SEC Comment Letter for PRECIGEN, INC. (PGEN) (CIK 0001356090) (PGEN) — Jun 6, 2013
PRECIGEN, INC. (PGEN) (CIK 0001356090)
Date: June 6, 2013 · CIK: 0001356090 · Accession: 0000000000-13-031067
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June 6, 2013 Via E -mail Randal J. Kirk President and Chief Executive Officer Intrexon Corporation 2875 South Ocean Boulevard, Suite 215 Palm Beach, Florida 33480 Re: Intrexon Corporation Draft Registration Statement on Form S -1 Submitted May 10, 2013 and amended May 31, 2013 CIK No. 0001356090 Dear Mr. Kirk: 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 registration statement or filed registration statement, 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 po ssible. Please note that we may have comments on these materials once they are provided. 2. We note that you intend to seek confidential treatment for several of your exhibits. Please note that comments on your confidential treatment request will be sent u nder separate cover. 3. Please confirm that the graphics included in your registration statement are the only graphics you will use in your prospectus. If those are not the only graphics, please provide any additional graphics prior to their use for our r eview. Randal J. Kirk Intrexon Corporation June 6, 2013 Page 2 4. 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. Similarly, please supplementally provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering. 5. Please revise your disclosure throughout your registration statement to clarify whether you applied to obtain listing of your common stock, and if so, the status of your application. If you have not yet filed an application, please expand your disclosure to clearly state that an application has not yet been filed and disclose when you expect to file such a n application. 6. Please update your filing with financial statements for the quarterly period ended March 31, 2013 as required by Rule 3 -12 of Regulation S -X. 7. We note your statement, “While we believe these industry publications and third -party research, s urveys and studies are reliable, we have not independently verified such data.” It is not appropriate to imply that you are not liable for statements included in your registration statement. Please delete this sentence or specifically state that you are responsible for the referenced information. Prospectus Summary Company overview, page 1 8. Please provide the basis for your statement, “Intrexon is a leader in the field of synthetic biology….” Alternatively, please delete this assertion throughout your p rospectus or make clear that it is your “belief” that you are a leader in the field of synthetic biology. 9. Please describe what you mean by the terms “gene programs” and “cellular systems” the first time you use the terms. 10. Please expand your disclosur e to briefly describe your technology platforms. 11. Please expand the sentence at the bottom of page 1 to clarify that no commercial products have been enabled by your technologies to date. Our competitive strengths, page 2 12. Please expand your disclosure to describe your “extensive bioinformatic network.” Randal J. Kirk Intrexon Corporation June 6, 2013 Page 3 Risks associated with our business, page 4 13. In your last bullet point, please identify your key management personnel to which you are referring. Risk Factors If we lose key personnel, including key management personnel, or are unable…, page 18 14. To the extent that you have experienced problems attracting and retaining key management personnel in the recent past, please revise your disclosure to describe these problems. 15. Please quantify the amount of k ey man insurance that you maintain on Dr. Reed. We may be sued for product liability, page 20 16. To the extent that you have received notice of any material liability claims, please revise your disclosure to discuss such claims and the potential consequence s. Also, please quantify the level of coverage of product liability insurance that your collaborators are required to obtain under your ECCs. The markets in which our collaborators are developing products using our…, page 24 17. We note your disclosure that there are numerous companies that are developing products that may compete with, and could adversely affect the prices for, and products developed by your collaborators using your technologies. Please expand your disclosure to identify your main competit ors and the products they are developing. Risks related to our intellectual property, page 25 18. We note that you have patents in the U.S. and abroad that begin to expire in 2014 and 2017. Please expand your disclosure in this section to discuss your mat erial patents, including the foreign jurisdictions in which they are granted and the specific expiration dates. Obtaining and maintaining our patent protection depends on compliance…, page 28 19. To the extent that you have failed to comply with any procedural, documentary, fee payment or other provisions during the patent process that could result in the abandonment or lapse of a patent or patent application, please discuss the situation and potential consequences. Randal J. Kirk Intrexon Corporation June 6, 2013 Page 4 Enforcing our intellectual prop erty rights may be difficult and unpredictable, page 27 20. We note your statement, “Although we believe that we have conducted our patent prosecution in accordance with the duty of candor and in good faith, the outcome following legal assertions of invalidit y and unenforceability during patent litigation is unpredictable.” It appears that you may have initiated some actions related to possible infringement of your intellectual property. If so, please discuss the situation and potential consequences in this risk factor discussion. If our technologies or products using our technologies are stolen…, page 30 21. To the extent that any of your technologies, or products using your technologies, have been stolen, misappropriated or reverse engineered, please discus s the situation and potential consequences in this risk factor discussion. AquaBounty will need additional capital, page 30 22. Please expand your disclosure in this section to quantify the amount of AquaBounty’s cash and cash equivalents and working capital as of the most recent date practicable. Also, please disclose for how long these amounts will provide adequate funds for AquaBounty’s ongoing operations. Lastly, to the extent known, please disclose the additional amount of funds that you may be require d to invest in AquaBounty. There is a significant uncertainty regarding regulatory approval of…, page 30 23. Please describe the significant delays that AAS has experienced in the regulatory process thus far. The loss of AquaBounty broodstock would result in the loss of AquaBounty’s…, page 31 24. Please define the term “broodstock” the first time it is used. Use of proceeds, page 40 25. We note your intended uses of proceeds listed in the third paragraph of this section. Please expand your disclosure to specify the amount of proceeds that will be used for each of the purposes listed in this section. In regard to the proceeds that will be used to fund continued investment in your research and development platforms, please describe how far in the development proc ess these funds will bring each of your platforms. Also, please update the section entitled, “Future capital requirements” on page 58 accordingly. Dilution, page 44 26. It appears that your calculations of historical net tangible book value include redeemab le convertible preferred stock. The amounts attributable to preferred shareholders would Randal J. Kirk Intrexon Corporation June 6, 2013 Page 5 only be available to common shareholders upon the conversion of preferred stock to common stock. Please revise your calculations of historical net tangible book valu e to exclude redeemable convertible preferred stock or explain to us the basis for your calculation. Management’s discussion and analysis of financial condition and results of operations Results of operations Research and development expenses, page 54 27. Please disclose the following information for each of your key research and development projects: a. The nature, objective, and current status of the project; b. The costs incurred during each period presented and to date; c. The nature of efforts and steps necessary to complete the project; d. The risks and uncertainties associated with completing development; e. The extent and nature of additional resources that need to be obtained if current liquidity is not expected to be sufficient to complete the project ; a nd, f. Whether a future milestone such as completion of a development phase, date of filing an NDA with a regulatory agency, or approval from a regulatory agency can be reliably determined. Net operating losses, page 60 28. We note that the utilization of port ions of the net operations losses may be subject to annual limitations. Please quantify the amount of losses that may be limited and the annual limitations. Critical Accounting Policies and Estimates Share -based c ompensation, page 66 29. We acknowledge your existing disclosure. Please expand your disclosure regarding the common stock valuations to discuss the method used to determine enterprise value at each valuation date. Also, prior to the effective date, please update your filing with additional disclos ure that progressively bridges from your latest price per share to the mid-point of your estimated IPO price range. Reconcile and explain the differences between the values included in your analysis. Business Our suite of proprietary and complementary te chnologies The UltraVector gene design and fabrication platform, page 80 30. We note that the UltraVector -driven build phase is performed via a proprietary modular assembly platform that incorporates a broad spectrum of DNA assembly methodologies. Please exp and your disclosure to describe the “broad spectrum of DNA assembly methodologies.” Randal J. Kirk Intrexon Corporation June 6, 2013 Page 6 31. Please define the terms “in vivo” and “ex vivo” the first time you use them. 32. We note that your Attsite recombinases mediate predictable gene exchange into host cells thereby eliminating “many of the difficulties seen with traditional gene insertions.” Please describe the difficulties with traditional gene insertions and how your Attsite recombinases remedy the difficulties. Cell Systems Informatics, page 82 33. Please d efine the terms “in silico” and “de novo” the first time you use them. Our ECCs Ziopharm Oncology, page 88 34. Please disclose the aggregate amount of future milestones you could receive under the ECC with Ziopharm. Elanco, page 89 35. Please identify the le ad programs that are currently in the research phase under the ECC with Elanco and the indications that each program is designed to treat. Oragenics, page 90 36. Please identify the infectious diseases that lantibiotics are being developed to treat. Synthet ic Biologics, page 90 37. Please identify the lead program that is currently in preclinical development under the ECC with Synthetic Biologics and the indications that this program is designed to treat. 38. Please disclose the aggregate amount of future mileston es that you could receive from Synthetic Biologics. AmpliPhi, page 91 39. We note that you are entitled to various milestone payments in the lower to mid -single - digit millions of dollars. Please quantify the aggregate amount of milestones that you are entitled to receive under the AmpliPhi ECC. Genopaver, page 91 40. Please identify the lead programs under the Genopaver ECC and their specific uses. Randal J. Kirk Intrexon Corporation June 6, 2013 Page 7 Soligenix, page 92 41. Please identify the lead program under the Soligenix ECC which is currently in the research phase. 42. We note that you are entitled to various milestone payments in the lower to mid -single - digit millions of dollars. Please quantify the aggregate amount of milestones that you are entitled to receive under the Soligenix ECC. Competition, page 92 43. Under the first bullet point, please identify the companies which can synthesize DNA, and the companies that can develop monoclonal antibodies. Intellectual property, page 93 44. We note that you have also filed counterpart patents and patent applic ations in other countries. Please disclose the foreign jurisdictions where you have material patents or patent applications and the expiration date of your material foreign patents. Regulatory environment Regulations affecting Intrexon, page 94 45. We note that your research operations are subject to various environmental regulations. Please identify and describe these “various environmental regulations.” Regulations affecting our ECC collaborators, page 95 46. Please describe FDA regulations, Depart ment of Agriculture regulations, Environmental Protection Agency regulations, EMA regulations and the REACH program to which your collaborators are subject. Management Executive officers and directors, page 99 47. We note that there are gaps in time in Mr. a nd Mrs. Krishnan’s business experience during the past five years. Please revise your disclosure to include Mr. and Mrs. Krishnan’s business experience during the past five years pursuant to Item 401(e)(1) of Regulation S -K. Executive and director compen sation Narrative to summary compensation table, page 109 48. Please disclose the annual salary that Mr. Kirk will receive as of the closing of this offering. Randal J. Kirk Intrexon Corporation June 6, 2013 Page 8 49. We note that you typically establish bonus targets for your named executive officers and evaluate the ir performance based on your achievement of corporate goals and the achievement of specified goals and objectives by each individual employee. Please expand your disclosure to describe your bonus targets. Also, please describe your corporate goals and th e specified goals and objectives for each individual named executive officer, providing a quantification of the corporate or individual goal as appropriate. Lastly, please describe the level of achievement of each corporate and individual goal which led t o Mr. Krishnan and Dr. Reed receiving bonuses in the amounts of $600,000 and $120,000, respectively, for the fiscal year ended December 31, 2012. Certain relationships and related person transactions Transactions with Third Security, LLC and affiliates 50. In the risk factor entitled, “We have engaged in transactions with companies in which Randal J. Kirk, our Chief Executive Officer, and his affiliates have an interest,” you refer to your research collaboration with Biolife Cell Bank, Inc. We also note that the agreement is listed as an exhibit to be filed pursuant to Item 601(b)(10) of Regulation S - K in your initial draft regist