Agile Therapeutics, Inc. (Pink: AGRX), a women's healthcare
company, today reported financial results for the three and twelve
months ended December 31, 2023 and provided a corporate update.
“2023 was a year for Agile that we believe demonstrated our
ability to continue to grow Twirla,” said Agile Therapeutics
Chairperson and Chief Executive Officer Al Altomari. “We believe we
answered questions about our business model’s sustainability in
2023 by once again demonstrating meaningful year-over-year growth
in net revenue, Twirla demand, and Twirla factory sales while
simultaneously keeping operating expenses at responsible levels. We
continue to believe in our business model with an emphasis on
partnerships to maximize Twirla’s growth potential. We will
continue to explore any and all strategic opportunities, both
internally and externally, that have the ability to maximize Twirla
growth and increase shareholder value.”
Fourth Quarter & Full Year
2023 Performance Updates
- Twirla delivered $19.6
million in net revenue in 2023. This was an increase of
80% from the $10.9 million reported for full year 2022. Net revenue
for the fourth quarter 2023 was $3.6 million, a 46% decrease from
the third quarter 2023 net revenue of $6.7 million. The fourth
quarter 2024 decrease in net revenue was primarily due to decreased
demand and an increase in gross-to-net charges primarily due to
increased activity in the Company’s Medicaid business, an increase
in the Company’s returns reserve, and a larger mix of non-retail
business.
- Fourth quarter and full year 2023
net revenue reflects performance in the following key areas:
- Continued Year-Over-Year Twirla
Demand Growth
- Twirla demand for full year 2023 was 243,841 total
cycles, a 131% increase from the 105,741 total cycles reported for
full year 2022.
- For the fourth quarter 2023, Twirla demand was 68,793 total
cycles, a 7% decrease from the 74,325 total cycles reported for the
third quarter 2023.
- Based on first quarter 2024 activity to date, Twirla January
demand numbers (26,464 total cycles) show that the Company achieved
the highest number of retail channel cycles in a single month since
launch.
- Additionally, despite being a short month, February total
demand (24,729 total cycles) was larger than any single month of
the fourth quarter 2023 in both retail and total cycles.
- Twirla Factory Sales
- Twirla factory sales for the full year 2023 were
248,220 total cycles, a 117% increase from the 114,546 total cycles
reported for the full year 2022.
- For the fourth quarter 2023, Twirla factory sales were 68,580
total cycles, an 8% decrease from the 74,424 total cycles reported
for the third quarter 2023.
- Company Operating Expenses
- Full year 2023 operating expenses were $30.5 million, a
decrease of 33% from the $45.5 million reported for
2022.
- Fourth quarter 2023 operating
expenses were $5.5 million, a decrease of 33% from the $8.2 million
for the third quarter 2023. This reduction is primarily due to the
Company’s decision to forgo bonuses for all of 2023 for all
employees, including management.
Additional Corporate Updates
- Elimination of Debt Facility
with Perceptive Advisors
- In March 2024, the Company announced the payoff of the
remaining debt owed to Perceptive Advisors. The Company believes
this significant milestone will provide more flexibility on its
balance sheet moving forward.
- Delisting from
Nasdaq
- On March 25, 2024, the Company announced it received a final
delisting notice from Nasdaq due to its failure to regain
compliance with the Nasdaq minimum stockholders’ equity
requirement.
- As of March 26, 2024, the Company’s common stock is now trading
on the “over the counter” market operated by the OTC Markets Group
under its existing “AGRX” trading symbol. The Company has applied
for trading on the OTC-QB market.
- The Company does not expect the transition to OTC to impact its
business operation and it remains focused on executing its business
plan while continuing to explore strategic opportunities.
- Potential for Enhanced
Access to Twirla
- The Company remains optimistic about the steps being taken by
the Biden-Harris Administration to enhance access to no-cost
contraception products like Twirla. In January 2024, the
Administration announced new guidance to enable expanded access to
all FDA-approved contraceptives without cost.
- Implementation of the new guidance could eliminate financial
barriers for contraceptive products like Twirla for an estimated 49
million women.
Fourth Quarter & Full Year
2023 Financial Results
- Net Revenue: In the fourth
quarter 2023, the Company realized net product sales revenue of
$3.6 million, a decrease of 46% as compared to the third quarter
2023 revenue of $6.7 million. Full year 2023 net revenue was $19.6
million, a 80% increase from the $10.9 million reported for full
year 2022.
- Cost of Goods Sold (COGS): Cost of goods sold,
which consists of direct and indirect costs related to the
manufacturing of Twirla, were $2.2 million for the fourth quarter
and $9.0 million for the full year 2023, compared to the $1.7
million and $6.8 million reported for the same periods in
2022.
- Total operating expenses: Total GAAP operating
expenses were $5.5 million for the quarter ended December 31, 2023,
compared to $9.2 million for the comparable period in 2022 – a
decrease of 41%. For the full year 2023, GAAP operating expenses
were $30.5 million, compared to $45.5 million for the full year
2022, representing a 33% decrease year on year.
- GAAP Net loss: GAAP net loss was $4.5 million,
or $1.51 per share, for the quarter ended December 31, 2023,
compared to a GAAP net loss of $3.9 million, or $4.76 per share,
for the comparable period in 2022. For full year 2023, net loss was
$14.5 million, or $6.71 a share, compared to $25.4 million, or
$58.82 per share in the full year 2022.
- Non-GAAP Net Loss: Non-GAAP net loss was $4.3
million, or $1.46 per share, for the quarter ended December 31,
2023, compared to a non-GAAP net loss of $7.3 million, or $8.82 per
share, for the comparable period in 2022. For the full year 2023,
non-GAAP net loss was $21.2 million, or $9.84 a share, compared to
$39.8 million, or $92.15 per share in the full year 2022. These
results reflect the exclusion of the $6.8 million in other income
for 2023 and $25.5 million in other income for 2022 resulting from
the change in value of the Company’s warrant liability. A
reconciliation of non-GAAP to GAAP net loss is provided in the
tables accompanying this press release.
- Cash: As of December 31, 2023, the Company had
$2.5 million of cash, compared to $5.2 million of cash and cash
equivalents as of the end of the fourth quarter 2022. In February
2024, the Company raised $4.8 million in gross proceeds through a
warrant exercise agreement with a holder of the Company’s warrants.
The Company will continue to evaluate all available options to
finance the Company and continue to explore all opportunities that
can potentially accelerate the timeline to generating positive cash
flow.
- Shares Outstanding: As of December 31, 2023,
Agile had 2,963,657 shares outstanding and 2,156,726 weighted
average shares of common stock outstanding for the year ended
December 31, 2023.
Conference Call
and Webcast
Date |
Thursday, March 28, 2024 |
Time |
8:30 a.m. ET |
Webcast (live and archived) |
Events &
Presentations |
Registration Link |
Register Here |
A live webcast of the conference call may be accessed via the
Investor Relations portion of the Agile Therapeutics website
at https://ir.agiletherapeutics.com/events-and-presentations.
To participate in the live conference call via
telephone, please register here.
Upon registering, a dial-in number and unique PIN will be provided
to join the conference call.
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), 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 and LinkedIn account.
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 also 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 Prescription
DataThe Company receives prescription data for
Twirla from Symphony Health Solutions, and the data are not created
or owned by the Company. Prescription data are available through
other subscription services as well, such as IQVIA. Unless
otherwise noted, the prescription data results reported in this
press release are reported as of December 31, 2023, by Symphony
Health Solutions. The prescription data terms are defined as
follows: Twirla cycles dispensed are the number of 3-patch packages
dispensed.
Each 3-patch package represents one 28-day cycle of therapy.
Total Cycles Dispensed represents every cycle dispensed from both
retail and non-retail channels. Retail channels include retail
pharmacies, mail order, and long-term care while non-retail
channels include clinics and hospitals and other entities where
prescriptions are dispensed directly to the patient. Total
prescriptions (TRx) are the total number of prescriptions dispensed
through the retail channels. This represents both new and refill
prescriptions. New prescriptions (NRx) are new prescriptions
dispensed through retail channels. Refill prescriptions (RRx) are
refill prescriptions filled through retail channels. Total
prescribers are the cumulative number of prescribers whose
prescriptions were filled through retail channels since launch. Not
all prescription demand in the non-retail channel is reported into
third parties like Symphony Health Solutions and IQVIA. The factory
sales reported from Twirla wholesalers do include sales to the
non-retail channel and, therefore, the Company believes factory
sales more closely represent the total demand for Twirla across all
channels.
Use of Non-GAAP Financial MeasuresTo supplement
our consolidated financial statements, which are prepared and
presented in accordance with U.S. generally accepted accounting
principles (GAAP), we use non-GAAP operating expenses and non-GAAP
net loss to measure our financial performance. We define the term
non-GAAP operating expenses as GAAP operating expenses excluding
one-time, non-cash charges incurred in connection with the loss on
disposition of assets. We define the term non-GAAP net loss as GAAP
net loss excluding recurring unrealized gains or losses pertaining
to liability classified warrants and one-time non-cash charges
incurred in connection with the loss on disposition of assets. We
believe that the presentation of these non-GAAP financial metrics
provides useful information about our operating results, enhances
the overall understanding of past financial performance and future
prospects, allows for greater transparency with respect to metrics
used by our management in its financial and operational
decision-making and produces a useful measure for period-to-period
comparisons of our business.
The presentation of these non-GAAP financial measures are not
intended to be a substitute for, or superior to, the financial
information prepared and presented in accordance with GAAP and may
be different from non-GAAP financial measures used by other
companies, and therefore, may not be comparable among companies. We
believe the presentation of these non-GAAP financial measures
provides meaningful supplemental information regarding our
performance; however, we urge investors to review the
reconciliation of this financial measures to the comparable GAAP
financial measures included in the accompanying tables, and not to
rely on any single financial measure to evaluate our business.
Forward-Looking
StatementsCertain 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 in
2024, our partnership with Afaxys and its ability to promote
growth, our product supply agreement with Nurx and its ability to
educate patients about Twirla, our connected TV (CTV) campaign and
its ability to promote growth, our prospects for future financing
arrangements, and our financial condition, growth and strategies.
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 raise additional capital, ability to pay
our obligations as they become due, 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 of 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, 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, 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:info@agiletherapeutics.com
Agile
Therapeutics, Inc.Balance
Sheets(in thousands, except par value and share
data) |
|
|
December 31, |
|
December 31, |
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
2,557 |
|
|
$ |
5,246 |
|
Accounts receivable, net |
|
|
3,392 |
|
|
|
3,377 |
|
Inventory, net |
|
|
2,738 |
|
|
|
1,332 |
|
Prepaid expenses and other current assets |
|
|
843 |
|
|
|
1,403 |
|
Total current assets |
|
|
9,530 |
|
|
|
11,358 |
|
Property and equipment,
net |
|
|
75 |
|
|
|
177 |
|
Right of use asset |
|
|
412 |
|
|
|
695 |
|
Other non-current assets |
|
|
238 |
|
|
|
2,012 |
|
Total
assets |
|
$ |
10,255 |
|
|
$ |
14,242 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ deficit |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Long-term debt and notes payable |
|
$ |
1,706 |
|
|
$ |
1,426 |
|
Accounts payable |
|
|
9,574 |
|
|
|
7,734 |
|
Accrued expenses |
|
|
9,131 |
|
|
|
3,908 |
|
Lease liability, current portion |
|
|
366 |
|
|
|
319 |
|
Total current liabilities |
|
|
20,777 |
|
|
|
13,387 |
|
|
|
|
|
|
|
|
Lease liabilities,
long-term |
|
|
100 |
|
|
|
466 |
|
Warrant liability |
|
|
5,696 |
|
|
|
5,934 |
|
Total liabilities |
|
|
26,573 |
|
|
|
19,787 |
|
Stockholders’
deficit |
|
|
|
|
|
|
Preferred stock, $.0001 par
value, 10,000,000 shares authorized, 4,850 issued and no shares
outstanding at December 31, 2023 and no shares issued and
outstanding at December 31, 2022 |
|
|
- |
|
|
|
- |
|
Common stock, $.0001 par
value, 300,000,000 shares authorized, 2,963,657 and 859,402 issued
and outstanding at December 31, 2023 and
December 31, 2022, respectively |
|
|
4 |
|
|
|
4 |
|
Additional paid-in
capital |
|
|
406,846 |
|
|
|
403,153 |
|
Accumulated deficit |
|
|
(423,168 |
) |
|
|
(408,702 |
) |
Total stockholders’
deficit |
|
|
(16,318 |
) |
|
|
(5,545 |
) |
Total liabilities and
stockholders’ deficit |
|
$ |
10,255 |
|
|
$ |
14,242 |
|
Agile Therapeutics, Inc.Statement
of Operations and Comprehensive Loss(in thousands,
except share and per share data) |
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
December 31, |
|
Year Ended |
|
|
(Unaudited) |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues, net |
|
$ |
3,615 |
|
|
$ |
3,996 |
|
|
$ |
19,593 |
|
|
$ |
10,884 |
|
Cost of product revenues |
|
|
2,191 |
|
|
|
1,653 |
|
|
|
8,978 |
|
|
|
6,836 |
|
Gross profit |
|
|
1,424 |
|
|
|
2,343 |
|
|
|
10,615 |
|
|
|
4,048 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
54 |
|
|
$ |
352 |
|
|
$ |
2,225 |
|
|
$ |
3,253 |
|
Selling and marketing |
|
|
3,729 |
|
|
|
6,844 |
|
|
|
17,769 |
|
|
|
30,369 |
|
General and administrative |
|
|
1,691 |
|
|
|
2,023 |
|
|
|
10,505 |
|
|
|
11,860 |
|
Loss on disposition of assets |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
11,122 |
|
Total operating expenses |
|
|
5,474 |
|
|
|
9,219 |
|
|
|
30,499 |
|
|
|
56,604 |
|
Loss from operations |
|
|
(4,050 |
) |
|
|
(6,876 |
) |
|
|
(19,884 |
) |
|
|
(52,556 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
17 |
|
|
|
30 |
|
|
|
78 |
|
|
|
80 |
|
Interest expense |
|
|
(304 |
) |
|
|
(432 |
) |
|
|
(1,419 |
) |
|
|
(3,131 |
) |
Unrealized (loss) gain on warrant liability |
|
|
(130 |
) |
|
|
3,349 |
|
|
|
6,760 |
|
|
|
25,520 |
|
Total other income (expense),
net |
|
|
(417 |
) |
|
|
2,947 |
|
|
|
5,419 |
|
|
|
22,469 |
|
Loss before benefit from
income taxes |
|
|
(4,467 |
) |
|
|
(3,929 |
) |
|
|
(14,465 |
) |
|
|
(30,087 |
) |
Benefit from income taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
4,675 |
|
Net loss |
|
$ |
(4,467 |
) |
|
$ |
(3,929 |
) |
|
$ |
(14,465 |
) |
|
$ |
(25,412 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share (basic and
diluted) |
|
$ |
(1.51 |
) |
|
$ |
(0.10 |
) |
|
$ |
(6.71 |
) |
|
$ |
(1.18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares
(basic and diluted) |
|
|
2,963,657 |
|
|
|
41,232,562 |
|
|
|
2,156,726 |
|
|
|
21,610,947 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,467 |
) |
|
$ |
(3,929 |
) |
|
$ |
(14,465 |
) |
|
$ |
(25,412 |
) |
Other comprehensive
income: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on marketable securities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Comprehensive loss |
|
$ |
(4,467 |
) |
|
$ |
(3,929 |
) |
|
$ |
(14,465 |
) |
|
$ |
(25,412 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Agile Therapeutics,
Inc.Reconciliation of GAAP Operating Expenses to
Non-GAAP Operating
Expenses(Unaudited)(in
thousands) |
|
|
Three Months Ended |
|
Twelve Months Ended |
|
|
|
12/31/2023 |
|
9/30/2023 |
|
6/30/2023 |
|
3/31/2023 |
|
12/31/2022 |
|
|
12/31/2023 |
|
|
12/31/2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Operating expenses |
|
$ |
5,474 |
|
8,185 |
|
8,322 |
|
8,518 |
|
9,219 |
|
$ |
30,499 |
|
$ |
56,604 |
Non-GAAP adjustment: Loss on
disposition of assets |
|
$ |
- |
|
- |
|
- |
|
- |
|
- |
|
$ |
- |
|
|
11,122 |
Non-GAAP operating
expenses |
$ |
5,474 |
|
8,185 |
|
8,322 |
|
8,518 |
|
9,219 |
|
$ |
30,499 |
|
$ |
45,482 |
Agile Therapeutics, Inc. Unaudited
Reconciliation of Net Loss (GAAP) to adjusted Net Loss
(non-GAAP)(in thousands) |
|
Three Months Ended |
|
Twelve Months Ended |
|
|
12/31/2023 |
|
9/30/2023 |
|
6/30/2023 |
|
3/31/2023 |
|
12/31/2022 |
|
|
12/31/2023 |
|
|
12/31/2022 |
GAAP Net Loss |
$ |
(4,467 |
) |
|
(799 |
) |
|
(3,809 |
) |
|
(5,390 |
) |
|
(3,929 |
) |
|
$ |
(14,465 |
) |
|
$ |
(25,412 |
) |
Unrealized (loss) gain on warrant liability |
|
(130 |
) |
|
3,529 |
|
|
1,674 |
|
|
1,687 |
|
|
3,349 |
|
|
|
6,760 |
|
|
|
25,520 |
|
Loss on disposition of assets |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
|
- |
|
|
|
(11,122 |
) |
Non-GAAP Net Loss |
$ |
(4,337 |
) |
|
(4,328 |
) |
|
(5,483 |
) |
|
(7,077 |
) |
|
(7,278 |
) |
|
$ |
(21,225 |
) |
|
$ |
(39,810 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net Loss Per
Share |
$ |
(1.46 |
) |
|
(1.47 |
) |
|
(3.10 |
) |
|
(7.76 |
) |
|
(8.82 |
) |
|
$ |
(9.84 |
) |
|
$ |
(92.15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted avg shares |
|
2,963,657 |
|
|
2,950,136 |
|
|
1,769,803 |
|
|
912,044 |
|
|
824,651 |
|
|
|
2,156,726 |
|
|
|
432,219 |
|
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