits of the separation and distribution. Please expand your disclosure to also provide a similar description of the costs and risks associated with the trans action which you have outlined on page 41. Dale Schenk, PhD Neotope Corporation Limited October 28, 2012 Page 6 Improved Management Incentive Tools, page 41 26. Similar to your disclosure of each of the benefits of the transaction, please expand your disclosure to include a discussion of each of the costs and risks associated with the transaction rather than just listing general items. Manner of Effecting the Separation and Distribut ion and Related Transaction Distribution of Our Ordinary Shares, page 42 27. We note that the aggregate value of the ordinary shares issued by Neotope will be equal to the value of the Neotope Business transferred by Elan to Neotope. Please expand your discl osure to describe how the value of the Neotope Business will be determined. Arrangement s Between Elan and Neotope , page 55 28. In this section you have referenced other ancillary agreements. Please expand your disclosure to include all material terms of thes e agreements, including the material payment terms, duration and termination provisions and file copies of these agreements as exhibits to your amended registration statement. See Item 601(b)(10)(ii)(A) and (B) of Regulation S -K. Alternatively, please pro vide us with a description of each agreement and a detailed analysis that supports your conclusion that these agreements are not material and are not required to be filed. 29. Please expand your disclosure of each of the agreements in this sectio n to disclose the term and termination provisions of each agreement. Separation and Distribution Agreement, page 55 30. Please expand your disclosure to list the material assets to be transferred and the material liabilities to be assumed by Neo tope. Transition Services Agreement, page 57 and Research Services Agreement, page 58 31. Please expand your disclosure to provide a summary of the “specified services” which are the subject of the Transition Services Agreement. Similarly, plea se do the same for the “certain research and development services” which are the subject of the Research Services Agreement. Unaudited Pro Forma condensed Carve -Out Combined Financial Statements, page 64 32. In the first question on page 9 you indicate how existing Elan equity -based awards to your employees will be treated upon and after your separation and distribution transactions. Please tell us and revise your disclosure in MD&A and/or elsewhere to indicate how you will account for these awards going forward and reference for us Dale Schenk, PhD Neotope Corporation Limited October 28, 2012 Page 7 separat ely the authoritative literature you rely upon to support your anticipated accounting. To the extent that compensation will be recorded related to the accelerated vesting of some awards, please disclose the anticipated amount of the charge that will be recorded upon the completion of your anticipated transactions. In addition, to the extent appropriate, disclose that you do not include this charge in your pro forma statements of operations as it is directly attributable to the anticipated transactions and is non -recurring. Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of Operations Research and Development Expenses, page 71 33. Please expand your disclosure by referring to the Division of Corporation Finance “Current Issues and Rulemaking Projects Quarterly Update” under section VIII – Industry Specific Issues – Accounting and Disclosure by Companies Engaged in Research and Development Activities. You can find it at the following website address: http://www.sec.gov/divisions/corpfin/cfcrq032001.htm#secviii . Please disclose the following information for each of your major research and development projects: The costs incurred durin g each period presented and to date on the project; The nature, timing and estimated costs of the efforts necessary to complete the project; and The period in which material net cash i