BIJUVA™ Commercial Launch in April 2019
Completed $300 Million Non-Dilutive Term Loan
Financing Facility in April 2019
IMVEXXY® Continues Strong Positive Trends for
Prescriptions and Patient Refills
Conference Call Scheduled for 4:30 p.m. ET
Today
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading
women’s healthcare company, today announced its commercial and
corporate update for the first quarter ended March 31, 2019.
“We are pleased with our recent progress on achieving several
business objectives, which include the on-time launch of BIJUVA,
the expansion of our sales force to 200 sales representatives who
are now selling BIJUVA and IMVEXXY, the continued strong
prescriptions and refills for IMVEXXY, and the significant
strengthening of the company’s financial position with the
completion of our $300 million non-dilutive term loan facility,
which also increases our flexibility to support the launches of
BIJUVA and ANNOVERA,” said Robert G. Finizio, Chief Executive
Officer of TherapeuticsMD.
IMVEXXY Continues Strong Prescriptions and Refills
IMVEXXY prescription growth continues as highlighted by a record
month in April 2019 with approximately 31,200 prescriptions
dispensed and paid for by patients. Approximately 75,000
prescriptions of IMVEXXY were dispensed and paid for by patients
during the first quarter of 2019. This is an increase of
approximately 58% in prescription volume for the first quarter of
2019 as compared to the fourth quarter of 2018. Strong refill rates
continue to indicate that women are having a positive experience
with IMVEXXY.
Through April 30, 2019, the company achieved unrestricted
coverage for IMVEXXY with seven of the top ten commercial payers of
VVA products. One of these plans, United Healthcare, began
adjudication on March 1, 2019. The company also achieved
unrestricted Medicare Part D coverage on United Healthcare and
Kaiser.
Summary of First Quarter 2019 Financial Results
Net revenues for the first quarter of 2019 were approximately
$3.9 million, compared with net revenues of approximately $3.8
million for the prior year’s quarter. Net revenues for IMVEXXY for
the first quarter of 2019 were approximately $2.0 million and were
greatly affected by the company’s patient savings program
introduced to launch IMVEXXY, which allows eligible patients to
access the product at a reasonable cost of no more than $35 per
prescription regardless of insurance coverage. The company expects
revenues related to IMVEXXY to improve as commercial payer coverage
for IMVEXXY increases and insurance plans complete the process
needed to adjudicate IMVEXXY prescriptions at pharmacies.
Net revenues from the company’s prescription prenatal vitamin
business were approximately $1.9 million for the first quarter of
2019, compared with approximately $3.8 million for the first
quarter of 2018. A portion of the lower revenue was created by a
price increase in the first quarter of 2019, causing some customers
to increase purchases of the company’s prescription prenatal
vitamins in the fourth quarter of 2018.
R&D expenses for the first quarter of 2019 were
approximately $6.3 million, compared with approximately $7.0
million for the prior year’s quarter. The decrease in first quarter
2019 R&D expenses was primarily a result of the completion of
the REPLENISH trial for BIJUVA and the FDA approval of IMVEXXY and
BIJUVA, partially offset by scale-up and manufacturing activities
for BIJUVA before FDA approval, as well as increased pre-clinical
work to support our product pipeline.
Sales, general and administrative (SG&A) expenses for the
first quarter of 2019 increased to approximately $34.9 million,
compared with approximately $20.8 million for the prior year’s
quarter. The increase in first quarter 2019 sales and marketing
expenses was primarily a result of increased expenses associated
with sales and marketing efforts to support the launch and
commercialization of IMVEXXY and BIJUVA, including costs related to
sales force expansion, outsourced sales personnel and their related
expenses, physician education and product samples, and other
expenses related to product commercialization. The company expects
sales and marketing expenses to continue to increase as it
continues the launch of BIJUVA, prepares for the launch of ANNOVERA
and continues to support its growing business and commercialization
of its products.
Net loss for the first quarter of 2019 was approximately $39.5
million, or $0.16 per basic and diluted share, compared with
approximately $24.4 million, or $0.11 per basic and diluted share,
for the first quarter of 2018.
Balance Sheet
As of March 31, 2019, the company’s cash on hand totaled
approximately $122.9 million, compared with approximately $161.6
million at December 31, 2018. Total outstanding debt, net of
issuance costs, was approximately $73.5 million as of March 31,
2019.
In April 2019, the company entered into a financing agreement
for a $300 million non-dilutive term loan facility with TPG Sixth
Street Partners (TSSP). The initial tranche of $200 million was
drawn on April 24, 2019, with additional tranches of $50 million
available to the company upon the designation of ANNOVERA as a new
category of contraception by the U.S. Food and Drug Administration
on or prior to December 31, 2019 and another $50 million available
to the company upon achieving $11 million in net revenues from
IMVEXXY, ANNOVERA and BIJUVA for the fourth quarter of 2019. A
portion of the proceeds from the initial tranche of the TSSP
facility was used to repay all amounts outstanding under the
company’s prior credit facility.
Conference Call and Webcast Details
TherapeuticsMD will host a conference call and audio webcast
today at 4:30 p.m. ET to discuss these financial results and
provide a business update.
Date: Monday, May 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: 5799911
A live webcast and audio archive for the event may be accessed
on the home page or from the “Investors & Media” section of the
TherapeuticsMD website at www.therapeuticsmd.com. Please connect to
the website prior to the start of the presentation to ensure
adequate time for any software downloads that may be necessary to
listen to the webcast. A replay of the webcast will be archived on
the website for at least 30 days. In addition, a digital recording
of the conference call will be available for replay beginning two
hours after the call's completion and for at least 30 days, with
the dial-in 855-859-2056 or international 404-537-3406 and
Conference ID: 5799911.
Please see the Full Prescribing Information, including
indication and Boxed WARNING, for each TherapeuticsMD product as
follows:
- 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 TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative, leading healthcare
company, focused on developing and commercializing novel products
exclusively for women. Our products are designed to address the
unique changes and challenges women experience through the various
stages of their lives with a therapeutic focus in family planning,
reproductive health, and menopause management. The company is
committed to advancing the health of women and championing
awareness of their healthcare issues. To learn more about
TherapeuticsMD, please visit www.therapeuticsmd.com or follow us on
Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.
Forward-Looking Statements
This press release by TherapeuticsMD, Inc. may contain
forward-looking statements. Forward-looking statements may include,
but are not limited to, statements relating to TherapeuticsMD’s
objectives, plans and strategies as well as statements, other than
historical facts, that address activities, events or developments
that the company intends, expects, projects, believes or
anticipates will or may occur in the future. These statements are
often characterized by terminology such as “believes,” “hopes,”
“may,” “anticipates,” “should,” “intends,” “plans,” “will,”
“expects,” “estimates,” “projects,” “positioned,” “strategy” and
similar expressions and are based on assumptions and assessments
made in light of management’s experience and perception of
historical trends, current conditions, expected future developments
and other factors believed to be appropriate. Forward-looking
statements in this press release are made as of the date of this
press release, and the company undertakes no duty to update or
revise any such statements, whether as a result of new information,
future events or otherwise. Forward-looking statements are not
guarantees of future performance and are subject to risks and
uncertainties, many of which are outside of the company’s control.
Important factors that could cause actual results, developments and
business decisions to differ materially from forward-looking
statements are described in the sections titled “Risk Factors” in
the company’s filings with the Securities and Exchange
Commission, including its most recent Annual Report on Form 10-K
and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K,
and include the following: the company’s ability to maintain or
increase sales of its products; the company’s ability to develop
and commercialize IMVEXXY®, ANNOVERA™, BIJUVA™ and its hormone
therapy drug candidates and obtain additional financing necessary
therefor; whether the company will be able to comply with the
covenants and conditions under its term loan facility; the
potential of adverse side effects or other safety risks that could
adversely affect the commercialization of the company’s current or
future approved products or preclude the approval of the company’s
future drug candidates; the length, cost and uncertain results of
future clinical trials; the company’s reliance on third parties to
conduct its manufacturing, research and development and clinical
trials; the availability of reimbursement from government
authorities and health insurance companies for the company’s
products; the impact of product liability lawsuits; the influence
of extensive and costly government regulation; the volatility of
the trading price of the company’s common stock and the
concentration of power in its stock ownership. PDF copies of the
company’s historical press releases and financial tables can be
viewed and downloaded at its
website: www.therapeuticsmd.com/pressreleases.aspx.
THERAPEUTICSMD, INC. AND SUBSIDIARIES CONSOLIDATED
BALANCE SHEETS March 31, 2019 December 31,
2018 (Unaudited) ASSETS Current Assets: Cash $122,883,852 $
161,613,077 Accounts receivable, net of allowance for doubtful
accounts of $678,886 and $596,602, respectively 14,944,750
11,063,821 Inventory 4,955,715 3,267,670 Other current assets
9,846,899 10,834,693 Total current assets 152,631,216 186,779,261
Fixed assets, net 668,607 472,683 Other Assets:
License rights 20,000,000 20,000,000 Intangible assets, net
4,455,730 4,092,679 Other assets 3,821,566 324,855 Security deposit
314,446 314,446 Total other assets 28,591,742 24,731,980 Total
assets $ 181,891,565 $ 211,983,924 LIABILITIES AND
STOCKHOLDERS' EQUITY Current Liabilities: Accounts payable $
25,365,243 $ 22,743,841 Other current liabilities 19,607,439
18,334,948 Total current liabilities 44,972,682 41,078,789
Long-Term Liabilities: Long-term debt 73,501,160 73,381,014
Operating lease liability
2,724,501 - Total liabilities 121,198,343 114,459,803
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 619,234,655 616,559,938 Accumulated deficit
(558,782,655) (519,276,280) Total stockholders' equity 60,693,222
97,524,121 Total liabilities and stockholders' equity $ 181,891,565
$ 211,983,924
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
Three Months Ended
March 31, 2019 March 31, 2018 Revenues, net $
3,946,651 $ 3,773,392 Cost of goods sold 762,827
633,623 Gross profit 3,183,824
3,139,769 Operating expenses: Sales,
general, and administrative 34,864,082 20,757,237 Research and
development 6,317,882 7,039,297 Depreciation and amortization
106,938 59,621 Total operating expenses
41,288,902 27,856,155 Operating loss
(38,105,078 ) (24,716,386 ) Other (expense)
income Miscellaneous income 688,721 314,557 Interest expense
(2,090,018 ) - Total (expense) income
(1,401,297 ) 314,557 Loss before income taxes
(39,506,375 ) (24,401,829 ) Provision for income taxes
- - Net loss $ (39,506,375 ) $
(24,401,829 ) Loss per share, basic and diluted: Net
loss per share, basic and diluted $ (0.16 ) $ (0.11 )
Weighted average number of common shares outstanding, basic and
diluted 241,006,032 216,525,316
THERAPEUTICSMD, INC. AND SUBSIDIARIES CONSOLIDATED
STATEMENTS OF CASH FLOWS (Unaudited) Three
Months Ended March 31, 2019 March 31, 2018
CASH
FLOWS FROM OPERATING ACTIVITIES Net loss $ (39,506,375) $
(24,401,829) Adjustments to reconcile net loss to net cash used in
operating activities: Depreciation of fixed assets 66,494 38,424
Amortization of intangible assets 40,444 21,197 Non-cash operating
lease expense 219,765 - Provision for doubtful accounts 82,284
22,955 Share-based compensation 2,586,948 1,751,358 Amortization of
deferred financing costs 120,146 - Changes in operating assets and
liabilities: Accounts receivable (3,963,214) (790,885) Inventory
(1,688,045) (135,514) Other current assets 987,794 1,506,152
Accounts payable 2,621,402 2,186,224 Accrued expenses and other
liabilities 268,939 152,223 Net cash used in
operating activities (38,163,418) (19,649,695)
CASH FLOWS
FROM INVESTING ACTIVITIES Patent costs (403,496) (142,136)
Purchase of fixed assets (262,418) (26,908) Payment of security
deposit - (11,486) Net cash used in investing activities
(665,914) (180,530)
CASH FLOWS FROM FINANCING
ACTIVITIES Proceeds from exercise of options 100,107 44,057 Net
cash provided by financing activities 100,107 44,057
Decrease in cash (38,729,225) (19,786,168) Cash, beginning of
period 161,613,077 127,135,628 Cash, end of period $ 122,883,852 $
107,349,460
Supplemental disclosure of cash flow
information Interest paid 1,913,956 -
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190506005690/en/
Investor ContactNichol
OchsnerVice President, Investor Relations561-961-1900, ext.
2088Nochsner@TherapeuticsMD.com
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