Full Press Release Details
TherapeuticsMD, Inc. 8-K
TherapeuticsMD Provides COVID-19-Related
- 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 -
BOCA RATON, Fla. - March 26, 2020
- 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:
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:
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.
Remote Pharmacy and At-Home Delivery Options
TherapeuticsMD is prepared to provide continued
access to its products for patients.
TherapeuticsMD does not anticipate a shortage
of its products due to COVID-19 at this time.
2020 Financial Guidance
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.
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
@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;