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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

 

FORM 10-Q

 

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 001-36407

 

ALNYLAM PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

 

Delaware

 

77-0602661

(State or Other Jurisdiction of

Incorporation or Organization)

 

(I.R.S. Employer

Identification No.)

 

300 Third Street,

Cambridge, MA

 

02142

(Address of Principal Executive Offices)

 

(Zip Code)

(617) 551-8200

(Registrant’s Telephone Number, Including Area Code)

 

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

 

Title of Each Class

 

Trading Symbol(s)

 

Name of Each Exchange on Which Registered

Common Stock, $0.01 par value per share

 

ALNY

 

The Nasdaq Stock Market LLC

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, 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  

At July 31, 2019, the registrant had 111,207,651 shares of Common Stock, $0.01 par value per share, outstanding.

 

 

1


 

 

 

 

INDEX

 

 

 

PAGE

NUMBER

 

 

 

PART I.  FINANCIAL INFORMATION

 

 

 

 

ITEM 1. FINANCIAL STATEMENTS (Unaudited)

 

 

 

 

 

CONDENSED CONSOLIDATED BALANCE SHEETS AS OF JUNE 30, 2019 AND DECEMBER 31, 2018

 

3

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2019 AND 2018

 

4

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2019 AND 2018

 

5

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE SIX MONTHS ENDED JUNE 30, 2019 AND 2018

 

6

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

7

 

 

 

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

22

 

 

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

32

 

 

 

ITEM 4. CONTROLS AND PROCEDURES

 

32

 

 

 

PART II.  OTHER INFORMATION

 

 

 

 

 

ITEM 1.  LEGAL PROCEEDINGS

 

33

 

 

 

ITEM 1A.  RISK FACTORS

 

33

 

 

 

ITEM 6. EXHIBITS

 

63

 

 

 

SIGNATURES

 

65

 

 

 

 

 

“Alnylam,” ONPATTRO® and Alnylam Act® are registered trademarks of Alnylam Pharmaceuticals, Inc. Our logo, trademarks and service marks are property of Alnylam. All other trademarks or service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective holders.

 

2


    ALNYLAM PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except per share amounts)

(Unaudited)

 

 

 

June 30, 2019

 

 

December 31, 2018

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

1,136,289

 

 

$

420,146

 

Marketable debt securities

 

 

790,542

 

 

 

662,803

 

Accounts receivable, net

 

 

30,739

 

 

 

18,760

 

Inventory

 

 

40,587

 

 

 

24,068

 

Prepaid expenses and other current assets

 

 

65,616

 

 

 

74,919

 

Total current assets

 

 

2,063,773

 

 

 

1,200,696

 

Property, plant and equipment, net

 

 

371,769

 

 

 

320,658

 

Operating lease right-of-use assets

 

 

226,357

 

 

 

 

Restricted investments

 

 

44,825

 

 

 

44,825

 

Other assets

 

 

9,687

 

 

 

8,623

 

Total assets

 

$

2,716,411

 

 

$

1,574,802

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

71,215

 

 

$

59,708

 

Accrued expenses

 

 

138,800

 

 

 

112,719

 

Operating lease liability

 

 

29,347

 

 

 

 

Deferred rent

 

 

 

 

 

3,571

 

Deferred revenue

 

 

89,242

 

 

 

3,496

 

Total current liabilities

 

 

328,604

 

 

 

179,494

 

Operating lease liability, net of current portion

 

 

277,211

 

 

 

 

Deferred rent, net of current portion

 

 

 

 

 

57,920

 

Deferred revenue, net of current portion

 

 

313,887

 

 

 

458

 

Long-term debt

 

 

30,000

 

 

 

30,000

 

Other liabilities

 

 

9,514

 

 

 

4,965

 

Total liabilities

 

 

959,216

 

 

 

272,837

 

Commitments and contingencies (Note 14)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.01 par value per share, 5,000 shares authorized and no shares

   issued and outstanding at June 30, 2019 and December 31, 2018

 

 

 

 

 

Common stock, $0.01 par value per share, 250,000 and 125,000 shares authorized at June 30, 2019 and December 31, 2018, respectively; 111,114 shares issued and outstanding at June 30, 2019; 101,177 shares issued and outstanding at December 31, 2018

 

 

1,110

 

 

 

1,011

 

Additional paid-in capital

 

 

5,034,284

 

 

 

4,175,139

 

Accumulated other comprehensive loss

 

 

(35,831

)

 

 

(33,213

)

Accumulated deficit

 

 

(3,242,368

)

 

 

(2,840,972

)

Total stockholders’ equity

 

 

1,757,195

 

 

 

1,301,965

 

Total liabilities and stockholders’ equity

 

$

2,716,411

 

 

$

1,574,802

 

 

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

3


ALNYLAM PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In thousands, except per share amounts)

(Unaudited)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenues, net

 

$

38,231

 

 

$

 

 

$

64,522

 

 

$

 

 

Net revenue from collaborators

 

 

6,483

 

 

 

29,907

 

 

 

13,486

 

 

 

51,806

 

 

Total revenues

 

 

44,714

 

 

 

29,907

 

 

 

78,008

 

 

 

51,806

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

 

4,326

 

 

 

 

 

 

7,673

 

 

 

 

 

Research and development

 

 

163,890

 

 

 

137,582

 

 

 

293,017

 

 

 

234,439

 

 

Selling, general and administrative

 

 

112,769

 

 

 

84,679

 

 

 

202,377

 

 

 

157,126

 

 

Total costs and expenses

 

 

280,985

 

 

 

222,261

 

 

 

503,067

 

 

 

391,565

 

 

Loss from operations

 

 

(236,271

)

 

 

(192,354

)

 

 

(425,059

)

 

 

(339,759

)

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

8,781

 

 

 

6,101

 

 

 

16,306

 

 

 

11,895

 

 

Other (expense) income

 

 

(453

)

 

 

2,208

 

 

 

(410

)

 

 

2,543

 

 

Change in fair value of liability obligation

 

 

9,422

 

 

 

 

 

 

9,422

 

 

 

 

 

Gain on litigation settlement

 

 

 

 

 

20,564

 

 

 

 

 

 

20,564

 

 

      Total other income

 

 

17,750

 

 

 

28,873

 

 

 

25,318

 

 

 

35,002

 

 

Loss before income taxes

 

 

(218,521

)

 

 

(163,481

)

 

 

(399,741

)

 

 

(304,757

)

 

Provision for income taxes

 

 

(960

)

 

 

(79

)

 

 

(1,655

)

 

 

(17

)

 

Net loss

 

$

(219,481

)

 

$

(163,560

)

 

$

(401,396

)

 

$

(304,774

)

 

Net loss per common share - basic and diluted

 

$

(2.02

)

 

$

(1.63

)

 

$

(3.75

)

 

$

(3.04

)

 

Weighted-average common shares used to compute basic and diluted net loss per common share

 

 

108,576

 

 

 

100,519

 

 

 

106,997

 

 

 

100,251

 

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(219,481

)

 

$

(163,560

)

 

$

(401,396

)

 

$

(304,774

)

 

Unrealized gain on marketable securities, net of tax

 

 

462

 

 

 

1,046

 

 

 

822

 

 

 

626

 

 

Foreign currency translation

 

 

842

 

 

 

 

 

 

842

 

 

 

 

 

Unrealized loss on pension obligation

 

 

(4,282

)

 

 

 

 

 

(4,282

)

 

 

 

 

Comprehensive loss

 

$

(222,459

)

 

$

(162,514

)

 

$

(404,014

)

 

$

(304,148

)

 

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

4


ALNYLAM PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands)

(Unaudited)

 

 

Three Months Ended June 30, 2019

 

 

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance at March 31, 2019

 

 

106,400

 

 

$

1,064

 

 

$

4,601,662

 

 

$

(32,853

)

 

$

(3,022,887

)

 

$

1,546,986

 

Exercise of common stock options, net of tax withholdings

 

 

203

 

 

 

2

 

 

 

6,180

 

 

 

 

 

 

 

 

 

6,182

 

Issuance of common stock under equity plans

 

 

55

 

 

 

 

 

 

4,022

 

 

 

 

 

 

 

 

 

4,022

 

Issuance of common stock under benefit plans

 

 

12

 

 

 

 

 

 

1,089

 

 

 

 

 

 

 

 

 

1,089

 

Issuance of common stock, net of offering costs

 

 

4,444

 

 

 

44

 

 

 

390,533

 

 

 

 

 

 

 

 

 

390,577

 

Stock-based compensation expense related to equity-classified

   awards

 

 

 

 

 

 

 

 

30,798

 

 

 

 

 

 

 

 

 

30,798

 

Other comprehensive loss, net of tax

 

 

 

 

 

 

 

 

 

 

 

(2,978

)

 

 

 

 

 

(2,978

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(219,481

)

 

 

(219,481

)

Balance at June 30, 2019

 

 

111,114

 

 

$

1,110

 

 

$

5,034,284

 

 

$

(35,831

)

 

$

(3,242,368

)

 

$

1,757,195

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30, 2018

 

 

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance at March 31, 2018

 

 

100,468

 

 

$

1,005

 

 

$

4,009,342

 

 

$

(34,853

)

 

$

(2,220,689

)

 

$

1,754,805

 

Exercise of common stock options, net of tax withholdings

 

 

53

 

 

 

 

 

 

2,561

 

 

 

 

 

 

 

 

 

2,561

 

Issuance of common stock under equity plans

 

 

41

 

 

 

 

 

 

3,124

 

 

 

 

 

 

 

 

 

3,124

 

Issuance of common stock under benefit plans

 

 

7

 

 

 

 

 

 

829

 

 

 

 

 

 

 

 

 

829

 

Stock-based compensation expense related to equity-classified

   awards

 

 

 

 

 

 

 

 

21,997

 

 

 

 

 

 

 

 

 

21,997

 

Other comprehensive gain, net of tax

 

 

 

 

 

 

 

 

 

 

 

1,046

 

 

 

 

 

 

1,046

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(163,560

)

 

 

(163,560

)

Balance at June 30, 2018

 

 

100,569

 

 

$

1,005

 

 

$

4,037,853

 

 

$

(33,807

)

 

$

(2,384,249

)

 

$

1,620,802

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended June 30, 2019

 

 

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2018

 

 

101,177

 

 

$

1,011

 

 

$

4,175,139

 

 

$

(33,213

)

 

$

(2,840,972

)

 

$

1,301,965

 

Exercise of common stock options, net of tax withholdings

 

 

410

 

 

 

5

 

 

 

17,586

 

 

 

 

 

 

 

 

 

17,591

 

Issuance of common stock under equity plans

 

 

59

 

 

 

 

 

 

3,964

 

 

 

 

 

 

 

 

 

3,964

 

Issuance of common stock under benefit plans

 

 

24

 

 

 

 

 

 

1,873

 

 

 

 

 

 

 

 

 

1,873

 

Issuance of common stock, net of offering costs

 

 

9,444

 

 

 

94

 

 

 

772,383

 

 

 

 

 

 

 

 

 

772,477

 

Stock-based compensation expense related to equity-classified

   awards

 

 

 

 

 

 

 

 

63,339

 

 

 

 

 

 

 

 

 

63,339

 

Other comprehensive loss, net of tax

 

 

 

 

 

 

 

 

 

 

 

(2,618

)

 

 

 

 

 

(2,618

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(401,396

)

 

 

(401,396

)

Balance at June 30, 2019

 

 

111,114

 

 

$

1,110

 

 

$

5,034,284

 

 

$

(35,831

)

 

$

(3,242,368

)

 

$

1,757,195

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended June 30, 2018

 

 

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2017

 

 

99,667

 

 

$

997

 

 

$

3,947,552

 

 

$

(34,433

)

 

$

(2,147,685

)

 

$

1,766,431

 

Cumulative effect adjustment from the adoption of new revenue

   standard

 

 

 

 

 

 

 

 

 

 

 

 

 

 

68,210

 

 

 

68,210

 

Exercise of common stock options, net of tax withholdings

 

 

848

 

 

 

8

 

 

 

44,443

 

 

 

 

 

 

 

 

 

44,451

 

Issuance of common stock under equity plans

 

 

43

 

 

 

 

 

 

3,001

 

 

 

 

 

 

 

 

 

3,001

 

Issuance of common stock under benefit plans