-Strong early launch indicators for IMVEXXY™-
-BIJUVA™ commercial launch planned for 2Q 2019-
-ANNOVERA™ commercial launch planned for 4Q 2019-
-Conference call scheduled for
“We are extremely pleased with the momentum of the IMVEXXY launch,
including our progress with negotiating commercial payer coverage,” said
Third Quarter and Recent Developments
-
On
October 28, 2018 , the company receivedU.S. Food and Drug Administration (FDA ) approval of BIJUVA™ (estradiol and progesterone) capsules, 1 mg/100 mg. BIJUVA is the first and onlyFDA -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 inSeptember 2018 with 150 sales representatives. IMVEXXY is available in major pharmacy chains in the U.S. as well as through our BIO-IGNITE™ 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.
-
From launch through
-
On
August 10, 2018 , the company receivedFDA 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 thePopulation 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 toKnight 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.) inCanada andIsrael . -
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
Net revenue from the company’s prescription prenatal vitamin business
was approximately
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
Net loss for the third quarter of 2018 was approximately
Balance Sheet
As of
Conference Call and Webcast Details
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, 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
Estrogen Plus Progestin Therapy
|
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
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-Alone Therapy
|
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.
Forward-Looking Statements
This press release by
__________________
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.
ii Consensus estimate based on Symphony Health Solutions
PHAST Data powered by IDV; 12 months as of
View source version on businesswire.com: https://www.businesswire.com/news/home/20181107005813/en/
Source:
TherapeuticsMD, Inc.
Nichol Ochsner, 561-961-1900, ext. 2088
Vice
President Investor Relations
Nochsner@TherapeuticsMD.com