Item 5.02. Departure of Directors or Principal Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
As previously disclosed, on May 20, 2022, Dennis P. Reilly, Chief Financial
Officer of Agile Therapeutics, Inc. (the "Company"), notified the Company that
he will voluntarily resign from his position in order to retire, which is
expected to be effective on May 31, 2022.
On May 23, 2022, the Board of Directors of the Company appointed Jason Butch,
the Company's Vice President and Chief Accounting Officer, to serve as Principal
Financial Officer, in addition to his current role as Principal Accounting
Officer, effective upon the effective date of Mr. Reilly's resignation. Mr.
Butch's compensation will remain unchanged at this time.
Mr. Butch, age 45, has served as the Company's Vice President and Chief
Accounting Officer since July 2020. Prior to joining Agile, Mr. Butch served as
Corporate Controller at Teligent, Inc., a publicly traded pharmaceutical
company, from April 2019 to July 2020. Prior to that, Mr. Butch served in roles
of increasing responsibility at MISTRAS Group, Inc., a publicly traded
engineering services company, including as Products and Systems Controller from
February 2012 to October 2013, and as Corporate Controller from October 2013 to
October 2018. Previously, Mr. Butch served as Audit Senior Manager at BDO USA,
LLP. Mr. Butch holds both a B.B.A. and an M.B.A. from Saint Bonaventure
There are no arrangements or understandings between Mr. Butch and any other
person pursuant to which he was selected for the positions to which he was
appointed. There are no family relationships between Mr. Butch and any director
or executive officer of the Company and Mr. Butch has no direct or indirect
material interest in any transaction required to be disclosed pursuant to Item
404(a) of Regulation S-K.
Item 7.01. Regulation FD Disclosure.
As previously announced, the Company will participate in the H.C. Wainwright
Global Investment Conference in Miami, Florida, which is being held on Tuesday,
May 24, 2022, at 10:00 a.m. Eastern Time, and has updated the corporate
presentation that it intends to use at the conference. Specifically, the Company
has provided a business update and guidance on demand for Twirla and expected
operating expenses in the second quarter 2022. In addition to implementing its
business plan to grow demand for Twirla®, the Company is evaluating its
operating expenses. The Company's goal is to optimize its available cash by
engaging in targeted, focused spending in support of growing Twirla, while also
seeking reductions in its spending in other areas of its operations.
As previously disclosed in the Company's Form 8-K filed on May 23, 2022, based
on its current performance and a review of operating expenses, the Company is
providing guidance indicating that it expects total cycles of Twirla® in the
range of 20,000 to 22,000 in the second quarter of 2022, which represents growth
of approximately 21% to 33% over the first quarter of 2022. The Company also
projects operating expenses for the second quarter of 2022 in the range of $12.5
million to $13.5 million, which represents a 15% to 21% reduction in operating
expenses over the first quarter of 2022.
The reduction of expenses in the second quarter is expected to be driven by the
elimination of cash bonuses for the Company's officers and members of senior
management, which was previously disclosed on May 12, 2022, and reductions in
general and administrative spending. Additionally, the first quarter 2022
operating expenses included the purchase of samples which are expected to be
utilized through-out 2022, and the Company does not plan to purchase additional
samples in the second quarter of 2022. The Company continues to evaluate its
operating structure and the second quarter 2022 reductions are intended to be
part of a longer-term strategy to reduce the Company's operating expenses on a
continuing basis. The Company has focused its reduced spending in the areas of
general and administrative support, research and development activities, timing
of its direct-to-consumer activities, and non-essential operational activities.
The Company may use this updated corporate presentation in meetings with
investors from time to time as well. In addition to the above-referenced
disclosure regarding the Company's product demand and operating expenses, the
updates primarily involve the Company's marketing and commercialization plans
A copy of the Company's updated corporate presentation is attached hereto as
Exhibit 99.1 and is hereby incorporated by reference herein.
In accordance with General Instructions B.2 and B.6 of Form 8-K, the information
included in this Item 7.01, including Exhibit 99.1 hereto, shall not be deemed
"filed" for the purposes of Section 18 of the Securities Exchange Act of 1934,
as amended (the "Exchange Act"), or otherwise subject to the liabilities of that
section, nor shall it be deemed incorporated by reference into any filing made
by the Company under the Exchange Act or the Securities Act of 1933, as amended,
except as shall be expressly set forth by specific reference in such a filing.
Certain information contained in this Report may include "forward-looking
statements." Our use of terms such as "predicts," "believes," "potential,"
"continue," "estimates," "anticipates," "expects," "plans," "intends," "may,"
"could," "might," "will," "should" or other words that convey uncertainty of
future events or outcomes may identify these forward-looking statements.
In particular, statements regarding our planned management changes, strategy and
business plans, including with respect to Twirla, projected product sales, cost
reduction measures and operating expenses are examples of such forward-looking
statements. Such forward-looking statements are subject to important risks and
uncertainties, including, but not limited to, risks related to our ability to
maintain regulatory approval of Twirla and the labeling under any approval we
obtain, the ability of Corium to produce commercial supply in quantities and
quality sufficient to satisfy market demand for Twirla, our ability to
successfully enhance the commercialization and increase the uptake for Twirla,
the size and growth of the markets for Twirla and our ability to serve those
markets, regulatory and legislative developments in the United States and
foreign countries, our ability to obtain and maintain intellectual property
protection for Twirla and our product candidates, the effects of the ongoing
COVID-19 pandemic on our commercialization efforts, clinical trials, supply
chain, operations and the operations of third parties we rely on for services
such as manufacturing, marketing support and sales support, as well as on our
potential customer base, our ability to maintain compliance with the listing
requirements of the Nasdaq Capital Market, and other factors, including general
economic conditions and regulatory developments, not within the Company's
These factors could cause actual results and developments to be materially
different from those expressed in or implied by such statements. These
forward-looking statements are made only as of the date of this Report and the
Company undertakes no obligation to publicly update such forward-looking
statements to reflect subsequent events or circumstances. For additional
information about the risks and uncertainties that may affect our business
please see the factors discussed in "Risk Factors" in the Company's periodic
reports filed with the SEC.
Item 9.01. Financial Statements and Exhibits.
99.1 Investor Presentation dated May 23, 2022
104 Cover Page Interactive Data File (Embedded within the Inline XBRL
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