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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長 93% 至 430 萬美元

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

JATENZO 2021 年第三季度處方藥總額增長® 環比增長12%,同比增長132%

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

美國東部時間今天下午 5:15 的電話會議和網絡直播 

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.  

伊利諾伊州諾斯布魯克,2021年11月18日(環球新聞專線)——致力於通過推進男性和女性雄激素和代謝療法爲未滿足的醫療需求提供解決方案的製藥公司Clarus Therapeutics Holdings, Inc.(Clarus)(納斯達克股票代碼:CRXT)今天公佈了2021年第三季度的財務業績。

"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."

“本季度我們取得了一些激動人心的里程碑,” Clarus總裁兼首席執行官兼全資運營子公司Clarus Therapeutics, Inc.的創始人羅伯特·達德利博士說,“在患者和醫生的積極反饋下,JATENZO的處方量持續增長。我們仍然非常熱情和樂觀,專注於執行我們的計劃,通過教育醫生和患者了解JATENZO的特性,提高人們對睾丸激素替代療法市場上唯一獲得美國食品藥品管理局批准的具有靈活劑量選擇的口服軟膠囊的認識。”

"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."

達德利博士繼續說:“9月10日標誌着我們作爲一家在納斯達克上市的上市合併公司首次亮相。”“同樣在9月,我們宣佈內部產品線的持續多元化和增長,並增加了一項獲得麥吉爾大學許可的新技術,該技術有可能治療與CoQ相關的罕見疾病。10缺陷。除了最近與HaVah Therapeutics簽訂的許可協議,該協議涉及可能治療雄激素依賴性炎症性乳腺疾病和某些形式的乳腺癌的 CLAR-121 的全球開發和商業化權,這使我們能夠專注於爲男性和女性開發雄激素和代謝療法的使命。我們感謝所有人,包括我們的患者、醫生和股東,一直以來的支持。”

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 年第三季度財務業績
-2021年第三季度的總收入從去年同期的220萬美元增長了92.7%,至430萬美元。在截至2021年9月30日的九個月中,總收入爲940萬美元,較2020年同期的390萬美元增長了138.3%。
-2021年第三季度的毛利率爲88.1%,而去年同期爲88.4%,截至2021年9月30日的九個月的毛利率爲84.8%,而去年同期的毛利率爲負數。
-2021年第三季度的運營支出從去年同期的1,320萬美元下降了7.6%,至1,220萬美元,這主要歸因於廣告和促銷費用的時機,但被主要由於員工人數和融資相關成本增加而導致的一般和管理費用略有增加所抵消。在截至2021年9月30日的九個月中,運營支出從2020年同期的3,460萬美元增長了16.7%,至4,040萬美元,這主要是由於人事成本增加而增加的一般和管理費用增加,以及與JATENZO廣告和促銷相關的銷售和營銷費用增加。
-2021年第三季度的研發費用從去年同期的140萬美元下降了11.3%,至130萬美元(佔收入的29.7%),這主要是由於該季度諮詢服務成本的下降,但被該期間許可費的增加所抵消。在截至2021年9月30日的九個月中,研發費用從去年同期的280萬美元增長了9.8%,至310萬美元,這主要是由於與我們的主要商業資產JATENZO相關的臨床成本以及與HaVah和McGill協議相關的許可費,但被諮詢成本的下降所抵消。
-2021年第三季度淨虧損爲280萬美元,普通股每股淨虧損0.26美元,而去年同期淨收益爲540萬美元,普通股每股淨虧損0.63美元。在截至2021年9月30日的九個月中,淨虧損爲3630萬美元,普通股每股淨虧損爲5.68美元,而去年同期淨收益爲410萬美元,普通股每股淨虧損爲2.03美元。
-截至2021年9月30日,現金及現金等價物爲2,200萬美元。
-2021年9月,合併後的公司在完成藍水收購公司(藍水)和Clarus Therapeutics, Inc.之間的業務合併後,收到了2530萬澳元的現金,扣除交易費用。業務合併完成後,Blue Water更名爲Clarus Therapeutics Holdings, Inc.
-截至2021年9月30日,Clarus的已發行普通股加權平均值爲920萬股,用於計算歸屬於普通股股東的基本和攤薄後的每股淨(虧損)收益。
近期業務亮點
-2021年第三季度,JATENZO的處方總額持續增長,環比增長12%,同比增長132%,這主要是由於廣告和促銷以及所有付款人渠道的付款人覆蓋範圍的增加
-宣佈與Lipocine全面和解專利訴訟,解決所有未決索賠,並向Clarus支付款項,作爲和解協議的一部分
-收到美國專利商標局(USPTO)的兩份關於JATENZO的許可通知
-完成了Blue Water和Clarus Therapeutics之間的業務合併,並作爲一家專注於雄激素和代謝療法的上市合併公司首次亮相
-與加拿大排名第一的醫學博士大學麥吉爾大學簽訂了全球獨家許可協議,以開發和商業化治療與CoQ相關的罕見疾病的技術10缺陷
-與總部位於澳大利亞的生物製藥公司HaVah Therapeutics簽訂了獨家許可協議,該公司開發炎症性乳腺疾病和某些形式的乳腺癌的雄激素療法

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. 

電話會議和網絡直播
Clarus 將於美國東部時間今天下午 5:15 主持電話會議,討論結果。國內來電者的撥入號碼爲 (844) 249-2007,國際來電者的撥入號碼爲 (224) 619-3902。會議 ID 號爲 1354439。可通過Clarus Therapeutics網站Investors.clarusTherapeutics.com的投資者欄目觀看電話會議的網絡直播和重播。 

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).

關於 Clarus Therapeutics Holdings, Inc
Clarus Therapeutics Holdings, Inc. 是一家制藥公司,在開發男性和女性雄激素和代謝療法(包括孤兒適應症的潛在療法)方面擁有專業知識。Clarus Therapeutics的第一個商業產品是JATENZO(十一酸睾丸激素)。欲了解更多信息,請訪問 www.clarustherapeutics.com 和 www.jatenzo.com。在推特 (@Clarus_Thera) 和 LinkedIn(Clarus Therapeutics)上關注我們。

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 前瞻性陳述
就聯邦證券法而言,本新聞稿中的某些陳述構成 “前瞻性陳述”。“預期”、“相信”、“考慮”、“繼續”、“可能”、“估計”、“預期”、“打算”、“可能”、“計劃”、“可能”、“潛在”、“預測”、“項目”、“應該”、“將” 和類似的表述可以識別前瞻性陳述,但這些詞語的缺失並不意味着陳述是不是前瞻性的。Clarus 在本新聞稿中的前瞻性陳述包括但不限於有關提高對 JATENZO 的認識和不斷增加的處方、麥吉爾大學許可技術的潛力、CLAR-121 的潛力及其執行使命的能力等的陳述。這些前瞻性陳述基於當前對未來發展及其潛在影響的預期和信念。無法保證影響我們的未來發展會像克拉魯斯所預期的那樣。這些前瞻性陳述涉及許多風險、不確定性(其中一些是克拉魯斯無法控制的)或其他假設,這些假設可能導致實際業績或業績與這些前瞻性陳述所表達或暗示的結果或業績存在重大差異。這些風險和不確定性包括但不限於與藥品開發相關的風險、與Clarus財務狀況相關的風險,以及2021年10月7日根據第424(b)(3)條向美國證券交易委員會(SEC)提交的招股說明書中 “風險因素” 標題下描述的因素,以及Clarus未來向美國證券交易委員會提交的任何文件(包括10-Q)中包含的因素。將來,COVID-19 疫情可能會加劇其中一些風險和不確定性,並可能存在克拉魯斯認爲非實質性或未知的其他風險。不可能預測或識別所有這些風險。Clarus的前瞻性陳述僅反映其發表之日,除非適用的證券法另有要求,否則Clarus不承擔任何義務更新或修改任何前瞻性陳述,無論是由於新信息、未來事件還是其他原因。

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

JATENZO®是 Clarus Therapeutics Holdings, Inc. 的註冊商標

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

Clarus 投資者關係聯繫人:
卡拉·斯坦塞爾
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日的三個月和九個月的運營報表:

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 療法控股有限公司
簡明合併運營報表
(未經審計;以千計,股票和每股數據除外)
  三個月已結束
9月30日
  九個月已結束
9月30日
  2021
  2020
  2021   2020
收入:                              
產品淨收入 $ 4,286     $ 2,224     $ 9,395     $ 3,943  
產品銷售成本   510       257       1,431       8,328  
毛利(虧損)   3,776       1,967       7,964       (4,385) )
運營費用:              
銷售和營銷   7,550       8,733       25,017       23,557  
一般和行政   3,384       3,040       12,316       8,261  
研究和開發   1,275       1,437       3,093       2,818  
運營費用總額   12,209       13,210       40,426       34,636  
運營損失   (8,433) )     (11,243 )     (32,462 )     (39,021) )
其他(支出)收入,淨額:              
認股權證負債和衍生品公允價值的變化,淨額   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) )
訴訟和解   2500             2500        
其他(支出)收入總額,淨額   5,664
      16,649       (3,853) )     43,088  
所得稅前淨(虧損)收入   (2,769 )     5,406       (36,315) )     4,067  
所得稅準備金                      
淨(虧損)收入 $ (2,769 )   $ 5,406     $ (36,315) )   $ 4,067  
歸屬於普通股股東的淨(虧損)收益,基本 $ (2,357 )   $ 5,396     $ (35,903) )   $ (4,059) )
攤薄後歸屬於普通股股東的淨虧損 $ (2,357 )   $ (13,743) )   $ (35,903) )   $ (44,279) )
歸屬於普通股股東的每股普通股淨(虧損)收益,基本 $ (0.26 )   $ 1.10     $ (5.68 )   $ 0.83  
攤薄後歸屬於普通股股東的每股普通股淨虧損 $ (0.26 )   $ (0.63 )   $ (5.68 )   $ (2.03 )
歸屬於普通股股東的每股淨(虧損)收益中使用的加權平均普通股,基本   9,153,848       4,901,564       6,318,992       4,901,564  
攤薄後用于歸屬於普通股股東的每股淨虧損的加權平均普通股   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 療法控股有限公司
簡明合併資產負債表
(未經審計;以千計,股票和每股數據除外)
  9月30日   十二月三十一日
  2021   2020
資產          
流動資產:          
現金和現金等價物 $ 21,953     $ 7,233  
應收賬款,淨額   6,932       4,400  
庫存,淨額   12,480       5,857  
預付費用和其他流動資產   3,891       1,846  
流動資產總額   45,256       19,336  
財產和設備,淨額   66       64  
總資產 $ 45,322     $ 19,400  
負債、可贖回可轉換優先股和股東赤字          
流動負債:          
優先應付票據 $ 40,339     $ 41,902  
應付賬款   15,843       12,107  
應計費用   7,373       4,631  
遞延收入   827       1,172  
流動負債總額   64,382       59,812  
應付給關聯方的可轉換票據         77,911  
特許權使用費義務         9,262  
衍生權證責任   6,465        
負債總額   70,847       146,985  
承付款和意外開支          
面值0.001美元的可贖回可轉換優先股,以及2021年9月30日和2020年12月31日授權的53,340,636股股票;以及截至2021年9月30日和2020年12月31日分別已發行和流通的36,756,498股股票         198,195  
股東赤字:          
優先股,面值0.0001美元;已獲授權1,000萬股;截至2021年9月30日和2020年12月31日分別未發行和流通股票          
普通股面值0.0001美元;已授權1.25億股;截至2021年9月30日和2020年12月31日分別已發行和流通的21,725,817股和4,901,564股股票   2       1  
額外的實收資本   291,825
       
累計赤字   (317,352) )     (325,781) )
股東赤字總額   (25,525) )     (325,780) )
負債總額、可贖回可轉換優先股和股東赤字 $ 45,322     $ 19,400  

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