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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2024
OR
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☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to .
Commission File Number: 001-36042
PRECIGEN, INC.
(Exact name of registrant as specified in its charter)
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| Virginia | | 26-0084895 |
| (State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification Number) |
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| 20374 Seneca Meadows Parkway | | |
| Germantown, | Maryland | | 20876 |
| (Address of principal executive offices) | | (Zip Code) |
(301) 556-9900
(Registrant's telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Exchange Act:
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Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
Common Stock, no par value | | PGEN | | Nasdaq Global Select Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.
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Large accelerated filer | | ☐ | | Accelerated filer | | ☐ |
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Non-accelerated filer | | ☒ | | Smaller reporting company | | ☒ |
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| | | | Emerging growth company | | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of April 30, 2024, 252,419,690 shares of common stock, no par value per share, were issued and outstanding.
PRECIGEN, INC.
FORM 10-Q
TABLE OF CONTENTS
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Precigen®, AdenoVerse®, UltraCAR-T®, RheoSwitch®, UltraVector®, RTS®, UltraPorator®, ActoBiotics® and RheoSwitch Therapeutic System® are our and/or our affiliates' registered trademarks in the United States and GenVec™, ActoBio Therapeutics™, AttSite™, and Precigen Therapeutics™ are our and/or our affiliates' common law trademarks in the United States are our and/or our affiliates' common law trademarks in the United States. This Quarterly Report on Form 10-Q, or Quarterly Report, and the information incorporated herein by reference contain references to trademarks, service marks, and trade names owned by us or other companies. Solely for convenience, trademarks, service marks, and trade names referred to in this Quarterly Report and the information incorporated herein, including logos, artwork, and other visual displays, may appear without the ® or ™ symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks, service marks, and trade names. We do not intend our use or display of other companies' trade names, service marks, or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Other trademarks, trade names, and service marks appearing in this Quarterly Report are the property of their respective owners. Unless the context requires otherwise, references in this Quarterly Report to "Precigen", "we", "us", and "our" refer to Precigen, Inc.
Special Note Regarding Forward-Looking Statements
This Quarterly Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which statements involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this Quarterly Report, including statements regarding our strategy; future events, including their outcome or timing; future operations; future financial position; future revenue; projected costs; prospects; plans; objectives of management; and expected market growth, are forward-looking statements. The words "aim", "anticipate", "assume", "believe", "continue", "could", "due", "estimate", "expect", "intend", "may", "plan", "positioned", "potential", "predict", "project", "seek", "should", "target", "will", "would", and the negatives of these terms or similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements may relate to, among other things: (i) the timeliness of regulatory approvals; (ii) our strategy and overall approach to our business model, our efforts to realign our business, and our ability to exercise more control and ownership over the development process and commercialization path; (iii) our ability to successfully enter new markets or develop additional product candidates, including the expected timing and results of investigational studies and preclinical and clinical trials, whether with our collaborators or independently; (iv) our ability to consistently manufacture our product candidates on a timely basis or to establish agreements with third-party manufacturers; (v) our ability to successfully enter into optimal strategic relationships with our subsidiaries and operating companies that we may form in the future; (vi) our ability to hold or generate significant operating capital, including through partnering, asset sales, and operating cost reductions; (vii) actual or anticipated variations in our operating results; (viii) actual or anticipated fluctuations in competitors' or collaborators' operating results or changes in their respective growth rates; (ix) our cash position; (x) market conditions in our industry; (xi) the volatility of our stock price; (xii) the ability, and the ability of our collaborators, to protect our intellectual property and other proprietary rights and technologies; (xiii) outcomes of pending and future litigation; (xiv) the rate and degree of market acceptance of any products developed by us, our subsidiaries, collaborations, or joint ventures, or JVs, and competition from existing technologies and products or new technologies and products that may emerge; (xv) our ability to retain and recruit key personnel; (xvi) expectations related to the use of proceeds from public offerings and other financing efforts; and (xvii) estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; (xviii) our substantial doubt about our ability to continue as a going concern; and (xix) our timeline to commercialization of our product candidates.
Forward-looking statements are based on our beliefs, assumptions, and expectations of our future performance, and may also concern our expectations relating to our subsidiaries and other affiliates. We caution you that the foregoing list may not contain all of the forward-looking statements made in this Quarterly Report.
We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Quarterly Report, particularly in Part II, Item 1A, "Risk Factors," that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, JVs, or investments that we may make.
You should read this Quarterly Report, the documents that we reference in this Quarterly Report, our Annual Report on Form 10-K for the year ended December 31, 2023, the other reports we have filed with the Securities and Exchange Commission, or SEC, and the documents that we have filed as exhibits to our filings with the SEC completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
PART I. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
Precigen, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(Unaudited)
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(Amounts in thousands, except share data) | March 31, 2024 | | December 31, 2023 | |
Assets | | | | |
Current assets | | | | |
Cash and cash equivalents | $ | 17,478 | | | $ | 7,578 | | |
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Short-term investments | 27,280 | | | 55,277 | | |
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Receivables | | | | |
Trade, less allowance for credit losses of $0 and $184 as of March 31, 2024 and December 31, 2023 | 872 | | | 902 | | |
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Other | 290 | | | 673 | | |
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Prepaid expenses and other | 3,626 | | | 4,325 | | |
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Total current assets | 49,546 | | | 68,755 | | |
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Property, plant and equipment, net | 12,620 | | | 7,111 | | |
Intangible assets, net | 38,717 | | | 40,701 | | |
Goodwill | 26,555 | | | 26,612 | | |
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Right-of-use assets | 6,658 | | | 7,097 | | |
Other assets | 751 | | | 767 | | |
Total assets | $ | 134,847 | | | $ | 151,043 | | |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
Precigen, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(Unaudited)
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(Amounts in thousands, except share data) | March 31, 2024 | | December 31, 2023 |
Liabilities and Shareholders' Equity | | | |
Current liabilities | | | |
Accounts payable | $ | 4,716 | | | $ | 1,726 | |
Accrued compensation and benefits | 9,962 | | | 8,250 | |
Other accrued liabilities | 7,296 | | | 6,223 | |
Settlement and indemnification accruals | 5,075 | | | 5,075 | |
Deferred revenue | 407 | | | 509 | |
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Current portion of lease liabilities | 1,318 | | | 1,202 | |
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Total current liabilities | 28,774 | | | 22,985 | |
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Deferred revenue, net of current portion | 1,888 | | | 1,818 | |
Lease liabilities, net of current portion | 5,387 | | | 5,895 | |
Deferred tax liabilities | 1,779 | | | 1,847 | |
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Total liabilities | 37,828 | | | 32,545 | |
Commitments and contingencies (Note 13) | | | |
Shareholders' equity | | | |
Common stock, no par value, 400,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 256,398,527 shares issued as of March 31, 2024 and December 31, 2023, 250,248,808 shares and 248,919,096 shares outstanding as of March 31, 2024 and December 31, 2023, respectively. | — | | | — | |
Additional paid-in capital | 2,088,025 | | | 2,084,916 | |
Accumulated deficit | (1,988,209) | | | (1,964,471) | |
Accumulated other comprehensive loss | (2,797) | | | (1,947) | |
Total shareholders' equity | 97,019 | | | 118,498 | |
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Total liabilities and shareholders' equity | $ | 134,847 | | | $ | 151,043 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
Precigen, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited)
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(Amounts in thousands, except share and per share data) | Three Months Ended March 31, | | |
2024 | | 2023 | | | | |
Revenues | | | | | | | |
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Product revenues | $ | 138 | | | $ | 324 | | | | | |
Service revenues | 919 | | | 1,527 | | | | | |
Other revenues | 8 | | | — | | | | | |
Total revenues | 1,065 | | | 1,851 | | | | | |
Operating Expenses | | | | | | | |
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Cost of products and services | 1,075 | | | 1,527 | | | | | |
Research and development | 14,249 | | | 12,163 | | | | | |
Selling, general and administrative | 10,151 | | | 11,639 | | | | | |
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Total operating expenses | 25,475 | | | 25,329 | | | | | |
Operating loss | (24,410) | | | (23,478) | | | | | |
Other Income (Expense), Net | | | | | | | |
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Interest expense | (2) | | | (324) | | | | | |
Interest income | 608 | | | 633 | | | | | |
Other income, net | 37 | | | 380 | | | | | |
Total other income, net | 643 | | | 689 | | | | | |
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Loss before income taxes | (23,767) | | | (22,789) | | | | | |
Income tax benefit | 29 | | | 55 | | | | | |
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Net loss | (23,738) | | | (22,734) | | | | | |
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Net loss per share | | | | | | | |
| | | | | | | |
| | | | | | | |
Net loss per share, basic and diluted | $ | (0.10) | | | $ | (0.10) | | | | | |
Weighted average shares outstanding, basic and diluted | 249,220,335 | | | 229,770,381 | | | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
Precigen, Inc. and Subsidiaries
Condensed Consolidated Statements of Comprehensive Loss
(Unaudited)
| | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | |
(Amounts in thousands) | 2024 | | 2023 | | | | |
Net loss | $ | (23,738) | | | $ | (22,734) | | | | | |
Other comprehensive income (loss): | | | | | | | |
Unrealized gain (loss) on investments | (1) | | | 262 | | | | | |
(Loss) gain on foreign currency translation adjustments | (849) | | | 527 | | | | | |
| | | | | | | |
Comprehensive loss | $ | (24,588) | | | $ | (21,945) | | | | | |
| | | | | | | |
| | | | | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
Precigen, Inc. and Subsidiaries
Condensed Consolidated Statements of Shareholders' Equity
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(Amounts in thousands, except share data) | Common Stock | | Treasury Stock | | Additional Paid-in Capital | | Accumulated Other Comprehensive Income (Loss) | | Accumulated Deficit | | Total Shareholders' Equity | | | | |
Shares | | Amount | | Shares | | Amount | | | | | | |
Balances at December 31, 2023 | 248,919,096 | | | $ | — | | | 7,479,431 | | | $ | — | | | $ | 2,084,916 | | | $ | (1,947) | | | $ | (1,964,471) | | | $ | 118,498 | | | | | |
| | | | | | | | | | | | | | | | | | | |
Stock-based compensation expense | — | | | — | | | — | | | — | | | 2,581 | | | — | | | — | | | 2,581 | | | | | |
Shares issued upon vesting of restricted stock units | 961,534 | | | — | | | (961,534) | | | — | | | — | | | — | | | — | | | — | | | | | |
| | | | | | | | | | | | | | | | | | | |
Shares issued as payment for services | 368,178 | | | — | | | (368,178) | | | — | | | 528 | | | — | | | — | | | 528 | | | | | |
| | | | | | | | | | | | | | | | | | | |
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| | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | |
Net loss | — | | | — | | | — | | | — | | | — | | | — | | | (23,738) | | | (23,738) | | | | | |
| | | | | | | | | | | | | | | | | | | |
Other comprehensive loss | — | | | — | | | — | | | — | | | — | | | (850) | | | — | | | (850) | | | | | |
Balances at March 31, 2024 | 250,248,808 | | | $ | — | | | 6,149,719 | | | $ | — | | | $ | 2,088,025 | | | $ | (2,797) | | | $ | (1,988,209) | | | $ | 97,019 | | | | | |
.
Precigen, Inc. and Subsidiaries
Condensed Consolidated Statements of Shareholders' Equity
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(Amounts in thousands, except share data) | Common Stock | | Treasury Stock | Additional Paid-in Capital | | Accumulated Other Comprehensive Income (Loss) | | Accumulated Deficit | | Total Shareholders' Equity | | | | |
Shares | | Amount | | Shares | | Amount | | | | | |
Balances at December 31, 2022 | 208,150,021 | | | $ | — | | | — | | | $ | — | | $ | 1,998,314 | | | $ | (3,488) | | | $ | (1,868,567) | | | $ | 126,259 | | | | | |
| | | | | | | | | | | | | | | | | | |
Stock-based compensation expense | — | | | — | | | — | | | — | | 3,131 | | | — | | | — | | | 3,131 | | | | | |
Shares issued upon vesting of restricted stock units and for exercises of stock options | 697,815 | | | — | | | — | | | — | | — | | | — | | | — | | | — | | | | | |
Shares issued for accrued compensation | 2,206,469 | | | — | | | — | | | — | | 3,361 | | | — | | | — | | | 3,361 | | | | | |
Shares issued as payment for services | 465,808 | | | — | | | — | | | — | | 545 | | | — | | | — | | | 545 | | | | | |
Shares issued in public offerings, net of issuance costs | 43,962,640 | | | — | | | — | | | — | | 72,782 | | | — | | | — | | | 72,782 | | | | | |
| | | | | | | | | | | | | | | | | | |
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| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
Net loss | — | | | — | | | — | | | — | | — | | | — | | | (22,734) | | | (22,734) | | | | | |
| | | | | | | | | | | | | | | | | | |
Other comprehensive income | — | | | — | | | — | | | — | | — | | | 789 | | | — | | | 789 | | | | | |
Balances at March 31, 2023 | 255,482,753 | | | $ | — | | | — | | | $ | — | | $ | 2,078,133 | | | $ | (2,699) | | | $ | (1,891,301) | | | $ | 184,133 | | | | | |
| | | | | | | | | | | | | | | | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
Precigen, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| | | | | | | | | | | |
| Three Months Ended March 31, |
(Amounts in thousands) | 2024 | | 2023 |
Cash flows from operating activities | | | |
Net loss | $ | (23,738) | | | $ | (22,734) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | |
Depreciation and amortization | 1,595 | | | 1,711 | |
Gain on disposals of assets, net | (3) | | | — | |
| | | |
| | | |
| | | |
Gain on debt retirement | — | | | (106) | |
| | | |
| | | |
| | | |
Amortization of (discounts) premiums on investments, net | (397) | | | (203) | |
| | | |
Stock-based compensation expense | 2,581 | | | 3,131 | |
Shares issued as payment for services | 528 | | | 545 | |
| | | |
Accretion of debt discount and amortization of deferred financing costs | — | | | 34 | |
Deferred income taxes | (29) | | | (55) | |
| | | |
| | | |
Changes in operating assets and liabilities: | | | |
Receivables: | | | |
Trade | 30 | | | (793) | |
| | | |
| | | |
Other | 383 | | | (925) | |
| | | |
Prepaid expenses and other | 699 | | | 743 | |
Other assets | 4 | | | (27) | |
Accounts payable | 2,653 | | | (249) | |
Accrued compensation and benefits | 1,722 | | | 1,936 | |
Other accrued liabilities | (126) | | | (1,597) | |
Deferred revenue | (32) | | | 22 | |
Lease liabilities | 40 | | | 195 | |
| | | |
| | | |
Other long-term liabilities | — | | | (16) | |
Net cash used in operating activities | (14,090) | | | (18,388) | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
Precigen, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| | | | | | | | | | | |
| Three Months Ended March 31, |
(Amounts in thousands) | 2024 | | 2023 |
Cash flows from investing activities | | | |
Purchases of investments | $ | (17,190) | | | $ | (108,163) | |
Sales and maturities of investments | 45,583 | | | 57,909 | |
| | | |
| | | |
| | | |
| | | |
| | | |
Purchases of property, plant and equipment | (4,351) | | | (154) | |
Proceeds from sale of assets | 3 | | | — | |
| | | |
| | | |
| | | |
Net cash provided by (used in) investing activities | 24,045 | | | (50,408) | |
Cash flows from financing activities | | | |
Proceeds from issuance of shares, net of issuance costs | — | | | 73,501 | |
| | | |
| | | |
| | | |
| | | |
Payments of long-term debt and convertible notes, including cost to retire of $57 in 2023 | — | | | (29,327) | |
| | | |
| | | |
| | | |
Net cash provided by financing activities | — | | | 44,174 | |
Effect of exchange rate changes on cash, cash equivalents, and restricted cash | (60) | | | (28) | |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 9,895 | | | (24,650) | |
Cash, cash equivalents, and restricted cash | | | |
Beginning of period | 7,848 | | | 48,596 | |
End of period | $ | 17,743 | | | $ | 23,946 | |
Supplemental disclosure of cash flow information | | | |
Cash paid during the period for interest | $ | 3 | | | $ | 924 | |
| | | |
Significant noncash activities | | | |
| | | |
| | | |
Accrued compensation paid in equity awards | $ | — | | | $ | 3,361 | |
Purchases of property and equipment included in accounts payable and other accrued liabilities | 2,109 | | | 24 | |
| | | |
| | | |
Issuance costs included in accounts payable and other accrued liabilities | — | | | 719 | |
| | | |
The following table provides a reconciliation of the cash, cash equivalents, and restricted cash balances as of March 31, 2024 and December 31, 2023 as shown above:
| | | | | | | | | | | |
| March 31, 2024 | | December 31, 2023 |
Cash and cash equivalents | $ | 17,478 | | | $ | 7,578 | |
| | | |
| | | |
Restricted cash included in other assets | 265 | | | 270 | |
Cash, cash equivalents, and restricted cash | $ | 17,743 | | | $ | 7,848 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
Precigen, Inc. and Subsidiaries
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
(Amounts in thousands, except share and per share data)
1. 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 has two 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."
2. 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 of three 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.
3. 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 | |
4. 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:
| | | | | | | | | | | | | | | | | | | | | | | |
| Amortized Cost | | Gross Unrealized Gains | | Gross Unrealized Losses | | Aggregate Fair 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:
| | | | | | | | | | | | | | | | | | | | | | | |
| Amortized Cost | | Gross Unrealized Gains | | Gross Unrealized Losses | | Aggregate Fair 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.
5. 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.
6. 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.
7. 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.
8. 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 was no 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 | | | | | |
9. 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.
10. 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) | |
11. 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 and no 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 and no 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.
12. 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 of one to seven years, some of which may include options to extend the lease and some of which may include options to terminate the lease within one 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 | |
13. 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 In re 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 had no 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.
14. 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 to three customers in 2024 and four 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 were no revenues derived in foreign countries for any periods presented.
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
The following "Management's Discussion and Analysis of Financial Condition and Results of Operations" should be read in conjunction with the unaudited financial information and the notes thereto included in this Quarterly Report on Form 10-Q, or Quarterly Report, and our Annual Report on Form 10-K for the year ended December 31, 2023, or Annual Report.
The following discussion contains forward-looking statements that reflect our plans, estimates, expectations, and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements and you are cautioned not to place undue reliance on forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Quarterly Report, particularly in "Special Note Regarding Forward-Looking Statements" and "Risk Factors." The forward-looking statements included in this Quarterly Report are made only as of the date hereof.
Overview
We are 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. We are leveraging our proprietary technology platforms to develop product candidates designed to target urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. We have developed an extensive pipeline of therapies across multiple indications.
We believe that our array of technology platforms uniquely positions us among other biotechnology companies to advance precision medicine. Precision medicine is the practice of therapeutic product development that takes into account specific genetic variations within populations impacted by a disease to design targeted therapies to improve outcomes for a disease or patient population. Our proprietary and complementary technology platforms provide a strong foundation to realize the core promise of precision medicine by supporting our efforts to construct powerful gene programs to drive efficacy, deliver these programs through viral, non-viral, and microbe-based approaches to drive lower costs, and control gene expression to drive safety. Our therapeutic platforms, including UltraCAR-T, AdenoVerse immunotherapy, and ActoBiotics, are designed to allow us to precisely control the level and physiological location of gene expression and modify biological molecules to control the function and output of living cells to treat underlying disease conditions.
We are actively advancing our lead clinical programs, including: PRGN-3005, PRGN-3006 and PRGN-3007, which are built on our UltraCAR-T platform; PRGN-2009 and PRGN-2012, which are based on our AdenoVerse immunotherapy platform. In addition, we have completed a Phase 1b/2a study of AG019, which is built on our ActoBiotics platform. We also have a robust pipeline of preclinical programs that we are pursuing in order to drive long-term value creation.
We have developed a proprietary electroporation device, UltraPorator, designed to further streamline and ensure the rapid and cost-effective manufacturing of UltraCAR-T therapies. UltraPorator has received U.S. Food and Drug Administration, or FDA, clearance for manufacturing UltraCAR-T cells in clinical trials, and we have been dosing patients with UltraCAR-T cells manufactured with UltraPorator in our clinical trials.
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 believe we can more effectively allocate resources to programs that we believe show the most promise and advance such programs to clinical trials.
Our Biopharmaceuticals reportable segment is primarily comprised of the Company's legal entities of Precigen and ActoBio. Our Exemplar reportable segment is comprised of Exemplar Genetics LLC, doing business as Precigen Exemplar, or Exemplar, our wholly owned subsidiary focused on developing research models and services for healthcare research applications.
Biopharmaceuticals
Precigen
We are developing therapies built on our UltraCAR-T therapeutics platform and our "off-the-shelf" AdenoVerse immunotherapy platform. Our AdenoVerse immunotherapy platform utilizes a library of proprietary adenovectors for the efficient gene delivery of therapeutic effectors, immunomodulators, and vaccine antigens. We have established proprietary manufacturing cell lines and production methodologies from our AdenoVerse immunotherapy platform, which we believe are scalable for commercial supply. We believe that our proprietary gorilla adenovectors, part of the AdenoVerse technology, have superior performance characteristics as compared to current competition, including standard human adenovirus serotype 5, rare human adenovirus types and other non-human primate adenovirus types.
Through our UltraCAR-T therapeutics platform, we are able to precision-engineer UltraCAR-T cells to produce a homogeneous cell product that simultaneously expresses antigen-specific chimeric antigen receptor, or CAR, kill switch, and our proprietary
membrane-bound interleukin-15, or mbIL15, genes in any genetically modified UltraCAR-T cell. Our decentralized and rapid proprietary manufacturing process allows us to manufacture UltraCAR-T cells overnight at a medical center's current good manufacturing practices facility, or cGMP, and reinfuse the patient the following day after gene transfer. This process improves upon current approaches to CAR-T manufacturing, which require extensive ex vivo expansion following viral vector transduction to achieve clinically relevant cell numbers that we believe can result in the exhaustion of CAR-T cells prior to their administration, limiting their potential for persistence in patients. We have developed a proprietary electroporation device, UltraPorator, designed to further streamline and ensure the rapid and cost-effective manufacturing of UltraCAR-T therapies. The UltraPorator system includes proprietary hardware and software solutions and potentially represents major advancements over current electroporation devices by significantly reducing the processing time and contamination risk. UltraPorator is intended to be a viable scale-up and commercialization solution for decentralized UltraCAR-T manufacturing.
Our most advanced programs are as follows:
PRGN-2012 is a first-in-class, investigational "off-the-shelf" AdenoVerse immunotherapy for the treatment of recurrent respiratory papillomatosis, or RRP. PRGN-2012 is an innovative therapeutic vaccine with optimized antigen design that uses our gorilla adenovector technology, part of our proprietary AdenoVerse platform, to elicit immune responses directed against cells infected with HPV6 and HPV11. PRGN-2012 is in a Phase 1/2 clinical trial for adult patients with RRP. We have completed the Phase 1 portion of the clinical trial. The Phase 2 portion of the clinical trial is ongoing. We have announced that the FDA has agreed that the ongoing Phase 1/2 clinical trial of PRGN-2012 will serve as pivotal for the purpose of filing an accelerated approval request for licensure. PRGN-2012 has been granted Breakthrough Therapy Designation and Orphan Drug designation for the treatment of RRP by the FDA. PRGN-2012 has received Orphan Drug Designation for the Treatment of RRP from the European Commission as well. PRGN-2012 Phase 2 pivotal trial data are anticipated in the second quarter of 2024. We plan to submit a BLA under an accelerated approval pathway in the second half of 2024. We are preparing for commercial readiness for a potential launch, if approved, of PRGN-2012 in 2025.
PRGN-2009 is a first-in-class, "off-the-shelf" investigational immunotherapy designed to activate the immune system to recognize and target human papillomavirus-positive, or HPV+, solid tumors. PRGN-2009 leverages our UltraVector and AdenoVerse platforms to optimize HPV type 16 and HPV type 18, antigen designed for delivery via a proprietary gorilla adenovector with a large genetic payload capacity and the ability for repeat administrations. We have completed a Phase 1 clinical trial of PRGN-2009 as a monotherapy or in combination with bintrafusp alfa, or M7824, an investigational bifunctional fusion protein, for patients with HPV-associated cancers in collaboration with the National Cancer Institute, or NCI, pursuant to a cooperative research and development arrangement, or CRADA. A Phase 2 clinical trial of PRGN-2009 in combination with pembrolizumab in newly diagnosed oropharyngeal squamous cell carcinoma patients is ongoing in collaboration with the NCI pursuant to a CRADA. In addition, Phase 2 clinical trial of PRGN-2009 in combination with pembrolizumab to treat patients with recurrent or metastatic cervical cancer is ongoing.
PRGN-3005 is a first-in-class, investigational autologous CAR-T therapy that utilizes our UltraCAR-T platform to simultaneously express a CAR targeting the unshed portion of the Mucin 16 antigen, mbIL15, and kill switch genes. PRGN-3005 is currently being evaluated in a Phase 1/1b clinical trial for the treatment of advanced, recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. We have completed enrollment in the Phase 1 dose escalation cohorts of the intraperitoneal (IP) and intravenous (IV) arms without lymphodepletion as well as in the lymphodepletion cohort in the IV arm. The Phase 1b dose expansion trial is ongoing.
PRGN-3006 is a first-in-class, investigational autologous CAR-T therapy that utilizes our UltraCAR-T platform to express a CAR to target CD33 (Siglec-3), mbIL15 and a kill switch gene. PRGN-3006 is currently being evaluated in a Phase 1/1b clinical trial for the treatment of relapsed or refractory, or r/r, acute myeloid leukemia, or AML, and high-risk myelodysplastic syndromes, or MDS. PRGN-3006 has been granted Fast Track designation in patients with r/r AML by the FDA. Previously PRGN-3006 was granted Orphan Drug Designation in patients with AML by the FDA. We have completed the Phase 1 dose escalation trial. The Phase 1b dose expansion trial is ongoing.
PRGN-3007 is a first-in-class, investigational autologous CAR-T therapy that utilizes the next generation UltraCAR-T platform to express a CAR which targets ROR1, mbIL15, a kill switch, and a novel mechanism for the intrinsic blockade of the programmed death 1, or PD-1, gene expression. PRGN-3007 is being evaluated in a Phase 1/1b clinical trial for patients with advanced receptor tyrosine kinase-like orphan receptor 1-positive, or ROR1+, hematological (Arm 1) and solid tumors (Arm 2). The target patient population for Arm 1 includes relapsed or refractory CLL, relapsed or refractory MCL, relapsed or refractory B-ALL, and relapsed or refractory DLBCL. The target patient population for Arm 2 includes locally advanced unresectable or metastatic histologically confirmed TNBC Arm 1 and Arm 2 will enroll in parallel. The study is designed to enroll in two parts:
an initial 3+3 dose escalation in each arm followed by a dose expansion at the maximum tolerated dose. The Phase 1 dose escalation portion of the Phase 1/1b study is ongoing.
In addition to our clinical programs, we have a robust pipeline of preclinical programs in order to drive long-term value creation. Our pipeline includes product candidates based on UltraCAR-T and "off-the-shelf" AdenoVerse immunotherapy therapeutic platforms. We expect to continue development of a number of potential product candidates in our preclinical pipeline to identify product candidates for evaluation in clinical trials.
Precigen ActoBio, Inc.
ActoBio is pioneering a proprietary class of microbe-based biopharmaceuticals, referred to as ActoBiotics, that enable expression and local delivery of disease-modifying therapeutics. Our ActoBiotics platform is a unique delivery platform precisely tailored for specific disease modification with the potential for superior efficacy and safety. ActoBiotics combine the advantages of highly selective protein-based therapeutic agents with local delivery by the well-characterized, food-grade bacterium Lactococcus lactis, or L. lactis. ActoBiotics can be delivered orally in a capsule, through an oral rinse, or in a topical solution. ActoBiotics work via genetically modified bacteria which deliver proteins and peptides at mucosal sites, rather than the insertion of one or more genes into a human cell by means of a virus or other delivery mechanism. By foregoing this insertion, ActoBiotics enable "gene therapy" without the need for cell transformation.
AG019, is a first-in-class disease modifying antigen-specific, investigational immunotherapy for the prevention, delay, or reversal of type 1 diabetes mellitus, or T1D. AG019 is an easy-to-take capsule formulation of ActoBiotics engineered to deliver autoantigen human proinsulin, or hPINS, and the tolerance-enhancing cytokine human interleukin-10 to the mucosal lining of gastro-intestinal tissues in patients with T1D. We have completed a Phase 1b/2a clinical trial of AG019 for the treatment of early-onset T1D. The Phase 1b portion of the study evaluated the safety and tolerability of AG019 monotherapy administered both as a single dose and as repeated daily doses in adult and adolescent patients. The Phase 2a double-blind portion of the study investigated the safety and tolerability of AG019 in combination with teplizumab, or PRV-031. The primary endpoint of assessing safety and tolerability in both the Phase 1b AG019 monotherapy and the Phase 2a AG019 combination therapy has been met. AG019 was well-tolerated when administered to adults and adolescents either as monotherapy or in combination with teplizumab. A single 8-week treatment cycle of oral AG019 as a monotherapy and in combination with teplizumab showed stabilization or increase of C-peptide levels during the first 6 months post treatment initiation in recent-onset T1D.
Precigen Exemplar
Exemplar is committed to enabling the study of life-threatening human diseases through the development of Yucatan MiniSwine miniature preclinical research models and services, as well as enabling the production of cells and organs in its genetically engineered MiniSwine for regenerative medicine applications. Historically, researchers have lacked animal models that faithfully represent human diseases. As a result, a sizeable barrier has blocked progress in the discovery of human disease mechanisms; novel diagnostics, procedures, devices, prevention strategies and therapeutics; as well as the ability to predict in humans the efficacy of next-generation procedures, devices, and therapeutics. Exemplar's MiniSwine models are genetically engineered to exhibit a wide variety of human disease states, which provides a more accurate platform to test the efficacy of new medications and devices.
Segments
As of March 31, 2024, our 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.
Financial overview
We have incurred significant losses since our inception. We anticipate that we may continue to incur significant losses for the foreseeable future, and we may never achieve or maintain profitability. Our historical collaboration and licensing revenues were generated under a business model from which we have gradually transitioned, and we do not expect to expend significant resources servicing our historical collaborations in the future. We may enter into strategic transactions for individual platforms or programs in the future from which we may generate new collaboration and licensing revenues. We continue to generate product and service revenues through our Exemplar subsidiary. Products currently in our clinical pipeline will require regulatory approval and/or commercial scale-up before they may commence significant product sales and operating profits.
As we continue our efforts to focus our business and generate additional capital, we may be willing to enter into transactions involving one or more of our operating segments and reporting units for which we have goodwill and intangible assets. These efforts could result in us identifying impairment indicators or recording impairment charges in future periods. In addition, market changes and changes in judgements, assumptions, and estimates that we have made in assessing the fair value of goodwill could cause us to consider some portion or all of certain assets to become impaired.
See further discussion regarding our ability to continue as a going concern below under the future capital requirements section on Item 2.
Sources of revenue
Our primary current revenues arise from Exemplar, which generates product and service revenues through the development and sale of genetically engineered miniature swine models. We recognize revenue when control of the promised product or service is transferred to the customer.
As we have shifted our focus to our healthcare business, we have and may continue to mutually terminate historical collaboration agreements or repurchase rights to the exclusive fields from collaborators, relieving us of any further performance obligations under the agreement. Upon such circumstances or when we determine no further performance obligations are required of us under an agreement, we may recognize any remaining deferred revenue as either collaboration revenue or as a reduction of operating expense, depending on the circumstances. See "Notes to the Consolidated Financial Statements (Unaudited) - Note 3" appearing elsewhere in this Quarterly Report for a discussion of changes to our significant collaborations.
In future periods, in connection with our focus on healthcare, our revenues will primarily depend on our ability to advance and create our own programs and the extent to which we bring products enabled by our technologies to market. Other than for collaboration revenues recognized upon cancellation or modification of an existing collaboration or for revenues generated pursuant to future strategic transactions for any of our existing platforms or programs, we expect our collaboration revenues will continue to decrease in the near term, although if any new collaboration agreements or strategic transactions are entered into, revenue could be positively impacted. Our revenues will also depend upon our ability to maintain or improve the volume and pricing of Exemplar's current product and service offerings and to develop and scale up production of new offerings from the various technologies of Exemplar. As we focus on our healthcare business, we anticipate that our expenses will increase substantially if, and as, we continue to advance the preclinical and clinical development of our existing product candidates and our research programs. We expect a significant period of time could pass before commercialization of our various product candidates or before the achievement of contractual milestones and the realization of royalties on product candidates commercialized under our collaborations. Accordingly, there can be no assurance as to the timing, magnitude, and predictability of revenues, if any, to which we might be entitled.
Cost of products and services
Cost of products and services, all which are related to our Exemplar reporting segment, includes primarily labor and related costs, drugs and supplies, feed used in production, and facility charges, including rent and depreciation. Fluctuations in the price of livestock and feed have not had a significant impact on our operating margins and no derivative financial instruments are used to mitigate the price risk.
Research and development expenses
We recognize research and development expenses as they are incurred. Our research and development expenses consist primarily of:
•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 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 unallocated expenses for rent and maintenance of facilities and other operating costs.
Our research and development expenses are generally incurred by our reportable segments and primarily relate to either costs incurred to expand or otherwise improve our technologies or the costs incurred to develop our own products and services. Our Biopharmaceuticals segment is progressing preclinical and clinical programs that target urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases, including PRGN-3005, PRGN-3006, PRGN-3007, PRGN-2009, and PRGN-2012 and AG019. Our Exemplar segment's research and development activities relate to new and improved pig research models. The following table summarizes our research and development expenses incurred by reportable segment and reconciles those expenses to research and development expenses on the condensed consolidated statements of operations for the three months ended March 31, 2024 and 2023.
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| Three Months Ended March 31, | | | | |
| 2024 | | 2023 | | | | | | | | |
Biopharmaceuticals | $ | 14,226 | | | $ | 12,097 | | | | | | | | | |
Exemplar | 23 | | | 66 | | | | | | | | | |
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Total consolidated research and development expenses | $ | 14,249 | | | $ | 12,163 | | | | | | | | | |
The amount of research and development expenses may be impacted by, among other things, the number and nature of our own proprietary programs, and the number and size of programs we may support on behalf of collaboration agreements. We expect that our research and development expenses will increase as we continue to develop our own proprietary programs, including progression of these programs into preclinical and clinical stages. We believe these increases will likely include increased costs paid to consultants and contract research organizations and increased costs related to laboratory supplies.
Research and development expenses may also increase as a result of in-licensing of technologies or ongoing research and development operations that we might assume through mergers and acquisitions.
Selling, general and administrative expenses
Selling, general and administrative, or SG&A, expenses consist primarily of salaries and related costs, including stock-based compensation expense, for employees in executive, operational (including commercialization), finance, information technology, legal, and corporate communications functions. Other significant SG&A expenses include rent and utilities, insurance, accounting, and legal services (including the cost of settling any claims and lawsuits), and expenses associated with obtaining and maintaining our intellectual property.
SG&A expenses may fluctuate in the future depending on the scaling of our corporate functions required to support our corporate initiatives, the build-up of our commercialization efforts and the outcomes of legal claims and assessments against us.
Other income (expense), net
Other income consists of gain on convertible debt retirement (for 2023) and interest earned on our cash and cash equivalents and short-term and long-term investments, and may fluctuate based on amounts invested and current interest rates.
Other expense consisted primarily of interest on our Convertible Notes, which decreased in 2023 due to the retirement of our Convertible Notes. See "Notes to the Condensed Consolidated Financial Statements (Unaudited) - Note 8" appearing elsewhere in this Quarterly Report for further discussion.
Segment performance
We use Segment Adjusted EBITDA as our primary measure of segment performance. We define 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. See "Notes to the Condensed Consolidated Financial Statements (Unaudited) - Note 14" appearing elsewhere in this Quarterly Report for further discussion of Segment Adjusted EBITDA.
Results of operations
Comparison of the three months ended March 31, 2024 and the three months ended March 31, 2023
The following table summarizes our results of operations for the three months ended March 31, 2024 and 2023, together with the changes in those items in dollars and as a percentage:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | Dollar Change | | Percent Change |
| 2024 | | 2023 | |
| (In thousands) | | |
| | | | | | | |
| | | | | | | |
Product revenues | 138 | | 324 | | | (186) | | | (57.4) | % |
Service revenues | 919 | | 1,527 | | | (608) | | | (39.8) | % |
Other revenues | 8 | | | — | | | 8 | | | N/A |
Total revenues | 1,065 | | | 1,851 | | | (786) | | | (42.5) | % |
Operating expenses | | | | | | | |
| | | | | | | |
Cost of product and services | 1,075 | | | 1,527 | | | (452) | | | (29.6) | % |
Research and development | 14,249 | | | 12,163 | | | 2,086 | | | 17.2 | % |
Selling, general and administrative | 10,151 | | | 11,639 | | | (1,488) | | | (12.8) | % |
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Total operating expenses | 25,475 | | | 25,329 | | | 146 | | | 0.6 | % |
Operating loss | (24,410) | | | (23,478) | | | (932) | | | 4.0 | % |
Total other income (expense), net | 643 | | | 689 | | | (46) | | | (6.7) | % |
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Loss before income taxes | (23,767) | | | (22,789) | | | (978) | | | 4.3 | % |
Income tax benefit | 29 | | | 55 | | | (26) | | | (47.3) | % |
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Net loss | $ | (23,738) | | | $ | (22,734) | | | $ | (1,004) | | | 4.4 | % |
(1)See "Notes to the Condensed Consolidated Financial Statements (Unaudited) - Note 3" appearing elsewhere in this Quarterly Report.
Product and service revenues and gross margin
Product and service revenues decreased $0.8 million, or 43%, compared to the three months ended March 31, 2023. This decrease is related to reductions in services performed at Exemplar. Gross margin on product and services declined in the current period primarily as a result of the decreased revenues at Exemplar.
Research and development expenses
Research and development expenses increased $2.1 million, or 17%, compared to the three months ended March 31, 2023. Salaries, benefits, and other personnel costs increased $1.5 million due to an increase in the hiring of employees throughout 2023 to support the growth in the Company's clinical development activities as well as increased fees paid to consultants and contract research organizations during the period compared to the prior year period.
Selling, general and administrative expenses
SG&A expenses decreased $1.5 million, or 13%, compared to the three months ended March 31, 2023. This decrease was primarily driven by a reduction in stock compensation and insurance expenses in 2024 versus the same period in 2023.
Segment performance
The following table summarizes Segment Adjusted EBITDA, which is our primary measure of segment performance, for the three months ended March 31, 2024 and 2023, for each of our reportable segments.
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| Three Months Ended March 31, | | Dollar Change | | Percent Change |
| 2024 | | 2023 | |
| (In thousands) | | |
Segment Adjusted EBITDA: | | | | | | | |
Biopharmaceuticals | $ | (23,820) | | | $ | (21,343) | | | $ | (2,477) | | | (11.6) | % |
Exemplar | (200) | | | 121 | | | (321) | | | <(200)% |
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For a reconciliation of Segment Adjusted EBITDA to net loss from continuing operations before income taxes, see "Notes to the Condensed Consolidated Financial Statements (Unaudited) - Note 14" appearing elsewhere in this Quarterly Report.
The following table summarizes revenues from external customers for the three months ended March 31, 2024 and 2023, for each of our reportable segments.
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| Three Months Ended March 31, | | Dollar Change | | Percent Change |
| 2024 | | 2023 | |
| (In thousands) | | |
| | | | | | | |
Exemplar | 1,065 | | | 1,851 | | | (786) | | | (42.5) | % |
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Biopharmaceuticals
Segment Adjusted EBITDA loss increased primarily due to our increase in Research and Development expenses within the reportable segment.
Exemplar
Revenues for Exemplar decreased due to a decrease in services performed resulting from a lower demand from existing customers. The decline in Segment Adjusted EBITDA was primarily due to the decreased revenues.
Liquidity and capital resources
Sources of liquidity
We have incurred losses from operations since our inception, and as of March 31, 2024, we had an accumulated deficit of $2.0 billion. From our inception through March 31, 2024, we have funded our operations principally with proceeds received from private and public equity and debt offerings, cash received from our collaborators, and through product and service sales made directly to customers. As of March 31, 2024, we had cash and cash equivalents of $17.5 million and short-term investments of $27.3 million. Cash in excess of immediate requirements is typically invested primarily in money market funds, certificate of deposits and U.S. government debt securities in order to maintain liquidity and preserve capital.
In January 2023, we closed a public offering of 43,962,640 shares of our common stock, resulting in net proceeds to us of $72.8 million, after deducting underwriting discounts, fees, and other offering expenses.
Cash flows
The following table sets forth the significant sources and uses of cash for the periods set forth below:
| | | | | | | | | | | |
| Three Months Ended March 31, |
| 2024 | | 2023 |
| (In thousands) |
Net cash (used in) provided by: | | | |
Operating activities | $ | (14,090) | | | $ | (18,388) | |
Investing activities | 24,045 | | | (50,408) | |
Financing activities | — | | | 44,174 | |
Effect of exchange rate changes on cash, cash equivalents, and restricted cash | (60) | | | (28) | |
Net decrease in cash, cash equivalents, and restricted cash | $ | 9,895 | | | $ | (24,650) | |
Cash flows from operating activities:
During the three months ended March 31, 2024, our net loss was $23.7 million, which includes the following significant noncash expenses totaling $4.3 million: (i) $2.6 million of stock-based compensation expense, (ii) $1.6 million of depreciation and amortization expense, (iii) $0.5 million of shares issued as payment for services, and (iv) $0.4 million due to amortization of discounts on investments.
During the three months ended March 31, 2023, our net loss was $22.7 million, which includes the following significant noncash expenses totaling $5.1 million: (i) $3.1 million of stock-based compensation expense, (ii) $1.7 million of depreciation and amortization expense, and (iii) $0.5 million of shares issued as payment for services.
Cash flows from investing activities:
During the three months ended March 31, 2024, we received $28.4 million of investments, from sales and maturities, net of purchases, and purchased $4.4 million of property, plant and equipment.
During the three months ended March 31, 2023, we purchased $50.3 million of investments, net of sales and maturities, primarily using the proceeds received from the underwritten public offering discussed below under cash flows from financing activities.
Cash flows from financing activities:
During the three months ended March 31, 2024, we did not have any cash provided or used in financing activities.
During the three months ended March 31, 2023, we received $73.5 million proceeds from the sale of our common stock in an underwritten public offering and retired $29.3 million of our Convertible Notes using restricted cash.
Future capital requirements
Our future capital requirements will depend on many factors, including:
•progress in our research and development programs, as well as the magnitude and speed of development of these programs;
•capital expenditures to building out our manufacturing capabilities and preparing for commercial readiness;
•the timing of regulatory approval of our product candidates and those of our collaborations;
•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.
Until such time, if ever, as we can regularly generate positive operating cash flows, we plan to finance our cash needs through a combination of equity offerings, debt financings, government, or other third-party funding, strategic alliances, sales of assets, and licensing arrangements. We may not be able to raise sufficient additional funds on terms that are favorable to us, if at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our common shareholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common shareholders. Our current stock price may make it more difficult to pursue equity financings and lead to substantial dilution if the price of our common stock does not increase. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise additional funds through strategic transactions, collaborations, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates, or to grant licenses on terms that may not be favorable to us.
We are subject to a number of risks similar to those of other companies conducting high-risk, early-stage research and development of 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 product candidates. Our success is dependent upon our ability to continue to raise additional capital in order to fund ongoing research and development, adequately satisfy or renegotiate long-term debt obligations, obtain regulatory approval of our products, successfully commercialize our products, generate revenue, meet our obligations, and, ultimately, attain profitable operations.
Our consolidated financial statements as of March 31, 2024 have been prepared on the basis that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Based on our balance of cash, cash equivalents and short-term investments of $44.8 million at March 31, 2024 and forecasted negative cash flows from operating activities for the foreseeable future, there is substantial doubt about our ability to continue as a going concern within one year after the date that these financial statements are issued.
See the section entitled "Risk Factors" in our Annual Report for additional risks associated with our substantial capital requirements.
Contractual obligations and commitments
The following table summarizes our significant contractual obligations and commitments from continuing operations as of March 31, 2024 and the effects such obligations are expected to have on our liquidity and cash flows in future periods:
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| Total | | Less Than 1 Year | | 1 - 3 Years | | 3 - 5 Years | | More Than 5 Years |
| (In thousands) |
Operating leases | $ | 9,133 | | | $ | 2,017 | | | $ | 3,076 | | | $ | 2,509 | | | $ | 1,532 | |
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Total | $ | 9,133 | | | $ | 2,017 | | | $ | 3,076 | | | $ | 2,509 | | | $ | 1,532 | |
(1)See "Notes to the Condensed Consolidated Financial Statements (Unaudited) - Notes 8" appearing elsewhere in this Quarterly Report for further discussion of our convertible debt.
In addition to the obligations in the table above, as of March 31, 2024, we are party to license agreements with various third parties that contain future milestones and royalty payment obligations related to development milestones and/or commercial sales of products that incorporate or use their technologies. Because these agreements are generally subject to termination by us or are dependent on certain condition precedents within our control, no amounts are included in the tables above. As of March 31, 2024, we also had research and development commitments with third parties totaling $19.2 million that had not yet been incurred.
Off-balance sheet arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements as defined under SEC rules.
Critical accounting policies and estimates
Our management's discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which we have prepared in accordance with generally accepted accounting principles in the United States. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Our actual results may differ from these estimates under different assumptions or conditions.
There have been no material changes to our critical accounting policies from those described in "Management's Discussion and Analysis of Financial Condition and Results of Operations" included in our Annual Report.
Recent accounting pronouncements
For information with respect to recent accounting pronouncements and the impact of these pronouncements on our condensed consolidated financial statements, see "Notes to the Condensed Consolidated Financial Statements (Unaudited) - Note 2" appearing elsewhere in this Quarterly Report.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
The following sections provide quantitative information on our exposure to interest rate risk. We make use of sensitivity analyses that are inherently limited in estimating actual losses in fair value that can occur from changes in market conditions.
Interest rate risk
We had cash, cash equivalents and short-term investments of $44.8 million and $62.9 million as of March 31, 2024 and December 31, 2023, respectively. Our cash and cash equivalents and short-term investments consist of cash, money market funds, U.S. government debt securities, certificates of deposit, and corporate bonds. The primary objectives of our investment activities are to preserve principal, maintain liquidity, and maximize income without significantly increasing risk. Our
investments consist of U.S. government debt securities, certificates of deposit, and corporate bonds which may be subject to market risk due to changes in prevailing interest rates that may cause the fair values of our investments to fluctuate. We believe that a hypothetical 100 basis point increase in interest rates would not materially affect the fair value of our interest-sensitive financial instruments and any such losses would only be realized if we sold the investments prior to maturity.
Item 4. Controls and Procedures
Pursuant to Rule 13a-15(b) under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), we carried out an evaluation, under supervision and with the participation of our management, including our Chief Executive Officer ("CEO"), who is our principal executive officer, and our Chief Financial Officer ("CFO"), who is our principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined under Rule 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this report. Based upon that evaluation, as of the end of the period covered by this report, our CEO and CFO concluded that our disclosure controls and procedures are effective at the reasonable assurance level to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act, is recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and forms, and that such information is accumulated and communicated to our management, including our CEO and CFO, as appropriate, to allow timely decisions regarding required disclosure.
There has been no change in our internal control over financial reporting during the three months ended March 31, 2024, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
In the course of our business, we are involved in litigation or legal matters, including governmental investigations. Such matters are subject to many uncertainties and outcomes are not predictable with assurance. We accrue 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, we do not believe that any such matters, individually or in the aggregate, will have a material adverse effect on our business, financial condition, results of operations, or cash flows.
See "Notes to the Condensed Consolidated Financial Statements (Unaudited) - Note 13" appearing elsewhere in this Quarterly Report for further discussion of ongoing legal matters.
Item 1A. Risk Factors
As disclosed in "Summary of Risk Factors" and "Item 1A. Risk Factors" in our Annual Report, there are a number of risks and uncertainties that may have a material effect on the operating results of our business and our financial condition. There are no additional material updates or changes to our risk factors since the filing of our Annual Report.
In evaluating our risks, readers also should carefully consider the risk factors discussed in our Annual Report, which could materially affect our business, financial condition, or operating results, in addition to the other information set forth in this report and in our other filings with the SEC.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults on Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
Item 6. Exhibits
| | | | | | | | |
Exhibit No. | | Description |
| |
31.1 | | |
| |
31.2 | | |
| |
32.1** | | |
| |
32.2** | | |
| |
101** | | Interactive Data File (Quarterly Report on Form 10-Q, for the quarterly period ended March 31, 2024, formatted in Inline XBRL (eXtensible Business Reporting Language)). Attached as Exhibit 101.0 to this Quarterly Report on Form 10-Q are the following documents formatted in XBRL: (i) the Condensed Consolidated Balance Sheets as of March 31, 2024 and December 31, 2023, (ii) the Condensed Consolidated Statements of Operations for the three months ended March 31, 2024 and 2023, (iii) the Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2024 and 2023, (iv) the Condensed Consolidated Statements of Shareholders' Equity for the three months ended March 31, 2024 and 2023, (v) the Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2024 and 2023, and (vi) the Notes to the Condensed Consolidated Financial Statements. |
| |
104** | | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
** Furnished herewith.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| | | | | | | | | | | | | | |
| | Precigen, Inc. |
| | (Registrant) |
| | |
Date: May 14, 2024 | | By: | | /s/ HARRY THOMASIAN JR. |
| | | | Harry Thomasian Jr. |
| | | | Chief Financial Officer |
| | | | (Principal Financial and Accounting Officer) |
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Helen Sabzevari, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of Precigen, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: May 14, 2024
| | |
/s/ HELEN SABZEVARI |
|
Helen Sabzevari |
Chief Executive Officer |
(Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Harry Thomasian Jr., certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of Precigen, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5.The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: May 14, 2024
| | |
/s/ HARRY THOMASIAN JR. |
|
Harry Thomasian Jr. |
Chief Financial Officer |
(Principal Financial Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
I, Helen Sabzevari, Chief Executive Officer of Precigen, Inc. (the "Company"), do hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
•the Quarterly Report on Form 10-Q of the Company for the quarter ended March 31, 2024 (the "Report") fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
•the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: May 14, 2024
| | |
/s/ HELEN SABZEVARI |
|
Helen Sabzevari |
Chief Executive Officer |
(Principal Executive Officer) |
A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933 or the Securities Exchange Act of 1934 (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
I, Harry Thomasian Jr., Chief Financial Officer of Precigen, Inc. (the "Company"), do hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
•the Quarterly Report on Form 10-Q of the Company for the quarter ended March 31, 2024 (the "Report") fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
•the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: May 14, 2024
| | |
/s/ HARRY THOMASIAN JR. |
|
Harry Thomasian Jr. |
Chief Financial Officer |
(Principal Financial Officer) |
A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933 or the Securities Exchange Act of 1934 (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.
v3.24.1.1.u2
Cover Page - shares
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Apr. 30, 2024 |
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PRECIGEN, INC.
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VA
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20374 Seneca Meadows Parkway
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v3.24.1.1.u2
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Current assets |
|
|
Cash and cash equivalents |
$ 17,478
|
$ 7,578
|
Short-term investments |
27,280
|
55,277
|
Receivables |
|
|
Trade, less allowance for credit losses of $0 and $184 as of March 31, 2024 and December 31, 2023 |
872
|
902
|
Other |
290
|
673
|
Prepaid expenses and other |
3,626
|
4,325
|
Total current assets |
49,546
|
68,755
|
Property, plant and equipment, net |
12,620
|
7,111
|
Intangible assets, net |
38,717
|
40,701
|
Goodwill |
26,555
|
26,612
|
Right-of-use assets |
6,658
|
7,097
|
Other assets |
751
|
767
|
Total assets |
134,847
|
151,043
|
Current liabilities |
|
|
Accounts payable |
4,716
|
1,726
|
Accrued compensation and benefits |
9,962
|
8,250
|
Other accrued liabilities |
7,296
|
6,223
|
Settlement and indemnification accruals |
5,075
|
5,075
|
Deferred revenue |
407
|
509
|
Current portion of lease liabilities |
1,318
|
1,202
|
Total current liabilities |
28,774
|
22,985
|
Deferred revenue, net of current portion |
1,888
|
1,818
|
Lease liabilities, net of current portion |
5,387
|
5,895
|
Deferred tax liabilities |
1,779
|
1,847
|
Total liabilities |
37,828
|
32,545
|
Commitments and contingencies (Note 13) |
|
|
Shareholders' equity |
|
|
Common stock, no par value, 400,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 256,398,527 shares issued as of March 31, 2024 and December 31, 2023, $250,248,808 shares and $248,919,096 shares outstanding as of March 31, 2024 and December 31, 2023, respectively. |
0
|
0
|
Additional paid-in capital |
2,088,025
|
2,084,916
|
Accumulated deficit |
(1,988,209)
|
(1,964,471)
|
Accumulated other comprehensive loss |
(2,797)
|
(1,947)
|
Total shareholders' equity |
97,019
|
118,498
|
Total liabilities and shareholders' equity |
$ 134,847
|
$ 151,043
|
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Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Shareholders' equity |
|
|
Accounts receivable allowance for credit losses |
$ 0
|
$ 184
|
Common stock, no par value (in usd per share) |
$ 0
|
$ 0
|
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400,000,000
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400,000,000
|
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256,398,527
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256,398,527
|
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250,248,808
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248,919,096
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Condensed Consolidated Statements of Operations - USD ($) $ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Other Income (Expense), Net |
|
|
Loss before income taxes |
$ (23,767)
|
$ (22,789)
|
Income tax benefit |
29
|
55
|
Net loss |
$ (23,738)
|
$ (22,734)
|
Net loss per share |
|
|
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$ (0.10)
|
$ (0.10)
|
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$ (0.10)
|
$ (0.10)
|
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249,220,335
|
229,770,381
|
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249,220,335
|
229,770,381
|
Continuing Operations |
|
|
Revenues |
|
|
Total revenues |
$ 1,065
|
$ 1,851
|
Operating Expenses |
|
|
Research and development |
14,249
|
12,163
|
Selling, general and administrative |
10,151
|
11,639
|
Total operating expenses |
25,475
|
25,329
|
Operating loss |
(24,410)
|
(23,478)
|
Other Income (Expense), Net |
|
|
Interest expense |
(2)
|
(324)
|
Interest income |
608
|
633
|
Other income, net |
37
|
380
|
Total other income, net |
643
|
689
|
Loss before income taxes |
(23,767)
|
(22,789)
|
Income tax benefit |
29
|
55
|
Continuing Operations | Product revenues |
|
|
Revenues |
|
|
Total revenues |
138
|
324
|
Continuing Operations | Service revenues |
|
|
Revenues |
|
|
Total revenues |
919
|
1,527
|
Operating Expenses |
|
|
Cost of products and services |
1,075
|
1,527
|
Continuing Operations | Other revenues |
|
|
Revenues |
|
|
Total revenues |
$ 8
|
$ 0
|
X |
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Condensed Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands |
Total |
Common Stock |
Treasury Stock |
Additional Paid-in Capital |
Accumulated Other Comprehensive Income (Loss) |
Accumulated Deficit |
Increase (Decrease) in Stockholders' Equity |
|
|
|
|
|
|
Treasury stock (in shares) beginning balance |
|
|
0
|
|
|
|
Balances (in shares) at Dec. 31, 2022 |
|
208,150,021
|
|
|
|
|
Balances at Dec. 31, 2022 |
$ 126,259
|
$ 0
|
$ 0
|
$ 1,998,314
|
$ (3,488)
|
$ (1,868,567)
|
Increase (Decrease) in Stockholders' Equity |
|
|
|
|
|
|
Stock-based compensation expense |
3,131
|
|
|
3,131
|
|
|
Shares issued upon vesting of restricted stock units and for exercises of stock options (in shares) |
|
(697,815)
|
|
|
|
|
Shares issued upon vesting of restricted stock units |
0
|
|
|
|
|
|
Shares issued for accrued compensation (in shares) |
|
2,206,469
|
|
|
|
|
Shares issued for accrued compensation |
3,361
|
|
|
3,361
|
|
|
Shares issued as payment for services (in shares) |
|
(465,808)
|
|
|
|
|
Shares issued as payment for services |
545
|
|
|
545
|
|
|
Shares issued in public offering, net of issuance costs (in shares) |
|
43,962,640
|
|
|
|
|
Shares issued in public offerings, net of issuance costs |
72,782
|
|
|
72,782
|
|
|
Net loss |
(22,734)
|
|
|
|
|
(22,734)
|
Other comprehensive loss |
789
|
|
|
|
789
|
|
Treasury stock (in shares) ending balance at Mar. 31, 2023 |
|
|
0
|
|
|
|
Balances (in shares) at Mar. 31, 2023 |
|
255,482,753
|
|
|
|
|
Balances at Mar. 31, 2023 |
$ 184,133
|
$ 0
|
$ 0
|
2,078,133
|
(2,699)
|
(1,891,301)
|
Increase (Decrease) in Stockholders' Equity |
|
|
|
|
|
|
Treasury stock (in shares) beginning balance |
|
|
0
|
|
|
|
Treasury stock (in shares) beginning balance |
|
|
7,479,431
|
|
|
|
Balances (in shares) at Dec. 31, 2023 |
248,919,096
|
248,919,096
|
|
|
|
|
Balances at Dec. 31, 2023 |
$ 118,498
|
$ 0
|
$ 0
|
2,084,916
|
(1,947)
|
(1,964,471)
|
Increase (Decrease) in Stockholders' Equity |
|
|
|
|
|
|
Stock-based compensation expense |
2,581
|
|
|
2,581
|
|
|
Shares issued upon vesting of restricted stock units and for exercises of stock options (in shares) |
|
(961,534)
|
(961,534)
|
|
|
|
Shares issued upon vesting of restricted stock units |
0
|
|
|
|
|
|
Shares issued as payment for services (in shares) |
|
(368,178)
|
(368,178)
|
|
|
|
Shares issued as payment for services |
528
|
|
|
528
|
|
|
Net loss |
(23,738)
|
|
|
|
|
(23,738)
|
Other comprehensive loss |
$ (850)
|
|
|
|
(850)
|
|
Treasury stock (in shares) ending balance at Mar. 31, 2024 |
|
|
6,149,719
|
|
|
|
Balances (in shares) at Mar. 31, 2024 |
250,248,808
|
250,248,808
|
|
|
|
|
Balances at Mar. 31, 2024 |
$ 97,019
|
$ 0
|
$ 0
|
$ 2,088,025
|
$ (2,797)
|
$ (1,988,209)
|
Increase (Decrease) in Stockholders' Equity |
|
|
|
|
|
|
Treasury stock (in shares) beginning balance |
|
|
6,149,719
|
|
|
|
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v3.24.1.1.u2
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Cash flows from operating activities |
|
|
Net loss |
$ (23,738)
|
$ (22,734)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
1,595
|
1,711
|
Gain on disposals of assets, net |
(3)
|
0
|
Gain on debt retirement |
0
|
(106)
|
Amortization of (discounts) premiums on investments, net |
(397)
|
(203)
|
Stock-based compensation expense |
2,581
|
3,131
|
Shares issued as payment for services |
528
|
545
|
Accretion of debt discount and amortization of deferred financing costs |
0
|
34
|
Deferred income taxes |
(29)
|
(55)
|
Receivables: |
|
|
Trade |
30
|
(793)
|
Other |
383
|
(925)
|
Prepaid expenses and other |
699
|
743
|
Other assets |
4
|
(27)
|
Accounts payable |
2,653
|
(249)
|
Accrued compensation and benefits |
1,722
|
1,936
|
Other accrued liabilities |
(126)
|
(1,597)
|
Deferred revenue |
(32)
|
22
|
Lease liabilities |
40
|
195
|
Other long-term liabilities |
0
|
(16)
|
Net cash used in operating activities |
(14,090)
|
(18,388)
|
Cash flows from investing activities |
|
|
Purchases of investments |
(17,190)
|
(108,163)
|
Sales and maturities of investments |
45,583
|
57,909
|
Purchases of property, plant and equipment |
(4,351)
|
(154)
|
Proceeds from sale of assets |
3
|
0
|
Net cash provided by (used in) investing activities |
24,045
|
(50,408)
|
Cash flows from financing activities |
|
|
Proceeds from issuance of shares, net of issuance costs |
0
|
73,501
|
Payments of long-term debt and convertible notes, including cost to retire of $57 in 2023 |
0
|
(29,327)
|
Net cash provided by financing activities |
0
|
44,174
|
Effect of exchange rate changes on cash, cash equivalents, and restricted cash |
(60)
|
(28)
|
Net increase (decrease) in cash, cash equivalents, and restricted cash |
9,895
|
(24,650)
|
Cash, cash equivalents, and restricted cash |
|
|
Beginning of period |
7,848
|
48,596
|
End of period |
17,743
|
23,946
|
Supplemental disclosure of cash flow information |
|
|
Cash paid during the period for interest |
3
|
924
|
Accrued compensation paid in equity awards |
0
|
3,361
|
Purchases of property and equipment included in accounts payable and other accrued liabilities |
2,109
|
24
|
Issuance costs included in accounts payable and other accrued liabilities |
0
|
719
|
Cash, cash equivalents, and restricted cash |
|
|
Cash and cash equivalents |
17,478
|
|
Restricted cash included in other assets |
265
|
|
Cash, cash equivalents, and restricted cash |
$ 17,743
|
$ 23,946
|
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v3.24.1.1.u2
Organization
|
3 Months Ended |
Mar. 31, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization |
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 has two 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."
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v3.24.1.1.u2
Summary of Significant Accounting Policies
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
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 of three 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.
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v3.24.1.1.u2
Collaboration and Licensing Revenue
|
3 Months Ended |
Mar. 31, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Collaboration and Licensing Revenue |
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 | |
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v3.24.1.1.u2
Short-term and Long-term Investments
|
3 Months Ended |
Mar. 31, 2024 |
Investments, Debt and Equity Securities [Abstract] |
|
Short-term and Long-term Investments |
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: | | | | | | | | | | | | | | | | | | | | | | | | | Amortized Cost | | Gross Unrealized Gains | | Gross Unrealized Losses | | Aggregate Fair 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: | | | | | | | | | | | | | | | | | | | | | | | | | Amortized Cost | | Gross Unrealized Gains | | Gross Unrealized Losses | | Aggregate Fair 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.
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v3.24.1.1.u2
Fair Value Measurements
|
3 Months Ended |
Mar. 31, 2024 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
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.
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- DefinitionThe entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.
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v3.24.1.1.u2
Property, Plant and Equipment, Net
|
3 Months Ended |
Mar. 31, 2024 |
Property, Plant and Equipment [Abstract] |
|
Property, Plant and Equipment, Net |
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
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.24.1.1.u2
Goodwill and Intangible Assets, Net
|
3 Months Ended |
Mar. 31, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Goodwill and Intangible Assets, Net |
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
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v3.24.1.1.u2
Debt
|
3 Months Ended |
Mar. 31, 2024 |
Debt Disclosure [Abstract] |
|
Debt |
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 was no 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 | | | | | |
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.24.1.1.u2
Income Taxes
|
3 Months Ended |
Mar. 31, 2024 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
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.
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v3.24.1.1.u2
Shareholders' Equity
|
3 Months Ended |
Mar. 31, 2024 |
Equity [Abstract] |
|
Shareholders' Equity |
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) | |
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v3.24.1.1.u2
Share-Based Payments
|
3 Months Ended |
Mar. 31, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Share-Based Payments |
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 and no 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 and no 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.
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- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.1.1.u2
Operating Leases
|
3 Months Ended |
Mar. 31, 2024 |
Leases [Abstract] |
|
Operating Leases |
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 of one to seven years, some of which may include options to extend the lease and some of which may include options to terminate the lease within one 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 | |
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- DefinitionThe entire disclosure for operating leases of lessee. Includes, but is not limited to, description of operating lease and maturity analysis of operating lease liability.
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v3.24.1.1.u2
Commitments and Contingencies
|
3 Months Ended |
Mar. 31, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
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 In re 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 had no 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.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.1.1.u2
Segments
|
3 Months Ended |
Mar. 31, 2024 |
Segment Reporting [Abstract] |
|
Segments |
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 to three customers in 2024 and four 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 were no revenues derived in foreign countries for any periods presented.
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- DefinitionThe entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.
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v3.24.1.1.u2
Summary of Significant Accounting Policies (Policies)
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
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.
|
Consolidation |
The accompanying condensed consolidated financial statements reflect the operations of Precigen and its majority-owned subsidiaries. All intercompany accounts and transactions have been eliminated.
|
Research and Development |
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.
|
Cash and Cash Equivalents |
Cash and Cash Equivalents All highly liquid investments with an original maturity of three 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 |
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 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 |
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.
|
Segment Information |
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 |
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 and Adopted Accounting Pronouncements |
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.
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v3.24.1.1.u2
Summary of Significant Accounting Policies (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Schedule of Antidilutive Securities Excluded from Computation of Net Loss per Share |
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 | |
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- DefinitionTabular disclosure of securities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) in the future that were not included in the computation of diluted EPS because to do so would increase EPS amounts or decrease loss per share amounts for the period presented, by antidilutive securities.
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v3.24.1.1.u2
Collaboration and Licensing Revenue (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Summary of Deferred Revenue |
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 | |
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- DefinitionTabular disclosure of receivable, contract asset, and contract liability from contract with customer. Includes, but is not limited to, change in contract asset and contract liability.
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v3.24.1.1.u2
Short-term and Long-term Investments (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Investments, Debt and Equity Securities [Abstract] |
|
Summary of Amortized Cost, Gross Unrealized Gains and Losses, and Fair Value of Short-term and Long-term Investments |
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: | | | | | | | | | | | | | | | | | | | | | | | | | Amortized Cost | | Gross Unrealized Gains | | Gross Unrealized Losses | | Aggregate Fair 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 | |
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: | | | | | | | | | | | | | | | | | | | | | | | | | Amortized Cost | | Gross Unrealized Gains | | Gross Unrealized Losses | | Aggregate Fair 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 | |
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v3.24.1.1.u2
Fair Value Measurements (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Fair Value Disclosures [Abstract] |
|
Summary of Placement in the Fair Value Hierarchy of Financial Assets that are Measured at Fair Value on a Recurring Basis |
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 | |
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v3.24.1.1.u2
Property, Plant and Equipment, Net (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Property, Plant and Equipment |
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 | |
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v3.24.1.1.u2
Goodwill and Intangible Assets, Net (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Schedule of Changes in Carrying Amount of Goodwill |
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 | |
|
Schedule of Intangible Assets |
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 | | | | | | | | | | | | | | | | | | | |
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v3.24.1.1.u2
Shareholders' Equity (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Equity [Abstract] |
|
Components of Accumulated Other Comprehensive Income |
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) | |
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v3.24.1.1.u2
Share-Based Payments (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Stock-Based Compensation Costs |
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 | | | | | | | | | |
|
Schedule of Stock Option Activity |
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 |
|
Schedule of Restricted Stock Unit Activity |
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 |
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- DefinitionTabular disclosure of allocation of amount expensed and capitalized for award under share-based payment arrangement to statement of income or comprehensive income and statement of financial position. Includes, but is not limited to, corresponding line item in financial statement.
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v3.24.1.1.u2
Operating Leases (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Leases [Abstract] |
|
Components of Lease Costs |
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 | | | | | | | | | |
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 | |
|
Maturities of Lease Liabilities |
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 | |
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Segments (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Segment Reporting [Abstract] |
|
Information by Reportable Segment |
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) | | | | | | | | | |
|
Reconciliation of Operating Profit (Loss) from Segments to Consolidated |
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) | | | | | | | | | |
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v3.24.1.1.u2
Summary of Significant Accounting Policies - Liquidity and Going Concern - Additional Information (Details) - USD ($) $ in Thousands |
3 Months Ended |
|
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Accounting Policies [Abstract] |
|
|
|
Net income (loss) attributable to parent |
$ (23,738)
|
$ (22,734)
|
|
Accumulated deficit |
1,988,209
|
|
$ 1,964,471
|
Cash, cash equivalents, and short-term investments |
$ 44,758
|
|
|
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v3.24.1.1.u2
Summary of Significant Accounting Policies - Net (Loss) Income Per Share - Additional Information (Details) - $ / shares
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
23,502,258
|
18,822,517
|
3.5% Convertible Notes Due 2023 |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Conversion price (in usd per share) |
|
$ 17.05
|
Options |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
22,715,549
|
16,945,209
|
Restricted stock units |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
786,709
|
1,877,308
|
Convertible debt |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
|
812,178
|
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v3.24.1.1.u2
Short-term and Long-term Investments - Summary of Amortized Cost, Gross Unrealized Gains and Losses, and Fair Value of Short-term and Long-term Investments (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Debt Securities, Available-for-sale [Line Items] |
|
|
Amortized Cost |
$ 27,314
|
$ 55,310
|
Gross Unrealized Gains |
1
|
103
|
Gross Unrealized Losses |
(35)
|
(136)
|
Aggregate Fair Value |
27,280
|
55,277
|
U.S. government debt securities |
|
|
Debt Securities, Available-for-sale [Line Items] |
|
|
Amortized Cost |
25,013
|
51,704
|
Gross Unrealized Gains |
1
|
102
|
Gross Unrealized Losses |
(35)
|
(135)
|
Aggregate Fair Value |
24,979
|
51,671
|
Certificates of deposit |
|
|
Debt Securities, Available-for-sale [Line Items] |
|
|
Amortized Cost |
2,273
|
3,361
|
Gross Unrealized Gains |
0
|
1
|
Gross Unrealized Losses |
0
|
(1)
|
Aggregate Fair Value |
2,273
|
3,361
|
Corporate bonds |
|
|
Debt Securities, Available-for-sale [Line Items] |
|
|
Amortized Cost |
28
|
245
|
Gross Unrealized Gains |
0
|
0
|
Gross Unrealized Losses |
0
|
0
|
Aggregate Fair Value |
$ 28
|
$ 245
|
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v3.24.1.1.u2
Short-term and Long-term Investments - Additional Information (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Debt Securities, Available-for-sale [Line Items] |
|
|
Debt securities, available-for-sale |
$ 27,280
|
$ 55,277
|
Debt Securities, Available-for-Sale, Maturity, Allocated and Single Maturity Date, Rolling within One Year, Fair Value |
27,280
|
|
U.S. government debt securities |
|
|
Debt Securities, Available-for-sale [Line Items] |
|
|
Debt securities, available-for-sale |
$ 24,979
|
51,671
|
Debt securities, available-for-sale, term |
3 months
|
|
Cash and Cash Equivalents | U.S. government debt securities |
|
|
Debt Securities, Available-for-sale [Line Items] |
|
|
Debt securities, available-for-sale |
$ 12,290
|
$ 1,502
|
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v3.24.1.1.u2
Fair Value Measurements - Summary of Placement in the Fair Value Hierarchy of Financial Assets that are Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Assets |
|
|
Fair value of financial assets measured at fair value on a recurring basis |
$ 27,280
|
$ 55,277
|
Quoted Prices in Active Markets (Level 1) |
|
|
Assets |
|
|
Fair value of financial assets measured at fair value on a recurring basis |
0
|
0
|
Significant Other Observable Inputs (Level 2) |
|
|
Assets |
|
|
Fair value of financial assets measured at fair value on a recurring basis |
27,280
|
55,277
|
Significant Unobservable Inputs (Level 3) |
|
|
Assets |
|
|
Fair value of financial assets measured at fair value on a recurring basis |
0
|
0
|
U.S. government debt securities |
|
|
Assets |
|
|
Fair value of financial assets measured at fair value on a recurring basis |
24,979
|
51,671
|
U.S. government debt securities | Quoted Prices in Active Markets (Level 1) |
|
|
Assets |
|
|
Fair value of financial assets measured at fair value on a recurring basis |
0
|
0
|
U.S. government debt securities | Significant Other Observable Inputs (Level 2) |
|
|
Assets |
|
|
Fair value of financial assets measured at fair value on a recurring basis |
24,979
|
51,671
|
U.S. government debt securities | Significant Unobservable Inputs (Level 3) |
|
|
Assets |
|
|
Fair value of financial assets measured at fair value on a recurring basis |
0
|
0
|
Certificates of deposit |
|
|
Assets |
|
|
Fair value of financial assets measured at fair value on a recurring basis |
2,273
|
3,361
|
Certificates of deposit | Quoted Prices in Active Markets (Level 1) |
|
|
Assets |
|
|
Fair value of financial assets measured at fair value on a recurring basis |
0
|
0
|
Certificates of deposit | Significant Other Observable Inputs (Level 2) |
|
|
Assets |
|
|
Fair value of financial assets measured at fair value on a recurring basis |
2,273
|
3,361
|
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|
|
Assets |
|
|
Fair value of financial assets measured at fair value on a recurring basis |
0
|
0
|
Corporate bonds |
|
|
Assets |
|
|
Fair value of financial assets measured at fair value on a recurring basis |
28
|
245
|
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|
|
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|
|
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|
|
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|
|
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|
|
Fair value of financial assets measured at fair value on a recurring basis |
28
|
245
|
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|
|
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|
|
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|
|
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v3.24.1.1.u2
Property, Plant and Equipment, Net - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Abstract] |
|
|
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
|
Property, plant and equipment, gross |
37,210
|
31,394
|
Less: Accumulated depreciation and amortization |
(24,590)
|
(24,283)
|
Property, plant and equipment, net |
$ 12,620
|
$ 7,111
|
X |
- DefinitionAmount before accumulated depreciation of animals maintained to create offspring or to produce goods to be sold for profit.
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3 Months Ended |
|
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
|
|
Goodwill, impaired, accumulated impairment loss |
$ 24,873
|
|
$ 24,873
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$ 1,215
|
$ 1,205
|
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Dec. 31, 2023 |
Finite-Lived Intangible Assets, Net [Abstract] |
|
|
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$ 82,501
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v3.24.1.1.u2
Shareholders' Equity - Narrative (Details) - USD ($) $ in Thousands |
1 Months Ended |
3 Months Ended |
Jan. 31, 2023 |
Jul. 31, 2018 |
Mar. 31, 2024 |
Mar. 31, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
Shares issued (in shares) |
43,962,640
|
|
|
|
Proceeds from issuance of shares, net of issuance costs |
$ 72,808
|
|
$ 0
|
$ 73,501
|
Borrowed shares, number issued (in shares) |
|
7,479,431
|
|
|
Related Parties, Aggregated |
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
Shares issued (in shares) |
11,517,712
|
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v3.24.1.1.u2
Shareholders' Equity - Components of Accumulated Other Comprehensive Income (Loss) (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Mar. 31, 2023 |
Dec. 31, 2022 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
Precigen shareholders' equity |
$ 97,019
|
$ 118,498
|
$ 184,133
|
$ 126,259
|
Total accumulated other comprehensive loss |
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
Precigen shareholders' equity |
(2,797)
|
(1,947)
|
$ (2,699)
|
$ (3,488)
|
Unrealized loss on investments |
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
Precigen shareholders' equity |
(34)
|
(33)
|
|
|
Loss on foreign currency translation adjustments |
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
Precigen shareholders' equity |
$ (2,763)
|
$ (1,914)
|
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v3.24.1.1.u2
Share-Based Payments - Schedule of Stock-Based Compensation Costs (Details) - USD ($) $ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
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|
|
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$ 2,581
|
$ 3,131
|
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|
|
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|
|
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17
|
13
|
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|
|
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|
|
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533
|
509
|
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|
|
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|
|
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|
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v3.24.1.1.u2
Share-Based Payments - Additional Information (Details) - shares
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
Options outstanding (in shares) |
22,715,549
|
22,057,340
|
Restricted stock units |
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
RSUs outstanding (in shares) |
786,709
|
961,534
|
Precigen Stock Option Plan 2023 Plan and 2013 Plan |
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
Number of shares authorized for issuance (in shares) |
16,418,137
|
|
Precigen Stock Option Plan 2013 Plan |
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
Remaining shares available to grant (in shares) |
0
|
|
Options outstanding (in shares) |
17,994,408
|
|
Precigen Stock Option Plan 2013 Plan | Restricted stock units |
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
RSUs outstanding (in shares) |
0
|
|
Precigen Stock Option Plan 2023 Plan |
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
Remaining shares available to grant (in shares) |
15,769,637
|
|
Options outstanding (in shares) |
648,500
|
|
Precigen Stock Option Plan 2023 Plan | Restricted stock units |
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
RSUs outstanding (in shares) |
0
|
|
Precigen Stock Option Plan 2019 Plan |
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
Remaining shares available to grant (in shares) |
2,432,945
|
|
Options outstanding (in shares) |
4,072,641
|
|
Number of shares authorized for issuance (in shares) |
12,000,000
|
|
Precigen Stock Option Plan 2019 Plan | Restricted stock units |
|
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] |
|
|
RSUs outstanding (in shares) |
786,709
|
|
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v3.24.1.1.u2
Share-Based Payments - Schedule of Stock Option Activity (Details) - $ / shares
|
3 Months Ended |
12 Months Ended |
Mar. 31, 2024 |
Dec. 31, 2023 |
Number of Shares |
|
|
Balances at beginning of period (in shares) |
22,057,340
|
|
Granted (in shares) |
1,237,634
|
|
Exercised (in shares) |
0
|
|
Forfeited (in shares) |
(240,000)
|
|
Expired (in shares) |
(339,425)
|
|
Balances at end of period (in shares) |
22,715,549
|
22,057,340
|
Exercisable at end of period (in shares) |
14,261,414
|
|
Weighted Average Exercise Price |
|
|
Balances at beginning of period (in usd per share) |
$ 6.90
|
|
Granted (in usd per share) |
1.43
|
|
Exercised (in usd per share) |
0
|
|
Forfeited (in usd per share) |
1.41
|
|
Expired (in usd per share) |
28.83
|
|
Balances at period end (in usd per share) |
6.33
|
$ 6.90
|
Exercisable, weighted average exercise price, at end of period (in usd per share) |
$ 8.93
|
|
Weighted Average Remaining Contractual Term (Years) |
|
|
Balances, weighted average remaining contractual period |
7 years 1 month 9 days
|
7 years 1 month 13 days
|
Exercisable at period end, weighted average remaining contractual period |
6 years 1 month 24 days
|
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v3.24.1.1.u2
Operating Leases - Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] |
|
|
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 lease liabilities |
1,318
|
$ 1,202
|
Long-term portion of operating lease liabilities |
$ 5,387
|
$ 5,895
|
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v3.24.1.1.u2
Commitments and Contingencies - Narrative (Details) - USD ($)
|
3 Months Ended |
|
|
|
Mar. 31, 2024 |
Sep. 30, 2023 |
Mar. 31, 2023 |
Apr. 30, 2024 |
Dec. 31, 2023 |
Aug. 31, 2022 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] |
|
|
|
|
|
|
Insurance settlements receivable |
$ 0
|
|
|
|
$ 0
|
|
Gain (loss) on disposition of assets |
3,000
|
|
$ 0
|
|
|
|
Precigen Securities Litigation |
|
|
|
|
|
|
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] |
|
|
|
|
|
|
Loss contingency accrual |
13,000,000
|
|
|
|
13,000,000
|
|
Trans Ova | Discontinued Operations, Held-for-sale |
|
|
|
|
|
|
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] |
|
|
|
|
|
|
Disposal group, including discontinued operation, ownership interest disposed of |
|
|
|
|
|
100.00%
|
Consideration |
|
|
|
|
|
$ 170,000,000
|
Disposal group, including discontinued operation, earn-out payments, range of outcomes, value high |
|
|
|
|
|
10,000,000
|
Disposal group, including discontinued operation, indemnification claim |
5,075,000
|
|
|
|
$ 5,750,000
|
|
Increase (decrease) settlement and identification accruals |
|
$ 675,000
|
|
|
|
|
Trans Ova | Discontinued Operations, Held-for-sale | Subsequent Event |
|
|
|
|
|
|
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] |
|
|
|
|
|
|
Disposal group, including discontinued operation, indemnification claim |
|
|
|
$ 1,862,000
|
|
|
Trans Ova | Discontinued Operations, Held-for-sale | Maximum |
|
|
|
|
|
|
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] |
|
|
|
|
|
|
Disposal group, including discontinued operation, earn-out payments |
|
|
|
|
|
$ 5,000,000
|
Disposal group, including discontinued operation, reimbursement limit |
$ 5,750,000
|
|
|
|
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3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Segment Reporting Information [Line Items] |
|
|
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|
$ (21,222)
|
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|
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|
(1,711)
|
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|
0
|
Stock-based compensation expense |
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|
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|
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|
545
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Consolidated loss before income taxes |
(23,767)
|
(22,789)
|
Operating segments |
|
|
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|
|
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4,348
|
154
|
Interest income |
608
|
633
|
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|
|
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|
|
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(2)
|
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|
Depreciation and amortization |
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|
(1,711)
|
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3
|
0
|
Stock-based compensation expense |
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|
(3,132)
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0
|
3,360
|
Shares issued as payment for services |
(528)
|
(545)
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Corporate noncash items |
0
|
(2)
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|
|
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$ (21,222)
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|
3 Months Ended |
12 Months Ended |
Mar. 31, 2024
USD ($)
customer
|
Mar. 31, 2023
USD ($)
customer
|
Dec. 31, 2023
USD ($)
|
Exemplar |
|
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|
Segment Reporting Information [Line Items] |
|
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Percentage of revenue attributable to customer |
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|
82.50%
|
|
Number of customers | customer |
3
|
4
|
|
Exemplar | Operating segments |
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
Total revenues |
$ 1,065,000
|
$ 1,851,000
|
|
Non-US |
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
Long-lived assets |
1,120,000
|
|
$ 1,958,000
|
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$ 0
|
|
$ 0
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