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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, 2022

 

 

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 August 9, 2022, there were 8,069,001 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

 

44

 

 

 

 

 

 

 

Item 5.

 

Other Information

 

44

 

 

 

 

 

 

 

Item 6.

 

Exhibits

 

44

 

 

 

 

 

 

SIGNATURES

 

45

 

 

 

 

 

 

 

 

2

 


 

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this Quarterly Report regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are 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 twelve 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 maintaining an acceptable price for and 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 and grow market demand;
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 trials and preclinical studies;
our ability to source materials needed for our drug candidates, optimize formulations for stability and other characteristics;
our relationships with Alkermes plc, or Alkermes, other third parties, licensors, collaborators, and our employees;
potential indemnification liabilities we may owe to Societal CDMO, Inc., or Societal CDMO, formerly Recro Pharma, Inc., after the separation of Societal CDMO’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 Societal CDMO 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, supply chain 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 Societal CDMO for which we have agreed to indemnify Societal CDMO;

3

 


 

our ability to recruit or retain key scientific, technical, commercial, and management personnel or to retain our executive officers;
our ability to raise future financing and attain profitability for continued development of our business and commercialization or other monetization 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;
the volatility of capital markets and other macroeconomic factors, including inflation, geopolitical tensions or the outbreak or escalation of hostilities or war;
our ability to operate under increased leverage and comply with 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 COVID-19 pandemic including, but not limited to, the emergence of variants of the virus, the availability and efficacy 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, including but not limited to manufacturing components and raw materials, 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, 2021 filed with the SEC on March 16, 2022, or the 2021 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

 

 

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

 

June 30, 2022

 

 

December 31, 2021

 

 

 

Unaudited

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

5,210

 

 

$

15,891

 

Accounts receivable, net

 

 

616

 

 

 

542

 

Inventory

 

 

5,255

 

 

 

5,002

 

Prepaid expenses and other current assets

 

 

1,398

 

 

 

2,059

 

Total current assets

 

 

12,479

 

 

 

23,494

 

Property, plant and equipment, net

 

 

4,941

 

 

 

5,015

 

Intangible assets, net

 

 

20,390

 

 

 

21,678

 

Goodwill

 

 

2,127

 

 

 

2,127

 

Other long-term assets

 

 

897

 

 

 

963

 

Total assets

 

$

40,834

 

 

$

53,277

 

Liabilities and Shareholders' Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

3,064

 

 

$

1,468

 

Accrued expenses and other current liabilities

 

 

3,812

 

 

 

5,540

 

Current portion of long-term debt, net

 

 

3,611

 

 

 

2,222

 

Current portion of contingent consideration

 

 

7,694

 

 

 

6,416

 

Total current liabilities

 

 

18,181

 

 

 

15,646

 

Long-term debt, net

 

 

5,099

 

 

 

6,309

 

Long-term portion of contingent consideration

 

 

12,692

 

 

 

17,446

 

Other long-term liabilities

 

 

632

 

 

 

650

 

Total liabilities

 

 

36,604

 

 

 

40,051

 

Commitments and contingencies (Note 12)

 

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.01 par value. Authorized, 10,000,000 shares; issued and
   outstanding,
0 shares at June 30, 2022 and 8,289 shares at
   December 31, 2021

 

 

 

 

 

 

Common stock, $0.01 par value. Authorized, 190,000,000 shares; issued and
   outstanding,
8,068,853 shares at June 30, 2022 and 2,807,239 shares at
   December 31, 2021

 

 

81

 

 

 

28

 

Additional paid-in capital

 

 

156,578

 

 

 

145,287

 

Accumulated deficit

 

 

(152,429

)

 

 

(132,089

)

Total shareholders’ equity

 

 

4,230

 

 

 

13,226

 

Total liabilities and shareholders’ equity

 

$

40,834

 

 

$

53,277

 

 

See accompanying notes to consolidated financial statements.

5

 


 

BAUDAX BIO, INC.

Consolidated Statements of Operations

(Unaudited)

 

 

 

For the Three Months Ended June 30,

 

 

For the Six Months Ended June 30,

 

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

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue, net

 

$

300

 

 

$

201

 

 

$

722

 

 

$

399

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales

 

 

361

 

 

 

586

 

 

 

1,009

 

 

 

1,407

 

Research and development

 

 

912

 

 

 

857

 

 

 

2,205

 

 

 

1,965

 

Selling, general and administrative

 

 

4,029

 

 

 

10,608

 

 

 

18,219

 

 

 

22,696

 

Amortization of intangible assets

 

 

644

 

 

 

644

 

 

 

1,288

 

 

 

1,288

 

Change in warrant valuation

 

 

(1

)

 

 

(59

)

 

 

(6

)

 

 

(41

)

Change in contingent consideration valuation

 

 

1,327

 

 

 

3,881

 

 

 

(2,476

)

 

 

5,722

 

Total operating expenses

 

 

7,272

 

 

 

16,517

 

 

 

20,239

 

 

 

33,037

 

Operating loss

 

 

(6,972

)

 

 

(16,316

)

 

 

(19,517

)

 

 

(32,638

)

Other expense:

 

 

 

 

 

 

 

 

 

 

 

 

Other (expense) income, net

 

 

(559

)

 

 

987

 

 

 

(823

)

 

 

397

 

Net loss

 

$

(7,531

)

 

$

(15,329

)

 

$

(20,340

)

 

$

(32,241

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Per share information:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share of common stock, basic

 

$

(1.05

)

 

$

(7.17

)

 

$

(3.63

)

 

$

(16.43

)

Net loss per share of common stock, diluted

 

$

(1.05

)

 

$

(7.18

)

 

$

(3.63

)

 

$

(16.43

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding, basic

 

 

7,181,640

 

 

 

2,137,191

 

 

 

5,610,037

 

 

 

1,962,655

 

Weighted average common shares outstanding, diluted

 

 

7,181,640

 

 

 

2,138,100

 

 

 

5,610,037

 

 

 

1,962,655

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See accompanying notes to consolidated financial statements.

6

 


 

BAUDAX BIO, INC.

Consolidated Statements of Shareholders’ Equity (Deficit)

(Unaudited)

 

For the Six Months Ended June 30, 2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preferred Stock

 

 

Common Stock

 

 

Additional

 

 

 

 

 

 

 

(amounts in thousands, except share data)

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

paid-in
capital

 

 

Accumulated
Deficit

 

 

Total

 

Balance, December 31, 2021

 

 

8,289

 

 

$

 

 

 

2,807,239

 

 

$

28

 

 

$

145,287

 

 

$

(132,089

)

 

$

13,226

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

521

 

 

 

 

 

 

521

 

Issuance of common stock and warrants for
   public offering, net

 

 

 

 

 

 

 

 

3,508,772

 

 

 

35

 

 

 

8,784

 

 

 

 

 

 

8,819

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13

)

 

 

 

 

 

(13

)

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

 

 

 

 

 

 

 

 

2,234

 

 

 

 

 

 

(1

)

 

 

 

 

 

(1

)

Conversion of preferred stock

 

 

(8,289

)

 

 

 

 

 

94,734

 

 

 

1

 

 

 

(1

)

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,809

)

 

 

(12,809

)

Balance, March 31, 2022

 

 

 

 

$

 

 

 

6,412,979

 

 

$

64

 

 

$

154,577

 

 

$

(144,898

)

 

$

9,743

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

325

 

 

 

 

 

 

325

 

Issuance of common stock and warrants for
   public offering, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(28

)

 

 

 

 

 

(28

)

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

 

 

 

 

 

 

 

 

1,646,091

 

 

 

16

 

 

 

1,704

 

 

 

 

 

 

1,720

 

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

 

 

 

 

 

 

 

 

9,783

 

 

 

1

 

 

 

 

 

 

 

 

 

1

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,531

)

 

 

(7,531

)

Balance, June 30, 2022

 

 

 

 

$

 

 

 

8,068,853

 

 

$

81

 

 

$

156,578

 

 

$

(152,429

)

 

$

4,230

 

 

See accompanying notes to consolidated financial statements.

 

7

 


 

BAUDAX BIO, INC.

Consolidated Statements of Shareholders’ Equity (Deficit)

(Unaudited)

 

For the Six Months Ended June 30, 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preferred Stock

 

 

Common Stock

 

 

Additional

 

 

 

 

 

 

 

(amounts in thousands, except share data)

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

paid-in
capital

 

 

Accumulated
Deficit

 

 

Total

 

Balance, December 31, 2020

 

 

 

 

$

 

 

 

1,391,099

 

 

$

14

 

 

$

97,507

 

 

$

(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

 

 

 

 

 

 

 

 

314,286

 

 

 

3

 

 

 

16,424

 

 

 

 

 

 

16,427

 

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

 

 

 

 

 

 

 

 

1,205

 

 

 

 

 

 

(41

)

 

 

 

 

 

(41

)

Exercise of warrants

 

 

 

 

 

 

 

 

297,484

 

 

 

3

 

 

 

12,152

 

 

 

 

 

 

12,155

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(16,912

)

 

 

(16,912

)

Balance, March 31, 2021

 

 

 

 

$

 

 

 

2,004,074

 

 

$

20

 

 

$

128,218

 

 

$

(129,232

)

 

$

(994

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

854

 

 

 

 

 

 

854

 

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

 

 

 

 

 

 

 

 

400,815

 

 

 

4

 

 

 

10,897

 

 

 

 

 

 

10,901

 

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

 

 

 

 

 

 

 

 

2,917

 

 

 

 

 

 

(5

)

 

 

 

 

 

(5

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(15,329

)

 

 

(15,329

)

Balance, June 30, 2021

 

 

 

 

$

 

 

 

2,407,806

 

 

$

24

 

 

$

139,964