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Insmed(INSM) - 2022 Q1 - Quarterly Report
2022-05-05 11:29
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Consolidated Financial Statements](index=3&type=section&id=ITEM%201.%20Consolidated%20Financial%20Statements) Unaudited consolidated financial statements for Q1 2022 report **$53.1 million** in revenue and a **$94.6 million** net loss Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2022 (unaudited) | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $515,704 | $716,782 | | Total assets | $1,153,315 | $1,243,508 | | Total liabilities | $1,033,435 | $833,040 | | Total shareholders' equity | $119,880 | $410,468 | Consolidated Statement of Comprehensive Loss Highlights (in thousands, except per share data) | Account | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Product revenues, net | $53,107 | $40,214 | | Research and development | $84,356 | $61,390 | | Selling, general and administrative | $56,748 | $51,550 | | Operating loss | $(89,833) | $(83,833) | | Net loss | $(94,621) | $(91,641) | | Basic and diluted net loss per share | $(0.80) | $(0.89) | Consolidated Statement of Cash Flows Highlights (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(105,161) | $(128,281) | | Net cash used in investing activities | $(101,407) | $(1,181) | | Net cash provided by financing activities | $6,459 | $6,703 | | Net decrease in cash and cash equivalents | $(201,078) | $(123,005) | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2022 financial performance, highlighting a **32.1%** increase in ARIKAYCE net product revenues and rising R&D expenses for clinical trials - The company's first commercial product, **ARIKAYCE**, is approved in the US, Europe, and Japan for treating MAC lung disease, with a clinical-stage pipeline including **brensocatib** and **TPIP**[127](index=127&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk) Product Revenues, Net by Geography (in thousands) | Geography | Q1 2022 | Q1 2021 | Increase (decrease) $ | Increase (decrease) % | | :--- | :--- | :--- | :--- | :--- | | US | $40,782 | $37,254 | $3,528 | 9.5% | | Japan | $10,676 | $— | $10,676 | NA | | Europe and rest of world | $1,649 | $2,960 | $(1,311) | (44.3)% | | **Total** | **$53,107** | **$40,214** | **$12,893** | **32.1%** | External R&D Expenses by Product (in thousands) | Product | Q1 2022 | Q1 2021 | Increase (decrease) $ | Increase (decrease) % | | :--- | :--- | :--- | :--- | :--- | | ARIKAYCE | $16,678 | $14,640 | $2,038 | 13.9% | | Brensocatib | $21,726 | $9,597 | $12,129 | 126.4% | | Other | $10,066 | $10,304 | $(238) | (2.3)% | | **Total** | **$48,470** | **$34,541** | **$13,929** | **40.3%** | - **R&D expenses** are expected to increase in 2022 due to ongoing clinical trials for **brensocatib** (Phase 3 **ASPEN**), **ARIKAYCE** (confirmatory **ARISE** and **ENCORE**), and **TPIP**[180](index=180&type=chunk) - As of March 31, 2022, cash and cash equivalents totaled **$515.7 million**, with marketable securities at **$149.0 million**, primarily decreasing due to marketable securities purchases and operating activities[190](index=190&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=35&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) Market risk exposure primarily relates to fixed-rate convertible notes and foreign currency fluctuations, neither of which has materially impacted financial results - The company holds **$800.0 million** in fixed-rate convertible notes (**1.75%** for 2025 Notes, **0.75%** for 2028 Notes), minimizing exposure to interest rate fluctuations[198](index=198&type=chunk) - The majority of business is conducted in US dollars, with some exposure to Euros, British Pounds, and Japanese Yen, though historically, foreign currency fluctuations have not had a material impact on financial results[199](index=199&type=chunk) [Controls and Procedures](index=35&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2022, with no material changes to internal control over financial reporting - The CEO and CFO concluded that as of March 31, 2022, the company's disclosure controls and procedures were effective[200](index=200&type=chunk) - No changes occurred in internal control over financial reporting during the first quarter of 2022 that have materially affected, or are reasonably likely to materially affect, these controls[201](index=201&type=chunk) [PART II. OTHER INFORMATION](index=36&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=36&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is involved in various legal proceedings, but management does not anticipate a material adverse effect on its financial condition or operations - The company states that it is party to various legal proceedings arising in the ordinary course of business but does not expect them to have a material adverse effect on its financial condition[203](index=203&type=chunk) [Risk Factors](index=36&type=section&id=ITEM%201A.%20Risk%20Factors) Investors are directed to the Annual Report on Form 10-K for a comprehensive review of risk factors that could materially affect the company - The report refers to the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, for a comprehensive understanding of the risks and uncertainties facing the business[204](index=204&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - None reported[205](index=205&type=chunk) [Other Information](index=36&type=section&id=ITEM%205.%20Other%20Information) No other information was reported for the period - None reported[206](index=206&type=chunk) [Exhibits](index=37&type=section&id=ITEM%206.%20Exhibits) This section provides an index of exhibits filed with the Form 10-Q, including employment agreements and required certifications - Lists various exhibits filed with the report, including amended employment agreements for executives and required SEC certifications[209](index=209&type=chunk)
Insmed(INSM) - 2021 Q4 - Earnings Call Transcript
2022-02-17 19:02
Insmed Incorporated (NASDAQ:INSM) Q4 2021 Earnings Conference Call February 17, 2022 8:00 AM ET Company Participants Will Lewis - Chairman and Chief Executive Officer Eleanor Barisser - Associate Director, Investor Relations Martina Flammer - Chief Medical Officer Roger Adsett - Chief Operating Officer Sara Bonstein - Chief Financial Officer Conference Call Participants Jessica Fye - JP Morgan Melina Santoro - Morgan Stanley Ritu Baral - Cowen Judah Frommer - Credit Suisse Joori Park - SVB Leerink Stephen W ...
Insmed(INSM) - 2021 Q4 - Annual Report
2022-02-17 12:00
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 54-1972729 (I.R.S. employer identification no.) Commission File Number 0-30739 INSMED INCORPORATED (Exact name of registrant as specified in its ...
Insmed(INSM) - 2021 Q3 - Earnings Call Transcript
2021-10-28 18:53
Insmed Incorporated (NASDAQ:INSM) Q3 2021 Earnings Conference Call October 28, 2021 8:30 AM ET Company Participants Eleanor Barisser – Associate Director, Investor Relations Will Lewis – Chairman and Chief Executive Officer Martina Flammer – Chief Medical Officer Roger Adsett – Chief Operating Officer Sara Bonstein – Chief Financial Officer Conference Call Participants Jennifer Kim – Cantor Fitzgerald Anita Dushyanth – Berenberg Capital Markets Joori Park – SVB Leerink Jeff Hung – Morgan Stanley Stephen Wil ...
Insmed(INSM) - 2021 Q3 - Quarterly Report
2021-10-28 11:29
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 000-30739 INSMED INCORPORATED (Exact name of registrant as specified in its charter) Virginia 54-1972729 (State or other jurisdi ...
Insmed(INSM) - 2021 Q2 - Earnings Call Transcript
2021-08-07 20:15
Insmed Inc. (NASDAQ:INSM) Q2 2021 Earnings Conference Call August 5, 2021 8:30 AM ET Company Participants Eleanor Barisser - Associate Director of IR Will Lewis - Chair and Chief Executive Officer Sara Bonstein - Chief Financial Officer Martina Flammer - Chief Medical Officer Roger Adsett - Chief Operating Officer Conference Call Participants Joseph Schwartz - SVB Leerink Lyla Youssef - Cowen and Company Anita Dushyanth - Berenberg Stephen Willey - Stifel Graig Suvannavejh - Goldman Sachs Operator Welcome t ...
Insmed(INSM) - 2021 Q2 - Quarterly Report
2021-08-05 11:29
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 June 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 000-30739 INSMED INCORPORATED (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or ...
Insmed (INSM ) Presents At 2021 Jefferies Virtual Healthcare Conference - Slideshow
2021-06-03 00:16
Promising Therapies Inspired by Urgent Unmet Patient Needs 2 of the Company, PARI or the Company's other third-party manufacturers to comply with regulatory requirements related to ARIKAYCE or the Lamira® Nebulizer System; the Company's inability to obtain adequate reimbursement from government or third-party payors for ARIKAYCE or acceptable prices for ARIKAYCE; development of unexpected safety or efficacy concerns related to ARIKAYCE or the Company's product candidates; inaccuracies in the Company's estim ...
Insmed(INSM) - 2021 Q1 - Earnings Call Transcript
2021-05-09 03:15
Insmed Incorporated (NASDAQ:INSM) Q1 2021 Earnings Conference Call May 6, 2021 8:30 AM ET Company Participants Eleanor Barisser - Investor Relations Will Lewis - Chair and Chief Executive Officer Martina Flammer - Chief Medical Officer Roger Adsett - Chief Operating Officer Sara Bonstein - Chief Financial Officer Conference Call Participants Joori Park - SVB Leerink Lyla Youssef - Cowen Connor Meehan - Morgan Stanley Anita Dushyanth - Berenberg Capital Graig Suvannavejh - Goldman Sachs Stephen Willey - Stif ...
Insmed(INSM) - 2021 Q1 - Quarterly Report
2021-05-06 11:30
(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q 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 For the transition period from to Commission File Number 000-30739 INSMED INCORPORATED (Exact name of registrant as specified in its charter) Virginia 54-1972729 (State or other jurisdictio ...