- 3Q19 Net Revenue (Product and License) Increased to
- 3Q19 Product Net Revenue Increased 34% to
- The Company Reaffirms 4Q19 Financial Guidance -
- Conference Call Scheduled for
“We are very pleased with our results for the quarter, which are in-line with our financial guidance, and reaffirm our fourth quarter 2019 financial guidance,” said
Third Quarter and Recent Developments
-
IMVEXXY® (estradiol vaginal inserts) third quarter 2019 product net revenue increased by 53% to approximately
$4.8 million and prescriptions dispensed and paid for by patients increased 26% to approximately 134,000 as compared to the second quarter of 2019. Strong refill rates continued with patients adhering to therapy at an average rate of four fills per year throughSeptember 2019 . -
IMVEXXY has market access for the majority of lives under commercial plans with approximately 68% unrestricted commercial access. IMVEXXY is now covered by eight of the ten top commercial payers of vulvar and vaginal atrophy (VVA) products. A ninth top-ten commercial payer will adjudicate beginning in
January 2020 . Two of the top sixMedicare Part D payers of VVA products cover IMVEXXY and additionalMedicare coverage decisions are expected by the end of 2019. -
BIJUVA® (estradiol and progesterone) capsules third quarter 2019 product net revenue and prescriptions increased two-fold to approximately
$0.5 million and approximately 15,800 prescriptions dispensed and paid for by patients during the third quarter as compared to the second quarter of 2019. - BIJUVA currently has approximately 55% unrestricted commercial access and is covered by six of the top ten commercial payers.
-
ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) generated third quarter product net revenue of approximately
$0.4 million . The company is in the “test and learn” market introduction phase of launch for ANNOVERA, the first and only long-lasting, patient-controlled, procedure-free, reversible prescription contraceptive option for women. - ANNOVERA has already achieved approximately 62% unrestricted commercial access and is covered by six of the top ten commercial payers by commercial payer lives.
-
On
October 29, 2019 , the company received net proceeds of approximately$77.0 million from an underwritten public offering of its common stock to support commercialization efforts for its threeFDA -approved products and to maximize ANNOVERA’s consumer-focused commercialization strategy.
Summary of Third Quarter 2019 Financial Results
Total net revenue increased to approximately
Product net revenue increased to approximately
The following table provides information about disaggregated revenue by product mix for the three months ended
|
Three Months
|
||
|
2019 |
|
2018 |
Prenatal vitamins |
$2,550,330 |
|
$3,261,459 |
IMVEXXY |
4,772,354 |
|
212,076 |
BIJUVA |
490,705 |
|
- |
ANNOVERA |
399,952 |
|
- |
License revenue |
15,506,400 |
|
- |
Net revenue |
$23,719,741 |
|
$3,473,535 |
Net revenue for IMVEXXY and BIJUVA has been greatly affected by the company’s co-pay assistance programs introduced to provide products at a reasonable cost regardless of insurance coverage. We expect our product revenues to improve as commercial and
Research and development (R&D) expenses for the third quarter of 2019 decreased to approximately
Sales, general and administrative (SG&A) expenses increased for the third quarter of 2019 to approximately
For the third quarter of 2019, net loss decreased to approximately
Balance Sheet
As of
Total outstanding debt, net of issuance costs, was approximately
Financial Guidance
The company reaffirms its previously announced fourth quarter 2019 financial guidance outlined below:
-
FDA -approved product net revenue is expected to be in a range of$11 million to $13 million ; -
Prescription prenatal vitamin net revenue is expected to be in a range of
$1.75 million to $2.25 million ; and -
Total product net revenue is expected to be in a range of
$12.75 million to $15.25 million .
Conference Call and Webcast Details
Date: |
Wednesday, November 6, 2019 |
Time: |
4:30 p.m. ET |
Telephone Access (US): |
866-665-9531 |
Telephone Access (International): |
724-987-6977 |
Access Code for All Callers: |
7045719 |
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 | ||||
September 30, 2019 | December 31, 2018 | |||
(Unaudited) | ||||
ASSETS | ||||
Current Assets: | ||||
Cash |
$ 155,330,050 |
$ 161,613,077 |
||
Accounts receivable, net of allowance for doubtful accounts | ||||
of $691,699 and $596,602, respectively |
15,323,614 |
11,063,821 |
||
Inventory |
10,532,844 |
3,267,670 |
||
Other current assets |
10,578,260 |
10,834,693 |
||
Total current assets |
191,764,768 |
186,779,261 |
||
Fixed assets, net |
2,338,346 |
472,683 |
||
Other Assets: | ||||
License rights, net |
39,984,002 |
20,000,000 |
||
Intangible assets, net |
4,942,151 |
4,092,679 |
||
Right-of-use asset |
10,459,635 |
|
||
Other assets |
473,009 |
639,301 |
||
Total other assets |
55,858,797 |
24,731,980 |
||
Total assets |
$ 249,961,911 |
$ 211,983,924 |
||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
Current Liabilities: | ||||
Accounts payable |
$ 24,133,506 |
$ 22,743,841 |
||
Other current liabilities |
43,196,032 |
18,334,948 |
||
Total current liabilities |
67,329,538 |
41,078,789 |
||
Long-Term Liabilities: | ||||
Long-term debt |
194,361,169 |
73,381,014 |
||
Operating lease liability |
9,500,133 |
- |
||
Total liabilities |
271,190,840 |
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: | ||||
241,277,076 and 240,462,439 issued and outstanding, respectively |
241,277 |
240,463 |
||
Additional paid-in capital |
624,515,559 |
616,559,938 |
||
Accumulated deficit |
(645,985,765) |
(519,276,280) |
||
Total stockholders' (deficit) equity |
(21,228,929) |
97,524,121 |
||
Total liabilities and stockholders' equity |
$ 249,961,911 |
$ 211,983,924 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
(Unaudited) | |||||||
Three Months Ended | Nine Months Ended | ||||||
September 30, | September 30, | ||||||
2019 |
|
2018 |
|
2019 |
|
2018 |
|
Product revenue, net |
$ 8,213,341 |
$ 3,473,535 |
$ 18,238,857 |
$ 11,009,937 |
|||
License revenue |
15,506,400 |
- |
15,506,400 |
- |
|||
Total revenue, net |
23,719,741 |
3,473,535 |
33,745,257 |
11,009,937 |
|||
Cost of goods sold |
1,444,308 |
699,118 |
3,455,995 |
1,786,902 |
|||
Gross profit |
22,275,433 |
2,774,417 |
30,289,262 |
9,223,035 |
|||
Operating expenses: | |||||||
Sales, general, and administrative |
45,126,986 |
30,354,072 |
121,378,519 |
80,578,079 |
|||
Research and development |
4,077,738 |
6,708,271 |
15,359,988 |
20,545,948 |
|||
Depreciation and amortization |
141,959 |
73,321 |
363,956 |
198,545 |
|||
Total operating expenses |
49,346,683 |
37,135,664 |
137,102,463 |
101,322,572 |
|||
Operating loss |
(27,071,250) |
(34,361,247) |
(106,813,201) |
(92,099,537) |
|||
Other expense | |||||||
Loss on extinguishment of debt |
- |
- |
(10,057,632) |
- |
|||
Miscellaneous income |
703,662 |
809,022 |
1,878,980 |
1,457,817 |
|||
Interest expense |
(5,599,005) |
(2,053,077) |
(11,717,632) |
(2,584,459) |
|||
Total other expense |
(4,895,343) |
(1,244,055) |
(19,896,284) |
(1,126,642) |
|||
Loss before income taxes |
(31,966,593) |
(35,605,302) |
(126,709,485) |
(93,226,179) |
|||
Provision for income taxes |
- |
- |
- |
- |
|||
Net loss |
$ (31,966,593) |
$ (35,605,302) |
$ (126,709,485) |
$ (93,226,179) |
|||
Loss per share, basic and diluted: | |||||||
Net loss per share, basic and diluted |
$ (0.13) |
$ (0.16) |
$ (0.53) |
$ (0.42) |
|||
Weighted average number of common | |||||||
shares outstanding, basic and diluted |
241,261,299 |
228,107,240 |
241,163,994 |
220,466,673 |
THERAPEUTICSMD, INC. AND SUBSIDIARIES | |||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||
(Unaudited) | |||||||
Nine Months Ended | |||||||
September 30, | |||||||
|
2019 |
|
|
2018 |
|
||
CASH FLOWS FROM OPERATING ACTIVITIES | |||||||
Net loss |
$ |
(126,709,485 |
) |
$ |
(93,226,179 |
) |
|
Adjustments to reconcile net loss to net cash used in | |||||||
operating activities: | |||||||
Depreciation of fixed assets |
|
223,750 |
|
|
121,423 |
|
|
Amortization of intangible assets |
|
140,206 |
|
|
77,123 |
|
|
Write off of patent and trademark cost |
|
78,864 |
|
|
- |
|
|
Non-cash operating lease expense |
|
711,836 |
|
|
- |
|
|
Provision for doubtful accounts |
|
95,097 |
|
|
231,475 |
|
|
Loss on extinguishment of debt |
|
10,057,632 |
|
|
- |
|
|
Share-based compensation |
|
7,859,357 |
|
|
6,388,635 |
|
|
Amortization of intellectual property license fee |
|
15,998 |
|
|
- |
|
|
Amortization of deferred financing fees |
|
582,829 |
|
|
149,909 |
|
|
Changes in operating assets and liabilities: | |||||||
Accounts receivable |
|
(4,354,890 |
) |
|
(8,705,325 |
) |
|
Inventory |
|
(7,265,174 |
) |
|
(892,863 |
) |
|
Other current assets |
|
(1,128,515 |
) |
|
1,233,482 |
|
|
Accounts payable |
|
1,389,665 |
|
|
7,284,493 |
|
|
Accrued expenses and other liabilities |
|
3,402,511 |
|
|
8,670,986 |
|
|
Net cash used in operating activities |
|
(114,900,319 |
) |
|
(78,666,841 |
) |
|
CASH FLOWS FROM INVESTING ACTIVITIES | |||||||
Payment for intellectual property license |
|
- |
|
|
(20,000,000 |
) |
|
Patent costs |
|
(1,068,542 |
) |
|
(748,906 |
) |
|
Purchase of fixed assets |
|
(2,089,413 |
) |
|
(66,295 |
) |
|
Payment of security deposit |
|
(20,420 |
) |
|
(11,485 |
) |
|
Net cash used in investing activities |
|
(3,178,375 |
) |
|
(20,826,686 |
) |
|
CASH FLOWS FROM FINANCING ACTIVITIES | |||||||
Proceeds from Financing Agreement |
|
200,000,000 |
|
|
- |
|
|
Proceeds from exercise of options and warrants |
|
108,656 |
|
|
1,236,313 |
|
|
Proceeds from sale of common stock, net of costs |
|
- |
|
|
89,907,797 |
|
|
Proceeds from Credit Agreement |
|
- |
|
|
75,000,000 |
|
|
Payment of deferred financing fees |
|
(6,652,270 |
) |
|
(3,786,918 |
) |
|
Repayment of Credit Agreement |
|
(81,660,719 |
) |
|
- |
|
|
Net cash provided by financing activities |
|
111,795,667 |
|
|
162,357,192 |
|
|
(Decrease) increase in cash |
|
(6,283,027 |
) |
|
62,863,665 |
|
|
Cash, beginning of period |
|
161,613,077 |
|
|
127,135,628 |
|
|
Cash, end of period |
$ |
155,330,050 |
|
$ |
189,999,293 |
|
|
Supplemental disclosure of cash flow information | |||||||
Interest paid |
$ |
12,446,792 |
|
$ |
1,759,316 |
|
|
Non-cash investing activity | |||||||
Amount accrued for intellectual property license |
$ |
20,000,000 |
|
$ |
- |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20191106005995/en/
Source:
Investor Contact
Nichol Ochsner
Vice President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com