Category: TXMD

TXMD – TherapeuticsMD Announces Issuance of a J-Code for ANNOVERA® to Be Utilized in the Public Health Sector

BOCA RATON, Fla.–()–TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today announced that the Centers for Medicare and Medicaid Services (CMS) confirmed its preliminary recommendation to assign a permanent product-specific Healthcare Common Procedure Coding System (HCPCS) J Code for ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system). As a result, CMS established the new HCPCS Level II code J7294 “Segesterone acetate and ethinyl estradiol 0.15mg, 0.013mg per 24 hours; yearly vaginal system, each,” which will allow Title X facilities to be reimbursed for dispensing ANNOVERA. The coding action will be effective October 1st, 2021.

This new J Code will allow dispensing Public Health facilities the opportunity to gain reimbursement for ANNOVERA, including the approximately 4,900 Title X Family Planning clinics. Public Health claims submission and payment are standardized with a J Code, facilitating and streamlining billing and reimbursement. Public Health insured patients represent a growing segment of the ANNOVERA user base.

“Having a permanent J Code will simplify Public Health billing and payment, further enhancing patient access to ANNOVERA in a growing segment of our user base. This code is separate and unique to ANNOVERA as the only yearly patient controlled and procedure free vaginal system in the marketplace,” stated Hugh O’Dowd, President of TherapeuticsMD.

About ANNOVERA

ANNOVERA is the first and only FDA-approved long-lasting, reversible contraceptive for women of reproductive age that is patient-controlled and procedure-free. It is inserted for 21 continuous days and removed for 7 days each cycle for one year (13 cycles). ANNOVERA was developed by the global non-profit research organization, Population Council, and has been licensed to TherapeuticsMD for the U.S. market.

IMPORTANT RISK INFORMATION

  • Do not use ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious heart and blood vessel (cardiovascular) side effects from hormonal birth control methods, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.
  • ANNOVERA does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs). 

DO NOT USE ANNOVERA IF YOU

  • have or have had a blood clot in your arms, legs, lungs, or eyes.
  • have had a stroke.
  • have reduced blood flow to your brain (cerebrovascular disease).
  • have reduced blood flow or blockage in 1 or more of the arteries that supply blood to your heart (coronary artery disease).
  • have had a heart attack.
  • have heart rhythm or heart valve problems that increase your risk of having blood clots, such as an infection of the inner lining of the heart and heart valves or a type of irregular heartbeat called atrial fibrillation.
  • have a problem with your blood that makes it clot more than normal.
  • have high blood pressure that is not controlled with medicine or have high blood pressure with blood vessel damage.
  • have diabetes and are over 35 years old; have diabetes with high blood pressure or problems with your kidneys, blood vessels, eyes, or nerves; or have had diabetes for longer than 20 years.
  • have headaches with changes in vision, numbness or weakness, have migraine headaches with aura, or are over age 35 years old and have any type of migraine headaches.
  • have liver disease or liver tumors.
  • have or have had breast cancer or any cancer that is sensitive to the female hormones estrogen or progesterone.
  • have unexplained vaginal bleeding.
  • are allergic to segesterone acetate, ethinyl estradiol, or any of the ingredients in ANNOVERA.
  • take any Hepatitis C drug combination medicine containing ombitasvir/paritaprevir/ ritonavir, with or without dasabuvir.

WARNINGS

ANNOVERA can cause serious side effects, including: blood clots; toxic shock syndrome (TSS); liver problems, including liver tumors; high blood pressure; gallbladder problems; changes in the sugar and fat (cholesterol and triglycerides) levels in your blood; headache; irregular or unusual vaginal bleeding and spotting between your menstrual periods; depression; possible cancer in your cervix; swelling of your skin especially around your mouth, eyes, and in your throat (angioedema); dark patches of skin on your forehead, cheeks, upper lip, and chin (chloasma). Call your healthcare provider or get emergency medical care right away if any of these serious side effects occur.

The most common side effects of ANNOVERA include:

  • headache, including migraine
  • nausea/vomiting
  • vaginal yeast infection (candidiasis)
  • lower/upper abdomen pain
  • painful periods
  • vaginal discharge
  • urinary tract infection
  • breast pain/tenderness
  • irregular vaginal bleeding
  • diarrhea
  • genital itching

USE

ANNOVERA is a ring-shaped vaginal system with hormones used by females to prevent pregnancy.

ANNOVERA has not been adequately studied in females with a body mass index >29 kg/m2.

The risk information provided here is not complete. To learn more, review the ANNOVERA Patient Information and talk with your healthcare provider or pharmacist. The FDA-approved product labeling, including Patient Information, can be found at annovera.com/pi.pdf.

You may report side effects to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088.

You may also report side effects to TherapeuticsMD at 1-888-228-0150.

About TherapeuticsMD

TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The Company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit www.therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

Forward Looking Statements

This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: whether Title X family planning clinics will prescribe ANNOVERA and utilize the product-specific J Code; the effects of the COVID-19 pandemic; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility; whether the company will be able to successfully divest or obtain an investment in its vitaCare business and the proceeds that may be generated by such divestiture or investment; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; whether the FDA will approve the lower dose of BIJUVA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the ability of the company’s marketing contractors to market ANNOVERA; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

TXMD – The Sun Sentinel Names TherapeuticsMD, Inc. a Winner of the South Florida Top Workplaces 2021 Award

BOCA RATON, Fla.–()–TherapeuticsMD, Inc. (NASDAQ: TXMD), has been awarded a Top Workplaces 2021 honor by The Sun Sentinel. The list is based solely on employee feedback gathered through a third-party survey administered by employee engagement technology partner Energage, LLC. The anonymous survey uniquely measures 15 culture drivers that are critical to the success of any organization including alignment, execution, and connection.

“During this very challenging time, Top Workplaces has proven to be a beacon of light for organizations, as well as a sign of resiliency and strong business performance,” said Eric Rubino, Energage CEO. “When you give your employees a voice, you come together to navigate challenges and shape your path forward. Top Workplaces draw on real-time insights into what works best for their organization, so they can make informed decisions that have a positive impact on their people and their business.”

“I’m incredibly proud of the employees in the TherapeuticsMD family. Winning this amazing award is a testament to the culture we have built and maintain– entrepreneurial, respectful, focused on success, and dedicated to our mission of advancing women’s health and improving therapeutic options for women,” said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD. “Getting through these difficult pandemic months has made us all appreciate the value of working with purpose and working together to create a great future for our organization.”

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

About Energage

Making the world a better place to work together.™

Energage is a purpose-driven company that helps organizations turn employee feedback into useful business intelligence and credible employer recognition through Top Workplaces. Built on 14 years of culture research and the results from 23 million employees surveyed across more than 70,000 organizations, Energage delivers the most accurate competitive benchmark available. With access to a unique combination of patented analytic tools and expert guidance, Energage customers lead the competition with an engaged workforce and an opportunity to gain recognition for their people-first approach to culture. For more information or to nominate your organization, visit energage.com or topworkplaces.com.

Forward-Looking Statements

This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the effects of the COVID-19 pandemic; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility; whether the company will be able to successfully divest its vitaCare business and how the proceeds that may be generated by any such divestiture will be utilized; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; whether the FDA will approve the lower dose of BIJUVA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the ability of the company’s marketing contractors to market ANNOVERA; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

TXMD – TherapeuticsMD to Report Fourth Quarter 2020 Results on March 2, 2021

BOCA RATON, Fla.–(BUSINESS WIRE)–TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced that it will report its fourth quarter 2020 financial results on Tuesday, March 2, 2021, before the opening of the U.S. financial markets. Following the announcement, executive management will host a conference call and webcast at 8:30 a.m. ET on such date to discuss the Company’s financial results and provide a business update.

Conference Call & Audio Webcast Details

Date

Tuesday, March 2, 2021

Time

8:30 a.m. ET

Telephone Access: U.S. and Canada

866-665-9531

Telephone Access: International

724-987-6977

Access Code For All Callers

6184646

Live Audio Webcast

www.therapeuticsmd.com

See Home Page or “Investors & Media” Section

A live webcast and audio archive for the event may be accessed on the home page or from the “Investors & Media” section of the TherapeuticsMD website at www.therapeuticsmd.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least 30 days. In addition, a digital recording of the conference call will be available for replay beginning two hours after the call’s completion and for at least 30 days with the dial-in 855-859-2056 or international 404-537-3406 and Conference ID: 6184646.

About TherapeuticsMD

TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The Company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit www.therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

Forward-Looking Statements

This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the effects of the COVID-19 pandemic; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefore; whether the company will be able to comply with the covenants and conditions under its term loan facility; whether the company will be able to successfully divest its vitaCare business and the proceeds that may be generated by such divestiture; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; whether the FDA will approve the lower dose of BIJUVA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the ability of the company’s marketing contractors to market ANNOVERA; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

TXMD – TherapeuticsMD (TXMD) Surges: Stock Moves 6.8% Higher

TherapeuticsMD, Inc. (TXMD Free Report) was a big mover last session, as the company saw its shares rise nearly 7% on the day. The move came on solid volume too with far more shares changing hands than in a normal session. This continues the recent uptrend for the company—as the stock is now up 18.3% in the past one-month time frame.

The company has seen no changes when it comes to estimate revision over the past few weeks, while the Zacks Consensus Estimate for the current quarter has also remained unchanged. The recent price action is encouraging though, so make sure to keep a close watch on this firm in the near future.

TherapeuticsMD currently has a Zacks Rank #4 (Sell) while its Earnings ESP is 0.00%.

TherapeuticsMD, Inc. Price

A better-ranked stock in the Medical – Drugs industry is Protara Therapeutics, Inc. (TARA Free Report) , which currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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