Full Press Release Details
TherapeuticsMD, Inc. 8-K
TherapeuticsMD Announces Third Quarter 2018 Financial Results
early launch indicators for IMVEXXY -
commercial launch planned for 2Q 2019-
commercial launch planned for 4Q 2019-
call scheduled for 4:30 p.m. ET today-
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.
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."
Quarter and Recent Developments
of Third Quarter 2018 Financial Results
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
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.
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.
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.
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.
Call and Webcast Details
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
| 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 |
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.
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 |
INC. AND SUBSIDIARIES
STATEMENTS OF OPERATIONS
| 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 |
INC. AND SUBSIDIARIES
STATEMENTS OF CASH FLOWS
| 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 | $ | - |
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.
SAFETY INFORMATION FOR IMVEXXY
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.
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
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.
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%).
note that this information is not comprehensive. Please see the Full Prescribing Information, including BOXED WARNING, for BIJUVA
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.
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).
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.
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.
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.
does not protect against HIV-infection (AIDS) and other sexually transmitted infections.
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. 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