8-K
false 0001817944 0001817944 2022-05-16 2022-05-16 0001817944 us-gaap:CommonStockMember 2022-05-16 2022-05-16 0001817944 us-gaap:WarrantMember 2022-05-16 2022-05-16

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 16, 2022

 

 

CLARUS THERAPEUTICS HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-39802   85-1231852

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

555 Skokie Boulevard, Suite 340

Northbrook, Illinois

  60062
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (847) 562-4300

N/A

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 $0.0001 per share   CRXT   The Nasdaq Global Market
Warrants to purchase one share of common stock at an exercise price of $11.50   CRXTW   The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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.

 

 

 


Item 2.02

Results of Operations and Financial Condition.

On May 16, 2022, Clarus Therapeutics Holdings, Inc. (“Clarus”) issued a press release announcing its financial results as of and for the first quarter ended March 31, 2022.

A copy of the press release is furnished hereto as Exhibit 99.1 and is incorporated herein by reference. The information contained in this Item 2.02 and in Exhibit 99.1 to this current report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit
Number
   Description
99.1    Press release of Clarus Therapeutics Holdings, Inc. dated May 16, 2022
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: May 16, 2022     CLARUS THERAPEUTICS HOLDINGS, INC.
    By:  

/s/ Robert E. Dudley

    Name:   Robert E. Dudley
    Title:   Chief Executive Officer
EX-99.1

Exhibit 99.1

 

LOGO

Clarus Therapeutics Reports First Quarter 2022 Financial and Operating Results

First quarter 2022 net revenue increased 72% year-over-year to $4.0 million

First quarter 2022 total prescription growth for JATENZO® increased 12% sequentially and increased 75% year-over-year

Conference call and webcast today at 5:15 p.m. ET

NORTHBROOK, Ill.—May 16, 2022—Clarus Therapeutics Holdings, Inc. (Clarus) (Nasdaq:CRXT), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, today reported financial results for the first quarter of 2022.

“We delivered a strong first quarter, as the total number of prescriptions written for JATENZO continued to increase,” said Dr. Robert Dudley, President and Chief Executive Officer of Clarus. “With the closing of our recent upsized $30 million underwritten public offering, we intend to continue our strategic marketing initiatives designed to increase awareness about JATENZO and fuel its further growth. We are excited about additional patent coverage for JATENZO and new patent coverage for CLAR-121, as we recently received a notice of allowance for each. We also applied for Orphan Drug Designation for CLAR-121. Our focus remains on driving long-term stockholder value as we accomplish our business objectives. We thank our employees for their commitment to excellence and our stockholders for their loyalty during these extraordinary times.”

Recent Business Highlights

 

   

Increased total prescriptions for JATENZO in the first quarter of 2022 sequentially and year over year by 12% and 75%, respectively, compared to the fourth quarter of 2021 and first quarter of 2021, driven primarily by advertising and promotion and an increase in payer coverage across all payer channels

 

   

Presented new data for JATENZO at the Androgen Society 4th Annual Meeting and at the 2022 American Urological Association Annual Meeting

 

   

Received a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for patent claims covering JATENZO; once issued, this will be the eighth patent for JATENZO to be listed in the U.S. Food and Drug Administration’s (FDA’s) Orange Book

 

   

Received a notice of allowance from the USPTO for patent claims covering CLAR-121, a proprietary combination of testosterone and anastrozole delivered by a subcutaneous implant for the treatment of androgen receptor-mediated inflammatory breast disease that predominantly affects women


   

Applied for Orphan Drug Designation from the FDA for CLAR-121 for the treatment of inflammatory periductal mastitis (PDM) for women

 

   

Announced pricing and closing of an upsized $30 million underwritten public offering, extending cash runway into approximately September 2022

 

   

Continued to explore strategic alternatives to maximize stockholder value

First Quarter 2022 Highlights

First quarter 2022 net revenue increased 72% to $4.0 million from $2.3 million in the same period last year, related to the continued growth in sales of JATENZO.

Gross margin was 83% for the first quarter of 2022, compared to 84% for the prior year period.

First quarter 2022 operating expenses increased by 33% to $16.9 million from $12.8 million in the same period last year, primarily attributed to an increase in sales and marketing activity associated with the promotion of JATENZO and increases in general and administrative expenses associated with increased headcount, partially offset by decreased research and development expenses.

Included in total operating expenses for first quarter 2022 was an increase in sales and marketing expenses of 35% to $10.7 million from $7.9 million in the same period last year, primarily attributed to advertising and promotional spend associated with JATENZO.

Also included in total operating expenses for first quarter 2022 was an increase in general and administrative expenses of 47% to $5.3 million from $3.6 million in the same period last year, primarily attributed to an increase in personnel costs associated with a growing business and expenses associated with being a public company.

Total operating expenses for first quarter 2022 also reflect a decrease in research and development expenses of 27% to $0.9 million from $1.2 million in the same period last year, primarily attributed to the timing of clinical costs associated with our lead commercial asset.

First quarter 2022 net loss was $14.9 million, or $0.61 per common share, compared to net loss of $15.4 million, or $0.00 per common share, in the same period last year.

Major Upcoming Milestones

 

   

Phase 4 clinical trial for JATENZO as testosterone therapy for female-to-male transgender individuals (Investigator-Initiated Study) expected to be initiated in the second half of 2022

 

   

Phase 2 clinical trial for CLAR-121 (testosterone + anastrozole) for the treatment of PDM expected to be initiated in the second half of 2022, subject to availability of funding

 

   

Phase 2 clinical trial for once daily oral testosterone undecanoate for the treatment of male hypogonadism expected to be initiated in the second half of 2022, subject to availability of funding

 

   

Phase 1 clinical trial for CLAR-222 (CoQ10 + caspofungin) for the treatment of primary forms of CoQ10 deficiency and related mitochondrial dysfunction expected to be initiated in the second half of 2022, subject to availability of funding


   

Results from the Phase 4 clinical trial of JATENZO for the treatment of hypogonadal men with chronic kidney disease expected in the first half of 2023

Conference Call and Webcast

Clarus will host a conference call today at 5:15 p.m. ET to discuss the results. The dial-in numbers are (844) 249-2007 for domestic callers and (224) 619-3902 for international callers. The conference ID number is 7677008. A live webcast and replay of the conference call will be accessible through the Investors section of Clarus Therapeutics’ website at Investors.ClarusTherapeutics.com. 

About Clarus Therapeutics Holdings, Inc.

Clarus Therapeutics Holdings, Inc. is a pharmaceutical company with expertise in developing androgen and metabolic therapies for men and women – including potential therapies for orphan indications. Clarus Therapeutics’ first commercial product is JATENZO (testosterone undecanoate). For more information, visit www.clarustherapeutics.com and www.jatenzo.com. Follow us on Twitter (@Clarus_Thera) and LinkedIn (Clarus Therapeutics).

Clarus Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” for purposes of the federal securities laws. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Clarus’ forward-looking statements in this press release include, but are not limited to, statements regarding its strategic marketing initiatives for JATENZO, potential Orphan Drug Designation for CLAR-121, expectations regarding Clarus’ cash runway, exploring strategic alternatives, and the timing of initiation and data from clinical trials for JATENZO and other product candidates, among others. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Clarus will be those anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Clarus’ control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks associated with pharmaceutical development, risks associated with Clarus’ financial position, and those factors described under the heading “Risk Factors” in Clarus’ annual report on 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission (the SEC) on March 31, 2022, and those that are included in any of Clarus’ future filings with the SEC. Some of these risks and uncertainties may in the future be amplified by the ongoing COVID-19 pandemic and there may be additional risks that Clarus considers immaterial, or which are unknown. It is not possible to predict or identify all such risks. Clarus’ forward-looking statements only speak as of the date they are made, and Clarus does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

JATENZO® is a registered trademark of Clarus Therapeutics Holdings, Inc.


# # #

Clarus Contact:

Kara Stancell

Vice President, Investor Relations & Corporate Communications

kstancell@clarustherapeutics.com

(847) 562-4300 x 206


The following presents Clarus Therapeutics Holdings, Inc. statements of operations for the three months ended March 31, 2022 and 2021:

CLARUS THERAPEUTICS HOLDINGS, INC.

Consolidated Statements of Operations

(Unaudited)

(in thousands, except share and per share data)

 

     Three Months Ended
March 31,
 
     2022     2021  

Revenue:

    

Net product revenue

   $ 4,011     $ 2,330  

Cost of product sales

     664       367  
  

 

 

   

 

 

 

Gross profit

     3,347       1,963  

Operating expenses:

    

Sales and marketing

     10,729       7,937  

General and administrative

     5,285       3,605  

Research and development

     881       1,210  
  

 

 

   

 

 

 

Total operating expenses

     16,895       12,752  
  

 

 

   

 

 

 

Loss from operations

     (13,548     (10,789

Other (expense) income, net:

    

Change in fair value of warrant liability, net

     642       —    

Interest income

     1       —    

Interest expense

     (1,965     (4,640
  

 

 

   

 

 

 

Total other (expense), net

     (1,322     (4,640
  

 

 

   

 

 

 

Net loss before income taxes

     (14,870     (15,429

Provision for income taxes

     —         —    
  

 

 

   

 

 

 

Net loss

   $ (14,870   $ (15,429
  

 

 

   

 

 

 

Accretion of preferred stock

     —         (3,939
  

 

 

   

 

 

 

Net loss attributable to common stockholders, basic and diluted

   $ (14,870   $ (19,368
  

 

 

   

 

 

 

Net loss per common share attributable to common stockholders, basic and diluted

   $ (0.61     —    
  

 

 

   

 

 

 

Weighted-average common shares used in net loss per share attributable to common stockholders, basic and diluted

     24,202,842       —    
  

 

 

   

 

 

 


CLARUS THERAPEUTICS HOLDINGS, INC.

Consolidated Balance Sheets

(Unaudited)

(in thousands, except share and per share data)

 

     March 31,     December 31,  
     2022     2021  

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 9,137     $ 26,415  

Accounts receivable, net

     8,005       6,341  

Inventory, net

     14,930       14,214  

Prepaid expenses

     4,383       4,673  
  

 

 

   

 

 

 

Total current assets

     36,455       51,643  

Property and equipment, net

     67       65  
  

 

 

   

 

 

 

Total assets

   $ 36,522     $ 51,708  
  

 

 

   

 

 

 

Liabilities and stockholders’ deficit

    

Current liabilities:

    

Senior notes payable

   $ 38,485     $ 42,269  

Accounts payable

     14,056       13,945  

Accrued expenses

     11,433       8,261  

Deferred revenue

     1,980       1,585  
  

 

 

   

 

 

 

Total current liabilities

     65,954       66,060  

Derivative warrant liability

     925       1,567  
  

 

 

   

 

 

 

Total liabilities

     66,879       67,627  

Commitments and contingencies

    

Stockholders’ deficit:

    

Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively

     —         —    

Common stock, $0.0001 par value; 125,000,000 shares authorized; 24,750,011 and 24,025,817 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively

     2       2  

Additional paid-in capital

     306,166       305,734  

Accumulated deficit

     (336,525     (321,655
  

 

 

   

 

 

 

Total stockholders’ deficit

     (30,357     (15,919
  

 

 

   

 

 

 

Total liabilities and stockholders’ deficit

   $ 36,522     $ 51,708