Agile Therapeutics Reports First Quarter 2021 Financial Results
May 04 2021 - 4:05PM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today reported financial results for the three months
ended March 31, 2021 and provided a corporate update.
“In December 2020, we began our initial commercial shipments of
Twirla® to wholesalers, who have been working down their
inventories during the first quarter of 2021. As wholesalers
complete the inventory work-down, we expect product revenue from
wholesalers will more closely reflect script demand growth for
Twirla at the retail level. We are encouraged by recent
trends, which we believe reflect our anticipated momentum and show
steady, increasing demand for our product and a growing base of
prescribers.” said Chairman and Chief Executive Officer, Al
Altomari. “We continue to be optimistic about Twirla’s trajectory
and are encouraged by the response to our product, the first and
only weekly contraceptive patch that delivers a low dose of
estrogen.”
Recent Corporate Developments and First Quarter 2021
Results:
Twirla Performance and Updates
- During the first quarter 2021, total prescriptions were 1,853.
The growth was driven by an increase in the number of prescribers,
which as of March 31, 2021 was more than 850 HCPs, and growing
refill rates. As of March 31, 2021, 447 of prescriptions dispensed
at pharmacies were refills. The Company also saw an increase in the
number of total prescriptions by prescriber.
- The Company believes its momentum in prescriptions reflects
underlying demand for Twirla and is supported by steady growth in
the first quarter, which has continued into the early second
quarter.
- The Company continues to focus on expanding access and
reimbursement coverage for Twirla across managed care and
government health insurance plans. During the first quarter 2021,
the Company made progress in obtaining Medicaid coverage for
Twirla. Currently, Twirla is covered with no prior authorization in
20 states with expected coverage pending in Texas in May 2021. The
Medicaid market represents a large number of combined hormonal
contraceptive (“CHC”) users; Medicaid volumes for oral CHC total
prescriptions in 2020 were nearly eight million.
- In February 2021, the Company entered into a specialty
distribution agreement with Sterling Specialty Pharmacy
(“Sterling”). The Company believes that the relationship with
Sterling will facilitate increased access to Twirla based on early
results, which have been productive in increasing uptake of Twirla.
Agile continues to explore the potential to expand its distribution
network through other channels that can support growth of Twirla
demand including telemedicine.
Marketing Campaign Updates
- The Company continues to support I’m So Done, an
education and empowerment unbranded awareness campaign that
encourages women to think about their current contraceptive method
and decision-making journey. The Company has seen increased
activity on its website and various applications, including Tik
Tok.
- Beginning in the second quarter the Company plans to shift a
significant portion of its investment in marketing to its branded
campaign. The Company plans to focus its branded campaign efforts
on driving awareness and trial of Twirla, with a goal of meeting
women throughout their everyday routine with a targeted digital
strategy.
- Ongoing efforts include a multi-channel creative campaign that
positions Twirla as the first and only weekly contraceptive patch
that delivers a low dose of estrogen.
- The Company plans to expand its digital reach to other
applications including Tinder and OkCupid, as well as
Spotify. These three applications reach millions of U.S.
women between the ages of 18 and 34 on a monthly basis.
First Quarter 2021 Financial Results
- Net revenue: The Company delivered $116,000 in
net product sales revenue in the first quarter, as wholesalers
worked down their inventory levels after the initial stocking of
Twirla in the prior quarter.
- Cost of product revenues: The cost of product
revenues for the quarter ended March 31, 2021 was $1.2 million
which included expenses supporting our manufacturing and
distribution efforts, including personnel costs and approximately
$500,000 of non-cash depreciation expense. The Company expects
these relatively fixed costs to become less significant as a
percentage of sales with anticipated volume increases. There
was no direct cost of product revenue during the three months ended
March 31, 2021, as all product sold consisted of validation
inventory which was previously expensed as research and development
expense in the fourth quarter of 2020. The Company expects
all validation inventory with a carrying value of zero to be
utilized in 2021.
- Total operating expenses: Total
operating expenses were $15.2 million for the quarter
ended March 31, 2021, compared to $7.6 million for
the comparable period in 2020. The increase in year-over-year
expenses mostly reflected higher selling and marketing expenses,
including our contract sales force expenses and brand-building
expenses. The Company anticipates its second quarter 2021 total
operating expenses will be approximately $18 to $20 million
reflecting increased commercial costs from product samples and
spending on branded marketing.
- Research and development (R&D)
expenses: R&D expenses were
approximately $2.1 million for the quarter
ended March 31, 2021, compared to $3.2 million for
the comparable period in 2020. The decrease in period-over-period
R&D expenses was primarily attributable to the absence of 2020
pre-validation manufacturing costs for commercial manufacturing of
Twirla by Corium, the Company’s contract manufacturer, offset in
part by higher clinical development and personnel-related
expenses.
- Selling and marketing expenses: Selling and
marketing expenses were $9.2 million for the quarter ended March
31, 2021, compared to $1.7 million for the comparable period in
2020. The increase in period-over-period selling and marketing
expenses was due to higher costs associated with activities for
Twirla, including brand building and advocacy, and development of
the Company’s contract sales force.
- General and administrative (G&A)
expenses: G&A expenses were $3.9
million for the quarter ended March 31, 2021, compared
to $2.7 million for the comparable period in 2020.
The increase in year-over-year G&A expenses reflected higher
personnel costs and professional fees in preparation for product
launch and commercial activities, as well as an increase in stock
compensation expense.
- Net loss: Net loss was $17.1
million, or $0.20 per share, for the quarter
ended March 31, 2021, compared to a net loss of $7.9
million, or $0.10 per share, for the comparable period in
2020.
- Cash, cash equivalents and marketable
securities: As of March 31, 2021, Agile had $40.1 million
of cash, cash equivalents and marketable securities, compared to
$54.5 million as of December 31, 2020.
- Shares Outstanding: As of March 31, 2021,
Agile had 88,263,741 shares of common stock outstanding.
Financial Update
- Agile has $25 million of capital potentially available through
its loan facility with Perceptive Advisors, including a tranche of
$15 million in 2021, and a tranche of $10 million, which will be
available through June 2022, both contingent on achieving a
pre-determined revenue target.
- Additionally, the Company has the potential to access
additional capital through its existing at-the-market arrangement,
under which Agile may sell up to an aggregate of $50 million in
gross proceeds through the sale of shares of common stock.
Conference Call and Webcast Agile
Therapeutics will host a conference call and webcast to
discuss financial results for the first quarter ended March
31, 2021, today at 4:30 pm ET. Investors interested in
listening to the conference call may do so by dialing (866)
324-3683 for domestic callers or (509) 844-0959 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. 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
contraindicated in women over 35 years old who smoke. Cigarette
smoking increases the risk of serious cardiovascular events from
CHC use. 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 forward-looking women's healthcare company
dedicated to fulfilling the unmet health needs of today’s
women. Our product and 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), a 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 Statement Certain 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 our
ongoing and planned manufacturing and commercialization of Twirla®,
the potential market acceptance and uptake of Twirla, including the
increasing demand for Twirla, our results of operations, revenues,
financial condition, liquidity, prospects, growth and strategies,
the expected benefits of our marketing and sales distribution
strategies, including the use of samples to grow prescriptions,
current and future Medicare coverage for Twirla, the development of
our other potential product candidates, the length of time that we
will be able to continue to fund our operating expenses and capital
expenditures and our expected financing needs and sources of
financing, including our debt financing from Perceptive
Advisors. 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, 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 accuracy of our estimates of the potential market and
the market demand 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, our
ability to meet or exceed the revenue thresholds necessary to
permit us to access the remaining amount available under our
existing debt financing from Perceptive Advisors 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.
Contact: Matt Riley Head of Investor
Relations & Corporate Communications
mriley@agiletherapeutics.com
Agile Therapeutics,
Inc.Balance
Sheets(Unaudited)(in thousands,
except par value and share data)
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
2021 |
|
2020 |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
16,464 |
|
|
$ |
14,463 |
|
Marketable securities |
|
23,647 |
|
|
|
40,008 |
|
Accounts receivable, net |
|
322 |
|
|
|
865 |
|
Inventory |
|
1,590 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
1,651 |
|
|
|
1,449 |
|
Total current assets |
|
43,674 |
|
|
|
56,785 |
|
Property and equipment, net |
|
13,801 |
|
|
|
14,243 |
|
Right of use asset |
|
106 |
|
|
|
138 |
|
Other non-current assets |
|
1,896 |
|
|
|
1,896 |
|
Total
assets |
$ |
59,477 |
|
|
$ |
73,062 |
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
5,944 |
|
|
$ |
3,867 |
|
Accrued expenses |
|
2,737 |
|
|
|
3,348 |
|
Lease liability, current portion |
|
106 |
|
|
|
138 |
|
Total current liabilities |
|
8,787 |
|
|
|
7,353 |
|
|
|
|
|
|
|
Long-term debt |
|
15,636 |
|
|
|
16,381 |
|
Total
liabilities |
|
24,423 |
|
|
|
23,734 |
|
Commitments and
contingencies |
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
Common stock, $.0001 par value, 150,000,000 shares authorized,
88,263,741 and 87,563,753 issued and outstanding at
March 31, 2021 and December 31, 2020,
respectively |
|
9 |
|
|
|
9 |
|
Additional paid-in capital |
|
364,396 |
|
|
|
361,539 |
|
Accumulated other comprehensive income |
|
— |
|
|
|
3 |
|
Accumulated deficit |
|
(329,351 |
) |
|
|
(312,223 |
) |
Total stockholders’
equity |
|
35,054 |
|
|
|
49,328 |
|
Total liabilities and
stockholders’ equity |
$ |
59,477 |
|
|
$ |
73,062 |
|
|
|
|
|
|
|
|
|
Agile Therapeutics,
Inc.Statements of
Operations(Unaudited)(in
thousands, except per share and share data)
|
|
|
|
|
|
|
Three Months Ended |
|
March 31, |
|
2021 |
|
2020 |
|
|
|
|
|
|
Revenues, net |
$ |
116 |
|
|
$ |
— |
|
Cost of product revenues |
|
1,161 |
|
|
|
— |
|
Gross profit |
|
(1,045 |
) |
|
|
— |
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
2,113 |
|
|
$ |
3,164 |
|
Selling and marketing |
|
9,163 |
|
|
|
1,742 |
|
General and administrative |
|
3,901 |
|
|
|
2,711 |
|
Total operating expenses |
|
15,177 |
|
|
|
7,617 |
|
Loss from operations |
|
(16,222 |
) |
|
|
(7,617 |
) |
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
Interest income |
|
16 |
|
|
|
132 |
|
Interest expense |
|
(922 |
) |
|
|
(398 |
) |
Total other income (expense),
net |
|
(906 |
) |
|
|
(266 |
) |
Loss before benefit from income
taxes |
|
(17,128 |
) |
|
|
(7,883 |
) |
Benefit from income taxes |
|
— |
|
|
|
— |
|
Net loss |
$ |
(17,128 |
) |
|
$ |
(7,883 |
) |
|
|
|
|
|
|
Net loss per share (basic and
diluted) |
$ |
(0.20 |
) |
|
$ |
(0.10 |
) |
|
|
|
|
|
|
Weighted-average common shares
(basic and diluted) |
|
87,625,990 |
|
|
|
76,652,190 |
|
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