SPECIAL CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q includes statements that
are, or may be deemed, “forward-looking statements.” In some cases,
these forward-looking statements can be identified by the use of
forward-looking terminology, including the terms “believes,”
“estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,”
“designed,” “could,” “might,” “will,” “should,” “approximately” or,
in each case, their negative or other variations thereon or
comparable terminology, although not all forward-looking statements
contain these words. They appear in a number of places throughout
this Quarterly Report on Form 10-Q and include statements regarding
our current intentions, beliefs, projections, outlook, analyses or
current expectations concerning, among other things, our ongoing
and planned manufacturing and commercialization of Twirla®, the
potential market uptake of Twirla and the development of our
potential product candidates, the strength and breadth of our
intellectual property, our ongoing and planned clinical trials, the
timing of and our ability to make regulatory filings and obtain and
maintain regulatory approvals for our potential product candidates,
the legal and regulatory landscape impacting our business, the
degree of clinical utility of our products, particularly in
specific patient populations, expectations regarding clinical trial
data, our development and validation of manufacturing capabilities,
our results of operations, financial condition, liquidity,
prospects, growth and strategies, the length of time that we will
be able to continue to fund our operating expenses and capital
expenditures, our expected financing needs and sources of
financing, the industry in which we operate and the trends that may
affect the industry or us.
By their nature, forward-looking statements involve risks and
uncertainties because they relate to events, competitive dynamics,
and healthcare, regulatory and scientific developments and depend
on the economic circumstances that may or may not occur in the
future or may occur on longer or shorter timelines than
anticipated. Although we believe that we have a reasonable basis
for each forward-looking statement contained in this Quarterly
Report on Form 10-Q, we caution you that forward-looking
statements are not guarantees of future performance and that our
actual results of operations, financial condition and liquidity,
and the development of the industry in which we operate may differ
materially from the forward-looking statements contained in this
Quarterly Report on Form 10-Q. In addition, even if our
results of operations, financial condition and liquidity, and the
development of the industry in which we operate are consistent with
the forward-looking statements contained in this Quarterly Report
on Form 10-Q, they may not be predictive of results or
developments in future periods.
Some of the factors that we believe could cause actual results to
differ from those anticipated or predicted include:
•our ability to successfully launch and commercialize
Twirla;
•our ability along with the ability of our
third-party manufacturer, Corium International, Inc., or Corium, to
complete successfully the scale up of the commercial manufacturing
process for Twirla, including the qualification and validation of
equipment related to the expansion of Corium’s manufacturing
facility;
•the rate and degree of market acceptance of Twirla
and any of our product candidates;
•the size and growth of the markets for Twirla and
our product candidates and our ability to serve those markets;
•the effects of the COVID-19 pandemic on our
operations and the operations of third parties we rely on for
services such as manufacturing, marketing support and sales
support, as well as the effects of the COVID-19 pandemic on our
potential customer base;
•regulatory and legislative developments in the
United States and foreign countries;
•our available cash and our ability to obtain
additional financing to fund our business plan without delay;
•the accuracy of our estimates regarding expenses,
future revenues, capital requirements and needs for additional
financing;
•our inability to timely obtain from Corium
sufficient quantities or quality of Twirla and our potential
product candidates or other materials required for a clinical trial
or other tests or studies;