PRECIGEN, INC. - Annual Report: 2019 (Form 10-K)

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•	our ability to successfully enter new markets or develop product candidates, including the expected timing and results of investigational studies and preclinical and clinical trials, and our research and development programs;

•	the timing or likelihood of regulatory filings for any product candidates we develop and our ability to obtain and maintain regulatory approvals for such product candidates for any indication;

•	our intentions and ability to successfully commercialize our product candidates;

•	the rate and degree of market acceptance of any products developed by us;

•	our ability to successfully execute and achieve benefits from our leadership transition plan and organizational restructuring, and to manage the transition to a new chief executive officer;

•	our efforts to hold or generate significant operating capital, including through partnering, potential asset sales of our non-healthcare assets, and operating cost reductions;

•	our cash position;

•	our estimates regarding expenses, future revenue, capital requirements, and need for additional financing;

•	our strategy and overall approach to our business model, including our efforts to focus our business in the healthcare industry;

•	our ability to adapt to changes in laws, regulations, and policies;

•	our reliance on and the performance of third parties, including exclusive channel collaborations, or ECCs, and joint ventures, or JVs;

•	competition from existing technologies and products or new technologies and products that may emerge;

•	our expectations related to the use of proceeds from our public offerings and other financing efforts;

•	actual or anticipated variations in our operating results;

•	market conditions in our industry;

•	our ability to protect our intellectual property and other proprietary rights and technologies;

•	our ability to retain and recruit key personnel;

•	our ability to successfully enter into optimal strategic relationships with our subsidiaries and operating companies that we may form in the future; and

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•	the result of litigation proceedings or investigations that we currently face or may face in the future.

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Item 1.	Business

•	Financial Discipline. Responsibly allocate capital in an effort to ensure maximum value creation.

•	Active Portfolio Management. Continuously evaluate our portfolio and strictly adhere to data-driven "go" and "no go" decisions to advance programs with the highest probability of success.

•	Rapid Execution. Advance selected programs quickly to "go" and "no go" decisions and value inflection points.

•	Strategic Partnerships. Seek strategic partnerships to maximize value generation.

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Advancing our lead programs and seeking opportunities to maximize their value. We are actively advancing our lead programs, including: PRGN-3005 and PRGN-3006, which are built on our UltraCAR-T platform; AG019, which is built on our ActoBiotics platform; and INXN-4001 non-viral triple effector plasmid DNA, which is built on our UltraVector platform. PRGN-3005 is in a Phase 1 clinical trial for advanced ovarian cancer patients and PRGN-3006 is in a Phase 1/1b clinical trial for patients with relapsed or refractory AML or high-risk MDS. The primary objective of the ongoing clinical studies is to determine the safety and maximum tolerated dose, or MTD, of PRGN-3005 and PRGN-3006. AG019 is currently being studied in a Phase 1b/2a multi-center study conducted in participants with clinical recent-onset T1D. INXN-4001 is being evaluated in a Phase 1 study to evaluate the safety of retrograde coronary sinus infusion of INXN-4001 in outpatient left ventricular assist device, or LVAD, recipients. We intend to efficiently pursue these programs toward clinical proof-of-concept and commercialization, whether independently or with collaborators.

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Strategically pursuing our preclinical programs. We have a robust pipeline of preclinical programs that we are pursuing in order to drive long-term value creation. We exercise discipline in our portfolio management by systematically evaluating data from our preclinical programs in order to make rapid "go" and "no go" decisions. Through this process, we can more effectively allocate resources to programs that we believe show the most promise and advance such programs to clinical trials.

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Leveraging our technology and therapeutic platforms across indications. Through the application of our suite of proprietary and complementary synthetic biology technologies, we believe we can create optimized biological processes and overcome the limitations of traditional techniques, leading to precision medicines that are manufactured more efficiently and cost-effectively with superior performance. We continually assess the application of these technologies across therapeutic areas to determine where we can develop and provide unique solutions to challenges facing existing therapies.

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•	completion of preclinical laboratory tests and in vivo studies in accordance with the FDA's current Good Laboratory Practice regulations and standards, and other applicable requirements;

•	submission to the FDA of an IND for human clinical testing, which must become effective before human clinical trials commence;

•	performance of adequate and well-controlled human clinical trials according to the FDA's Good Clinical Practices, or GCP, regulations, and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed product candidate for each intended use;

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•	preparation and submission to the FDA of an application for marketing approval that includes substantial evidence of safety, purity and potency for a biologic, or of safety and efficacy for a non-biologic drug, including from results of nonclinical testing and clinical trials;

•	satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the product candidate is produced to assess compliance with cGMP and to assure that the facilities, methods and controls are adequate to preserve the product candidate's identity, safety, strength, quality, potency and purity;

•	potential FDA inspection of the nonclinical and clinical trial sites that generated the data in support of the application; and

•	FDA review and approval of the application.

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Phase 1. The product candidate is introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain early understanding of its effectiveness. For some product candidates for severe or life-threatening diseases, especially when the product candidate may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients with the targeted disease.

•	Phase 2. The product candidate is administered and evaluated in a limited patient population to identify possible adverse effects and safety risks, to evaluate preliminary efficacy evidence for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule.

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Phase 3. The product candidate is administered to an expanded patient population, often at geographically dispersed clinical trial sites, in adequate and well-controlled clinical trials to generate sufficient data to evaluate the safety and efficacy of the non-biologic drug, or the safety, purity, and potency of the biologic. These clinical trials are intended to establish the overall risk/benefit ratio of the product candidate and provide an adequate basis for product labeling.

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Item 1A.	Risk Factors

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•	progress in our research and development programs, as well as the magnitude of these programs;

•	the timing of regulatory approval of products of our collaborations and operations;

•	the timing, receipt, and amount of any payments received in connection with strategic transactions;

•	the timing, receipt, and amount of upfront, milestone, and other payments, if any, from present and future collaborators, if any;

•	the timing, receipt, and amount of sales and royalties, if any, from our product candidates;

•	the timing and capital requirements to scale up our various product candidates and service offerings and customer acceptance thereof;

•	our ability to maintain and establish additional collaborative arrangements and/or new strategic initiatives;

•	the resources, time, and cost required for the preparation, filing, prosecution, maintenance, and enforcement of our intellectual property portfolio;

•	strategic mergers and acquisitions, if any, including both the upfront acquisition cost as well as the cost to integrate, maintain, and expand the strategic target; and

•	the costs associated with legal activities, including litigation, arising in the course of our business activities and our ability to prevail in any such legal disputes.

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•	sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials;

•	timely and successful completion of preclinical studies and our clinical trials;

•	acceptance of INDs for future product candidates;

•	successful enrollment in and completion of clinical trials;

•	successful data from our clinical program that supports an acceptable risk-benefit profile of our product candidates in

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•	our ability to consistently manufacture our product candidates on a timely basis or to establish agreements with third-party manufacturers;

•	whether we are required by the FDA or comparable foreign regulatory authorities to conduct additional clinical trials or other studies beyond those planned or anticipated to support approval of our product candidates;

•	acceptance of our proposed indications and the primary endpoint assessments evaluated in the clinical trials of our product candidates by the FDA and comparable foreign regulatory authorities;

•	receipt and maintenance of timely marketing approvals from applicable regulatory authorities;

•	the successful launch of commercial sales of our product candidates, if approved;

•	the prevalence, duration and severity of potential side effects or other safety issues experienced with our product candidates, if approved;

•	entry into collaborations to further the development of our product candidates;

•	our ability to obtain and maintain patent and other intellectual property protection or regulatory exclusivity for our product candidates;

•	acceptance of the benefits and uses of our product candidates, if approved, by patients, the medical community, and third-party payors;

•	maintenance of a continued acceptable safety, tolerability and efficacy profile of the product candidates following approval;

•	our compliance with any post-approval requirements imposed on our products, such as postmarketing studies, a REMS, or additional requirements that might limit the promotion, advertising, distribution or sales of our products or make the products cost prohibitive;

•	our ability to compete effectively with other therapies; and

•	our ability to obtain and maintain healthcare coverage and adequate reimbursement from third-party payors.

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•	developing and deploying consistent and reliable processes for engineering a patient's T-cells ex vivo and infusing the engineered T-cells back into the patient;

•	possibly conditioning patients with chemotherapy in conjunction with delivering each of the potential product candidates, which may increase the risk of adverse side effects of the potential products;

•	educating medical personnel regarding the potential side effect profile of each of the potential products, such as the potential adverse side effects related to cytokine release;

•	developing processes for the safe administration of these potential products, including long-term follow-up for all patients who receive the potential products;

•	sourcing additional clinical and, if approved, commercial supplies for the materials used to manufacture and process the potential products;

•	developing a manufacturing process and distribution network with a cost of goods that allows for an attractive return on investment;

•	establishing sales and marketing capabilities after obtaining any regulatory approval required to gain market access and acceptance;

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•	developing therapies for types of cancers beyond those addressed by the current potential products;

•	not infringing the intellectual property rights, in particular, the patent rights, of third parties, including competitors developing alternative CAR T-cell therapies; and

•	avoiding any applicable regulatory barriers to market, such as data and marketing exclusivities held by third parties, including competitors with approved CAR T-cell therapies.

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•	deficiencies in the conduct of the clinical trials, including failure to conduct the clinical trial in accordance with regulatory requirements or study protocols;

•	deficiencies in the clinical trial operations or trial sites;

•	unforeseen adverse side effects or the emergence of undue risks to study subjects;

•	deficiencies in the trial design necessary to demonstrate efficacy;

•	the product candidate may not appear to offer benefits over current therapies; or

•	the quality or stability of the product candidate may fall below acceptable standards.

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the federal Anti-Kickback Statute, which prohibits persons from, among other things, knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, the referral of an individual for the furnishing or arranging for the furnishing, or the purchase, lease or order, or arranging for or recommending purchase, lease or order, or any good or service for which payment may be made under a federal healthcare program such as Medicare and Medicaid;

•	the federal civil False Claims Act, which imposes liability, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

•	HIPAA's fraud provisions, which impose criminal liability for knowingly and willfully executing a scheme to defraud any healthcare benefit program, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a health care offense, or knowingly and willfully making false statements relating to healthcare matters;

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HIPAA generally, which also imposes obligations on certain covered entity health care providers, health plans and health care clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

•	the federal Physician Payment Sunshine Act, being implemented as the Open Payments Program, which requires manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare,

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analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers in those jurisdictions; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; some states also prohibit certain marketing-related activities including the provision of gifts, meals, or other items to certain health care providers, and others restrict the ability of manufacturers to offer co-pay support to patients for certain prescription drugs; other states and cities require identification or licensing of sales representatives; and state and foreign laws that govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

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•	reduced resources of our management to pursue our business strategy;

•	decreased demand for products enabled by our technologies;

•	injury to our or our collaborators' reputations and significant negative media attention;

•	withdrawal of clinical trial participants;

•	initiation of investigations by regulators;

•	product recalls, withdrawals or labeling, marketing or promotional restrictions;

•	significant costs to defend resulting litigation;

•	substantial monetary awards to trial participants or patients;

•	loss of revenue; and

•	the inability to commercialize any products using our technologies.

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•	tariffs and trade barriers;

•	currency fluctuations, which could decrease our revenues or increase our costs in United States dollars;

•	regulations related to customs and import/export matters;

•	tax issues, such as tax law changes and variations in tax laws;

•	limited access to qualified staff;

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•	inadequate infrastructure;

•	cultural and language differences;

•	inadequate banking systems;

•	different and/or more stringent environmental laws and regulations;

•	restrictions on the repatriation of profits or payment of dividends;

•	disease outbreaks, environmental catastrophes, crime, strikes, riots, civil disturbances, terrorist attacks or wars;

•	nationalization or expropriation of property;

•	law enforcement authorities and courts that are weak or inexperienced in commercial matters; and

•	deterioration of political relations among countries.

•	issue additional equity securities, which would dilute our current shareholders;

•	incur substantial debt to fund the acquisitions; or

•	assume significant liabilities.

•	problems integrating the purchased operations, facilities, technologies, or products;

•	unanticipated costs and other liabilities;

•	the potential disruption of our ongoing business and diversion of management resources;

•	adverse effects on existing business relationships with current and/or prospective collaborators, customers and/or suppliers;

•	unanticipated expenses related to the acquired operations;

•	risks associated with entering markets in which we have no or limited prior experience;

•	potential unknown liabilities associated with the acquired business and technology;

•	potential liabilities related to litigation involving the acquired companies;

•	potential periodic impairment of goodwill and intangible assets acquired; and

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•	potential loss of key employees or potential inability to retain, integrate, and motivate key personnel.

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•	stop selling, incorporating or using products that use the intellectual property at issue;

•	obtain from the third party asserting its intellectual property rights a license to sell or use the relevant technology, which license may not be available on reasonable terms, if at all; or

•	redesign those products or processes that use any allegedly infringing technology, or relocate the operations relating to the allegedly infringing technology to another jurisdiction, which may result in significant cost or delay to us, or that could be technically infeasible.

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•	our ability to achieve or maintain profitability;

•	the outcomes of our research programs, clinical trials, or other product development and approval processes;

•	our ability to develop and successfully commercialize our products;

•	the timing, receipt, and amount of any payments received in connection with upfront, milestone, and sale and royalty payments, if any;

•	our ability to successfully scale up production of our commercial products and customer acceptance thereof;

•	our ability to enter into strategic transactions;

•	our ability to develop and maintain our technologies;

•	our ability to manage our growth;

•	risks associated with the international aspects of our business;

•	our ability to accurately report our financial results in a timely manner;

•	our dependence on, and the need to attract and retain, key management, and other personnel;

•	our ability to obtain, protect and enforce our intellectual property rights;

•	our ability to prevent the theft or misappropriation of our intellectual property, know-how or technologies;

•	the costs associated with legal activities, including litigation, arising in the course of our business activities and our ability to prevail in any such legal disputes;

•	potential advantages that our competitors and potential competitors may have in securing funding or developing competing technologies or products;

•	our ability to obtain additional capital that may be necessary to expand our business;

•	business interruptions such as power outages and other natural disasters;

•	our ability to integrate any businesses or technologies we may acquire with our business;

•	negative public opinion and increased regulatory scrutiny of gene and cell therapies;

•	the impact of new accounting pronouncements on our current and future operating results;

•	our ability to use our net operating loss carryforwards to offset future taxable income; and

•	the results of our consolidated subsidiaries.

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•	announcements of acquisitions, collaborations, financings, divestitures, or other transactions by us;

•	public concern as to the safety of our products;

•	termination or delay of a development program;

•	the recruitment or departure of key personnel; and

•	the other factors described in this "Risk Factors" section.

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•	delay, defer, or prevent a change in control;

•	entrench our management and/or the board of directors; or

•	impede a merger, consolidation, takeover, or other business combination involving us that other shareholders may desire.

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•	include a provision allowing our board of directors to issue preferred stock with rights senior to those of the common stock without any vote or action by the holders of our common stock. The issuance of preferred stock could adversely affect the rights and powers, including voting rights, of the holders of common stock;

•	establish advance notice requirements for nominations for election to the board of directors or for proposing matters

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•	provide for the inability of shareholders to convene a shareholders' meeting without the support of shareholders owning together 25 percent of our common stock;

•	provide for the application of Virginia law prohibiting us from entering into a business combination with the beneficial owner of 10 percent or more of our outstanding voting stock for a period of three years after the 10 percent or greater owner first reached that level of stock ownership, unless we meet certain criteria;

•	allow the authorized number of our directors to be changed only by resolution of our board of directors;

•	limit the manner in which shareholders can remove directors from the board;

•	require that shareholder actions must be effected at a duly called shareholder meeting and prohibit actions by our shareholders by written consent; and

•	limit who may call a special meeting of shareholders.

Item 1B.	Unresolved Staff Comments

Item 2.	Properties

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Item 3.	Legal Proceedings

Item 4.	Mine Safety Disclosures

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Item 5.	Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

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Item 6.	Selected Financial Data

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(1)

Revenues and deferred revenue in 2019 and 2018 are accounted for under Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers, or ASC 606, and revenues and deferred revenue prior to 2018 are accounted for under ASC 605, Revenue Recognition, or ASC 605. We adopted ASC 606 on January 1, 2018 using the modified retrospective method, which applies the changes in accounting prospectively and does not restate prior periods. See "Notes to the Consolidated Financial Statements - Notes 4, 6, and 18" for discussions of transactions in 2018 resulting in a decrease in the balances of deferred revenue.

(2)

Total assets include $191, $161,225, and $129,545 of investments in preferred stock as of December 31, 2018, 2017, and 2016, respectively. In conjunction with the ZIOPHARM License Agreement in 2018, all of our ZIOPHARM preferred shares were returned to ZIOPHARM. See "Notes to the Consolidated Financial Statements - Notes 10 and 11" for discussions of impairment losses on long-lived assets recognized in 2019.

(3)	In 2018, we completed a registered underwritten public offering of $200,000 aggregate principal amount of Convertible Notes.

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(4)	Other liabilities include $8,801 and $15,629 of deferred consideration as of December 31, 2016 and 2015, respectively.

Item 7.	Management's Discussion and Analysis of Financial Condition and Results of Operations

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•	salaries and benefits, including stock-based compensation expense, for personnel in research and development functions;

•	fees paid to consultants and contract research organizations who perform research on our behalf and under our direction;

•	costs related to laboratory supplies used in our research and development efforts and acquiring, developing, and manufacturing preclinical study and clinical trial materials;

•	costs related to certain in-licensed technology rights or reacquired in-process research and development;

•	amortization of patents and related technologies acquired in mergers and acquisitions; and

•	facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.

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(1)	Including $11,832 and $55,573 from related parties for the years ended December 31, 2019 and 2018, respectively.

(2)

The results of operations in the table above include the operations related to the Transactions, as well as adjustments to those businesses as a result of the Transactions, in loss from discontinued operations, net of income tax benefit. The increase in the loss from discontinued operations in 2019 is due to additional impairment losses recorded related to the Transactions. See "Notes to the Consolidated Financial Statements - Note 3" appearing elsewhere in this Annual Report.

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(1)	For the years ended December 31, 2019 and 2018, revenue recognized from collaborations with Harvest start-up entities include Exotech Bio, Inc.; AD Skincare, Inc.; and Thrive Agrobiotics, Inc. For the year ended December 31, 2018, revenues recognized from collaborations with Harvest start-up entities also include Genten Therapeutics, Inc. and CRS Bio, Inc.

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(1)	Revenues in 2018 are accounted for under ASC 606 and revenues in 2017 are accounted for under ASC 605. We adopted ASC 606 on January 1, 2018 using the modified retrospective method, which applies the changes in accounting prospectively and does not restate prior periods.

(2)	Including $55,573 and $122,485 from related parties for the years ended December 31, 2018 and 2017, respectively.

(3)	The results of operations in the table above include the operations related to the Transactions in loss from discontinued operations, net of income tax benefit. The increase in the loss from discontinued operations in 2018 is due to additional impairment losses recorded at Oxitec. See "Notes to the Consolidated Financial Statements - Note 3" appearing elsewhere in this Annual Report.

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(1)	For the years ended December 31, 2018 and 2017, revenue recognized from collaborations with Harvest start-up entities include Genten Therapeutics, Inc.; CRS Bio, Inc.; Exotech Bio, Inc.; AD Skincare, Inc.; and Thrive Agrobiotics, Inc. For the year ended December 31, 2017, revenues recognized from collaborations with Harvest start-up entities also include Relieve Genetics, Inc.

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•	progress in our research and development programs, as well as the magnitude of these programs;

•	the timing of regulatory approval of products of our collaborations and operations;

•	the timing, receipt and amount of any payments received in connection with strategic transactions;

•	the timing, receipt, and amount of upfront, milestone, and other payments, if any, from present and future collaborators, if any;

•	the timing, receipt, and amount of sales and royalties, if any, from our product candidates;

•	the timing and capital requirements to scale up our various product candidates and service offerings and customer acceptance thereof;

•	our ability to maintain and establish additional collaborative arrangements and/or new strategic initiatives;

•	the resources, time, and cost required for the preparation, filing, prosecution, maintenance, and enforcement of our intellectual property portfolio;

•	strategic mergers and acquisitions, if any, including both the upfront acquisition cost as well as the cost to integrate, maintain, and expand the strategic target; and

•	the costs associated with legal activities, including litigation, arising in the course of our business activities and our ability to prevail in any such legal disputes.

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(1)	Of the $256.2 million convertible debt, $200.0 million may be converted into Precigen common stock, and $56.2 million may be converted into either Precigen common stock or the stock of certain of our subsidiaries. See "Notes to the Consolidated Financial Statements - Note 12" appearing elsewhere in this Annual Report for further discussion of these instruments.

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•	The consideration is commensurate with either the entity's performance to achieve the milestone or the enhancement of the value of the delivered item or items as a result of a specific outcome resulting from the entity's performance to achieve the milestone;

•	The consideration relates solely to past performance; and

•	The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement.

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Item 7A.	Quantitative and Qualitative Disclosures About Market Risk

Item 8.	Financial Statements and Supplementary Data

Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9A.	Controls and Procedures

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(i)	pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets;

(ii)	provide reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and

(iii)	provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the consolidated financial statements.

Item 9B.	Other Information

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Item 10.	Directors, Executive Officers and Corporate Governance

Item 11.	Executive Compensation

Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Item 13.	Certain Relationships and Related Transactions, and Director Independence

Item 14.	Principal Accounting Fees and Services

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Item 15.	Exhibits, Financial Statement Schedules

(a)	The following consolidated financial statements of Precigen, Inc. and its subsidiaries, and the independent registered public accounting firm reports thereon, are included in Part II, Item 8 of this Annual Report:

1.	Financial Statements.

2.	Financial Statement Schedules.

3.	Exhibits.

(b)	Exhibits

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*	Previously filed and incorporated by reference to the exhibit indicated in the following filings by the Company:

(1)	Amendment No. 1 to Registration Statement on Form S-1, filed with the Securities and Exchange Commission on July 29, 2013.

(2)	Current Report on Form 8-K/A, filed with the Securities and Exchange Commission on April 4, 2014.

(3)	Current Report on Form 8-K, filed with the Securities and Exchange Commission on January 14, 2015.

(4)	Current Report on Form 8-K, filed with the Securities and Exchange Commission on June 13, 2014.

(5)	Current Report on Form 8-K, filed with the Securities and Exchange Commission on June 17, 2015.

(6)	Current Report on Form 8-K, filed with the Securities and Exchange Commission on November 12, 2015.

(7)	Current Report on Form 8-K, filed with the Securities and Exchange Commission on June 13, 2016.

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(8)	Amendment No. 2 to the Registration Statement on Form S-4, filed with the Securities and Exchange Commission on May 11, 2017.

(9)	Current Report on Form 8-K, filed with the Securities and Exchange Commission on June 30, 2017.

(10)	Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 1, 2018.

(11)	Current Report on Form 8-K, filed with the Securities and Exchange Commission on June 8, 2018.

(12)	Current Report on Form 8-K, filed with the Securities and Exchange Commission on July 3, 2018.

(13)	Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on November 8, 2018.

(14)	Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 1, 2019.

(15)	Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on May 9, 2019.

(16)	Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on August 9, 2019.

(17)	Current Report on Form 8-K, filed with the Securities and Exchange Commission on October 31, 2019.

(18)	Current Report on Form 8-K, filed with the Securities and Exchange Commission on January 2, 2020.

(19)	Current Report on Form 8-K, filed with the Securities and Exchange Commission on January 7, 2020.

(20)	Current Report on Form 8-K, filed with the Securities and Exchange Commission on February 4, 2020.

**	Furnished herewith

†	Indicates management contract or compensatory plan.

#	Portions of the exhibit (indicated by asterisks) have been omitted as permitted by the Securities and Exchange Commission.

(c)	Financial Statement Schedules

Item 16.	Form 10-K Summary

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•	We tested the operating effectiveness of controls over contract revenue, including those over the estimates of total contract costs and revenue for performance obligations.

•	We selected a sample of collaboration and licensing contracts and performed the following:

•	Evaluated whether the contracts were properly included in management's calculation of contract revenue based on the terms and conditions of each contract, including whether transfer of control to the customer occurred as progress was made toward fulfilling the performance obligation.

•	Compared the transaction price to the consideration expected to be received based on current rights and obligations under the contracts and any modifications that were agreed upon with the customers.

•	Tested management's identification of the distinct performance obligation(s) by evaluating whether the underlying technology license, services, or both were highly interdependent and interrelated.

•	Evaluated management's determination of the contractual term and the appropriateness of management's method to measure its progress over that term.

•	Tested the accuracy and completeness of the total contract costs incurred to date for the performance obligation.

•	Evaluated the estimates of total contract costs and revenue for the performance obligation by:

•	Comparing costs incurred to date to the costs management estimated to be incurred to date.

•	Evaluating management's ability to achieve the estimates of total contract costs by performing corroborating inquiries with the Company's project managers and financial analysts, and comparing the estimates to management's work plans and cost estimates.

•	We evaluated management's ability to estimate total contract costs accurately by comparing actual costs to management's historical estimates for performance obligations that have been fulfilled.

•	Tested the mathematical accuracy of management's calculation of revenue for the performance obligation.

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•	We tested the operating effectiveness of controls over management's goodwill impairment evaluation, including those over the determination of the Trans Ova reporting unit fair value, such as controls related to management's forecasts and selection of the discount rate.

•	We evaluated management's ability to accurately forecast revenues and operating margins by comparing actual results to management's historical forecasts and external information.

•	With the assistance of our fair value specialists, we evaluated the discount rate, including testing the underlying source information and the mathematical accuracy of the calculations, and developing a range of independent estimates and comparing those to the discount rate selected by management.

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(1)	The consideration is commensurate with either the entity's performance to achieve the milestone or the enhancement of the value of the delivered item or items as a result of a specific outcome resulting from the entity's performance to achieve the milestone;

(2)	The consideration relates solely to past performance; and

(3)	The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement.

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•	As a period charge in the future period in which the tax arises; or

•	As part of deferred taxes related to the investment or subsidiary.

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•	Intrexon Produce Holdings, Inc. is the parent company of the Company's non-browning apple subsidiaries, Okanagan Specialty Fruits, Inc. and Fruit Orchard Holdings, Inc. (collectively referred herein as "Okanagan");

•	Intrexon UK Holdings, Inc. is the parent company of Oxitec Limited and subsidiaries, which is a pioneering company in biological insect solutions (referred to herein as "Oxitec");

•	ILH Holdings, Inc. includes the Company's fine chemicals operations that were focused primarily on microbial production of therapeutic compounds ("Fine Chemicals"); and

•	Blue Marble AgBio LLC which was formed in January 2020 and includes the Company's agriculture biotechnology assets and operations which were previously a division within Precigen ("AgBio").

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(1)	Includes deferred revenue, current, from related parties of $1,243.

(2)	Includes deferred revenue, net of current portion, from related parties of $6,836.

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(1)	Includes deferred revenue, current, from related parties of $443.

(2)	Includes deferred revenue, net of current portion, from related parties of $7,455.

(1)	Includes revenue recognized from related parties of $3,042.

(2)	Includes the impairment charge of $89,679 related to the Transactions discussed above.

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(1)	Includes revenue recognized from related parties of $4,665.

(2)	Includes an impairment charge of $60,504 recorded in 2018 related to Oxitec's developed technology targeting the Aedes Aegypti mosquito and a $5,057 loss on disposal of certain leasehold improvements, equipment and other fixed assets in conjunction with the closing of one of Oxitec's research and development facilities in Brazil.

(1)	Includes revenue recognized from related parties of $8,185.

(2)	Includes an impairment charge of $2,950 recorded as part of its annual impairment assessment of indefinite-lived intangible assets.

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(1)	For the years ended December 31, 2019, 2018, and 2017, revenue recognized from collaborations with Harvest start-up entities include Exotech Bio, Inc.; AD Skincare, Inc.; and Thrive Agrobiotics, Inc. For the years ended December 31, 2018 and 2017, revenue recognized from collaborations with Harvest start-up entities also include Genten Therapeutics

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(1)	As of December 31, 2019 and 2018, the balance of deferred revenue for collaborations with Harvest start-up entities includes Exotech Bio, AD Skincare, and Thrive Agrobiotics.

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•	During any calendar quarter commencing after the calendar quarter ended on September 30, 2018, if the last reported sales price of Precigen's common stock for at least 20 trading days (whether or not consecutive) during the last 30 consecutive trading days of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day;

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•	During the five business day period after any five consecutive trading day period in which the trading price, as defined in the Indenture, for the Convertible Notes is less than 98% of the product of the last reported sales price of Precigen's common stock and the conversion rate for the Convertible Notes on each such trading day; or

•	Upon the occurrence of specified corporate events as defined in the Indenture.

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(1)	During the fourth quarter of 2019, the Company recorded a goodwill impairment charge related to the Trans Ova reporting unit (Note 11) as well as impairment charges on certain assets held for sale (Note 3).

(1)

During the fourth quarter of 2018, the Company reacquired certain in-process research and development from ZIOPHARM, Ares Trading, and Intrexon T1D Partners, all of which were immediately expensed (Notes 5 and 6). The Company also recorded a loss on abandonment of certain of its intangible assets (Note 11). The Company also recognized the remaining balance of deferred revenue associated with Histogenics and Synthetic Biologics upon the mutual termination of the ECCs with these entities (Note 18).