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Precigen(PGEN) - 2024 Q1 - Quarterly Results
2024-05-14 21:19
Financial Performance - Total revenues decreased by $0.8 million, or 43%, compared to the three months ended March 31, 2023[14]. - Total revenues for Q1 2024 were $1,065,000, a decrease of 42.3% compared to $1,851,000 in Q1 2023[29]. - Product revenues decreased to $138,000 from $324,000, while service revenues fell to $919,000 from $1,527,000[29]. - Operating loss for Q1 2024 was $24,410,000, compared to a loss of $23,478,000 in Q1 2023[29]. - Net loss was $23.7 million, or $(0.10) per basic and diluted share, compared to a net loss of $22.7 million, or $(0.10) per basic and diluted share, in the prior year[14]. - Net loss for Q1 2024 was $23,738,000, consistent with a net loss of $22,734,000 in Q1 2023[29]. - The company reported a net loss per share of $0.10 for both Q1 2024 and Q1 2023[29]. Research and Development - Research and development expenses increased by $2.1 million, or 17%, compared to the same period in 2023[12]. - Research and development expenses increased to $14,249,000, up from $12,163,000 in the same period last year[29]. - 50% of patients in the Phase 1 portion of the PRGN-2012 study achieved Complete Response, defined as no surgeries needed during the 12-month period following treatment[6]. - 83% of patients had a reduction in RRP surgeries in the 12-month period after PRGN-2012 treatment compared to the 12 months pre-treatment[7]. - The FDA confirmed that the ongoing Phase 1/2 study of PRGN-2012 will serve as pivotal, eliminating the need for additional randomized trials for BLA submission[9]. - Precigen is advancing its UltraCAR-T library approach to enhance personalized cell therapy for cancer patients[21]. Cash and Assets - Cash, cash equivalents, and short-term investments totaled $44.8 million as of March 31, 2024[11]. - Cash and cash equivalents rose to $17,478,000 as of March 31, 2024, compared to $7,578,000 at the end of 2023[27]. - Total assets decreased to $134,847,000 from $151,043,000 at the end of 2023[27]. - Total liabilities increased to $37,828,000 from $32,545,000 at the end of 2023[27]. Corporate Initiatives - The company plans to co-sponsor the inaugural RRP Awareness Day on June 11, 2024, to raise awareness about recurrent respiratory papillomatosis[5]. - PRGN-2012 rolling BLA submission is anticipated in the second half of 2024, with commercial readiness activities underway for a potential launch in 2025[5]. Operating Expenses - SG&A costs decreased by $1.5 million, or 13%, compared to the same period in 2023[13].
Precigen Reports First Quarter 2024 Financial Results and Business Updates
Prnewswire· 2024-05-14 20:05
– Pivotal Phase 2 study data of PRGN-2012 for the treatment of patients with recurrent respiratory papillomatosis to be presented at the 2024 ASCO Annual Meeting as a late-breaking oral presentation on June 3rd – – Company to host a conference call on June 3rd following the PRGN-2012 ASCO presentation to discuss in detail the pivotal study results and provide business updates – – PRGN-2012 rolling BLA submission, under an accelerated approval pathway, is anticipated in the second half of 2024; commercial re ...
Precigen(PGEN) - 2023 Q4 - Earnings Call Transcript
2024-03-20 00:49
Precigen, Inc. (NASDAQ:PGEN) Q4 2023 Earnings Conference Call March 19, 2024 4:30 PM ET Company Participants Steve Harasym - Vice President, Investor Relations Helen Sabzevari - President & Chief Executive Officer Harry Thomasian - Chief Financial Officer Jim Shaffer - Head of our Commercial Conference Call Participants Jason Butler - Citizens JMP Jennifer Kim - Cantor Fitzgerald Swayampakula Ramakanth - H.C. Wainwright Brian Cheng - JPMorgan Operator Good afternoon and welcome to the Precigen Full-Year 202 ...
Precigen(PGEN) - 2023 Q4 - Annual Report
2024-03-19 20:48
PART I [Business Overview](index=12&type=section&id=Item%201.%20Business) Precigen is a discovery and clinical-stage biopharmaceutical company advancing gene and cell therapies for immuno-oncology, autoimmune disorders, and infectious diseases, leveraging proprietary technology platforms [Overview](index=12&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 discovery and clinical-stage biopharmaceutical company focused on gene and cell therapies for immuno-oncology, autoimmune disorders, and infectious diseases[31](index=31&type=chunk) - The company leverages proprietary technology platforms including UltraCAR-T, AdenoVerse immunotherapy, and ActoBiotics[32](index=32&type=chunk) - Key operating tenets include **Financial Discipline**, **Active Portfolio Management**, **Rapid Execution**, and **Strategic Partnerships**[37](index=37&type=chunk) [Our Strategy](index=13&type=section&id=Our%20Strategy) The company's strategy focuses on advancing clinical programs, systematically evaluating preclinical data, and leveraging synthetic biology for precision medicines - Strategy focuses on advancing lead clinical programs towards proof-of-concept and commercialization, either independently or with collaborators[40](index=40&type=chunk) - Systematically evaluates preclinical data for rapid 'go' and 'no go' decisions to allocate resources to programs with the highest probability of success[40](index=40&type=chunk) - Leverages proprietary synthetic biology technologies across therapeutic areas to create optimized biological processes for efficient and cost-effective precision medicines[40](index=40&type=chunk) [Our Clinical Pipeline](index=14&type=section&id=Our%20Clinical%20Pipeline) Precigen's clinical pipeline includes investigational therapies across immuno-oncology, autoimmune disorders, and infectious diseases Precigen Clinical Pipeline Overview | Platform | Product | Target | Indication | Status | | :--- | :--- | :--- | :--- | :--- | | AdenoVerse Immunotherapy | PRGN-2012 | HPV 6/11 | RRP | Phase 1B (Breakthrough Therapy Designation, Orphan Drug Designation) | | AdenoVerse Immunotherapy | PRGN-2009 | HPV 16/18 | OPSCC/Head & Neck Cancer | Phase 1B | | AdenoVerse Immunotherapy | PRGN-2009 (+pembrolizumab) | HPV 16/18 | R/M Cervical Cancer | Phase 2 IND cleared | | UltraCAR-T | PRGN-3005 | Unshed MUC16 | Ovarian Cancer | Phase 1B | | UltraCAR-T | PRGN-3006 | CD33 | R/R AML, MDS | Phase 1B (Fast Track Designation, Orphan Drug Designation) | | UltraCAR-T | PRGN-3007 | ROR1 | ROR1* Hematological & Solid Tumors | Phase 1/1B | | ActoBiotics | AG019 | hPINS + hIL-10 | Type 1 Diabetes | Phase 1B/2A completed | [Our Healthcare Business](index=14&type=section&id=Our%20Healthcare%20Business) The healthcare business comprises Biopharmaceuticals (Precigen and ActoBio) for gene and cell therapies, and Exemplar for research models - The Biopharmaceuticals segment includes Precigen and ActoBio, focusing on gene and cell therapies for immuno-oncology, autoimmune disorders, and infectious diseases[43](index=43&type=chunk)[44](index=44&type=chunk) - The Exemplar segment, a wholly-owned subsidiary, develops MiniSwine Yucatan miniature pig research models and services for healthcare research applications[43](index=43&type=chunk)[138](index=138&type=chunk) [Biopharmaceuticals](index=15&type=section&id=Biopharmaceuticals) Precigen's biopharmaceutical segment develops gene and cell therapies using precision technology, leveraging proprietary platforms for gene program design, delivery, and expression control [Precigen's Technology Platforms](index=15&type=section&id=Precigen's%20Technology%20Platforms) Precigen utilizes advanced synthetic biology platforms for gene program design, delivery, and expression control in therapeutic development - UltraVector platform: Utilizes advanced DNA construction and computational models to design optimized multigenic programs for therapeutic approaches[46](index=46&type=chunk) - Gene delivery systems: Includes non-viral Sleeping Beauty transposon/transposase system, AttSite recombinases for stable site-specific gene integration, and the AdenoVerse library of engineered adenovector serotypes (e.g., gorilla adenovectors)[47](index=47&type=chunk)[48](index=48&type=chunk) - Gene expression control: Employs RheoSwitch Therapeutic System for inducible gene expression, kill switches for selective cell elimination, and tissue-specific promoters for localized expression[49](index=49&type=chunk) [Precigen's Therapeutic Platforms](index=16&type=section&id=Precigen's%20Therapeutic%20Platforms) Key therapeutic platforms include UltraCAR-T and AdenoVerse, designed to address complex disorders and advance precision medicine - Key therapeutic platforms include UltraCAR-T and AdenoVerse, developed to address complex disorders and realize precision medicine[50](index=50&type=chunk) ["Off-the-shelf" AdenoVerse Immunotherapy](index=16&type=section&id=Of%20-the-shelf%20AdenoVerse%20Immunotherapy) The AdenoVerse immunotherapy platform uses proprietary gorilla adenovectors for efficient, safe, and repeatable gene delivery, with internal cGMP manufacturing - Key advantages of AdenoVerse immunotherapy: large genetic payload capacity (up to **12kb**), suitability for repeat administration (low seroprevalence of gorilla adenoviruses), and replication incompetence for safety[52](index=52&type=chunk)[53](index=53&type=chunk)[54](index=54&type=chunk) - Internal cGMP manufacturing capabilities for AdenoVerse-based therapeutics in Germantown, Maryland, aim to reduce risks and costs associated with outsourcing[57](index=57&type=chunk) - Most advanced programs are PRGN-2012 for RRP and PRGN-2009 for HPV-associated cancers[58](index=58&type=chunk) [PRGN-2012](index=17&type=section&id=PRGN-2012) PRGN-2012 is an investigational "off-the-shelf" AdenoVerse immunotherapy for Recurrent Respiratory Papillomatosis (RRP), with Breakthrough Therapy and Orphan Drug Designations - PRGN-2012 is an investigational "off-the-shelf" AdenoVerse immunotherapy for Recurrent Respiratory Papillomatosis (RRP), a rare disease caused by HPV6/11 with no approved therapeutic treatment[59](index=59&type=chunk)[60](index=60&type=chunk) - Phase 1 data showed PRGN-2012 was well-tolerated with no DLTs or TRAEs greater than Grade 2. At Dose Level 2, **50% of patients achieved a Complete Response** (no surgeries in 12 months post-treatment) and **58% had an Overall Response Rate (ORR)**[66](index=66&type=chunk)[68](index=68&type=chunk) - PRGN-2012 has received **Breakthrough Therapy Designation** and **Orphan Drug designation** from the FDA and **Orphan Drug Designation** from the European Commission for RRP. Phase 2 data is anticipated in Q2 2024, with BLA submission planned for H2 2024 and potential commercial launch in 2025[73](index=73&type=chunk)[74](index=74&type=chunk) [PRGN-2009](index=20&type=section&id=PRGN-2009) PRGN-2009 is an "off-the-shelf" immunotherapy targeting HPV type 16 and 18 positive solid tumors, showing promising response rates in clinical trials - PRGN-2009 is an "off-the-shelf" immunotherapy designed to target HPV type 16 and 18 positive solid tumors, leveraging UltraVector and AdenoVerse platforms for optimized antigen design and delivery[75](index=75&type=chunk) - Phase 1 data showed PRGN-2009 was well-tolerated. In combination with bintrafusp alfa, it achieved a **30% objective response rate (ORR)** in pretreated recurrent or metastatic HPV-associated cancers[79](index=79&type=chunk)[80](index=80&type=chunk) - A Phase 2 clinical trial is ongoing in collaboration with NCI for HPV-associated oropharyngeal cancer, and an IND has been cleared for a Phase 2 randomized trial in combination with pembrolizumab for R/M cervical cancer[83](index=83&type=chunk)[84](index=84&type=chunk) [UltraCAR-T](index=23&type=section&id=UltraCAR-T) The UltraCAR-T platform offers rapid, decentralized, overnight CAR-T manufacturing, utilizing a non-viral multigenic delivery system for enhanced persistence and safety - UltraCAR-T platform aims to disrupt CAR-T treatment by shortening manufacturing time from weeks to days, decreasing costs, and improving outcomes through overnight, decentralized manufacturing[86](index=86&type=chunk)[93](index=93&type=chunk) - Features an advanced non-viral multigenic delivery system (Sleeping Beauty) to co-express CAR, kill switch, mbIL15, and intrinsic checkpoint blockade without gene editing, enhancing persistence and safety[89](index=89&type=chunk)[91](index=91&type=chunk)[92](index=92&type=chunk) - The proprietary UltraPorator electroporation device has received FDA clearance for manufacturing UltraCAR-T cells in clinical trials[94](index=94&type=chunk) [PRGN-3005](index=27&type=section&id=PRGN-3005) PRGN-3005 is an UltraCAR-T therapy targeting MUC16 for advanced ovarian, fallopian tube, or primary peritoneal cancers, demonstrating promising preclinical and Phase 1 clinical results - PRGN-3005 is an UltraCAR-T therapy targeting the unshed portion of Mucin 16 (MUC16) for advanced ovarian, fallopian tube, or primary peritoneal cancers, where MUC16 is overexpressed in over **80% of tumors**[98](index=98&type=chunk)[100](index=100&type=chunk) - Preclinical studies demonstrated robust MUC16-specific cytotoxicity, a stem-cell like memory phenotype, and superior anti-tumor response and durable persistence in mouse models[102](index=102&type=chunk)[103](index=103&type=chunk) - Phase 1 data showed PR
Precigen(PGEN) - 2023 Q4 - Annual Results
2024-03-19 20:17
[Executive Summary & Business Outlook](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Outlook) This section provides an overview of Precigen's biopharmaceutical focus and strategic outlook from its leadership [Company Overview](index=1&type=section&id=Company%20Overview) Precigen is a biopharmaceutical company developing innovative gene and cell therapies to improve patients' lives - Precigen is a biopharmaceutical company specializing in innovative gene and cell therapies to improve the lives of patients[2](index=2&type=chunk) [CEO & CFO Statements](index=1&type=section&id=CEO%20%26%20CFO%20Statements) Leadership highlights a transformative 2024 outlook, key program milestones, and prudent financial management - Precigen is on track to present pivotal Phase 2 data and submit a BLA for PRGN-2012 in 2024, with a potential **commercial launch in 2025**, bolstered by Breakthrough Therapy Designation[3](index=3&type=chunk) - UltraCAR-T programs offer a novel approach compared to traditional CAR-T therapies and have garnered **significant interest from potential partners** due to safety, preliminary efficacy, and manufacturing advantages[3](index=3&type=chunk) - The company is evaluating various financing opportunities to strengthen its balance sheet as it prepares PRGN-2012 for potential commercial launch in 2025[3](index=3&type=chunk) [Key Program Highlights & Business Updates](index=1&type=section&id=Key%20Program%20Highlights%20%26%20Business%20Updates) This section details advancements in the company's core therapeutic platforms, AdenoVerse and UltraCAR-T [AdenoVerse Immunotherapies](index=1&type=section&id=AdenoVerse%20Immunotherapies) The AdenoVerse platform is advancing key programs for RRP and HPV-associated cancers through clinical development - The AdenoVerse immunotherapy platform uses a library of proprietary adenovectors for efficient gene delivery to modulate the immune system and generate **high-level, durable antigen-specific T-cell immune responses**[21](index=21&type=chunk) - PRGN-2012 for RRP is on track for **Phase 2 data presentation in Q2 2024** and **BLA submission in H2 2024**, with commercial readiness underway for a 2025 launch[3](index=3&type=chunk)[5](index=5&type=chunk)[7](index=7&type=chunk) - PRGN-2009 for HPV-associated recurrent/metastatic cervical cancer received IND clearance for a randomized Phase 2 study, which is now active and recruiting patients[5](index=5&type=chunk)[11](index=11&type=chunk) [PRGN-2012 in RRP](index=1&type=section&id=PRGN-2012%20in%20RRP) - PRGN-2012 received **Breakthrough Therapy Designation** and **Orphan Drug Designation** from the FDA and Orphan Drug Designation from the European Commission for the treatment of RRP[5](index=5&type=chunk)[6](index=6&type=chunk)[22](index=22&type=chunk) - The Phase 1 portion of the Phase 1/2 study demonstrated strong efficacy and a favorable safety profile, with **50% of patients (N=12) in durable and ongoing Complete Response** more than two years after treatment[6](index=6&type=chunk) - Enrollment and dosing in the Phase 2 portion of the study are complete, with data presentation anticipated in **Q2 2024**, and a BLA submission under an accelerated approval pathway anticipated in **H2 2024**[6](index=6&type=chunk)[7](index=7&type=chunk) [PRGN-2009 in OPSCC and Cervical Cancer](index=3&type=section&id=PRGN-2009%20in%20OPSCC%20and%20Cervical%20Cancer) - The Phase 2 study of PRGN-2009 in combination with pembrolizumab in newly diagnosed patients with HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) is enrolling patients[11](index=11&type=chunk)[22](index=22&type=chunk) - A Phase 2 randomized, open-label study of PRGN-2009 in combination with pembrolizumab in patients with HPV-associated recurrent/metastatic cervical cancer is active and recruiting patients[11](index=11&type=chunk)[22](index=22&type=chunk) [AdenoVerse Immunotherapy Platform](index=6&type=section&id=AdenoVerse%20Immunotherapy%20Platform) - Precigen's AdenoVerse immunotherapy platform utilizes a library of proprietary adenovectors, including gorilla adenovectors, for efficient gene delivery of therapeutic effectors, immunomodulators, and vaccine antigens[21](index=21&type=chunk) - AdenoVerse immunotherapies generate **high-level and durable antigen-specific T-cell immune responses** and have the ability to boost these responses via repeat administration[21](index=21&type=chunk) [UltraCAR-T Cell Therapies](index=3&type=section&id=UltraCAR-T%20Cell%20Therapies) The UltraCAR-T platform offers an innovative, rapid-manufacturing approach for autologous cell therapies - UltraCAR-T is a multigenic autologous CAR-T platform that uses Precigen's non-viral Sleeping Beauty system to simultaneously express an antigen-specific CAR, membrane-bound IL-15 (mbIL15) for enhanced expansion and persistence, and a kill switch for improved safety[16](index=16&type=chunk) - UltraCAR-T investigational therapies are manufactured via an **overnight process** using the proprietary UltraPorator electroporation system at the patient's medical center, allowing administration only one day following gene transfer[16](index=16&type=chunk) - The UltraCAR-T platform is currently under clinical investigation for hematological and solid tumors, including PRGN-3005 (ovarian cancer), PRGN-3006 (AML/MDS), and PRGN-3007 (ROR1+ advanced cancers)[17](index=17&type=chunk) [PRGN-3006 in AML/MDS](index=3&type=section&id=PRGN-3006%20in%20AML%2FMDS) - Interim data from the ongoing Phase 1b study of PRGN-3006 UltraCAR-T in relapsed/refractory AML or higher-risk myelodysplastic syndromes (MDS) is anticipated in the **second half of 2024**[5](index=5&type=chunk)[11](index=11&type=chunk) - First-in-human Phase 1 data showed PRGN-3006 was well-tolerated with **no dose-limiting toxicities (DLTs)** and a **27% objective response rate (ORR)** in heavily pre-treated r/r AML patients[11](index=11&type=chunk) - PRGN-3006 has been granted **Orphan Drug Designation** in AML and **Fast Track Designation** in relapsed/refractory AML by the FDA[11](index=11&type=chunk)[17](index=17&type=chunk) [PRGN-3005 in Ovarian Cancer](index=3&type=section&id=PRGN-3005%20in%20Ovarian%20Cancer) - The Phase 1b dose expansion portion of the Phase 1/1b study of PRGN-3005 UltraCAR-T in patients with advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer is ongoing[11](index=11&type=chunk)[17](index=17&type=chunk) [PRGN-3007 in Advanced ROR1+ Cancers](index=3&type=section&id=PRGN-3007%20in%20Advanced%20ROR1%2B%20Cancers) - Preliminary data from the Phase 1 study of PRGN-3007, a next-generation UltraCAR-T incorporating PD-1 checkpoint inhibition, in ROR1+ advanced cancers is anticipated in the **second half of 2024**[5](index=5&type=chunk)[11](index=11&type=chunk) - PRGN-3007 targets ROR1-positive chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL), and triple negative breast cancer (TNBC)[11](index=11&type=chunk)[17](index=17&type=chunk) [UltraCAR-T Platform & Library Approach](index=5&type=section&id=UltraCAR-T%20Platform%20%26%20Library%20Approach) - The UltraCAR-T platform addresses the inhibitory tumor microenvironment by incorporating a novel mechanism for **intrinsic checkpoint blockade** without complex and expensive gene editing techniques[16](index=16&type=chunk) - Precigen's UltraCAR-T library approach aims to transform personalized cell therapy by enabling medical centers to deliver personalized, autologous UltraCAR-T treatment with **overnight manufacturing**, selecting non-viral plasmids based on the patient's cancer and biomarker profile[18](index=18&type=chunk) [UltraPorator System](index=5&type=section&id=UltraPorator%20System) The UltraPorator system is a proprietary electroporation device enabling rapid, cGMP-compliant manufacturing of UltraCAR-T therapies - The UltraPorator system is an exclusive device and proprietary software solution for the scale-up of **rapid and cost-effective manufacturing** of UltraCAR-T therapies[19](index=19&type=chunk) - It is a high-throughput, semi-closed electroporation system for modifying T cells using Precigen's proprietary non-viral gene transfer technology, significantly **reducing processing time and contamination risk**[19](index=19&type=chunk)[20](index=20&type=chunk) - UltraPorator is being utilized for clinical manufacturing of Precigen's investigational UltraCAR-T therapies in compliance with current good manufacturing practices[20](index=20&type=chunk) [Full Year 2023 Financial Results](index=1&type=section&id=Full%20Year%202023%20Financial%20Results) This section presents the company's detailed financial performance and position for the fiscal year 2023 [Financial Highlights Summary](index=1&type=section&id=Financial%20Highlights%20Summary) The company reported $62.9 million in cash and investments and achieved a 16% reduction in SG&A costs Key Financial Position and Cost Management | Metric | As of Dec 31, 2023 | | :------------------------------------------ | :----------------- | | Cash, cash equivalents, short-term & long-term investments | $62.9 million | | SG&A costs reduction (YoY) | 16% | [Detailed Financial Performance](index=3&type=section&id=Detailed%20Financial%20Performance) FY2023 performance was marked by lower revenues and a goodwill impairment charge, offset by reduced SG&A expenses - Total revenues decreased significantly by **76.9%** in FY2023, primarily driven by a **99.5% reduction** in collaboration and licensing revenues[11](index=11&type=chunk)[12](index=12&type=chunk) - SG&A expenses decreased by **15.8%** due to reduced professional and legal fees, while R&D expenses increased by **3.1%** due to higher personnel costs[9](index=9&type=chunk)[10](index=10&type=chunk) - A **$10.4 million goodwill impairment charge** was recorded in the fourth quarter of 2023 related to its Exemplar subsidiary[14](index=14&type=chunk) [Revenues](index=3&type=section&id=Revenues) Full Year Revenue Performance | Metric | FY2023 (in thousands) | FY2022 (in thousands) | Change ($) | Change (%) | | :-------------------------- | :-------------------- | :-------------------- | :--------- | :--------- | | Total Revenues | $6,225 | $26,909 | $(20,684) | (76.9%) | | Collaboration & Licensing | $75 | $14,661 | $(14,586) | (99.5%) | | Product & Services | $6,141 | $11,997 | $(5,856) | (48.8%) | [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Full Year Operating Expenses | Metric | FY2023 (in thousands) | FY2022 (in thousands) | Change ($) | Change (%) | | :-------------------------- | :-------------------- | :-------------------- | :--------- | :--------- | | Research & Development | $48,614 | $47,170 | $1,444 | 3.1% | | Selling, General & Admin. | $40,415 | $48,006 | $(7,591) | (15.8%) | | Impairment of goodwill | $10,390 | $482 | $9,908 | 2055.6% | [Other Income (Expense), Net](index=4&type=section&id=Other%20Income%20(Expense)%2C%20Net) Full Year Other Income (Expense), Net | Metric | FY2023 (in thousands) | FY2022 (in thousands) | Change ($) | | :-------------------------- | :-------------------- | :-------------------- | :--------- | | Total Other Income (Expense), Net | $3,396 | $(5,102) | $8,498 | | Interest Expense | $(468) | $(6,774) | $6,306 | | Interest Income | $3,237 | $133 | $3,104 | - The increase in total other income, net, was primarily due to **$6.3 million in reduced interest expense** associated with the full retirement of Convertible Notes in Q2 2023, and **$3.1 million increased interest income** due to higher interest rates on investments[13](index=13&type=chunk) [Net Loss and EPS](index=5&type=section&id=Net%20Loss%20and%20EPS) Full Year Net Loss and EPS | Metric | FY2023 | FY2022 | | :------------------------------------ | :------- | :------- | | Loss from continuing operations | $(95.9)M | $(79.8)M | | Loss per share (basic & diluted) | $(0.39) | $(0.40) | | Net loss | $(95.9)M | $28.3M | | Net loss per share (basic & diluted) | $(0.39) | $0.14 | [Consolidated Balance Sheets](index=8&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased while total liabilities saw a significant reduction due to the retirement of long-term debt Consolidated Balance Sheet Highlights | Metric | Dec 31, 2023 (in thousands) | Dec 31, 2022 (in thousands) | Change ($) | Change (%) | | :-------------------------- | :-------------------------- | :-------------------------- | :--------- | :--------- | | Total Assets | $151,043 | $215,977 | $(64,934) | (30.1%) | | Cash & Cash Equivalents | $7,578 | $4,858 | $2,720 | 56.0% | | Restricted Cash | $- | $43,339 | $(43,339) | (100.0%) | | Short-term Investments | $55,277 | $51,092 | $4,185 | 8.2% | | Total Current Liabilities | $22,985 | $78,645 | $(55,660) | (70.8%) | | Current portion of long-term debt | $- | $43,219 | $(43,219) | (100.0%) | | Settlement and Indemnification Accrual | $5,075 | $18,750 | $(13,675) | (72.9%) | | Total Liabilities | $32,545 | $89,718 | $(57,173) | (63.7%) | | Total Shareholders' Equity | $118,498 | $126,259 | $(7,761) | (6.1%) | [Consolidated Statements of Operations](index=9&type=section&id=Consolidated%20Statements%20of%20Operations) The statement details decreased revenues and a goodwill impairment charge, leading to an increased loss from continuing operations - The full Consolidated Statements of Operations provide a detailed breakdown of revenues, operating expenses, other income/expense, and net loss for the years ended December 31, 2023, and 2022[29](index=29&type=chunk) [Additional Information](index=7&type=section&id=Additional%20Information) This section contains supplementary details including trademarks, forward-looking statements, and contact information [Trademarks](index=7&type=section&id=Trademarks) This section lists the trademarks owned by Precigen and its affiliates - Key trademarks include Precigen, UltraCAR-T, UltraPorator, AdenoVerse, UltraVector, and Advancing Medicine with Precision[23](index=23&type=chunk) [Cautionary Statement Regarding Forward-Looking Statements](index=7&type=section&id=Cautionary%20Statement%20Regarding%20Forward-Looking%20Statements) This statement advises that the press release contains forward-looking statements involving risks and uncertainties - Forward-looking statements in the press release are based upon the Company's current expectations and projections about future events and involve risks and uncertainties, with actual future results potentially differing materially[24](index=24&type=chunk) - Readers are advised to refer to the 'Risk Factors' section in the Company's most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission for further information on potential risks and uncertainties[24](index=24&type=chunk) [Investor & Media Contacts](index=7&type=section&id=Investor%20%26%20Media%20Contacts) This section provides contact information for investor relations and media inquiries - Contact information for investor relations (Steven M. Harasym) and media inquiries (Donelle M. Gregory, Glenn Silver) is provided[25](index=25&type=chunk)
Precigen(PGEN) - 2023 Q3 - Quarterly Report
2023-11-09 22:08
[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 analysis for Precigen, Inc [Item 1. Condensed Consolidated Financial Statements](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) This section presents Precigen, Inc.'s unaudited condensed consolidated financial statements and detailed notes for Q3 2023 and 2022 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position at specific points in time Condensed Consolidated Balance Sheet Highlights (Amounts in thousands) | Metric | Sep 30, 2023 | Dec 31, 2022 | Change (2023 vs 2022) | % Change | | :-------------------------------- | :----------- | :----------- | :-------------------- | :------- | | Cash and cash equivalents | $10,076 | $4,858 | $5,218 | 107.4% | | Restricted cash | — | $43,339 | $(43,339) | -100.0% | | Short-term investments | $63,679 | $51,092 | $12,587 | 24.6% | | Total current assets | $92,988 | $118,159 | $(25,171) | -21.3% | | Total assets | $190,688 | $215,977 | $(25,289) | -11.7% | | Total current liabilities | $32,875 | $78,645 | $(45,770) | -58.2% | | Total liabilities | $43,010 | $89,718 | $(46,708) | -52.1% | | Total shareholders' equity | $147,678 | $126,259 | $21,419 | 17.0% | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's revenues, expenses, and net income or loss over specific periods Condensed Consolidated Statements of Operations Highlights (Amounts in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :-------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Total revenues | $1,379 | $16,722 | $4,997 | $25,146 | | Total operating expenses | $22,316 | $24,336 | $70,531 | $79,075 | | Operating loss | $(20,937) | $(7,614) | $(65,534) | $(53,929) | | Net (loss) income | $(19,795) | $87,379 | $(62,848) | $50,493 | | Net (loss) income per share, basic and diluted | $(0.08) | $0.44 | $(0.26) | $0.25 | - Total revenues for the three months ended September 30, 2023, decreased by **91.8% to $1,379 thousand** from $16,722 thousand in the prior year, primarily due to a **100% decrease in collaboration and licensing revenues**. For the nine months ended September 30, 2023, total revenues decreased by **80.1% to $4,997 thousand** from $25,146 thousand[23](index=23&type=chunk)[170](index=170&type=chunk)[184](index=184&type=chunk) - The company reported a **net loss of $(19,795) thousand** for the three months ended September 30, 2023, compared to a net income of $87,379 thousand in the same period last year, largely influenced by the absence of income from discontinued operations in 2023. For the nine months, the **net loss was $(62,848) thousand**, a significant change from the $50,493 thousand net income in 2022[23](index=23&type=chunk)[170](index=170&type=chunk)[184](index=184&type=chunk) [Condensed Consolidated Statements of Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) This section presents the net loss and other comprehensive income or loss components for the reporting periods Condensed Consolidated Statements of Comprehensive Loss Highlights (Amounts in thousands) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :-------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Net (loss) income | $(19,795) | $87,379 | $(62,848) | $50,493 | | Unrealized gain (loss) on investments | $123 | $99 | $614 | $(905) | | Loss on foreign currency translation adjustments | $(1,166) | $(2,724) | $(687) | $(6,479) | | Comprehensive (loss) income | $(20,838) | $84,754 | $(62,921) | $43,109 | [Condensed Consolidated Statements of Shareholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders%27%20Equity) This section outlines changes in the company's equity, including common stock, additional paid-in capital, and accumulated deficit Condensed Consolidated Statements of Shareholders' Equity Highlights (Amounts in thousands, except share data) | Metric | Sep 30, 2023 | Dec 31, 2022 | | :-------------------------------- | :----------- | :----------- | | Common stock shares outstanding | 256,398,527 | 208,150,021 | | Additional paid-in capital | $2,082,654 | $1,998,314 | | Accumulated deficit | $(1,931,415) | $(1,868,567) | | Total shareholders' equity | $147,678 | $126,259 | - Total shareholders' equity increased by **$21,419 thousand** from December 31, 2022, to September 30, 2023, primarily driven by **$72,808 thousand in net proceeds** from a public offering of common stock in January 2023, partially offset by a **net loss of $(62,848) thousand**[20](index=20&type=chunk)[32](index=32&type=chunk)[98](index=98&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section reports the cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows Highlights (Nine Months Ended September 30, Amounts in thousands) | Cash Flow Activity | 2023 | 2022 | | :----------------- | :---------- | :---------- | | Operating activities | $(51,164) | $(49,649) | | Investing activities | $(16,380) | $214,996 | | Financing activities | $29,589 | $(116,010) | | Net (decrease) increase in cash, cash equivalents, and restricted cash | $(38,261) | $48,533 | | Cash, cash equivalents, and restricted cash, End of period | $10,335 | $91,876 | - Net cash used in operating activities increased slightly to **$(51,164) thousand** in 2023 from $(49,649) thousand in 2022. Net cash used in investing activities was **$(16,380) thousand** in 2023, a significant change from $214,996 thousand provided in 2022, primarily due to the absence of proceeds from the sale of discontinued operations (Trans Ova) in 2023. Net cash provided by financing activities was **$29,589 thousand** in 2023, compared to $(116,010) thousand used in 2022, driven by proceeds from a public offering and the retirement of Convertible Notes[199](index=199&type=chunk)[202](index=202&type=chunk)[203](index=203&type=chunk)[204](index=204&type=chunk)[205](index=205&type=chunk)[206](index=206&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [1. Organization](index=13&type=section&id=1.%20Organization) This note describes Precigen's business, strategic focus on gene and cell therapies, and its key subsidiaries - Precigen, Inc. is a discovery and clinical-stage biopharmaceutical company focused on gene and cell therapies for immuno-oncology, autoimmune disorders, and infectious diseases, leveraging proprietary technology platforms like UltraCAR-T, AdenoVerse immunotherapy, and ActoBiotics[39](index=39&type=chunk) - The company operates through two wholly-owned subsidiaries: Precigen ActoBio, Inc. (ActoBio) in Belgium, pioneering microbe-based biopharmaceuticals, and Exemplar Genetics, LLC (Exemplar) in Iowa, developing Yucatan MiniSwine preclinical research models and services[40](index=40&type=chunk)[41](index=41&type=chunk) [2. Summary of Significant Accounting Policies](index=13&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and estimates used in preparing the financial statements - The company's financial statements are prepared on a going concern basis, but management expects continued operating losses and negative cash flows, requiring additional capital to fund operations and achieve profitability[44](index=44&type=chunk) - Research and development expenses are recognized as incurred, including salaries, technology rights, contract research, materials, and facility costs[46](index=46&type=chunk) - The company adopted ASU 2020-06 on January 1, 2022, which resulted in an **$18,196 thousand increase in long-term debt**, a **$36,868 thousand decrease in additional paid-in capital**, and an **$18,672 thousand reduction in accumulated deficit**[57](index=57&type=chunk)[58](index=58&type=chunk) [3. Discontinued Operations](index=16&type=section&id=3.%20Discontinued%20Operations) This note details the financial impact and sale of the Trans Ova subsidiary, classified as discontinued operations - In August 2022, Precigen completed the sale of its wholly-owned subsidiary, Trans Ova, for **$170,000 thousand**, with potential earn-out payments. The company received **$162,306 thousand in net proceeds**[60](index=60&type=chunk) - As of September 30, 2023, and December 31, 2022, settlement and indemnification accruals related to the Trans Ova sale were **$5,075 thousand** and $5,750 thousand, respectively[62](index=62&type=chunk) Financial Results of Discontinued Operations (Trans Ova) (Amounts in thousands) | Metric | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2022 | | :-------------------------- | :------------------------------ | :----------------------------- | | Total revenues | $12,202 | $71,151 | | Total operating expenses | $12,200 | $58,898 | | Operating income | $2 | $12,253 | | Gain on divesture | $94,702 | $94,702 | | Income from discontinued operations | $95,023 | $108,094 | [4. Collaboration and Licensing Revenue](index=17&type=section&id=4.%20Collaboration%20and%20Licensing%20Revenue) This note explains the recognition of collaboration and licensing revenues, including changes in agreements - In September 2022, the company recognized **$14,561 thousand in revenue** from Intrexon Energy Partners and Intrexon Energy Partners II after gaining control and determining no further performance obligations. No such revenue was recognized in 2023[69](index=69&type=chunk)[70](index=70&type=chunk) - An amended license agreement with Alaunos Therapeutics in April 2023 grants Alaunos exclusive, royalty-free licenses for T-cell receptor products for cancer and HPV fields, in exchange for an **annual license fee of $0.1 million**, with no further milestone or royalty obligations[71](index=71&type=chunk)[72](index=72&type=chunk)[74](index=74&type=chunk) Deferred Revenue (Amounts in thousands) | Type of Deferred Revenue | Sep 30, 2023 | Dec 31, 2022 | | :----------------------- | :----------- | :----------- | | Current portion | $509 | $25 | | Long-term portion | $1,818 | $1,818 | [5. Short-term and Long-term Investments](index=19&type=section&id=5.%20Short-term%20and%20Long-term%20Investments) This note details the company's available-for-sale investments, including their fair values and maturities Available-for-Sale Investments (Amounts in thousands) | Investment Type | Sep 30, 2023 Fair Value | Dec 31, 2022 Fair Value | | :---------------------- | :---------------------- | :---------------------- | | U.S. government debt securities | $61,280 | $50,995 | | U.S. agency securities | $992 | — | | Certificates of deposit | $6,678 | $97 | | Total | $68,950 | $51,092 | Available-for-Sale Investments by Maturity (Sep 30, 2023, Amounts in thousands) | Maturity Period | Fair Value | | :-------------------- | :--------- | | Due within one year | $63,679 | | After one year through two years | $5,271 | | Total | $68,950 | [6. Fair Value Measurements](index=19&type=section&id=6.%20Fair%20Value%20Measurements) This note describes the fair value hierarchy and measurement techniques used for financial instruments - The company uses a three-tier fair value hierarchy (Level 1, 2, 3) for financial instruments. As of September 30, 2023, all available-for-sale investments (U.S. government debt, agency securities, and certificates of deposit) totaling **$68,950 thousand** were classified as Level 2, based on professional pricing sources[51](index=51&type=chunk)[52](index=52&type=chunk)[81](index=81&type=chunk) - The fair value of Convertible Notes was approximately **$43,000 thousand** as of December 31, 2022, classified as Level 2, based on third-party trades[82](index=82&type=chunk) [7. Property, Plant and Equipment, Net](index=21&type=section&id=7.%20Property,%20Plant%20and%20Equipment,%20Net) This note provides details on the company's property, plant, and equipment, including depreciation expenses Property, Plant and Equipment, Net (Amounts in thousands) | Category | Sep 30, 2023 | Dec 31, 2022 | | :-------------------------- | :----------- | :----------- | | Total gross PP&E | $30,776 | $30,768 | | Accumulated depreciation and amortization | $(23,661) | $(23,439) | | Property, plant and equipment, net | $7,115 | $7,329 | - Depreciation expense was **$434 thousand** for the three months ended September 30, 2023 (down from $564 thousand in 2022) and **$1,415 thousand** for the nine months ended September 30, 2023 (down from $1,833 thousand in 2022)[84](index=84&type=chunk) [8. Goodwill and Intangible Assets, Net](index=21&type=section&id=8.%20Goodwill%20and%20Intangible%20Assets,%20Net) This note presents information on goodwill and other intangible assets, including amortization and impairment Goodwill and Intangible Assets, Net (Amounts in thousands) | Category | Sep 30, 2023 | Dec 31, 2022 | | :-------------------------------- | :----------- | :----------- | | Goodwill | $36,894 | $36,923 | | Patents, developed technologies and know-how, net | $40,426 | $44,455 | | Total Intangible Assets, net | $40,426 | $44,455 | - Goodwill decreased slightly due to foreign currency translation adjustments. The company recorded **$482 thousand of goodwill impairment** in Q1 2022. Amortization expense for intangible assets was **$1,217 thousand** for Q3 2023 and **$3,639 thousand** for the nine months ended September 30, 2023[85](index=85&type=chunk)[88](index=88&type=chunk) [9. Lines of Credit and Short-Term Debt](index=22&type=section&id=9.%20Lines%20of%20Credit%20and%20Short-Term%20Debt) This note details the company's credit lines and the retirement of Convertible Notes, including related interest expenses - Exemplar's **$2,500 thousand revolving line of credit** matured on October 31, 2023, with no outstanding balance as of September 30, 2023. A new **$5,000 thousand line of credit** was entered into on October 20, 2023, maturing November 1, 2024, at 8.5% interest[89](index=89&type=chunk) - The company's Convertible Notes, with an aggregate principal amount of **$200,000 thousand**, were fully retired by June 30, 2023, through open market purchases and payment upon maturity. This resulted in a **gain on extinguishment of debt of approximately $61 thousand** during the nine months ended September 30, 2023[91](index=91&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk) Interest Expense Related to Convertible Notes (Amounts in thousands) | Type of Interest Expense | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :----------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Cash interest expense | — | $1,697 | $397 | $5,197 | | Non-cash interest expense | — | $338 | $60 | $934 | | Total interest expense | — | $2,035 | $457 | $6,131 | [10. Income Taxes](index=23&type=section&id=10.%20Income%20Taxes) This note explains the company's income tax benefit and the factors influencing its effective tax rate - The company recorded an **income tax benefit of $6 thousand** for the three months and **$126 thousand** for the nine months ended September 30, 2023. The effective tax rate differs from the U.S. statutory rate primarily due to a valuation allowance offsetting net deferred tax assets, given the company's history of net losses[95](index=95&type=chunk)[97](index=97&type=chunk) [11. Shareholders' Equity](index=23&type=section&id=11.%20Shareholders%27%20Equity) This note details changes in shareholders' equity, including public offerings and share lending agreements - In January 2023, Precigen completed a public offering of **43,962,640 shares of common stock**, generating **net proceeds of $72,808 thousand**. Related parties, including the CEO and Chairman, purchased **11,517,712 shares**[98](index=98&type=chunk) - A share lending agreement with J.P. Morgan Securities LLC, involving **7,479,431 shares**, terminated on October 1, 2023, with shares returned to Precigen on October 5, 2023[100](index=100&type=chunk) Components of Accumulated Other Comprehensive Loss (Amounts in thousands) | Component | Sep 30, 2023 | Dec 31, 2022 | | :-------------------------------- | :----------- | :----------- | | Unrealized loss on investments | $(146) | $(760) | | Loss on foreign currency translation adjustments | $(3,415) | $(2,728) | | Total accumulated other comprehensive loss | $(3,561) | $(3,488) | [12. Share-Based Payments](index=24&type=section&id=12.%20Share-Based%20Payments) This note provides information on stock-based compensation expense and equity award activity Stock-Based Compensation Expense (Amounts in thousands) | Category | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :-------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Cost of products and services | $20 | $22 | $55 | $85 | | Research and development | $579 | $524 | $1,666 | $1,658 | | Selling, general and administrative | $1,707 | $1,638 | $5,905 | $6,244 | | Total | $2,306 | $2,125 | $7,626 | $7,996 | Stock Option and RSU Activity (Shares) | Metric | Stock Options (Sep 30, 2023) | RSUs (Sep 30, 2023) | | :-------------------------- | :--------------------------- | :------------------ | | Balances at Dec 31, 2022 | 15,201,276 | 697,815 | | Granted | 7,706,369 | 4,083,777 | | Exercised/Vested | — | (3,820,058) | | Forfeited | (244,000) | — | | Expired | (712,305) | — | | Balances at Sep 30, 2023 | 21,951,340 | 961,534 | [13. Operating Leases](index=25&type=section&id=13.%20Operating%20Leases) This note outlines the company's operating lease costs and the maturities of its lease liabilities Lease Costs (Amounts in thousands) | Lease Cost Type | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :---------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Operating lease costs | $621 | $600 | $1,853 | $1,840 | | Short-term lease costs | $11 | $53 | $41 | $155 | | Variable lease costs | $89 | $84 | $295 | $308 | | Total Lease costs | $721 | $737 | $2,189 | $2,303 | Maturities of Lease Liabilities (Sep 30, 2023, Amounts in thousands) | Year | Amount | | :--- | :----- | | 2023 | $465 | | 2024 | $2,011 | | 2025 | $1,886 | | 2026 | $1,494 | | 2027 | $1,238 | | 2028 | $1,260 | | Thereafter | $1,847 | | Total | $10,201 | [14. Commitments and Contingencies](index=26&type=section&id=14.%20Commitments%20and%20Contingencies) This note discloses the company's legal commitments and contingencies, including a shareholder class action lawsuit - A shareholder class action lawsuit was resolved with final court approval of a **$13,000 thousand settlement** on November 6, 2023. The company recorded an **accrual of $13,000 thousand** and a corresponding **insurance receivable of $12,592 thousand** as of September 30, 2023[116](index=116&type=chunk)[117](index=117&type=chunk) - Other legal matters, including a derivative shareholder action and a lawsuit for inspection of books and records, are ongoing. The company does not believe these will have a material adverse effect on its financial condition[118](index=118&type=chunk)[119](index=119&type=chunk) [15. Segments](index=27&type=section&id=15.%20Segments) This note provides financial information by reportable segment, Biopharmaceuticals and Exemplar, and their performance metrics - The company's reportable segments are Biopharmaceuticals (Precigen and ActoBio) and Exemplar. Segment performance is assessed using Segment Adjusted EBITDA[122](index=122&type=chunk) Segment Adjusted EBITDA (Amounts in thousands) | Segment | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :---------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Biopharmaceuticals | $(17,068) | $(18,082) | $(56,345) | $(58,956) | | Exemplar | $(464) | $346 | $(426) | $4,699 | | Total | $(17,532) | $(17,736) | $(56,771) | $(54,257) | Revenues by Reportable Segment (Amounts in thousands) | Segment | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :---------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Biopharmaceuticals | $— | $14,624 | $— | $14,778 | | Exemplar | $1,379 | $2,098 | $4,997 | $10,368 | | Total | $1,379 | $16,722 | $4,997 | $25,146 | - For the three and nine months ended September 30, 2023, **78.7% and 78.2% of total consolidated revenue**, respectively, was attributable to four customers in the Exemplar segment. In 2022, one customer accounted for **41.1% (Q3) and 62.4% (9M) of revenue**[126](index=126&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Precigen's financial condition, operational results, strategic biopharmaceutical focus, liquidity, and future outlook [Overview](index=30&type=section&id=Overview) This overview introduces Precigen's biopharmaceutical focus, key clinical programs, and financial challenges - Precigen is a discovery and clinical-stage biopharmaceutical company focused on gene and cell therapies for immuno-oncology, autoimmune disorders, and infectious diseases, leveraging proprietary technology platforms like UltraCAR-T, AdenoVerse immunotherapy, and ActoBiotics[131](index=131&type=chunk)[132](index=132&type=chunk) - Key clinical programs include PRGN-3005, PRGN-3006, PRGN-3007 (UltraCAR-T), PRGN-2009, PRGN-2012 (AdenoVerse), and AG019 (ActoBiotics). The UltraPorator device streamlines UltraCAR-T manufacturing[133](index=133&type=chunk)[134](index=134&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk)[146](index=146&type=chunk) - The company has incurred significant losses since inception and expects continued losses, requiring additional capital. Revenues are primarily from the Exemplar segment, with a shift away from historical collaboration and licensing agreements[153](index=153&type=chunk)[155](index=155&type=chunk) [Sources of revenue](index=33&type=section&id=Sources%20of%20revenue) This section discusses the company's current revenue streams, primarily from its Exemplar subsidiary - Current primary revenues are from the Exemplar subsidiary, which sells genetically engineered miniature swine models and services. The company expects collaboration revenues to decrease in the near term, with future revenues dependent on advancing and commercializing its own product candidates[155](index=155&type=chunk)[157](index=157&type=chunk)[158](index=158&type=chunk) [Cost of products and services](index=34&type=section&id=Cost%20of%20products%20and%20services) This section outlines the components of the cost of products and services, exclusively from the Exemplar segment - Cost of products and services, entirely related to the Exemplar segment, includes labor, drugs, supplies, feed, and facility charges. Fluctuations in livestock and feed prices have not significantly impacted operating margins[159](index=159&type=chunk) [Research and development expenses](index=34&type=section&id=Research%20and%20development%20expenses) This section details R&D expenses, their components, and allocation across Biopharmaceuticals and Exemplar segments - R&D expenses primarily cover personnel costs, consultant fees, laboratory supplies, technology rights, and facility expenses. The Biopharmaceuticals segment focuses on clinical programs (PRGN-3005, PRGN-3006, PRGN-3007, PRGN-2009, PRGN-2012, AG019), while Exemplar focuses on new pig research models[160](index=160&type=chunk) Research and Development Expenses by Segment (Amounts in thousands) | Segment | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :---------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Biopharmaceuticals | $11,517 | $12,536 | $35,411 | $36,133 | | Exemplar | $66 | $86 | $209 | $244 | | Total | $11,583 | $12,622 | $35,620 | $36,377 | - R&D expenses decreased by **$1.0 million (8%)** for the three months and **$0.8 million (2.1%)** for the nine months ended September 30, 2023, primarily due to continued reprioritization of clinical product candidates[173](index=173&type=chunk)[187](index=187&type=chunk) [Selling, general and administrative expenses](index=35&type=section&id=Selling,%20general%20and%20administrative%20expenses) This section describes SG&A expenses, including personnel, professional fees, and their recent fluctuations - SG&A expenses include salaries, benefits, stock-based compensation, rent, utilities, insurance, accounting, legal services, and intellectual property costs. These expenses may fluctuate based on corporate function scaling and legal claim outcomes[163](index=163&type=chunk)[164](index=164&type=chunk) - SG&A expenses decreased by **$0.9 million (9%)** for the three months and **$6.3 million (17.4%)** for the nine months ended September 30, 2023, mainly due to reduced professional fees (legal) and lower salaries/benefits from reduced headcount[175](index=175&type=chunk)[188](index=188&type=chunk) [Other income (expense), net](index=35&type=section&id=Other%20income%20(expense),%20net) This section explains the components of other income and expense, including gains on debt retirement and interest income - Other income consists of gains on convertible debt retirement and interest earned on investments. Other expense primarily relates to interest on Convertible Notes, which decreased in 2023 due to their retirement[165](index=165&type=chunk)[166](index=166&type=chunk) - Total other income, net, increased by **$2.1 million** for the three months and **$7.3 million** for the nine months ended September 30, 2023, driven by reduced interest expense from Convertible Notes retirement and increased interest income from higher rates on investments[176](index=176&type=chunk)[189](index=189&type=chunk) [Equity in net income or loss of affiliates](index=35&type=section&id=Equity%20in%20net%20income%20or%20loss%20of%20affiliates) This section defines the company's share of operating results from equity method investments - Equity in net income or loss of affiliates represents the company's pro-rata share of equity method investments' operating results, adjusted for basis difference accretion[167](index=167&type=chunk) [Segment performance](index=35&type=section&id=Segment%20performance) This section describes how segment performance is measured using Segment Adjusted EBITDA - Segment Adjusted EBITDA is the primary measure of segment performance, excluding non-cash revenues and expenses not reflective of underlying business performance[168](index=168&type=chunk) [Results of operations](index=35&type=section&id=Results%20of%20operations) This section analyzes the financial performance and key changes in revenues and expenses over the reporting periods [Comparison of the three months ended September 30, 2023 and the three months ended September 30, 2022](index=35&type=section&id=Comparison%20of%20the%20three%20months%20ended%20September%2030,%202023%20and%20the%20three%20months%20ended%20September%2030,%202022) This section compares the company's financial results for the three-month periods ended September 30, 2023 and 2022 Key Financial Changes (Three Months Ended September 30, Amounts in thousands) | Metric | 2023 | 2022 | Dollar Change | Percent Change | | :-------------------------------- | :---------- | :---------- | :------------ | :------------- | | Collaboration and licensing revenues | $— | $14,561 | $(14,561) | -100.0% | | Product and service revenues | $1,378 | $2,092 | $(714) | -34.1% | | Total revenues | $1,379 | $16,722 | $(15,343) | -91.8% | | Research and development | $11,583 | $12,622 | $(1,039) | -8.2% | | Selling, general and administrative | $9,196 | $10,137 | $(941) | -9.3% | | Operating loss | $(20,937) | $(7,614) | $(13,323) | 175.0% | | Total other income (expense), net | $1,136 | $(942) | $2,078 | >200% | | Net (loss) income | $(19,795) | $87,379 | $(107,174) | -122.7% | - Biopharmaceuticals Segment Adjusted EBITDA increased by **$1,014 thousand (5.6%)** due to reduced SG&A and R&D expenses. Exemplar Segment Adjusted EBITDA decreased by **$(810) thousand (over 200%)** due to decreased revenues from lower demand[178](index=178&type=chunk)[181](index=181&type=chunk)[182](index=182&type=chunk) [Comparison of the nine months ended September 30, 2023 and the nine months ended September 30, 2022](index=37&type=section&id=Comparison%20of%20the%20nine%20months%20ended%20September%2030,%202023%20and%20the%20nine%20months%20ended%20September%2030,%202022) This section compares the company's financial results for the nine-month periods ended September 30, 2023 and 2022 Key Financial Changes (Nine Months Ended September 30, Amounts in thousands) | Metric | 2023 | 2022 | Dollar Change | Percent Change | | :-------------------------------- | :---------- | :---------- | :------------ | :------------- | | Collaboration and licensing revenues | $— | $14,561 | $(14,561) | -100.0% | | Product and service revenues | $4,991 | $10,351 | $(5,360) | -51.8% | | Total revenues | $4,997 | $25,146 | $(20,149) | -80.1% | | Research and development | $35,620 | $36,377 | $(757) | -2.1% | | Selling, general and administrative | $30,150 | $36,496 | $(6,346) | -17.4% | | Operating loss | $(65,534) | $(53,929) | $(11,605) | 21.5% | | Total other income (expense), net | $2,560 | $(4,730) | $7,290 | 154.1% | | Net (loss) income | $(62,848) | $50,493 | $(113,341) | <(200)% | - Biopharmaceuticals Segment Adjusted EBITDA increased by **$2,611 thousand (4.4%)** due to reduced SG&A expenses. Exemplar Segment Adjusted EBITDA decreased by **$(5,125) thousand (109.1%)** due to decreased revenues from lower customer demand and prior year revenue recognition[191](index=191&type=chunk)[194](index=194&type=chunk)[195](index=195&type=chunk) [Liquidity and capital resources](index=39&type=section&id=Liquidity%20and%20capital%20resources) This section assesses the company's ability to meet its financial obligations and fund future operations - As of September 30, 2023, the company had an **accumulated deficit of $1.9 billion**, with **cash and cash equivalents of $10.1 million** and **investments of $69.0 million**. Operations have historically been funded by equity/debt offerings, collaborator cash, and product/service sales[196](index=196&type=chunk)[197](index=197&type=chunk) - In January 2023, a public offering of common stock generated **net proceeds of $72.8 million**. The company believes existing liquid assets will fund operations for at least the next 12 months but will require additional capital for long-term funding[198](index=198&type=chunk)[207](index=207&type=chunk) - Future capital requirements depend on R&D progress, regulatory approvals, strategic transactions, sales/royalties, collaborative arrangements, intellectual property costs, and potential M&A. Funding strategies include equity offerings, debt financings, and strategic alliances, which may dilute ownership or impose covenants[207](index=207&type=chunk)[208](index=208&type=chunk)[209](index=209&type=chunk) [Contractual obligations and commitments](index=42&type=section&id=Contractual%20obligations%20and%20commitments) This section details the company's contractual obligations, primarily operating leases and R&D commitments Contractual Obligations and Commitments (Sep 30, 2023, Amounts in thousands) | Obligation | Total | Less Than 1 Year | 1 - 3 Years | 3 - 5 Years | More Than 5 Years | | :------------------------ | :------- | :--------------- | :---------- | :---------- | :---------------- | | Operating leases | $10,201 | $1,973 | $3,575 | $2,491 | $2,162 | | Operating leases not yet commenced | $706 | $176 | $471 | $59 | $— | | Total | $10,907 | $2,149 | $4,046 | $2,550 | $2,162 | - As of September 30, 2023, the company also had **$16.8 million** in un-incurred research and development commitments with third parties, which are generally cancellable[211](index=211&type=chunk) [Off-balance sheet arrangements](index=42&type=section&id=Off-balance%20sheet%20arrangements) This section confirms the absence of any off-balance sheet arrangements during the reporting periods - The company did not have any off-balance sheet arrangements during the periods presented[212](index=212&type=chunk) [Critical accounting policies and estimates](index=42&type=section&id=Critical%20accounting%20policies%20and%20estimates) This section refers to the consistency of critical accounting policies with the prior annual report - There have been no material changes to the company's critical accounting policies from those described in its Annual Report on Form 10-K for the year ended December 31, 2022[214](index=214&type=chunk) [Recent accounting pronouncements](index=42&type=section&id=Recent%20accounting%20pronouncements) This section directs to Note 2 for details on recent accounting pronouncements and their impact - Information regarding recent accounting pronouncements and their impact is detailed in Note 2 to the Condensed Consolidated Financial Statements[215](index=215&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section details the company's exposure to market risks, focusing on interest rate risk for its cash and investment portfolio [Interest rate risk](index=42&type=section&id=Interest%20rate%20risk) This section assesses the potential impact of interest rate fluctuations on the company's financial instruments - As of September 30, 2023, the company held **$79.0 million** in cash, cash equivalents, and short-term/long-term investments, primarily in money market funds, certificates of deposit, and U.S. government debt/agency securities[217](index=217&type=chunk)[218](index=218&type=chunk) - A hypothetical **100 basis point increase** in interest rates is not expected to materially affect the fair value of its interest-sensitive financial instruments, with losses only realized if investments are sold prior to maturity[218](index=218&type=chunk) [Item 4. Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) This section evaluates the effectiveness of the company's disclosure controls and internal control over financial reporting [Disclosure Controls and Procedures](index=43&type=section&id=Disclosure%20Controls%20and%20Procedures) This section reports on the effectiveness of the company's disclosure controls and procedures - The CEO and CFO concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of September 30, 2023[219](index=219&type=chunk) [Internal Control Over Financial Reporting](index=43&type=section&id=Internal%20Control%20Over%20Financial%20Reporting) This section confirms no material changes to the company's internal control over financial reporting - There have been no material changes in the company's internal control over financial reporting during the three months ended September 30, 2023[220](index=220&type=chunk) [PART II - OTHER INFORMATION](index=44&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This part provides additional information on legal proceedings, risk factors, equity sales, and other disclosures [Item 1. Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) This section outlines the company's involvement in legal matters and ongoing litigation - The company is involved in various legal matters, but as of September 30, 2023, it does not believe any, individually or in aggregate, will have a material adverse effect on its business, financial condition, results of operations, or cash flows. Further details are in Note 14[223](index=223&type=chunk)[224](index=224&type=chunk) [Item 1A. Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the company's risk factors as previously disclosed in its Annual Report - There are no additional material updates or changes to the company's risk factors since the filing of its Annual Report on Form 10-K[225](index=225&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=44&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section confirms no unregistered sales of equity securities occurred during the reporting period - None[227](index=227&type=chunk) [Item 3. Defaults on Senior Securities](index=44&type=section&id=Item%203.%20Defaults%20on%20Senior%20Securities) This section confirms no defaults on senior securities occurred during the reporting period - None[228](index=228&type=chunk) [Item 4. Mine Safety Disclosures](index=44&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that mine safety disclosures are not applicable to the company's operations - Not applicable[229](index=229&type=chunk) [Item 5. Other Information](index=44&type=section&id=Item%205.%20Other%20Information) This section confirms no other material information is required to be reported - None[230](index=230&type=chunk) [Item 6. Exhibits](index=45&type=section&id=Item%206.%20Exhibits) This section lists the exhibits included in the Quarterly Report on Form 10-Q - Exhibits include certifications from the CEO and CFO (31.1, 31.2, 32.1, 32.2) and Interactive Data Files (101, 104) formatted in Inline XBRL[232](index=232&type=chunk) [Signatures](index=46&type=section&id=Signatures) This section contains the official signatures for the Quarterly Report on Form 10-Q - The report was signed on November 9, 2023, by Harry Thomasian Jr., Chief Financial Officer (Principal Financial and Accounting Officer) of Precigen, Inc[236](index=236&type=chunk)
Precigen(PGEN) - 2023 Q2 - Earnings Call Transcript
2023-08-09 19:03
Precigen, Inc. (NASDAQ:PGEN) Q2 2023 Earnings Conference Call August 9, 2023 8:30 AM ET Company Participants Steve Harasym - Vice President, Investor Relations Helen Sabzevari - President & Chief Executive Officer Harry Thomasian - Chief Financial Officer Conference Call Participants Jason Butler - JMP Securities Jennifer Kim - Cantor Fitzgerald Arthur He - H.C. Wainwright Ben Burnett - Stifel Brian Cheng - JPMorgan Operator Good morning and welcome to the Precigen Second Quarter and First Half 2023 Financi ...
Precigen(PGEN) - 2023 Q2 - Quarterly Report
2023-08-09 12:21
PART I - FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) The company's unaudited statements show a Q2 2023 net loss of $20.3 million and increased shareholders' equity [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $207.5 million while shareholders' equity rose to $166.2 million due to debt retirement Condensed Consolidated Balance Sheet Data (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $16,546 | $4,858 | | Short-term investments | $71,888 | $51,092 | | Total current assets | $105,632 | $118,159 | | Total assets | $207,527 | $215,977 | | **Liabilities & Shareholders' Equity** | | | | Total current liabilities | $30,773 | $78,645 | | Total liabilities | $41,317 | $89,718 | | Total shareholders' equity | $166,210 | $126,259 | | Total liabilities and shareholders' equity | $207,527 | $215,977 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a Q2 2023 net loss of $20.3 million on revenues of $1.8 million Statement of Operations Highlights (in thousands, except per share data) | Metric | Q2 2023 | Q2 2022 | H1 2023 | H1 2022 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $1,767 | $2,911 | $3,618 | $8,424 | | Research and development | $11,874 | $11,954 | $24,037 | $23,755 | | Selling, general and administrative | $9,316 | $12,670 | $20,954 | $26,359 | | Operating loss | ($21,120) | ($24,162) | ($44,597) | ($46,315) | | Net loss | ($20,319) | ($17,635) | ($43,053) | ($36,886) | | Net loss per share, basic and diluted | ($0.08) | ($0.09) | ($0.18) | ($0.18) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $34.2 million, while financing activities provided $29.6 million from a stock offering Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($34,156) | ($25,836) | | Net cash (used in) provided by investing activities | ($26,905) | $33,141 | | Net cash provided by (used in) financing activities | $29,589 | ($276) | | Net decrease in cash, cash equivalents, and restricted cash | ($31,644) | $6,558 | - In January 2023, the company received **net proceeds of $72.8 million** from a public offering of common stock[38](index=38&type=chunk)[100](index=100&type=chunk) - The company **retired $43.1 million** of its Convertible Notes during the first six months of 2023[38](index=38&type=chunk)[95](index=95&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Notes detail key events including a subsidiary sale, debt retirement, a $72.8 million stock offering, and a lawsuit settlement - Management believes existing liquid assets will allow the company to **continue operations for at least one year** from the financial statement issuance date, despite expecting continued operating losses[45](index=45&type=chunk) - In August 2022, the company completed the **sale of its subsidiary, Trans Ova, for $170 million** plus potential earn-outs, with results reported as discontinued operations[62](index=62&type=chunk)[147](index=147&type=chunk) - On June 30, 2023, the company repurchased all remaining outstanding Convertible Notes, retiring a total of **$43.34 million in principal** during H1 2023[92](index=92&type=chunk)[95](index=95&type=chunk) - In January 2023, the company closed a public offering of 43.96 million shares, resulting in **net proceeds of $72.8 million**[100](index=100&type=chunk) - The company reached an agreement to **settle a shareholder class action lawsuit for $13.0 million**, for which an accrual has been recorded[116](index=116&type=chunk)[117](index=117&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses decreased revenue, lower operating expenses, and sufficient liquidity following a recent equity offering [Overview](index=30&type=section&id=Overview) Precigen is a clinical-stage biopharmaceutical company developing gene and cell therapies across two operating segments - The company is advancing lead clinical programs including **PRGN-3005, PRGN-3006, and PRGN-3007** (UltraCAR-T platform), and **PRGN-2009 and PRGN-2012** (AdenoVerse platform)[132](index=132&type=chunk) - **PRGN-2012** for recurrent respiratory papillomatosis (RRP) has received **Breakthrough Therapy Designation** from the FDA[138](index=138&type=chunk) - The company's reportable segments are **Biopharmaceuticals** (Precigen and ActoBio) and **Exemplar** (research models and services)[135](index=135&type=chunk)[148](index=148&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Q2 2023 revenues fell 39% year-over-year, while a 27% drop in SG&A expenses helped narrow the operating loss Q2 2023 vs Q2 2022 Performance (in thousands) | Metric | Q2 2023 | Q2 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $1,767 | $2,911 | ($1,144) | (39.3)% | | Research and development | $11,874 | $11,954 | ($80) | (0.7)% | | Selling, general and administrative | $9,316 | $12,670 | ($3,354) | (26.5)% | | Operating loss | ($21,120) | ($24,162) | $3,042 | (12.6)% | H1 2023 vs H1 2022 Performance (in thousands) | Metric | H1 2023 | H1 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $3,618 | $8,424 | ($4,806) | (57.1)% | | Research and development | $24,037 | $23,755 | $282 | 1.2% | | Selling, general and administrative | $20,954 | $26,359 | ($5,405) | (20.5)% | | Operating loss | ($44,597) | ($46,315) | $1,718 | (3.7)% | - The decrease in SG&A expenses was primarily driven by a **reduction in professional fees of $2.2 million for Q2 and $4.2 million for H1**, mainly due to lower legal fees[168](index=168&type=chunk)[181](index=181&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $16.5 million in cash and believes its liquid assets are sufficient for the next 12 months - As of June 30, 2023, the company had **cash and cash equivalents of $16.5 million** and **investments of $79.0 million**[189](index=189&type=chunk) - The company raised **$72.8 million in net proceeds** from a public stock offering in January 2023[190](index=190&type=chunk) - Management believes existing liquid assets will fund operating expenses and capital requirements for **at least the next 12 months**[199](index=199&type=chunk) - Future funding may be sought through equity offerings, debt financing, or strategic alliances, which could lead to **dilution or relinquishing valuable rights**[201](index=201&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuation on its $95.6 million investment portfolio - The company's investment portfolio, valued at **$95.6 million** as of June 30, 2023, is exposed to interest rate risk[211](index=211&type=chunk) - The company believes a **100 basis point increase in interest rates would not have a material effect** on the fair value of its interest-sensitive financial instruments[211](index=211&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2023 - Management, including the CEO and CFO, concluded that **disclosure controls and procedures were effective** as of the end of the reporting period[213](index=213&type=chunk) - **No material changes** to internal control over financial reporting occurred during the three months ended June 30, 2023[214](index=214&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) Management believes ongoing legal matters will not have a material adverse effect on the company's business - The company does not believe that any ongoing legal matters will have a **material adverse effect** on its business, financial condition, or cash flows[217](index=217&type=chunk) - For further details on legal matters, the report refers to **Note 14** of the Condensed Consolidated Financial Statements[218](index=218&type=chunk) [Item 1A. Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors have occurred since the company's last Annual Report on Form 10-K - **No material updates or changes** to risk factors have occurred since the filing of the company's Annual Report[219](index=219&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=44&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 reporting period - None[221](index=221&type=chunk) [Item 6. Exhibits](index=45&type=section&id=Item%206.%20Exhibits) This section lists filed exhibits, including an amended license agreement and required CEO/CFO certifications - An **Amended and Restated Exclusive License Agreement with Alaunos Therapeutics**, dated April 3, 2023, was filed as an exhibit[226](index=226&type=chunk)
Precigen(PGEN) - 2023 Q1 - Earnings Call Transcript
2023-05-10 18:59
Call Start: 08:00 January 1, 0000 9:01 AM ET Precigen, Inc. (NASDAQ:PGEN) Q1 2023 Earnings Conference Call May 10, 2023 08:00 ET Company Participants Steve Harasym - Vice President, Investor Relations Helen Sabzevari - President & Chief Executive Officer Harry Thomasian - Chief Financial Officer Conference Call Participants Jason Butler - JMP Securities Jennifer Kim - Cantor Fitzgerald Carolina Ibanez Ventoso - Stifel Arthur He - H.C. Wainwright Operator Good morning and welcome to the Precigen First Quarte ...
Precigen(PGEN) - 2023 Q1 - Quarterly Report
2023-05-10 12:02
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-36042 PRECIGEN, INC. (Exact name of registrant as specified in its charter) Virginia 26-0084895 (State or other jurisd ...