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Editas Medicine(EDIT) - 2019 Q2 - Quarterly Report
2019-08-07 20:13
PART I. FINANCIAL INFORMATION [Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Unaudited condensed consolidated financial statements report a net loss of **$63.0 million** and total assets of **$355.6 million** as of June 30, 2019 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Total Assets** | **$355,625** | **$420,386** | | Cash and cash equivalents | $210,605 | $134,776 | | **Total Liabilities** | **$162,563** | **$184,224** | | Deferred revenue, total | $131,947 | $131,326 | | **Total Stockholders' Equity** | **$193,062** | **$236,162** | | Accumulated deficit | $(478,510) | $(416,278) | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | Collaboration and other revenues | $2,330 | $7,372 | $4,399 | $11,299 | | Research and development | $23,565 | $32,718 | $39,408 | $54,017 | | General and administrative | $14,414 | $14,311 | $31,903 | $28,498 | | **Net loss** | **$(33,786)** | **$(38,723)** | **$(63,035)** | **$(69,661)** | | Net loss per share | $(0.69) | $(0.82) | $(1.29) | $(1.50) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | $(54,809) | $(39,193) | | Net cash provided by (used in) investing activities | $126,736 | $(30,861) | | Net cash provided by financing activities | $3,902 | $55,348 | | **Net increase (decrease) in cash** | **$75,829** | **$(14,706)** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies, financial instruments, collaborations, and commitments, highlighting ASC 842 adoption and a subsequent CEO appointment - The company is a clinical-stage genome editing company with an accumulated deficit of **$478.5 million** as of June 30, 2019, and management believes existing cash, cash equivalents, and marketable securities will fund operations for **at least the next 24 months**[23](index=23&type=chunk)[26](index=26&type=chunk) - Effective January 1, 2019, the company adopted the new lease accounting standard ASC 842, resulting in the initial recognition of a **$19.5 million** right-of-use asset and a **$19.7 million** lease liability[31](index=31&type=chunk)[38](index=38&type=chunk) - For the six months ended June 30, 2019, the company recognized **$4.3 million** in revenue from its strategic alliance with Allergan and no revenue from its collaboration with Juno Therapeutics, with deferred revenue related to these agreements being **$94.9 million** and **$32.0 million**, respectively, as of June 30, 2019[75](index=75&type=chunk)[78](index=78&type=chunk) - The company is obligated to reimburse Broad Institute and Harvard for patent prosecution expenses, which amounted to **$6.9 million** for the six months ended June 30, 2019[60](index=60&type=chunk) - On August 6, 2019, the Board of Directors appointed **Cynthia Collins as President and Chief Executive Officer**, effective August 19, 2019[95](index=95&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial results, clinical program progress, and operational changes, confirming sufficient capital for the next 24 months - The company's most advanced program, EDIT-101 for Leber congenital amaurosis 10 (LCA10), began patient screening for a Phase 1/2 clinical trial in partnership with Allergan, with patient dosing expected in the **second half of 2019**[102](index=102&type=chunk) Comparison of Results for the Three Months Ended June 30 (in thousands) | Item | 2019 | 2018 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $2,330 | $7,372 | $(5,042) | (68)% | | R&D Expenses | $23,565 | $32,718 | $(9,153) | (28)% | | G&A Expenses | $14,414 | $14,311 | $103 | 1% | | **Net Loss** | **$(33,786)** | **$(38,723)** | **$4,937** | **(13)%** | Comparison of Results for the Six Months Ended June 30 (in thousands) | Item | 2019 | 2018 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $4,399 | $11,299 | $(6,900) | (61)% | | R&D Expenses | $39,408 | $54,017 | $(14,609) | (27)% | | G&A Expenses | $31,903 | $28,498 | $3,405 | 12% | | **Net Loss** | **$(63,035)** | **$(69,661)** | **$6,626** | **(10)%** | - As of June 30, 2019, the company had cash, cash equivalents, and marketable securities of **$317.9 million**, which is expected to fund operating expenses and capital expenditure requirements for **at least the next 24 months**[151](index=151&type=chunk)[164](index=164&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Market risk exposure is detailed, primarily interest rate sensitivity on cash and marketable securities, with no material foreign currency risk - The company's primary market risk is interest rate sensitivity on its **$210.6 million** in cash and cash equivalents and **$107.3 million** in marketable securities[173](index=173&type=chunk) - Due to the short-term maturities and low-risk profiles of its investments, management believes an immediate **100 basis point change** in interest rates would **not have a material effect** on the fair market value of its investments[173](index=173&type=chunk) - The company has **no material exposure** to foreign currency exchange rate risk as substantially all liabilities are denominated in U.S. dollars[174](index=174&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2019, with new internal controls implemented for ASC 842 adoption - Management, including the CEO and interim CFO, concluded that the company's disclosure controls and procedures were **effective at the reasonable assurance level as of June 30, 2019**[176](index=176&type=chunk) - In Q1 2019, the company implemented internal controls related to its adoption of the new lease accounting standard, ASC 842, with **No other material changes** to internal control over financial reporting occurring during the quarter[177](index=177&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not a party to material litigation, but acknowledges ongoing intellectual property disputes detailed in Risk Factors - The company is **not a party to any material litigation** or other legal proceedings arising from the ordinary course of business[180](index=180&type=chunk) - Certain intellectual property rights licensed to the company are **subject to priority and validity disputes**, as discussed in the Risk Factors section[180](index=180&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) Numerous risks are outlined, including financial losses, uncertainties of novel genome editing technology, intellectual property disputes, and intense competition - The company has a history of significant operating losses, with an accumulated deficit of **$478.5 million** as of June 30, 2019, and expects to **incur losses for the foreseeable future, requiring substantial additional funding**[182](index=182&type=chunk)[183](index=183&type=chunk)[187](index=187&type=chunk) - The company's focus on novel genome editing technology is high-risk, as **no therapeutic product using this technology has been approved** in the U.S. or Europe, with risks including **potential for off-target edits, unpredictable long-term effects, and an uncertain regulatory pathway**[205](index=205&type=chunk)[206](index=206&type=chunk)[232](index=232&type=chunk) - The company's in-licensed patents are subject to significant and ongoing legal challenges, including a **second interference proceeding declared by the PTAB on June 24, 2019, and multiple opposition proceedings in Europe**, which could result in the **loss of valuable intellectual property rights**[375](index=375&type=chunk)[379](index=379&type=chunk)[386](index=386&type=chunk) - The company faces **significant competition** from other companies developing CRISPR and other gene-editing technologies, as well as from traditional therapies, with **ProQR Therapeutics N.V. is a direct competitor** for its LCA10 program with an ongoing clinical trial[257](index=257&type=chunk)[285](index=285&type=chunk)[287](index=287&type=chunk) [Other Information](index=87&type=section&id=Item%205.%20Other%20Information) Formal appointment of Cynthia Collins as President and CEO, effective August 19, 2019, detailing her compensation and equity awards - On August 6, 2019, the Board of Directors appointed **Cynthia Collins as President and Chief Executive Officer, effective August 19, 2019**, after she had been serving as interim CEO since March 2019[531](index=531&type=chunk) - Ms. Collins' employment agreement includes a **$625,000** base salary, a **60% target bonus**, and **substantial equity grants**, including a time-vesting option for **500,000 shares**, a performance-vesting option for **250,000 shares**, and a restricted stock unit award for **20,000 shares**[532](index=532&type=chunk) [Exhibits](index=88&type=section&id=Item%206.%20Exhibits) Index of exhibits filed with the Quarterly Report on Form 10-Q, including officer certifications and Inline XBRL financial data - The exhibits filed with the report include **Rule 13a-14(a) and Section 1350 certifications** by the Principal Executive Officer and Principal Financial Officer, and **financial data in Inline XBRL format**[537](index=537&type=chunk) Signatures - The report was **duly authorized and signed on August 7, 2019**, by **Cynthia Collins, Chief Executive Officer (Principal Executive Officer)**[541](index=541&type=chunk)[543](index=543&type=chunk)
Editas Medicine(EDIT) - 2019 Q1 - Quarterly Report
2019-05-08 20:03
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, 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, INC. (Exact name of registrant as specified in its charter) Delaw ...
Editas Medicine(EDIT) - 2018 Q4 - Annual Report
2019-02-28 23:03
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, 2018 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 | --- | --- | --- | |------------------------------------------------------------------ ...