knsa_Current_Folio_10Q

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

 

For the transition period from           to         

Commission file number: 001-38492

 


Kiniksa Pharmaceuticals, Ltd.

(Exact name of registrant as specified in its charter)

 


 

Bermuda

 

98-1327726

(State or other jurisdiction of

 

(I.R.S. Employer

incorporation or organization)

 

Identification Number)

 

Kiniksa Pharmaceuticals, Ltd.

Clarendon House

2 Church Street

Hamilton HM11, Bermuda

(808) 451-3453

(Address, zip code and telephone number, including area code of principal executive offices)

 

Kiniksa Pharmaceuticals Corp.

100 Hayden Avenue

Lexington, MA, 02421

(781) 431-9100

(Address, zip code and telephone number, including area code of agent for service)

N/A

(Former name, former address and former fiscal year, if changed since last report)

 

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 ☒ 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   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

 

 

Accelerated Filer

 

  

 

 

 

 

 

 

 

Non-accelerated Filer

 

 

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  

 

Securities registered pursuant to Section 12(b) of the Act:

 

 

 

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Class A Common Shares

KNSA

The Nasdaq Global Select Market

 

As of October 31, 2019, there were 54,881,340 common shares outstanding in aggregate, comprised of:

 

19,188,913 Class A common shares, par value $0.000273235 per share

 

4,638,855 Class B common shares, par value $0.000273235 per share

 

14,995,954 Class A1 common shares, par value $0.000273235 per share

 

16,057,618 Class B1 common shares, par value $0.000273235 per share

 

 

 

Table of Contents

Kiniksa Pharmaceuticals, Ltd.

FORM 10‑Q

FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2019

TABLE OF CONTENTS

 

Page

PART I — FINANCIAL INFORMATION 

5

Item 1. Financial Statements (unaudited) 

5

Consolidated Balance Sheets as of September 30, 2019 and December 31, 2018 

5

Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2019 and 2018 

6

Consolidated Statements of Convertible Preferred Shares and Shareholders’ Equity for the three and nine months ended September 30, 2019 and 2018 

7

Consolidated Statements of Cash Flows for the nine months ended September 30, 2019 and 2018 

8

Notes to Consolidated Financial Statements 

9

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 

33

Item 3. Quantitative and Qualitative Disclosures About Market Risk 

46

Item 4. Controls and Procedures 

47

 

 

PART II — OTHER INFORMATION 

48

Item 1. Legal Proceedings 

48

Item 1A. Risk Factors 

48

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 

111

Item 3. Defaults Upon Senior Securities 

111

Item 4. Mine Safety Disclosures 

112

Item 5. Other Information 

112

Item 6. Exhibits 

112

 

 

SIGNATURES 

114

 

 

2

Table of Contents

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward‑looking statements. All statements other than statements of historical facts contained in this Quarterly Report including statements regarding our future results of operations and financial position, expected timeline for our cash, cash equivalents and short-term investments, business strategy, prospective products and product candidates, their expected properties, performance and impact on healthcare, the expected timeline for achievement of our clinical milestones, the timing of, and potential results from, clinical and other trials, marketing authorization from the FDA or regulatory authorities in other jurisdictions, coverage and reimbursement for our product candidates, if approved, research and development costs, timing of regulatory filings and feedback, timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated products, are forward‑looking statements.

These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward‑looking statements.

In some cases, you can identify forward‑looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “goal,” “design,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward‑looking statements contain these identifying words. The forward‑looking statements in this Quarterly Report are only predictions. We have based these forward‑looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward‑looking statements speak only as of the date of this Quarterly Report and are subject to a number of risks, uncertainties and assumptions described under the sections in this Quarterly Report entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report. These forward‑looking statements are subject to numerous risks, including, without limitation, the following:

·

our status as a clinical‑stage biopharmaceutical company and our expectation to incur losses in the future;

·

our future capital needs and our need to raise additional funds;

·

our limited operating history;

·

the lengthy and expensive clinical development process with its uncertain outcome and potential for clinical failure or delay;

·

the decision by any applicable regulatory authority whether to clear our product candidates for clinical development and, ultimately, whether to approve them for marketing and sale;

·

our ability to anticipate and prevent adverse events caused by our product candidates;

·

our ability to identify, in‑license, acquire, discover or develop additional product candidates;

·

our ability to have our product candidates manufactured in accordance with regulatory requirements;

·

the market acceptance of our product candidates;

·

our ability to timely and successfully develop and commercialize our existing and future product candidates, if approved;

·

competitive and potentially competitive products and technologies;

3

Table of Contents

·

physician awareness and adoption of our product candidates;

·

the size of the market for our product candidates;

·

our ability to meet the quality expectations of physicians or patients;

·

our ability to improve our product candidates;

·

the decision of third‑party payors not to cover our product candidates or to require extensive or independently performed clinical trials prior to covering or maintaining coverage of our product candidates;

·

our ability to successfully manage our growth;

·

our ability to avoid product liability claims and maintain adequate product liability insurance;

·

our ability to obtain regulatory exclusivity;

·

our ability to obtain, maintain, protect and enforce our intellectual property rights related to our product candidates;

·

federal, state and foreign regulatory requirements applicable to our product candidates; and

·

ownership concentration of our executive officers and certain members of senior management may prevent our shareholders from influencing significant corporate decisions.

Because forward‑looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward‑looking statements as predictions of future events. The events and circumstances reflected in our forward‑looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward‑looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. As a result of these factors, we cannot assure you that the forward‑looking statements in this Quarterly Report will prove to be accurate. Except as required by applicable law, we do not plan to publicly update or revise any forward‑looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

You should read this Quarterly Report and the documents that we reference in this Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward‑looking statements by these cautionary statements.

Industry and other data

Unless otherwise indicated, certain industry data and market data included in this Quarterly Report were obtained from independent third‑party surveys, market research, publicly available information, reports of governmental agencies and industry publications and surveys. All of the market data used in this Quarterly Report involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. We believe that the information from these industry publications and surveys included in this Quarterly Report is reliable.

 

4

Table of Contents

Part I — Financial Information

Item 1. Financial Statements (unaudited)

KINIKSA PHARMACEUTICALS, LTD.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

September 30, 

 

December 31, 

 

    

2019

    

2018

Assets

 

 

  

 

 

  

Current assets:

 

 

  

 

 

  

Cash and cash equivalents

 

$

68,809

 

$

71,976

Short-term investments

 

 

189,936

 

 

235,328

Prepaid expenses and other current assets

 

 

9,595

 

 

6,446

Total current assets

 

 

268,340

 

 

313,750

Property and equipment, net

 

 

6,409

 

 

6,356

Operating lease right-of-use assets

 

 

2,218

 

 

 —

Restricted cash

 

 

210

 

 

210

Deferred offering costs

 

 

 —

 

 

433

Deferred tax assets

 

 

4,628

 

 

1,216

Total assets

 

$

281,805

 

$

321,965

 

 

 

 

 

 

 

Liabilities and Shareholders’ Equity

 

 

  

 

 

  

Current liabilities:

 

 

  

 

 

  

Accounts payable

 

$

6,440

 

$

10,918

Accrued expenses

 

 

19,360

 

 

16,418

Accrued milestones

 

 

150

 

 

15,000

Operating lease liabilities

 

 

1,610

 

 

 —

Other current liabilities

 

 

 —

 

 

218

Total current liabilities

 

 

27,560

 

 

42,554

Noncurrent liabilities:

 

 

  

 

 

  

Noncurrent operating lease liabilities

 

 

1,391

 

 

 —

Other long-term liabilities

 

 

943

 

 

144

Total liabilities

 

 

29,894

 

 

42,698

Commitments and contingencies (Note 12)

 

 

  

 

 

  

Shareholders’ equity:

 

 

 

 

 

 

Class A common shares, par value of $0.000273235 per share; 19,178,913 shares and 15,797,220 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively

 

 

 6

 

 

 4

Class B common shares, par value of $0.000273235 per share; 4,638,855 shares issued and outstanding as of September 30, 2019 and December 31, 2018

 

 

 1

 

 

 1

Class A1 common shares, $0.000273235 par value; 14,995,954 shares and 12,995,954 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively

 

 

 4

 

 

 4

Class B1 common shares, $0.000273235 par value; 16,057,618 shares issued and outstanding as of September 30, 2019 and December 31, 2018

 

 

 4

 

 

 4

Additional paid-in capital

 

 

576,129

 

 

473,483

Accumulated other comprehensive income (loss)

 

 

62

 

 

(4)

Accumulated deficit

 

 

(324,295)

 

 

(194,225)

Total shareholders’ equity

 

 

251,911

 

 

279,267

Total liabilities and shareholders’ equity

 

$

281,805

 

$

321,965

 

The accompanying notes are an integral part of these consolidated financial statements.

5

Table of Contents

KINIKSA PHARMACEUTICALS, LTD.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

September 30, 

 

September 30, 

 

    

2019

    

2018

    

2019

    

2018

Operating expenses:

 

 

  

    

 

  

    

 

  

 

 

 

Research and development

 

$

22,014

 

$

20,644

 

$

112,115

 

$

50,475

General and administrative

 

 

8,432

 

 

5,515

 

 

25,267

 

 

13,550

Total operating expenses

 

 

30,446

 

 

26,159

 

 

137,382

 

 

64,025

Loss from operations

 

 

(30,446)

 

 

(26,159)

 

 

(137,382)

 

 

(64,025)

Interest income

 

 

1,386

 

 

1,622

 

 

4,919

 

 

2,992

Loss before benefit for income taxes

 

 

(29,060)

 

 

(24,537)

 

 

(132,463)

 

 

(61,033)

Benefit for income taxes

 

 

2,002

 

 

131

 

 

2,393

 

 

386

Net loss

 

$

(27,058)

 

$

(24,406)

 

$

(130,070)

 

$

(60,647)

Net loss per share attributable to common shareholders—basic and diluted

 

$

(0.49)

 

$

(0.51)

 

$

(2.42)

 

$

(2.62)

Weighted average common shares outstanding—basic and diluted

 

 

54,831,308

 

 

48,183,424

 

 

53,767,003

 

 

23,174,841

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(27,058)

 

$

(24,406)

 

$

(130,070)

 

$

(60,647)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on short-term investments and currency translation adjustments, net of tax

 

 

(39)

 

 

 —

 

 

66

 

 

 —

Total other comprehensive income (loss)

 

 

(39)

 

 

 —

 

 

66

 

 

 —

Total comprehensive loss

 

$

(27,097)

 

$

(24,406)

 

$

(130,004)

 

$

(60,647)

 

The accompanying notes are an integral part of these consolidated financial statements.

 

 

6

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KINIKSA PHARMACEUTICALS, LTD.

CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS’ EQUITY

(In thousands, except share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Convertible Preferred Shares

 

 

Common Shares

 

Additional

 

Accumulated

 

 

 

 

Total

 

 

(Series A, B and C)

 

 

(Class A, B, A1 and B1)

 

Paid-In

 

Other Comprehensive

 

Accumulated

 

Shareholders'

 

  

Shares

  

Amount

 

 

Shares

  

Amount

  

Capital

  

Income (Loss)

  

Deficit

  

Equity

Balances at December 31, 2018

 

 —

 

$

 —

 

 

49,489,647

 

$

13

 

$

473,483

 

$

(4)

 

$

(194,225)

 

$

279,267

Issuance of Class A common shares upon completion of follow-on offering, inclusive of the over-allotment option exercise, net of underwriting discounts and commissions and offering costs

 

 —

 

 

 —

 

 

2,816,110

 

 

 2

 

 

48,474

 

 

 —

 

 

 —

 

 

48,476

Issuance of Class A1 common shares upon completion of private placement, net of underwriting discounts and commissions and offering costs

 

 —

 

 

 —

 

 

2,000,000

 

 

 —

 

 

34,511

 

 

 —

 

 

 —

 

 

34,511

Class A common shares issued or to be issued in connection with the acquisition of all issued and outstanding equity securities of Primatope Therapeutics, Inc.

 

 —

 

 

 —

 

 

337,008

 

 

 —

 

 

7,000

 

 

 —

 

 

 —

 

 

7,000

Exercise of options

 

 —

 

 

 —

 

 

50,070

 

 

 

 

 

181

 

 

 —

 

 

 —

 

 

181

Share-based compensation expense

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

2,893

 

 

 —

 

 

 —

 

 

2,893

Unrealized gain on short-term investments

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

12

 

 

 —

 

 

12

Net loss

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(65,821)

 

 

(65,821)

Balances at March 31, 2019

 

 —

 

$

 —

 

 

54,692,835

 

$

15

 

$

566,542

 

$

 8

 

$

(260,046)

 

$

306,519

Class A common shares issued or to be issued in connection with a milestone payment due to Primatope Therapeutics, Inc.

 

 —

 

 

 —

 

 

94,284

 

 

 —

 

 

1,800

 

 

 —

 

 

 —

 

 

1,800

Exercise of options and issuance of shares under the employee share purchase plan

 

 —

 

 

 —

 

 

70,573

 

 

 —

 

 

512

 

 

 —

 

 

 —

 

 

512

Share-based compensation expense

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

3,464

 

 

 —

 

 

 —

 

 

3,464

Unrealized gain on short-term investments

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

93

 

 

 —

 

 

93

Net loss

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(37,191)

 

 

(37,191)

Balances at June 30, 2019

 

 —

 

$

 —

 

 

54,857,692

 

$

15

 

$

572,318

 

$

101

 

$

(297,237)

 

$

275,197

Exercise of options

 

 —

 

 

 —

 

 

13,648

 

 

 —

 

 

53

 

 

 —

 

 

 —

 

 

53

Share-based compensation expense

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

3,758

 

 

 —

 

 

 —

 

 

3,758

Unrealized loss on short-term investments and currency translation adjustments

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(39)

 

 

 —

 

 

(39)

Net loss

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(27,058)

 

 

(27,058)

Balances at September 30, 2019

 

 —

 

$

 —

 

 

54,871,340

 

$

15

 

$

576,129

 

$

62

 

$

(324,295)

 

$

251,911

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Convertible Preferred Shares

 

 

Common Shares

 

Additional

 

Accumulated

 

 

 

 

Total

 

 

(Series A, B and C)

 

 

(Class A, B, A1 and B1)

 

Paid-In

 

Other Comprehensive

 

Accumulated

 

Shareholders'

 

  

Shares

  

Amount

 

 

Shares

  

Amount

  

Capital

  

Income (Loss)

  

Deficit

  

Equity

Balances at December 31, 2017

 

22,885,492

 

$

119,770

 

 

4,288,329

 

$

 1

 

$

1,289

 

$

 —

 

$

(90,998)

 

$

(89,708)

Issuance of Series C convertible preferred shares, net of issuance costs of $9,178

 

12,784,601

 

 

190,822

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

Exercise of options

 

 —

 

 

 —

 

 

4,574

 

 

 —

 

 

17

 

 

 —

 

 

 —

 

 

17

Share-based compensation expense

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

558

 

 

 —

 

 

 —

 

 

558

Net loss

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(15,982)

 

 

(15,982)

Balances at March 31, 2018

 

35,670,093

 

$

310,592

 

 

4,292,903

 

$

 1

 

$

1,864

 

$

 —

 

$

(106,980)

 

$

(105,115)

Conversion of convertible preferred shares to common shares

 

(35,670,093)

 

 

(310,592)

 

 

35,670,093

 

 

 8

 

 

310,584

 

 

 —

 

 

 —

 

 

310,592

Issuance of Class A common shares upon completion of initial public offering, net of underwriting discounts and commissions and offering costs

 

 —

 

 

 —

 

 

9,484,202

 

 

 4

 

 

155,511

 

 

 —

 

 

 —

 

 

155,515

Share-based compensation expense

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

1,059

 

 

 —

 

 

 —

 

 

1,059

Unrealized gain on short-term investments

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 7

 

 

 —

 

 

 7

Net loss

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(20,259)

 

 

(20,259)

Balances at June 30, 2018

 

 —

 

$

 —

 

 

49,447,198

 

$

13

 

$

469,018

 

$

 7

 

$

(127,239)

 

$

341,799

Issuance of Class A common shares upon completion of initial public offering, net of underwriting discounts and commissions and offering costs

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

21

 

 

 —

 

 

 —

 

 

21

Exercise of options

 

 —

 

 

 —

 

 

17,486

 

 

 —

 

 

59

 

 

 —

 

 

 —

 

 

59

Share-based compensation expense

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

1,502

 

 

 —

 

 

 —

 

 

1,502

Unrealized loss on short-term investments

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(62)

 

 

 —

 

 

(62)

Net loss

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

(24,406)

 

 

(24,406)

Balances at September 30, 2018

 

 —

 

$

 —

 

 

49,464,684

 

$

13

 

$

470,600

 

$

(55)

 

$

(151,645)

 

$

318,913

 

The accompanying notes are an integral part of these consolidated financial statements.

 

 

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KINIKSA PHARMACEUTICALS, LTD.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

 

 

 

 

 

 

 

 

Nine Months Ended

 

 

September 30, 

 

    

2019

 

2018

Cash flows from operating activities:

 

 

  

 

 

 

Net loss

 

$

(130,070)

 

$

(60,647)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

  

 

 

  

Depreciation expense

 

 

1,502

 

 

32

Share-based compensation expense

 

 

10,115

 

 

3,119

Class A common shares issued or to be issued as consideration for Primatope, including milestone payments

 

 

8,800

 

 

 —

Loss on disposal of property and equipment

 

 

23

 

 

66

Non-cash rent expense

 

 

 —

 

 

258

Accretion of discounts on short-term investments

 

 

(3,044)

 

 

(670)

Deferred income taxes

 

 

(3,411)

 

 

(935)

Changes in operating assets and liabilities:

 

 

 

 

 

  

Prepaid expenses, right-of-use assets and other assets

 

 

(1,472)

 

 

(4,027)

Accounts payable

 

 

(4,504)

 

 

2,981

Accrued expenses and other liabilities

 

 

2,685

 

 

6,449

Accrued milestones

 

 

(14,850)

 

 

 —

Operating lease liabilities

 

 

(916)

 

 

 —

Other long-term liabilities

 

 

943

 

 

 —

Net cash used in operating activities

 

 

(134,199)

 

 

(53,374)

Cash flows from investing activities:

 

 

  

 

 

 

Purchases of property and equipment

 

 

(1,207)

 

 

(1,274)

Purchases of short-term investments

 

 

(406,135)

 

 

(292,584)

Proceeds from the maturities of short-term investments

 

 

454,640

 

 

25,000

Net cash provided by (used in) investing activities

 

 

47,298

 

 

(268,858)

Cash flows from financing activities:

 

 

  

 

 

 

Proceeds from issuance of Series C convertible preferred shares, net of issuance costs

 

 

 —

 

 

190,822

Proceeds from issuance of Class A common shares upon completion of initial public offering, net of underwriting commissions and discounts, inclusive of the over-allotment option exercise

 

 

 —

 

 

159,193

Proceeds from issuance of Class A common shares from follow-on offering, net of underwriting commissions and discounts, inclusive of the over-allotment option exercise

 

 

48,595

 

 

 —

Proceeds from issuance of Class A1 common shares from private placement, net of underwriting commissions and discounts

 

 

34,511

 

 

 —

Payments of offering costs

 

 

(118)

 

 

(3,646)

Proceeds from exercise of options and employee share purchase plan

 

 

746

 

 

76

Net cash provided by financing activities

 

 

83,734

 

 

346,445

Net increase in cash and cash equivalents and restricted cash

 

 

(3,167)

 

 

24,213

Cash and cash equivalents and restricted cash at beginning of period

 

 

72,186

 

 

45,660

Cash and cash equivalents and restricted cash at end of period

 

$

69,019

 

$

69,873

 

 

 

 

 

 

 

Supplemental information:

 

 

 

 

 

 

Cash paid for income taxes

 

$

1,727

 

$

345

 

 

 

 

 

 

 

Supplemental disclosure of non-cash investing and financing activities:

 

 

 

 

 

 

Deferred offering costs included in accrued expenses and accounts payable

 

$

 —

 

$

11

Property and equipment included in accrued expenses and accounts payable

 

$

371

 

$

1,058

 

The accompanying notes are an integral part of these consolidated financial statements.

 

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KINIKSA PHARMACEUTICALS, LTD

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Amounts in thousands, except share and per share amounts)

(Unaudited)

 

1.           Nature of the Business and Basis of Presentation

Kiniksa Pharmaceuticals, Ltd. (the “Company”) is a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. The Company was incorporated in July 2015 as a Bermuda exempted company. The Company has a pipeline of product candidates across various stages of development, focused on autoinflammatory and autoimmune conditions.

The Company is subject to risks and uncertainties common to early‑stage companies in the biopharmaceutical industry. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s technology will be obtained, that any products developed will obtain necessary government regulatory approval or that any products, if approved, will be commercially viable.  The Company does not currently generate revenue from sales of any products, and it may never be able to develop or commercialize a marketable product. The Company has not yet successfully completed any Phase 3 or other pivotal clinical trials, obtained any regulatory approvals, manufactured a commercial‑scale drug, or conducted sales and marketing activities. The Company operates in an environment of rapid technological innovation and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, consultants and service providers. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.

Principles of Consolidation

The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and include the accounts of the Company and its wholly owned subsidiaries, Kiniksa Pharmaceuticals Corp. (“Kiniksa US”), Kiniksa Pharmaceuticals (UK), Ltd., Kiniksa Pharmaceuticals (Germany) GmbH, Kiniksa Pharmaceuticals (France) SARL and Primatope Therapeutics, Inc. (“Primatope”), after elimination of all significant intercompany accounts and transactions. 

In assessing the consolidation requirement for variable interest entities (“VIEs”), the Company focuses on identifying whether it has both the power to direct the activities that most significantly impact the VIE’s economic performance and the obligation to absorb losses or the right to receive benefits from the VIE. In the event that the Company is the primary beneficiary of a VIE, the assets, liabilities, and results of operations of the VIE would be included in the Company’s consolidated financial statements.  At December 31, 2018 and during the year then ended and at September 30, 2019 and during the three and nine months then ended, the Company was not the primary beneficiary of a VIE.

Use of Estimates

The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses and the valuation of common shares and share‑based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. 

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KINIKSA PHARMACEUTICALS, LTD.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Amounts in thousands, except share and per share amounts)

(Unaudited)

Reporting and Functional Currency

The financial results of the Company's global activities are reported in U.S. dollars (“USD”) and its foreign subsidiaries generally utilize their respective local currency to be their functional currency.

Transactions in other currencies are recorded in the functional currency at the rate of exchange prevailing when the transactions occur. Monetary assets and liabilities denominated in other currencies are re-measured into the functional currency at the rate of exchange in effect at the balance sheet date. Exchange rate gains and losses arising from re-measurement of foreign currency-denominated monetary assets and liabilities are included in income or losses in the period in which they occur.

For the Company’s foreign subsidiaries where the local currency is the functional currency, assets and liabilities denominated in local currencies are translated into USD at end-of-period exchange rates and the resulting translation adjustments are reported as a component of accumulated other comprehensive loss within shareholders' equity.

Unaudited Interim Consolidated Financial Information

The accompanying unaudited consolidated financial statements have been prepared in accordance with GAAP for interim financial information. The accompanying unaudited consolidated financial statements do not include all of the information and footnotes required by GAAP for complete consolidated financial statements. The accompanying year-end consolidated balance sheet was derived from audited financial statements but does not include all disclosures required by GAAP.  The unaudited interim consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2019 and the results of its operations for the three and nine months ended September 30, 2019 and 2018 and its cash flows for the nine months ended September 30, 2019 and 2018. The results for the three and nine months ended September 30, 2019 are not necessarily indicative of results to be expected for the year ending December 31, 2019, any other interim periods or any future year or period.

Reverse Share Split

On May 11, 2018, the Company effected a 1-for-2.73235 reverse share split of its authorized, designated, issued and outstanding common shares and preferred shares. Accordingly, all share and per share amounts for all periods presented in the accompanying consolidated financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect this reverse share split.

Initial Public Offering

On May 23, 2018, the Company’s registration statement on Form S-1 relating to its initial public offering of its Class A common shares (the “IPO”) was declared effective by the Securities and Exchange Commission (“SEC”).  On May 29, 2018, the Company completed the IPO of 8,477,777 Class A common shares at a public offering price of $18.00 per share for gross proceeds of $152,600. In addition, on June 22, 2018, the Company completed the sale of 1,006,425 Class A common shares to the underwriters of the IPO following the exercise in part of their over-allotment option to purchase additional shares at a public offering price of $18.00 per share for gross proceeds of $18,116. The aggregate net proceeds to the Company from the IPO, inclusive of the over-allotment option exercise, was $155,536 after deducting underwriting discounts and commissions and other offering costs.

Upon the closing of the IPO, all convertible preferred shares then outstanding automatically converted into 5,546,019 Class A common shares, 1,070,502 Class B common shares, 12,995,954 Class A1 common shares and

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KINIKSA PHARMACEUTICALS, LTD.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Amounts in thousands, except share and per share amounts)

(Unaudited)

16,057,618 Class B1 common shares. In connection with the closing of the IPO, the Company amended and restated its bye-laws (the “Amended & Restated Bye-Laws”).

Follow-on Offering and Private Placement

On February 4, 2019, the Company completed a follow-on offering of 2,654,984 Class A common shares at a public offering price of $18.26 and a concurrent private placement of 2,000,000 Class A1 common shares at an offering price of $18.26 per share for aggregate gross proceeds of $85,000.  In addition, on March 1, 2019, the Company completed the sale of 161,126 Class A common shares to the underwriters of the follow-on offering following the exercise in part of their over-allotment option to purchase additional shares at a public offering price of $18.26 per share for gross proceeds of $2,942.  The aggregate net proceeds to the Company from the follow-on offering and concurrent private placement, inclusive of the over-allotment option exercise, was $82,988 after deducting underwriting discounts and commissions and other offering costs

Liquidity

In accordance with Accounting Standards Update (“ASU”) No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. As of September 30, 2019, the Company had an accumulated deficit of $324,295. During the nine months ended September 30, 2019, the Company incurred a net loss of $130,070 and used $134,199 of net cash in operating activities. The Company expects to continue to generate operating losses for the foreseeable future. As of September 30, 2019, the Company had cash, cash equivalents and short-term investments of $258,745.

Based on its current operating plan, the Company expects that its cash, cash equivalents and short-term investments will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of these consolidated financial statements. The future viability of the Company beyond that point is dependent on its ability to raise additional capital to finance its operations. Although the Company has been successful in raising capital in the past, there is no assurance that it will be successful in obtaining such additional financing on terms acceptable to the Company, if at all. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations.

 

 

2.           Summary of Significant Accounting Policies

Cash and Cash Equivalents

The Company classifies deposits in banks, money market funds and cash invested temporarily in various instruments with maturities of three months or less at the time of purchase as cash and cash equivalents. At September 30, 2019 and December 31, 2018, cash and cash equivalents consisted principally of U.S. Treasury notes, amounts held in money market funds and cash on deposit at commercial banks.

Short-Term Investments

The Company generally invests its excess cash in money market funds and short-term investments in U.S. Treasury notes. Such investments included in short-term investments on the Company's consolidated balance sheets are considered available-for-sale debt securities and are reported at fair value with unrealized gains and losses included as a

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KINIKSA PHARMACEUTICALS, LTD.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Amounts in thousands, except share and per share amounts)

(Unaudited)

component of shareholders’ equity. Realized gains and losses, if any, on short-term investments are included in interest income. 

The Company evaluates its short-term investments with unrealized losses for other-than-temporary impairment.  When assessing short-term investments for other-than-temporary declines in value, the Company considers such factors as, among other things, how significant the decline in value is as a percentage of the original cost, the Company’s ability and intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general.  If any adjustment to fair value reflects a decline in the value of the investment that the Company considers to be “other than temporary,” the Company reduces the investment to fair value through a charge to the consolidated statement of operations and comprehensive loss.  No such adjustments were necessary during the periods presented.

Concentrations of Credit Risk

Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents and short-term investments. At September 30, 2019 and December 31, 2018, substantially all of the Company’s cash, cash equivalents and short-term investments were held at two financial institutions.  The Company generally maintains balances in various operating accounts at financial institutions that management believes to be of high credit quality, in amounts that may exceed federally insured limits.  The Company has not experienced any losses related to its cash, cash equivalents and short-term investments and does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.

Restricted Cash

In conjunction with the Company’s lease agreement entered into in March 2018 (see Note 5), the Company maintains a letter of credit for the benefit of the landlord. As of September 30, 2019 and December 31, 2018, the underlying cash balance of $210 securing this letter of credit, was classified as non‑current in its consolidated balance sheet.

Fair Value Measurements

Certain assets and liabilities of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

·

Level 1—Quoted prices in active markets for identical assets or liabilities.

·

Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

·

Level 3—Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

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KINIKSA PHARMACEUTICALS, LTD.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Amounts in thousands, except share and per share amounts)

(Unaudited)

The Company’s restricted cash, which is held in a money market fund, is carried at fair value, determined based on Level 1 inputs in the fair value hierarchy described above (see Note 3). The Company’s cash equivalents and short-term investments, consisting of money market funds and U.S. Treasury notes, are carried at fair value, determined based on Level 1 and 2 inputs in the fair value hierarchy described above (see Note 3). The carrying values of the Company’s prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values due to the short‑term nature of these assets and liabilities.

Leases

In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”), which set forth the principles for recognition, measurement, presentation and disclosure of lease arrangements to enhance the transparency and comparability of financial reporting related to the arrangements. ASU 2016-02, including subsequently issued amendments, is collectively referred to as Accounting Standards Codification, Leases (Topic 842) (“ASC 842”). The Company adopted the new standard on January 1, 2019 using the modified retrospective transition approach as applied to leases existing as of the adoption date.  The standard will be applied to all leases entered into after the initial adoption date.

At the inception of an arrangement, the Company determines whether the arrangement is or contains a “lease” as defined by ASC 842. A lease is an arrangement, or part of an arrangement, that conveys the right to control the use of identified property, plant, or equipment (an identified asset) for a period of time in exchange for consideration. The Company determines if the arrangement conveys the right to control the use of an identified asset for a period of time. It assesses throughout the period of use whether the Company has both of the following (1) the right to obtain substantially all of the economic benefits from use of the identified asset and (2) the right to direct the use of the identified asset. This determination is reassessed if the terms of the arrangement are changed. Leases are classified as operating or finance leases based on the terms of the lease agreement and certain characteristics of the identified asset. Right-of-use (“ROU”) assets and lease liabilities are recognized at lease commencement date based on the present value of the minimum future lease payments.

Most leases with a term greater than one year are recognized on the balance sheet as ROU assets with corresponding lease liabilities and, if applicable, long-term lease liabilities. The Company has elected not to recognize leases with a term of one year or less on its balance sheet. Operating leases, ROU assets and their corresponding lease liabilities are recorded based on the present value of lease payments over the expected remaining lease term. However, certain adjustments to the ROU assets may be required for items such as incentives received. The interest rate implicit in lease arrangements is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.

In accordance with the guidance in ASU 2016-02, components of a lease should be split into three categories: lease components (e.g., land, building, etc.), non-lease components (e.g., common area maintenance, consumables, etc.), and non-components (e.g., property taxes, insurance, etc.); then the fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based on fair values to the lease components and non-lease components.

Although separation of lease and non-lease components is required, certain practical expedients are available. Companies may elect the practical expedient to not separate lease and non-lease components. In which case, the Company would account for each lease component and the related non-lease component together as a single component. The Company has elected to account for the lease and non-lease components of each of its operating leases as a single lease component and allocate all of the arrangement consideration to the lease component only. The lease component

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KINIKSA PHARMACEUTICALS, LTD.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Amounts in thousands, except share and per share amounts)

(Unaudited)

results in an operating right-of-use asset being recorded on the balance sheet and amortized on a straight-line basis as lease expense.

Research and Development Costs

Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred to discover, research and develop drug candidates, including personnel expenses, share‑based compensation expense, allocated facility‑related and depreciation expenses, third‑party license fees and external costs of outside vendors engaged to conduct preclinical and clinical development activities and clinical trials as well as to manufacture clinical trial materials. Non‑refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered, or the services rendered.

Research Contract Costs and Accruals

The Company has entered into various research and development-related contracts with companies both inside and outside of the United States. The related costs are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ materially from the Company's estimates. The Company's historical accrual estimates have not been materially different from the actual costs.

Share‑Based Compensation

The Company measures all share-based awards granted to employees and directors based on their fair value on the date of the grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award. Forfeitures are accounted for as they occur. The Company issues share-based awards with only service-based vesting conditions and records the expense for these awards using the straight-line method. The Company has not issued any share-based awards with performance-based vesting conditions.

For share-based awards granted to consultants and non-employees, compensation expense is recognized over the vesting period of the awards, which is generally the period during which services are rendered by such consultants and non-employees until completed. At the end of each financial reporting period prior to completion of the service, the fair value of these awards is remeasured using the then-current fair value of the Company's Class A common shares and updated assumption inputs in the Black-Scholes option-pricing model.

The Company classifies share-based compensation expense in its consolidated statements of operations and comprehensive loss in the same manner in which the award recipient's payroll costs are classified or in which the award recipient's service payments are classified.

The fair value of each restricted share award is estimated on the date of grant based on the fair value of the Company’s Class A common shares or Class B common shares on that same date. The fair value of each option grant is estimated using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions, including the expected share price volatility, the expected term of the award, the risk-free interest rate, and expected dividends (see Note 9).  Prior to May 2018, the Company was a private company and, accordingly, lacks company-specific historical and implied volatility information for its shares. Therefore, it estimates its expected share price volatility based on the historical volatility of publicly traded peer companies and expects to continue to do so until such

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KINIKSA PHARMACEUTICALS, LTD.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Amounts in thousands, except share and per share amounts)

(Unaudited)

time as it has adequate historical data regarding the volatility of its own traded share price. The expected term of the Company’s options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of options granted to non-employees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common shares and does not expect to pay any cash dividends in the foreseeable future.

Comprehensive Loss

Comprehensive loss includes net loss as well as other changes in shareholders’ equity that result from transactions and economic events other than those with shareholders. For the three and nine months ended September 30, 2019, the Company’s other comprehensive loss was primarily related to unrealized gain on short-term investments as well as cumulative translation adjustments. For the three and nine months ended September 30, 2018, there was no difference between net loss and comprehensive loss.

Net Loss per Share

The Company follows the two‑class method when computing net loss per share as the Company has issued shares that meet the definition of participating securities. The two‑class method determines net loss per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two‑class method requires income available to common shareholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed.

Basic net loss per share attributable to common shareholders is computed by dividing the net loss attributable to common shareholders by the weighted average number of common shares outstanding for the period. Diluted net loss attributable to common shareholders is computed by adjusting net loss attributable to common shareholders to reallocate undistributed earnings based on the potential impact of dilutive securities. Diluted net loss per share attributable to common shareholders is computed by dividing the diluted net loss attributable to common shareholders by the weighted average number of common shares outstanding for the period, including potential dilutive common shares. For purpose of this calculation, outstanding options, unvested restricted common shares and convertible preferred shares are considered potential dilutive common shares.

Prior to the closing of the IPO, when the Company’s convertible preferred shares converted to common shares, the Company's convertible preferred shares contractually entitled the holders of such shares to participate in dividends but did not contractually require the holders of such shares to participate in losses of the Company. Accordingly, for periods in which the Company reported a net loss attributable to common shareholders, such losses were not allocated to convertible preferred shareholders.  In periods in which the Company reports a net loss attributable to common shareholders, diluted net loss per share attributable to common shareholders is the same as basic net loss per share attributable to common shareholders, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss attributable to common shareholders for the three and nine months ended September 30, 2019 and 2018.

Income Taxes

As an exempted company incorporated under the laws of Bermuda, the Company is principally subject to taxation in Bermuda. Under the current laws of Bermuda, tax on a company’s income is assessed at a zero percent tax rate. As a result, the Company has not recorded any income tax benefits from our losses incurred in Bermuda during

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KINIKSA PHARMACEUTICALS, LTD.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Amounts in thousands, except share and per share amounts)

(Unaudited)

each reporting period, and no net operating loss carryforwards will be available to the Company for those losses. The Company’s wholly owned U.S. subsidiary, Kiniksa US, is subject to federal and state income taxes in the United States.

The Company’s benefit for income taxes relates to net credits earned against taxable income generated by Kiniksa US under a cost‑plus arrangement that it has with the Company.  The benefit for income taxes is impacted by the Foreign Derived Intangible Income, or FDII, deduction and U.S. federal and state research and development tax credits.  FDII was enacted as part of the tax reform enacted by the United States in December 2017, generally referred to as the U.S. Tax Cuts and Jobs Act with additional proposed regulations and guidance issued in 2019.  Upon the completion of the Company’s assessment, the Company has included the tax impact of FDII in its income tax expense for the three and nine months ended September 30, 2019, based on its understanding of the rules available at the time of this filing. However, the amounts recorded could be impacted in the future when the proposed regulations and guidance are finalized.  

Recently Adopted Accounting Pronouncements

In February 2016, the FASB issued ASU 2016-02, Leases. The standard, including subsequently issued amendments, collectively referred to as ASC 842, established principles of recognition, measurement, presentation and disclosure of lease arrangements applicable to lessees and lessors in order to enhance the transparency and compatibility of financial reporting related to the arrangements, including with respect to the amount, timing and uncertainty of cash flows arising from a lease. The Company adopted new accounting guidance regarding the accounting for leases as of January 1, 2019 using a modified retrospective transition approach that was applied to leases existing as of, or entered into prior to, January 1, 2019.  See Note 2, Summary of Significant Accounting Policies, “Leases” for a discussion of the Company’s policy with respect to this standard and Note 5, “Leases” for a discussion of the Company’s adoption of this standard and its impact on its consolidated financial statements and related disclosures.

Upon the adoption of ASC 842, the Company recorded operating lease right-of-use assets of $3,682 and operating lease liabilities of $3,917 for its leases which were in effect and had commenced prior to January 1, 2019 and had original lease terms of more than 12 months.

 

3.           Fair Value of Financial Assets and Liabilities

Short-term investments as of September 30, 2019 and December 31, 2018 consisted of U.S. Treasury notes which investments are each due within six months of such respective period.  As of September 30, 2019 and December 31, 2018, the fair value of short-term investments was $189,936 and $235,328, respectively.  As of September 30, 2019,

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KINIKSA PHARMACEUTICALS, LTD.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

(Amounts in thousands, except share and per share amounts)

(Unaudited)

the amortized cost was $189,871 and gross unrealized gain was $65.  As of December 31, 2018, the amortized cost was $235,332 and gross unrealized loss was $4. 

The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy used to determine such fair values:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair Value Measurements

 

 

as of September 30, 2019 Using:

 

    

Level 1

    

Level 2

    

Level 3

    

Total

Assets:

 

 

  

 

 

  

 

 

  

 

 

  

Restricted cash — money market funds

 

$

210

 

$

 —

 

$

 —

 

$

210

Cash equivalents — money market funds

 

 

5,902

 

 

 —

 

 

 —

 

 

5,902

Cash equivalents — U.S. Treasury notes

 

 

 —

 

 

43,304

 

 

 —

 

 

43,304

Short-term investments — U.S. Treasury notes

 

 

 —

 

 

189,936

 

 

 —

 

 

189,936

 

 

$

6,112

 

$

233,240

 

$

 —

 

$

239,352

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair Value Measurements

 

 

as of December 31, 2018 Using:

 

    

Level 1

    

Level 2

    

Level 3

    

Total

Assets:

 

 

  

 

 

  

 

 

  

 

 

  

Restricted cash — money market funds

 

$

210

 

$

 —

 

$

 —

 

$

210

Cash equivalents — money market funds

 

 

29,721

 

 

 —

 

 

 —

 

 

29,721

Cash equivalents — U.S. Treasury notes

 

 

 —

 

 

15,634

 

 

 —

 

 

15,634

Short-term investments — U.S. Treasury notes

 

 

 —

 

 

235,328

 

 

 —

 

 

235,328

 

 

$

29,931

 

$

250,962

 

$

 —

 

$

280,893