- 1Q20 total net product revenue of
- Significantly reducing operating expenses, while maintaining goal of achieving EBITDA breakeven in 2021 -
- In discussions with
- First Orange Book listed patent for ANNOVERA® issued providing potential extended exclusivity to 2039 -
- Strengthened board of directors with diverse industry veterans -
- Conference call scheduled for
“I would like to thank our team for delivering a successful quarter during a challenging time. We have made significant progress across the business,” said
- The Company continued to evaluate its strategy and commercial infrastructure as the impact of COVID-19 persisted. Our strategy remains the same: to drive revenues by prioritizing ANNOVERA® (segesterone acetate and ethinyl estradiol vaginal system) as the lead product, IMVEXXY® (estradiol vaginal inserts) in the second position and BIJUVA® (estradiol and progesterone) in the third position. The Company’s approach is straightforward, reallocate resources towards those products and initiatives that drive the fastest revenue growth, while reducing overall operating expenses. Total operating expenses excluding non-cash items for the first quarter of 2020 were approximately
$57.5 million . The Company has initiated measures to reduce its operating expenses for the second quarter by approximately$10 million to$12 million and plans to further reduce total operating expenses to approximately$40 million or below for the third and fourth quarters of 2020. The Company’s goal still remains to achieve EBITDA break even in 2021. - Due to the uncertainty created by COIVD-19 and its impact, the Company has been in discussions with
TPG Sixth Street Partners (“Sixth Street”) regarding the revenue covenants in the loan document. The Company is working with Sixth Street to defer the scheduled start of the quarterly revenue covenant for two to three quarters to reflect the impact of COVID-19. Sixth Street has expressed preliminary support and while there is currently no final agreement or obligation, they understand the importance of flexibility for our Company at this time. - Net product revenue for the first quarter of 2020 was
$12.3 million . The Company anticipated that net revenue would be lower in the first quarter of 2020 compared to fourth quarter of 2019 due to the impact of high deductible insurance plans resetting. - The COVID-19 pandemic had an impact on all of the Company’s product revenue with the sales force being out of the field for about four weeks of the quarter. In particular, the full commercial launch of ANNOVERA was paused on
March 1, 2020 as the Company deferred sales and marketing initiatives due to lack of access to healthcare providers and a shift of patients’ focus during the pandemic. - ANNOVERA net revenue of
$2.3 million for the first quarter of 2020. Total prescriptions sold to patients doubled for the first quarter of 2020 over the fourth quarter of 2019. Patient demand was greater than the wholesale orders for the first quarter of 2020, reducing inventory with our distributors. Net revenue per unit, calculated from sales to wholesalers and pharmacies, for the first quarter 2020 was approximately$1,350 . - For the long-term success of ANNOVERA, the Company is focusing on establishing the broad availability of ANNOVERA with retail pharmacies, mail order pharmacies, and online distributors, as well as public health and the military, which allows access where contraception is prescribed.
- Medicaid access is advancing with 37 states now covering ANNOVERA with average copays of
$5 or less. ANNOVERA will be available for Title X entities in early 2020 and expects universities to adopt and prescribe ANNOVERA during the fall 2020 semester. ANNOVERA was added to formulary for theDepartment of Defense and is currently selling at 92 bases.
- Medicaid access is advancing with 37 states now covering ANNOVERA with average copays of
- The United States Patent and Trademark Office (USPTO) recently issued a patent that covers the labeled indication for ANNOVERA that has been listed in the
U.S. Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book). In addition to this patent, which provides patent exclusivity through 2039, ANNOVERA contains segesterone acetate, which qualifies ANNOVERA for FDA regulatory exclusivity throughAugust 2023 under the Hatch-Waxman Act as a “new chemical entity.” Additional utility patent applications for ANNOVERA have been filed, including a design patent that, if issued, would strengthen the product’s exclusivity position. - IMVEXXY® first quarter 2020 net revenue was
$6.4 million . In the first quarter of 2020, approximately 134,000 IMVEXXY prescriptions were dispensed to patients. Average calculated net revenue per unit on these dispensed products was approximately$48 for the first quarter of 2020. IMVEXXY is the fastest growing product in the vulvar and vaginal atrophy (VVA) market with 10.8% market share of total prescriptions inMarch 2020 . Strong IMVEXXY refill rates continued with patients adhering to therapy. Patients on IMEXXY for one year average six fills. - IMVEXXY has market access for the majority of lives under commercial plans with 72% unrestricted commercial coverage, including all of the top ten commercial payors of VVA products. Three of the top eight Medicare Part D payors of VVA products cover IMVEXXY. While COVID-19 has slowed down the payor review process, the Company will continue to seek profitable preferred level access in Medicare Part D to keep patient copay experience consistent across commercial and Part D. IMVEXXY Medicaid access is advancing with 21 states now unrestricted in Medicaid with average copays of
$5 or less. - BIJUVA® capsules first quarter 2020 net revenue was
$1.1 million . In the first quarter of 2020, approximately 26,000 prescriptions were dispensed to patients. Average calculated net revenue per unit on these dispensed products was approximately$43 for the first quarter of 2020. - BIJUVA has market access for the majority of lives under commercial plans with 54% commercial coverage, including seven of the top ten commercial payors of vasomotor symptoms (VMS) products. BIJUVA Medicaid access is advancing with 21 states now unrestricted in Medicaid with average copays of
$5 or less. - On behalf of the Board of Directors of
TherapeuticsMD, Inc. , ChairmanTommy G. Thompson recently strengthened the Board with the appointments ofPaul Bisaro ,Gail Naughton , Ph.D. andKaren Ling . These independent directors bring diversity, significant experience and a unique skillset to contribute to the Company’s next stage of growth. As part of the Board of Directors' continued review of its composition and effectiveness, the Board has reduced its size from eleven directors to nine directors.
First Quarter 2020 Revenue Performance
For the quarter ended
|
|
Three Months Ended |
|
|
Three Months Ended |
|
Three Months Ended |
|
|||
Prenatal vitamins |
|
$ |
2,473,691 |
|
|
$ |
1,935,971 |
|
$ |
2,576,319 |
|
IMVEXXY |
|
|
6,392,601 |
|
|
|
2,010,680 |
|
|
6,347,301 |
|
BIJUVA |
|
|
1,111,604 |
|
|
|
— |
|
|
1,211,456 |
|
ANNOVERA |
|
|
2,272,761 |
|
|
|
— |
|
|
5,766,604 |
|
Net revenue |
|
$ |
12,250,657 |
|
|
$ |
3,946,651 |
|
$ |
15,901,680 |
|
Net Product Revenue
Net product revenue for the quarter was significantly affected by the COVID-19 pandemic for all product sales. Though ANNOVERA was commercially launched in early March of 2020, the Company subsequently paused the launch due to the COVID-19 pandemic. Net product revenue of
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. The Company expects net product revenue to improve as commercial and Medicare payor coverage increases, and the plans complete the process needed to adjudicate IMVEXXY, BIJUVA, and ANNOVERA prescriptions at pharmacies.
Expense, EPS and Related Information
Research and Development (R&D) expenses for the first quarter of 2020 were
SG&A expenses increased to
Human resources costs, including salaries, benefits and taxes, for the three months ended
Net loss for the first quarter of 2020 increased to
Balance Sheet
As of
Total outstanding debt, net of issuance costs, was approximately
Conference Call and Webcast Details
Date: |
|
|||
Time: |
|
|||
Telephone Access (US): |
866-665-9531 |
|||
Telephone Access (International): |
724-987-6977 |
|||
Access Code for All Callers: |
5832796 |
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
Forward-Looking Statements
This press release by
|
||||||
CONSOLIDATED BALANCE SHEETS |
||||||
(Unaudited) |
||||||
ASSETS |
||||||
Current Assets: | ||||||
Cash |
$ |
170,097,813 |
$ |
160,829,713 |
||
Accounts receivable, net of allowance for doubtful accounts of |
|
20,664,009 |
|
24,395,958 |
||
Inventory |
|
14,607,453 |
|
11,860,716 |
||
Other current assets |
|
6,618,367 |
|
11,329,793 |
||
Total current assets |
|
211,987,642 |
|
208,416,180 |
||
Fixed assets, net |
|
2,330,190 |
|
2,507,775 |
||
Other Assets: | ||||||
License rights, net |
|
38,475,797 |
|
39,221,308 |
||
Intangible assets, net |
|
5,616,832 |
|
5,258,211 |
||
Right of use assets |
|
9,757,167 |
|
10,109,154 |
||
Other assets |
|
473,009 |
|
473,009 |
||
Total other assets |
|
54,322,805 |
|
55,061,682 |
||
Total assets |
$ |
268,640,637 |
$ |
265,985,637 |
||
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY |
||||||
Current Liabilities: | ||||||
Accounts payable |
$ |
28,714,327 |
$ |
19,181,212 |
||
Other current liabilities |
|
32,924,485 |
|
33,823,613 |
||
Total current liabilities |
|
61,638,812 |
|
53,004,825 |
||
Long-Term Liabilities: | ||||||
Long-term debt |
|
243,428,671 |
|
194,634,643 |
||
Operating lease liability |
|
8,782,274 |
|
9,145,049 |
||
Total long term liabilities |
|
252,210,945 |
|
203,779,692 |
||
Total liabilities |
|
313,849,757 |
|
256,784,517 |
||
Commitments and Contingencies | ||||||
Stockholders' (Deficit) Equity: | ||||||
Preferred stock - par value |
|
- |
|
- |
||
Common stock - par value |
||||||
271,677,742 and 271,177,076 issued and outstanding, respectively |
|
271,678 |
|
271,177 |
||
Additional paid-in capital |
|
706,789,283 |
|
704,351,222 |
||
Accumulated deficit |
|
(752,270,081) |
|
(695,421,279) |
||
Total stockholders' (deficit) equity |
|
(45,209,120) |
|
9,201,120 |
||
Total liabilities and stockholders' equity |
$ |
268,640,637 |
$ |
265,985,637 |
||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||
(Unaudited) | ||||||||||||
Three Months Ended | Three Months Ended | |||||||||||
2020 |
2019 |
2019 |
||||||||||
Product revenue, net |
$ |
12,250,657 |
|
$ |
3,946,651 |
|
$ |
15,901,680 |
|
|||
Cost of goods sold |
|
2,715,051 |
|
|
762,827 |
|
|
2,878,590 |
|
|||
Gross profit |
|
9,535,606 |
|
|
3,183,824 |
|
|
13,023,090 |
|
|||
Operating expenses: | ||||||||||||
Sales, general, and administrative |
|
56,927,021 |
|
|
34,864,082 |
|
|
52,734,093 |
|
|||
Research and development |
|
3,268,829 |
|
|
6,317,882 |
|
|
4,432,224 |
|
|||
Depreciation and amortization |
|
261,994 |
|
|
106,938 |
|
|
248,830 |
|
|||
Total operating expenses |
|
60,457,844 |
|
|
41,288,902 |
|
|
57,415,147 |
|
|||
Operating loss |
|
(50,922,238 |
) |
|
(38,105,078 |
) |
|
(44,392,057 |
) |
|||
Other income (expense) | ||||||||||||
Miscellaneous income |
|
335,482 |
|
|
688,721 |
|
|
621,126 |
|
|||
Interest expense |
|
(6,262,046 |
) |
|
(2,090,018 |
) |
|
(5,664,583 |
) |
|||
Total other expense |
|
(5,926,564 |
) |
|
(1,401,297 |
) |
|
(5,043,457 |
) |
|||
Loss before income taxes |
|
(56,848,802 |
) |
|
(39,506,375 |
) |
|
(49,435,514 |
) |
|||
Provision for income taxes |
|
- |
|
|
- |
|
|
- |
|
|||
Net loss |
$ |
(56,848,802 |
) |
$ |
(39,506,375 |
) |
$ |
(49,435,514 |
) |
|||
Loss per share, basic and diluted: | ||||||||||||
Net loss per share, basic and diluted |
$ |
(0.21 |
) |
$ |
(0.16 |
) |
$ |
(0.19 |
) |
|||
Weighted average number of common shares outstanding, basic and diluted |
|
271,459,522 |
|
|
241,006,032 |
|
|
261,752,076 |
|
|||
CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
(Unaudited) | ||||||||
Three Months Ended | ||||||||
2020 |
2019 |
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
Net loss |
$ |
(56,848,802 |
) |
$ |
(39,506,375 |
) |
||
Adjustments to reconcile net loss to net cash used in operating activities | ||||||||
Depreciation of fixed assets |
|
198,839 |
|
|
66,494 |
|
||
Amortization of intangible assets |
|
63,155 |
|
|
40,444 |
|
||
Non-cash operating lease expense |
|
351,987 |
|
|
219,765 |
|
||
(Recovery of) provision for doubtful accounts |
|
(122,621 |
) |
|
82,284 |
|
||
Share-based compensation |
|
2,366,453 |
|
|
2,586,948 |
|
||
Amortization of deferred financing fees |
|
319,408 |
|
|
120,146 |
|
||
Amortization of license fee |
|
745,511 |
|
|
- |
|
||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable |
|
3,854,569 |
|
|
(3,963,214 |
) |
||
Inventory |
|
(2,746,737 |
) |
|
(1,688,045 |
) |
||
Other current assets |
|
4,436,047 |
|
|
987,794 |
|
||
Accounts payable |
|
9,533,115 |
|
|
2,621,402 |
|
||
Accrued expenses and other current liabilities |
|
(1,261,904 |
) |
|
268,939 |
|
||
Net cash used in operating activities |
|
(39,110,980 |
) |
|
(38,163,418 |
) |
||
CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
Patent costs |
|
(421,775 |
) |
|
(403,496 |
) |
||
Purchase of fixed assets |
|
(21,254 |
) |
|
(262,418 |
) |
||
Net cash used in investing activities |
|
(443,029 |
) |
|
(665,914 |
) |
||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
Proceeds from exercise of options and warrants |
|
72,109 |
|
|
100,107 |
|
||
Proceeds from Financing Agreement |
|
50,000,000 |
|
|
- |
|
||
Payment of deferred financing fees |
|
(1,250,000 |
) |
|
- |
|
||
Net cash provided by financing activities |
|
48,822,109 |
|
|
100,107 |
|
||
Increase (decrease) in cash |
|
9,268,100 |
|
|
(38,729,225 |
) |
||
Cash, beginning of period |
|
160,829,713 |
|
|
161,613,077 |
|
||
Cash, end of period |
$ |
170,097,813 |
|
$ |
122,883,852 |
|
||
Supplemental disclosure of cash flow information | ||||||||
Interest paid |
$ |
5,892,639 |
|
$ |
1,913,956 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200506005336/en/
Investor Contact
Vice President, Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
Source: