IMVEXXY® Net Revenue
Total Net Revenue for the Second Quarter of 2019 Above Guidance at
Company Raises Full-Year Net Revenue Guidance to Range of
Conference Call Scheduled for
“We are pleased to report a solid quarter that came in ahead of our expectations and believe the next few quarters will be transformative,” said
Second Quarter and Recent Developments
-
IMVEXXY (estradiol vaginal inserts) prescription growth continues as highlighted by a record month in
July 2019 with approximately 45,500 prescriptions dispensed and paid for by patients. Approximately 106,000 prescriptions of IMVEXXY were dispensed and paid for by patients during the second quarter of 2019. This is an increase of approximately 41% in prescription volume for the second quarter of 2019 as compared to the first quarter of 2019. Strong refill rates continue to indicate that women are having a positive experience with IMVEXXY. -
IMVEXXY currently has unrestricted access with seven of the top commercial payers of VVA products and two of the top
Medicare Part D payers of VVA products. The company expects additional coverage decisions by the top commercial andMedicare Part D payers of VVA products during the third and fourth quarters of 2019. -
The commercial launch of BIJUVA (estradiol and progesterone capsules) commenced on
April 17, 2019 and approximately 8,900 prescriptions have been dispensed and paid for by patients throughJuly 31, 2019 . -
BIJUVA currently has unrestricted access with four of the top ten commercial payers. This includes two new plans,
United Healthcare and OptumRX, that began adjudicating BIJUVA onAugust 1, 2019 . -
Pre-launch activities have commenced for ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system). The company plans to continue discussions with the
U.S. Food and Drug Administration (FDA ) on the potential for ANNOVERA to be designated a new, 19th method of contraception, and begin discussions with payers with a full-scale launch planned for the first quarter of 2020. -
The company recently closed an exclusive license and supply transaction with Theramex, a leading, global specialty pharmaceutical company dedicated to women’s health, to commercialize BIJUVA and IMVEXXY outside of
the United States . OnAugust 5, 2019 , the company received an upfront payment under this agreement of approximately$15.4 million and is eligible to receive additional regulatory and sales milestone payments, as well as a royalty on net sales.
Summary of Second Quarter 2019 Financial Results
Total net revenues for the second quarter of 2019 increased 62%, to approximately
Net revenues have been greatly affected by the company’s co-pay assistance programs introduced to launch IMVEXXY and BIJUVA, which allowed eligible enrolled patients to access the products at a reasonable cost of no more than
Research and development (R&D) expenses for the second quarter of 2019 decreased to approximately
Sales, general and administrative (SG&A) expenses increased for the second quarter of 2019 to approximately
During the second quarter of 2019, the company took a one-time charge for extinguishment of debt of approximately
Balance Sheet
As of
Financial Guidance
The following table outlines TherapeuticsMD’s revised 2019 financial guidance (in millions).
3Q 2019 |
4Q 2019 |
FY 2019 |
||||
Original |
Revised |
Original |
Revised |
Original |
Revised |
|
FDA-Approved Products |
$4.50-$6.50 |
Unchanged |
$11.00-$13.00 |
Unchanged |
$20.00-$24.5 |
$20.75-$24.75 |
Prescription Prenatal Vitamins |
$1.75-$2.25 |
$2.25-$2.50 |
$1.50-$2.00 |
$1.75-$2.25 |
$7.15-$8.65 |
$8.70-$9.45 |
Total Net Revenues |
$6.25-$8.75 |
$6.75-$9.00 |
$12.50-$15.00 |
$12.75-$15.25 |
$27.10-$33.10 |
$29.45-$34.20 |
Conference Call and Webcast Details
Date:
Time:
Telephone Access (US): 866-665-9531
Telephone Access (International): 724-987-6977
Access Code for All Callers: 1392883
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 (estradiol vaginal inserts) at https://imvexxy.com/pi.pdf
- BIJUVA (estradiol and progesterone capsules) at https://www.bijuva.com/pi.pdf
- ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) at www.annovera.com/pi.pdf
About
Forward-Looking Statements
This press release by
THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||
CONSOLIDATED BALANCE SHEETS | ||||
June 30, 2019 | December 31, 2018 | |||
(Unaudited) | ||||
ASSETS | ||||
Current Assets: | ||||
Cash |
$ 182,846,301 |
$ 161,613,077 |
||
Accounts receivable, net of allowance for doubtful accounts | ||||
of $764,102 and $596,602, respectively |
18,383,012 |
11,063,821 |
||
Inventory |
7,494,440 |
3,267,670 |
||
Other current assets |
7,739,048 |
10,834,693 |
||
Total current assets |
216,462,801 |
186,779,261 |
||
Fixed assets, net |
1,432,137 |
472,683 |
||
Other Assets: | ||||
License rights |
20,000,000 |
20,000,000 |
||
Intangible assets, net |
4,688,114 |
4,092,679 |
||
Other assets |
3,635,227 |
324,855 |
||
Security deposit |
334,866 |
314,446 |
||
Total other assets |
28,658,207 |
24,731,980 |
||
Total assets |
$ 246,553,145 |
$ 211,983,924 |
||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
Current Liabilities: | ||||
Accounts payable |
$ 19,499,238 |
$ 22,743,841 |
||
Other current liabilities |
22,376,617 |
18,334,948 |
||
Total current liabilities |
41,875,855 |
41,078,789 |
||
Long-Term Liabilities: | ||||
Long-term debt |
194,095,220 |
73,381,014 |
||
Operating lease liability |
2,488,101 |
- |
||
Total liabilities |
238,459,176 |
114,459,803 |
||
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: | ||||
241,221,840 and 240,462,439 issued and outstanding, respectively |
241,222 |
240,463 |
||
Additional paid-in capital |
621,871,919 |
616,559,938 |
||
Accumulated deficit |
(614,019,172) |
(519,276,280) |
||
Total stockholders' equity |
8,093,969 |
97,524,121 |
||
Total liabilities and stockholders' equity |
$ 246,553,145 |
$ 211,983,924 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
(Unaudited) | ||||||||
Three Months Ended | Six Months Ended | |||||||
June 30, | June 30, | |||||||
2019 |
2018 |
2019 |
2018 |
|||||
Revenues, net |
$ 6,078,865 |
$ 3,763,010 |
$ 10,025,516 |
$ 7,536,402 |
||||
Cost of goods sold |
1,248,860 |
454,161 |
2,011,687 |
1,087,784 |
||||
Gross profit |
4,830,005 |
3,308,849 |
8,013,829 |
6,448,618 |
||||
Operating expenses: | ||||||||
Sales, general, and administrative |
41,387,451 |
29,466,770 |
76,251,533 |
50,224,007 |
||||
Research and development |
4,964,368 |
6,798,380 |
11,282,250 |
13,837,677 |
||||
Depreciation and amortization |
115,059 |
65,603 |
221,997 |
125,224 |
||||
Total operating expenses |
46,466,878 |
36,330,753 |
87,755,780 |
64,186,908 |
||||
Operating loss |
(41,636,873) |
(33,021,904) |
(79,741,951) |
(57,738,290) |
||||
Other (expense) income | ||||||||
Loss on extinguishment of debt |
(10,057,632) |
- |
(10,057,632) |
- |
||||
Miscellaneous income |
486,597 |
334,238 |
1,175,318 |
648,795 |
||||
Interest expense |
(4,028,609) |
(531,382) |
(6,118,627) |
(531,382) |
||||
Total other (expense) income |
(13,599,644) |
(197,144) |
(15,000,941) |
117,413 |
||||
Loss before income taxes |
(55,236,517) |
(33,219,048) |
(94,742,892) |
(57,620,877) |
||||
Provision for income taxes |
- |
- |
- |
- |
||||
Net loss |
$ (55,236,517) |
$ (33,219,048) |
$ (94,742,892) |
$ (57,620,877) |
||||
Loss per share, basic and diluted: | ||||||||
Net loss per share, basic and diluted |
$ (0.23) |
$ (0.15) |
$ (0.39) |
$ (0.27) |
||||
Weighted average number of common | ||||||||
shares outstanding, basic and diluted |
241,221,840 |
216,640,186 |
241,114,532 |
216,583,067 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | ||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
(Unaudited) | ||||||||
Six Months Ended | ||||||||
June 30, | ||||||||
|
2019 |
|
|
2018 |
|
|||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
Net loss |
$ |
(94,742,892 |
) |
$ |
(57,620,877 |
) |
||
Adjustments to reconcile net loss to net cash used in | ||||||||
operating activities: | ||||||||
Depreciation of fixed assets |
|
133,049 |
|
|
79,201 |
|
||
Amortization of intangible assets |
|
88,948 |
|
|
46,023 |
|
||
Write off of patent and trademark cost |
|
78,864 |
|
|
- |
|
||
Non-cash operating lease expense |
|
443,734 |
|
|
- |
|
||
Provision for doubtful accounts |
|
167,500 |
|
|
38,024 |
|
||
Loss on extinguishment of debt |
|
10,057,632 |
|
|
- |
|
||
Share-based compensation |
|
5,224,212 |
|
|
4,128,440 |
|
||
Amortization of deferred financing fees |
|
316,880 |
|
|
30,155 |
|
||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable |
|
(7,486,691 |
) |
|
(1,335,209 |
) |
||
Inventory |
|
(4,226,770 |
) |
|
(395,219 |
) |
||
Other current assets |
|
1,710,697 |
|
|
2,539,394 |
|
||
Accounts payable |
|
(3,244,603 |
) |
|
7,329,560 |
|
||
Accrued expenses and other liabilities |
|
2,801,717 |
|
|
561,615 |
|
||
Net cash used in operating activities |
|
(88,677,723 |
) |
|
(44,598,893 |
) |
||
CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
Patent costs |
|
(763,247 |
) |
|
(434,677 |
) |
||
Purchase of fixed assets |
|
(1,092,504 |
) |
|
(45,720 |
) |
||
Payment of security deposit |
|
(20,420 |
) |
|
(11,486 |
) |
||
Net cash used in investing activities |
|
(1,876,171 |
) |
|
(491,883 |
) |
||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
Proceeds from exercise of options and warrants |
|
100,107 |
|
|
1,128,996 |
|
||
Repayment of the Credit Agreement |
|
(81,660,719 |
) |
|
- |
|
||
Proceeds from the Financing Agreement |
|
200,000,000 |
|
|
75,000,000 |
|
||
Payment of deferred financing fees |
|
(6,652,270 |
) |
|
(3,786,918 |
) |
||
Net cash provided by financing activities |
|
111,787,118 |
|
|
72,342,078 |
|
||
Increase in cash |
|
21,233,224 |
|
|
27,251,302 |
|
||
Cash, beginning of period |
|
161,613,077 |
|
|
127,135,628 |
|
||
Cash, end of period |
$ |
182,846,301 |
|
$ |
154,386,930 |
|
||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||||||||
Cash paid for interest |
$ |
6,989,570 |
|
$ |
- |
|
||
Cash paid for income taxes |
$ |
- |
|
$ |
- |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20190806005910/en/
Source:
Investor Contact
Nichol Ochsner
Vice President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com