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Precigen(PGEN) - 2022 Q2 - Earnings Call Transcript
2022-08-09 00:21
Precigen, Inc. (NASDAQ:PGEN) Q2 2022 Earnings Conference Call August 8, 2022 4:30 PM ET Company Participants Steven Harasym - Vice President and Head of Investor Relations Helen Sabzevari - President and Chief Executive Officer Harry Thomasian - Chief Financial Officer Conference Call Participants Nick Abbott - Wells Fargo Securities, LLC Jason Butler - JMP Securities, LLC Jennifer Kim - Cantor Fitzgerald & Co. Operator Good day, and welcome to the Precigen Second Quarter and First Half 2022 Financial Resul ...
Precigen(PGEN) - 2022 Q2 - Earnings Call Presentation
2022-08-08 22:16
| --- | --- | --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------|-------|-------------------------------------------------| | | | | | | | Precigen, Inc. | | | | | | | | | | | | | | | | Q2 and 1H '22 Earnings and Business Update Call | Forward-looking Statements 2 Some of the statements made in this presenta0on are forward-looking statements. These forward-looking statements are based upon the Company's current expecta0ons and projec0ons about future events and generally relate to plans, ...
Precigen(PGEN) - 2022 Q2 - Quarterly Report
2022-08-08 20:27
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ 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) Virginia 26-0084895 (State or other jurisdi ...
Precigen(PGEN) - 2022 Q1 - Quarterly Report
2022-05-09 20:19
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY 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) Virginia 26-0084895 (State or other jurisdiction of incorporation or organization) 20374 Seneca Meadows Parkway Germantown, Maryland 20876 (Address of principal executive offices) (Z ...
Precigen(PGEN) - 2021 Q4 - Annual Report
2022-03-01 13:18
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ 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) Virginia 26-0084895 (State or other jurisdiction ...
Pipeline and Corporate Updates at 40th Annual JP Morgan Health Care Conference (SlideShow)
2022-01-13 03:43
© Precigen. All rights reserved. Precigen, Inc. January 12, 2022 Helen Sabzevari, PhD President & Chief Executive Officer 40th Annual J.P. Morgan Healthcare Conference Forward-looking Statements 2 Some of the statements made in this presentation are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based upon Precigen's current expectations and projections about future events and generally rela ...
Precigen(PGEN) - 2021 Q3 - Quarterly Report
2021-11-08 13:02
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ 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) Virginia 26-0084895 (State or other ju ...
Precigen(PGEN) - 2021 Q2 - Earnings Call Transcript
2021-08-10 01:56
Precigen, Inc. (NASDAQ:PGEN) Q2 2021 Results Earnings Conference Call August 9, 2021 4:05 PM ET Company Participants Steven Harasym - Vice President, IR Helen Sabzevari - President & CEO Conference Call Participants Nick Abbott - Wells Fargo Jason Butler - JMP Securities Ben Burnett - Stifel Swayampakula Ramakanth - H.C. Wainwright Justin Walsh - B. Riley Eric Joseph - JPMorgan Operator Good day. And welcome to the Precigen Second Quarter and First Half 2021 Financial Results Conference Call. [Operator Inst ...
Precigen(PGEN) - 2021 Q2 - Quarterly Report
2021-08-09 20:04
[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section presents Precigen, Inc.'s unaudited condensed consolidated financial information, including statements and detailed notes [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28unaudited%29) This section presents Precigen, Inc.'s unaudited condensed consolidated financial statements and detailed notes for the specified periods [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The Condensed Consolidated Balance Sheets show the company's financial position as of June 30, 2021, and December 31, 2020 | Metric (in thousands) | June 30, 2021 | December 31, 2020 | Change | % Change | | :-------------------- | :------------ | :---------------- | :----- | :------- | | Total Assets | $402,573 | $314,587 | $87,986 | 27.97% | | Total Liabilities | $243,377 | $247,413 | $(4,036) | -1.63% | | Total Shareholders' Equity | $159,196 | $67,174 | $92,022 | 137.00% | | Cash and cash equivalents | $36,412 | $51,792 | $(15,380)| -29.70% | | Short-term investments | $78,694 | $48,325 | $30,369 | 62.84% | | Long-term investments | $85,269 | $0 | $85,269 | N/A | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The Condensed Consolidated Statements of Operations reflect the company's financial performance for the three and six months ended June 30, 2021 and 2020 3 Months Ended June 30, 2021 vs 2020 | Metric (in thousands) | 3 Months Ended June 30, 2021 | 3 Months Ended June 30, 2020 | Change | % Change | | :-------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Total Revenues | $33,580 | $30,424 | $3,156 | 10.4% | | Total Operating Expenses | $49,254 | $42,254 | $7,000 | 16.6% | | Operating Loss | $(15,674) | $(11,830) | $(3,844) | 32.5% | | Net Loss | $(20,050) | $(43,354) | $23,304 | -53.8% | | Net Loss per Share (basic & diluted) | $(0.10) | $(0.26) | $0.16 | -61.5% | 6 Months Ended June 30, 2021 vs 2020 | Metric (in thousands) | 6 Months Ended June 30, 2021 | 6 Months Ended June 30, 2020 | Change | % Change | | :-------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Total Revenues | $58,091 | $60,262 | $(2,171) | -3.6% | | Total Operating Expenses | $91,453 | $88,692 | $2,761 | 3.1% | | Operating Loss | $(33,362) | $(28,430) | $(4,932) | 17.3% | | Net Loss | $(37,368) | $(99,352) | $61,984 | -62.4% | | Net Loss per Share (basic & diluted) | $(0.19) | $(0.61) | $0.42 | -68.9% | [Condensed Consolidated Statements of Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) The Condensed Consolidated Statements of Comprehensive Loss detail the net loss and other comprehensive income (loss) components 3 Months Ended June 30, 2021 vs 2020 | Metric (in thousands) | 3 Months Ended June 30, 2021 | 3 Months Ended June 30, 2020 | Change | % Change | | :-------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Net loss | $(20,050) | $(43,354) | $23,304 | -53.8% | | Other comprehensive income (loss) | $795 | $704 | $91 | 12.9% | | Comprehensive loss | $(19,255) | $(42,650) | $23,395 | -54.8% | 6 Months Ended June 30, 2021 vs 2020 | Metric (in thousands) | 6 Months Ended June 30, 2021 | 6 Months Ended June 30, 2020 | Change | % Change | | :-------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Net loss | $(37,368) | $(99,352) | $61,984 | -62.4% | | Other comprehensive income (loss) | $(1,456) | $26,546 | $(28,002)| -105.5% | | Comprehensive loss | $(38,824) | $(72,534) | $33,710 | -46.5% | [Condensed Consolidated Statements of Shareholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders%27%20Equity) The Condensed Consolidated Statements of Shareholders' Equity detail changes in equity components, including common stock and additional paid-in capital Shareholders' Equity Summary | Metric (in thousands) | June 30, 2021 | December 31, 2020 | Change | % Change | | :-------------------- | :------------ | :---------------- | :----- | :------- | | Additional Paid-in Capital | $2,017,413 | $1,886,567 | $130,846 | 6.94% | | Accumulated Deficit | $(1,860,758) | $(1,823,390) | $(37,368)| 2.05% | | Total Shareholders' Equity | $159,196 | $67,174 | $92,022 | 137.00% | | Shares Issued and Outstanding (June 30, 2021) | 206,580,928 | 187,663,207 | 18,917,721 | 10.08% | - In January 2021, the company completed a public offering of **17,250,000 shares** of common stock, generating net proceeds of **$121,045 thousand**[30](index=30&type=chunk)[118](index=118&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The Condensed Consolidated Statements of Cash Flows illustrate the company's cash generation and usage across operating, investing, and financing activities Cash Flow Summary | Metric (in thousands) | 6 Months Ended June 30, 2021 | 6 Months Ended June 30, 2020 | Change | % Change | | :-------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Net cash used in operating activities | $(24,160) | $(41,548) | $17,388 | -41.8% | | Net cash used in investing activities | $(112,482) | $(12,586) | $(99,896)| 793.7% | | Net cash provided by financing activities | $121,063 | $32,891 | $88,172 | 268.1% | | Net decrease in cash, cash equivalents, and restricted cash | $(15,395) | $(21,302) | $5,907 | -27.7% | - Cash outflows from operations decreased by **$17.4 million**, driven by increased cash inflows from Trans Ova and Exemplar, reduced cash needs for MBP Titan, and streamlined corporate operations[240](index=240&type=chunk) - Investing activities included **$116.2 million** in net purchases of investments in 2021, compared to **$76.3 million** in 2020, primarily funded by proceeds from public offerings[241](index=241&type=chunk) - Financing activities in 2021 were significantly boosted by **$121.0 million** in net proceeds from a public offering of common stock[242](index=242&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed disclosures and explanations for the figures presented in the condensed consolidated financial statements [1. Organization](index=13&type=section&id=1.%20Organization) Precigen, Inc. is a synthetic biology company focusing on gene and cellular therapies for immuno-oncology, autoimmune disorders, and infectious diseases - Precigen is a synthetic biology company focused on discovery and clinical stage gene and cellular therapies for immuno-oncology, autoimmune disorders, and infectious diseases[37](index=37&type=chunk) - Key subsidiaries include PGEN Therapeutics (gene/cell therapies), Precigen ActoBio (microbe-based biopharmaceuticals), Exemplar Genetics (MiniSwine research models), and Trans Ova Genetics (bovine reproductive technologies)[38](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk)[41](index=41&type=chunk) - The company completed a strategic shift by suspending MBP Titan's methane bioconversion operations and selling most non-healthcare assets in early 2020 to focus on healthcare[42](index=42&type=chunk)[43](index=43&type=chunk) [2. Summary of Significant Accounting Policies](index=13&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the significant accounting policies, including the basis of presentation for unaudited interim financial statements and going concern considerations - The interim condensed consolidated financial statements are unaudited and prepared in accordance with U.S. GAAP, with certain disclosures condensed or omitted[44](index=44&type=chunk) - Management believes existing liquid assets will fund operations for at least one year, but expects continued operating losses and negative cash flows, requiring additional capital[46](index=46&type=chunk) - COVID-19 has caused delays in clinical trials (AG019, PRGN-3005) and introduces uncertainty regarding future impacts on business, operations, and financial performance[48](index=48&type=chunk)[49](index=49&type=chunk) - Starting Q1 2021, reportable segments are Biopharmaceuticals, Exemplar, and Trans Ova, with corporate expenses managed at a consolidated level[53](index=53&type=chunk) [3. Discontinued Operations](index=16&type=section&id=3.%20Discontinued%20Operations) This note details the financial impact of discontinued operations, primarily the wind-down of MBP Titan and the sale of non-healthcare assets - MBP Titan's operations were suspended in Q2 2020 and substantially wound down by December 31, 2020, due to market uncertainty from COVID-19 and the energy sector[58](index=58&type=chunk) - In January 2021, MBP Titan's property and equipment sale resulted in a **$464 thousand** gain, and a lease termination generated a **$4,602 thousand** gain, both included in income from discontinued operations[59](index=59&type=chunk) Income (Loss) from Discontinued Operations | Metric (in thousands) | 6 Months Ended June 30, 2021 | 6 Months Ended June 30, 2020 | | :-------------------- | :--------------------------- | :--------------------------- | | Income (loss) from discontinued operations (MBP Titan) | $4,539 | $(36,741) | | Income (loss) from discontinued operations (Transactions) | $0 | $(26,056) | | Total Income (loss) from discontinued operations | $4,539 | $(62,797) | - The Transactions in January 2020 involved selling a majority of non-healthcare assets for **$53 million** and contingent rights, and the sale of EnviroFlight equity for **$12.2 million**[64](index=64&type=chunk)[66](index=66&type=chunk) - The TS Biotechnology Sale in January 2020 resulted in a **$26,957 thousand** loss from the release of cumulative foreign currency translation losses[68](index=68&type=chunk) [4. Investments in Joint Ventures](index=19&type=section&id=4.%20Investments%20in%20Joint%20Ventures) This note details the company's investments in joint ventures, specifically Intrexon Energy Partners and Intrexon Energy Partners II - Precigen holds a **50% membership interest** in Intrexon Energy Partners, a JV formed to optimize MBP technology for fuels and lubricants, with a remaining capital commitment of **$4,225 thousand** as of June 30, 2021[75](index=75&type=chunk) - Precigen also holds a **50% membership interest** in Intrexon Energy Partners II, a JV for 1,4-butanediol production using MBP technology, with a remaining capital commitment of **$10,000 thousand** as of June 30, 2021[79](index=79&type=chunk) - Both JVs are classified as Variable Interest Entities (VIEs), but the company is not the primary beneficiary, having no risk of loss related to them as of June 30, 2021[52](index=52&type=chunk) [5. Collaboration and Licensing Revenue](index=20&type=section&id=5.%20Collaboration%20and%20Licensing%20Revenue) This note explains the company's collaboration and licensing revenue recognition policies, which typically involve upfront fees, R&D reimbursements, and milestone payments - Collaboration and licensing revenues are derived from agreements for technology development and commercialization, including licenses, R&D services, and potential milestone/royalty payments[82](index=82&type=chunk) Collaboration and Licensing Revenues (3 Months Ended) | Counterparty (in thousands) | 3 Months Ended June 30, 2021 | 3 Months Ended June 30, 2020 | Change | % Change | | :-------------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Castle Creek Biosciences, Inc. | $294 | $4,210 | $(3,916)| -93.0% | | Total Collaboration and Licensing Revenues | $301 | $4,315 | $(4,014)| -93.0% | Collaboration and Licensing Revenues (6 Months Ended) | Counterparty (in thousands) | 6 Months Ended June 30, 2021 | 6 Months Ended June 30, 2020 | Change | % Change | | :-------------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Castle Creek Biosciences, Inc. | $353 | $14,573 | $(14,220)| -97.6% | | Total Collaboration and Licensing Revenues | $367 | $15,036 | $(14,669)| -97.6% | Deferred Revenue | Deferred Revenue (in thousands) | June 30, 2021 | December 31, 2020 | | :------------------------------ | :------------ | :---------------- | | Collaboration and licensing agreements | $23,062 | $23,420 | | Prepaid product and service revenues | $3,097 | $2,126 | | Total | $26,299 | $25,823 | [6. Short-term and Long-term Investments](index=22&type=section&id=6.%20Short-term%20and%20Long-term%20Investments) The company's investments are classified as available-for-sale and primarily consist of U.S. government debt securities and certificates of deposit Investment Fair Value | Investment Type (in thousands) | June 30, 2021 Fair Value | December 31, 2020 Fair Value | Change | % Change | | :----------------------------- | :----------------------- | :--------------------------- | :----- | :------- | | U.S. government debt securities | $163,698 | $48,061 | $115,637 | 240.6% | | Certificates of deposit | $265 | $264 | $1 | 0.4% | | Total | $163,963 | $48,325 | $115,638 | 239.3% | Contractual Maturity of Investments | Contractual Maturity (in thousands) | June 30, 2021 Fair Value | | :---------------------------------- | :----------------------- | | Due within one year | $78,694 | | After one year through three years | $85,269 | | Total | $163,963 | [7. Fair Value Measurements](index=22&type=section&id=7.%2E%20Fair%20Value%20Measurements) This note describes how the company measures the fair value of its financial assets and liabilities, categorizing them into a three-level hierarchy - The fair value of cash, receivables, accounts payable, and accrued liabilities approximates their carrying amount due to short maturities[91](index=91&type=chunk) Financial Assets Fair Value Hierarchy | Financial Asset (in thousands) | Level 1 | Level 2 | Level 3 | June 30, 2021 Total | | :----------------------------- | :------ | :--------- | :------ | :------------------ | | U.S. government debt securities | $0 | $163,698 | $0 | $163,698 | | Other | $0 | $265 | $0 | $265 | | Total | $0 | $163,963 | $0 | $163,963 | - The fair value of the Convertible Notes was approximately **$173,000 thousand** as of June 30, 2021, and **$165,000 thousand** as of December 31, 2020, classified as Level 2 based on third-party trades[95](index=95&type=chunk) [8. Inventory](index=23&type=section&id=8.%20Inventory) Inventory consists of supplies, embryos, other production materials, work in process, livestock, and feed Inventory Components | Inventory Component (in thousands) | June 30, 2021 | December 31, 2020 | Change | % Change | | :--------------------------------- | :------------ | :---------------- | :----- | :------- | | Supplies, embryos and other production materials | $2,098 | $2,060 | $38 | 1.8% | | Work in process | $2,624 | $2,348 | $276 | 11.8% | | Livestock | $5,640 | $5,047 | $593 | 11.8% | | Feed | $1,051 | $1,904 | $(853) | -44.8% | | Total inventory | $11,413 | $11,359 | $54 | 0.5% | [9. Property, Plant and Equipment, Net](index=24&type=section&id=9.%20Property%2C%20Plant%20and%20Equipment%2C%20Net) This note details the company's property, plant, and equipment, net, showing a decrease primarily due to accumulated depreciation Property, Plant and Equipment Summary | Asset Category (in thousands) | June 30, 2021 | December 31, 2020 | Change | % Change | | :---------------------------- | :------------ | :---------------- | :----- | :------- | | Total Gross Carrying Amount | $70,612 | $69,876 | $736 | 1.1% | | Less: Accumulated depreciation and amortization | $(37,867) | $(34,952) | $(2,915)| 8.3% | | Property, plant and equipment, net | $32,745 | $34,924 | $(2,179)| -6.2% | - Depreciation expense for the six months ended June 30, 2021, was **$3,186 thousand**, a decrease from **$3,816 thousand** in the prior year[98](index=98&type=chunk) [10. Goodwill and Intangible Assets, Net](index=24&type=section&id=10.%20Goodwill%20and%20Intangible%20Assets%2C%20Net) This note details the company's goodwill and intangible assets, net, showing a decrease in intangibles due to ongoing amortization Goodwill and Intangible Assets Summary | Asset Category (in thousands) | June 30, 2021 | December 31, 2020 | Change | % Change | | :---------------------------- | :------------ | :---------------- | :----- | :------- | | Goodwill | $54,273 | $54,363 | $(90) | -0.2% | | Intangible assets, net | $59,942 | $65,396 | $(5,454)| -8.3% | - Amortization expense for intangible assets was **$3,857 thousand** for the six months ended June 30, 2021, compared to **$3,762 thousand** in the prior year[101](index=101&type=chunk) [11. Lines of Credit and Long-Term Debt](index=25&type=section&id=11.%20Lines%20of%20Credit%20and%20Long-Term%20Debt) This note details the company's lines of credit and long-term debt, primarily consisting of convertible senior notes - Trans Ova has a **$5,000 thousand** revolving line of credit (matures April 2022, interest at U.S. Prime Rate or 3.00%, **3.25%** as of June 30, 2021) with no outstanding balance[102](index=102&type=chunk) - Exemplar has a **$700 thousand** revolving line of credit (matures October 2021, interest at **4.00%**) with no outstanding balance[103](index=103&type=chunk) Long-Term Debt Summary | Debt Type (in thousands) | June 30, 2021 | December 31, 2020 | Change | % Change | | :----------------------- | :------------ | :---------------- | :----- | :------- | | Convertible debt | $173,777 | $168,147 | $5,630 | 3.3% | | Notes payable | $3,438 | $3,655 | $(217) | -5.9% | | Total Long-term debt, less current portion | $176,922 | $171,522 | $5,400 | 3.1% | - The Convertible Notes have an outstanding principal balance of **$200,000 thousand**, mature on July 1, 2023, and bear interest at **3.50%** per year, with an effective interest rate of **11.02%** including amortization[106](index=106&type=chunk)[109](index=109&type=chunk) Interest Expense (Convertible Notes) | Interest Expense Component (in thousands) | 6 Months Ended June 30, 2021 | 6 Months Ended June 30, 2020 | Change | % Change | | :---------------------------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Cash interest expense | $3,500 | $3,500 | $0 | 0.0% | | Non-cash interest expense | $5,630 | $5,101 | $529 | 10.4% | | Total interest expense (Convertible Notes) | $9,130 | $8,601 | $529 | 6.2% | [12. Income Taxes](index=27&type=section&id=12.%20Income%20Taxes) The company calculates interim tax provisions based on actual taxable income or loss, as it cannot reliably estimate its annual effective income tax rate - The company reported U.S. taxable losses of approximately **$57,500 thousand** for the six months ended June 30, 2021, and **$107,000 thousand** for the same period in 2020[115](index=115&type=chunk) Income Tax Components | Income Tax Component (in thousands) | 6 Months Ended June 30, 2021 | 6 Months Ended June 30, 2020 | Change | % Change | | :---------------------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Current foreign income tax expense | $7 | $56 | $(49) | -87.5% | | Deferred income tax benefit | $(119) | $(136) | $17 | -12.5% | | Total income tax benefit | $(112) | $(80) | $(32) | 40.0% | - As of June 30, 2021, the company had approximately **$813,700 thousand** in U.S. federal NOL carryforwards, **$211,500 thousand** in U.S. capital loss carryforwards, and **$10,500 thousand** in federal and state R&D tax credits, mostly offset by a valuation allowance[117](index=117&type=chunk) [13. Shareholders' Equity](index=28&type=section&id=13.%20Shareholders%27%20Equity) This note details changes in shareholders' equity, primarily driven by issuances of common stock, including a public offering in January 2021 - In January 2021, a public offering of **17,250,000 shares** of common stock generated net proceeds of **$121,045 thousand**[118](index=118&type=chunk) - In January 2020, TS Biotechnology purchased **5,972,696 shares** of common stock for **$35,000 thousand** in a private placement[119](index=119&type=chunk) - The company entered into a Share Lending Agreement for **7,479,431 shares** of common stock, which is equity-classified and not included in loss per share calculations unless the borrower defaults[121](index=121&type=chunk)[122](index=122&type=chunk) Accumulated Other Comprehensive Income | Component (in thousands) | June 30, 2021 | December 31, 2020 | Change | % Change | | :----------------------- | :------------ | :---------------- | :----- | :------- | | Unrealized gain (loss) on investments | $(72) | $13 | $(85) | -653.8% | | Income on foreign currency translation adjustments | $2,613 | $3,984 | $(1,371)| -34.4% | | Total accumulated other comprehensive income | $2,541 | $3,997 | $(1,456)| -36.4% | [14. Share-Based Payments](index=29&type=section&id=14.%20Share-Based%20Payments) This note details the company's share-based payment plans, including stock options and restricted stock units (RSUs), and the associated compensation expense Total Stock-Based Compensation Expense (3 Months Ended) | Expense Category (in thousands) | 3 Months Ended June 30, 2021 | 3 Months Ended June 30, 2020 | Change | % Change | | :------------------------------ | :--------------------------- | :--------------------------- | :----- | :------- | | Total Stock-based compensation expense | $3,557 | $4,897 | $(1,340)| -27.4% | Total Stock-Based Compensation Expense (6 Months Ended) | Expense Category (in thousands) | 6 Months Ended June 30, 2021 | 6 Months Ended June 30, 2020 | Change | % Change | | :------------------------------ | :--------------------------- | :--------------------------- | :----- | :------- | | Total Stock-based compensation expense | $8,972 | $9,269 | $(297) | -3.2% | Share-Based Awards Outstanding | Share-Based Award | Outstanding at June 30, 2021 | | :---------------- | :--------------------------- | | Stock Options | 12,660,387 | | RSUs | 554,146 | - The Executive Chairman's compensation arrangement, effective 2021, includes an annual retainer, fully vested stock options, and RSUs, contributing to selling, general, and administrative expenses[130](index=130&type=chunk) [15. Operating Leases](index=30&type=section&id=15.%20Operating%20Leases) The company leases facilities and equipment under operating leases, with terms ranging from one to nine years Total Lease Costs | Lease Cost Component (in thousands) | 6 Months Ended June 30, 2021 | 6 Months Ended June 30, 2020 | Change | % Change | | :---------------------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Operating lease costs | $1,668 | $1,798 | $(130) | -7.2% | | Short-term lease costs | $947 | $852 | $95 | 11.2% | | Variable lease costs | $464 | $449 | $15 | 3.3% | | Total Lease costs | $3,079 | $3,099 | $(20) | -0.6% | Lease Liabilities | Lease Liability (in thousands) | June 30, 2021 | | :----------------------------- | :------------ | | Total Lease Liabilities | $19,790 | | Present value adjustment | $(6,032) | | Total | $13,758 | | Current portion | $1,937 | | Long-term portion | $11,821 | - The weighted average remaining lease term was **6.50 years** as of June 30, 2021, with a weighted average discount rate of **10.96%**[132](index=132&type=chunk) [16. Commitments and Contingencies](index=31&type=section&id=16.%20Commitments%20and%20Contingencies) This note outlines the company's commitments and contingencies, including ongoing legal proceedings and past settlements - Trans Ova is involved in a second patent infringement lawsuit by XY, LLC, with five patents at issue, and a trial expected in January 2022[134](index=134&type=chunk) - In September 2020, the company settled an SEC investigation regarding MBP program disclosures, consenting to a cease and desist order and paying a **$2,500 thousand** civil money penalty[136](index=136&type=chunk) - Shareholder class action lawsuits and a derivative shareholder action were filed in late 2020, asserting claims similar to the SEC allegations, which the company intends to vigorously defend[137](index=137&type=chunk) - In December 2020, the company settled disputes with Harvest by issuing **2,117,264 shares** of common stock (valued at **$18,103 thousand**) in exchange for terminating ECC agreements and returning ownership interests in certain start-up entities[138](index=138&type=chunk) [17. Related Party Transactions](index=33&type=section&id=17.%20Related%20Party%20Transactions) This note details transactions with related parties, primarily Third Security and its affiliates, due to the Executive Chairman's role - The company reimburses Third Security for tax-related services and out-of-pocket expenses, totaling **$46 thousand** for the six months ended June 30, 2021[142](index=142&type=chunk) - Sublease income from Third Security for administrative offices was **$41 thousand** for the six months ended June 30, 2021[143](index=143&type=chunk) - Past transactions included holding convertible preferred stock, a convertible note, common shares, and warrants of Castle Creek, which ceased to be a related party after its acquisition in December 2019[145](index=145&type=chunk) [18. Net Loss per Share](index=33&type=section&id=18.%20Net%20Loss%20per%20Share) This note provides the computation of basic and diluted net loss per share, showing significant improvement due to reduced net loss and increased shares outstanding Net Loss per Share Summary | Metric | 6 Months Ended June 30, 2021 | 6 Months Ended June 30, 2020 | Change | % Change | | :----- | :--------------------------- | :--------------------------- | :----- | :------- | | Net loss | $(37,368) | $(99,352) | $61,984 | -62.4% | | Weighted average shares outstanding | 196,275,820 | 162,201,915 | 34,073,905 | 21.0% | | Net loss per share, basic and diluted | $(0.19) | $(0.61) | $0.42 | -68.9% | Potentially Dilutive Securities | Potentially Dilutive Securities | June 30, 2021 | June 30, 2020 | | :------------------------------ | :------------ | :------------ | | Convertible debt | 11,732,440 | 24,750,914 | | Options | 12,660,387 | 11,383,039 | | Restricted stock units | 554,146 | 1,897,181 | | Warrants | 121,888 | 133,264 | | Total | 25,068,861 | 38,164,398 | - All potentially dilutive securities were excluded from diluted EPS computations for both periods as their inclusion would have been anti-dilutive[147](index=147&type=chunk) [19. Segments](index=34&type=section&id=19.%20Segments) This note provides financial information by reportable segment: Biopharmaceuticals, Exemplar, and Trans Ova, with performance assessed using Segment Adjusted EBITDA - The company's reportable segments are Biopharmaceuticals, Exemplar, and Trans Ova, with performance measured by Segment Adjusted EBITDA[150](index=150&type=chunk) Segment Adjusted EBITDA (6 Months Ended) | Segment Adjusted EBITDA (in thousands) | 6 Months Ended June 30, 2021 | 6 Months Ended June 30, 2020 | Change | % Change | | :------------------------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Biopharmaceuticals | $(21,394) | $(17,345) | $(4,049)| 23.3% | | Exemplar | $3,695 | $857 | $2,838 | >200% | | Trans Ova | $18,433 | $7,668 | $10,765 | 140.4% | | Total Segment Adjusted EBITDA | $734 | $(8,820) | $9,554 | -108.3% | Revenues from External Customers (6 Months Ended) | Revenues from External Customers (in thousands) | 6 Months Ended June 30, 2021 | 6 Months Ended June 30, 2020 | Change | % Change | | :---------------------------------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Biopharmaceuticals | $594 | $15,322 | $(14,728)| -96.1% | | Exemplar | $6,656 | $4,256 | $2,400 | 56.4% | | Trans Ova | $50,841 | $40,630 | $10,211 | 25.1% | | Total Consolidated Revenues | $58,091 | $60,262 | $(2,171)| -3.6% | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=37&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, highlighting its strategic shift to a healthcare-focused biopharmaceutical company [Overview](index=37&type=section&id=Overview) Precigen is a discovery and clinical-stage biopharmaceutical company focused on gene and cell therapies for immuno-oncology, autoimmune disorders, and infectious diseases - Precigen is a biopharmaceutical company advancing gene and cell therapies for immuno-oncology, autoimmune disorders, and infectious diseases[156](index=156&type=chunk) - Key technology platforms include UltraCAR-T, AdenoVerse immunotherapy, and ActoBiotics, designed for precision medicine with controlled gene expression and delivery[157](index=157&type=chunk) - Lead clinical programs include PRGN-3005, PRGN-3006 (UltraCAR-T), PRGN-2009, PRGN-2012 (AdenoVerse), and AG019 (ActoBiotics)[158](index=158&type=chunk) - The UltraPorator device received FDA clearance in October 2020 for manufacturing UltraCAR-T cells in clinical trials, streamlining rapid and cost-effective production[159](index=159&type=chunk) [Our Healthcare Business](index=37&type=section&id=Our%20Healthcare%20Business) Precigen's healthcare business focuses on human therapeutics and research models, including Biopharmaceuticals and Exemplar Genetics - The healthcare business comprises Biopharmaceuticals (PGEN Therapeutics, ActoBio, Triple-Gene) and Exemplar Genetics[161](index=161&type=chunk) - PGEN Therapeutics advances gene and cell therapies using UltraCAR-T (e.g., PRGN-3005 for ovarian cancer, PRGN-3006 for AML) and AdenoVerse immunotherapy (e.g., PRGN-2009 for HPV+ cancers, PRGN-2012 for RRP)[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk) - ActoBio pioneers microbe-based biopharmaceuticals (ActoBiotics), with AG019 (for type 1 diabetes) in Phase 1b/2a clinical trials, showing encouraging safety and C-peptide level trends[169](index=169&type=chunk)[170](index=170&type=chunk) - Precigen Triple-Gene's INXN-4001 (non-viral triple-effector plasmid for heart failure) completed a Phase 1 trial, demonstrating safety and feasibility[171](index=171&type=chunk) - Exemplar Genetics develops genetically engineered MiniSwine Yucatan miniature pig research models for studying life-threatening human diseases[174](index=174&type=chunk) [Our Non-Healthcare Business](index=41&type=section&id=Our%20Non-Healthcare%20Business) As of June 30, 2021, Precigen's sole non-healthcare business is Trans Ova Genetics, L.C., a bovine genetics company - Trans Ova Genetics, L.C. is Precigen's only non-healthcare business as of June 30, 2021[175](index=175&type=chunk) - Trans Ova offers advanced bovine reproductive technologies such as embryo transfer, IVF, sexed-semen, genetic preservation, and cloning[176](index=176&type=chunk) [COVID-19 Impact](index=41&type=section&id=COVID-19%20Impact) The COVID-19 pandemic has significantly impacted global health and economic environments, causing delays in Precigen's clinical trials - COVID-19 caused temporary suspensions in AG019 Phase 1b/2a and PRGN-3005 Phase 1 clinical trials in early 2020, which have since resumed[178](index=178&type=chunk) - The full impact of the COVID-19 pandemic on the company's ongoing business, results of operations, and financial performance remains uncertain and cannot be reliably estimated[180](index=180&type=chunk) [Discontinued Operations](index=42&type=section&id=Discontinued%20Operations) Precigen has strategically shifted its focus to healthcare, divesting non-healthcare assets and suspending MBP Titan's methane bioconversion operations - The company divested non-healthcare assets in January 2020 and suspended MBP Titan's operations in 2020 as part of a strategic shift to focus on healthcare[181](index=181&type=chunk)[182](index=182&type=chunk) - Remaining assets and contractual obligations from MBP Titan, including equity interests and collaboration agreements with Intrexon Energy Partners and Intrexon Energy Partners II, are managed at the corporate level[182](index=182&type=chunk) [Segments](index=42&type=section&id=Segments) As of June 30, 2021, Precigen's reportable segments are Biopharmaceuticals, Exemplar, and Trans Ova, with corporate expenses managed at a consolidated level - Reportable segments as of June 30, 2021, are Biopharmaceuticals, Exemplar, and Trans Ova[184](index=184&type=chunk) - Corporate expenses, including finance, accounting, legal, HR, IT, and investor relations, are unallocated and managed at a consolidated level[185](index=185&type=chunk) [Financial overview](index=42&type=section&id=Financial%20overview) Precigen has incurred significant losses since inception and expects this trend to continue, necessitating additional capital - The company has incurred significant losses since inception, with an accumulated deficit of **$1.9 billion** as of June 30, 2021, and expects continued losses[186](index=186&type=chunk)[234](index=234&type=chunk) - Future revenues will depend on advancing proprietary healthcare programs, regulatory approvals, commercial scale-up, and maintaining/improving Trans Ova's and Exemplar's offerings[192](index=192&type=chunk) - Research and development expenses are expected to increase with the progression of proprietary preclinical and clinical programs[197](index=197&type=chunk) - Interest expense is projected to increase due to noncash amortization of the long-term debt discount and debt issuance costs related to convertible senior notes[201](index=201&type=chunk) [Results of operations](index=47&type=section&id=Results%20of%20operations) Precigen's results of operations show mixed performance, with increased revenues in some segments but also higher operating losses, offset by discontinued operations income [Comparison of the three months ended June 30, 2021 and the three months ended June 30, 2020](index=47&type=section&id=Comparison%20of%20the%20three%20months%20ended%20June%2030%2C%202021%20and%20the%20three%20months%20ended%20June%2030%2C%202020) This section compares the company's financial performance for the three months ended June 30, 2021 and 2020, highlighting revenue and expense trends | Metric (in thousands) | 3 Months Ended June 30, 2021 | 3 Months Ended June 30, 2020 | Dollar Change | Percent Change | | :-------------------- | :--------------------------- | :--------------------------- | :------------ | :------------- | | Total Revenues | $33,580 | $30,424 | $3,156 | 10.4% | | Collaboration and licensing revenues | $301 | $4,315 | $(4,014) | (93.0)% | | Product revenues | $8,335 | $8,540 | $(205) | (2.4)% | | Service revenues | $24,803 | $17,381 | $7,422 | 42.7% | | Total Operating Expenses | $49,254 | $42,254 | $7,000 | 16.6% | | Research and development | $13,681 | $9,474 | $4,207 | 44.4% | | Selling, general and administrative | $19,997 | $17,869 | $2,128 | 11.9% | | Operating Loss | $(15,674) | $(11,830) | $(3,844) | 32.5% | | Net Loss | $(20,050) | $(43,354) | $23,304 | (53.8)% | - Biopharmaceuticals' Segment Adjusted EBITDA declined by **71.2%** due to decreased collaboration revenues and increased costs for clinical and preclinical programs[212](index=212&type=chunk)[215](index=215&type=chunk) - Exemplar's Segment Adjusted EBITDA improved by **over 200%** due to increased service demand, price adjustments, and operational efficiencies[212](index=212&type=chunk)[216](index=216&type=chunk) - Trans Ova's Segment Adjusted EBITDA increased by **47.8%** due to higher customer demand, increased procedures, and improved pricing structure[212](index=212&type=chunk)[217](index=217&type=chunk) [Comparison of the six months ended June 30, 2021 and the six months ended June 30, 2020](index=50&type=section&id=Comparison%20of%20the%20six%20months%20ended%20June%2030%2C%202021%20and%20the%20six%20months%20ended%20June%2030%2C%202020) This section compares the company's financial performance for the six months ended June 30, 2021 and 2020, focusing on revenue, expenses, and net loss | Metric (in thousands) | 6 Months Ended June 30, 2021 | 6 Months Ended June 30, 2020 | Dollar Change | Percent Change | | :-------------------- | :--------------------------- | :--------------------------- | :------------ | :------------- | | Total Revenues | $58,091 | $60,262 | $(2,171) | (3.6)% | | Collaboration and licensing revenues | $367 | $15,036 | $(14,669) | (97.6)% | | Product revenues | $14,716 | $13,501 | $1,215 | 9.0% | | Service revenues | $42,734 | $31,327 | $11,407 | 36.4% | | Total Operating Expenses | $91,453 | $88,692 | $2,761 | 3.1% | | Research and development | $24,202 | $20,801 | $3,401 | 16.4% | | Selling, general and administrative | $38,699 | $39,355 | $(656) | (1.7)% | | Operating Loss | $(33,362) | $(28,430) | $(4,932) | 17.3% | | Net Loss | $(37,368) | $(99,352) | $61,984 | (62.4)% | - Biopharmaceuticals' Segment Adjusted EBITDA declined by **23.3%** due to accelerated recognition of deferred revenue in the prior period and increased costs for clinical and preclinical programs[227](index=227&type=chunk)[230](index=230&type=chunk) - Exemplar's Segment Adjusted EBITDA improved by **over 200%** due to increased service demand, price adjustments, and operational efficiencies[227](index=227&type=chunk)[231](index=231&type=chunk) - Trans Ova's Segment Adjusted EBITDA increased by **140.4%** due to higher customer demand, increased procedures, and improved pricing structure[227](index=227&type=chunk)[232](index=232&type=chunk) [Liquidity and capital resources](index=52&type=section&id=Liquidity%20and%20capital%20resources) This section discusses the company's liquidity and capital resources, including its accumulated deficit, cash position, and future funding requirements - As of June 30, 2021, the company had **$36.4 million** in cash and cash equivalents and **$164.0 million** in short-term and long-term investments[234](index=234&type=chunk) - Net cash used in operating activities decreased by **$17.4 million** for the six months ended June 30, 2021, primarily due to increased cash inflows from Trans Ova and Exemplar, and reduced cash requirements for MBP Titan[236](index=236&type=chunk)[240](index=240&type=chunk) - Net cash provided by financing activities increased significantly by **$88.2 million**, driven by **$121.0 million** in net proceeds from a public offering of common stock in 2021[236](index=236&type=chunk)[242](index=242&type=chunk) - Future capital requirements depend on R&D progress, clinical trial outcomes, regulatory approvals, strategic transactions, and the impact of the COVID-19 pandemic[243](index=243&type=chunk) Contractual Obligations | Contractual Obligation (in thousands) | Total | Less Than 1 Year | 1 - 3 Years | 3 - 5 Years | More Than 5 Years | | :------------------------------------ | :-------- | :--------------- | :---------- | :---------- | :---------------- | | Operating leases | $19,790 | $3,344 | $6,192 | $4,945 | $5,309 | | Convertible debt | $200,000 | $0 | $200,000 | $0 | $0 | | Cash interest payable on convertible debt | $17,500 | $7,000 | $10,500 | $0 | $0 | | Long-term debt, excluding convertible debt | $3,501 | $356 | $772 | $783 | $1,590 | | Total | $240,791 | $10,700 | $217,464 | $5,728 | $6,899 | - Remaining capital contribution commitments to JVs were **$14.2 million** as of June 30, 2021, not included in the table due to timing uncertainty[250](index=250&type=chunk) - The company has net operating loss carryforwards of approximately **$813.7 million** for U.S. federal income tax purposes, largely offset by a valuation allowance[252](index=252&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=56&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the company's exposure to market risks, primarily interest rate risk, for its cash, cash equivalents, and investments - As of June 30, 2021, the company held **$200.4 million** in cash, cash equivalents, and short-term and long-term investments[259](index=259&type=chunk) - Investments primarily consist of money market funds, U.S. government debt securities, and certificates of deposit[259](index=259&type=chunk) - A hypothetical **100 basis point** increase in interest rates is not expected to materially affect the fair value of interest-sensitive financial instruments[259](index=259&type=chunk) [Item 4. Controls and Procedures](index=56&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated the effectiveness of its disclosure controls and procedures as of June 30, 2021, concluding they are effective - The CEO and Executive Director, Finance, concluded that disclosure controls and procedures were effective as of June 30, 2021[260](index=260&type=chunk) - No material changes to internal control over financial reporting occurred during the three months ended June 30, 2021[261](index=261&type=chunk) [PART II - OTHER INFORMATION](index=57&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section provides additional information beyond the financial statements, covering legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=57&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in various legal matters, but management does not believe these will have a material adverse effect on its business or financial condition - The company is involved in litigation and governmental investigations, but management does not believe these will have a material adverse effect on the business as of June 30, 2021[264](index=264&type=chunk) [Item 1A. Risk Factors](index=57&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2020 - No additional material updates or changes to risk factors have occurred since the filing of the Annual Report on Form 10-K for the year ended December 31, 2020[266](index=266&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=57&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states that there were no unregistered sales of equity securities or use of proceeds to report for the period [Item 3. Defaults on Senior Securities](index=57&type=section&id=Item%203.%20Defaults%20on%20Senior%20Securities) This section indicates that there were no defaults on senior securities to report for the period [Item 4. Mine Safety Disclosures](index=57&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company [Item 5. Other Information](index=57&type=section&id=Item%205.%20Other%20Information) This section states that there is no other information to report for the period [Item 6. Exhibits](index=58&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications from the CEO and Executive Director, Finance - Exhibits include certifications from the CEO and Executive Director, Finance, as per Sarbanes-Oxley Act sections 302 and 906[273](index=273&type=chunk) - An Interactive Data File (XBRL) of the Condensed Consolidated Financial Statements is attached as Exhibit 101.0[273](index=273&type=chunk) [SIGNATURES](index=59&type=section&id=SIGNATURES) The report is duly signed on behalf of Precigen, Inc. by James V. Lambert, Executive Director, Finance, on August 9, 2021 - The report was signed by James V. Lambert, Executive Director, Finance (Interim Principal Financial and Accounting Officer) on August 9, 2021[275](index=275&type=chunk)
Precigen(PGEN) - 2021 Q1 - Quarterly Report
2021-05-10 20:49
[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28unaudited%29%3A) This section presents Precigen, Inc.'s unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows, with detailed notes [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to $407.0 million, liabilities decreased to $232.2 million, and shareholders' equity grew to $174.8 million as of March 31, 2021 Condensed Consolidated Balance Sheet Data (in thousands) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $27,355 | $51,792 | | Total current assets | $144,118 | $148,948 | | Total assets | $406,984 | $314,587 | | **Liabilities & Equity** | | | | Total current liabilities | $25,243 | $42,127 | | Total liabilities | $232,189 | $247,413 | | Total shareholders' equity | $174,795 | $67,174 | | Total liabilities and shareholders' equity | $406,984 | $314,587 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Total revenues decreased to $24.5 million, while net loss improved significantly to $17.3 million for the three months ended March 31, 2021 Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Total revenues | $24,511 | $29,838 | | Operating loss | $(17,688) | $(16,600) | | Loss from continuing operations | $(21,844) | $(20,846) | | Income (loss) from discontinued operations | $4,526 | $(35,152) | | Net loss | $(17,318) | $(55,998) | | Net loss per share, basic and diluted | $(0.09) | $(0.35) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $16.4 million, while financing activities provided $121.0 million, resulting in a $24.5 million net decrease in cash Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(16,384) | $(27,743) | | Net cash used in investing activities | $(129,102) | $(36,553) | | Net cash provided by financing activities | $121,040 | $34,151) | | Net decrease in cash, cash equivalents, and restricted cash | $(24,457) | $(30,184) | [Notes to the Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) These notes detail accounting policies, business organization, discontinued operations, revenue recognition, debt structure, and confirm sufficient liquidity for the next year - The company is a synthetic biology firm focusing on gene and cellular therapies for immuno-oncology, autoimmune disorders, and infectious diseases. It operates through subsidiaries including PGEN Therapeutics, ActoBio, and Exemplar[34](index=34&type=chunk)[35](index=35&type=chunk)[36](index=36&type=chunk) - The company completed the wind-down of its methane bioconversion subsidiary, MBP Titan, in January 2021, resulting in a gain of **$4.6 million** from lease termination and a gain of **$0.46 million** on asset sales, included in income from discontinued operations for Q1 2021[55](index=55&type=chunk)[56](index=56&type=chunk) - In January 2021, the company closed a public offering of **17,250,000 shares** of common stock, resulting in net proceeds of **$121.0 million**[117](index=117&type=chunk) - As of March 31, 2021, the company had **$200 million** in principal outstanding on its **3.50% convertible senior notes** due 2023, with a carrying value of **$170.9 million**[108](index=108&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's transition to a clinical-stage biopharmaceutical focus, reviewing segment performance, financial results, and confirming sufficient liquidity for the next 12 months - Precigen is a clinical-stage biopharmaceutical company focused on gene and cell therapies for immuno-oncology, autoimmune disorders, and infectious diseases, utilizing platforms like UltraCAR-T, AdenoVerse, and ActoBiotics[157](index=157&type=chunk)[158](index=158&type=chunk) - Key clinical programs include PRGN-3005 (ovarian cancer), PRGN-3006 (AML), PRGN-2009 (HPV+ tumors), PRGN-2012 (RRP), and AG019 (type 1 diabetes), with ongoing preclinical programs and the UltraPorator device for rapid UltraCAR-T manufacturing[159](index=159&type=chunk)[160](index=160&type=chunk) Results of Operations Comparison (in thousands) | Line Item | Q1 2021 | Q1 2020 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $24,511 | $29,838 | $(5,327) | (17.9)% | | Operating loss | $(17,688) | $(16,600) | $(1,088) | 6.6% | | Loss from continuing operations | $(21,844) | $(20,846) | $(998) | 4.8% | | Net loss | $(17,318) | $(55,998) | $38,680 | (69.1)% | Segment Adjusted EBITDA (in thousands) | Segment | Q1 2021 | Q1 2020 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Biopharmaceuticals | $(8,854) | $(10,022) | $1,168 | 11.7% | | Exemplar | $1,806 | $250 | $1,556 | >200% | | Trans Ova | $6,421 | $(457) | $6,878 | >200% | - The company believes its existing liquid assets of **$27.4 million** in cash and **$181.9 million** in investments will be sufficient to fund operations and capital requirements for at least the next **12 months**[221](index=221&type=chunk)[230](index=230&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=52&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuations on its **$209.3 million** cash and investments, with no material impact expected from a 100 basis point rate increase - The company is exposed to interest rate risk on its **$209.3 million** in cash, cash equivalents, and investments, with the portfolio structured to preserve principal and maintain liquidity[246](index=246&type=chunk) - Management believes a hypothetical **100 basis point** increase in interest rates would not have a material effect on the fair value of its financial instruments, and losses would only be realized upon sale before maturity[246](index=246&type=chunk) [Item 4. Controls and Procedures](index=52&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2021, with no material changes to internal control over financial reporting - The CEO and interim Principal Financial Officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2021[247](index=247&type=chunk) - No material changes were made to the company's internal control over financial reporting during the first quarter of 2021[248](index=248&type=chunk) [PART II - OTHER INFORMATION](index=53&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=53&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in various legal matters, none of which are expected to have a material adverse effect on its financial condition or operations - The company does not believe that any ongoing legal matters will have a material adverse effect on its business, financial condition, or cash flows as of March 31, 2021[251](index=251&type=chunk) [Item 1A. Risk Factors](index=53&type=section&id=Item%201A.%20Risk%20Factors) No material updates or changes to the company's previously disclosed risk factors have occurred - No material updates or changes to the company's risk factors have occurred since the filing of the Annual Report[253](index=253&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=53&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[255](index=255&type=chunk) [Item 6. Exhibits](index=54&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including CEO and CFO certifications and Interactive Data Files - The report includes certifications from the CEO and interim Principal Financial Officer as required by the Sarbanes-Oxley Act, as well as Interactive Data Files (XBRL)[260](index=260&type=chunk)