PRECIGEN INC
For the period ended Mar 31, 2024. Filed May 14, 2024.
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Mar 31, 2024 · Filed May 14, 2024
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Notes to the Condensed Consolidated Financial Statements
(Amounts in thousands, except share and per share data)
- Organization
Precigen, Inc. ("Precigen"), a Virginia corporation, is a dedicated discovery and clinical-stage biopharmaceutical company advancing the next generation of gene and cell therapies with the overall goal of improving outcomes for patients with significant unmet medical needs. Precigen is leveraging its proprietary technology platforms to develop product candidates designed to target urgent and intractable diseases in its core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Precigen has developed an extensive pipeline of therapies across multiple indications within these core focus areas. Precigen’s primary operations are located in the State of Maryland.
Precigen also hastwo wholly owned operating subsidiaries: Precigen ActoBio, Inc. ("ActoBio"), and Exemplar Genetics, LLC, doing business as Precigen Exemplar ("Exemplar").
ActoBio is pioneering a proprietary class of microbe-based biopharmaceuticals that enable expression and local delivery of disease-modifying therapeutics, with its primary operations located in Ghent, Belgium.
Exemplar is committed to enabling the study of life-threatening human diseases through the development of Yucatan MiniSwine preclinical research models and services, as well as enabling the production of cells and organs in its genetically engineered MiniSwine for regenerative medicine applications. Exemplar’s primary operations are located in the State of Iowa.
Precigen and its consolidated subsidiaries are hereinafter referred to as the "Company."
- Summary of Significant Accounting Policies
Basis of Presentation
The accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP"). Certain information and footnote disclosures normally included in the Company's annual financial statements have been condensed or omitted. These interim condensed consolidated financial statements, in the opinion of management, reflect all normal recurring adjustments necessary for fair statement of the Company's financial position as of March 31, 2024 and results of operations and cash flows for the interim periods ended March 31, 2024 and 2023. The year-end condensed consolidated balance sheet data was derived from the Company's audited financial statements but does not include all disclosures required by U.S. GAAP. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, 2024, or for any other future annual or interim period. The accompanying interim unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and related notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023.
The accompanying condensed consolidated financial statements reflect the operations of Precigen and its majority-owned subsidiaries. All intercompany accounts and transactions have been eliminated.
Liquidity and Going Concern
During the three months ended March 31, 2024, the Company incurred a net loss of $23,738 and used $14,090 of cash in our operations, and as of March 31, 2024, had an accumulated deficit of $1,988,209. The Company has incurred operating losses since its inception and management expects operating losses and negative cash flows from operations to continue for the foreseeable future and, as a result, the Company will require additional capital to fund its operations and execute its business plan. In addition, as of March 31, 2024, the Company had $44,758 in cash, cash equivalents and short-term investments, and had no committed source of additional funding from either debt or equity financings. The Company’s current cash and investments position is not sufficient to fund the Company's planned operations through one year after the date the interim financial statements are issued and accordingly, there is substantial doubt about the Company's ability to continue as a going concern. The analysis used to determine the Company's ability to continue as a going concern does not include cash sources outside of the Company's direct control that management expects to be available within the next twelve months.
The Company’s ability to fund its operations on an ongoing basis is dependent upon the successful execution of management’s plans, which include raising additional capital in the near term. This additional capital could be raised through a combination of non-dilutive financings (including debt financings, collaborations, strategic alliances, monetization of non-core assets, marketing, distribution or licensing arrangements), dilutive financings (including equity and/or debt financings which may include an equity component) and, in the longer term, from revenue related to product sales, to the extent its product candidates receive marketing approval and can be commercialized. There can be no assurance that new financings or other transactions will be available to the Company on commercially acceptable terms, or at all. Also, any collaborations, strategic alliances, monetization of non-core assets or marketing, distribution or licensing arrangement may require the Company to give up some or all of its rights to a product or technology, which in some cases may be at less than the full potential value of such rights. If the Company is unable to obtain additional capital, the Company will assess its capital resources and may be required to delay, reduce the scope of, or eliminate some or all of its operations, which may include research and development and clinical trials. This may have a material adverse effect on the Company’s business, financial condition, results of operations and ability to operate as a going concern.
These interim financial statements have been prepared on a going concern basis and do not include any adjustments to the amounts and classification of assets and liabilities that may be necessary in the event the Company can no longer continue as a going concern.
Risks and Uncertainties
The Company is subject to a number of risks similar to those of other companies conducting high-risk, early-stage research and development of therapeutic product candidates. Principal among these risks are dependence on key individuals and intellectual property, competition from other products and companies, and the technical risks associated with the successful research, development, and clinical manufacturing of its and its collaborators' therapeutic product candidates.
Research and Development
The Company considers that regulatory requirements inherent in the research and development of new products preclude it from capitalizing such costs. Research and development expenses include salaries and related costs of research and development personnel, including stock-based compensation expense, costs to acquire technology rights, contract research organizations and consultants, facilities, materials and supplies associated with research and development projects as well as various laboratory studies. Costs incurred in conjunction with collaboration and licensing arrangements are included in research and development. Indirect research and development costs include depreciation, amortization, and other indirect overhead expenses.
The Company has research and development arrangements with third parties that include upfront and milestone payments. As of March 31, 2024 and December 31, 2023, the Company had research and development commitments with third parties that had not yet been incurred totaling $19,210 and $17,800, respectively. The commitments are generally cancellable by the Company by providing written notice at least sixty days before the desired termination date.
Cash and Cash Equivalents
All highly liquid investments with an original maturity ofthree months or less at the date of purchase are considered to be cash equivalents. Cash balances at a limited number of banks may periodically exceed insurable amounts. The Company believes that it mitigates its risk by investing in or through major financial institutions. Recoverability of investments is dependent upon the performance of the issuer.
Short-term and Long-Term Investments
As of March 31, 2024 and December 31, 2023 short-term and long-term investments include United States government debt and agency securities and certificates of deposit. The Company determines the appropriate classification as short-term or long-term at the time of purchase based on original maturities and management's reasonable expectation of sales and redemption. The Company reevaluates such classification at each balance sheet date.
Fair Value of Financial Instruments
Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset and liability. As a basis for considering such assumptions, the Company uses a three-tier fair value hierarchy that prioritizes the inputs used in its fair value measurements. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are as follows:
| Level 1: | Quoted prices in active markets for identical assets and liabilities; |
|---|---|
| Level 2: | Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly; and |
| Level 3: | Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available. |
Net Loss per Share
Basic net loss per share is calculated by dividing net loss attributable to common shareholders by the weighted average shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, using the treasury-stock method and the if-converted method. For purposes of the diluted net loss per share calculation, shares to be issued pursuant to convertible debt, stock options, RSUs, and warrants are considered to be common stock equivalents but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive as described in the next paragraph. Therefore, basic and diluted net loss per share were the same for all periods presented. See Note 10 for further discussion of the Company's Share Lending Agreement, which was terminated on October 1, 2023.
The following potentially dilutive securities as of March 31, 2024 and 2023, have been excluded from the above computations of diluted weighted average shares outstanding for the three months then ended as they would have been anti-dilutive:
| March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Options | 22,715,549 | 16,945,209 |
| Restricted stock units | 786,709 | 1,877,308 |
| Total | 23,502,258 | 18,822,517 |
In addition, the Company's Convertible Notes, prior to their retirement in the second quarter of 2023, were convertible at an exercise price of approximately $17.05 per share of common stock, representing approximately 812,178 shares at March 31, 2023. The shares underlying the Convertible Notes were considered for the dilutive calculation but were excluded in all periods presented for which the Convertible Notes were outstanding, as their effect was anti-dilutive. See Note 8 for further discussion of the Convertible Notes.
Segment Information
The Company's chief operating decision maker ("CODM") regularly reviews disaggregated financial information for various operating segments. The financial information regularly reviewed by the CODM consists of (i) Biopharmaceuticals and (ii) Exemplar, each an operating segment that was also determined to be a reportable segment. The Biopharmaceuticals reportable segment is primarily comprised of the Company's legal entities of Precigen and ActoBio. See Note 1 for a description of Precigen, ActoBio and Exemplar.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.
Recently Issued Accounting Pronouncements Not Yet Adopted
In November 2023, the FASB issued ASU 2023-07, Segment Reporting—Improvements to Reportable Segment Disclosures. According to ASU 2023-07, public entities are required to disclose its significant segment expense categories and amounts for each reportable segment. A significant segment expense is an expense that is significant to the segment, regularly provided to or easily computed from information regularly provided to the chief operating decision maker and included in the reported measure of segment profit or loss. This updated standard is effective for public entities for fiscal years beginning after December 15, 2023, and interim periods in fiscal years beginning after December 15, 2024. We do not believe the adoption of ASU 2023-07 will have a material impact on our consolidated financial statements and disclosures.
There are no other new accounting standards which have not yet been adopted that are expected to have a significant impact on our financial statements and related disclosures.
- Collaboration and Licensing Revenue
The Company's collaborations and licensing agreements may provide for multiple promises to be satisfied by the Company and typically include a license to the Company's technology platforms, participation in collaboration committees, and performance of certain research and development services. Based on the nature of the promises in the Company's collaboration and licensing agreements, the Company typically combines most of its promises into a single performance obligation because the promises are highly interrelated and not individually distinct. Options to acquire additional services are considered to determine if they constitute material rights. At contract inception, the transaction price is typically the upfront payment received and is allocated to the performance obligations. The Company has determined the transaction price should be recognized as revenue based on its measure of progress under the agreement primarily based on inputs necessary to fulfill the performance obligation.
The Company determines whether collaborations and licensing agreements are individually significant for disclosure based on a number of factors, including total revenue recorded by the Company pursuant to collaboration and licensing agreements, collaborators or licensees with equity method investments, or other qualitative factors. Collaboration and licensing revenues generated from consolidated subsidiaries are eliminated in consolidation.
There was no collaboration and licensing revenue recognized during both the three months ended March 31, 2024 and 2023.
Alaunos License Agreement
On April 3, 2023, the Company entered into an amended and restated exclusive license agreement (the “License Agreement”), with Alaunos Therapeutics (“Alaunos”). The License Agreement amended and replaced an Exclusive License Agreement by and between the Company and Alaunos, dated October 5, 2018.
Pursuant to the terms of the License Agreement, the Company granted Alaunos an exclusive, worldwide, royalty-free, sub-licensable license to certain patents and know-how to research, develop and commercialize T-cell receptor products, which are referred to as TCR Products, designed for neoantigens for the treatment of cancer or the treatment and prevention of human papilloma virus, or HPV, to the extent that the primary reason for such treatment or prevention is to prevent cancer, which is referred to as the HPV Field. The Company has also granted Alaunos an exclusive, worldwide, royalty-free, sub-licensable license to certain patents relating to the Sleeping Beauty technology to research, develop and commercialize TCR Products (other than those designed for neoantigens) for the treatment of cancer and in the HPV Field. The Company also granted Alaunos certain non-exclusive rights to certain patents and know-how to research, develop and commercialize products developed under or arising from a program of research and development focused on NK cells and gamma delta T-cells in the HPV field. Alaunos has the exclusive right to conduct in its sole discretion, and is solely responsible for all aspects of, the research, development and commercialization of the licensed products for the treatment of cancer and is not subject to a diligence obligation with respect to such efforts.
The License Agreement will terminate on a product-by-product and/or country-by-country basis upon the expiration of the last to expire patent claim for each licensed product. In addition, Alaunos may terminate the License Agreement on a country-by-country or program-by-program basis following written notice to the Company, and either party may terminate the License Agreement following notice of a material breach subject to a certain cure period.
Neither Alaunos nor the Company will have any other obligations with respect to the payment of milestones or royalties on products developed in connection with the License Agreement.
Deferred Revenue
Deferred revenue primarily consists of upfront and milestone consideration received for the Company's collaboration and licensing agreements. Revenue is recognized as services are performed. The arrangements classified as long-term are not active while the respective counterparties evaluate the status of the project and its desired future development activities since the Company cannot reasonably estimate the amount of services, if any, to be performed over the next year.
Deferred revenue consisted of the following:
| March 31,2024 | December 31,2023 | |
|---|---|---|
| Collaboration and licensing agreements | $1,818 | $1,818 |
| Prepaid product and service revenues | 15 | 15 |
| Other | 462 | 494 |
| Total | $2,295 | $2,327 |
| Current portion of deferred revenue | $407 | $509 |
| Long-term portion of deferred revenue | 1,888 | 1,818 |
| Total | $2,295 | $2,327 |
- Short-term and Long-term Investments
The Company's investments are classified as available-for-sale. The following table summarizes the amortized cost, gross unrealized gains and losses, and fair value of available-for-sale investments as of March 31, 2024:
| AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | AggregateFair Value | |
|---|---|---|---|---|
| U.S. government debt securities | $25,013 | $1 | $(35) | $24,979 |
| Certificates of deposit | 2,273 | — | — | 2,273 |
| Corporate bonds | 28 | — | — | 28 |
| Total | $27,314 | $1 | $(35) | $27,280 |
In addition, at March 31, 2024 and December 31, 2023, the Company held a U.S. government debt security valued at $12,290 and 1,502, respectively, which was included in cash and cash equivalents in the condensed consolidated balance sheet as this investment had an original maturity of less than three months when purchased.
The estimated fair value of available-for-sale investments was $27,280 as of March 31, 2024, and these available-for-sale investments all contractually mature within one year.
The following table summarizes the amortized cost, gross unrealized gains and losses, and fair value of available-for-sale investments as of December 31, 2023:
| AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | AggregateFair Value | |
|---|---|---|---|---|
| U.S. government debt securities | $51,704 | $102 | $(135) | $51,671 |
| Certificates of deposit | 3,361 | 1 | (1) | 3,361 |
| Corporate bonds | 245 | — | — | 245 |
| Total | $55,310 | $103 | $(136) | $55,277 |
Changes in market interest rates and bond yields cause certain investments to fall below their cost basis, resulting in unrealized losses on investments. The Company does not intend to sell these investments nor is it more likely than not that the Company will be required to sell these investments, prior to maturity or recovery of amortized cost.
- Fair Value Measurements
The carrying amount of cash and cash equivalents, receivables, accounts payable, accrued compensation and benefits, and other accrued liabilities approximate fair value due to the short maturity of these instruments.
Assets
The following table presents the placement in the fair value hierarchy of financial assets that are measured at fair value on a recurring basis as of March 31, 2024:
| Quoted Prices in Active Markets(Level 1) · Significant Other Observable Inputs(Level 2) · Significant Unobservable Inputs(Level 3) · March 31,2024 | ||||||
|---|---|---|---|---|---|---|
| Assets | ||||||
| U.S. government debt securities | $— | $24,979 | $— | $24,979 | ||
| Certificates of deposit | — | 2,273 | — | 2,273 | ||
| Corporate bonds | 28 | 28 | ||||
| Total | $— | $27,280 | $— | $27,280 | ||
The following table presents the placement in the fair value hierarchy of financial assets that are measured at fair value on a recurring basis as of December 31, 2023:
| Quoted Prices in Active Markets(Level 1) · Significant Other Observable Inputs(Level 2) · Significant Unobservable Inputs(Level 3) · December 31,2023 | ||||||
|---|---|---|---|---|---|---|
| Assets | ||||||
| U.S. government debt securities | $— | 51,671 | $— | $51,671 | ||
| Certificates of deposit | — | 3,361 | — | 3,361 | ||
| Corporate bonds | 245 | $245 | ||||
| Total | $— | $55,277 | $— | $55,277 | ||
The method used to estimate the fair value of the Level 2 short-term and long-term debt investments in the tables above is based on professional pricing sources for identical or comparable instruments, rather than direct observations of quoted prices in active markets.
- Property, Plant and Equipment, Net
Property, plant and equipment consist of the following:
| March 31,2024 | December 31,2023 | |
|---|---|---|
| Land and land improvements | $164 | $164 |
| Buildings and building improvements | 2,629 | 2,629 |
| Furniture and fixtures | 526 | 530 |
| Equipment | 18,527 | 18,576 |
| Leasehold improvements | 4,475 | 4,380 |
| Breeding stock | 94 | 79 |
| Computer hardware and software | 3,482 | 3,459 |
| Construction and other assets in progress | 7,313 | 1,577 |
| 37,210 | 31,394 | |
| Less: Accumulated depreciation and amortization | (24,590) | (24,283) |
| Property, plant and equipment, net | $12,620 | $7,111 |
Depreciation expense was $380 and $506 for the three months ended March 31, 2024 and 2023, respectively.
- Goodwill and Intangible Assets, Net
The changes in the carrying amount of goodwill for the three months ended March 31, 2024 were as follows:
| Balance at December 31, 2023 | $26,612 |
|---|---|
| Foreign currency translation adjustments | (57) |
| Balance at March 31, 2024 | $26,555 |
The Company had $24,873 of cumulative impairment losses as of both March 31, 2024 and December 31, 2023.
Intangible assets consist of the following as of March 31, 2024:
| Gross Carrying Amount | Accumulated Amortization | Net | |
|---|---|---|---|
| Patents, developed technologies and know-how | $81,047 | $(42,330) | $38,717 |
Intangible assets consist of the following as of December 31, 2023:
| Gross Carrying Amount | Accumulated Amortization | Net | |
|---|---|---|---|
| Patents, developed technologies and know-how | $82,501 | $(41,800) | $40,701 |
Amortization expense was $1,215 and $1,205 for the three months ended March 31, 2024 and 2023, respectively.
- Debt
Lines of Credit
Exemplar has a $5,000 revolving line of credit with a bank that matures on November 1, 2024. As of March 31, 2024, the line of credit bore interest at a stated rate of 8.50% per annum. As of March 31, 2024 and December 31, 2023, there wasno outstanding balance on the line of credit.
Convertible Notes
In July 2018, Precigen completed a registered underwritten public offering of $200,000 aggregate principal amount of Convertible Notes and issued the Convertible Notes under an indenture between Precigen and The Bank of New York Mellon Trust Company, N.A., as trustee, as supplemented by the First Supplemental Indenture.
The Convertible Notes matured on July 1, 2023, although certain notes were repurchased prior to their maturity beginning in third quarter of 2022. On June 30, 2023, the Company repurchased all remaining outstanding Convertible Notes at par plus accrued interest.
The components of interest expense related to the Convertible Notes were as follows:
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Cash interest expense | $— | $289 |
| Non-cash interest expense | — | 34 |
| Total interest expense | $— | $323 |
- Income Taxes
For the three months ended March 31, 2024 and 2023, the Company calculated its tax benefit using the estimated annual effective tax rate method. The rate is the ratio of estimated annual income tax expense related to estimated pretax loss from continuing operations, excluding significant unusual or infrequently occurring items. As a result of the pretax losses anticipated for the full year which are not benefited, this rate has been calculated and applied to the year-to-date interim period’s ordinary income or loss on a jurisdiction by jurisdiction basis to determine the income tax expense/benefit allocated to the year-to-date period. The annual effective tax rate is revised, if necessary, at the end of each interim period based on the Company’s most current best estimate. The Company recorded $29 and $55 of income tax benefit from continuing operations for the three months ended March 31, 2024 and 2023, respectively. The effective tax rate differs from the U.S. statutory tax rate, primarily as a result of the change in valuation allowance required.
The Company's net deferred tax assets are offset by a valuation allowance due to the Company's history of net losses combined with an inability to confirm recovery of the tax benefits of the Company's tax attributes and other net deferred tax assets. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment.
- Shareholders' Equity
Issuances of Precigen Common Stock
In January 2023, the Company closed a public offering of 43,962,640 shares of its common stock, resulting in net proceeds of $72,808, after deducting underwriting discounts, fees, and other offering expenses. Of the 43,962,640 shares,11,517,712 shares were purchased by related parties and their affiliates, including the Company's Chief Executive Officer, its Chairman of the Board of Directors and his affiliates, and certain other of the Company's officers.
The Company completed the offering of shares of common stock, utilizing a number of underwriters, with J.P. Morgan Securities LLC acting as representative of the underwriters. The services provided by JP Morgan Securities LLC were in the ordinary course of their role as lead underwriter, for which they received customary fees and commissions.
Share Lending Agreement
Concurrently with the offering of the Convertible Notes, Precigen entered into a share lending agreement (the "Share Lending Agreement") with J.P. Morgan Securities LLC (the "Share Borrower") pursuant to which Precigen loaned and delivered 7,479,431 shares of its common stock (the "Borrowed Shares") to the Share Borrower. The Share Lending Agreement terminated on October 1, 2023, and the Borrowed Shares were returned to Precigen on October 5, 2023.
The Share Lending Agreement was entered into at fair value and met the requirements for equity classification. Therefore, the value is netted against the issuance of the Borrowed Shares in additional paid-in capital. Additionally, the Borrowed Shares are not included in the denominator for loss per share attributable to Precigen shareholders.
Components of Accumulated Other Comprehensive Loss
The components of accumulated other comprehensive loss are as follows:
| March 31,2024 | December 31,2023 | |
|---|---|---|
| Unrealized loss on investments | $(34) | $(33) |
| Loss on foreign currency translation adjustments | (2,763) | (1,914) |
| Total accumulated other comprehensive loss | $(2,797) | $(1,947) |
- Share-Based Payments
The Company measures the fair value of stock options and restricted stock units ("RSUs") issued to employees and nonemployees as of the grant date for recognition of stock-based compensation expense. Stock-based compensation expense for employees and nonemployees is recognized over the requisite service period, which is typically the vesting period. Stock-based compensation costs included in the condensed consolidated statements of operations are presented below:
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Cost of products and services | 17 | 13 |
| Research and development | 533 | 509 |
| Selling, general and administrative | 2,031 | 2,609 |
| Total | $2,581 | $3,131 |
Precigen Equity Incentive Plans
In August 2013, Precigen adopted the 2013 Omnibus Incentive Plan ("the 2013 Plan"), for employees and nonemployees which provided for grants of share-based awards, including stock options, restricted stock units, shares of common stock and other awards, to employees, officers, consultants, advisors, and nonemployee directors. Upon the effectiveness of the 2023 Omnibus Incentive Plan in June 2023, as discussed in the next paragraph, (the "2023 Plan"), no new awards may be granted under the 2013 Plan and any awards granted under the 2013 Plan prior to the effectiveness of the 2023 Plan will remain outstanding under such plan and will continue to vest and/or become exercisable in accordance with their original terms and conditions. As of March 31, 2024, there were 17,994,408 stock options andno RSUs outstanding under the 2013 Plan.
In April 2023, Precigen adopted the 2023 Plan, which became effective upon shareholder approval in June 2023. The 2023 Plan permits the grant of share-based awards, including stock options, restricted stock awards, and RSUs and other awards, to officers, employees and nonemployees. The 2023 Plan authorizes for issuance pursuant to awards under the 2023 Plan an aggregate of 16,418,137 shares, which included shares remaining available for issuance under the 2013 Plan as of the adoption of the 2023 Plan. As of March 31, 2024, there were 648,500 stock options andno RSUs outstanding under the 2023 Plan and 15,769,637 shares were available for future grants.
In April 2019, Precigen adopted the 2019 Incentive Plan for Non-Employee Service Providers (the "2019 Plan"), which became effective upon shareholder approval in June 2019. The 2019 Plan permits the grant of share-based awards, including stock options, restricted stock awards, and RSUs, to nonemployee service providers, including board members. As of March 31,
2024, there were 12,000,000 shares authorized for issuance under the 2019 Plan, of which 4,072,641 stock options and 786,709 RSUs were outstanding and 2,432,945 shares were available for future grants.
Stock option activity was as follows:
| Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term (Years) | |
|---|---|---|---|
| Balances at December 31, 2023 | 22,057,340 | $6.90 | 7.12 |
| Granted | 1,237,634 | 1.43 | |
| Exercised | — | — | |
| Forfeited | (240,000) | 1.41 | |
| Expired | (339,425) | 28.83 | |
| Balances at March 31, 2024 | 22,715,549 | 6.33 | 7.11 |
| Exercisable at March 31, 2024 | 14,261,414 | 8.93 | 6.15 |
RSU activity was as follows:
| Number of Restricted Stock Units | Weighted Average Grant Date Fair Value | Weighted Average Remaining Contractual Term (Years) | |
|---|---|---|---|
| Balances at December 31, 2023 | 961,534 | $1.17 | 0.19 |
| Granted | 786,709 | 1.43 | |
| Vested | (961,534) | 1.17 | |
| Forfeited | — | — | |
| Balances at March 31, 2024 | 786,709 | 1.43 | 0.95 |
Precigen currently uses treasury shares and authorized and unissued shares to satisfy share award exercises.
- Operating Leases
The Company leases certain facilities and equipment under operating leases. Leases with a lease term of twelve months or less are considered short-term leases and are not recorded on the balance sheet, and expense for these leases is recognized over the term of the lease. All other leases have remaining terms ofone toseven years, some of which may include options to extend the lease and some of which may include options to terminate the lease withinone year. The Company uses judgment to determine whether it is reasonably possible to extend the lease beyond the initial term or terminate before the initial term ends and the length of the possible extension or early termination. The leases are renewable at the option of the Company and do not contain residual value guarantees, covenants, or other restrictions.
The components of lease costs were as follows:
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Operating lease costs | $609 | $615 |
| Short-term lease costs | 13 | 20 |
| Variable lease costs | 92 | 120 |
| Lease costs | $714 | $755 |
As of March 31, 2024, maturities of lease liabilities, excluding short-term and variable leases, for continuing operations were as follows:
| 2024 | $1,568 |
| 2025 | 1,651 |
| 2026 | 1,499 |
| 2027 | 1,307 |
| 2028 | 1,260 |
| 2029 | 1,295 |
| Thereafter | 553 |
| Total | 9,133 |
| Present value adjustment | (2,428) |
| Total | $6,705 |
| Current portion of operating lease liabilities | $1,318 |
| Long-term portion of operating lease liabilities | 5,387 |
| Total | $6,705 |
Other information related to operating leases in continuing operations was as follows:
| March 31,2024 | December 31,2023 | |
|---|---|---|
| Weighted average remaining lease term (years) | 4.98 | 5.39 |
| Weighted average discount rate | 11.3% | 11.2% |
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Supplemental disclosure of cash flow information | ||
| Cash paid for operating lease liabilities | $572 | $463 |
| Operating lease right-of-use assets obtained in exchange for new lease liabilities (includes new leases or modifications of existing leases) | 572 | 26 |
- Commitments and Contingencies
Contingencies
In October 2020, several shareholder class action lawsuits were filed in the United States District Court for the Northern District of California on behalf of certain purchasers of the Company's common stock. The complaints name as defendants the Company and certain of its current and former officers. The plaintiffs' claims challenged disclosures about the MBP program from May 10, 2017 to March 1, 2019. In March 2021, the Court granted an order consolidating the claims and, in April 2021, appointed a lead plaintiff and lead counsel in the case, captioned Inre Precigen Securities Litigation, Case No. 5:20-cv-06936-BLF (N.D. Cal.). On May 18, 2021, the lead plaintiff filed an Amended Class Action Complaint. On August 2, 2021, the defendants moved to dismiss the Amended Class Action Complaint. On September 27, 2021, the lead plaintiff filed a Second Amended Class Action Complaint in lieu of a response to the defendants’ motion to dismiss. On November 3, 2021, the defendants moved to dismiss the Second Amended Class Action Complaint and on May 31, 2022, the Court granted the defendants’ motion to dismiss the Second Amended Class Action Complaint with leave to amend. On August 1, 2022, the lead plaintiff filed a Third Amended Class Action Complaint.
On August 2, 2022, the Court granted the parties' request to conduct a private mediation session to explore potential resolution of the action. On November 17, 2022, at the conclusion of the mediation session, the parties executed a memorandum of understanding that agreed in principle to resolve the claims asserted in the securities class action. The settlement provides for a payment to the plaintiff class of $13,000. As a result, the shareholder class action lawsuit was resolved. On November 6, 2023, the Court granted final approval of the settlement, dismissed the litigation with prejudice, and entered final judgment. As a result, the Company hadno amounts recorded in settlement and indemnification accruals or an insurance receivable asset on the consolidated balance sheet as of March 31, 2024 and December 31, 2023, respectively.
In December 2020, a derivative shareholder action, captioned Edward D. Wright, derivatively on behalf of Precigen, Inc. F/K/A Intrexon Corp. v. Alvarez et al, was filed in the Circuit Court for Fairfax County in Virginia on behalf of Precigen, Inc. asserting similar claims under state law against Precigen's current directors and certain officers. The plaintiff seeks damages, forfeiture of benefits received by defendants, and an award of reasonable attorneys' fees and costs. The case was stayed by an order entered on June 14, 2021. On September 24, 2021, an individual shareholder filed a lawsuit in the Circuit Court for Henrico County styled Kent v. Precigen, Inc., Case CL21-6349. The Kent action demands inspection of certain books and records of the Company pursuant to Virginia statutory and common law. On April 1, 2022, the Court denied the demurrer and referred the matter to a hearing on the merits. The Company intends to defend the lawsuits vigorously; however, there can be no assurances regarding the ultimate outcome of these lawsuits.
In the course of its business, the Company is involved in litigation or legal matters, including governmental investigations. Such matters are subject to many uncertainties and outcomes are not predictable with assurance. The Company accrues liabilities for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. As of March 31, 2024, the Company does not believe that any such matters, individually or in the aggregate, will have a material adverse effect on the Company's business, financial condition, results of operations, or cash flows.
Trans Ova
As part of the Company's strategic shift to becoming a healthcare company, in August 2022, the Company completed the sale of 100% of the issued and outstanding membership interests in its wholly-owned subsidiary, Trans Ova, to Spring Bidco LLC (the “Buyer”), a Delaware limited liability company for $170,000 and up to $10,000 in cash earn-out payments contingent upon the performance of Trans Ova in each of 2022 and 2023, consisting of $5,000 for each year (the “Transaction”). In February 2023, the Buyer notified the Company that Trans Ova did not meet the financial measures required in 2022 in order to require the first $5,000 earn-out payment. In April 2024, the Buyer notified the Company that Trans Ova did not meet the financial measures required in 2023 in order to require the second $5,000 earn-out payment. The Company has disputed certain items reflected in the 2023 financial measures presented by the Buyer in the aforementioned notification.
In connection with the Transaction, the Company is required to indemnify the Buyer for certain expenses incurred post close (related to covenants and certain additional specified liabilities including certain patent infringement lawsuits), if incurred, in amounts not to exceed $5,750. Such indemnification was recorded as a reduction of the gain on divestiture in the third quarter of 2023. As of March 31, 2024 and December 31, 2023, $5,075 and $5,750 were included in settlement and indemnification accruals on the condensed consolidated balance sheets, respectively, related to this indemnification liability. In April 2024, the Company received an indemnification claim of $1,862 for expenses incurred by the buyer for the period from July 2023 to December 2023. In addition, during the three-months ended September 30,2023, the Company paid $675 for indemnification claims against this liability for the period from the date of sale to June 2023.
- Segments
The Company's CODM assesses the operating performance of and allocates resources for several operating segments using Segment Adjusted EBITDA. Management believes this financial metric is a key indicator of operating results since it excludes noncash revenues and expenses that are not reflective of the underlying business performance of an individual enterprise. The Company defines Segment Adjusted EBITDA as net income (loss) before (i) interest expense and interest income, (ii) income tax expense or benefit, (iii) depreciation and amortization, (iv) stock-based compensation expense, (v) loss on settlement agreements where noncash consideration is paid, (vi) adjustments for accrued bonuses paid in equity awards, (vii) gain or loss on disposals of assets, (viii) loss on impairment of goodwill and other noncurrent assets, (ix) equity in net income loss of affiliates, and (x) recognition of previously deferred revenue associated with upfront and milestone payments as well as cash outflows from capital expenditures and investments in affiliates, but includes proceeds from the sale of assets in the period sold. Segment Adjusted EBITDA excludes the gain or loss on disposals of assets and include proceeds from the sale of assets in the period sold.
Because the Company uses Segment Adjusted EBITDA as its primary measure of segment performance, it has included this measure in its discussion of segment operating results. The Company has also disclosed revenues from external customers and intersegment revenues for each reportable segment. The CODM does not use total assets by segment to evaluate segment performance or allocate resources, and accordingly, these amounts are not required to be disclosed.
For the three months ended March 31, 2024, the Company's reportable segments were (i) Biopharmaceuticals and (ii) Exemplar. These identified reportable segments met the quantitative thresholds to be reported separately for the three months ended March 31, 2024. See Note 1 for a description of Biopharmaceuticals and Exemplar.
Segment Adjusted EBITDA by reportable segment was as follows:
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Biopharmaceuticals | $(23,820) | $(21,343) |
| Exemplar | (200) | 121 |
| Segment Adjusted EBITDA for reportable segments | $(24,020) | $(21,222) |
The table below reconciles Segment Adjusted EBITDA for reportable segments to consolidated net loss from continuing operations before income taxes:
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Segment Adjusted EBITDA for reportable segments | $(24,020) | $(21,222) |
| Remove cash paid for capital expenditures, net of proceeds from sale of assets | 4,348 | 154 |
| Interest Income | 608 | 633 |
| Other expenses: | ||
| Interest expense | (2) | (324) |
| Depreciation and amortization | (1,595) | (1,711) |
| Gain (loss) on disposals of assets | 3 | — |
| Stock-based compensation expense | (2,581) | (3,132) |
| Adjustment related to accrued bonuses paid in equity awards | — | 3,360 |
| Shares issue for payment of services | (528) | (545) |
| Corporate noncash items | — | (2) |
| Consolidated loss before income taxes | $(23,767) | $(22,789) |
Revenues from external customers consisted of $1,065 and $1,851 in the Exemplar segment for the three months ended March 31, 2024 and 2023.
Total segment revenues from reportable segments equal total consolidated revenues on the condensed consolidated statements of operations.
For the three months ended March 31, 2024 and 2023,52.8% and 82.5%, respectively, of total consolidated revenue was attributable tothree customers in 2024 andfour customer in 2023 in the Exemplar segment.
As of March 31, 2024 and December 31, 2023, the Company had $1,120 and $1,958, respectively, of long-lived assets in foreign countries. There wereno revenues derived in foreign countries for any periods presented.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.