- 3Q19 Net Revenue (Product and License)
Increased to $23.7 Million -
- 3Q19 Product Net Revenue Increased 34% to
$8.2 Million Compared to 2Q19-
- The Company Reaffirms 4Q19 Financial Guidance
-
- Conference Call Scheduled for 4:30 p.m. ET
Today -
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading
women’s healthcare company, today reported financial results for
the third quarter ended September 30, 2019 and provided a business
update.
“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 Robert G. Finizio, Chief
Executive Officer of TherapeuticsMD. “This reiterates our
confidence that we will be able to access an additional $50 million
in capital from our term loan facility when fourth quarter 2019
results are announced. Additionally, we recently completed an
equity raise that netted the company approximately $77 million and
improved our liquidity. We believe we now have the resources and
momentum to continue to fully execute our plans into 2020 and
beyond.”
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 through September 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 six Medicare Part D payers of VVA products cover
IMVEXXY and additional Medicare 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 three
FDA-approved products and to maximize ANNOVERA’s consumer-focused
commercialization strategy.
Summary of Third Quarter 2019 Financial Results
Total net revenue increased to approximately $23.7 million, for
the third quarter of 2019 compared with net revenue of
approximately $3.5 million for the prior year’s quarter. During the
third quarter of 2019, the company recognized license revenue of
approximately $15.5 million from the upfront fee, a non-refundable
payment, under the company’s license agreement with Theramex, which
is included in total revenue for the quarter.
Product net revenue increased to approximately $8.2 million, for
the three months ended September 30, 2019 compared with
approximately $3.5 million for the three months ended September 30,
2018. Product net revenue increased primarily due to increases in
sales of approximately $4.5 million of IMVEXXY in the current
period, partially offset by a decrease in prenatal vitamin sales of
approximately $0.7 million. Product net revenue for the three
months ended September 2019 also included sales of BIJUVA of
approximately $0.5 million and sales of ANNOVERA of approximately
$0.4 million. The revenue decrease related to our prenatal vitamins
was primarily affected by a lower number of units sold as compared
to the prior year period, partially offset by increased revenue per
unit. The company launched IMVEXXY in the third quarter of 2018,
BIJUVA in the second quarter of 2019, and ANNOVERA in the third
quarter of 2019.
The following table provides information about disaggregated
revenue by product mix for the three months ended September 30,
2019 and 2018:
Three Months Ended September
30,
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 Medicare
payer coverage increases, and plans complete the process needed to
adjudicate IMVEXXY, BIJUVA and ANNOVERA prescriptions at
pharmacies.
Research and development (R&D) expenses for the third
quarter of 2019 decreased to approximately $4.1 million, compared
with approximately $6.7 million for the prior year’s quarter.
R&D costs decreased primarily as a result of transferring
certain costs and activities from R&D expenses to operations as
they begin to support commercial and launch efforts after the FDA
approval of IMVEXXY and BIJUVA. R&D expenses include costs
related to manufacturing validation as well as early development
trials and employment costs of personnel involved in R&D
activities.
Sales, general and administrative (SG&A) expenses increased
for the third quarter of 2019 to approximately $45.1 million,
compared with approximately $30.4 million for the prior year’s
quarter. The increase of SG&A expenses for third quarter 2019
was primarily a result of increased expenses associated with sales
and marketing efforts and personnel costs to support the launch and
commercialization of IMVEXXY, BIJUVA, and ANNOVERA including
outsourced sales personnel and their related expenses, physician
education, advertising, and travel expenses related to product
commercialization. The company expects sales and marketing expenses
to continue to increase as it continues the launch of BIJUVA and
ANNOVERA and continues to support its growing business and
commercialization of its products.
For the third quarter of 2019, net loss decreased to
approximately $32.0 million, or $0.13 per basic and diluted share,
compared with approximately $35.6 million, or $0.16 per basic and
diluted share, for the third quarter of 2018.
Balance Sheet
As of September 30, 2019, the company’s cash on hand totaled
approximately $155.3 million, compared with approximately $161.6
million at December 31, 2018. On October 29, 2019, the company
received net proceeds of approximately $77.0 million from an
underwritten public offering of its common stock.
Total outstanding debt, net of issuance costs, was approximately
$194.4 million as of September 30, 2019.
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
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:
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
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: 7045719.
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, including the conditions
to draw additional tranches thereunder; 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 ability of the company’s licensees to commercialize and
distribute the company’s products; 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 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/
Investor Contact Nichol
Ochsner Vice President, Investor Relations 561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
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