Editas Medicine(EDIT)

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Editas Medicine(EDIT) - 2021 Q4 - Annual Report
2022-02-23 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ 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 001-37687 EDITAS MEDICINE, INC. (Exact name of registrant as specified in its charter) Delaware ( ...
Editas Medicine(EDIT) - 2021 Q3 - Quarterly Report
2021-11-08 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ 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 001-37687 EDITAS MEDICINE, INC. (Exact name of registrant as specified in its charter) D ...
Editas Medicine(EDIT) - 2021 Q2 - Quarterly Report
2021-08-04 16:00
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) Comprehensive financial overview including statements, management's analysis, market risks, and controls [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Editas Medicine, Inc. as of June 30, 2021, showing increased net loss and operating expenses alongside a strengthened cash position Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Total Assets** | **$755,880** | **$572,602** | | Cash and cash equivalents | $337,834 | $139,682 | | Marketable securities | $360,303 | $372,092 | | **Total Liabilities** | **$142,519** | **$179,016** | | Deferred revenue | $89,221 | $94,927 | | **Total Stockholders' Equity** | **$613,361** | **$393,586** | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Collaboration and other revenues | $379 | $10,749 | $6,878 | $16,472 | | Research and development expenses | $33,753 | $28,007 | $75,690 | $62,576 | | General and administrative expenses | $22,027 | $14,081 | $43,471 | $31,852 | | **Operating Loss** | **($55,401)** | **($31,339)** | **($112,283)** | **($77,956)** | | **Net Loss** | **($55,256)** | **($23,572)** | **($111,984)** | **($61,296)** | | **Net loss per share, basic and diluted** | **($0.81)** | **($0.43)** | **($1.67)** | **($1.12)** | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($88,436) | ($84,942) | | Net cash provided by investing activities | $8,035 | $120,637 | | Net cash provided by financing activities | $278,553 | $214,200 | | **Net increase in cash, cash equivalents, and restricted cash** | **$198,152** | **$249,895** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business, liquidity, accounting policies, and financial statement items, confirming sufficient cash to fund operations into 2023 - The company is a clinical-stage genome editing company that has incurred net operating losses every year since inception and requires substantial additional capital to fund operations[19](index=19&type=chunk)[24](index=24&type=chunk) - In January/February 2021, the company raised approximately **$249.5 million** in net proceeds from a public offering of common stock[22](index=22&type=chunk)[23](index=23&type=chunk) - In May 2021, it established an At-The-Market (ATM) facility for up to **$300.0 million**, with no shares sold under it as of June 30, 2021[22](index=22&type=chunk)[23](index=23&type=chunk) - Management expects that existing cash, cash equivalents, and marketable securities as of June 30, 2021, will be sufficient to fund operating expenses and capital expenditures well into 2023[24](index=24&type=chunk) Stock-based Compensation Expense (in thousands) | Expense Category | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Research and development | $4,171 | $8,137 | | General and administrative | $9,355 | $17,593 | | **Total** | **$13,526** | **$25,730** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's business, financial results, and liquidity, highlighting decreased revenue, increased operating expenses, and a strengthened cash position [Overview](index=16&type=section&id=Overview) The company is a clinical-stage genome editing company advancing key programs EDIT-101 for LCA10 and EDIT-301 for sickle cell disease, expecting continued operating losses - The Phase 1/2 BRILLIANCE clinical trial for EDIT-101 (for LCA10) has completed dosing for the adult low-dose and mid-dose cohorts, with enrollment beginning in adult high-dose and pediatric cohorts in Q2 2021[59](index=59&type=chunk)[61](index=61&type=chunk) - The FDA cleared the IND for the EDIT-301 RUBY trial for sickle cell disease in January 2021, with patient screening underway and dosing expected to begin by the end of 2021[62](index=62&type=chunk) - The company plans to submit an IND for EDIT-301 for the treatment of beta-thalassemia by the end of 2021[62](index=62&type=chunk) - The company has incurred significant operating losses since inception, with a net loss of **$112.0 million** for the six months ended June 30, 2021, and an accumulated deficit of **$777.2 million**[66](index=66&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) This section details financial performance, showing significant revenue decrease due to alliance termination and increased R&D and G&A expenses driven by clinical development and stock-based compensation Comparison of Results for the Three Months Ended June 30 (in thousands) | Item | 2021 | 2020 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenues | $379 | $10,749 | ($10,370) | (96)% | | R&D Expenses | $33,753 | $28,007 | $5,746 | 21% | | G&A Expenses | $22,027 | $14,081 | $7,946 | 56% | | **Net Loss** | **($55,256)** | **($23,572)** | **($31,684)** | n/m | Comparison of Results for the Six Months Ended June 30 (in thousands) | Item | 2021 | 2020 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenues | $6,878 | $16,472 | ($9,594) | (58)% | | R&D Expenses | $75,690 | $62,576 | $13,114 | 21% | | G&A Expenses | $43,471 | $31,852 | $11,619 | 36% | | **Net Loss** | **($111,984)** | **($61,296)** | **($50,688)** | 83% | - The decrease in collaboration revenue was primarily due to **$7.6 million** from an out-license agreement in Q2 2020 and revenue from the terminated Allergan strategic alliance in 2020[85](index=85&type=chunk)[95](index=95&type=chunk) - The increase in G&A expenses was mainly driven by a **$6.6 million** increase in stock-based compensation in Q2 2021, related to performance awards for the CEO, and an **$11.7 million** increase for the six-month period, also related to the separation of the former CEO[90](index=90&type=chunk)[100](index=100&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is strong, with **$698.1 million** in cash and investments as of June 30, 2021, expected to fund operations well into 2023 - As of June 30, 2021, the company had cash, cash equivalents, and marketable securities of **$698.1 million**[106](index=106&type=chunk) - In January and February 2021, the company raised net proceeds of approximately **$249.5 million** from a public offering of common stock[106](index=106&type=chunk)[115](index=115&type=chunk) - In May 2021, the company established an at-the-market (ATM) offering facility to sell up to **$300.0 million** of common stock, but no shares were sold under this facility as of June 30, 2021[105](index=105&type=chunk) - The company expects its existing cash and investments will fund operating expenses and capital expenditure requirements well into 2023[119](index=119&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its short-term, low-risk investments, with no material foreign currency exchange rate exposure - The company's primary market risk is interest rate sensitivity on its cash and marketable securities, which are mainly invested in U.S. government-backed securities and corporate debt[132](index=132&type=chunk) - Due to the short-term maturities and low-risk profiles of its investments, an immediate **100 basis point** change in interest rates is not expected to have a material effect on the fair market value of its portfolio[132](index=132&type=chunk) - The company believes it does not have any material exposure to foreign currency exchange rate risk as liabilities are substantially denominated in U.S. dollars[133](index=133&type=chunk) [Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of June 30, 2021, with no material changes to internal control over financial reporting - Based on an evaluation as of June 30, 2021, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[134](index=134&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[135](index=135&type=chunk) [PART II. OTHER INFORMATION](index=29&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, intellectual property risks, equity sales, and required exhibits [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company may face litigation in the ordinary course of business, with intellectual property rights subject to ongoing priority and validity disputes - The company may become involved in litigation from the ordinary course of business[138](index=138&type=chunk) - Certain intellectual property rights licensed by the company are subject to priority and validity disputes, which are further detailed in the Risk Factors section[138](index=138&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) This section details significant intellectual property risks, particularly ongoing CRISPR/Cas9 patent disputes that could materially harm the business if unfavorable - The company's in-licensed patents are subject to multiple ongoing priority and validity disputes, including interference proceedings at the USPTO[140](index=140&type=chunk) - Key proceedings involve patents licensed from the Broad Institute against competing claims from CVC (University of California et al.), ToolGen, and Sigma-Aldrich regarding the invention of CRISPR/Cas9 systems in eukaryotic cells[142](index=142&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk) - In Europe, certain patents licensed from Broad have been revoked or amended by the European Patent Office, with appeals pending, potentially leading to the loss of key European patents[152](index=152&type=chunk) - An unsuccessful outcome in these disputes could force the company to license technology from competitors, which may not be available on reasonable terms, or to halt the development and commercialization of product candidates[153](index=153&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On June 14, 2021, the company issued unregistered stock options and restricted stock units as employment inducements to new executive officers - On June 14, 2021, the company granted stock options and restricted stock units to its new Chief Scientific Officer and Chief Regulatory Officer as inducements to employment[154](index=154&type=chunk) - These securities were issued without registration under the Securities Act of 1933, pursuant to Section 4(a)(2) and in accordance with Nasdaq Listing Rule 5635(c)(4)[154](index=154&type=chunk) [Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including the ATM sales agreement and officer certifications - The report includes the Common Stock Sales Agreement with Cowen and Company, LLC, dated May 14, 2021[158](index=158&type=chunk) - Certifications by the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act are filed as exhibits[158](index=158&type=chunk)
Editas Medicine(EDIT) - 2021 Q1 - Quarterly Report
2021-05-05 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | --- | |------------------------------------------------------------------|----------------------------------------------------------------------------------- ...
Editas Medicine(EDIT) - 2020 Q4 - Annual Report
2021-02-25 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 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 001-37687 EDITAS MEDICINE, INC. (Exact name of registrant as specified in its charter) Delaware ( ...
Editas Medicine(EDIT) - 2020 Q3 - Quarterly Report
2020-11-06 13:07
Revenue and Financial Performance - The company has not generated any revenue from product sales and does not expect to do so for the foreseeable future[86] - As of September 30, 2020, the company recorded $96.3 million of deferred revenue, with $79.3 million classified as long-term[86] - The company incurred net losses of $53.5 million and $96.0 million for the nine months ended September 30, 2020 and 2019, respectively, with an accumulated deficit of $602.7 million[83] - The company anticipates continued significant operating losses for the foreseeable future and does not expect to be profitable for the year ending December 31, 2020[83] - Net loss for the nine months ended September 30, 2020, was $53.5 million, a 44% improvement compared to a net loss of $96.0 million for the same period in 2019[113] - Interest income for the nine months ended September 30, 2020, decreased by 58% to $2.4 million compared to $5.7 million in the same period of 2019[113] - Net cash used in operating activities was approximately $139.7 million for the nine months ended September 30, 2020, compared to $81.7 million for the same period in 2019[129] - The company raised an aggregate of $648.7 million in net proceeds through public offerings and at-the-market offerings as of September 30, 2020[126] Research and Development - The company expects significant increases in research and development expenses as it progresses clinical development of EDIT-101 and other programs[95] - The company has initiated a Phase 1/2 clinical trial for EDIT-101, targeting approximately 18 patients, but enrollment has been slowed due to COVID-19[77] - The company plans to submit an IND for EDIT-301 for sickle cell disease by the end of 2020[77] - Research and development expenses rose by $11.2 million to $33.9 million for the three months ended September 30, 2020, with significant increases in process and platform development expenses[104] - Total research and development expenses increased by 55% to $96.5 million for the nine months ended September 30, 2020, compared to $62.1 million for the same period in 2019[119] - Research and development expenses for the nine months ended September 30, 2020, increased by $34.4 million to $96.5 million, primarily due to the obligation to fund all costs related to the LCA10 program following the termination of the agreement with Allergan[116] Collaboration and Revenue Recognition - Following the termination of the collaboration with Allergan, the company regained full global rights to develop and commercialize EDIT-101 and is obligated to make a one-time payment of $20 million[81] - The company recognized $63.2 million of previously deferred revenue related to Allergan during the third quarter of 2020[87] - The company has received an aggregate of $120 million from its collaboration with Juno Therapeutics, primarily from upfront and milestone payments[86] - Collaboration and other research and development revenues increased by $59.0 million to $62.8 million for the three months ended September 30, 2020, primarily due to the recognition of $59.9 million of previously deferred revenue from the termination of the strategic alliance with Allergan[103] Operating Expenses - General and administrative expenses increased by $4.2 million to $19.9 million for the three months ended September 30, 2020, driven by higher professional service expenses related to the Allergan agreement termination[109] - Total operating expenses for the nine months ended September 30, 2020, were $148.3 million, a 35% increase from $109.7 million in the same period of 2019[113] - General and administrative expenses increased by 9% to $51.8 million for the nine months ended September 30, 2020, compared to $47.6 million for the same period in 2019[121] - The company anticipates that general and administrative expenses will continue to be significant due to ongoing patent-related expenses and costs associated with operating as a public company[97] Cash and Funding - As of September 30, 2020, the company had cash, cash equivalents, and marketable securities totaling $541.3 million[126] - As of September 30, 2020, the company had cash and cash equivalents of $279.6 million, primarily in money market mutual funds and marketable securities totaling $215.7 million[148] - The company anticipates needing substantial additional funding to support ongoing operations and research activities[141] Market and Economic Conditions - The company's primary exposure to market risk is interest rate sensitivity, with an immediate 100 basis point change in interest rates not expected to materially affect the fair market value of investments due to their short-term maturities[148] - Substantially all total liabilities as of September 30, 2020 were denominated in U.S. dollars, indicating no material exposure to foreign currency exchange rate risk[149] - The company does not believe that inflation had a material effect on its business or financial condition during the nine months ended September 30, 2020 or 2019[147]
Editas Medicine(EDIT) - 2020 Q2 - Quarterly Report
2020-08-07 12:07
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Editas Medicine, Inc. as of June 30, 2020, show a significant increase in cash and total assets, primarily due to a public stock offering, with the company continuing to operate at a net loss, generating revenues from collaborations and incurring significant expenses in research and development, reflecting the financial position of a clinical-stage company investing heavily in its pipeline [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2020, the company's total assets increased to $655.5 million from $508.9 million at year-end 2019, driven by a substantial rise in cash and cash equivalents to $485.8 million largely due to proceeds from a public offering, while total liabilities decreased slightly to $228.7 million, and total stockholders' equity grew significantly to $426.8 million from $262.4 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $485,819 | $238,183 | | Total current assets | $610,126 | $463,844 | | Total assets | $655,481 | $508,885 | | **Liabilities & Equity** | | | | Total current liabilities | $68,150 | $59,963 | | Total liabilities | $228,709 | $246,448 | | Total stockholders' equity | $426,772 | $262,437 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2020, collaboration revenue increased significantly to $10.7 million compared to $2.3 million in the same period of 2019, with the net loss for the quarter narrowing to $23.6 million from $33.8 million year-over-year, and for the six-month period, revenue was $16.5 million, up from $4.4 million, while the net loss remained relatively stable at $61.3 million compared to $63.0 million in the prior year Statements of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Collaboration and other R&D revenues | $10,749 | $2,330 | $16,472 | $4,399 | | Research and development expense | $28,007 | $23,565 | $62,576 | $39,408 | | General and administrative expense | $14,081 | $14,414 | $31,852 | $31,903 | | Operating loss | $(31,339) | $(35,649) | $(77,956) | $(66,912) | | Net loss | $(23,572) | $(33,786) | $(61,296) | $(63,035) | | Net loss per share | $(0.43) | $(0.69) | $(1.12) | $(1.29) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2020, net cash used in operating activities was $84.9 million, net cash provided by investing activities was $120.6 million mainly from maturities of marketable securities, and net cash provided by financing activities was a significant $214.2 million primarily from a common stock offering that yielded $204.0 million in net proceeds, resulting in a net increase in cash of $249.9 million for the period Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(84,942) | $(54,809) | | Net cash provided by investing activities | $120,637 | $126,736 | | Net cash provided by financing activities | $214,200 | $3,902 | | **Net increase in cash** | **$249,895** | **$75,829** | - The company raised approximately **$204.0 million** in net proceeds from an offering of common stock during the first six months of 2020[22](index=22&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business as a clinical-stage genome editing company and its financial condition, including its reliance on equity financing and collaboration payments for funding, with existing cash expected to fund operations into **2023**, and a significant subsequent event being the termination of the strategic alliance with Allergan in August 2020, which resulted in Editas regaining full global rights to its ocular medicines, including EDIT-101 - In June 2020, the company completed a public offering of **6,900,000 shares** of common stock, receiving net proceeds of approximately **$203.7 million**[27](index=27&type=chunk) - Existing cash, cash equivalents, and marketable securities as of June 30, 2020, are expected to fund operating expenses and capital expenditure requirements into **2023**[28](index=28&type=chunk) - Subsequent to the quarter end, on August 5, 2020, the company terminated its strategic alliance with Allergan. Editas regained full global rights to its ocular medicines, including EDIT-101, and will now be responsible for its development and commercialization[63](index=63&type=chunk)[64](index=64&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's position as a clinical-stage genome editing company focused on ocular diseases and engineered cell medicines, with the lead program EDIT-101 having its first patient dosed in **Q1 2020**, and a key strategic change being the termination of the Allergan collaboration, giving Editas full rights to its ocular programs but also full financial responsibility, which is expected to significantly increase R&D expenses, while financially, revenue increased due to an out-license agreement and the Allergan alliance, and net loss narrowed in **Q2 2020**, with the company strengthening its balance sheet with a **$203.7 million** public offering, extending its cash runway into **2023** - The company's lead program, EDIT-101 for Leber congenital amaurosis 10 (LCA10), initiated a Phase 1/2 clinical trial in mid-2019, with the first patient dosed in **Q1 2020**[71](index=71&type=chunk) - The strategic alliance with Allergan was terminated on **August 5, 2020**. Editas regained full global rights to its ocular medicines, including EDIT-101, and will now bear the full cost of development, expecting a significant increase in R&D expenses[74](index=74&type=chunk)[75](index=75&type=chunk) - The company aims to submit an Investigational New Drug (IND) application for EDIT-301 for sickle cell disease by the end of **2020**[71](index=71&type=chunk) - As of June 30, 2020, the company had an accumulated deficit of **$610.5 million** and expects to continue incurring significant operating losses for the foreseeable future[77](index=77&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) For the three months ended June 30, 2020, revenues increased to $10.7 million from $2.3 million in 2019, primarily due to a $7.6 million recognition from a new out-license agreement, while R&D expenses rose **19%** to $28.0 million, driven by increased sublicense fees and employee costs, and general and administrative expenses remained flat, and for the six-month period, revenues grew to $16.4 million from $4.3 million, and R&D expenses increased **59%** to $62.6 million, mainly due to higher process and platform development costs related to manufacturing and clinical activities Comparison of Results for the Three Months Ended June 30 (in thousands) | Item | 2020 | 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $10,749 | $2,330 | $8,419 | n/m | | R&D Expenses | $28,007 | $23,565 | $4,442 | 19% | | G&A Expenses | $14,081 | $14,414 | $(333) | (2)% | | Net Loss | $(23,572) | $(33,786) | $10,214 | (30)% | Comparison of Results for the Six Months Ended June 30 (in thousands) | Item | 2020 | 2019 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $16,472 | $4,339 | $12,133 | n/m | | R&D Expenses | $62,576 | $39,408 | $23,168 | 59% | | G&A Expenses | $31,852 | $31,903 | $(51) | (0)% | | Net Loss | $(61,296) | $(63,095) | $1,799 | (3)% | [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2020, the company had $598.7 million in cash, cash equivalents, and marketable securities, with liquidity significantly bolstered by a June 2020 public offering that raised net proceeds of $203.7 million, and the company also established a $150.0 million at-the-market (ATM) facility in May 2020, though no shares have been sold under it, and management expects current capital to fund operations and capital expenditures into **2023**, with future funding needs depending on the progress of clinical programs like EDIT-101 and preclinical activities for EDIT-301 and EDIT-201 - In June 2020, a public offering of common stock yielded net proceeds of approximately **$203.7 million**[122](index=122&type=chunk) - The company established a **$150.0 million** at-the-market (ATM) offering facility in May 2020, but has not yet sold any shares under it[122](index=122&type=chunk) - Existing cash and marketable securities of **$598.7 million** as of June 30, 2020, are expected to fund operations into **2023**[122](index=122&type=chunk)[134](index=134&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure is to interest rate sensitivity due to its holdings of cash, cash equivalents, and marketable securities in U.S. government-backed securities, but due to the short-term maturities and low-risk profile of these investments, management believes a **100 basis point** change in interest rates would not have a material effect on their fair market value, and the company has no material exposure to foreign currency exchange rate risk as liabilities are denominated in U.S. dollars - The company's primary market risk is interest rate sensitivity on its **$485.8 million** in cash and cash equivalents and **$112.9 million** in marketable securities[144](index=144&type=chunk) - Due to the short-term and low-risk nature of its investments, a **1%** change in interest rates is not expected to have a material impact on the portfolio's fair value[144](index=144&type=chunk) - The company does not have material exposure to foreign currency exchange rate risk[145](index=145&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures as of June 30, 2020, concluding that these controls were effective at a reasonable assurance level, with no material changes in the company's internal control over financial reporting during the quarter - The CEO and CFO concluded that as of June 30, 2020, the company's disclosure controls and procedures were effective at the reasonable assurance level[146](index=146&type=chunk) - No changes occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[147](index=147&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company states that it may become involved in legal proceedings arising from the ordinary course of business, specifically noting that certain of its licensed intellectual property rights are subject to priority and validity disputes, and refers to the Risk Factors section for more details on these matters - The company acknowledges potential involvement in litigation from the ordinary course of business[150](index=150&type=chunk) - Certain intellectual property rights licensed by the company are subject to priority and validity disputes, which are further detailed in the Risk Factors section[150](index=150&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) This section outlines the numerous and substantial risks facing the company, including a history of significant financial losses and the need for substantial additional capital, risks inherent in developing novel genome editing therapies with an unproven regulatory and commercial track record, dependence on the success of its lead candidate EDIT-101, reliance on third parties for collaborations, clinical trials, and manufacturing, and significant, complex intellectual property disputes, particularly interference and opposition proceedings related to its licensed CRISPR patents, with other risks involving regulatory hurdles, public perception of gene editing, competition, and market volatility [Risks Related to Our Financial Position and Need for Additional Capital](index=39&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) The company has a history of significant operating losses, with an accumulated deficit of $610.5 million as of June 30, 2020, and expects to incur losses for the foreseeable future, requiring substantial additional funding to advance its clinical programs, particularly as it now bears the full cost for the EDIT-101 program after the Allergan termination, with failure to raise capital potentially forcing delays or elimination of R&D programs - The company has incurred significant operating losses since inception, with an accumulated deficit of **$610.5 million** as of June 30, 2020[153](index=153&type=chunk) - Substantial additional funding will be needed to advance clinical trials and R&D programs. Failure to raise capital could force the company to delay, reduce, or eliminate programs[157](index=157&type=chunk)[158](index=158&type=chunk) [Risks Related to Discovery, Development, and Commercialization](index=46&type=section&id=Risks%20Related%20to%20Discovery%2C%20Development%2C%20and%20Commercialization) The company's focus on novel genome editing technology presents significant risk, as no such therapeutic has been approved in the U.S. or Europe, with the regulatory landscape being uncertain and evolving, and risks of adverse events such as "off-target" edits potentially halting development, and the company being heavily dependent on the success of EDIT-101, now managing and funding the clinical trial itself after the Allergan termination despite limited experience, with failure or delays in this or other programs materially harming the business - The company's success depends on a novel genome editing technology, and no therapeutic product utilizing this technology has been approved in the U.S. or Europe[175](index=175&type=chunk)[176](index=176&type=chunk) - A significant risk in genome editing is "off-target" cuts, which could lead to serious adverse events and potentially halt clinical development[203](index=203&type=chunk) - Following the termination of the Allergan collaboration, Editas is now fully responsible for funding and conducting the Phase 1/2 clinical trial for EDIT-101, despite having limited experience in conducting such trials[196](index=196&type=chunk) [Risks Related to Our Dependence on Third Parties](index=78&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) Editas relies heavily on third parties, including collaborators for R&D, Contract Research Organizations (CROs) for clinical trials, and Contract Manufacturing Organizations (CMOs) for materials supply, with the termination of the Allergan collaboration highlighting the risks of such partnerships, and reliance on third parties reducing control over these activities and introducing risks related to performance, regulatory compliance, and supply chain continuity, which could delay or impair development and commercialization efforts - The company depends on collaborations for R&D and commercialization, and the termination of the Allergan agreement for the LCA10 program will significantly increase expenses[290](index=290&type=chunk)[301](index=301&type=chunk) - The company relies on third-party CROs to conduct clinical trials and preclinical testing, which reduces control over these activities and introduces risks of delays and non-performance[311](index=311&type=chunk)[312](index=312&type=chunk) - Manufacturing of materials for research, preclinical studies, and clinical trials is contracted to third-party CMOs, creating risks related to supply sufficiency, quality, cost, and regulatory compliance[318](index=318&type=chunk)[319](index=319&type=chunk) [Risks Related to Our Intellectual Property](index=85&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's success is highly dependent on a complex and contested intellectual property landscape for CRISPR technology, with many of its core patents in-licensed and subject to ongoing, costly, and uncertain legal challenges, including interference proceedings in the U.S. and opposition proceedings in Europe, and an adverse outcome in these disputes could result in the loss or narrowing of patent rights, requiring the company to obtain licenses from competitors or cease development, with the dynamic and litigious nature of the genome editing field posing a significant threat to the company's competitive position - The company heavily relies on in-licensed patents from institutions like The Broad Institute and Harvard, which are subject to complex priority and validity disputes[335](index=335&type=chunk)[337](index=337&type=chunk)[343](index=343&type=chunk) - Key in-licensed U.S. patents are involved in a second interference proceeding with the University of California/Vienna/Charpentier to determine priority of invention for CRISPR/Cas9 use in eukaryotic cells[347](index=347&type=chunk) - Several in-licensed European patents have been revoked or are under opposition, which could lead to the loss of patent protection in Europe and have a material adverse effect on the business[356](index=356&type=chunk) [Risks Related to Regulatory Approval and Other Legal Compliance Matters](index=109&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Other%20Legal%20Compliance%20Matters) The company faces a long, expensive, and uncertain regulatory approval process for its novel product candidates, with failure to obtain, or delays in obtaining, approval from the FDA and other global authorities preventing commercialization, and even if approved, products will be subject to ongoing regulation, potential marketing restrictions, and pricing pressures from healthcare reform and payors, and the company must also comply with complex anti-kickback and fraud laws, with changes in the political landscape, such as Brexit or U.S. healthcare policy shifts, potentially further complicating the path to market - The marketing approval process for novel genome editing therapies is expensive, time-consuming, and uncertain, with no guarantee of success[401](index=401&type=chunk) - Even if approved, products may face unfavorable pricing regulations, limited reimbursement from third-party payors, and challenges due to the high potential cost of single-administration therapies[258](index=258&type=chunk)[262](index=262&type=chunk) - The company's relationships with healthcare providers and payors are subject to strict anti-kickback, fraud, and abuse laws, violations of which can lead to significant penalties[419](index=419&type=chunk) [Risks Related to Employee Matters, Managing Growth, Public Health and Information Technology](index=126&type=section&id=Risks%20Related%20to%20Employee%20Matters%2C%20Managing%20Growth%2C%20Public%20Health%20and%20Information%20Technology) The company's success depends on attracting and retaining key management and scientific personnel in a competitive market, and it also faces operational risks from public health crises like the COVID-19 pandemic, which could disrupt R&D, clinical trials, and manufacturing, and as the company grows, it may encounter difficulties managing its expansion, furthermore, its information technology systems are vulnerable to security breaches, which could compromise sensitive data and disrupt business - The company is highly dependent on its ability to attract and retain key executives and qualified scientific personnel in a competitive environment[467](index=467&type=chunk)[471](index=471&type=chunk) - The COVID-19 pandemic poses risks of disruption to operations, including delays in preclinical studies, clinical trials, and manufacturing activities[472](index=472&type=chunk)[474](index=474&type=chunk) - Security breaches of the company's IT infrastructure could compromise intellectual property and other sensitive data, leading to liability and reputational damage[480](index=480&type=chunk)[481](index=481&type=chunk) [Risks Related to Our Common Stock](index=132&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) The market price of the company's common stock is likely to be volatile due to factors such as clinical trial results, regulatory developments, and competition, with a significant number of shares potentially being sold into the market, depressing the stock price, and as a public company, Editas incurs significant compliance costs, with provisions in its corporate governance documents and Delaware law potentially discouraging or preventing a change in control, limiting shareholder value - The market price of the company's common stock is subject to high volatility due to industry-specific and company-specific factors[484](index=484&type=chunk) - Sales of a significant number of shares in the public market, or the perception of such sales, could cause the stock price to decline[490](index=490&type=chunk) - Provisions in the company's certificate of incorporation and bylaws, as well as Delaware law, could discourage, delay, or prevent a change in control[501](index=501&type=chunk)[502](index=502&type=chunk) [Item 6. Exhibits](index=139&type=section&id=Item%206.%20Exhibits) This section provides an index of the exhibits filed with the Quarterly Report on Form 10-Q, including a Common Stock Sales Agreement, a Separation Agreement, an Advisory Services Agreement, and certifications by the Principal Executive Officer and Principal Financial Officer - The report includes several exhibits, such as the Common Stock Sales Agreement with Cowen and Company, LLC, and certifications required by the SEC[510](index=510&type=chunk)[511](index=511&type=chunk)
Editas Medicine(EDIT) - 2020 Q1 - Quarterly Report
2020-05-08 12:32
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------ ...
Editas Medicine(EDIT) - 2019 Q4 - Annual Report
2020-02-26 21:26
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 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 001-37687 | --- | --- | --- | --- | --- | |------------------------------------------------------ ...
Editas Medicine(EDIT) - 2019 Q3 - Quarterly Report
2019-11-12 21:04
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | --- | --- | |-------------------------------------------------------------------------------------------------------------------------------------------- ...