CLARUS THERAPEUTICS HOLDINGS, INC. Management’s Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q) -…
Posted: November 21, 2021 at 1:51 am
The following discussion and analysis of our financial condition and results ofoperations should be read in conjunction with our unaudited condensedconsolidated financial statements and notes thereto appearing elsewhere in thisQuarterly Report on Form10-Qand Old Clarus's audited financial statements and notes thereto for the yearended December 31, 2020 included in the Prospectus as filed with the Securitiesand Exchange Commission pursuant to Rule 424(b)(3) on October 7, 2021. Some ofthe information contained in this discussion and analysis or set forth elsewherein this Quarterly Report on Form10-Q,including information with respect to our plans and strategy for our businessand related financing, includes forward-looking statements that involve risksand uncertainties. As a result of many factors, our actual results could differmaterially from the results described in or implied by the forward-lookingstatements contained in the following discussion and analysis.Unless otherwise indicated or the context otherwise requires, references in thisManagement's Discussion & Analysis of Financial Condition and Results ofOperations section to "Clarus," "we," "us," "our" and other similar terms referto Old Clarus (as defined below) prior to the Business Combination (as definedbelow) and to the Company and its consolidated subsidiary after giving effect tothe Business Combination.OverviewWe are a pharmaceutical company focused on the commercialization of JATENZO, thefirst and only oralT-replacement,orT-replacementtherapy ("TRT") of its kind that has received final approval by the U.S. Foodand Drug Administration ("FDA"). We believe that current users of TRT are not satisfied with their currentoptions and desire a therapeutic that is safe, effective and more convenient.Our primary goal for JATENZO is for it to become the preferred choice for TRTamong men with hypogonadism - T deficiency accompanied by an associated medicalcondition. In parallel, our broader vision is for Clarus to become a profitablepharmaceutical company dedicated to providing solutions to unmet medical needsby advancing androgen and metabolic therapies for men and women.Our corporate objectives include maximizing the commercial success of JATENZO inthe United States and internationally by making it the preferred choice for TRTfor men with hypogonadism, expanding its research and development portfolio withadditional metabolic therapies for men and women and sourcing new technologiesthrough its business development efforts.We believe JATENZO offers hypogonadal men and prescribing physicians a safe andeffective oral replacement option and has a number of advantages over thecurrently approved replacement therapies, including:CONVENIENT Easy-to-swallow softgel taken BID with food (twice daily) Dose adjustableEFFECTIVE 87% of men achieved T levels in normal range Restored T levels to mid-normal rangeSAFE Safety profile consistent with TRT class
No liver toxicity - JATENZO bypasses first-pass hepatic metabolism; liver
toxicity not observed in clinical studies of up to 2 years duration.
continue to commercialize JATENZO in the United States for the treatment
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Table of Contents
incur sales and marketing costs to support the commercialization of JATENZO;
or acquire additional product candidates for other medical conditions;
adapt our regulatory compliance efforts to incorporate requirements
experience delays or encounters issues with additional outbreaks of the
pandemic in addition to any of the above.
salaries, benefits and other related costs, including stock-based
compensation expense, for personnel engaged in research and development
post-marketing requirements of the FDA for JATENZO and pharmaceutical
A $1.7 million decrease in outsourced advertising and promotion costs due
a $0.4 million increase in commercial analytic and market research costs,
A $1.0 million increase in personnel costs, including stock-based
a $0.6 million decrease in consulting and professional fees, primarily
A $1.0 million decrease in costs related to research and development
A $0.9 million increase in license fees related to the License Agreements
with HavaH and McGill.
A $2.6 million increase in marketing costs, primarily related to the
a $0.2 million increase in patient assistance costs and other sales and
a $1.3 million decrease in commercial analytics and market research costs.
A $2.6 million increase in personnel costs, including stock-based
compensation expense, primarily due to an increase headcount and external
a $0.8 million increase in consulting and professional fees, primarily
a $0.5 million increase in insurance fees, related to directors' and
a $0.2 million increase in other general and administrative expenses.
A $0.9 million increase in license fees related to the HavaH Agreement
a $1.0 million increase in clinical costs related to Phase 4 studies
related to the development of JATENZO, our lead commercial product;
a $1.6 million decrease in costs related to research and development
consulting services.
Net cash used in operating activities (34,452 ) (35,661 )Net cash used in investing activities
Net cash provided by financing activities 49,192 47,220
Net increase in cash and cash equivalents $ 14,720 $ 11,497
the costs of future activities, including product sales, marketing,
the costs of manufacturing commercial-grade product and necessary
the costs of preparing, filing and prosecuting patent applications,
obtaining, maintaining, expanding and enforcing its intellectual property
our ability to establish and maintain collaborations on favorable terms,
if at all.
(1) We have $43.1 million outstanding aggregate principal on our senior secured
notes that bear interest at 12.5% and mature on March 1, 2025.
(2) We have an operating lease agreement for our office space.
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