-Imvexxy™ early experience program underway; national launch to
-PDUFA target action date of
Second Quarter and Recent Developments
FDAapproval of Imvexxy™ (estradiol vaginal inserts) on May 29, 2018for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
Completed the first drawdown of
$75 millionon June 7, 2018under its previously announced $200 millionterm loan facility with MidCap Financial, managed by Apollo Capital Management, L.P, to support the commercial launch of its recently approved product.
Initiated Imvexxy’s limited launch (early experience program) on
July 9, 2018with the 10 mcg dose, which will be followed by the national launch of the 10 mcg dose that is expected to commence on August 6, 2018. In the first three weeks of limited launch ( July 9-27, 2018), approximately 1,363 healthcare providers have initiated at least one patient on treatment and sent in the follow-on prescription for continuation of treatment on the maintenance pack. The 4 mcg dose of Imvexxy is expected to be available in early September 2018.
Net revenue for the company’s prescription prenatal vitamin business
$3.8 millionfor the second quarter of 2018, compared with approximately $4.3 millionfor the second quarter of 2017.
Net loss was approximately
$33.2 millionfor the second quarter of 2018, compared with approximately $19.7 millionfor the second quarter of 2017.
Ended the quarter with approximately
$154.4 millionin cash and approximately $73.1 millionin outstanding debt.
- Grew the company’s intellectual property portfolio to a current total of 237 global patent applications with 20 issued foreign patents and 19 issued U.S. patents.
“We made important progress during the first half of 2018 that has given
us an exciting start to the year,” said
Summary of Second Quarter 2018 Financial Results
Net revenue from the company’s prescription prenatal vitamin business
Cost of goods sold was approximately
Total operating expenses for the second quarter of 2018 included
research and development (R&D) expenses and sales, general, and
administrative expenses (SG&A). R&D expenses for the second quarter of
2018 were approximately
Net loss for the second quarter of 2018 was approximately
Conference Call and Webcast Details
|Monday, July 30, 2018|
|8:30 a.m. EST|
Telephone Access (US):
Telephone Access (International):
Access Code for All Callers:
A live webcast and audio archive for the event may be accessed on the
home page or from the “Investors & Media” section of the
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 representing the lowest approved dose of vaginal estradiol available. The full prescribing information may be viewed by visiting www.Imvexxy.com.
IMPORTANT SAFETY INFORMATION FOR IMVEXXY
|WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA|
See full prescribing information for complete boxed warning.
|•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|
- 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.
- The most common adverse reaction with Imvexxy (incidence ≥ 3 percent) and greater than placebo was headache.
This press release by
THERAPEUTICSMD, INC. AND SUBSIDIARIES
|CONSOLIDATED BALANCE SHEETS|
|June 30, 2018||December 31, 2017|
Accounts receivable, net of allowance for doubtful accounts of $418,604 and $380,580, respectively
|Other current assets||5,203,734||6,604,284|
|Total current assets||167,097,228||139,554,072|
|Fixed assets, net||403,574||437,055|
|Intangible assets, net||3,488,401||3,099,747|
|Prepaid expenses-long term||759,229||-|
|Total other assets||4,398,152||3,238,783|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||9,785,210||9,223,595|
|Total current liabilities||21,212,370||13,321,195|
|Total long-term liabilities||73,141,311||-|
|Commitments and Contingencies|
Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding
Common stock - par value $0.001; 350,000,000 shares authorized: 216,834,059 and 216,429,642 issued and outstanding, respectively
|Additional paid-in capital||521,608,436||516,351,405|
|Total stockholders' equity||77,545,273||129,908,715|
|Total liabilities and stockholders' equity||$||171,898,954||$||143,229,910|
|THERAPEUTICSMD, INC. AND SUBSIDIARIES|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Cost of goods sold||454,161||681,725||1,087,784||1,341,360|
|Sales, general, and administration||29,466,770||14,628,927||50,224,007||31,466,544|
|Research and development||6,798,380||8,716,395||13,837,677||16,441,235|
|Depreciation and amortization||65,603||53,189||125,224||102,888|
|Total operating expense||36,330,753||23,398,511||64,186,908||48,010,667|
|Other income (expense):|
|Total other (expense) income||(197,144||)||152,886||117,413||282,721|
|Loss before taxes||(33,219,048||)||(19,676,917||)||(57,620,877||)||(40,833,409||)|
|Provision for income taxes||-||-||-||-|
|Net loss per share, basic and diluted||$||(0.15||)||$||(0.10||)||$||(0.27||)||$||(0.20||)|
Weighted average number of common shares outstanding
|THERAPEUTICSMD, INC. AND SUBSIDIARIES|
|CONSOLIDATED STATEMENTS OF CASH FLOWS|
|Six Months Ended|
|June 30, 2018||June 30, 2017|
|CASH FLOWS FROM OPERATING ACTIVITIES|
Adjustments to reconcile net loss to net cash flows used in operating activities:
|Depreciation of fixed assets||79,201||69,000|
|Amortization of intangible assets||46,023||33,888|
|Provision for (recovery of) doubtful accounts||38,024||(18,106||)|
|Amortization of deferred financing costs||30,155||-|
|Changes in operating assets and liabilities:|
|Other current assets||2,539,394||(58,601||)|
|Accrued expenses and other current liabilities||60,388||(2,443,867||)|
|Net cash used in operating activities||(44,598,893||)||(38,665,526||)|
|CASH FLOWS FROM INVESTING ACTIVITIES|
|Purchase of fixed assets||(45,720||)||(35,849||)|
|Payment of security deposit||(11,486||)||-|
|Net cash used in investing activities||(491,883||)||(403,451||)|
|CASH FLOWS FROM FINANCING ACTIVITIES|
|Proceeds from term loan||75,000,000||-|
|Payment of deferred financing fees||(3,786,918||)||-|
|Proceeds from exercise of options||1,128,996||212,360|
|Proceeds from exercise of warrants||-||3,798,999|
|Net cash provided by financing activities||72,342,078||4,011,359|
|Increase (decrease) in cash||27,251,302||(35,057,618||)|
|Cash, beginning of period||127,135,628||131,534,101|
|Cash, end of period||$||154,386,930||$||96,476,483|
Nichol Ochsner, 561-961-1900, ext. 2088
Vice President Investor Relations