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Clarus Therapeutics Reports Third Quarter 2021 Financial and Operating Results

GlobeNewswire ·  2021/11/18 16:12

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% 至 430 万美元

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

JATENZO 2021 年第三季度处方药总额增长® 环比增长12%,同比增长132%

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

美国东部时间今天下午 5:15 的电话会议和网络直播 

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.  

伊利诺伊州诺斯布鲁克,2021年11月18日(环球新闻专线)——致力于通过推进男性和女性雄激素和代谢疗法为未满足的医疗需求提供解决方案的制药公司Clarus Therapeutics Holdings, Inc.(Clarus)(纳斯达克股票代码:CRXT)今天公布了2021年第三季度的财务业绩。

"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."

“本季度我们取得了一些激动人心的里程碑,” Clarus总裁兼首席执行官兼全资运营子公司Clarus Therapeutics, Inc.的创始人罗伯特·达德利博士说,“在患者和医生的积极反馈下,JATENZO的处方量持续增长。我们仍然非常热情和乐观,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,提高人们对睾丸激素替代疗法市场上唯一获得美国食品药品管理局批准的具有灵活剂量选择的口服软胶囊的认识。”

"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上市合并公司首次亮相。”“同样在9月,我们宣布内部产品线的持续多元化和增长,并增加了一项获得麦吉尔大学许可的新技术,该技术有可能治疗与CoQ相关的罕见疾病。10缺陷。除了最近与HaVah Therapeutics签订的许可协议,该协议涉及可能治疗雄激素依赖性炎症性乳腺疾病和某些形式的乳腺癌的 CLAR-121 的全球开发和商业化权,这使我们能够专注于为男性和女性开发雄激素和代谢疗法的使命。我们感谢所有人,包括我们的患者、医生和股东,一直以来的支持。”

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年第三季度的总收入从去年同期的220万美元增长了92.7%,至430万美元。在截至2021年9月30日的九个月中,总收入为940万美元,较2020年同期的390万美元增长了138.3%。
-2021年第三季度的毛利率为88.1%,而去年同期为88.4%,截至2021年9月30日的九个月的毛利率为84.8%,而去年同期的毛利率为负数。
-2021年第三季度的运营支出从去年同期的1,320万美元下降了7.6%,至1,220万美元,这主要归因于广告和促销费用的时机,但被主要由于员工人数和融资相关成本增加而导致的一般和管理费用略有增加所抵消。在截至2021年9月30日的九个月中,运营支出从2020年同期的3,460万美元增长了16.7%,至4,040万美元,这主要是由于人事成本增加而增加的一般和管理费用增加,以及与JATENZO广告和促销相关的销售和营销费用增加。
-2021年第三季度的研发费用从去年同期的140万美元下降了11.3%,至130万美元(占收入的29.7%),这主要是由于该季度咨询服务成本的下降,但被该期间许可费的增加所抵消。在截至2021年9月30日的九个月中,研发费用从去年同期的280万美元增长了9.8%,至310万美元,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,但被咨询成本的下降所抵消。
-2021年第三季度净亏损为280万美元,普通股每股净亏损0.26美元,而去年同期净收益为540万美元,普通股每股净亏损0.63美元。在截至2021年9月30日的九个月中,净亏损为3630万美元,普通股每股净亏损为5.68美元,而去年同期净收益为410万美元,普通股每股净亏损为2.03美元。
-截至2021年9月30日,现金及现金等价物为2,200万美元。
-2021年9月,合并后的公司在完成蓝水收购公司(蓝水)和Clarus Therapeutics, Inc.之间的业务合并后,收到了2530万澳元的现金,扣除交易费用。业务合并完成后,Blue Water更名为Clarus Therapeutics Holdings, Inc.
-截至2021年9月30日,Clarus的已发行普通股加权平均值为920万股,用于计算归属于普通股股东的基本和摊薄后的每股净(亏损)收益。
近期业务亮点
-2021年第三季度,JATENZO的处方总额持续增长,环比增长12%,同比增长132%,这主要是由于广告和促销以及所有付款人渠道的付款人覆盖范围的增加
-宣布与Lipocine全面和解专利诉讼,解决所有未决索赔,并向Clarus支付款项,作为和解协议的一部分
-收到美国专利商标局(USPTO)的两份关于JATENZO的许可通知
-完成了Blue Water和Clarus Therapeutics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大学麦吉尔大学签订了全球独家许可协议,以开发和商业化治疗与CoQ相关的罕见疾病的技术10缺陷
-与总部位于澳大利亚的生物制药公司HaVah Therapeutics签订了独家许可协议,该公司开发炎症性乳腺疾病和某些形式的乳腺癌的雄激素疗法

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. 

电话会议和网络直播
Clarus 将于美国东部时间今天下午 5:15 主持电话会议,讨论结果。国内来电者的拨入号码为 (844) 249-2007,国际来电者的拨入号码为 (224) 619-3902。会议 ID 号为 1354439。可通过Clarus Therapeutics网站Investors.clarusTherapeutics.com的投资者栏目观看电话会议的网络直播和重播。 

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).

关于 Clarus Therapeutics Holdings, Inc
Clarus Therapeutics Holdings, Inc. 是一家制药公司,在开发男性和女性雄激素和代谢疗法(包括孤儿适应症的潜在疗法)方面拥有专业知识。Clarus Therapeutics的第一个商业产品是JATENZO(十一酸睾丸激素)。欲了解更多信息,请访问 www.clarustherapeutics.com 和 www.jatenzo.com。在推特 (@Clarus_Thera) 和 LinkedIn(Clarus Therapeutics)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.

Clarus 前瞻性陈述
就联邦证券法而言,本新闻稿中的某些陈述构成 “前瞻性陈述”。“预期”、“相信”、“考虑”、“继续”、“可能”、“估计”、“预期”、“打算”、“可能”、“计划”、“可能”、“潜在”、“预测”、“项目”、“应该”、“将” 和类似的表述可以识别前瞻性陈述,但这些词语的缺失并不意味着陈述是不是前瞻性的。Clarus 在本新闻稿中的前瞻性陈述包括但不限于有关提高对 JATENZO 的认识和不断增加的处方、麦吉尔大学许可技术的潜力、CLAR-121 的潜力及其执行使命的能力等的陈述。这些前瞻性陈述基于当前对未来发展及其潜在影响的预期和信念。无法保证影响我们的未来发展会像克拉鲁斯所预期的那样。这些前瞻性陈述涉及许多风险、不确定性(其中一些是克拉鲁斯无法控制的)或其他假设,这些假设可能导致实际业绩或业绩与这些前瞻性陈述所表达或暗示的结果或业绩存在重大差异。这些风险和不确定性包括但不限于与药品开发相关的风险、与Clarus财务状况相关的风险,以及2021年10月7日根据第424(b)(3)条向美国证券交易委员会(SEC)提交的招股说明书中 “风险因素” 标题下描述的因素,以及Clarus未来向美国证券交易委员会提交的任何文件(包括10-Q)中包含的因素。将来,COVID-19 疫情可能会加剧其中一些风险和不确定性,并可能存在克拉鲁斯认为非实质性或未知的其他风险。不可能预测或识别所有这些风险。Clarus的前瞻性陈述仅反映其发表之日,除非适用的证券法另有要求,否则Clarus不承担任何义务更新或修改任何前瞻性陈述,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.

JATENZO®是 Clarus Therapeutics Holdings, Inc. 的注册商标

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

Clarus 投资者关系联系人:
卡拉·斯坦塞尔
kstancell@clarustherapeutics.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 Therapeutics Holdings, Inc.截至2021年9月30日和2020年9月30日的三个月和九个月的运营报表:

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  
CLARUS 疗法控股有限公司
简明合并运营报表
(未经审计;以千计,股票和每股数据除外)
  三个月已结束
9月30日
  九个月已结束
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:              
销售和营销   7,550       8,733       25,017       23,557  
一般和行政   3,384       3,040       12,316       8,261  
研究和开发   1,275       1,437       3,093       2,818  
运营费用总额   12,209       13,210       40,426       34,636  
运营损失   (8,433) )     (11,243 )     (32,462 )     (39,021) )
其他(支出)收入,净额:              
认股权证负债和衍生品公允价值的变化,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   2500             2500        
其他(支出)收入总额,净额   5,664
      16,649       (3,853) )     43,088  
所得税前净(亏损)收入   (2,769 )     5,406       (36,315) )     4,067  
所得税准备金                      
净(亏损)收入 $ (2,769 )   $ 5,406     $ (36,315) )   $ 4,067  
归属于普通股股东的净(亏损)收益,基本 $ (2,357 )   $ 5,396     $ (35,903) )   $ (4,059) )
摊薄后归属于普通股股东的净亏损 $ (2,357 )   $ (13,743) )   $ (35,903) )   $ (44,279) )
归属于普通股股东的每股普通股净(亏损)收益,基本 $ (0.26 )   $ 1.10     $ (5.68 )   $ 0.83  
摊薄后归属于普通股股东的每股普通股净亏损 $ (0.26 )   $ (0.63 )   $ (5.68 )   $ (2.03 )
归属于普通股股东的每股净(亏损)收益中使用的加权平均普通股,基本   9,153,848       4,901,564       6,318,992       4,901,564  
摊薄后用于归属于普通股股东的每股净亏损的加权平均普通股   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  
CLARUS 疗法控股有限公司
简明合并资产负债表
(未经审计;以千计,股票和每股数据除外)
  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,净额   66       64  
总资产 $ 45,322     $ 19,400  
负债、可赎回可转换优先股和股东赤字          
流动负债:          
优先应付票据 $ 40,339     $ 41,902  
应付账款   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  
应付给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        
负债总额   70,847       146,985  
承付款和意外开支          
面值0.001美元的可赎回可转换优先股,以及2021年9月30日和2020年12月31日授权的53,340,636股股票;以及截至2021年9月30日和2020年12月31日分别已发行和流通的36,756,498股股票         198,195  
股东赤字:          
优先股,面值0.0001美元;已获授权1,000万股;截至2021年9月30日和2020年12月31日分别未发行和流通股票          
普通股面值0.0001美元;已授权1.25亿股;截至2021年9月30日和2020年12月31日分别已发行和流通的21,725,817股和4,901,564股股票   2       1  
额外的实收资本   291,825
       
累计赤字   (317,352) )     (325,781) )
股东赤字总额   (25,525) )     (325,780) )
负债总额、可赎回可转换优先股和股东赤字 $ 45,322     $ 19,400  

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