IMVEXXY® Net Revenue $3.1 Million for the
Second Quarter of 2019
Total Net Revenue for the Second Quarter of
2019 Above Guidance at $6.1 Million
Company Raises Full-Year Net Revenue Guidance
to Range of $29.45 Million to $34.20 Million
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 second quarter ended June 30, 2019 and provided a business
update.
“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 Robert G. Finizio, Chief Executive Officer of
TherapeuticsMD. “As we move into the second half of the year, we
plan to conduct pre-launch activities for ANNOVERATM and continue
to expand market access for our menopause portfolio. We expect
IMVEXXY and BIJUVA® to have extensive coverage for
commercially insured lives by the end of the year. We are pursuing
preferred status for IMVEXXY on Medicare Part D plans and expect
coverage decisions by the fourth quarter, which is significant
given the higher proportion of IMVEXXY Medicare Part D
business.”
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 and Medicare 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 through
July 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 on August 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. On
August 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 $6.1 million, compared with net revenues of
approximately $3.8 million for the prior year’s quarter. The
increase was primarily due to sales of approximately $3.1 million
of IMVEXXY and $134,000 of BIJUVA in the second quarter of 2019,
partially offset by a decrease in the company’s prescription
prenatal vitamin business of approximately $940,000 from the
comparable quarter in 2018.
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 $35 per prescription regardless of
insurance coverage. The company expects revenues related to IMVEXXY
and BIJUVA will improve as commercial and Medicare Part D payer
coverage increases, and plans complete the process needed to
adjudicate prescriptions at pharmacies.
Research and development (R&D) expenses for the second
quarter of 2019 decreased to approximately $5.0 million, compared
with approximately $6.8 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 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 pre-clinical work to support the company’s
R&D activities.
Sales, general and administrative (SG&A) expenses increased
for the second quarter of 2019 to approximately $41.4 million,
compared with approximately $29.5 million for the prior year’s
quarter. The increase in second quarter 2019 SG&A expenses was
primarily a result of increased expenses associated with sales and
marketing efforts and personnel costs 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.
During the second quarter of 2019, the company took a one-time
charge for extinguishment of debt of approximately $10.1 million in
connection with the refinancing of its term loan. As a result of
the foregoing, net loss increased to approximately $55.2 million,
or $0.23 per basic and diluted share, for the second quarter of
2019. Excluding the one-time charge for extinguishment of debt, the
net loss for the second quarter was approximately $45.2 million, or
$0.19 per basic and diluted share, compared with approximately
$33.2 million, or $0.15 per basic and diluted share, for the second
quarter of 2018.
Balance Sheet
As of June 30, 2019, the company’s cash on hand totaled
approximately $182.8 million, compared with approximately $161.6
million at December 31, 2018. Total outstanding debt, net of
issuance costs, was approximately $194.1 million as of June 30,
2019.
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
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: Tuesday, August 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: 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
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: 1392883.
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 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 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/
Investor Contact Nichol
Ochsner Vice President, Investor Relations 561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
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