Company Quick10K Filing
Quick10K
Insmed
Closing Price ($) Shares Out (MM) Market Cap ($MM)
$28.60 78 $2,220
10-Q 2019-06-30 Quarter: 2019-06-30
10-Q 2019-03-31 Quarter: 2019-03-31
10-K 2018-12-31 Annual: 2018-12-31
10-Q 2018-09-30 Quarter: 2018-09-30
10-Q 2018-06-30 Quarter: 2018-06-30
10-Q 2018-03-31 Quarter: 2018-03-31
10-K 2017-12-31 Annual: 2017-12-31
10-Q 2017-09-30 Quarter: 2017-09-30
10-Q 2017-06-30 Quarter: 2017-06-30
10-Q 2017-03-31 Quarter: 2017-03-31
10-K 2016-12-31 Annual: 2016-12-31
10-Q 2016-09-30 Quarter: 2016-09-30
10-Q 2016-06-30 Quarter: 2016-06-30
10-Q 2016-03-31 Quarter: 2016-03-31
10-K 2015-12-31 Annual: 2015-12-31
10-Q 2015-09-30 Quarter: 2015-09-30
10-Q 2015-06-30 Quarter: 2015-06-30
10-Q 2015-03-31 Quarter: 2015-03-31
10-K 2014-12-31 Annual: 2014-12-31
10-Q 2014-09-30 Quarter: 2014-09-30
10-Q 2014-06-30 Quarter: 2014-06-30
10-Q 2014-03-31 Quarter: 2014-03-31
10-K 2013-12-31 Annual: 2013-12-31
8-K 2019-08-01 Earnings, Exhibits
8-K 2019-06-25 Other Events, Exhibits
8-K 2019-05-24 Regulation FD, Exhibits
8-K 2019-05-21 Other Events, Exhibits
8-K 2019-05-16 Officers, Shareholder Vote
8-K 2019-05-01 Earnings, Officers, Exhibits
8-K 2019-04-08 Earnings, Exhibits
8-K 2019-02-22 Earnings, Exhibits
8-K 2019-01-09 Officers
8-K 2019-01-04 Earnings, Regulation FD, Exhibits
8-K 2018-11-06 Officers, Other Events, Exhibits
8-K 2018-10-30 Earnings, Exhibits
8-K 2018-09-28 Regulation FD, Exhibits
8-K 2018-09-11 Enter Agreement, Off-BS Arrangement, Exhibits
8-K 2018-08-02 Earnings, Exhibits
8-K 2018-05-16 Regulation FD, Exhibits
8-K 2018-05-15 Officers, Shareholder Vote
8-K 2018-03-29 Regulation FD, Exhibits
8-K 2018-02-14 Regulation FD, Exhibits
8-K 2018-01-26 Enter Agreement, Off-BS Arrangement, Other Events, Exhibits
8-K 2018-01-03 Regulation FD, Exhibits
PAYC Paycom 12,160
HPP Hudson Pacific Properties 5,320
AMEH Apollo Medical 724
EB Eventbrite 673
RM Regional Management 284
OMEX Odyssey Marine Exploration 46
LEU Centrus Energy 33
TYHT Shineco 25
TISA Top Image Systems 0
SEP Spectra Energy Partners 0
INSM 2019-06-30
Part I. Financial Information
Item 1. Consolidated Financial Statements
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Item 4. Controls and Procedures
Part II. Other Information
Item 1. Legal Proceedings
Item 1A. Risk Factors
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Item 5. Other Information
Item 6. Exhibits
EX-10.1 insm20190630ex101.htm
EX-10.2 insm20190630ex102.htm
EX-10.3 insm20190630ex103.htm
EX-10.4 insm20190630ex104.htm
EX-10.5 insm20190630ex105.htm
EX-10.6 insm20190630ex106.htm
EX-10.7 insm20190630ex107.htm
EX-31.1 insm20190630ex311.htm
EX-31.2 insm20190630ex312.htm
EX-32.1 insm20190630ex321.htm
EX-32.2 insm20190630ex322.htm

Insmed Earnings 2019-06-30

INSM 10Q Quarterly Report

Balance SheetIncome StatementCash Flow

Document
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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, 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 000-30739
INSMED INCORPORATED
(Exact name of registrant as specified in its charter)
Virginia54-1972729
(State or other jurisdiction of incorporation or organization)(I.R.S. employer identification no.)
10 Finderne Avenue, Building 10
 
Bridgewater, New Jersey
08807
(Address of principal executive offices)(Zip Code)
(908) 977-9900
(Registrant’s telephone number including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section12(b) of the Act:
Title of each classTrading symbolsName of each exchange on which registered
Common stock, par value $0.01 per shareINSMNasdaq Global Select Market
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No 
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer x
Accelerated filer o
Non-accelerated filer o
Smaller reporting company 

Emerging growth company


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes  No x
As of July 29, 2019, there were 89,207,638 shares of the registrant’s common stock outstanding.



Table of Contents
INSMED INCORPORATED
FORM 10-Q
FOR THE QUARTER ENDED JUNE 30, 2019
 
INDEX
 
 
 
 
 
 
Unless the context otherwise indicates, references in this Form 10-Q to “Insmed Incorporated” refers to Insmed Incorporated, a Virginia corporation, and “Company,” “Insmed,” “we,” “us” and “our” refer to Insmed Incorporated together with its consolidated subsidiaries. INSMED, ARIKAYCE, and CONVERT are trademarks of Insmed Incorporated. This Form 10-Q also contains trademarks of third parties. Each trademark of another company appearing in this Form 10-Q is the property of its owner.

2

Table of Contents
PART I.  FINANCIAL INFORMATION
 
ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS
 
INSMED INCORPORATED
Consolidated Balance Sheets
(in thousands, except par value and share data)
 
As ofAs of
June 30, 2019December 31, 2018
 (unaudited) 
Assets  
Current assets:  
Cash and cash equivalents$601,260 $495,072 
Accounts receivable11,638 5,515 
Inventory20,160 7,032 
Prepaid expenses and other current assets15,856 11,327 
Total current assets648,914 518,946 
Intangibles, net56,179 58,675 
Fixed assets, net38,913 22,636 
Operating lease right-of-use assets42,316 — 
Other assets16,461 4,299 
Total assets$802,783 $604,556 
Liabilities and shareholders’ equity  
Current liabilities:  
Accounts payable$17,031 $17,741 
Accrued expenses49,363 38,254 
Accrued compensation10,218 22,208 
Lease liabilities9,184 — 
Other current liabilities234 1,529 
Total current liabilities86,030 79,732 
Debt, long-term326,128 316,558 
Long-term lease liabilities33,530 — 
Other long-term liabilities522  
Total liabilities446,210 396,290 
Shareholders’ equity:  
Common stock, $0.01 par value; 500,000,000 authorized shares, 89,207,455 and 77,307,521 issued and outstanding shares at June 30, 2019 and December 31, 2018, respectively
892 773 
Additional paid-in capital1,778,517 1,489,664 
Accumulated deficit(1,422,829)(1,282,162)
Accumulated other comprehensive loss(7)(9)
Total shareholders’ equity356,573 208,266 
Total liabilities and shareholders’ equity$802,783 $604,556 
See accompanying notes to consolidated financial statements
3

Table of Contents
INSMED INCORPORATED
Consolidated Statements of Comprehensive Loss (unaudited)
(in thousands, except per share data)
 Three Months Ended June 30,Six Months Ended June 30,
 2019201820192018
Revenues, net$29,972 $ $51,874 $ 
Costs and expenses:    
Cost of product revenues (excluding amortization of intangible assets)4,919  9,069  
Research and development33,538 35,722 64,741 65,820 
Selling, general and administrative52,433 37,160 107,243 69,813 
Amortization of intangible assets1,248  2,496  
Total costs and expenses92,138 72,882 183,549 135,633 
Operating loss(62,166)(72,882)(131,675)(135,633)
Investment income2,578 2,729 4,994 4,769 
Interest expense(6,785)(6,488)(13,511)(12,130)
Loss on extinguishment of debt   (2,209)
Other (expense) income, net(51)244 (170)330 
Loss before income taxes(66,424)(76,397)(140,362)(144,873)
Provision for income taxes90 40 305 88 
Net loss$(66,514)$(76,437)$(140,667)$(144,961)
Basic and diluted net loss per share$(0.81)$(1.00)$(1.77)$(1.89)
Weighted average basic and diluted common shares outstanding
81,806 76,767 79,685 76,693 
Net loss$(66,514)$(76,437)$(140,667)$(144,961)
Other comprehensive income:    
Foreign currency translation (losses) gains(37)(21)2 21 
Total comprehensive loss$(66,551)$(76,458)$(140,665)$(144,940)
 
See accompanying notes to consolidated financial statements

4

Table of Contents
INSMED INCORPORATED
Consolidated Statements of Shareholders' Equity (unaudited)
(in thousands)

 Common StockAdditional
Paid-in
Capital
Accumulated
Deficit
Accumulated
Other
Comprehensive
Income (Loss)
Total
SharesAmount
Balance at April 1, 201876,623 $766 $1,460,460 $(1,026,409)$39 $434,856 
Comprehensive loss:      
Net loss(76,437)(76,437)
Other comprehensive income(21)(21)
Exercise of stock options369 4 5,639 5,643 
Equity component of convertible debt issuance(29)(29)
Issuance of common stock for vesting of RSUs47  
Stock compensation expense6,629 6,629 
Balance at June 30, 201877,039 $770 $1,472,699 $(1,102,846)$18 $370,641 
Balance at April 1, 201977,596 $776 $1,499,646 $(1,356,315)$30 $144,137 
Comprehensive loss:      
Net loss(66,514)(66,514)
Other comprehensive income(37)(37)
Exercise of stock options and ESPP shares910 8 10,447 10,455 
Net proceeds from issuance of common stock10,658 107 261,071 261,178 
Issuance of common stock for vesting of RSUs4311 
Stock compensation expense7,353 7,353 
Balance at June 30, 201989,207 $892 $1,778,517 $(1,422,829)$(7)$356,573 

See accompanying notes to consolidated financial statements


5

Table of Contents
INSMED INCORPORATED
Consolidated Statements of Shareholders' Equity (unaudited) (continued)
(in thousands)


 Common StockAdditional
Paid-in
Capital
Accumulated
Deficit
Accumulated
Other
Comprehensive
Income (Loss)
Total
SharesAmount
Balance at January 1, 201876,611 $766 $1,318,181 $(957,885)$(3)$361,059 
Comprehensive loss:      
Net loss(144,961)(144,961)
Other comprehensive income21 21 
Exercise of stock options381 4 5,781 5,785 
Equity component of convertible debt issuance136,434 136,434 
Issuance of common stock for vesting of RSUs47  
Stock compensation expense12,303 12,303 
Balance at June 30, 201877,039 $770 $1,472,699 $(1,102,846)$18 $370,641 
Balance at January 1, 201977,308 $773 $1,489,664 $(1,282,162)$(9)$208,266 
Comprehensive loss:      
Net loss(140,667)(140,667)
Other comprehensive income2 2 
Exercise of stock options and ESPP shares1,163 11 13,493 13,504 
Net proceeds from issuance of common stock10,658 107 261,071 261,178 
Issuance of common stock for vesting of RSUs78 11 
Stock compensation expense14,289 14,289 
Balance at June 30, 201989,207 $892 $1,778,517 $(1,422,829)$(7)$356,573 

See accompanying notes to consolidated financial statements
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Table of Contents
INSMED INCORPORATED
Consolidated Statements of Cash Flows (unaudited)
(in thousands)
 Six Months Ended June 30,
 20192018
Operating activities  
Net loss$(140,667)$(144,961)
Adjustments to reconcile net loss to net cash used in operating activities:  
Depreciation2,245 1,698 
Amortization of intangible assets2,496  
Stock-based compensation expense14,289 12,303 
Loss on extinguishment of debt 2,209 
Amortization of debt issuance costs698 585 
Accretion of debt discount and back-end fee8,872 7,302 
Changes in operating assets and liabilities:  
Accounts receivable(6,123) 
Inventory(13,128) 
Prepaid expenses and other current assets(4,588)(3,653)
Other assets(12,087) 
Accounts payable(1,284)1,981 
Accrued expenses and other7,390 5,037 
Accrued compensation(11,990)(4,826)
Net cash used in operating activities(153,877)(122,325)
Investing activities  
Purchase of fixed assets(14,638)(8,212)
Net cash used in investing activities(14,638)(8,212)
Financing activities  
Proceeds from exercise of stock options and ESPP13,504 5,785 
Proceeds from issuance of common stock, net261,178  
Payment on extinguishment of debt (2,835)
Payment of debt  (55,000)
Proceeds from issuance of 1.75% convertible senior notes due 2025
 450,000 
Payment of debt issuance costs (14,235)
Net cash provided by financing activities274,682 383,715 
Effect of exchange rates on cash and cash equivalents21 (14)
Net increase in cash and cash equivalents106,188 253,164 
Cash and cash equivalents at beginning of period495,072 381,165 
Cash and cash equivalents at end of period$601,260 $634,329 
Supplemental disclosures of cash flow information:  
Cash paid for interest$3,941 $1,276 
Cash paid for income taxes$200 $93 
 See accompanying notes to consolidated financial statements

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INSMED INCORPORATED
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
 
1.                                    The Company and Basis of Presentation

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. The Company's first commercial product, ARIKAYCE (amikacin liposome inhalation suspension), received accelerated approval in the United States (US) in September 2018 for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. MAC lung disease is a rare and often chronic infection that can cause irreversible lung damage and can be fatal. The Company's clinical-stage pipeline includes INS1007 and INS1009. INS1007 is a novel oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) with therapeutic potential in non-cystic fibrosis (non-CF) bronchiectasis and other inflammatory diseases. INS1009 is an inhaled formulation of a treprostinil prodrug that may offer a differentiated product profile for rare pulmonary disorders, including pulmonary arterial hypertension (PAH).

The Company was incorporated in the Commonwealth of Virginia on November 29, 1999 and its principal executive offices are in Bridgewater, New Jersey. The Company has legal entities in the US, Ireland, Germany, France, the United Kingdom (UK), the Netherlands, Bermuda and Japan.
 
The accompanying unaudited interim consolidated financial statements have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by accounting principles generally accepted in the US for complete consolidated financial statements are not included herein. The unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018.
 
The results of operations of any interim period are not necessarily indicative of the results of operations for the full year. The unaudited interim consolidated financial information presented herein reflects all normal adjustments that are, in the opinion of management, necessary for a fair statement of the financial position, results of operations and cash flows for the periods presented. All intercompany transactions and balances have been eliminated in consolidation and certain prior year amounts have been reclassified to conform to the current year presentation.
 
The Company had $601.3 million in cash and cash equivalents as of June 30, 2019 and reported a net loss of $140.7 million for the six months ended June 30, 2019. Historically, the Company has funded its operations through public offerings of equity securities and debt financings. The Company commenced commercial shipments of ARIKAYCE in October 2018. The Company expects to continue to incur operating losses both at our US and certain international entities while funding research and development (R&D) activities for ARIKAYCE and our other pipeline programs, continuing commercial launch activities for ARIKAYCE in the US, continuing to invest in pre-commercial and regulatory activities for ARIKAYCE in Europe and Japan, and funding other general and administrative activities. The Company expects its future cash requirements to be substantial, and the Company may need to raise additional capital to fund operations, including the commercialization of ARIKAYCE and additional clinical trials related to ARIKAYCE, to develop INS1007 and INS1009 and to develop, acquire, in-license or co-promote other products or product candidates that address orphan or rare diseases.

  In the second quarter of 2019, the Company completed an underwritten offering of 10,657,692 shares of the Company's common stock, which included the underwriters' exercise in full of its over-allotment option of 1,042,307 shares from the Company at a price to the public of $26.00, less underwriting discounts and commissions. The Company's net proceeds from the sale of the shares, after deducting the underwriting discounts and commissions and offering expenses of $15.9 million, were $261.2 million. The offering also included the sale of 400,000 shares from the Company's Chairman and Chief Executive Officer, from which the Company received no proceeds. The source, timing and availability of any future financing or other transaction will depend principally upon continued progress in the Company’s commercial, regulatory and development activities. Any equity or debt financing will also be contingent upon equity and debt market conditions and interest rates at the time. If the Company is unable to obtain sufficient additional funds when required, the Company may be forced to delay, restrict or eliminate all or a portion of its development programs or commercialization efforts.


2.                                      Summary of Significant Accounting Policies
 
The following are the required interim disclosure updates to the Company's significant accounting policies described in Note 2 of the notes to the consolidated financial statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018:
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Fair Value Measurements - The Company categorizes its financial assets and liabilities measured and reported at fair value in the financial statements on a recurring basis based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels, which are directly related to the amount of subjectivity associated with the inputs used to determine the fair value of financial assets and liabilities, are as follows:
 
Level 1 — Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
 
Level 2 — Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the assets or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.
 
Level 3 — Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
 
Each major category of financial assets and liabilities measured at fair value on a recurring basis is categorized based upon the lowest level of significant input to the valuations. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Financial instruments in Level 1 generally include US treasuries and mutual funds listed in active markets.
 
The Company’s only financial assets and liabilities which were measured at fair value as of June 30, 2019 and December 31, 2018 were Level 1 assets comprised of cash and cash equivalents. The Company's cash and cash equivalents permit daily redemption and the fair values of these investments are based upon the quoted prices in active markets provided by the holding financial institutions. The following table shows assets and liabilities that are measured at fair value on a recurring basis and their carrying value (in millions):

As of June 30, 2019
Fair Value
Carrying ValueLevel 1Level 2Level 3
Cash and cash equivalents$601.3 $601.3 $ $ 

The Company recognizes transfers between levels within the fair value hierarchy, if any, at the end of each quarter. There were no transfers in or out of Level 1, Level 2 or Level 3 during the six months ended June 30, 2019 and 2018, respectively.

As of June 30, 2019 and December 31, 2018, the Company held no securities that were in an unrealized gain or loss position.

The Company reviews the status of each security quarterly to determine whether an other-than-temporary impairment has occurred. In making its determination, the Company considers a number of factors, including: (1) the significance of the decline; (2) whether the securities were rated below investment grade; (3) how long the securities have been in an unrealized loss position; and (4) the Company’s ability and intent to retain the investment for a sufficient period of time for it to recover.

The estimated fair value of the liability component of the Company's 1.75% convertible senior notes due 2025 (the Convertible Notes) (categorized as a Level 2 liability for fair value measurement purposes) as of June 30, 2019 was $431.9 million, determined using current market factors and the ability of the Company to obtain debt on comparable terms to the Convertible Notes. The $326.1 million carrying value of the Convertibles Notes as of June 30, 2019 excludes the $116.1 million of the unamortized portion of the debt discount.
 
Net Loss Per Share - Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares and other dilutive securities outstanding during the period. Potentially dilutive securities from stock options, restricted stock units (RSUs) and convertible debt securities would be anti-dilutive as the Company incurred a net loss. Potentially dilutive common shares resulting from the assumed exercise of outstanding stock options and from the assumed conversion of the Convertible Notes are determined based on the treasury stock method.
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The following table sets forth the reconciliation of the weighted average number of common shares used to compute basic and diluted net loss per share for the three and six months ended June 30, 2019 and 2018:
 
 Three Months Ended June 30,Six Months Ended June 30,
 2019201820192018
 (in thousands, except per share amounts)
Numerator:    
Net loss$(66,514)$(76,437)$(140,667)$(144,961)
Denominator:    
Weighted average common shares used in calculation of basic net loss per share:81,806 76,767 79,685 76,693 
Effect of dilutive securities:    
Common stock options    
RSUs    
Convertible debt securities    
Weighted average common shares outstanding used in calculation of diluted net loss per share81,806 76,767 79,685 76,693 
Net loss per share:    
Basic and diluted$(0.81)$(1.00)$(1.77)$(1.89)
 
The following potentially dilutive securities have been excluded from the computations of diluted weighted average common shares outstanding as of June 30, 2019 and 2018 as their effect would have been anti-dilutive (in thousands):
 
As of June 30,
 20192018
Stock options to purchase common stock11,034 9,578 
Unvested RSUs475 236 
Convertible debt securities11,492 11,492 
 
Concentration of Credit Risk—Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company places its cash equivalents with high credit-quality financial institutions and may invest its short-term investments in US treasury securities, mutual funds and government agency bonds. The Company has established guidelines relative to credit ratings and maturities that seek to maintain safety and liquidity.
The Company is exposed to risks associated with extending credit to customers related to the sale of products. The Company does not require collateral to secure amounts due from its customers. The following table presents the percentage of gross product revenue represented by the Company's three largest customers as of the six months ended June 30, 2019.
Percentage of Total Gross Product Revenue
Customer A31 
Customer B30 
Customer C19 
The Company did not have product revenue prior to US FDA approval of ARIKAYCE in September 2018. The Company relies on third-party manufacturers and suppliers for manufacturing and supply of its products. The inability of the suppliers or manufacturers to fulfill supply requirements of the Company could materially impact future operating results. A change in the relationship with the suppliers or manufacturer, or an adverse change in their business, could materially impact future operating results.
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Revenue Recognition—In accordance with Accounting Standards Codification (ASC) 606, Revenue from Contracts with Customers, the Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for the goods or services provided. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: (1) identify the contracts with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when or as the entity satisfies a performance obligation. At contract inception, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied. For all contracts that fall into the scope of ASC 606, the Company has identified one performance obligation: the sale of ARIKAYCE to its customers. The Company has not incurred or capitalized any incremental costs associated with obtaining contracts with customers.

Product revenues consist primarily of sales of ARIKAYCE in the US. Product revenues are recognized once the Company performs and satisfies all five steps mentioned above. In October 2018, the Company began shipping ARIKAYCE to its customers in the US, which include specialty pharmacies and specialty distributors. The Company recognizes revenues for product received by its customers, net of allowances for customer credits, including prompt pay discounts, service fees, estimated rebates, including government rebates such as Medicaid rebates and Medicare Part D coverage gap reimbursements in the US, chargebacks and returns.
 
Customer credits: The Company’s customers are offered various forms of consideration, including service fees and prompt payment discounts. The Company anticipates that its customers will earn prompt payment discounts and, therefore, deducts the full amount of these discounts from total gross product revenues when revenues are recognized. Service fees are also deducted from total gross product revenues as they are earned.
 
Rebates: The Company contracts with Medicaid, other government agencies and various private organizations, or collectively, third-party payors, so that ARIKAYCE will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. The Company estimates the rebates it will provide to third-party payors and deducts these estimated amounts from total gross product revenues at the time the revenues are recognized.
 
Chargebacks: Chargebacks are discounts that occur when certain contracted customers, currently public health service institutions and federal government entities purchasing via the Federal Supply Schedule, purchase directly from the Company's specialty distributor. Contracted customers generally purchase the product at a discounted price and the specialty distributor, in turn, charges back to the Company the difference between the price initially paid by the specialty distributor and the discounted price paid by the contracted customers. The Company estimates the chargebacks it provides to the specialty distributor and deducts these estimated amounts from total gross product revenues at the time the revenues are recognized.
Co-payment assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. The Company accrues a liability for co-payment assistance based on actual program participation and estimates of program redemption using data provided by a third-party administrator.
If any, or all, of the Company’s actual experience vary from the estimates above, the Company may need to adjust prior period accruals, affecting revenue in the period of adjustment.
The Company has initiated early access programs (EAPs) in Europe and other countries, some of which may be fully reimbursed. EAPs are intended to make products available on a named patient basis before they are commercially available in accordance with local regulations.
Cost of product revenues (excluding amortization of intangible assets) - Cost of product revenues (excluding amortization of intangible assets) consist primarily of direct and indirect costs related to the manufacturing of ARIKAYCE sold, including third-party manufacturing costs, packaging services, freight, and allocation of overhead costs, in addition to royalty expenses due to PARI Pharma GmbH (PARI). Prior to FDA approval of ARIKAYCE, the Company expensed all inventory related costs in the period incurred. Inventory used for clinical development purposes is expensed to research and development (R&D) expense when consumed.

Recently Adopted Accounting Pronouncements - In August 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standard Update (ASU) 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments, which addressed eight specific cash flow issues with the objective of reducing the existing diversity in practice. Among the updates, the standard requires debt extinguishment costs to be classified as cash outflows for
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financing activities. This standard update became effective as of the first quarter of 2018. As a result of the adoption of the standard, in the first quarter of 2018, the Company reported a $2.2 million loss on extinguishment of debt in the operating activities section of its consolidated statement of cash flows. The Company had no material debt extinguishment costs prior to the first quarter of 2018. The impact of adopting this standard was not material to the Company.

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) in order to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet for those leases classified as operating leases under previous generally accepted accounting principles. ASU 2016-02 requires a lessee to recognize a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term on the balance sheet. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018 (including interim periods within those years) and early adoption was permitted. In August 2018, the FASB issued ASU 2018-11, Targeted Improvements to ASC 842, which provided a transition option in which an entity would initially apply ASU 2016-02 at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. The Company used the new transition option and the package of practical expedients that allowed it to not reassess: (1) whether any expired or existing contracts are or contain leases; (2) lease classification for any expired or existing leases; and (3) initial direct costs for any expired or existing leases. The Company also used the practical expedient that allows it to treat the lease and non-lease components of its leases as a single component. The Company adopted ASU 2016-02 effective January 1, 2019. The impact of the adoption of ASU 2016-02 on the consolidated balance sheet was $47.4 million. Refer to Note 7 - Leases for additional details about the Company's lease portfolio, including Topic 842 required disclosures.
 
New Accounting Pronouncements (Not Yet Adopted)—In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses which requires financial assets measured at an amortized cost basis to be presented at the net amount expected to be collected. The measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. ASU 2016-13 is effective for fiscal years beginning after December 15, 2019. Different aspects of the guidance require modified retrospective or prospective adoption. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
 
3.        Inventory
As of June 30, 2019 and December 31, 2018, the Company's inventory balance consists of the following (in thousands):
June 30, 2019December 31, 2018
Raw materials$9,216 $2,145 
Work-in-process9,008 4,567 
Finished goods1,936 320 
$20,160 $7,032 

Inventory is stated at the lower of cost and net realizable value and consists of raw materials, work-in-process and finished goods. Cost is determined using a standard cost method, which approximates actual cost, and assumes a FIFO flow of goods. The Company began capitalizing inventory costs following FDA approval of ARIKAYCE in September 2018. The Company has not recorded any inventory write downs since that time. The Company currently uses a limited number of third-party contract manufacturing organizations (CMOs) to produce its inventory.

4.                                      Intangibles, net
 
As of June 30, 2019, the Company's identifiable intangible assets consisted of acquired ARIKAYCE R&D and a milestone paid to PARI for the license to use PARI's Lamira® Nebulizer System for the delivery of ARIKAYCE to patients as a result of the FDA approval of ARIKAYCE in September 2018. Total intangible assets, net was $56.2 million as of June 30, 2019 and $58.7 million as of December 31, 2018.

Intangible assets are measured at their respective fair values on the date they were recorded and, with respect to the acquired ARIKAYCE milestone, at the date of subsequent adjustments of fair value. The Company began amortizing its intangible assets in October 2018, over ARIKAYCE's initial regulatory exclusivity period of 12 years. A rollforward of the Company's intangible assets for the six months ended June 30, 2019 follows (in thousands):
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2019
Intangible AssetJanuary 1,AdditionsAmortizationJune 30,
Acquired ARIKAYCE R&D$56,988 $ $(2,425)$54,563 
PARI milestone upon FDA approval1,687  (71)1,616 
     Intangible assets$58,675 $ $(2,496)$56,179 

Amortization of intangible assets during each of the next five years is estimated to be approximately $5.0 million per year. The Company reviews the recoverability of these finite-lived intangible assets whenever events or changes in circumstances indicate that the carrying value of such assets may not be recoverable. During the quarter ended June 30, 2019, no indicators of impairment were identified.
 
5. Fixed Assets, net

Fixed assets are stated at cost and depreciated using the straight-line method, based on useful lives as follows (in thousands):

Estimated
Useful Life (years)
Asset DescriptionAs of June 30, 2019As of December 31, 2018
Lab equipment7$8,557 $7,935 
Furniture and fixtures72,559 2,320 
Computer hardware and software
3-5
4,841 3,796 
Office equipment76565
Manufacturing equipment71,398 1,166 
Leasehold improvementslease term8,861 7,202 
Construction in Progress (CIP)— 29,050 14,325 
55,331 36,809 
Less accumulated depreciation(16,418)(14,173)
Fixed assets, net$38,913 $22,636 

Fixed assets, net of depreciation increased to $38.9 million as of June 30, 2019 from $22.6 million as of December 31, 2018. The increase was primarily due to $14.7 million in CIP for the manufacturing equipment related to the long-term capacity build-out at the Patheon UK Limited (Patheon) facility and build-out of the Company's new corporate headquarters.

6.                                      Accrued Expenses
 
As of June 30, 2019 and December 31, 2018, the Company's accrued expenses balance consist of the following (in thousands): 
June 30, 2019December 31, 2018
Accrued clinical trial expenses$6,179 $6,635 
Accrued professional fees10,014 13,398 
Accrued technical operation expenses13,513 9,371 
Accrued royalty payable1,389 409 
Accrued interest payable3,631 3,631 
Accrued sales allowances and related costs3,206 818 
Accrued construction costs6,521 2,946 
Other accrued expenses4,910 1,046 
 $49,363 $38,254 
 
7.                                    Leases

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The Company's lease portfolio consists primarily of office space, manufacturing facilities and fleet vehicles. Currently, all of the Company's leases that have commenced are classified as operating leases. The terms of the Company's lease agreements that have commenced range from less than one year to seven years. In its assessment of the term of each such lease, the Company has not included any options to extend or terminate the lease due to the absence of economic incentives in its lease agreements. As permitted by the practical expedient in ASU 2016-02, leases that qualify for treatment as a short-term lease are expensed as incurred. These short-term leases are not material to the Company's financial position. Furthermore, the Company has elected the practical expedient to not separate lease and non-lease components for all classes of underlying assets. The Company's leases do not contain residual value guarantees and it does not sublease any of its leased assets.

The Company outsources its manufacturing operations to CMOs. Upon review of the agreements with its CMOs, the Company determined that these contracts contain embedded leases for dedicated manufacturing facilities. The Company obtains substantially all of the economic benefits from the use of the manufacturing facilities, has the right to direct how and for what purpose the facility is used throughout the period of use, and the supplier does not have the right to change the operating instructions of the facility. The operating lease right-of-use assets and corresponding lease liabilities associated with the manufacturing facilities is the sum of the minimum guarantees over the life of the production contracts.

In order to determine the appropriate discount rate for each lease, the Company determined its public credit rating and constructed debt yield curves. The debt yield curves were adjusted to reflect a collateral borrowing and differences in foreign currencies, where applicable, as well as to match the term of each lease.

The table below summarizes the Company's total lease costs included in its consolidated financial statements, as well as other required quantitative disclosures (in thousands).
Three Months EndedSix Months Ended
June 30, 2019June 30, 2019
Lease cost
 Operating lease cost$3,075 $6,154 
Total lease cost$3,075 $6,154 
Other information:
Cash paid for amounts included in the measurement of lease liabilities:
  Operating cash flows for operating leases$3,141 $6,275 
Right-of-use assets obtained in exchange for new operating lease liabilities$ $47,396 
Weighted average remaining lease term - operating leases (years)5.3 years5.3 years
Weighted average discount rate - operating leases7.3 %7.3 %

The table below presents the maturity of lease liabilities on an annual basis for the remaining years of the Company's commenced lease agreements (in thousands).

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Year ending December 31,
2019 (remaining)$6,230 
2020 11,000 
2021 10,287 
2022 6,000 
2023 6,000 
Thereafter
12,000 
Total51,517 
Less: present value discount
8,803 
Present value of lease liabilities$42,714 
Balance sheet classification at June 30, 2019:
  Current lease liabilities$9,184 
  Long-term lease liabilities33,530 
Total lease liabilities$42,714 


In addition to the Company's lease agreements that have previously commenced and are reflected in the consolidated financial statements, the Company has entered into additional lease agreements that have not yet commenced. In September 2018, the Company entered into an agreement to lease its new corporate headquarters in Bridgewater, NJ for which the initial lease term expires in June 2030. Upon commencement of the lease, which is anticipated to occur in the second half of 2019, the lease will be accounted for as a finance lease and the Company estimates the impact on its consolidated balance sheet will be approximately $20 million to $25 million.

Additionally, in October 2017, the Company entered into certain agreements with Patheon related to increasing its long-term production capacity for ARIKAYCE commercial inventory. Similar to the CMO arrangements previously described, the Company has determined that this agreement with Patheon contains an embedded lease for the manufacturing facility and the specialized equipment contained therein. Certain costs incurred by the Company under the agreement of $12.4 million, subsequent to the adoption of ASU 2016-02, have been classified within other assets in the Company's consolidated balance sheet. Upon the commencement date, the lease will be accounted for as an operating lease and prepaid costs and minimum guarantees specified in the agreement will be combined to establish an operating lease right-of-use asset and related lease liability.

8.                                    Debt
 
In January 2018, the Company completed an underwritten public offering of the Convertible Notes, in which the Company sold $450.0 million aggregate principal amount of Convertible Notes, including the exercise in full of the underwriters' option to purchase additional Convertible Notes of $50.0 million. The Company's net proceeds from the offering, after deducting underwriting discounts and commissions and other offering expenses of $14.2 million, were approximately $435.8 million. The Convertible Notes bear interest payable semiannually in arrears on January 15 and July 15 of each year, beginning on July 15, 2018. The Convertible Notes mature on January 15, 2025, unless earlier converted, redeemed, or repurchased.

On or after October 15, 2024, until the close of business on the second scheduled trading day immediately preceding January 15, 2025, holders may convert their Convertible Notes at any time. Upon conversion, holders may receive cash, shares of the Company's common stock or a combination of cash and shares of the Company's common stock, at the Company's option. The initial conversion rate is 25.5384 shares of common stock per $1,000 principal amount of Convertible Notes (equivalent to an initial conversion price of approximately $39.16 per share of common stock). The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest.

Holders may convert their Convertible Notes prior to October 15, 2024, only under the following circumstances, subject to the conditions set forth in an indenture, dated as of January 26, 2018, between the Company and Wells Fargo Bank, National Association (Wells Fargo), as trustee, as supplemented by the first supplemental indenture, dated January 26, 2018, between the Company and Wells Fargo (as supplemented, the Indenture): (i) during the five business day period immediately after any five consecutive trading day period (the measurement period) in which the trading price per $1,000 principal amount of convertible notes, as determined following a request by a holder of the convertible notes, for each trading day of the
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measurement period was less than 98% of the product of the last reported sale price of the common stock and the conversion rate on such trading day, (ii) the Company elects to distribute to all or substantially all holders of the common stock (a) any rights, options or warrants (other than in connection with a stockholder rights plan for so long as the rights issued under such plan have not detached from the associated shares of common stock) entitling them, for a period of not more than 45 days from the declaration date for such distribution, to subscribe for or purchase shares of common stock at a price per share that is less than the average of the last reported sale prices of the common stock for the 10 consecutive trading day period ending on, and including, the trading day immediately preceding the declaration date for such distribution, or (b) the Company’s assets, debt securities or rights to purchase securities of the Company, which distribution has a per share value, as reasonably determined by the board of directors, exceeding 10% of the last reported sale price of the common stock on the trading day immediately preceding the declaration date for such distribution, (iii) if a transaction or event that constitutes a fundamental change or a make-whole fundamental change occurs, or if the Company is a party to (a) a consolidation, merger, combination, statutory or binding share exchange or similar transaction, pursuant to which the common stock would be converted into, or exchanged for, cash, securities or other property or assets, or (b) any sale, conveyance, lease or other transfer or similar transaction in one transaction or a series of transactions of all or substantially all of the consolidated assets of the Company and its subsidiaries, taken as a whole, all or any portion of the Convertible Notes may be surrendered by a holder for conversion at any time from or after the date that is 30 scheduled trading days prior to the anticipated effective date of the transaction, (iv) if during any calendar quarter commencing after the calendar quarter ending on March 31, 2018 (and only during such calendar quarter), the last reported sale price of the common stock for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day, or, (v) if the Company sends a notice of redemption, a holder may surrender all or any portion of its Convertible Notes, to which the notice of redemption relates, for conversion at any time on or after the date the applicable notice of redemption was sent until the close of business on (a) the second business day immediately preceding the related redemption date or (b) if the Company fails to pay the redemption price on the redemption date as specified in such notice of redemption, such later date on which the redemption price is paid.
 
The Convertible Notes can be settled in cash, common stock, or a combination of cash and common stock at the Company's option, and thus, the Company determined the embedded conversion options in the convertible notes are not required to be separately accounted for as a derivative. However, since the Convertible Notes are within the scope of the accounting guidance for cash convertible instruments, the Company is required to separate the Convertible Notes into liability and equity components. The carrying amount of the liability component as of the date of issuance was calculated by measuring the fair value of a similar liability that did not have an associated equity component. The fair value was based on data from readily available pricing sources which utilize market observable inputs and other characteristics for similar types of instruments. The carrying amount of the equity component representing the embedded conversion option was determined by deducting the fair value of the liability component from the gross proceeds of the Convertible Notes. The excess of the principal amount of the liability component over its carrying amount is amortized to interest expense over the expected life of a similar liability that does not have an associated equity component using the effective interest method. The equity component is not remeasured as long as it continues to meet the conditions for equity classification in the accounting guidance for contracts in an entity’s own equity. The fair value of the liability component of the Convertible Notes on the date of issuance was estimated at $309.1 million using an effective interest rate of 7.6%, and accordingly, the residual equity component on the date of issuance was$140.9 million. The discount is being amortized to interest expense over the term of the Convertible Notes and has a remaining period of approximately 5.5 years. The following table presents the carrying value of the Company’s debt balance (in thousands):
 
June 30, 2019December 31, 2018
 1.75% convertible senior notes due 2025
$450,000 $450,000 
 Debt issuance costs, unamortized(7,742)(8,440)
 Discount on debt(116,130)(125,002)
Long-term debt, net$326,128 $316,558 
 
As of June 30, 2019, future principal repayments of the debt for each of the fiscal years through maturity were as follows (in thousands):
 
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Year Ending December 31: 
2019 $ 
2020  
2021  
2022  
2023  
2024 and thereafter450,000 
 $450,000 
 
In February 2018, the Company used part of the net proceeds from the issuance of the Convertible Notes to pay off its outstanding debt to Hercules Capital (Hercules). The payments to Hercules consisted of $55.0 million for the principal amount and an additional $3.2 million in back-end fees, outstanding interest, and prepayment penalty fees, which resulted in a $2.2 million loss on extinguishment of debt in the quarter ended March 31, 2018. 

Interest Expense

Interest expense related to the Convertible Notes for the three and six months ended June 30, 2019 and June 30, 2018, which includes the contractual interest coupon payable semi-annually in cash, the amortization of the issuance costs, and accretion of debt discount is as follows (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2019 2018 2019 2018 
Contractual interest expense$1,970 $1,971 $3,941 $4,243 
Amortization of debt issuance costs349 286 698 585 
Accretion of back-end fee on debt   50 
Accretion of debt discount4,466 4,231 8,872 7,252 
     Total interest expense$6,785 $6,488 $13,511 $12,130 

 
9.                                      Shareholders’ Equity
 
Common Stock — As of June 30, 2019, the Company had 500,000,000 shares of common stock authorized with a par value of $0.01 per share and 89,207,455 shares of common stock issued and outstanding. In addition, as of June 30, 2019, the Company had reserved 11,033,658 shares of common stock for issuance upon the exercise of outstanding stock options and 475,106 shares of common stock for issuance upon the vesting of RSUs. The Company has also reserved 11,492,280 shares of common stock for issuance upon conversion of the Convertible Notes, subject to adjustment in accordance with the Indenture.

In the second quarter of 2019, the Company completed an underwritten public offering of 10,657,692 shares of the Company's common stock, which included the underwriters' exercise in full of its over-allotment option of 1,042,307 shares from the Company at a price to the public of $26.00, less underwriting discounts and commissions. The Company's net proceeds from the sale of the shares, after deducting the underwriting discounts and commissions and offering expenses of $15.9 million, were $261.2 million. The offering also included the sale of 400,000 shares from the Company's Chairman and Chief Executive Officer, from which the Company received no proceeds.

In January 2018, the Company completed an underwritten public offering of $450.0 million aggregate principal amount of Convertible Notes, including the exercise in full of the underwriter's option to purchase additional Convertible Notes. The fair value of the liability component of the Convertible Notes on the date of issuance was estimated at $309.1 million, and accordingly, the equity component (included in additional paid-in capital) on the date of issuance was calculated as $140.9 million using the residual method, as further described in Note 8 Debt.

Preferred Stock — As of June 30, 2019, the Company had 200,000,000 shares of preferred stock authorized with a par value of $0.01 per share and no shares of preferred stock were issued and outstanding.

10.                                      Stock-Based Compensation
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The Company’s current equity compensation plan, the 2019 Incentive Plan, was approved by shareholders at the Company’s Annual Meeting of Shareholders on May 16, 2019. The 2019 Incentive Plan is administered by the Compensation Committee and the Board of Directors of the Company. Under the terms of the 2019 Incentive Plan, the Company is authorized to grant a variety of incentive awards based on its common stock, including stock options (both incentive stock options and non-qualified stock options), RSUs, performance options/shares and other stock awards to eligible employees and non-employee directors. On May 16, 2019, upon the approval of the 2019 Incentive Plan by shareholders, 3,500,000 shares were authorized for issuance thereunder, plus any shares subject to then-outstanding awards under the 2017 Incentive Plan, 2015 Incentive Plan and the 2013 Incentive Plan that subsequently were canceled, terminated unearned, expired, were forfeited, lapsed for any reason or were settled in cash without the delivery of shares. As of June 30, 2019, 3,817,005 shares remained for future issuance under the 2019 Incentive Plan. The 2019 Incentive Plan will terminate on May 16, 2029 unless it is extended or terminated earlier pursuant to its terms. In addition, from time to time, the Company makes inducement grants of stock options to new hires, which awards are made pursuant to the NASDAQ inducement grant exception. During the six months ended June 30, 2019, the Company granted inducement stock options covering 137,430 shares of the Company's common stock to new employees.
 
On May 15, 2018, the 2018 Employee Stock Purchase Plan (2018 ESPP) was approved by shareholders at the Company’s Annual Meeting of Shareholders. The Company has reserved the following for issuance under the 2018 ESPP: (i) 1,000,000 shares of common stock, plus (ii) commencing on January 1, 2019 and ending on December 31, 2023, an additional number of shares to be added on the first day of each calendar year equal to the lesser of (A) 1,200,000 shares of common stock, (B) 2% of the number of outstanding shares of common stock on such date and (C) an amount determined by the administrator.

Stock Options - As of June 30, 2019, there was $38.7 million of unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted average period of 2.9 years. During the quarter ended September 30, 2018, performance-condition options totaling $1.1 million, or 133,334 shares, met their recognition criteria as a result of the FDA approval of ARIKAYCE and vested in full. As of June 30, 2019, there were no performance-condition options outstanding.
  
Restricted Stock Units — As of June 30, 2019, there was $9.7 million of unrecognized compensation expense related to unvested RSU awards which is expected to be recognized over a weighted average period of 3.2 years.
 
The following table summarizes the aggregate stock-based compensation expense recorded in the consolidated statements of comprehensive loss related to stock options and RSUs during the three and six months ended June 30, 2019 and 2018, respectively (in millions): 
 Three Months Ended June 30,Six Months Ended June 30,
 2019201820192018
Research and development$