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Filing

Savara Pharmaceuticals / Investors / SEC Filings / Filing
svra-10q_20170930.htm

 

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, 2017

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 001-32157

 

Savara Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

84-1318182

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

 

 

900 South Capital of Texas Highway, Las Cimas IV, Suite 150

Austin, TX

 

78746

(Address of principal executive offices)

 

(Zip Code)

(512) 961-1891

(Registrant’s telephone number, including area code)

N/A

 

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post 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  ☒

As of November 8, 2017, the registrant had 30,500,693 shares of common stock, $0.001 par value per share, outstanding.

 

 


Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements (Unaudited)

1

 

Condensed Consolidated Balance Sheets

1

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

2

 

Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders’ Deficit

3

 

Condensed Consolidated Statements of Cash Flows

4

 

Notes to Condensed Consolidated Financial Statements

5

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

25

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

33

Item 4.

Controls and Procedures

34

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

35

Item 1A.

Risk Factors

35

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

56

Item 3.

Defaults Upon Senior Securities

56

Item 4.

Mine Safety Disclosures

56

Item 5.

Other Information

56

Item 6.

Exhibits

56

Exhibit Index

57

Signatures

58

 

 

 

i

 


Savara Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

September 30,

2017

 

 

December 31,

2016

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

19,813

 

 

$

13,373

 

Short-term investments

 

 

33,473

 

 

 

—

 

Grants and award receivable

 

 

—

 

 

 

400

 

Prepaid expenses and other current assets

 

 

2,235

 

 

 

840

 

Total current assets

 

 

55,521

 

 

 

14,613

 

Property and equipment, net

 

 

582

 

 

 

793

 

In-process R&D

 

 

33,449

 

 

 

10,477

 

Goodwill

 

 

28,332

 

 

 

3,051

 

Other non-current assets

 

 

1,004

 

 

 

—

 

Total assets

 

$

118,888

 

 

$

28,934

 

Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,665

 

 

$

536

 

Accrued expenses

 

 

4,147

 

 

 

2,477

 

Current portion of capital lease obligation

 

 

265

 

 

 

442

 

Total current liabilities

 

 

6,077

 

 

 

3,455

 

Long-term liabilities:

 

 

 

 

 

 

 

 

Accrued interest on convertible promissory notes

 

 

—

 

 

 

151

 

Debt facility

 

 

14,675

 

 

 

—

 

Convertible promissory notes

 

 

—

 

 

 

3,448

 

Put option derivative liability

 

 

—

 

 

 

979

 

Contingent consideration

 

 

11,816

 

 

 

9,708

 

Deferred tax liability

 

 

11,263

 

 

 

2,305

 

Capital lease obligation, net of current portion

 

 

297

 

 

 

579

 

Warrant liability

 

 

—

 

 

 

303

 

Other long-term liabilities

 

 

115

 

 

 

20

 

Total liabilities

 

 

44,243

 

 

 

20,948

 

Redeemable convertible preferred stock:

 

 

 

 

 

 

 

 

Series A redeemable convertible preferred stock, $0.001 par value, 0 and 1,799,906

   shares authorized, issued, and outstanding, as of September 30, 2017 and

   December 31, 2016, respectively

 

 

—

 

 

 

3,232

 

Series B redeemable convertible preferred stock, $0.001 par value, 0 and 6,000,000

   shares authorized as of September 30, 2017 and December 31, 2016, respectively;

   0 and 5,675,387 shares issued and outstanding as of September 30, 2017 and

   December 31, 2016; respectively

 

 

—

 

 

 

17,301

 

Series C redeemable convertible preferred stock, $0.001 par value; 0 and 8,000,000

   shares authorized as of September 30, 2017 and December 31, 2016, respectively;

   0 and 4,452,582 shares issued and outstanding as of September 30, 2017 and

   December 31, 2016, respectively

 

 

—

 

 

 

23,328

 

Total redeemable convertible preferred stock

 

 

—

 

 

 

43,861

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

 

 

Common stock, $0.001 par value, 500,000,000 and 27,000,000 shares authorized as of

   September 30, 2017 and December 31, 2016, respectively; 24,389,105 and 3,162,573

   shares (after giving effect to the Exchange Ratio and Reverse Stock Split) issued and

   outstanding as of September 30, 2017 and December 31, 2016, respectively

 

 

26

 

 

 

5

 

Additional paid-in capital

 

 

135,571

 

 

 

3,117

 

Accumulated other comprehensive income (loss)

 

 

747

 

 

 

(591

)

Accumulated deficit

 

 

(61,699

)

 

 

(38,406

)

Total stockholders’ equity (deficit)

 

 

74,645

 

 

 

(35,875

)

Total liabilities, redeemable convertible preferred stock, and stockholder’s equity (deficit)

 

$

118,888

 

 

$

28,934

 

 

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

1


Savara Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Grant and award revenue

 

$

—

 

 

$

—

 

 

$

—

 

 

$

—

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

4,966

 

 

 

2,142

 

 

 

12,076

 

 

 

4,694

 

General and administrative

 

 

1,486

 

 

 

1,002

 

 

 

8,410

 

 

 

1,955

 

Depreciation

 

 

91

 

 

 

86

 

 

 

272

 

 

 

256

 

Total operating expenses

 

 

6,543

 

 

 

3,230

 

 

 

20,758

 

 

 

6,905

 

Loss from operations

 

 

(6,543

)

 

 

(3,230

)

 

 

(20,758

)

 

 

(6,905

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(277

)

 

 

(190

)

 

 

(1,038

)

 

 

(207

)

Foreign currency exchange gain (loss)

 

 

(71

)

 

 

92

 

 

 

(225

)

 

 

20

 

Loss on extinguishment of debt

 

 

—

 

 

 

—

 

 

 

(1,816

)

 

 

—

 

Change in fair value of financial instruments

 

 

(43

)

 

 

101

 

 

 

(280

)

 

 

137

 

Total other income (expense)

 

 

(391

)

 

 

3

 

 

 

(3,359

)

 

 

(50

)

Loss before income taxes

 

 

(6,934

)

 

 

(3,227

)

 

 

(24,117

)

 

 

(6,955

)

Income tax benefit

 

 

117

 

 

 

—

 

 

 

824

 

 

 

—

 

Net loss

 

$

(6,817

)

 

$

(3,227

)

 

$

(23,293

)

 

$

(6,955

)

Accretion of redeemable convertible preferred stock

 

 

—

 

 

 

(44

)

 

 

(578

)

 

 

(70

)

Deemed dividend on beneficial conversion feature

 

 

—

 

 

 

—

 

 

 

(404

)

 

 

—

 

Net loss attributable to common stockholders

 

$

(6,817

)

 

$

(3,271

)

 

$

(24,275

)

 

$

(7,025

)

Other comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gain (loss) on foreign currency translation

 

 

348

 

 

 

39

 

 

 

1,343

 

 

 

39

 

Unealized gain (loss) on short-term investments

 

 

(5

)

 

 

—

 

 

 

(5

)

 

 

—

 

Total Comprehensive Loss

 

$

(6,474

)

 

$

(3,188

)

 

$

(21,955

)

 

$

(6,916

)

Net loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.28

)

 

$

(1.21

)

 

$

(1.76

)

 

$

(4.40

)

Weighted average common shares outstanding

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

24,209,517

 

 

 

2,707,055

 

 

 

13,770,032

 

 

 

1,596,123

 

 

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

 

 

 

2


Savara Inc. and Subsidiaries

Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

Period Ended September 30, 2017

(In thousands, except share amounts)

(Unaudited)

 

 

Redeemable Convertible Preferred Stock

 

 

 

 

 

 

Stockholders’ Equity (Deficit)

 

 

Redeemable

Convertible Series A

Preferred Stock

 

 

Redeemable

Convertible Series B

Preferred Stock

 

 

Redeemable

Convertible Series C

Preferred Stock

 

 

 

 

 

 

Common Stock

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

Number of

Shares

 

 

Amount

 

 

Number of

Shares

 

 

Amount

 

 

Number of

Shares

 

 

Amount

 

 

Total

 

 

Number of

Shares

 

 

Amount

 

 

Additional

Paid-In

Capital

 

 

Accumulated

Deficit

 

 

Other

Comprehensive

Income

 

 

Total

 

Balance on December 31, 2016

 

1,799,906

 

 

$

3,232

 

 

 

5,675,387

 

 

$

17,301

 

 

 

4,452,582

 

 

$

23,328

 

 

$

43,861

 

 

 

3,162,573

 

 

$

5

 

 

$

3,117

 

 

$

(38,406

)

 

$

(591

)

 

$

(35,875

)

Repurchase of forfeited restricted common stock

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(19,045

)

 

—

 

 

—

 

 

—

 

 

—

 

 

—

 

Accretion of redeemable convertible preferred stock

 

—

 

 

 

22

 

 

 

—

 

 

 

460

 

 

 

—

 

 

 

96

 

 

 

578

 

 

 

—

 

 

—

 

 

 

(578

)

 

—

 

 

—

 

 

 

(578

)

Issuance of common stock upon exercise of warrants

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

111,799

 

 

 

—

 

 

 

384

 

 

—

 

 

—

 

 

 

384

 

Conversion of convertible notes into common stock

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

1,140,046

 

 

 

1

 

 

 

10,044

 

 

—

 

 

—

 

 

 

10,045

 

Conversion of redeemable convertible preferred

   stock to common stock as effected for the reverse

   merger exchange ratio

 

(1,799,906

)

 

 

(3,254

)

 

 

(5,675,387

)

 

 

(17,761

)

 

 

(4,452,582

)

 

 

(23,424

)

 

 

(44,439

)

 

 

7,034,102

 

 

 

7

 

 

 

44,431

 

 

—

 

 

—

 

 

 

44,438

 

Reclassification of warrant liability

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

—

 

 

 

370

 

 

—

 

 

—

 

 

 

370

 

Beneficial conversion feature

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

—

 

 

 

404

 

 

—

 

 

—

 

 

 

404

 

Business combination upon Merger

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

3,639,189

 

 

 

4

 

 

 

35,842

 

 

—

 

 

—

 

 

 

35,846

 

Issuance of common stock upon public offering, net

   closing costs

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

9,034,210

 

 

 

9

 

 

 

39,513

 

 

—

 

 

—

 

 

 

39,522

 

Issuance of detachable warrants with debt instrument

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

—

 

 

 

359

 

 

—

 

 

—

 

 

 

359

 

Issuance of common stock upon At The Market

   sales, net

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

124,210

 

 

 

—

 

 

 

991

 

 

—

 

 

—

 

 

 

991

 

Issuance of common stock for settlement of RSUs

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

72,361

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Issuance of common stock upon cashless exercise

   of stock options

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

89,660

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Issuance of call option derivative

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

-

 

 

 

—

 

 

 

344

 

 

 

—

 

 

 

—

 

 

 

344

 

Stock-based compensation

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

350

 

 

 

—

 

 

 

—

 

 

 

350

 

Foreign exchange translation adjustment

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

1,343

 

 

 

1,343

 

Unrealized gain (loss) on short-term investments

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(5

)

 

 

(5

)

Net loss incurred

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

(23,293

)

 

 

—

 

 

 

(23,293

)

Balance on September 30, 2017

 

—

 

 

$

—

 

 

 

—

 

 

$

—

 

 

 

—

 

 

$

—

 

 

$

—

 

 

 

24,389,105

 

 

$

26

 

 

$

135,571

 

 

$

(61,699

)

 

$

747

 

 

$

74,645

 

 

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

 

 

 

3


Savara Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

Nine Months Ended

September 30,

 

 

 

2017

 

 

2016

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(23,293

)

 

$

(6,955

)

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

 

 

 

 

 

 

 

 

Depreciation

 

 

272

 

 

 

256

 

Changes in fair value of financial instruments

 

 

280

 

 

 

(137

)

Change in fair value of contingent consideration

 

 

2,108

 

 

 

—

 

Noncash interest

 

 

395

 

 

 

99

 

Loss on extinguishment of debt

 

 

1,816

 

 

 

—

 

Foreign currency gain/(loss)

 

 

225

 

 

 

(20

)

Accretion on discount to convertible promissory notes

 

 

—

 

 

 

121

 

Amortization of debt issuance costs

 

 

301

 

 

 

—

 

Accretion on discount to short-term investments

 

 

(34

)

 

 

—

 

Stock-based compensation

 

 

350

 

 

 

154

 

Issuance of call option derivative

 

 

344

 

 

 

—

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Grant and award receivable

 

 

400

 

 

 

—

 

Tax refund receivable

 

 

(785

)

 

 

—

 

Prepaid expenses and other current assets

 

 

(1,272

)

 

 

(479

)

Deferred rent

 

 

(14

)

 

 

15

 

Accounts payable and accrued expenses

 

 

143

 

 

 

766

 

Net cash used in operating activities

 

$

(18,764

)

 

$

(6,180

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Cash acquired through Merger

 

$

3,442

 

 

$

—

 

Purchase of property and equipment

 

 

(61

)

 

 

(8

)

Purchase of available-for-sale securities

 

 

(33,443

)

 

 

—

 

Net cash used in investing activities

 

$

(30,062

)

 

$

(8

)

Cash flows from financing activity:

 

 

 

 

 

 

 

 

Proceeds from debt facility

 

$

14,894

 

 

$

—

 

Proceeds from convertible promissory note

 

 

3,569

 

 

 

4,315

 

Issuance of common stock upon exercise of warrants

 

 

384

 

 

 

—

 

Issuance of common stock upon public offering, net

 

 

39,522

 

 

 

—

 

Repayment of long-term debt

 

 

(3,567

)

 

 

—

 

Issuance of common stock upon at the market offerings, net

 

 

991

 

 

 

—

 

Proceeds from exercise of stock option

 

 

—

 

 

 

1

 

Proceeds from issuance of Series C preferred stock, net

 

 

—

 

 

 

782

 

Capital lease obligation principal payments

 

 

(460

)

 

 

(81

)

Net cash provided by financing activities

 

$

55,333

 

 

$

5,017

 

Effect of exchange rate changes on cash and cash equivalents

 

 

(67

)

 

 

—

 

Increase / (Decrease) in cash and cash equivalents

 

$

6,440

 

 

$

(1,171

)

Cash and cash equivalents beginning of period

 

 

13,373

 

 

 

16,683

 

Cash and cash equivalents end of period

 

$

19,813

 

 

$

15,512

 

 

 

 

 

 

 

 

 

 

Non-cash transactions:

 

 

 

 

 

 

 

 

Issuance of common stock for Serendex

 

$

—

 

 

$

2,851

 

Net assets acquired in business combination of Serendex

 

 

—

 

 

 

(12,375

)

Contingent liability related to purchase of Serendex

 

 

—

 

 

 

9,524

 

Extinguishment and derecognition of put options

 

 

2,202

 

 

 

—

 

Conversion of convertible notes into common stock