- 2Q20 total net product revenue of $10.7
million resilient despite COVID-19 pandemic -
- ANNOVERA® prescriptions increased
approximately 100% for the eight weeks ended July 24, 2020 over the
previous eight week period-
- IMVEXXY® new prescriptions increased 33% for
the eight weeks ended July 24, 2020 over the previous eight week
period-
- Consumer campaign for ANNOVERA achieved over
3 million unique views in first 30 days -
- Initial consumer marketing campaign for
IMVEXXY to be launched in August -
- Amended Sixth Street Partners revenue
covenants to reflect impact of COVID-19 pandemic -
- Conference call scheduled for 8:30 a.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, 2020.
“Our organization made significant progress in the second
quarter while navigating the COVID-19 pandemic and its impact on
our business,” said Robert G. Finizio, Chief Executive Officer of
TherapeuticsMD. “We delivered a strong quarter of operational
execution during very unique circumstances, quickly reducing our
operating expenses, reorienting our sales force, and addressing our
credit facility future minimum net revenue covenants. These
strategic and operational changes and our reshaped Board of
Directors and management team are focused on driving revenue and
achieving our goal of reaching EBITDA break even in 2021, which we
believe will result in long-term shareholder value.”
Recent Updates
- Prescription volume for ANNOVERA (segesterone acetate and
ethinyl estradiol vaginal system) for the eight weeks ended July
24, 2020 increased approximately 100% over the previous eight weeks
(the time period most heavily impacted by COVID-19). ANNOVERA
current prescription trend exceeds the product’s pre-COVID-19
launch trajectory.
- The Company initiated the direct-to-consumer marketing campaign
for ANNOVERA on July 1, 2020. Digital metrics show that the
“Unapologetically ANNOVERA” campaign has quickly gained visibility
resulting in over 100 million impressions and 3 million unique
views since launch.
- The Company is working with the Department of Defense, public
health organizations, and telehealth platforms to expand access to
women and contribute to the Company’s growth in the second half of
the year.
- As of July 1, 2020, ANNOVERA achieved 79% commercial coverage
and 46% Medicaid coverage. The vast majority of patients are
covered without a copay.
- IMVEXXY (estradiol vaginal inserts) new prescriptions for the
eight weeks ended July 24, 2020 increased 33% over the previous
eight weeks ended May 29, 2020 (the time period most heavily
impacted by COVID-19). IMVEXXY continues to experience strong
refill rates. These trends should positively impact total
prescriptions going forward.
- The Company plans to launch the consumer marketing campaign for
IMVEXXY during August 2020.
- IMVEXXY’s commercial market access is 72% unrestricted
commercial coverage, including all of the top ten commercial payors
of VVA products. The Company added Wellcare as a Medicare Part D
payor.
- As of July 1, 2020, BIJUVA® (estradiol and progesterone)
capsules commercial market access increased to 73% unrestricted
commercial coverage with nine of the top ten commercial
payors.
Sixth Street Update
- The Company worked with Sixth Street Partners (“Sixth Street”)
to adjust the total minimum net revenue covenant in its financing
agreement to reflect the impact of COVID-19. The covenants begin
with the results for the fourth quarter of 2020.
- The total minimum net revenue requirement for ANNOVERA,
IMVEXXY, and BIJUVA was adjusted to $20 million for the fourth
quarter of 2020. In 2021, the minimum net revenue covenant will be
$25 million, $37.5 million, $47.5 million, and $57.5 million for
the first, second, third, and fourth quarters, respectively. Given
the Company’s current rate of growth, the Company believes it is
well positioned to meet or exceed these minimum covenants.
- The Company and Sixth Street are not moving forward with the
undrawn $50 million tranche under the financing agreement, which
was designed to be drawn following the successful full commercial
launch of ANNOVERA in the second quarter, due to the pause in the
launch timing caused by the COVID-19 pandemic. There continues to
be an active dialogue with Sixth Street regarding potential
additional financing.
Second Quarter Highlights
- Net product revenue for the second quarter of 2020 was $10.7
million.
- The COVID-19 pandemic had a significant impact on the Company’s
product revenue early in the second quarter of 2020. The Company’s
products returned to growth mid to late quarter. Notwithstanding
COVID-19, the Company expects continued growth in the second half
of 2020.
- In the second quarter 2020, ANNOVERA net revenue was $1.8
million. Approximately 2,400 ANNOVERA prescriptions were dispensed.
Net revenue per unit, calculated from sales to wholesalers and
pharmacies, was $1,332.
- In the second quarter 2020, IMVEXXY net revenue was $5.1
million. Approximately 118,000 IMVEXXY prescriptions were
dispensed. Net revenue per unit was $41. Strong IMVEXXY refill
rates continued with patients adhering to therapy.
- In the second quarter 2020, BIJUVA net revenue was $1.4
million. Approximately 27,600 BIJUVA prescriptions were dispensed.
Net revenue per unit was $45 for the second quarter of 2020.
Net Product Revenue
Three Months Ended June 30,
2020
Three Months Ended June 30,
2019
Three Months Ended March 31,
2020
ANNOVERA
$
1,835,460
$
—
$
2,272,761
IMVEXXY
5,085,190
3,121,711
6,392,601
BIJUVA
1,352,001
134,282
1,111,604
Prenatal vitamins
2,428,382
2,822,872
2,473,691
Net revenue
$
10,701,033
$
6,078,865
$
12,250,657
Net product revenue for the second quarter of 2020 was affected
by the COVID-19 pandemic across all of our products.
Cost of Goods Sold/Gross Margin
Cost of goods sold increased $1.7 million for the second quarter
of 2020 compared to the first quarter of 2020, as the result of a
non-cash write-off of $1.9 million primarily related to BIJUVA
inventory obsolescence, partially offset by the impact of an
overall decline in unit sales. The charge is the result of the
Company’s reprioritization of selling resources to ANNOVERA and
IMVEXXY along with the impact of the COVID-19 pandemic on sales
forecasts of BIJUVA for future quarters. This charge caused gross
margin percentage to decline from 78% for the quarter ended March
31, 2020 to 59% for the quarter ended June 30, 2020.
Expense, EPS and Related Information
Total operating expenses decreased by $9.2 million to $51.3
million for the second quarter of 2020 as compared to $60.5 million
for the first quarter of 2020. The decrease in operating expenses
was primarily a result of the Company’s cost containment and
spend-rebalancing efforts to reduce overall spend in the remaining
quarters of the 2020 fiscal year. For the remainder of 2020, spend
will focus on delivering the necessary resources to support the
launch of ANNOVERA, continued ramp-up of IMVEXXY, and ongoing brand
management of BIJUVA. The second quarter of 2020 was impacted by
$3.9 million in charges related to product samples expense as a
result of the Company’s decision to reduce sampling of BIJUVA.
Net loss for the quarter ended June 30, 2020 decreased to $52.0
million, or $0.19 per basic and diluted share, compared with $56.8
million, or $0.21 per basic and diluted share, for the quarter
ended March 31, 2020. Net loss per share for the second quarter of
2020 was impacted by inventory and sample expense charges related
primarily to BIJUVA of $0.02 per basic and diluted share.
Balance Sheet
As of June 30, 2020, the Company’s cash on hand totaled $113.8
million, compared with $170.1 million on March 31, 2020. The
decline in cash was due primarily to the net loss for the quarter
ended June 30, 2020, less certain non-cash items, as well as the
timing of advertising, marketing, and social media campaigns for
ANNOVERA that were incurred at the end of the quarter ended March
31, 2020 and funded early in the quarter ended June 30, 2020. Total
outstanding debt, net of issuance costs, was $243.8 million as of
June 30, 2020, compared to $243.4 million as of March 31, 2020. The
change is due to the amortization of debt discount of $400,000.
Sixth Street Additional Information
- In connection with the adjustment to the Sixth Street total
minimum net revenue covenant and in lieu of a cash amendment fee,
the Company issued to the Sixth Street lenders warrants to purchase
an aggregate of approximately 4.75 million shares of the Company’s
common stock with an exercise price of $1.58 per share and a ten
year term. The warrants are unregistered, do not have registration
rights, and do not have anti-dilution protection, other than for
customary stock splits and similar transactions.
- The total minimum net revenue requirement for ANNOVERA,
IMVEXXY, and BIJUVA in 2022 will be $65 million, $75 million, $85
million, and $95 million for the first, second, third, and fourth
quarters, respectively, and will remain at $95 million for
subsequent quarters.
Conference Call and Webcast Details
TherapeuticsMD will host a conference call and live audio
webcast today at 8:30 a.m. ET to discuss these financial results
and provide a business update.
Date:
Thursday, August 6, 2020
Time:
8:30 a.m. ET
Telephone Access (US):
866-665-9531
Telephone Access
(International):
724-987-6977
Access Code for All Callers:
2963048
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: 2963048.
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
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 effects of the COVID-19 pandemic; the company’s
ability to maintain or increase sales of its products; the
company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®,
and BIJUVA® 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; whether the FDA will approve the efficacy supplement
for the lower dose of BIJUVA; the company’s ability to protect its
intellectual property, including with respect to the Paragraph IV
notice letters the company received regarding IMVEXXY and BIJUVA;
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 ability of the company’s marketing
contractors to market ANNOVERA; 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, 2020
December 31, 2019 (Unaudited) ASSETS Current Assets: Cash
$
113,839,234
$
160,829,713
Accounts receivable, net of allowance for doubtful accounts of
$722,240 and $904,040, respectively
18,290,784
24,395,958
Inventory, net
10,172,312
11,860,716
Other current assets
6,641,587
11,329,793
Total current assets
148,943,917
208,416,180
Fixed assets, net
2,145,926
2,507,775
Other Assets: License rights, net
37,721,695
39,221,308
Intangible assets, net
5,942,873
5,258,211
Right of use assets
10,337,577
10,109,154
Other assets
446,925
473,009
Total other assets
54,449,070
55,061,682
Total assets
$
205,538,913
$
265,985,637
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY Current
Liabilities: Accounts payable
$
17,270,319
$
19,181,212
Other current liabilities
29,213,411
33,823,613
Total current liabilities
46,483,730
53,004,825
Long-Term Liabilities: Long-term debt
243,801,705
194,634,643
Operating lease liability
9,307,361
9,145,049
Other long-term liabilities
35,000
-
Total long-term liabilities
253,144,066
203,779,692
Total liabilities
299,627,796
256,784,517
Commitments and Contingencies Stockholders'
(Deficit) Equity: Preferred stock - par value $0.001; 10,000,000
shares authorized; no shares issued and outstanding - - Common
stock - par value $0.001; 600,000,000 and 350,000,000 shares
authorized; 272,294,380 and 271,177,076 issued and outstanding,
respectively
272,294
271,177
Additional paid-in capital
709,885,568
704,351,222
Accumulated deficit
(804,246,745)
(695,421,279)
Total stockholders' (deficit) equity
(94,088,883)
9,201,120
Total liabilities and stockholders' equity
$
205,538,913
$
265,985,637
THERAPEUTICSMD, INC. AND SUBSIDIARIES CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) Three Months
Ended Three Months Ended Six Months Ended June 30, March 31, June
30,
2020
2019
2020
2020
2019
Product revenue, net
$
10,701,033
$
6,078,865
$
12,250,657
$
22,951,690
$
10,025,516
Cost of goods sold
4,400,485
1,248,860
2,715,051
7,115,536
2,011,687
Gross profit
6,300,548
4,830,005
9,535,606
15,836,154
8,013,829
Operating expenses: Sales, general, and administrative
48,340,628
41,387,451
56,927,021
105,267,649
76,251,533
Research and development
2,742,032
4,964,368
3,268,829
6,010,861
11,282,250
Depreciation and amortization
256,557
115,059
261,994
518,551
221,997
Total operating expenses
51,339,217
46,466,878
60,457,844
111,797,061
87,755,780
Operating loss
(45,038,669)
(41,636,873)
(50,922,238)
(95,960,907)
(79,741,951)
Other (expense) income Loss on extinguishment of debt
-
(10,057,632)
-
-
(10,057,632)
Miscellaneous income
88,858
486,597
335,482
424,340
1,175,318
Interest expense
(7,026,853)
(4,028,609)
(6,262,046)
(13,288,899)
(6,118,627)
Total other expense
(6,937,995)
(13,599,644)
(5,926,564)
(12,864,559)
(15,000,941)
Loss before income taxes
(51,976,664)
(55,236,517)
(56,848,802)
(108,825,466)
(94,742,892)
Provision for income taxes
-
-
-
-
-
Net loss
$
(51,976,664)
$
(55,236,517)
$
(56,848,802)
$
(108,825,466)
$
(94,742,892)
Loss per share, basic and diluted: Net loss per
share, basic and diluted
$
(0.19)
$
(0.23)
$
(0.21)
$
(0.40)
$
(0.39)
Weighted average number of common shares outstanding, basic
and diluted
271,876,238
241,221,840
271,459,522
271,667,879
241,114,532
THERAPEUTICSMD, INC. AND SUBSIDIARIES CONSOLIDATED
STATEMENTS OF CASH FLOWS (Unaudited) Six Months
Ended June 30,
2020
2019
CASH FLOWS FROM OPERATING ACTIVITIES Net loss
$
(108,825,466)
$
(94,742,892)
Adjustments to reconcile net loss to net cash used in operating
activities: Depreciation of fixed assets
387,649
133,049
Amortization of intangible assets
130,902
88,948
Write off of patent and trademark costs
-
78,864
Operating lease impairment
81,309
-
Non-cash operating lease expense
689,089
443,734
(Recovery of) provision for doubtful accounts
(181,800)
167,500
Inventory obsolesence reserve
5,965,139
-
Loss on extinguishment of debt
-
10,057,632
Share-based compensation
5,369,279
5,224,212
Amortization of deferred financing fees
692,442
316,880
Amortization of license fee
1,499,613
-
Changes in operating assets and liabilities: Accounts receivable
6,286,974
(7,486,691)
Inventory
(4,276,735)
(4,226,770)
Other current assets
4,412,827
1,710,697
Accounts payable
(1,910,893)
(3,244,603)
Accrued expenses and other current liabilities
(5,420,628)
2,801,717
Net cash used in operating activities
(95,100,299)
(88,677,723)
CASH FLOWS FROM INVESTING ACTIVITIES Patent costs
(815,564)
(763,247)
Purchase of fixed assets
(25,800)
(1,092,504)
Security deposit
35,000
(20,420)
Net cash used in investing activities
(806,364)
(1,876,171)
CASH FLOWS FROM FINANCING ACTIVITIES Proceeds from
exercise of options and warrants
166,184
100,107
Repayment of the Credit Agreement
-
(81,660,719)
Proceeds from the Financing Agreement
50,000,000
200,000,000
Payment of deferred financing fees
(1,250,000)
(6,652,270)
Net cash provided by financing activities
48,916,184
111,787,118
Increase (decrease) in cash
(46,990,479)
21,233,224
Cash, beginning of period
160,829,713
161,613,077
Cash, end of period
$
113,839,234
$
182,846,301
Supplemental disclosure of cash flow information
Interest paid
$
12,032,014
$
6,989,570
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200806005293/en/
Investor Contact Nichol
Ochsner Vice President, Investor Relations 561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
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