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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: September 30, 2021

 

 

Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Commission File Number: 001-39101

 

Baudax Bio, Inc.

(Exact name of registrant as specified in its charter)

 

 

Pennsylvania

47-4639500

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

 

490 Lapp Road, Malvern, Pennsylvania

19355

(Address of principal executive offices)

(Zip Code)

 

(484) 395-2440

(Registrant’s telephone number, including area code)

 

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

 

Title of Each Class

Trading Symbol

Name of Exchange on Which Registered

Common Stock, par value $0.01

BXRX

Nasdaq Capital Market

 

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

None

 

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 Section13(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 2, 2021, there were 84,423,699 shares of common stock, par value $0.01 per share, outstanding.

 

1

 


 

TABLE OF CONTENTS

Index

 

 

 

 

 

 

Page

 

 

 

Forward-Looking Statements

 

3

 

 

 

PART I. FINANCIAL INFORMATION

 

5

 

 

 

 

 

 

 

Item 1.

 

Consolidated Financial Statements (Unaudited)

 

5

 

 

 

 

 

 

 

Item 2.

 

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

 

31

 

 

 

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

41

 

 

 

 

 

 

 

Item 4.

 

Controls and Procedures

 

41

 

 

 

 

 

 

PART II. OTHER INFORMATION

 

42

 

 

 

 

 

 

 

Item 1.

 

Legal Proceedings

 

42

 

 

 

 

 

 

 

Item 1A.

 

Risk Factors

 

42

 

 

 

 

 

 

 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

43

 

 

 

 

 

 

 

Item 3.

 

Defaults Upon Senior Securities

 

43

 

 

 

 

 

 

 

Item 4.

 

Mine Safety Disclosures

 

43

 

 

 

 

 

 

 

Item 5.

 

Other Information

 

43

 

 

 

 

 

 

 

Item 6.

 

Exhibits

 

43

 

 

 

 

 

 

SIGNATURES

 

44

 

 

 

 

 

 

 

 

2

 


 

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “would,” “could,” “should,” “potential,” “seek,” “evaluate,” “pursue,” “continue,” “design,” “impact,” “affect,” “forecast,” “target,” “outlook,” “initiative,” “objective,” “designed,” “priorities,” “goal,” or the negative of such terms and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are based on assumptions and expectations that may not be realized and are inherently subject to risks, uncertainties and other factors, many of which cannot be predicted with accuracy and some of which might not even be anticipated.

These forward-looking statements in this Quarterly Report include, among other things, statements about:

our estimates regarding expenses, revenue, capital requirements and timing and availability of and the need for additional financing;
our ability to continue as a going concern for the next 12 months;
our ability to operate under significant indebtedness;
our ability to maintain the listing of our common stock on the Nasdaq Capital Market;
our ability to maintain regulatory approval for ANJESO® (meloxicam) injection, or ANJESO, and obtain regulatory approval for any other product candidates that we may develop, and any related restrictions, limitations, or warnings in the label of any approved product candidates;
our ability to successfully manage the timing, costs and other aspects of the commercialization of ANJESO, including setting an acceptable price for and obtaining adequate coverage and reimbursement of ANJESO;
our ability to successfully market, commercialize and achieve broad market acceptance for ANJESO and any of our other product candidates once approved;
the acceptance of ANJESO by the medical community, including physicians, patients, healthcare providers and hospital formularies;
our ability and that of our third-party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO;
the results, timing and outcome of our clinical trials of our product candidates, and any future clinical and preclinical studies;
our relationships with Alkermes plc, or Alkermes, other third parties, licensors, collaborators, and our employees;
our ability to operate as a standalone company and execute our strategic priorities;
potential indemnification liabilities we may owe to Recro Pharma, Inc., or Recro, after the separation of Recro’s acute care business and transfer of such assets to us, or the Separation;
the effects of changes in our effective tax rate due to changes in the mix of earnings in countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities, tax impacts and net operating loss utilization related to the separation from Recro and changes in the tax laws;
our ability to comply with the regulatory schemes applicable to our business and other regulatory developments in the United States and foreign countries;
the performance of third-parties upon which we depend, including third-party contract research organizations, or CROs, and third-party suppliers, manufacturers including Alkermes and Patheon UK Limited, group purchasing organizations, distributors, and logistics providers;
our ability to obtain and maintain patent protection and defend our intellectual property rights against third-parties;
our ability to maintain our relationships, profitability and contracts with our key commercial partners;
our ability to defend any material litigation filed against us and avoid liabilities resulting from any material litigation, including any liabilities associated with the ongoing securities class action filed against Recro for which we have agreed to indemnify Recro;
our ability to recruit or retain key scientific, technical, commercial, and management personnel or to retain our executive officers;

3

 


 

our ability to raise future financing and attain profitability for continued development of our business and commercialization of ANJESO and our product candidates and to meet any required debt payments, and any milestone payments owing to Alkermes, or our other licensing and collaboration partners;
our ability to operate under increased leverage and associated lending covenants; to pay existing required interest and principal amortization payments when due; and/or to obtain acceptable refinancing alternatives; and
our expectations regarding the impact of the ongoing coronavirus 2019, or COVID-19, pandemic including, but not limited to, the availability of vaccines for COVID-19 and peoples’ willingness to avail themselves of such vaccines, the expected duration of disruption and immediate and long-term delays, disruption in the commercialization of ANJESO, our ability to access hospital systems and formulary committees, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, and the overall impact of the COVID-19 pandemic on our business, financial condition and results of operations.

Any forward-looking statements that we make in this Quarterly Report speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this Quarterly Report or to reflect the occurrence of unanticipated events. Comparisons of results for current and any prior periods are not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as historical data.

You should also read carefully the factors described in the “Risk Factors” included in Part II, Item 1A of this Quarterly Report and Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed with the SEC on February 16, 2021, or the 2020 Annual Report, to better understand significant risks and uncertainties inherent in our business and underlying any forward-looking statements. As a result of these factors, actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements in this Quarterly Report and you should not place undue reliance on any forward-looking statements.

4

 


 

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

BAUDAX BIO, INC.

Consolidated Balance Sheets

(Unaudited)

 

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

 

September 30, 2021

 

 

December 31, 2020

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

14,772

 

 

$

30,342

 

Short-term investments

 

 

10,150

 

 

 

 

Accounts receivable, net

 

 

422

 

 

 

51

 

Inventory

 

 

4,310

 

 

 

2,978

 

Prepaid expenses and other current assets

 

 

1,484

 

 

 

3,346

 

Total current assets

 

 

31,138

 

 

 

36,717

 

Property, plant and equipment, net

 

 

4,933

 

 

 

5,052

 

Intangible assets, net

 

 

22,322

 

 

 

24,254

 

Goodwill

 

 

2,127

 

 

 

2,127

 

Other long-term assets

 

 

979

 

 

 

583

 

Total assets

 

$

61,499

 

 

$

68,733

 

Liabilities and Shareholders' Deficit

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,819

 

 

$

3,653

 

Accrued expenses and other current liabilities

 

 

4,568

 

 

 

5,326

 

Current portion of long-term debt, net

 

 

1,389

 

 

 

683

 

Current portion of contingent consideration

 

 

6,666

 

 

 

8,467

 

Total current liabilities

 

 

14,442

 

 

 

18,129

 

Long-term debt, net

 

 

6,913

 

 

 

8,469

 

Long-term portion of contingent consideration

 

 

60,059

 

 

 

56,576

 

Other long-term liabilities

 

 

813

 

 

 

358

 

Total liabilities

 

 

82,227

 

 

 

83,532

 

Commitments and contingencies (Note 12)

 

 

 

 

 

 

Shareholders’ deficit:

 

 

 

 

 

 

Preferred stock, $0.01 par value. Authorized, 10,000,000 shares; none issued and
   outstanding

 

 

 

 

 

 

Common stock, $0.01 par value. Authorized, 190,000,000 shares; issued and
   outstanding,
84,423,342 shares at September 30, 2021 and 48,688,480 shares at
   December 31, 2020

 

 

844

 

 

 

487

 

Additional paid-in capital

 

 

139,951

 

 

 

97,034

 

Accumulated deficit

 

 

(161,523

)

 

 

(112,320

)

Total shareholders’ deficit

 

 

(20,728

)

 

 

(14,799

)

Total liabilities and shareholders’ deficit

 

$

61,499

 

 

$

68,733

 

 

See accompanying notes to consolidated financial statements.

5

 


 

BAUDAX BIO, INC.

Consolidated Statements of Operations

(Unaudited)

 

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

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

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue, net

 

$

281

 

 

$

68

 

 

$

680

 

 

$

417

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales

 

 

462

 

 

 

540

 

 

 

1,869

 

 

 

1,190

 

Research and development

 

 

658

 

 

 

1,469

 

 

 

2,623

 

 

 

5,889

 

Selling, general and administrative

 

 

11,074

 

 

 

13,763

 

 

 

33,770

 

 

 

33,026

 

Amortization of intangible assets

 

 

644

 

 

 

643

 

 

 

1,932

 

 

 

1,502

 

Change in warrant valuation

 

 

(6

)

 

 

(11,182

)

 

 

(47

)

 

 

2,863

 

Change in contingent consideration valuation

 

 

3,829

 

 

 

(17,427

)

 

 

9,551

 

 

 

14,252

 

Total operating expenses

 

 

16,661

 

 

 

(12,194

)

 

 

49,698

 

 

 

58,722

 

Operating (loss) income

 

 

(16,380

)

 

 

12,262

 

 

 

(49,018

)

 

 

(58,305

)

Other expense:

 

 

 

 

 

 

 

 

 

 

 

 

Other expense, net

 

 

(582

)

 

 

(577

)

 

 

(185

)

 

 

(753

)

Net (loss) income

 

$

(16,962

)

 

$

11,685

 

 

$

(49,203

)

 

$

(59,058

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Per share information:

 

 

 

 

 

 

 

 

 

 

 

 

Net (loss) income per share of common stock, basic

 

$

(0.20

)

 

$

0.64

 

 

$

(0.66

)

 

$

(3.84

)

Net (loss) income per share of common stock, diluted

 

$

(0.20

)

 

$

0.62

 

 

$

(0.66

)

 

$

(3.84

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding, basic

 

 

84,400,156

 

 

 

18,374,604

 

 

 

74,008,574

 

 

 

15,366,861

 

Weighted average common shares outstanding, diluted

 

 

84,400,156

 

 

 

18,768,376

 

 

 

74,008,574

 

 

 

15,366,861

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See accompanying notes to consolidated financial statements.

6

 


 

BAUDAX BIO, INC.

Consolidated Statements of Shareholders’ Deficit

(Unaudited)

 

For the Nine Months Ended September 30, 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

Additional

 

 

 

 

 

 

 

(amounts in thousands, except share data)

 

Shares

 

 

Amount

 

 

paid-in
capital

 

 

Accumulated
Deficit

 

 

Total

 

Balance, December 31, 2020

 

 

48,688,480

 

 

$

487

 

 

$

97,034

 

 

$

(112,320

)

 

$

(14,799

)

Recro Pharma allocation - stock-based
   compensation

 

 

 

 

 

 

 

 

1,201

 

 

 

 

 

 

1,201

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

975

 

 

 

 

 

 

975

 

Issuance of common stock and warrants for
   registered direct offerings, net

 

 

11,000,000

 

 

 

110

 

 

 

16,317

 

 

 

 

 

 

16,427

 

Issuance of shares pursuant to vesting of
   restricted stock units, net of shares
   withheld for income taxes

 

 

42,159

 

 

 

 

 

 

(41

)

 

 

 

 

 

(41

)

Exercise of warrants

 

 

10,411,969

 

 

 

104

 

 

 

12,051

 

 

 

 

 

 

12,155

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(16,912

)

 

 

(16,912

)

Balance, March 31, 2021

 

 

70,142,608

 

 

$

701

 

 

$

127,537

 

 

$

(129,232

)

 

$

(994

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

854

 

 

 

 

 

 

854

 

Issuance of common stock and warrants for
   registered direct offerings, net

 

 

14,028,520

 

 

 

141

 

 

 

10,760

 

 

 

 

 

 

10,901

 

Issuance of shares pursuant to vesting of
   restricted stock units, net of shares
   withheld for income taxes

 

 

102,094

 

 

 

1

 

 

 

(6

)

 

 

 

 

 

(5

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(15,329

)

 

 

(15,329

)

Balance, June 30, 2021

 

 

84,273,222

 

 

$

843

 

 

$

139,145

 

 

$

(144,561

)

 

$

(4,573

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

874

 

 

 

 

 

 

874

 

Issuance of common stock and warrants for
   registered direct offerings, net

 

 

 

 

 

 

 

 

(38

)

 

 

 

 

 

(38

)

Issuance of restricted stock units, net of
   shares withheld for income taxes

 

 

150,120

 

 

 

1

 

 

 

(30

)

 

 

 

 

 

(29

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(16,962

)

 

 

(16,962

)

Balance, September 30, 2021

 

 

84,423,342

 

 

$

844

 

 

$

139,951

 

 

$

(161,523

)

 

$

(20,728

)

 

See accompanying notes to consolidated financial statements.

 

7

 


 

BAUDAX BIO, INC.

Consolidated Statements of Shareholders’ Deficit

(Unaudited)

 

For the Nine Months Ended September 30, 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

Additional

 

 

 

 

 

 

 

(amounts in thousands, except share data)

 

Shares

 

 

Amount

 

 

paid-in
capital

 

 

Accumulated
Deficit

 

 

Total

 

Balance, December 31, 2019

 

 

9,350,709

 

 

$

94

 

 

$

19,405

 

 

$

(36,220

)

 

$

(16,721

)

Recro Pharma allocation - stock-based
   compensation

 

 

 

 

 

 

 

 

456

 

 

 

 

 

 

456

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

2,177

 

 

 

 

 

 

2,177

 

Issuance of common stock and warrants for
   public offering, net

 

 

7,692,308

 

 

 

77

 

 

 

14,899

 

 

 

 

 

 

14,976

 

Sale of common stock under equity
   facility, net of transaction costs

 

 

441,967

 

 

 

4

 

 

 

3,608

 

 

 

 

 

 

3,612

 

Issuance of common stock upon Separation

 

 

45,874

 

 

 

1

 

 

 

 

 

 

 

 

 

1

 

Issuance of shares pursuant to vesting of
   restricted stock units, net of shares
   withheld for income taxes

 

 

39,130

 

 

 

 

 

 

(95

)

 

 

 

 

 

(95

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(40,298

)

 

 

(40,298

)

Balance, March 31, 2020

 

 

17,569,988

 

 

$

176

 

 

$

40,450

 

 

$

(76,518

)

 

$

(35,892

)

Recro Pharma allocation - stock-based
   compensation

 

 

 

 

 

 

 

 

445

 

 

 

 

 

 

445

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

1,864

 

 

 

 

 

 

1,864

 

Stock issuance costs

 

 

 

 

 

 

 

 

(3

)

 

 

 

 

 

(3

)

Warrants issued in connection with financing
   facility

 

 

 

 

 

 

 

 

1,423

 

 

 

 

 

 

1,423

 

Exercise of warrants

 

 

804,616

 

 

 

8

 

 

 

3,196

 

 

 

 

 

 

3,204

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(30,445

)

 

 

(30,445

)

Balance, June 30, 2020

 

 

18,374,604

 

 

$

184

 

 

$

47,375

 

 

$

(106,963

)

 

$

(59,404

)

Recro Pharma allocation - stock-based
   compensation

 

 

 

 

 

 

 

 

444

 

 

 

 

 

 

444

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

2,045

 

 

 

 

 

 

2,045

 

Net income

 

 

 

 

 

 

 

 

 

 

 

11,685

 

 

 

11,685

 

Balance, September 30, 2020

 

 

18,374,604

 

 

$

184

 

 

$

49,864

 

 

$

(95,278

)

 

$

(45,230

)

 

See accompanying notes to consolidated financial statements.

8

 


 

BAUDAX BIO, INC.

Consolidated Statements of Cash Flows

(Unaudited)

 

 

 

For the Nine Months Ended September 30,

 

(amounts in thousands)

 

2021

 

 

2020

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(49,203

)

 

$

(59,058

)

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

 

 

 

 

 

 

Stock-based compensation

 

 

4,132

 

 

 

7,431

 

Non-cash interest expense

 

 

673

 

 

 

306

 

Gain on extinguishment of debt

 

 

(1,553

)

 

 

 

Depreciation expense

 

 

195

 

 

 

315

 

Amortization

 

 

1,932

 

 

 

1,502

 

Change in warrant valuation