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Clarus Therapeutics Reports Third Quarter 2021 Financial and Operating Results

Clarus Therapeutics Reports Third Quarter 2021 Financial and Operating Results

Clarus Treeutics报告2021年第三季度财务和运营业绩
GlobeNewswire ·  2021/11/19 05:11

Third quarter 2021 revenue increased 93% year-over-year to $4.3 million

2021年第三季度收入同比增长93%,达到430万美元

Third quarter 2021 total prescription growth for JATENZO® increased 12% sequentially and 132% year-over-year

JATENZO公司2021年第三季度处方药总量增长®环比增长12%,同比增长132%

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

今天下午5:15召开电话会议并进行网络直播。外星人

NORTHBROOK, Ill., Nov. 18, 2021 (GLOBE NEWSWIRE) -- 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 third quarter of 2021.  

环球新闻社,伊利诺伊州诺斯布鲁克,2021年11月18日--克拉鲁斯治疗控股公司(克拉鲁斯)(纳斯达克代码:CRXT)今天公布了2021年第三季度的财务业绩,该公司致力于通过推进男性和女性的雄激素和代谢疗法来为未得到满足的医疗需求提供解决方案。

"We have achieved some exciting milestones this quarter," said Dr. Robert Dudley, President and Chief Executive Officer of Clarus and founder of its wholly-owned operating subsidiary, Clarus Therapeutics, Inc. "JATENZO continues to grow in prescriptions with positive feedback from both patients and physicians. We remain very enthusiastic and optimistic as we focus on executing our plans to increase awareness about the only FDA-approved oral softgel with flexible dosing options in the testosterone replacement therapy market by educating physicians and patients alike about the attributes of JATENZO."

克拉鲁斯公司总裁兼首席执行官、其全资运营子公司克拉鲁斯治疗公司创始人罗伯特·达德利博士说:“本季度我们取得了一些令人振奋的里程碑。JATENZO的处方数量继续增长,患者和医生都给予了积极的反馈。我们仍然非常热情和乐观,因为我们专注于执行我们的计划,通过教育医生和患者了解JATENZO的特性,提高人们对FDA批准的唯一口服软胶囊的认识,这种口服软胶囊在睾酮替代疗法市场上具有灵活的剂量选择。“

"September 10 marked our debut as a public combined company trading on Nasdaq," continued Dr. Dudley. "Also in September, we announced the continued diversification and growth of our internal pipeline with the addition of a new technology we licensed from McGill University to potentially treat rare conditions associated with CoQ10 deficiencies. This, in addition to the recent license agreement with HavaH Therapeutics for the worldwide development and commercialization rights to CLAR-121 to potentially treat androgen-dependent inflammatory breast disease and certain forms of breast cancer, positions us well as we focus on our mission to develop androgen and metabolic therapies for men and women. We thank everyone, including our patients, physicians, and stockholders, for their continued support."

达德利博士继续说:“9月10日标志着我们作为一家在纳斯达克上市的合并公司首次亮相。”同样在9月份,我们宣布我们的内部渠道继续多样化和增长,增加了我们从麦吉尔大学获得许可的一项新技术,该技术可能会治疗与CoQ相关的罕见疾病。10不足之处。除了最近与HavaH Treeutics就CLAR-121的全球开发和商业化权利达成的许可协议外,CLAR-121可能用于治疗雄激素依赖型炎症性乳腺疾病和某些形式的乳腺癌,这也使我们在专注于为男性和女性开发雄激素和代谢疗法的使命上处于有利地位。我们感谢每个人,包括我们的病人、医生和股东,感谢他们的持续支持。“

Third Quarter 2021 Financial Results
- Third quarter 2021 total revenue increased 92.7% to $4.3 million from $2.2 million in the same period last year. For the nine months ended September 30, 2021, total revenue was $9.4 million, an increase of 138.3% from $3.9 million for the comparable period in 2020.
- Gross margin percentage was 88.1% for the third quarter of 2021 compared to 88.4% for the prior year period, and 84.8% for the nine months ended September 30, 2021 as compared to a negative margin in the prior year period.
- Third quarter 2021 operating expenses decreased by 7.6% to $12.2 million from $13.2 million in the same period last year, primarily attributable to the timing of advertising and promotion costs, offset by slight increases in general and administrative expenses primarily due to increased headcount and financing related costs. For the nine months ended September 30, 2021, operating expenses increased by 16.7% to $40.4 million from $34.6 million for the comparable period in 2020, primarily attributable to increased general and administrative expenses, which increased due to higher personnel costs, as well as increased sales and marketing expenses associated with JATENZO advertising and promotion.
- Third quarter 2021 research and development expenses decreased by 11.3% to $1.3 million (29.7% of revenue) from $1.4 million in the same period last year primarily due to decreased costs for consulting services during the quarter, offset by increased license fees in the period. For the nine months ended September 30, 2021, research and development expenses increased by 9.8% to $3.1 million from $2.8 million in the same period last year, primarily due to clinical costs associated with our lead commercial asset, JATENZO, and licensing fees related to the HavaH and McGill agreements, offset by decreased consulting costs.
- Third quarter 2021 net loss was $2.8 million, or net loss per common share of $0.26, compared to net income of $5.4 million, or net loss per common share of $0.63 in the same period last year. For the nine months ended September 30, 2021, net loss was $36.3 million, or net loss per common share of $5.68, compared to net income of $4.1 million, or net loss per common share of $2.03 in the same period last year.
- Cash and cash equivalents as of September 30, 2021 were $22.0 million.
- In September 2021, the combined company received $25.3 million in cash upon closing of the business combination between Blue Water Acquisition Corp. (Blue Water) and Clarus Therapeutics, Inc. before transaction expenses. Following completion of the business combination, Blue Water changed its name to Clarus Therapeutics Holdings, Inc.
- As of September 30, 2021, Clarus had 9.2 million weighted-average common shares outstanding for purposes of calculating net (loss) income per share attributable to common stockholders, basic and diluted.
Recent Business Highlights
- Continued total prescription growth for JATENZO in the third quarter of 2021 with an increase of 12% sequentially and 132% year-over-year driven primarily by advertising and promotion and an increase in payer coverage across all payer channels  
- Announced a comprehensive settlement of patent litigation with Lipocine, resolving all outstanding claims with payments to Clarus as part of the settlement
- Received two notices of allowance from the United States Patent and Trademark Office (USPTO) covering JATENZO
- Closed the business combination between Blue Water and Clarus Therapeutics, and debuted as a publicly traded combined company focused on androgen and metabolic therapies
- Entered into an exclusive worldwide license agreement with McGill University, Canada's top ranked medical doctoral university, to develop and commercialize technology to treat rare conditions associated with CoQ10 deficiencies
- Entered into an exclusive license agreement with HavaH Therapeutics, an Australia-based biopharmaceutical company developing androgen therapies for inflammatory breast disease and certain forms of breast cancer

2021年第三季度财务业绩
-2021年第三季度总收入从去年同期的220万美元增长到430万美元,增幅为92.7%。截至2021年9月30日的9个月,总营收为940万美元,较2020年同期的390万美元增长138.3。
-2021年第三季度毛利率为88.1%,而去年同期为88.4%,截至2021年9月30日的9个月毛利率为84.8%,而去年同期为负利润率。
-2021年第三季度运营费用从去年同期的1320万美元下降到1220万美元,降幅为7.6%,主要是由于广告和促销成本的时机,但主要是由于员工人数增加和融资相关成本,一般和行政费用略有增加,抵消了这一下降。截至2021年9月30日的9个月,营业费用从2020年同期的3,460万美元增加到4,040万美元,增幅为16.7%,主要原因是一般和行政费用增加,这是由于人员成本上升,以及与JATENZO广告和促销相关的销售和营销费用增加所致。
-2021年第三季度研发费用从去年同期的140万美元下降到130万美元,降幅为11.3%(占收入的29.7%),主要原因是该季度咨询服务成本下降,但被同期增加的许可费所抵消。在截至2021年9月30日的9个月中,研发费用从去年同期的280万美元增加到310万美元,增幅为9.8%,这主要是由于与我们的主要商业资产JATENZO相关的临床成本,以及与HavaH和McGill协议相关的许可费用,但被咨询成本的下降所抵消。
-2021年第三季度净亏损280万美元,或每股普通股净亏损0.26美元,而去年同期净收益为540万美元,或每股普通股净亏损0.63美元。截至2021年9月30日的9个月,净亏损为3630万美元,或每股普通股净亏损5.68美元,而去年同期的净收益为410万美元,或每股普通股净亏损2.03美元。
-截至2021年9月30日的现金和现金等价物为2200万美元。
-2021年9月,合并后的公司在交易费用前完成Blue Water Acquisition Corp.(Blue Water)和Clarus Treeutics,Inc.之间的业务合并后获得了2530万美元的现金。业务合并完成后,蓝水公司更名为克拉鲁斯治疗控股公司(Clarus Treateutics Holdings,Inc.)。
-截至2021年9月30日,Clarus有920万股加权平均流通股,用于计算普通股股东每股基本和稀释后的净(亏损)收入。
最近的业务亮点
-JATENZO的处方药总量在2021年第三季度继续增长,环比增长12%,同比增长132%,主要受广告和促销以及所有支付者渠道支付者覆盖率增加的推动
-宣布与利普钦就专利诉讼达成全面和解,解决所有悬而未决的索赔,并向Clarus支付款项作为和解的一部分
-收到美国专利商标局(USPTO)的两份补贴通知,涉及JATENZO
-结束了Blue Water和Clarus Treeutics之间的业务合并,并作为一家专注于雄激素和代谢疗法的上市合并公司首次亮相
-与加拿大排名第一的医学博士生大学麦吉尔大学(McGill University)达成独家全球许可协议,开发和商业化治疗与COQ相关的罕见疾病的技术10不足之处
-与HavaH Treeutics签订独家许可协议,HavaH Treeutics是一家总部位于澳大利亚的生物制药公司,为炎症性乳腺疾病和某些形式的乳腺癌开发雄激素疗法

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 1354439. A live webcast and replay of the conference call will be accessible through the Investors section of Clarus Therapeutics' website at Investors.ClarusTherapeutics.com. 

电话会议和网络广播
克拉鲁斯将于今天下午5点15分主持电话会议。ET讨论结果。国内来电的拨入号码是(844)249-2007,国际来电的拨入号码是(224)619-3902。会议ID号码是1354439。电话会议的现场网络直播和重播可通过Clarus治疗公司网站的投资者部分收看,网址为Investors.ClarusTreeutics.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).

克拉鲁斯治疗控股公司简介
克拉鲁斯治疗控股公司是一家制药公司,在为男性和女性开发雄激素和代谢疗法方面拥有专业知识,包括针对孤儿适应症的潜在疗法。Clarus治疗公司的第一个商业产品是JATENZO(十一酸睾酮)。欲了解更多信息,请访问www.clarusTreateutics.com和www.jatenzo.com。在Twitter(@Clarus_Thera)和LinkedIn(Clarus Treeutics)上关注我们。

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 increasing awareness of JATENZO and growing prescriptions, the potential of the technology licensed from McGill University, the potential of CLAR-121, and its ability to execute on its mission, 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 us will be those that Clarus has 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 the prospectus filed with the Securities and Exchange Commission (the SEC) under Rule 424(b)(3) on October 7, 2021, and those that are included in any of Clarus' future filings with the SEC, including the 10-Q. Some of these risks and uncertainties may in the future be amplified by the 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.

克拉鲁斯前瞻性陈述
根据联邦证券法的目的,本新闻稿中的某些陈述构成“前瞻性陈述”。词语“预期”、“相信”、“考虑”、“继续”、“可能”、“估计”、“预期”、“打算”、“可能”、“可能”、“计划”、“可能”、“潜在”、“预测”、“项目”、“应该”、“将会”、“将会”以及类似的表述可以识别前瞻性陈述。但没有这些字眼并不意味着声明没有前瞻性。Clarus在本新闻稿中的前瞻性陈述包括但不限于有关JATENZO的知名度不断提高和处方不断增加、麦吉尔大学授权的技术的潜力、CLAR-121的潜力以及执行其使命的能力等的陈述。这些前瞻性陈述是基于对未来发展及其潜在影响的当前预期和信念。不能保证影响我们的未来发展会是克拉鲁斯所预期的。这些前瞻性陈述涉及许多风险、不确定性(其中一些是Clarus无法控制的)或其他假设,可能导致实际结果或表现与这些前瞻性陈述明示或暗示的大不相同。这些风险和不确定性包括但不限于与制药开发相关的风险、与Clarus财务状况相关的风险、根据规则424(B)(3)于2021年10月7日提交给美国证券交易委员会(美国证券交易委员会)的招股说明书中“风险因素”标题下描述的那些因素,以及Clarus未来提交给美国证券交易委员会的任何文件(包括10-Q报告)中包含的那些因素。其中一些风险和不确定性在未来可能会因新冠肺炎大流行而放大,克拉勒斯认为可能还有更多的风险是无关紧要的, 或者哪些是未知的。要预测或识别所有此类风险是不可能的。Clarus的前瞻性陈述仅在发表之日发表,除非适用的证券法可能要求,否则Clarus不承担任何更新或修改任何前瞻性陈述的义务,无论是由于新信息、未来事件还是其他原因。

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

贾坦佐®是Clarus治疗控股公司的注册商标。

Clarus Investor Relations Contact:
Kara Stancell
kstancell@clarustherapeutics.com
(847) 562-4300 x 206

克拉鲁斯投资者关系部联系人:
卡拉·斯坦塞尔
邮箱:kstancell@clarusTreateutics.com
(847) 562-4300 x 206

The following presents Clarus Therapeutics Holdings, Inc. statements of operations for the three and nine months ended September 30, 2021 and 2020:

以下是Clarus治疗控股公司截至2021年9月30日和2020年9月30日的3个月和9个月的运营报表:

CLARUS THERAPEUTICS HOLDINGS, INC.
Condensed Consolidated Statements of Operations
(Unaudited; in thousands, except share and per share data)
  Three Months Ended
September 30,
  Nine Months Ended
September 30,
  2021
  2020
   2021   2020
Revenue:                              
Net product revenue $ 4,286     $ 2,224     $ 9,395     $ 3,943  
Cost of product sales   510       257       1,431       8,328  
Gross profit (loss)   3,776       1,967       7,964       (4,385 )
Operating expenses:              
Sales and marketing   7,550       8,733       25,017       23,557  
General and administrative   3,384       3,040       12,316       8,261  
Research and development   1,275       1,437       3,093       2,818  
Total operating expenses   12,209       13,210       40,426       34,636  
Loss from operations   (8,433 )     (11,243 )     (32,462 )     (39,021 )
Other (expense) income, net:              
Change in fair value of warrant liability and derivative, net   7,610
      20,939       7,610
      53,854  
Interest income   1       1       1       24  
Interest expense   (4,447 )     (4,291 )     (13,964 )     (10,790 )
Litigation settlement   2,500             2,500        
Total other (expense) income, net   5,664
      16,649       (3,853 )     43,088  
Net (loss) income before income taxes   (2,769 )     5,406       (36,315 )     4,067  
Provision for income taxes                      
Net (loss) income $ (2,769 )   $ 5,406     $ (36,315 )   $ 4,067  
Net (loss) income attributable to common stockholders, basic $ (2,357 )   $ 5,396     $ (35,903 )   $ (4,059 )
Net loss attributable to common stockholders, diluted $ (2,357 )   $ (13,743 )   $ (35,903 )   $ (44,279 )
Net (loss) income per common share attributable to common stockholders, basic $ (0.26 )   $ 1.10     $ (5.68 )   $ 0.83  
Net loss per common share attributable to common stockholders, diluted $ (0.26 )   $ (0.63 )   $ (5.68 )   $ (2.03 )
Weighted-average common shares used in net (loss) income per share attributable to common stockholders, basic   9,153,848       4,901,564       6,318,992       4,901,564  
Weighted-average common shares used in net loss per share attributable to common stockholders, diluted   9,153,848       21,828,570     6,318,992       21,828,570  
克拉鲁斯治疗控股公司(Clarus Treateutics Holdings,Inc.)
简明合并操作报表
(未经审计;以千为单位,不包括每股和每股数据)
截至三个月
9月30日,
截至9个月
9月30日,
2021
2020
2021 2020
收入:
产品净收入 $ 4,286 $ 2,224 $ 9,395 $ 3,943
产品销售成本 510 257 1,431 8,328
毛利(亏损) 3,776 1,967 7,964 (4,385 )
运营费用:
销售和市场营销 7,550 8,733 25,017 23,557
一般事务和行政事务 3,384 3,040 12,316 8,261
研发 1,275 1,437 3,093 2,818
总运营费用 12,209 13,210 40,426 34,636
运营亏损 (8,433 ) (11,243 ) (32,462 ) (39,021 )
其他(费用)收入,净额:
认股权证负债及衍生工具公允价值变动,净额 7,610
20,939 7,610
53,854
利息收入 1 1 1 24
利息支出 (4,447 ) (4,291 ) (13,964 ) (10,790 )
诉讼和解 2,500 2,500
其他(费用)收入合计(净额) 5,664
16,649 (3,853 ) 43,088
所得税前净(亏损)收益 (2,769 ) 5,406 (36,315 ) 4,067
所得税拨备
净(亏损)收入 $ (2,769 ) $ 5,406 $ (36,315 ) $ 4,067
普通股股东应占净(亏损)收入,基本 $ (2,357 ) $ 5,396 $ (35,903 ) $ (4,059 )
普通股股东应占净亏损,稀释后 $ (2,357 ) $ (13,743 ) $ (35,903 ) $ (44,279 )
普通股股东每股净(亏损)收益,基本 $ (0.26 ) $ 1.10 $ (5.68 ) $ 0.83
稀释后普通股股东应占每股普通股净亏损 $ (0.26 ) $ (0.63 ) $ (5.68 ) $ (2.03 )
加权平均普通股,可归因于普通股股东的每股净(亏损)收益,基本 9,153,848 4,901,564 6,318,992 4,901,564
加权平均普通股,每股应占普通股股东净亏损,稀释后 9,153,848 21,828,570 6,318,992 21,828,570
CLARUS THERAPEUTICS HOLDINGS, INC.
Condensed Consolidated Balance Sheets
(Unaudited; in thousands, except share and per share data)
  September 30,    December 31, 
  2021    2020 
Assets          
Current assets:          
Cash and cash equivalents $ 21,953     $ 7,233  
Accounts receivable, net   6,932       4,400  
Inventory, net   12,480       5,857  
Prepaid expenses and other current assets   3,891       1,846  
Total current assets   45,256       19,336  
Property and equipment, net   66       64  
Total assets $ 45,322     $ 19,400  
Liabilities, redeemable convertible preferred stock, and stockholders' deficit          
Current liabilities:          
Senior notes payable $ 40,339     $ 41,902  
Accounts payable   15,843       12,107  
Accrued expenses   7,373       4,631  
Deferred revenue   827       1,172  
Total current liabilities   64,382       59,812  
Convertible notes payable to related parties         77,911  
Royalty obligation         9,262  
Derivative warrant liability   6,465        
Total liabilities   70,847       146,985  
Commitments and contingencies          
Redeemable convertible preferred stock, $0.001 par value, — and 53,340,636 shares authorized at September 30, 2021 and December 31, 2020, respectively; — and 36,756,498 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively         198,195  
Stockholders' deficit:          
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively          
Common stock $0.0001 par value; 125,000,000 shares authorized; 21,725,817 and 4,901,564 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively   2       1  
Additional paid-in capital   291,825
       
Accumulated deficit   (317,352 )     (325,781 )
Total stockholders' deficit   (25,525 )     (325,780 )
Total liabilities, redeemable convertible preferred stock, and stockholders' deficit $ 45,322     $ 19,400  
克拉鲁斯治疗控股公司(Clarus Treateutics Holdings,Inc.)
简明综合资产负债表
(未经审计;以千为单位,不包括每股和每股数据)
9月30日, 十二月三十一日,
2021 2020
资产
流动资产:
现金和现金等价物 $ 21,953 $ 7,233
应收账款净额 6,932 4,400
库存,净额 12,480 5,857
预付费用和其他流动资产 3,891 1,846
流动资产总额 45,256 19,336
财产和设备,净值 66 64
总资产 $ 45,322 $ 19,400
负债、可赎回可转换优先股和股东亏损
流动负债:
应付优先票据 $ 40,339 $ 41,902
应付帐款 15,843 12,107
应计费用 7,373 4,631
递延收入 827 1,172
流动负债总额 64,382 59,812
应付关联方的可转换票据 77,911
特许权使用费义务 9,262
衍生权证责任 6,465
总负债 70,847 146,985
承诺和或有事项
可赎回可转换优先股,面值0.001美元-和分别于2021年9月30日和2020年12月31日授权的53,340,636股;以及分别于2021年9月30日和2020年12月31日发行和发行的36,756,498股 198,195
股东赤字:
优先股,面值0.0001美元;授权股票1000万股;分别于2021年9月30日和2020年12月31日没有发行和发行股票
普通股面值0.0001美元;授权股份1.25亿股;在2021年9月30日和2020年12月31日分别发行和发行了21,725,817股和4,901,564股 2 1
额外实收资本 291,825
累计赤字 (317,352 ) (325,781 )
股东亏损总额 (25,525 ) (325,780 )
总负债、可赎回可转换优先股和股东赤字 $ 45,322 $ 19,400

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