Successful Launch of IMVEXXY®, Strong Positive
Trends
Continue for Prescriptions and Patient Refills
BIJUVA™ Commercial Launch on Track for the Second Quarter of 2019
ANNOVERA™ Commercial Launch planned as Early as the Third Quarter of 2019
Conference Call Scheduled for
“In 2018, we completed our most successful year to date and transformed
into a leading women’s healthcare company,” said
IMVEXXY Launch Continues to Highlight Successful Launch Execution
-
The company commenced the U.S. commercial launch of IMVEXXY (estradiol
vaginal inserts) 10-mcg dose in
August 2018 and the 4-mcg dose inSeptember 2018 with the support of 150 sales representatives. IMVEXXY is currently available in major U.S. pharmacy chains and through BIO-IGNITE compounding pharmacy partners.- Approximately 47,500 prescriptions of IMVEXXY were dispensed to approximately 22,200 patients during the fourth quarter of 2018. The 3-fold increase in prescription volume for the fourth quarter of 2018 as compared to our launch during the third quarter of 2018.
-
From launch through
December 31, 2018 , approximately 62,400 prescriptions were dispensed to approximately 25,500 patients and approximately 7,300 prescribers had a filled prescription for the product. -
Strong refill rates suggest women are having a positive experience
with IMVEXXY. Patients who began treatment in
August 2018 have obtained an average of 4.9 refills throughJanuary 2019 , out of a possible 6 refills. -
Through
December 31, 2018 , the company achieved unrestricted coverage with six of the top ten commercial payers, with three of them adjudicating onJanuary 1, 2019 . This includes two commercial payers that were added in the fourth quarter of 2018, which was a large contributor to the 4-fold increase in net revenue growth for IMVEXXY for the fourth quarter of 2018 as compared to our launch during the third quarter of 2018. -
After year end, the company came to agreement for commercial
coverage of IMVEXXY with
United Healthcare , the third largest commercial payer in the U.S, to begin adjudication onMarch 1, 2019 . Additionally, the company secured coverage fromUnited Healthcare and Kaiser (limited to only the maintenance pack) for theirMedicare Part D plans. -
IMVEXXY prescription growth continues into 2019 as highlighted by
a record month in
January 2019 . -
IMVEXXY average weekly prescription volume for the first two weeks
of
February 2019 increased to approximately 5,800 as compared to average weekly volume of approximately 5,300 inJanuary 2019 .
Key Expected Events in 2019
-
1Q 2019 - Speaker medical education programs throughout
the United States highlighting the clinical and physical attributes of IMVEXXY
- 1Q 2019 through 3Q 2019 – Expand IMVEXXY Part D coverage
- 1Q 2019 – Expand sales force by 25% to 200 sales representatives to increase reach of IMVEXXY and launch BIJUVA
- 2H 2019 - Begin direct-to-consumer marketing for IMVEXXY
-
2Q 2019 – U.S. commercial launch of BIJUVA (estradiol and
progesterone) capsules and draw second
$75 million debt tranche withMidCap Financial Trust - 2H (targeting 3Q) 2019 - U.S. commercial launch of ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)
- 2H 2019 – Debt funding for ANNOVERA
- Summer 2019 - Company to hold Analyst Day
- Late 4Q 2019 - BIJUVA 6-month “new to market” payer block expected to end
- Full year 2019 - Oral presentations and posters related to clinical benefits of IMVEXXY, BIJUVA and ANNOVERA at medical meetings
- Throughout 2019 - Continue to expand BIO-IGNITE with a fuller expansion towards the end of 2019 when the six-month payer block for BIJUVA is expected to end
Summary of Fourth Quarter and Full Year 2018 Financial Results
For the year ended
Research and development (R&D) expenses for the full-year 2018 decreased
to approximately
Sales, general and administrative (SG&A) expenses for the full-year 2018
increased to approximately
Net loss for the full-year 2018 was approximately
Balance Sheet
As of
Conference Call and Webcast Details
Date:
Time:
Telephone Access (US): 866-665-9531
Telephone Access (International): 724-987-6977
Access Code for All Callers: 3494187
A live webcast and audio archive for the event may be accessed on the
home page or from the “Investors & Media” section of the
Please see the Full Prescribing Information, including indication and
Boxed WARNING, for each
- IMVEXXY at https://imvexxy.com/pi.pdf
- BIJUVA at https://www.bijuva.com/pi.pdf
- ANNOVERA at www.annovera.com/pi.pdf
Forward-Looking Statements
This press release by
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||
CONSOLIDATED BALANCE SHEETS | |||||||||||
December 31, | |||||||||||
2018 | 2017 | ||||||||||
ASSETS | |||||||||||
Current Assets: | |||||||||||
Cash | $ | 161,613,077 | $ | 127,135,628 | |||||||
Accounts receivable, net of allowance for doubtful accounts | |||||||||||
of $596,602 and $380,580, respectively | 11,063,821 | 4,328,802 | |||||||||
Inventory | 3,267,670 | 1,485,358 | |||||||||
Other current assets | 10,834,693 | 6,604,284 | |||||||||
Total current assets | 186,779,261 | 139,554,072 | |||||||||
Fixed assets, net | 472,683 | 437,055 | |||||||||
Other Assets: | |||||||||||
License rights | 20,000,000 | - | |||||||||
Intangible assets, net | 4,092,679 | 3,099,747 | |||||||||
Other assets | 324,855 | - | |||||||||
Security deposit | 314,446 | 139,036 | |||||||||
Total other assets | 24,731,980 | 3,238,783 | |||||||||
Total assets | $ | 211,983,924 | $ | 143,229,910 | |||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||||
Current Liabilities: | |||||||||||
Accounts payable | $ | 22,743,841 | $ | 4,097,600 | |||||||
Accrued expenses and other current liabilities | 18,334,948 | 9,223,595 | |||||||||
Total current liabilities | 41,078,789 | 13,321,195 | |||||||||
Long-Term Liabilities: | |||||||||||
Long-term debt | 73,381,014 | - | |||||||||
Total liabilities | 114,459,803 | 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: | |||||||||||
240,462,439 and 216,429,642 issued and outstanding, respectively | 240,463 | 216,430 | |||||||||
Additional paid-in capital | 616,559,938 | 516,351,405 | |||||||||
Accumulated deficit | (519,276,280 | ) | (386,659,120 | ) | |||||||
Total stockholders' equity | 97,524,121 | 129,908,715 | |||||||||
Total liabilities and stockholders' equity | $ | 211,983,924 | $ | 143,229,910 | |||||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||||
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||||||||
2018 | 2017 | 2018 | 2017 | 2016 | |||||||||||||||||
Revenues, net | $ | 5,089,523 | $ | 4,124,218 | $ | 16,099,460 | $ | 16,777,713 | $ | 19,356,450 | |||||||||||
Cost of goods sold | 950,750 | 594,769 | 2,737,652 | 2,636,943 | 4,185,708 | ||||||||||||||||
Gross profit | 4,138,773 | 3,529,449 | 13,361,808 | 14,140,770 | 15,170,742 | ||||||||||||||||
Operating expenses: | |||||||||||||||||||||
Sales, general, and administrative | 35,410,875 | 14,178,958 | 115,988,954 | 57,703,370 | 51,348,414 | ||||||||||||||||
Research and development | 6,753,190 | 10,974,956 | 27,299,138 | 33,852,993 | 53,943,477 | ||||||||||||||||
Depreciation and amortization | 95,341 | 56,174 | 293,886 | 213,117 | 132,451 | ||||||||||||||||
Total operating expenses | 42,259,406 | 25,210,088 | 143,581,978 | 91,769,480 | 105,424,342 | ||||||||||||||||
Operating loss | (38,120,633 | ) | (21,680,639 | ) | (130,220,170 | ) | (77,628,710 | ) | (90,253,600 | ) | |||||||||||
Other (expense) income | |||||||||||||||||||||
Miscellaneous income | 823,027 | 253,309 | 2,280,844 | 695,631 | 367,317 | ||||||||||||||||
Interest expense | (2,093,375 | ) | - | (4,677,834 | ) | - | - | ||||||||||||||
Accreted interest | - | - | - | 7,699 | 10,824 | ||||||||||||||||
Total other (expense) income | (1,270,348 | ) | 253,309 | (2,396,990 | ) | 703,330 | 378,141 | ||||||||||||||
Loss before income taxes | (39,390,981 | ) | (21,427,330 | ) | (132,617,160 | ) | (76,925,380 | ) | (89,875,459 | ) | |||||||||||
Provision for income taxes | - | - | - | - | - | ||||||||||||||||
Net loss | $ | (39,390,981 | ) | $ | (21,427,330 | ) | $ | (132,617,160 | ) | $ | (76,925,380 | ) | $ | (89,875,459 | ) | ||||||
Loss per share, basic and diluted: | |||||||||||||||||||||
Net loss per share, basic and diluted | $ | (0.17 | ) | $ | (0.10 | ) | $ | (0.59 | ) | $ | (0.37 | ) | $ | (0.46 | ) | ||||||
Weighted average number of common | |||||||||||||||||||||
shares outstanding, basic and diluted | 238,556,492 | 216,429,642 | 225,026,300 | 205,523,288 | 196,088,196 | ||||||||||||||||
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||||||||
Year Ended December, 31, | |||||||||||||||
2018 | 2017 | 2016 | |||||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||||||||
Net loss | $ | (132,617,160 | ) | $ | (76,925,380 | ) | $ | (89,875,459 | ) | ||||||
Adjustments to reconcile net loss to net cash used in | |||||||||||||||
operating activities: | |||||||||||||||
Depreciation of fixed assets | 181,412 | 141,601 | 77,906 | ||||||||||||
Amortization of intangible assets | 112,474 | 71,516 | 54,545 | ||||||||||||
Provision for doubtful accounts | 216,022 | 4,206 | 2,524,909 | ||||||||||||
Share-based compensation | 8,661,967 | 6,889,323 | 17,411,021 | ||||||||||||
Amortization of deferred financing costs | 269,859 | - | - | ||||||||||||
Changes in operating assets and liabilities: | |||||||||||||||
Accounts receivable | (6,951,041 | ) | 167,691 | (3,975,893 | ) | ||||||||||
Inventory | (1,782,312 | ) | (409,037 | ) | (386,168 | ) | |||||||||
Other current assets | (2,332,335 | ) | (4,434,130 | ) | 709,907 | ||||||||||
Other assets | (324,855 | ) | - | - | |||||||||||
Accounts payable | 18,646,241 | (3,260,914 | ) | 4,232,340 | |||||||||||
Accrued expenses and other current liabilities | 9,107,947 | 1,599,510 | 84,559 | ||||||||||||
Net cash used in operating activities | (106,811,781 | ) | (76,155,614 | ) | (69,142,333 | ) | |||||||||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||||||||||||
Payment for intellectual property license | (20,000,000 | ) | - | - | |||||||||||
Patent costs | (1,105,407 | ) | (765,291 | ) | (845,266 | ) | |||||||||
Purchase of fixed assets | (217,040 | ) | (61,817 | ) | (396,154 | ) | |||||||||
Payment of security deposit | (175,410 | ) | - | (14,036 | ) | ||||||||||
Net cash used in investing activities | (21,497,857 | ) | (827,108 | ) | (1,255,456 | ) | |||||||||
CASH FLOWS FROM FINANCING ACTIVITIES | |||||||||||||||
Proceeds from sale of common stock, net of costs | 89,907,797 | 68,572,635 | 134,863,475 | ||||||||||||
Proceeds from term loan | 75,000,000 | - | - | ||||||||||||
Payment of deferred financing fees | (3,786,918 | ) | - | - | |||||||||||
Proceeds from exercise of options | 1,666,208 | 212,615 | 989,060 | ||||||||||||
Proceeds from exercise of warrants | - | 3,798,999 | 1,373,000 | ||||||||||||
Net cash provided by financing activities | 162,787,087 | 72,584,249 | 137,225,535 | ||||||||||||
Increase (decrease) in cash | 34,477,449 | (4,398,473 | ) | 66,827,746 | |||||||||||
Cash, beginning of period | 127,135,628 | 131,534,101 | 64,706,355 | ||||||||||||
Cash, end of period | $ | 161,613,077 | $ | 127,135,628 | $ | 131,534,101 | |||||||||
Supplemental disclosure of cash flow information | |||||||||||||||
Interest paid | $ | 1,890,166 | $ | - | $ | - | |||||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20190221005922/en/
Source:
Investor Contact
Nichol Ochsner,
Vice
President Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com