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Precigen(PGEN) - 2022 Q4 - Annual Report
2023-03-06 21:47
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, 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 jurisdiction ...
Precigen(PGEN) - 2022 Q3 - Earnings Call Transcript
2022-11-10 03:59
Financial Data and Key Metrics Changes - The company completed the sale of its subsidiary, Trans Ova Genetics, for $170 million, which allowed for the retirement of $144 million in convertible notes, reducing outstanding debt to $56 million [29][30][34] - SG&A expenses decreased by 8% quarter-over-quarter and 9% year-to-date compared to the previous year, enabling a focus on clinical advancement and potential commercialization [32][33] - The company ended Q3 2022 with cash, cash equivalents, short-term investments, and restricted cash totaling $153.8 million, providing a cash runway into early Q4 2023 [35] Business Line Data and Key Metrics Changes - The AdenoVerse immunotherapy platform, particularly PRGN-2012 for Recurrent Respiratory Papillomatosis (RRP), is progressing rapidly with 15 patients treated and a strong safety profile reported [10][13] - PRGN-2009 for HPV-associated cancers has shown a 40% objective response rate in interim data from the Phase I combination arm [19][21] - Enrollment for PRGN-3006 in the UltraCAR-T trial for relapsed refractory AML is complete, with upcoming presentations expected to showcase safety and efficacy data [22][24] Market Data and Key Metrics Changes - The estimated market opportunity for PRGN-2012 in RRP is projected to exceed $1 billion in the U.S. and EU alone, with a global patient population potentially over 75,000 [15][16] - The company is focusing on markets with high unmet needs, aiming for accelerated regulatory pathways for its therapies [6][7] Company Strategy and Development Direction - The company emphasizes fiscal discipline and has reduced SG&A costs to allocate more resources towards clinical and commercialization efforts [9][34] - The strategy includes advancing differentiated therapies with potential for unique pricing models, leveraging the UltraPorator technology for decentralized manufacturing [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data presentations and the potential for significant advancements in their clinical pipeline [78][79] - The company is focused on creating shareholder value and addressing high unmet medical needs through innovative treatments [80] Other Important Information - The company is actively engaging with the FDA regarding regulatory pathways for its therapies, particularly for PRGN-2012 [60][68] - The UltraCAR-T platform is positioned as a unique solution for solid tumors, with ongoing discussions about its potential in the market [27][42] Q&A Session Summary Question: Can you provide details on the patients enrolled in the Phase II trial for PRGN-2012? - Management indicated that the patients treated have severe cases, often requiring multiple surgeries, highlighting the challenging nature of the disease [38] Question: What can you share about the patient who was retreated in the PRGN-3005 trial? - The patient is reportedly doing well after receiving a repeat dose, with positive expectations for future reports [40][41] Question: What factors influenced the decision to focus on dose Level 3 for the AML UltraCAR-T program? - The decision was based on previously reported efficacy and safety data, with a focus on expanding patient recruitment [45][47] Question: What is the status of the ROR1 3007 UltraCAR-T program? - Management noted that internal processes and committee approvals are the current gating factors for initiating patient dosing [52] Question: How is the repeat dosing regimen determined for patients in the UltraCAR-T programs? - The dosing is personalized based on the oncologist's discretion, differing from conventional therapies that require fixed schedules [61][63]
Precigen(PGEN) - 2022 Q3 - Quarterly Report
2022-11-09 21:19
Financial Performance - Total revenues for the three months ended September 30, 2022, were $16,722,000, a significant increase from $3,333,000 in the same period of 2021, representing a growth of 402%[24] - The company reported a net income of $87,379,000 for the three months ended September 30, 2022, compared to a net loss of $29,764,000 in the same period of 2021[27] - For the nine months ended September 30, 2022, the company reported a net income of $50,493, compared to a net loss of $67,132 for the same period in 2021[36] - The company reported a comprehensive income of $84,754,000 for the three months ended September 30, 2022, compared to a comprehensive loss of $30,790,000 in the same period of 2021[27] - Total consolidated revenues for the nine months ended September 30, 2022, were $25,146 million, a significant increase from $10,583 million in the same period of 2021, representing a growth of approximately 138.5%[157] - Operating loss decreased to $7.6 million for the three months ended September 30, 2022, from a loss of $21.5 million in the same period in 2021, reflecting an improvement of $13.9 million, or 64.6%[215] - Loss from continuing operations decreased to $7.6 million for the three months ended September 30, 2022, compared to a loss of $26.3 million in the same period in 2021, an improvement of $18.7 million, or 71.0%[215] Assets and Liabilities - Total current assets increased to $162,806,000 as of September 30, 2022, compared to $156,628,000 as of December 31, 2021[18] - The company's total liabilities decreased to $116,713,000 as of September 30, 2022, from $252,508,000 as of December 31, 2021, indicating a reduction of approximately 54%[21] - The company’s total assets were $259,245,000 as of September 30, 2022, down from $359,856,000 as of December 31, 2021[18] - The accumulated deficit as of September 30, 2022, was $1,846,391,000, a decrease from $1,915,556,000 as of December 31, 2021[21] - Long-term debt decreased to $82,069 as of September 30, 2022, from $179,934 as of December 31, 2021, reflecting a reduction of approximately 54.4%[105] Cash Flow and Investments - Cash and cash equivalents decreased to $9,067,000 as of September 30, 2022, down from $36,423,000 as of December 31, 2021[18] - Cash used in operating activities for the nine months ended September 30, 2022, was $49,649, compared to $41,182 for the same period in 2021[36] - The company generated $214,996 in net cash from investing activities for the nine months ended September 30, 2022, compared to a net cash used of $90,469 in 2021[39] - The company had $153,770 in cash, cash equivalents, short-term investments, and restricted cash as of September 30, 2022[48] Research and Development - Research and development expenses for the nine months ended September 30, 2022, were $36,377,000, slightly up from $35,755,000 in the same period of 2021[24] - Research and development expenses for the Biopharmaceuticals segment were $12.536 million for Q3 2022, compared to $12.355 million in Q3 2021, reflecting ongoing investment in proprietary programs[205] - Total consolidated research and development expenses for the nine months ended September 30, 2022, were $36.377 million, slightly up from $35.755 million in the same period of 2021[205] Operational Changes and Future Outlook - The company expects to continue incurring operating losses and negative cash flows from operations for the foreseeable future, requiring additional capital to fund its operations[48] - As of September 30, 2022, the company had no committed source of additional funding from either debt or equity financings[48] - The company has shifted focus to healthcare, resulting in the termination of several collaboration agreements and a decrease in collaboration revenues expected in the near term[200] - The company anticipates continued significant losses in the foreseeable future, with no assurance of achieving profitability[195] Segment Performance - Revenues from external customers in the Biopharmaceuticals segment for the three months ended September 30, 2022, were $14,624 million, a significant increase from $129 million in the same period of 2021[154] - The total segment revenues for the Exemplar segment for the three months ended September 30, 2022, were $2,098 million, compared to $3,204 million in the same period of 2021[154] - Precigen's Exemplar segment generated positive Segment Adjusted EBITDA in the nine months ended September 30, 2022, indicating operational profitability[195] Divestitures and Acquisitions - The company completed the sale of its subsidiary Trans Ova Genetics on August 18, 2022, which was previously a separate reportable segment[45] - The Company completed the sale of its subsidiary Trans Ova for $170 million, with an additional potential earn-out of up to $10 million based on performance in 2022 and 2023[65] - The Company recognized a gain on the divestiture of Trans Ova amounting to $94.7 million for the nine months ended September 30, 2022[69] COVID-19 Impact - The Company is closely monitoring the impact of COVID-19, which has caused uncertainty regarding its clinical and preclinical pipeline candidates[52] - The impact of COVID-19 on the company's operations remains uncertain, with potential delays in clinical and preclinical pipeline candidates[184] Stock and Financing - The company entered into a Controlled Equity Offering Sales Agreement to issue and sell up to $100,000 of its common stock, with no shares sold during the three months ended September 30, 2022[125][126] - The company has convertible notes with a face value of $82,440 due on July 1, 2023, raising substantial doubt about its ability to continue as a going concern[48] - The company successfully retired $117,560 of principal balance from the convertible notes during the three months ended September 30, 2022, recording a gain on extinguishment of debt of approximately $853[113] Other Financial Metrics - The effective interest rate on the convertible notes was 4.25% as of September 30, 2022[115] - The total interest expense for the nine months ended September 30, 2022, was $6,131 million, down from $13,891 million in the same period of 2021, indicating a significant reduction[116] - The company had U.S. taxable income of approximately $44,300 for the three months ended September 30, 2022, compared to a taxable loss of approximately $24,700 for the same period in 2021[118]
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 ...