10-Q 1 svra-20230930.htm 10-Q 10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2023

 

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

img198093632_0.jpg 

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.)

 

 

 

1717 Langhorne Newtown Road, Suite 300

Langhorne, Pennsylvania

19047

(Address of principal executive offices)

(Zip Code)

(512) 614-1848

(Registrant’s telephone number, including area code)

 

 

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

 

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, par value $0.001 per share

 

SVRA

 

The Nasdaq Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ 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 ☒

As of November 9, 2023, the registrant had 135,341,024 shares of common stock, $0.001 par value per share, outstanding.

 


 

Table of Contents

 

Page

PART I.

FINANCIAL INFORMATION

1

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 Stockholders’ Equity

3

Condensed Consolidated Statements of Cash Flows

5

Notes to Condensed Consolidated Financial Statements

6

Item 2.

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

17

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

22

Item 4.

Controls and Procedures

23

PART II.

OTHER INFORMATION

24

Item 1.

Legal Proceedings

24

Item 1A.

Risk Factors

24

Item 2.

Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities

24

Item 3.

Defaults Upon Senior Securities

24

Item 4.

Mine Safety Disclosures

24

Item 5.

Other Information

24

Item 6.

Exhibits

24

Exhibit Index

25

Signatures

26

 

i


 

PART I – FINANCIAL INFORMATION

Item I. Financial Information

 

Savara Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

 

 

 

September 30, 2023

 

 

December 31, 2022

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

27,690

 

 

$

52,100

 

Short-term investments

 

 

140,561

 

 

 

73,776

 

Prepaid expenses and other current assets

 

 

1,845

 

 

 

3,078

 

Total current assets

 

 

170,096

 

 

 

128,954

 

Property and equipment, net

 

 

277

 

 

 

51

 

In-process R&D

 

 

10,497

 

 

 

10,656

 

Other non-current assets

 

 

1,202

 

 

 

116

 

Total assets

 

$

182,072

 

 

$

139,777

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

3,219

 

 

$

1,334

 

Accrued expenses and other current liabilities

 

 

5,744

 

 

 

4,533

 

Total current liabilities

 

 

8,963

 

 

 

5,867

 

Long-term liabilities:

 

 

 

 

 

 

Long-term debt

 

 

26,281

 

 

 

26,078

 

Other long-term liabilities

 

 

284

 

 

 

54

 

Total liabilities

 

 

35,528

 

 

 

31,999

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock, $0.001 par value, 300,000,000 authorized as of September 30, 2023 and
   December 31, 2022;
135,339,836 and 114,046,345 shares issued and outstanding
   as of September 30, 2023 and December 31, 2022, respectively

 

 

137

 

 

 

116

 

Additional paid-in capital

 

 

524,619

 

 

 

446,938

 

Accumulated other comprehensive loss

 

 

(942

)

 

 

(605

)

Accumulated deficit

 

 

(377,270

)

 

 

(338,671

)

Total stockholders' equity

 

 

146,544

 

 

 

107,778

 

Total liabilities and stockholders’ equity

 

$

182,072

 

 

$

139,777

 

 

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

1


 

Savara Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

For the three months ended September 30,

 

 

For the nine months ended September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

13,867

 

 

$

8,151

 

 

$

31,516

 

 

$

20,253

 

General and administrative

 

 

4,147

 

 

 

2,376

 

 

 

10,816

 

 

 

7,687

 

Depreciation and amortization

 

 

30

 

 

 

8

 

 

 

45

 

 

 

24

 

Total operating expenses

 

 

18,044

 

 

 

10,535

 

 

 

42,377

 

 

 

27,964

 

Loss from operations

 

 

(18,044

)

 

 

(10,535

)

 

 

(42,377

)

 

 

(27,964

)

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

Interest income (expense)

 

 

1,444

 

 

 

152

 

 

 

2,917

 

 

 

(702

)

Foreign currency exchange (loss) gain

 

 

1

 

 

 

(8

)

 

 

64

 

 

 

21

 

Tax credit income

 

 

 

 

 

5

 

 

 

797

 

 

 

795

 

Total other income, net

 

 

1,445

 

 

 

149

 

 

 

3,778

 

 

 

114

 

Net loss

 

$

(16,599

)

 

$

(10,386

)

 

$

(38,599

)

 

$

(27,850

)

Net loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.10

)

 

$

(0.07

)

 

$

(0.24

)

 

$

(0.18

)

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

164,342,634

 

 

 

152,773,015

 

 

 

158,444,739

 

 

 

152,771,302

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Loss on foreign currency translation

 

 

(318

)

 

 

(668

)

 

 

(286

)

 

 

(1,621

)

Unrealized gain (loss) on short-term
   investments

 

 

(5

)

 

 

77

 

 

 

(51

)

 

 

9

 

Total comprehensive loss

 

$

(16,922

)

 

$

(10,977

)

 

$

(38,936

)

 

$

(29,462

)

 

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

2


 

Savara Inc. and Subsidiaries

Condensed Consolidated Statements of Changes in Stockholders’ Equity

Periods Ended September 30, 2023 and 2022

(In thousands, except share amounts)

(Unaudited)

 

 

Stockholders’ Equity

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

Number of
Shares

 

 

Amount

 

 

Additional
Paid-In
Capital

 

 

Accumulated
Deficit

 

 

Accumulated
Other
Comprehensive
Income (Loss)

 

 

Total

 

Balance on December 31, 2022

 

114,046,345

 

 

$

116

 

 

$

446,938

 

 

$

(338,671

)

 

$

(605

)

 

$

107,778

 

Issuance of common stock upon
  exercise of stock options

 

 

17,129

 

 

 

 

 

 

27

 

 

 

 

 

 

 

 

 

27

 

Issuance of common stock for
  settlement of RSUs

 

 

1,813

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Repurchase of shares for
  minimum tax withholdings

 

 

(551

)

 

 

 

 

 

(1

)

 

 

 

 

 

 

 

 

(1

)

Stock-based compensation

 

 

 

 

 

 

 

 

864

 

 

 

 

 

 

 

 

 

864

 

Foreign exchange translation
  adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

130

 

 

 

130

 

Unrealized gain on short-term
  investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14

 

 

 

14

 

Net loss

 

 

 

 

 

 

 

 

 

 

(10,557

)

 

 

 

 

 

(10,557

)

Balance on March 31, 2023

 

 

114,064,736

 

 

$

116

 

 

$

447,828

 

 

$

(349,228

)

 

$

(461

)

 

$

98,255

 

Issuance of common stock upon
  exercise of stock options

 

 

84,375

 

 

 

 

 

 

103

 

 

 

 

 

 

 

 

 

103

 

Issuance of common stock for
  settlement of RSUs

 

 

1,812

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Repurchase of shares for
  minimum tax withholdings

 

 

(468

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

958

 

 

 

 

 

 

 

 

 

958

 

Foreign exchange translation
  adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(98

)

 

 

(98

)

Unrealized loss on short-term
  investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(60

)

 

 

(60

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(11,443

)

 

 

 

 

 

(11,443

)

Balance on June 30, 2023

 

114,150,455

 

 

$

116

 

 

$

448,889

 

 

$

(360,671

)

 

$

(619

)

 

$

87,715

 

Issuance of common stock and
  pre-funded warrants in registered
  direct offering, net of offering
  costs
(1)

 

 

21,000,000

 

 

 

21

 

 

 

74,853

 

 

 

 

 

 

 

 

 

74,874

 

Issuance of common stock for
  settlement of RSUs

 

 

176,813

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Repurchase of shares for
  minimum tax withholdings

 

 

(51,042

)

 

 

 

 

 

(182

)

 

 

 

 

 

 

 

 

(182

)

Issuance of common stock upon
  exercise of stock options

 

 

63,610

 

 

 

 

 

 

64

 

 

 

 

 

 

 

 

 

64

 

Stock-based compensation

 

 

 

 

 

 

 

 

995

 

 

 

 

 

 

 

 

 

995

 

Foreign exchange translation
  adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(318

)

 

 

(318

)

Unrealized loss on short-term
  investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5

)

 

 

(5

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(16,599

)

 

 

 

 

 

(16,599

)

Balance on September 30, 2023

 

135,339,836

 

 

$

137

 

 

$

524,619

 

 

$

(377,270

)

 

$

(942

)

 

$

146,544

 

 

(1)
As discussed in Note 8. Stockholders’ Equity, the Company sold (i) an aggregate of 21,000,000 shares of the Company’s common stock, par value $0.001 per share and (ii) pre-funded warrants to purchase an aggregate of 5,666,667 shares of the Company's common stock at an exercise price, equal to the par value, of $0.001 per share.

 

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

3


 

Savara Inc. and Subsidiaries

Condensed Consolidated Statements of Changes in Stockholders’ Equity (continued)

Periods Ended September 30, 2023 and 2022

(In thousands, except share amounts)

(Unaudited)

 

 

 

Stockholders’ Equity

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

Number of
Shares

 

 

Amount

 

 

Additional
Paid-In
Capital

 

 

Accumulated
Deficit

 

 

Accumulated
Other
Comprehensive
Income (Loss)

 

 

Total

 

Balance on December 31, 2021

 

 

114,036,892

 

 

$

116

 

 

$

444,898

 

 

$

(300,521

)

 

$

5

 

 

$

144,498

 

Issuance of common stock for
  settlement of RSUs

 

 

3,688

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Repurchase of shares for
  minimum tax withholdings

 

 

(720

)

 

 

 

 

 

(1

)

 

 

 

 

 

 

 

 

(1

)

Stock-based compensation

 

 

 

 

 

 

 

 

574

 

 

 

 

 

 

 

 

 

574

 

Foreign exchange translation
  adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(208

)

 

 

(208

)

Unrealized loss on short-term
  investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(88

)

 

 

(88

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(8,300

)

 

 

 

 

 

(8,300

)

Balance on March 31, 2022

 

 

114,039,860

 

 

$

116

 

 

$

445,471

 

 

$

(308,821

)

 

$

(291

)

 

$

136,475

 

Issuance of common stock for
  settlement of RSUs

 

 

1,812

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Repurchase of shares for
  minimum tax withholdings

 

 

(401

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

456

 

 

 

 

 

 

 

 

 

456

 

Foreign exchange translation
  adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(745

)

 

 

(745

)

Unrealized gain on short-term
  investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

20

 

 

 

20

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(9,164

)

 

 

 

 

 

(9,164

)

Balance on June 30, 2022

 

 

114,041,271

 

 

$

116

 

 

$

445,927

 

 

$

(317,985

)

 

$

(1,016

)

 

$

127,042

 

Issuance of common stock for
  settlement of RSUs

 

 

1,813

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Repurchase of shares for
  minimum tax withholdings

 

 

(442

)

 

 

 

 

 

(1

)

 

 

 

 

 

 

 

 

(1

)

Stock-based compensation

 

 

 

 

 

 

 

 

450

 

 

 

 

 

 

 

 

 

450

 

Foreign exchange translation
  adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(668

)

 

 

(668

)

Unrealized gain on short-term
  investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

77

 

 

 

77

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(10,386

)

 

 

 

 

 

(10,386

)

Balance on September 30, 2022

 

 

114,042,642

 

 

$

116

 

 

$

446,376

 

 

$

(328,371

)

 

$

(1,607

)

 

$

116,514

 

 

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

4


 

Savara Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

For the nine months ended September 30,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(38,599

)

 

$

(27,850

)

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

 

 

 

 

 

 

Depreciation and amortization

 

 

45

 

 

 

24

 

Amortization of right-of-use assets

 

 

64

 

 

 

101

 

Foreign currency gain

 

 

(64

)

 

 

(21

)

Amortization of debt issuance costs

 

 

203

 

 

 

266

 

(Accretion) amortization on premium to short-term investments

 

 

(3,345

)

 

 

432

 

Stock-based compensation

 

 

2,817

 

 

 

1,480

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

1,142

 

 

 

1,257

 

Non-current assets

 

 

(792

)

 

 

(828

)

Accounts payable and accrued expenses and other current liabilities

 

 

3,071

 

 

 

(764

)

Net cash used in operating activities

 

 

(35,458

)

 

 

(25,903

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchase of property and equipment

 

 

(272

)

 

 

(9

)

Purchase of available-for-sale securities, net

 

 

(155,415

)

 

 

(16,004

)

Maturity of available-for-sale securities

 

 

92,000

 

 

 

116,593

 

Sale of available-for-sale securities, net

 

 

 

 

 

11,276

 

Net cash provided by (used in) investing activities

 

 

(63,687

)

 

 

111,856

 

Cash flows from financing activities:

 

 

 

 

 

 

Repayment of long-term debt (1)

 

 

 

 

 

(26,350

)

Proceeds from long-term debt, net (1)

 

 

 

 

 

26,438

 

Issuance of common stock and pre-funded warrants in registered direct offering, net of offering costs

 

 

74,874

 

 

 

 

Proceeds from exercise of stock options

 

 

194

 

 

 

 

Repurchase of shares for minimum tax withholdings

 

 

(183

)

 

 

(2

)

Net cash provided by financing activities

 

 

74,885

 

 

 

86

 

Effect of exchange rate changes on cash and cash equivalents

 

 

(150

)