TherapeuticsMD, Inc. 8-K

 

Exhibit 99.1

 

(THERAPEUTICSMD LOGO)

 

FOR IMMEDIATE RELEASE

 

TherapeuticsMD Announces Third Quarter 2018 Financial Results

 

-Strong early launch indicators for IMVEXXY™- 

-BIJUVA™ commercial launch planned for 2Q 2019- 

-ANNOVERA™ commercial launch planned for 4Q 2019- 

-Conference call scheduled for 4:30 p.m. ET today-

 

BOCA RATON, Fla. November 7, 2018 – TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced its clinical and corporate update for the quarter ended September 30, 2018.

 

“We are extremely pleased with the momentum of the IMVEXXY launch, including our progress with negotiating commercial payer coverage,” said Robert G. Finizio, Chief Executive Officer of TherapeuticsMD. “We are also pleased with the recent approvals of both BIJUVA and ANNOVERA. Over a short period of five months, we achieved three product approvals, which creates the solid foundation for our goal of becoming the leading women’s healthcare pharmaceutical company. We are focused on successfully commercializing all three of these highly differentiated products covering important stages in the lifespan of a woman from family planning to contraception through menopause.”

 

Third Quarter and Recent Developments

 

On October 28, 2018, the company received U.S. Food and Drug Administration (FDA) approval of BIJUVATM (estradiol and progesterone) capsules, 1 mg/100 mg. BIJUVA is the first and only FDA-approved bio-identicali hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.

The company commenced the U.S. commercial launch of IMVEXXY™ (estradiol vaginal inserts) 10 mcg dose in August 2018 and 4 mcg dose in September 2018 with 150 sales representatives. IMVEXXY is available in major pharmacy chains in the U.S. as well as through our BIO-IGNITETM compounding pharmacy partners.

From launch through October 31, 2018, approximately 28,200 prescriptions of IMVEXXY were dispensed to approximately 12,800 patients.

During the third quarter, approximately 14,900 prescriptions of IMVEXXY were dispensed to approximately 8,400 patients.

Executed a branded multichannel awareness campaign for healthcare practitioners leveraging digital, non-personal promotion and journal advertising.

On August 10, 2018, the company received FDA approval of ANNOVERA™ (segesterone acetate/ethinyl estradiol vaginal system), the first long-acting prescription birth control that is patient-controlled, procedure-free and reversible, to prevent ovulation for an entire year (administered in repeated four-week cycles for 13 cycles), after in-licensing the U.S. exclusive commercialization rights from the Population Council.

Presented ten oral presentations and posters related to IMVEXXY and BIJUVA at the Annual Meeting of the North American Menopause Society.

On July 30, 2018, the company licensed to Knight Therapeutics, Inc. (TSX: GUD) the exclusive rights to commercialize TX-004HR (branded as IMVEXXY in the U.S.) and TX-001HR (branded as BIJUVA in the U.S.) in Canada and Israel.

During July 2018, completed underwritten public offering of common stock and concurrent registered direct offering and received net proceeds of approximately $89.9 million.

 

 

 

Net revenue was approximately $3.5 million for the third quarter of 2018, compared with approximately $4.4 million for the third quarter of 2017.

Net loss was approximately $35.6 million for the third quarter of 2018, compared with approximately $14.7 million for the third quarter of 2017.

Ended the quarter with approximately $190 million in cash and approximately $75 million in outstanding debt.

As of September 30, 2018, the company has filed 241 global patent applications intellectual property portfolio with 22 issued foreign patents and 20 issued U.S. patents.

 

Summary of Third Quarter 2018 Financial Results 

Net revenue was approximately $3.5 million for the third quarter of 2018, compared with approximately $4.4 million for the third quarter of 2017. Net revenue decreased primarily due to a decrease in prenatal vitamin sales partially offset by an increase in sales of IMVEXXY.

 

Net revenue from the company’s prescription prenatal vitamin business was approximately $3.3 million for the third quarter of 2018, compared with approximately $4.4 million for the third quarter of 2017. The decrease was primarily related to the number of prenatal vitamin units sold and higher utilization of coupons offered to customers as compared to the third quarter of 2017. The company launched the IMVEXXY 10 mcg dose on August 6, 2018 followed by the 4 mcg dose on September 13, 2018. Net revenue for IMVEXXY was approximately $0.2 million for the third quarter of 2018 and were greatly affected by our co-pay assistance program, which is a maximum $35 out-of-pocket copay assistance program that allows patients to access the product for a reasonable cost. The company expects the net revenue for IMVEXXY to improve as commercial payer coverage for IMVEXXY increases and insurance plans complete the process needed to adjudicate IMVEXXY prescriptions at pharmacies.

 

Total operating expenses for the third quarter of 2018 included research and development (R&D) expenses and sales, general, and administrative expenses (SG&A). R&D expenses for the third quarter of 2018 were approximately $6.7 million compared with approximately $6.4 million for the prior year’s quarter. SG&A expenses for the third quarter of 2018 were approximately $30.4 million compared with approximately $12.1 million for the prior year’s quarter, primarily due to higher sales, marketing, and personnel costs to support commercialization of IMVEXXY and pre-commercialization activities for BIJUVA.

 

Net loss for the third quarter of 2018 was approximately $35.6 million, or $0.16 per basic and diluted share, compared with approximately $14.7 million, or $0.07 per basic and diluted share, for the third quarter of 2017.

 

Balance Sheet 

As of September 30, 2018, the company’s cash on hand totaled approximately $190 million, compared with approximately $127.1 million at December 31, 2017. Total outstanding debt, net of issuance costs, was approximately $73.3 million as of September 30, 2018.

 

Conference Call and Webcast Details 

TherapeuticsMD will host a conference call and audio webcast today, at 4:30 p.m. ET to present third quarter 2018 results and provide a business update.

 

Date: Wednesday, November 7, 2018
Time: 4:30 p.m. ET
Telephone Access (US): 866-665-9531
Telephone Access (International): 724-987-6977
Access Code for All Callers: 9651828

 

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: 9651828.

 

 
 

 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

   September 30,
2018
   December 31,
2017
 
   (Unaudited)      
ASSETS 
Current Assets:          
Cash  $189,999,293   $127,135,628 
Accounts receivable, net of allowance for doubtful accounts of $612,056 and $380,580, respectively   12,802,652    4,328,802 
Inventory   2,378,221    1,485,358 
Other current assets   6,509,646    6,604,284 
Total current assets   211,689,812    139,554,072 
           
Fixed assets, net   381,928    437,055 
           
Other Assets:          
Intangible assets, net   3,771,530    3,099,747 
License rights   20,000,000     
Long term deferred financing fees   759,229     
Security deposit   150,522    139,036 
Total other assets   24,681,281    3,238,783 
Total assets  $236,753,021   $143,229,910 
           
 LIABILITIES AND STOCKHOLDERS’ EQUITY 
Current Liabilities:          
Accounts payable  $11,382,093   $4,097,600 
Accrued expenses and other current liabilities   17,894,582    9,223,595 
Total current liabilities   29,276,675    13,321,195 
           
Long-term Liabilities:          
Long-term debt   73,261,065     
Total long-term liabilities   73,261,065     
Total liabilities   102,537,740    13,321,195 
           
Commitments and Contingencies          
           
Stockholders’ Equity:          
Preferred stock - par value $0.001; 10,000,000 shares authorized;  no shares issued and outstanding        
Common stock - par value $0.001; 350,000,000 shares authorized:          
    236,464,789 and 216,429,642 issued and outstanding, respectively   236,465    216,430 
Additional paid-in capital   613,864,115    516,351,405 
Accumulated deficit   (479,885,299)   (386,659,120)
Total stockholders’ equity   134,215,281    129,908,715 
Total liabilities and stockholders’ equity  $236,753,021   $143,229,910 

 

 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

   Three Months Ended   Nine Months Ended 
   September 30,   September 30, 
   2018   2017   2018   2017 
Revenues, net  $3,473,535   $4,417,598   $11,009,937   $12,653,495 
                     
Cost of goods sold   699,118    700,814    1,786,902    2,042,174 
Gross profit   2,774,417    3,716,784    9,223,035    10,611,321 
                     
Operating expenses:                    
Sales, general, and administration   30,354,072    12,057,868    80,578,079    43,524,412 
Research and development   6,708,271    6,436,802    20,545,948    22,878,037 
Depreciation and amortization   73,321    54,055    198,545    156,943 
Total operating expense   37,135,664    18,548,725    101,322,572    66,559,392 
                     
Operating loss   (34,361,247)   (14,831,941)   (92,099,537)   (55,948,071)
                     
Other income (expense):                    
Miscellaneous income   809,022    167,300    1,457,817    442,322 
Accreted interest               7,699 
Interest expense   (2,053,077)       (2,584,459)    
Total other (expense) income   (1,244,055)   167,300    (1,126,642)   450,021 
                     
Loss before taxes   (35,605,302)   (14,664,641)   (93,226,179)   (55,498,050)
                     
Provision for income taxes                
                     
Net loss  $(35,605,302)  $(14,664,641)  $(93,226,179)  $(55,498,050)
                     
Net loss per share, basic and diluted  $(0.16)  $(0.07)  $(0.42)  $(0.27)
                     
Weighted average number of common  shares outstanding                    
    228,107,240    207,938,338    220,466,673    203,282,335 

 

 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   Nine Months Ended 
   September 30,
2018
   September 30,
2017
 
CASH FLOWS FROM OPERATING ACTIVITIES          
Net loss  $(93,226,179)  $(55,498,050)
Adjustments to reconcile net loss to net cash flows used in operating activities:          
Depreciation of fixed assets   121,423    104,622 
Amortization of intangible assets   77,123    52,321 
Provision for doubtful accounts   231,475    1,555 
Share-based compensation   6,388,635    5,037,783 
Amortization of deferred financing costs   149,909     
Changes in operating assets and liabilities:          
Accounts receivable   (8,705,325)   106,509 
Inventory   (892,863)   (217,196)
Other current assets   1,233,482    (831,623)
Accounts payable   7,284,493    (3,159,145)
Accrued interest   59,375     
Accrued expenses and other current liabilities   8,611,611    (946,853)
Net cash used in operating activities   (78,666,841)   (55,350,077)
           
CASH FLOWS FROM INVESTING ACTIVITIES          
Payment for intellectual property license   (20,000,000)    
Patent costs   (748,906)   (439,770)
Purchase of fixed assets   (66,295)   (35,849)
Payment of security deposit   (11,485)    
Net cash used in investing activities   (20,826,686)   (475,619)
           
CASH FLOWS FROM FINANCING ACTIVITIES          
Proceeds from sale of common stock, net of costs   89,907,797    68,572,635 
Proceeds from term loan   75,000,000     
Payment of deferred financing fees   (3,786,918)    
Proceeds from exercise of options   1,236,313    212,615 
Proceeds from exercise of warrants       3,798,999 
Net cash provided by financing activities   162,357,192    72,584,249 
           
Increase in cash   62,863,665    16,758,553 
Cash, beginning of period   127,135,628    131,534,101 
Cash, end of period  $189,999,293   $148,292,654 
           
Supplemental disclosure of cash flow information          
Interest paid  $1,759,316   $ 

 

 

 

About IMVEXXY 

IMVEXXY (estradiol vaginal inserts) is approved in the U.S. for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. IMVEXXY is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose, the 4 mcg dose representing the lowest approved dose of vaginal estradiol available.

 

IMPORTANT SAFETY INFORMATION FOR IMVEXXY 

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER
and PROBABLE DEMENTIA

 

See full prescribing information for complete boxed warning. 

Estrogen-Alone Therapy 

● There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens 

● Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia  

● The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)  

● The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older  

Estrogen Plus Progestin Therapy 

● Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia  

● The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE) and myocardial infarction (MI)

● The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer

● The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

 

CONTRAINDICATIONS 

IMVEXXY™ is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema to IMVEXXY; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

 

WARNINGS AND PRECAUTIONS 

IMVEXXY is intended only for vaginal administration. Systemic absorption may occur with the use of IMVEXXY.

The use of estrogen-alone and estrogen plus progestin therapy has been reported to result in an increase in abnormal mammograms requiring further evaluation.

The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown.

Other warnings include: gallbladder disease; severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice.

Estrogen therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.

Women on thyroid replacement therapy should have their thyroid function monitored.

 

 

 

ADVERSE REACTIONS 

The most common adverse reaction with IMVEXXY (incidence ≥ 3 percent) and greater than placebo was headache.

 

Please note that this information is not comprehensive. Please visit www.Imvexxy.com for the Full Prescribing Information, including the Boxed WARNING, for IMVEXXY at https://imvexxy.com/pi.pdf.

 

About BIJUVA 

BIJUVA is a novel combination of bio-identical estradiol and bio-identical progesterone approved for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus in a once daily softgel capsule taken orally. Bio-identical refers to estradiol and progesterone that are molecularly identical to the hormones circulating naturally in the woman’s body. There is no evidence that bio-identical hormones are safer or more effective than synthetic hormones. BIJUVA is the first and only bio-identical estradiol and bio-identical progesterone product offering women an alternative to the available FDA-approved synthetic (non-bio-identical) hormones, the separate FDA-approved bio-identical estrogen and progesterone products that are used together but are not approved for combination use, and the unapproved compounded bio-identical hormone products. An estimated total of 15 to 20 million annual prescriptions of both the separate FDA-approved and compounded bio-identical estrogen and progesterone products are filled annually in the US.ii

 

INDICATION 

BIJUVA is a combination of an estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause.

 

IMPORTANT SAFETY INFORMATION 

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER, AND PROBABLE DEMENTIA 

See full prescribing information for complete boxed warning. 

Estrogen Plus Progestin Therapy 

●     Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia  

●     The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and myocardial infarction (MI) 

●    The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer  

●    The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age of older

Estrogen-Alone Therapy 

●    There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens  

●     Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia  

●     The WHI estrogen-alone substudy reported increased risks of stroke and DVT  

●    The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age or older

 

CONTRAINDICATIONS

BIJUVA is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding; Known, suspected, or history of cancer of the breast; Known or suspected estrogen-dependent neoplasia; Active DVT, PE, or history of these conditions; Active arterial thromboembolic disease (for example, stroke, MI), or a history of these conditions; Known anaphylactic reaction, angioedema, or hypersensitivity to BIJUVA or any of its ingredients; Known liver impairment or disease; Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

 

 

 

WARNINGS AND PRECAUTIONS

An increased risk of PE, DVT, stroke, and MI has been reported with estrogen plus progestin therapy. Should these occur or be suspected, therapy should be discontinued immediately. Risk factors for arterial vascular disease and/or venous thromboembolism (VTE) should be managed appropriately.

The WHI substudy of daily estrogen plus progestin after a mean follow-up of 5.6 years reported an increased risk of invasive breast cancer. Observational studies have also reported an increased risk of breast cancer for estrogen plus progestin therapy after several years of use. The risk increased with duration of use an appeared to return to baseline over about 5 years after stopping treatment (only the observational studies have substantial data on risk after stopping). The use of estrogen plus progestin therapy has been reported to result in an increase in abnormal mammograms requiring further evaluation.

Endometrial hyperplasia (a possible precursor to endometrial cancer) has been reported to occur at a rate of approximately less than one percent with BIJUVA. Clinical surveillance of all women using estrogen plus progestin therapy is important. Adequate diagnostic measures should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown.

In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen plus progestin when compared to placebo. It is unknown whether these findings apply to younger postmenopausal women.

Estrogens increase the risk of gallbladder disease.

Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs.

Monitor thyroid function in women on thyroid replacement hormone therapy.

 

ADVERSE REACTIONS  

The most common adverse reactions (≥3%) for BIJUVA are breast tenderness (10.4%), headache (3.4%), vaginal bleeding (3.4%), vaginal discharge (3.4%), and pelvic pain (3.1%).

 

Please note that this information is not comprehensive. Please see the Full Prescribing Information, including BOXED WARNING, for BIJUVA at https://www.bijuva.com/pi.pdf.

 

About ANNOVERA 

The ANNOVERA one-year contraceptive vaginal system combines a widely used estrogen (ethinyl estradiol) with a new progestin segesterone acetate (Nestorone®) into a single vaginal ring to prevent ovulation for an entire year (13 cycles; used in repeated four-week cycles (remaining in place continuously for three weeks followed by removal for one week)). Designed to empower women to be in complete control of their fertility and menstruation, ANNOVERA represents the first and only long-acting birth control product that is reversible and does not require a medical procedure for insertion or removal. The soft, flexible ring can be inserted and removed by the woman herself and without the help of a healthcare professional. The one-year vaginal system represents a new option for women, including nulliparous women (women who have not given birth) desiring long-acting reversible contraception. The one-year contraceptive vaginal system does not require refrigeration.

 

 

 

Indication 

ANNOVERA is a progestin/estrogen CHC indicated for use by females of reproductive potential to prevent pregnancy. (Limitation of use: Not adequately evaluated in females with a BMI of > 29 kg/m2).

 

Important Safety Information 

Cigarette smoking increases the risk of cardiovascular events from CHC use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. CHCs should not be used by females who are over 35 years of age and smoke.

 

Due to increased risks of serious side effects, ANNOVERA should not be used in females with certain medical conditions, including females who have a high risk of arterial or venous thrombotic diseases; who have or have had breast cancer or other estrogen- or progestin-sensitive cancer; who have liver tumors, acute hepatitis, severe cirrhosis, undiagnosed abnormal uterine bleeding, or hypersensitivity to any ingredients in ANNOVERA; who use certain Hepatitis C drug combinations; or who are pregnant or breastfeeding.

 

Risks from use of a CHC, like ANNOVERA, particularly in females with any condition listed above, include venous thrombotic events; cardiovascular events and cerebrovascular events such as stroke and myocardial infarction; liver disease; elevated liver enzymes with concomitant Hepatitis C treatment; hypertension; carbohydrate and lipid metabolic effects; headache; bleeding irregularities and amenorrhea.

 

ANNOVERA does not protect against HIV-infection (AIDS) and other sexually transmitted infections.

 

Please note that this information is not comprehensive. Please see the Full Prescribing Information, including the Boxed Warning, for ANNOVERA at www.annovera.com/pi.pdf.

 

About TherapeuticsMD, Inc. 

TherapeuticsMD, Inc. is an innovative 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 company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXYTM, ANNOVERATM, BIJUVA and its hormone therapy drug candidates and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan agreement; 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; the ability of licensees of the company’s products to commercialize such licensed products; 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 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. PDF copies of the company’s historical press releases and financial tables can be viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.

 

 
i“Bio-identical” refers to estradiol and progesterone that are molecularly identical to the hormones produced naturally in the woman’s body. There is no evidence that bio-identical hormones are safer or more effective than synthetic hormones.
iiConsensus estimate based on Symphony Health Solutions PHAST Data powered by IDV; 12 months as of December 31, 2017 and Fisher, J. QuintilesIMS, White Paper: A Profile of the US Compounding Pharmacy Market.

 

# # #

 

Investor Contact 

Nichol Ochsner, 

Vice President Investor Relations 

561-961-1900, ext. 2088

Nochsner@TherapeuticsMD.com

 

 

 

 


The following information was filed by Therapeuticsmd, Inc. (TXMD) on Wednesday, November 7, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

View differences made from one quarter to another to evaluate Therapeuticsmd, Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Therapeuticsmd, Inc..

Continue

Never Miss A New SEC Filing Again


Real-Time SEC Filing Notifications
Screenshot taken from Gmail for a new 10-K Annual Report
Last10K.com Member Feature

Receive an e-mail as soon as a company files an Annual Report, Quarterly Report or has new 8-K corporate news.

Continue

We Highlighted This SEC Filing For You


SEC Filing Sentiment Analysis - Bullish, Bearish, Neutral
Screenshot taken from Wynn's 2018 10-K Annual Report
Last10K.com Member Feature

Read positive and negative remarks made by management in their entirety without having to find them in a 10-K/Q.

Continue

Widen Your SEC Filing Reading Experience


Increased Reading Area for SEC Filings
Screenshot taken from Adobe Inc.'s 10-Q Quarterly Report
Last10K.com Member Feature

Remove data columns and navigations in order to see much more filing content and tables in one view

Continue

Uncover Actionable Information Inside SEC Filings


SEC Filing Disclosures
Screenshot taken from Lumber Liquidators 10-K Annual Report
Last10K.com Member Feature

Read both hidden opportunities and early signs of potential problems without having to find them in a 10-K/Q

Continue

Adobe PDF, Microsoft Word and Excel Downloads


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshots of actual 10-K and 10-Q SEC Filings in PDF, Word and Excel formats
Last10K.com Member Feature

Export Annual and Quarterly Reports to Adobe PDF, Microsoft Word and Excel for offline viewing, annotations and analysis

Continue

FREE Financial Statements


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshot of actual balance sheet from company 10-K Annual Report
Last10K.com Member Feature

Get one-click access to balance sheets, income, operations and cash flow statements without having to find them in Annual and Quarterly Reports

Continue for FREE

Intrinsic Value Calculator


Intrinsic Value Calculator
Screenshot of intrinsic value for AT&T (2019)
Last10K.com Member Feature

Our Intrinsic Value calculator estimates what an entire company is worth using up to 10 years of financial ratios to determine if a stock is overvalued or not

Continue

Financial Stability Report


Financial Stability Report
Screenshot of financial stability report for Coco-Cola (2019)
Last10K.com Member Feature

Our Financial Stability reports uses up to 10 years of financial ratios to determine the health of a company's EPS, Dividends, Book Value, Return on Equity, Current Ratio and Debt-to-Equity

Continue

Get a Better Picture of a Company's Performance


Financial Ratios
Available Financial Ratios
Last10K.com Member Feature

See how over 70 Growth, Profitability and Financial Ratios perform over 10 Years

Continue

Log in with your credentials

or    

Forgot your details?

Create Account