Agile Therapeutics Reports Second Quarter 2021 Financial Results
July 26 2021 - 4:05PM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today reported financial results for the three months
ended June 30, 2021 and provided a corporate update.
“The theme of Agile’s 2021 second quarter is growth. We believe
we have the building blocks in place for continued growth and we
remain on track to achieve our near-term goal of establishing
Twirla in the $4.1B U.S. hormonal contraceptive market,” said
Chairman and Chief Executive Officer Al Altomari. “We have an
approved product that is growing in all major prescription
performance areas and we believe we are only scratching the surface
as we unleash more direct-to-consumer advertising and further
develop the channels that provide women access to Twirla.”
Recent Corporate Developments and Second Quarter 2021
Results:
Twirla Performance and Updates
- During the second quarter 2021, total prescriptions were 5,027,
representing an increase of 171% from the end of the first quarter.
New prescriptions were 2,857 and grew by 103% over the same period.
The growth was driven by an increase in the number of prescribers,
which as of June 30, 2021 was more than 2,087 healthcare providers
(HCPs), and growing refill rates. As of June 30, 2021, 2,033
prescriptions dispensed at pharmacies were refills, which
represented an increase of 355% during the second quarter. The
Company also saw an increase in the number of total prescriptions
by prescriber.
- Twirla is now available to Medicaid patients in approximately
75% of states either through traditional Medicaid and/or managed
Medicaid. With these new additions, Twirla now has coverage in
approximately 50% of the total Medicaid transdermal TRx market with
no restrictions. Overall, Twirla has access in approximately 55% of
the commercial and government CHC market based on claims.
- In addition to progress on Medicaid and Managed Care access,
the Company also saw expanded access through state clinics, where
there was significant non-retail prescription volume in the second
quarter.
Marketing Campaign Updates
- The Company increased its incremental branded consumer
marketing investment quarter over quarter in the second quarter,
and Twirla’s advertising presence on dating apps such as Tinder and
OK Cupid exceeded expectations in less than a month.
- The Company believes that as more women in the target audience
gain exposure to Twirla through branded advertising efforts, Twirla
prescriptions will continue to grow.
Second Quarter 2021 Financial Results
- Net revenue: The Company delivered $1.2
million in net product sales revenue in the second quarter.
- Cost of product revenues: The cost of product
revenues for the quarter ended June 30, 2021 was $1.1 million which
included direct and indirect 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. Until May of 2021, the Company was selling units from
validation batches that had no associated product cost as the cost
had been previously expensed. Approximately 76% of the units sold
in the second quarter had associated product cost. All future sales
of product will have an associated product cost.
- Total operating expenses: Total
operating expenses were $16.7 million for the quarter
ended June 30, 2021, compared to $10.0 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.
- Research and development (R&D)
expenses: R&D expenses were
approximately $0.9 million for the quarter
ended June 30, 2021, compared to $3.7 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.
- Selling and marketing expenses: Selling and
marketing expenses were $11.7 million for the quarter ended June
30, 2021, compared to $3.2 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 $4.1
million for the quarter ended June 30, 2021, compared
to $3.2 million for the comparable period in 2020.
The increase in year-over-year G&A expenses reflected higher
personnel costs and higher professional fees.
- Net loss: Net loss was $17.6
million, or $0.20 per share, for the quarter
ended June 30, 2021, compared to a net loss of $10.8
million, or $0.12 per share, for the comparable period in
2020.
- Cash, cash equivalents and marketable
securities: As of June 30, 2021, Agile had $31.1 million
of cash, cash equivalents and marketable securities, compared to
$54.5 million as of December 31, 2020.
- Shares Outstanding: As of June 30, 2021,
Agile had 92,928,205 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
Date |
Monday, July 26, 2021 |
Time |
4:30 p.m. EDT |
Webcast (live and archived) |
Events & Presentations |
Dial-in numbers |
(833) 979-2857 (U.S. toll-free) or (236) 714-2948 |
Conference ID |
1732729 |
Investors interested in listening to the conference call may do
so by dialing (833) 979-2857 for domestic callers or (236) 714-2948
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 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)
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 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 amounts 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 RileyHead of Investor
Relations & Corporate Communications
mriley@agiletherapeutics.com
Agile Therapeutics,
Inc.Balance
Sheets(Unaudited)(in thousands,
except par value and share data)
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
2021 |
|
2020 |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
26,118 |
|
|
$ |
14,463 |
|
Marketable securities |
|
4,999 |
|
|
|
40,008 |
|
Accounts receivable, net |
|
1,167 |
|
|
|
865 |
|
Inventory |
|
3,462 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
1,202 |
|
|
|
1,449 |
|
Total current assets |
|
36,948 |
|
|
|
56,785 |
|
Property and equipment,
net |
|
13,363 |
|
|
|
14,243 |
|
Right of use asset |
|
72 |
|
|
|
138 |
|
Other non-current assets |
|
1,896 |
|
|
|
1,896 |
|
Total
assets |
$ |
52,279 |
|
|
$ |
73,062 |
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
6,410 |
|
|
$ |
3,867 |
|
Accrued expenses |
|
5,153 |
|
|
|
3,348 |
|
Lease liability, current portion |
|
72 |
|
|
|
138 |
|
Total current liabilities |
|
11,635 |
|
|
|
7,353 |
|
|
|
|
|
|
|
Long-term debt |
|
16,035 |
|
|
|
16,381 |
|
Total
liabilities |
|
27,670 |
|
|
|
23,734 |
|
Commitments and
contingencies (Note 12) |
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
Common stock, $.0001 par value, 150,000,000 shares authorized,
92,928,205 and 87,563,753 issued and outstanding at
June 30, 2021 and December 31, 2020,
respectively |
|
9 |
|
|
|
9 |
|
Additional paid-in capital |
|
371,588 |
|
|
|
361,539 |
|
Accumulated other comprehensive income |
|
— |
|
|
|
3 |
|
Accumulated deficit |
|
(346,988 |
) |
|
|
(312,223 |
) |
Total stockholders’
equity |
|
24,609 |
|
|
|
49,328 |
|
Total liabilities and
stockholders’ equity |
$ |
52,279 |
|
|
$ |
73,062 |
|
Agile Therapeutics,
Inc.Statements of
Operations(Unaudited)(in
thousands, except per share and share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
Revenues, net |
$ |
1,185 |
|
|
$ |
— |
|
|
$ |
1,301 |
|
|
$ |
— |
|
Cost of product revenues |
|
1,145 |
|
|
|
— |
|
|
|
2,306 |
|
|
|
— |
|
Gross profit (loss) |
|
40 |
|
|
|
— |
|
|
|
(1,005 |
) |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
862 |
|
|
$ |
3,661 |
|
|
$ |
2,975 |
|
|
$ |
6,825 |
|
Selling and marketing |
|
11,714 |
|
|
|
3,150 |
|
|
|
20,877 |
|
|
|
4,892 |
|
General and administrative |
|
4,115 |
|
|
|
3,228 |
|
|
|
8,016 |
|
|
|
5,939 |
|
Total operating expenses |
|
16,691 |
|
|
|
10,039 |
|
|
|
31,868 |
|
|
|
17,656 |
|
Loss from operations |
|
(16,651 |
) |
|
|
(10,039 |
) |
|
|
(32,873 |
) |
|
|
(17,656 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
7 |
|
|
|
115 |
|
|
|
23 |
|
|
|
247 |
|
Interest expense |
|
(993 |
) |
|
|
(902 |
) |
|
|
(1,915 |
) |
|
|
(1,300 |
) |
Total other income (expense),
net |
|
(986 |
) |
|
|
(787 |
) |
|
|
(1,892 |
) |
|
|
(1,053 |
) |
Loss before benefit from
income taxes |
|
(17,637 |
) |
|
|
(10,826 |
) |
|
|
(34,765 |
) |
|
|
(18,709 |
) |
Benefit from income taxes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
$ |
(17,637 |
) |
|
$ |
(10,826 |
) |
|
$ |
(34,765 |
) |
|
$ |
(18,709 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share (basic and
diluted) |
$ |
(0.20 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.23 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares
(basic and diluted) |
|
88,693,968 |
|
|
|
87,221,441 |
|
|
|
88,162,929 |
|
|
|
81,936,815 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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