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TherapeuticsMD(TXMD) - 2021 Q3 - Earnings Call Transcript
2021-11-11 16:25
TherapeuticsMD, Inc. (NASDAQ:TXMD) Q3 Earnings Conference Call November 11, 2021 8:30 AM ET Company Participants Lisa Wilson – Investor Relations Rob Finizio – Chief Executive Officer Hugh O’Dowd – President James D'Arecca – Chief Financial Officer Mark Glickman – Chief Commercial Officer Conference Call Participants Louise Chen – Cantor Fitzgerald Annabel Samimy – Stifel Douglas Tsao – HC Wainwright Operator Good morning, ladies and gentlemen. Thank you for joining us for TherapeuticsMD, Third Quarter ...
TherapeuticsMD(TXMD) - 2021 Q2 - Earnings Call Presentation
2021-08-05 20:33
TherapeuticsMD® For Her. For Life. ■ | --- | --- | --- | |-------|----------------------------------------------|-------| | | | | | | Building the Premier Women's Health Company | | Forward-Looking Statements | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ...
TherapeuticsMD(TXMD) - 2021 Q2 - Quarterly Report
2021-08-04 20:56
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-00100 THERAPEUTICSMD, INC. (Exact name of Registrant as specified in its Charter) of incorporati ...
TherapeuticsMD(TXMD) - 2021 Q2 - Earnings Call Transcript
2021-08-04 15:57
TherapeuticsMD, Inc. (NASDAQ:TXMD) Q2 2021 Earnings Conference Call August 4, 2021 8:30 AM ET Company Participants Lisa Wilson – Investor Relations Rob Finizio – Chief Executive Officer James D’Arecca – Chief Financial Officer Dawn Halkuff – Chief Commercial Officer Mitchell Krassan – Chief Strategy and Performance Officer Conference Call Participants Louise Chen – Cantor Annabel Samimy – Stifel Douglas Tsao – H.C. Wainwright Operator Good morning, ladies and gentlemen. Thank you for joining us for the Ther ...
TherapeuticsMD(TXMD) - 2021 Q1 - Earnings Call Presentation
2021-05-12 20:31
Financial Performance - Total net product revenue increased by 60% in 1Q21 compared to 1Q20[11] - ANNOVERA net revenue increased by 285%[11] - BIJUVA net revenue increased by 120%[11] - The company reduced debt to $184 million by a $50 million cash payment[14] - Operating expenses were reduced by $16 million to $44.5 million compared to 1Q20[14] - Gross margin was 76%, impacted by $0.9 million in write-offs of production-related costs for ANNOVERA[14] ANNOVERA Performance and Strategy - ANNOVERA total prescriptions (TRx) grew by 164% year-over-year and 5% quarter-over-quarter in 1Q21[19] - Net revenue per unit for ANNOVERA was $1,071 in 1Q21, with an expected annual average of ~$1,100[11, 19] - The number of prescribers for ANNOVERA increased by approximately 17% in 1Q21 compared to 4Q20, from ~2,700 to ~3,160[19] IMVEXXY Performance - IMVEXXY net revenue increased by 10%[11] - Net revenue per unit improved to $61[11]
TherapeuticsMD(TXMD) - 2021 Q1 - Quarterly Report
2021-05-06 20:56
[Part I – Financial Information](index=4&type=section&id=Part%20I%20%E2%80%93%20Financial%20Information) [Financial Statements (Unaudited)](index=4&type=section&id=Item%2E%201%2E%20Financial%20Statements%20%28Unaudited%29) This section presents TherapeuticsMD, Inc.'s unaudited consolidated financial statements for Q1 2021, including balance sheets, income statements, equity statements, cash flows, and detailed accounting notes [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Total assets increased to $239.3 million by March 31, 2021, driven by higher cash, while liabilities decreased and stockholders' deficit significantly improved due to equity financing Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $137,617 | $80,486 | | Total current assets | $187,042 | $128,404 | | Total assets | $239,306 | $181,610 | | **Liabilities & Equity** | | | | Total current liabilities | $61,284 | $59,238 | | Long-term debt, net | $178,970 | $237,698 | | Total liabilities | $248,784 | $305,611 | | Total stockholders' deficit | $(9,478) | $(124,001) | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Q1 2021 net revenue grew 62.2% to $19.9 million, narrowing operating loss to $(29.3) million and net loss to $(39.4) million due to higher gross profit and reduced expenses Q1 2021 vs Q1 2020 Statement of Operations (in thousands, except per share data) | Metric | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Product revenue, net | $19,632 | $12,251 | | Total revenue, net | $19,866 | $12,251 | | Gross profit | $15,179 | $9,536 | | Total operating expenses | $44,457 | $60,458 | | Loss from operations | $(29,278) | $(50,922) | | Net loss | $(39,383) | $(56,849) | | Loss per common share | $(0.11) | $(0.21) | [Consolidated Statements of Stockholders' Equity (Deficit)](index=6&type=section&id=Consolidated%20Statements%20of%20Stockholders%27%20Equity%20%28Deficit%29) Stockholders' deficit significantly improved to $(9.5) million in Q1 2021, driven by $150.9 million from 92.9 million common stock issuances, partially offset by net loss - The company issued **92.9 million shares** for the sale of common stock, resulting in net proceeds of **$150.9 million** in Q1 2021[14](index=14&type=chunk) - The net loss of **$39.4 million** increased the accumulated deficit, partially offsetting the capital raised[14](index=14&type=chunk) [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Q1 2021 saw net cash used in operations at $(38.4) million, while financing activities provided $95.9 million, leading to a $57.1 million net cash increase and a $137.6 million quarter-end balance Q1 2021 vs Q1 2020 Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(38,380) | $(39,111) | | Net cash used in investing activities | $(438) | $(443) | | Net cash provided by financing activities | $95,949 | $48,822 | | **Net increase in cash** | **$57,131** | **$9,268** | | **Cash, end of period** | **$137,617** | **$170,098** | [Notes to Unaudited Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) Notes detail the company's women's healthcare business, COVID-19 impacts, debt specifics, disaggregated revenue, and patent litigation for IMVEXXY and BIJUVA - The company is a women's healthcare company focused on commercializing products for pregnancy prevention through menopause, including IMVEXXY®, BIJUVA®, and ANNOVERA®[21](index=21&type=chunk) - The company continues to face risks from the COVID-19 pandemic but has implemented measures like virtual detailing and cost-saving initiatives to mitigate the impact. The full future impact remains uncertain[24](index=24&type=chunk)[25](index=25&type=chunk)[27](index=27&type=chunk) - The company is involved in patent infringement lawsuits against Teva and Amneal, who are seeking to market generic versions of IMVEXXY and BIJUVA, respectively[56](index=56&type=chunk)[57](index=57&type=chunk) Disaggregated Revenue by Product (in thousands) | Product | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | ANNOVERA | $8,750 | $2,273 | | IMVEXXY | $7,012 | $6,392 | | BIJUVA | $2,445 | $1,112 | | Prescription vitamin | $1,425 | $2,474 | | **Product revenue, net** | **$19,632** | **$12,251** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2021 financial performance, noting a 62.2% revenue increase to $19.9 million, reduced operating loss, improved liquidity from equity offerings, and critical accounting estimates [Business Overview and Product Portfolio](index=18&type=section&id=Business%20overview) TherapeuticsMD is a women's healthcare company commercializing products for contraception and menopause, including IMVEXXY, BIJUVA, and ANNOVERA, alongside prenatal vitamins - The company's mission is to create and commercialize innovative products for women's health, from pregnancy prevention through menopause[84](index=84&type=chunk) - Key pharmaceutical products being commercialized are: - **IMVEXXY:** For treatment of moderate-to-severe dyspareunia due to menopause - **BIJUVA:** The first FDA-approved bioidentical hormone therapy combination of estradiol and progesterone for moderate-to-severe vasomotor symptoms - **ANNOVERA:** A one-year, patient-controlled, reversible contraceptive vaginal system[87](index=87&type=chunk)[90](index=90&type=chunk)[95](index=95&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20operations) Q1 2021 total revenue rose 62.2% to $19.9 million, driven by ANNOVERA sales, while operating expenses fell 26.5%, significantly reducing operating and net losses Q1 2021 vs Q1 2020 Revenue by Product (in thousands) | Product | Q1 2021 | Q1 2020 | Change (%) | | :--- | :--- | :--- | :--- | | ANNOVERA | $8,750 | $2,273 | +285.0% | | IMVEXXY | $7,012 | $6,392 | +9.7% | | BIJUVA | $2,445 | $1,112 | +119.9% | | **Total Product Revenue** | **$19,632** | **$12,251** | **+60.2%** | - Total operating expenses decreased by **$16.0 million (26.5%)** YoY, mainly due to a **$15.9 million** reduction in selling and marketing costs reflecting cost-cutting initiatives[110](index=110&type=chunk)[112](index=112&type=chunk) - Net loss improved to **$39.4 million** in Q1 2021, compared to a net loss of **$56.8 million** in Q1 2020[119](index=119&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20capital%20resources) The company ended Q1 2021 with **$137.6 million** cash, bolstered by **$150.9 million** from equity offerings, ensuring sufficient liquidity and debt covenant compliance - The company ended Q1 2021 with a cash balance of **$137.6 million**[120](index=120&type=chunk) - Significant capital was raised in Q1 2021: - **2020 ATM Program:** Completed, raising a total of **$47.3 million** in net proceeds - **February 2021 Public Offering:** Raised **$96.6 million** in net proceeds - **2021 ATM Program:** Initiated in March, raising **$7.0 million** in net proceeds through March 31, 2021[121](index=121&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk) - The company is required to maintain a minimum unrestricted cash balance of **$60.0 million** under its Financing Agreement and was in compliance as of the filing date[131](index=131&type=chunk) [Critical Accounting Estimates](index=25&type=section&id=Critical%20accounting%20estimates) Critical accounting estimates primarily involve variable sales deductions like returns, rebates, and co-pay assistance, requiring significant judgment, especially for new products lacking historical data - The transaction price for products is variable due to deductions for returns, chargebacks, rebates, and coupons, which are estimated based on historical experience and other data[136](index=136&type=chunk) - For newly launched products, return estimates are based on industry data, sales information, and inventory levels in the distribution channel, as historical return data is not yet available[137](index=137&type=chunk) - Estimating the cost of the co-pay assistance program is a key challenge, as it is based on assumptions about patient utilization and insurance coverage, which are subject to change[139](index=139&type=chunk)[141](index=141&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) Primary market risk is interest rate sensitivity on **$200.0 million** variable-rate debt; a 1.0% rate change impacts annual loss by **$2.0 million**, while cash investments are low-risk - The company's debt under the Financing Agreement accrues interest at a variable rate tied to LIBOR or the prime rate[143](index=143&type=chunk) - Based on the **$200.0 million** debt balance as of March 31, 2021, a **1.0%** change in interest rates would result in an annual impact of **$2.0 million** to the loss before income taxes[143](index=143&type=chunk) [Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2021, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of the end of the period covered by the report, the company's disclosure controls and procedures were effective at a reasonable assurance level[145](index=145&type=chunk) - There were no changes in internal control over financial reporting during the first quarter of 2021 that materially affected, or are reasonably likely to materially affect, internal controls[148](index=148&type=chunk) [Part II – Other Information](index=27&type=section&id=Part%20II%20%E2%80%93%20Other%20Information) [Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is not involved in any material legal proceedings beyond the patent litigation for IMVEXXY and BIJUVA disclosed in Note 9 of the financial statements - The company is not involved in any material legal proceedings other than those disclosed in Note 9, which concern patent challenges from Teva and Amneal[149](index=149&type=chunk) [Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the company's risk factors have occurred since the 2020 Annual Report on Form 10-K filing - There have been no material changes to the Company's risk factors since the 2020 10-K Report[150](index=150&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=27&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In Q1 2021, the company issued **563,000** common shares from warrant exercises, including a cash exercise for **205,000** shares yielding **$50,000** for working capital, exempt from registration - During Q1 2021, warrants to purchase an aggregate of **563,000** shares of common stock were exercised. This included a cash exercise for **205,000** shares yielding **$50,000** and a cashless exercise resulting in the issuance of **298,000** shares[151](index=151&type=chunk) [Defaults Upon Senior Securities](index=27&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - None[152](index=152&type=chunk) [Mine Safety Disclosures](index=27&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[153](index=153&type=chunk) [Other Information](index=27&type=section&id=Item%205.%20Other%20Information) The company reported no other information for this item - None[154](index=154&type=chunk) [Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including financing agreement amendments, equity offering sales agreements, and CEO/CFO certifications
TherapeuticsMD(TXMD) - 2021 Q1 - Earnings Call Transcript
2021-05-06 17:45
TherapeuticsMD, Inc. (NASDAQ:TXMD) Q1 2021 Earnings Conference Call May 6, 2021 8:30 AM ET Company Participants Nichol Ochsner - Vice President of Investor Relations Rob Finizio - Chief Executive Officer James D'Arecca - Chief Financial Officer Dawn Halkuff - Chief Commercial Officer Mitchell Krassan - Chief Strategy & Performance Officer Conference Call Participants Dana Flanders - Guggenheim Partners Douglas Tsao - H.C. Wainwright Operator Good morning, ladies and gentlemen. Thank you for joining us for T ...
TherapeuticsMD (TXMD) Presents At H.C. Wainwright Global Life Sciences Conference
2021-03-12 19:25
TherapeuticsMD® 1 For Her. For Life. Building the Premier Women's Health Company Our focus for 2021 is on executing our plans to accelerate revenue growth March 9, 2021 Forward-Looking Statements 2 This presentation by TherapeuticsMD, Inc. (referred to as "we," "our," or the "Company") may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies, as well as statements, other than historical facts, that add ...
TherapeuticsMD(TXMD) - 2020 Q4 - Annual Report
2021-03-04 00:48
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________________ to ________________________ Commission File Number 001-00100 TherapeuticsMD, Inc. (Exact Name of Registrant as Specified in Its Charter) (State or Other ...
TherapeuticsMD(TXMD) - 2020 Q4 - Earnings Call Presentation
2021-03-03 20:36
TherapeuticsMD® For Her. For Life. ■ Building the Premier Women's Health Company 4Q 2020 Earnings March 2, 2021 Forward-Looking Statements This presentation by TherapeuticsMD, Inc. (referred to as "we," "our," or the "Company") may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that we intend, exp ...