Agile Therapeutics Reports First Quarter 2020 Financial Results
06 5월 2020 - 5:01AM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today reported financial results for the three months
ended March 31, 2020 and provided a corporate update.
“At the beginning of the COVID-19 pandemic, we
took proactive steps by moving all employees to work from home
settings for their health and safety, while pursuing business
continuity during this pivotal time in the Company’s history,”
said Al Altomari, Chairman and Chief Executive Officer of
Agile. “Despite a challenging operating environment, we
expect our precommercial activities to remain on track to bring
Twirla to market in the fourth quarter of 2020. With respect to our
manufacturing process, we have completed production of the
pre-validation batch and subject to final quality control testing
that we expect to be completed soon, we will transition into the
final validation phase. We plan to initiate the manufacture of our
validation batches at the same time that we expect to build our
sales force and commercial infrastructure to facilitate the product
launch. By raising more than $68 million in debt and equity
financing in recent months, we expect to have the financial runway
needed to achieve our next milestone, which is the initial shipment
of Twirla, so that we can begin taking a share of the $4.1 billion
estimated potential addressable market. It was a transformational
quarter for Agile with FDA approval of Twirla, a truly game
changing moment that now enables us to focus on
commercialization.”
First Quarter 2020 and Other Recent
Corporate Developments:
COVID-19
Update
- Agile Therapeutics has taken
preventative measures to protect the health and wellbeing of its
employees, such as a company-wide mandate to have all employees
work from home, in accordance with state and local guidelines. As
of today, the Company does not expect a material impact to
financial results, its hiring and training of its sales team,
pre-validation and validation of the commercial manufacturing
process or its current expectations to ship Twirla to wholesalers,
however, this expectation is subject to change depending on the
length, uncertainty and change in market conditions related to the
pandemic.
Twirla®
Update
- Twirla (levonorgestrel and ethynyl
estradiol) transdermal system Approved by FDA: On February 14,
2020, the Company announced that it had received FDA approval for
its lead product candidate, Twirla. Twirla is approved for
the prevention of pregnancy in women with a BMI <30 kg/m2 for
whom a combined hormonal contraceptive is appropriate.
Healthcare providers (HCPs) are encouraged to consider Twirla’s
reduced efficacy in women with a BMI ≥ 25 to <30 kg/m2 before
prescribing. Twirla is contraindicated in women with a BMI ≥
30 kg/m2.
- Twirla Commercialization Plans: The
Company has completed production of the planned manufacturing
pre-validation batch of Twirla and subject to completion of the
final quality assurance testing, the Company expects to begin
manufacture of the validation batches of Twirla® over the next four
months. The Company expects these validation batches, if
successful, will be available for commercial launch in the fourth
quarter of 2020. At the same time, the Company will
continue to prepare for the availability of commercial product
supply. The Company has initiated work with managed care and
patient payors to gain market access for Twirla. In the
second quarter of 2020, the Company plans to begin hiring and
training an initial sales team, which it estimates to be in the
range of 70 to 100 persons. The Company intends to begin to ship
product to wholesalers in the fourth quarter of 2020.
Financing Update
- In February 2020, the Company
entered into a credit agreement with Perceptive Advisors for a
senior secured term loan facility of up to $35 million. A first
tranche of $5 million was funded on execution of the credit
agreement. A second tranche of $15 million was funded as a result
of the approval of Twirla by the FDA. Another $15 million
tranche will be available upon the achievement of certain revenue
milestones. The Company is permitted to make interest-only payments
on the loan until February 2023. In addition, the Company
issued Perceptive warrants to purchase 1,400,000 shares of Agile
common stock.
- In February 2020, the Company
completed a public offering of 17,250,000 shares of common stock at
a public offering price of $3.00 per share. Net proceeds from the
offering, after deducting underwriting discounts and commissions
and offering expenses payable by Agile Therapeutics, were
approximately $48.4 million.
Financial
Guidance
- Moving forward, the Company plans
to monitor spending closely. The Company expects operating
expenses for the full year 2020 to be in the range of $52.0 million
to $56.0 million, with general and administrative expenses
accounting for approximately 70% of the spending as it builds out
its commercial infrastructure. Net revenue in the fourth
quarter of 2020, reflecting the initial launch of Twirla, is
expected to be in the range of $4.0 million to $6.0 million.
Based on the Company’s current business plan and ability to get
Twirla launched, the Company believes that its cash and cash
equivalents as of March 31, 2020 will be sufficient to meet its
projected operating requirements through the end of 2021. If
the COVID-19 outbreak or other factors impact the Company’s
business plan or its ability to generate revenue from the
launch of Twirla, the Company believes it has the ability to revise
its commercial plans, including curtailing sales and marketing
spending, to allow it to continue to fund its operations.
First Quarter Financial
Results
- Cash and cash
equivalents: As of March 31, 2020, Agile had $93.9
million of cash and cash equivalents compared to $34.5 million of
cash and cash equivalents as of December 31, 2019.
- Research and development
(R&D) expenses: R&D expenses were $3.2
million for the quarter ended March 31, 2020, compared to $2.9
million for the comparable period in 2019. The increase in R&D
expenses was primarily due to costs to complete manufacturing
development, process improvements, and pre-validation work for
commercial manufacturing of Twirla by Corium, our contract
manufacturer. These higher expenses were offset by lower
clinical development expenses related to the comparative wear study
of Twirla and Xulane, which was initiated and completed in the
quarter ended March 31, 2019.
- General and administrative
(G&A) expenses: G&A expenses were $4.4
million for the quarter ended March 31, 2020, compared to $1.8
million for the comparable period in 2019. The increase in
G&A expenses was primarily due to higher costs associated with
our pre-commercialization activities for Twirla such as brand
building, advocacy, market research and consulting. We also
incurred higher salaries and wages and higher professional fees
related to recruiting fees and consultants.
- Net loss:
Net loss was $7.9 million, or $0.10 per share, for the quarter
ended March 31, 2020, compared to a net loss of $4.7 million, or
$0.13 per share, for the quarter ended December 31,
2019.
- Shares
Outstanding: At March 31, 2020, Agile had 87,213,212
shares of common stock outstanding.
Conference Call and Webcast
Agile Therapeutics will host a conference call
and webcast to discuss financial results for the first quarter
ended March 31, 2020 today at 4:30pm ET. Investors interested in
listening to the conference call may do so by dialing (877)
407-2991 for domestic callers or (201) 389-0925 for international
callers. A live webcast will be available in the Events and
Presentations section of the Investor Relations page at
https://ir.agiletherapeutics.com/events-and-presentations/, or by
clicking here.
Please log in approximately 10 minutes prior to
the scheduled start time. The archived webcast will be available in
the Events and Presentations section of the Company's website.
About Twirla®
Twirla (levonorgestrel and ethinyl estradiol)
transdermal system is a once-weekly combined hormonal contraceptive
(CHC) patch that contains the active ingredients levonorgestrel
(LNG), a type of progestin, and ethinyl estradiol (EE), a type of
estrogen. Twirla is indicated for use as a method of contraception
by women of reproductive potential with a body mass index (BMI)
< 30 kg/m2 for whom a combined hormonal contraceptive is
appropriate to prevent pregnancy. Healthcare providers (HCPs) are
encouraged to consider Twirla’s reduced efficacy in women with a
BMI ≥ 25 to <30 kg/m2 before prescribing. Twirla is
contraindicated in women with a BMI ≥ 30 kg/m2. Twirla is designed
to be applied once weekly for three weeks, followed by a week
without a patch.
About Agile Therapeutics,
Inc.Agile Therapeutics is a women's healthcare
company dedicated to fulfilling the unmet health needs of today’s
women. Our product candidates are designed to provide women
with contraceptive options that offer freedom from taking a daily
pill, without committing to a longer-acting method. Our
initial product, Twirla®, (levonorgestrel and ethinyl estradiol)
transdermal system is a non-daily prescription contraceptive.
Twirla is based on our proprietary transdermal patch technology,
called Skinfusion®, which is designed to allow drug delivery
through the skin. For more information, please visit the company
website at www.agiletherapeutics.com. The
Company may occasionally disseminate material, nonpublic
information on the Company’s website.
Forward-Looking
StatementCertain information contained in this press
release includes “forward-looking statements”, within the meaning
of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. We
may, in some cases use terms such as “predicts,” “believes,”
“potential,” “continue,” “anticipates,” “estimates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “likely,” “will,”
“should” or other words that convey uncertainty of the future
events or outcomes to identify these forward-looking statements.
Our forward-looking statements are based on current beliefs and
expectations of our management team that involve risks, potential
changes in circumstances, assumptions, and uncertainties, including
statements regarding the market availability of Twirla, our
projected cash position, our projected fiscal year 2020 operating
expenses and revenue and the expected timing and structure of our
commercialization plan for Twirla. Any or all of the
forward-looking statements may turn out to be wrong or be affected
by inaccurate assumptions we might make or by known or unknown
risks and uncertainties. These forward-looking statements are
subject to risks and uncertainties including risks related to our
ability to maintain regulatory approval of Twirla, our ability
along with our third-party manufacturer, 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
performance and financial condition of Corium or any of its
suppliers, the ability of Corium to produce commercial supply in
quantities and quality sufficient to satisfy market demand for
Twirla, our ability to successfully commercialize Twirla, the
successful development of our sales and marketing capabilities, the
accuracy of our estimates of the potential market for Twirla,
regulatory and legislative developments in the United States and
foreign countries, our ability to obtain and maintain intellectual
property protection for Twirla, our strategy, business plans and
focus, the effects of the COVID-19 pandemic on our operations and
the operations of third parties we rely upon as well as on our
potential customer base, and the other risks set forth in our
filings with the U.S. Securities and Exchange Commission, including
our Annual Report on Form 10-K and our Quarterly Reports on Form
10-Q. For all these reasons, actual results and developments
could be materially different from those expressed in or implied by
our forward-looking statements. You are cautioned not to place
undue reliance on these forward-looking statements, which are made
only as of the date of this press release. We undertake no
obligation to publicly update such forward-looking statements to
reflect subsequent events or circumstances.
Source: Agile Therapeutics
Contact: Investor Relations --
609-683-1880
Agile Therapeutics,
Inc.Condensed Balance Sheets
(in
thousands) (Unaudited)
|
March 31, 2020 |
|
December 31, 2019 |
|
|
|
|
|
|
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$93,925 |
|
$34,479 |
|
Prepaid expenses |
672 |
|
840 |
|
Total current assets |
94,597 |
|
35,319 |
|
Property and equipment, net |
14,154 |
|
14,044 |
|
Other assets |
136 |
|
177 |
|
Total assets |
$108,887 |
|
$49,540 |
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
Current liabilities: |
|
|
Accounts payable and accrued expenses |
$2,680 |
|
$3,623 |
|
Lease liability, current portion |
128 |
|
172 |
|
Total current liabilities |
2,808 |
|
3,795 |
|
|
|
|
Long-term debt |
15,472 |
|
— |
|
|
|
|
Stockholders’
equity |
|
|
Common stock |
9 |
|
7 |
|
Additional paid‑in capital |
358,851 |
|
306,108 |
|
Accumulated deficit |
(268,253 |
) |
(260,370 |
) |
Total stockholders’ equity |
90,607 |
|
45,745 |
|
Total liabilities and
stockholders’ equity |
$108,887 |
|
$49,540 |
|
Agile
Therapeutics, Inc.Condensed Statements of
Operations
(in thousands, except share and per share
amounts) (Unaudited)
|
Three Months Ended March 31, |
|
2020 |
|
2019 |
Operating expenses: |
|
|
Research and development |
$3,164 |
|
|
$2,881 |
|
General and administrative |
4,453 |
|
|
1,826 |
|
Total operating expenses |
7,617 |
|
|
4,707 |
|
Loss from operations |
(7,617 |
) |
|
(4,707 |
) |
Other income (expense) |
|
|
Interest income |
132 |
|
|
38 |
|
Interest expense |
(398 |
) |
|
— |
|
Loss before benefit from income taxes |
(7,883 |
) |
|
(4,669 |
) |
Benefit from income taxes |
— |
|
|
— |
|
Net loss |
$(7,883 |
) |
|
$(4,669 |
) |
Net loss per share - basic and diluted |
$(0.10 |
) |
|
$(0.13 |
) |
|
|
|
|
|
|
|
|
|
Weighted‑average shares outstanding –basic and diluted |
76,652,190 |
|
|
37,308,232 |
|
Agile Therapeutics (NASDAQ:AGRX)
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Agile Therapeutics (NASDAQ:AGRX)
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