- Strong preliminary first quarter 2020 total
net revenue projected to be more than $11 million –
- vitaCare Prescription Services model allowing
the Company to connect with more than 80% of patients -
- Implementing staged contingency plan that can
be adjusted as COVID-19 situation evolves -
TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TherapeuticsMD” or the
“Company”), an innovative, leading women’s healthcare company,
today provided an update on its operations in response to the
continued spread of COVID-19 (coronavirus) pandemic. The Company
has developed a comprehensive COVID-19 contingency plan designed to
preserve the value of the Company’s investments in its sales and
marketing infrastructure, protect the Company’s balance sheet
during this period of market disruption, and meet the needs of the
Company’s patients and prescribers.
TherapeuticsMD’s COVID-19 contingency plan is designed to be
implemented in stages over the second and third quarters of 2020 as
the Company continues to evaluate the length of time that COVID-19
may impact its business, allowing the Company to conserve its
financial resources during the COVID-19 crisis and re-scale its
sales and marketing activity when conditions warrant.
“The health and safety of our employees, patients, prescribers,
and community are paramount at this time,” said Robert G. Finizio,
Chief Executive Officer of TherapeuticsMD. “We have taken a swift
and proactive approach to reduce our near-term cash burn and
provide for maximum flexibility to reinitiate our launch plans once
we have more visibility on the length of the COVID-19 crisis,” said
Mr. Finizio. “While we believe we were on track with executing our
plan for 2020, including being able to deliver a
better-than-planned first quarter, given the uncertainties around
COVID-19, we feel it is in the best interests of our Company and
our stockholders to temporarily scale down certain aspects of our
business to preserve cash during this pandemic. We plan to leverage
our best-in-class vitaCare Prescription Services patient model to
continue to meet the needs of our patients and prescribers during
this difficult time. Our highly-trained sales force remains engaged
with prescribers so that we can ramp-up our sales efforts at the
appropriate time.”
TherapeuticsMD’s COVID-19 contingency plan focuses on five key
areas:
- Containing costs and cutting spending.
- Addressing impacts and trends for the second quarter of
2020.
- Preparing for a potential longer-term impact throughout the
year.
- Leveraging vitaCare Prescription Services to continue to meet
the needs of our patients and prescribers.
- Ensuring continued availability of our products to
patients.
Cost Containment and Spending Cuts
TherapeuticsMD is implementing measures to initially cut or
defer more than $30 million in annual spending. This includes the
deferral of approximately $10 million in planned second quarter
consumer and healthcare practitioner marketing spend for ANNOVERA®
and IMVEXXY® and cuts of approximately $20 million in other planned
expenses for the year.
The Company has the ability to re-accelerate its planned
marketing spend for ANNOVERA and IMVEXXY should market conditions
improve, or to extend or expand the cost deferrals throughout the
year.
The Company’s cost cuts and reductions include permanent cost
savings that have been identified by management, as well as the
interim cessation of certain spending that may be restarted in
future quarters. These cost cuts include:
- Negotiating lower fees or suspending services from third party
vendors;
- Implementing a Company-wide hiring freeze;
- Delaying or cancelling non-critical IT projects; and
- Eliminating travel, entertainment, meeting, and event
expenses.
These savings can be extended further throughout the year or
expanded depending on the impact of the COVID-19 outbreak.
Employees and Sales Force
At present, the Company’s sales force continues to function
utilizing digital engagement tools and tactics and virtual
detailing to remain engaged with prescribers and distribution
channels.
- The Company has enhanced the ability of its sales force to
support healthcare providers remotely, including the sales forces’
ability to continue to provide healthcare practitioners with access
to patient product samples, product marketing information, and
information regarding patient affordability programs and support
services.
- The Company’s sales force is in regular interaction with
healthcare providers and also continues product training, including
sharing best practices, in advance of the Company’s anticipated
future sales and marketing ramp.
Remote Pharmacy and At-Home Delivery Options
TherapeuticsMD is prepared to provide continued access to its
products for patients.
- The Company’s vitaCare Prescription Services patient model
assists patients in obtaining easy and convenient access to their
prescriptions for products at a retail pharmacy of their choice,
including via home delivery retail pharmacy options. The Company
anticipates that home delivery pharmacy options will be attractive
to patients during the COVID-19 pandemic.
- Through vitaCare, the Company has connected with more than 80%
of its patients during the past month. The Company anticipates that
vitaCare will support continued patient access to the Company’s
products during the COVID-19 pandemic and will help sustain the
Company’s strong refill trends given vitaCare’s broad use by the
Company’s patients.
- The Company has also partnered with independent community
pharmacies and multiple third-party online pharmacies (such as
PillPack, PillClub, and Simple Health) and telemedicine providers
(such as PlushCare) that focus on contraception or menopause to
help ensure patients have real-time access to both diagnosis and
treatment.
Supply of Products
TherapeuticsMD does not anticipate a shortage of its products
due to COVID-19 at this time.
- The company already has sufficient inventory of finished
product in its warehouses to meet anticipated demand through at
least early third quarter of this year.
- Additionally, the Company currently does not foresee any
interruption in its ability to continue to manufacture additional
product to be used beyond this period and has sufficient active
pharmaceutical ingredients on hand for the continued manufacture of
its products.
- At this time, the Company continues to have uninterrupted
wholesale and retail distribution of its products and is actively
working to ensure that there continues to be an adequate supply of
its products at pharmacies for sales to patients.
Suspending 2020 Financial Guidance
Due to the unknown impact of COVID-19 on the Company’s business
and the rapidly evolving nature of the pandemic, TherapeuticsMD is
suspending its full-year 2020 financial guidance that was
previously provided in February 2020. The Company’s January and
February operating results were ahead of the internal forecasts
that were included in the Company’s full-year guidance. Together
with March operating results that will be partially affected by the
COVID-19 outbreak in the U.S., the Company projects that
preliminary first quarter net revenues will be more than $11
million. The Company believes that its vitaCare Prescription
Services patient model will support continued patient access to the
Company’s products during the COVID-19 pandemic and will help
sustain the Company’s strong refill trends across its menopause
products.
The foregoing amount is unaudited and preliminary, and does not
present all information necessary for an understanding of the
Company’s financial condition as of March 31, 2020. The review of
the Company’s consolidated financial statements for the three
months ending March 31, 2020 has not commenced and could result in
changes to this amounts due to the completion of financial closing
procedures, final adjustments and other developments that may arise
between now and the time the consolidated financial statements for
the three months ended March 31, 2020 are finalized and publicly
released. The Company’s independent registered public accounting
firm, Grant Thornton LLP, has not audited, reviewed, or compiled
this estimate.
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®,
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 an additional
tranche thereunder and whether the lender will make such tranche
available; 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 it website:
www.therapeuticsmd.com/pressreleases.aspx.
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version on businesswire.com: https://www.businesswire.com/news/home/20200326005697/en/
Investor Contact Nichol
Ochsner Vice President, Investor Relations 561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com
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