Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today reported financial results for the three months
ended March 31, 2023 and provided a corporate update.
“We are pleased to report another successful quarter for
Twirla®. We continue to be encouraged by Twirla net revenues to
date, along with Twirla demand continuing to grow at double-digit
rates,” said Agile Therapeutics’ Chairperson and Chief Executive
Officer Al Altomari. “Looking ahead to the second quarter 2023, we
expect to see meaningful quarter-over-quarter growth in net
revenue, factory sales and demand while continuing to manage our
operating expenses. This is the formula that is driving our
confidence in our ability to achieve 2023 net revenue in the range
of $25-$30 million.”
First Quarter
Performance Updates
- Twirla delivered $3.8
million in net revenue for the first quarter 2023. This
was an increase of 117% from the $1.8 million reported for the
first quarter 2022 and a decrease of 5% from the $4.0 million
reported for the fourth quarter 2022. Net revenue results for the
first quarter of 2023 reflect flat factory sales quarter on quarter
due to a wholesaler work down of inventory levels, which rose at
the end of 2022, and a slightly higher mix of non-retail sales
which represent higher gross-to-net deductions.
- Continued Twirla Demand Growth
- Twirla demand for the first quarter 2023 was 45,036
total cycles, a 20% increase from the fourth quarter 2022 and a
170% increase from the first quarter 2022.
- Retail demand, which is the Company’s most profitable channel,
was 30,576 total cycles in the first quarter 2023, a 20% increase
from the fourth quarter 2022 and a single-quarter record.
- Non-retail demand for the first quarter 2023 was 14,460 total
cycles, also a single-quarter record and an increase of 20% from
the fourth quarter 2022.
- Twirla Factory Sales
- Twirla factory sales for the first quarter 2023 were
43,446 total cycles, remaining flat compared to the fourth quarter
2022 and a 158% increase from the first quarter 2022.
- Wholesaler inventory levels decreased in the first quarter 2023
by 24% from December 31, 2022.
- Company Operating Expenses
- First quarter GAAP operating expenses were $8.5 million
for 2023, a decrease of 8% from the $9.2 million reported for the
fourth quarter 2022 and a 46% decrease from the
first quarter 2022.
- The Company plans to continue to actively manage its operating
expenses and expects operating expenses for the full year 2023 to
be lower than full year 2022.
- First quarter 2023 improvements in Twirla demand reflect a
continued increase of patient utilization in both the retail and
non-retail channels.
- Collaboration with Afaxys
- Non-retail factory sales
in the first
quarter of 2023
were 17,790, a 15% increase from
the 15,420 non-retail cycles
sold in the
fourth quarter 2022.
- The meaningful non-retail channel growth is the product of
Afaxys’ efforts to expand Twirla in the Planned Parenthood
network.
Potential Future Upside from Twirla Business
Plan
- The Company remains focused on
achieving its key goals of growing Twirla, attaining 2023 net
revenue in the range of $25-$30 million and, ultimately, generating
positive cash flow. The Company remains confident it can accomplish
these key goals by:
- Targeting Promotional Efforts on Five Key States
- The Company continues to focus its Twirla promotional efforts
on five states that have high levels of reimbursement potential for
Twirla and are estimated to reach 45% of U.S. women between the
ages of 18 and 24.
- Increasing Footprint in Telemedicine
- Beginning in the second quarter 2023, the Company expects to
see an impact in the retail channel from its collaboration with
female telehealth leader Nurx, as Twirla becomes the only patch
offered by Nurx’s partner pharmacy.
- Nurx has provided contraception to more than 1 million
patients.
- Capturing Greater Volume Growth
- After achieving non-retail factory
sales growth of 15% in the first quarter 2023, the Company believes
it can continue momentum throughout 2023 from both new and
returning orders.
- The Company believes there is
additional potential for Twirla volume growth in this channel based
on the reach of the Afaxys customer network, which includes Planned
Parenthood and student health centers.
- The Company also believes it will
start to experience increased growth in the retail channel from
physicians who gain more clinical experience with Twirla in the
Planned Parenthood setting and become more comfortable prescribing
Twirla in their other practices.
First Quarter 2023 Financial
Results
- Net Revenue: In the first
quarter 2023, the Company realized net product sales revenue of
$3.8 million, a decrease of 5% as compared to the fourth quarter
2022 revenue of $4.0 million. First quarter 2023 net revenue of
$3.8 million represents a 117% increase from the $1.8 million
reported for the comparable period in 2022.
- Cost of Goods Sold
(COGS): Cost of goods sold, which consists of direct and
indirect costs related to the manufacturing of Twirla, was $2.0
million for the first quarter 2023, compared to the $1.7 million
reported for the fourth quarter 2022 and $1.5 million for the
comparable period in 2022.
- Total operating
expenses: Total operating expenses were $8.5 million for
the first quarter 2023, compared to $9.2 million for the fourth
quarter 2022 and $15.8 million for the comparable period in
2022.
- Cash: As of March 31, 2023, the Company had
$4.4 million of cash, compared to $5.2 million of cash and cash
equivalents as of the end of the fourth quarter 2022. In addition
to the at-the-market (ATM) arrangement, 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.
- GAAP Net Loss: GAAP net loss was $5.4 million,
or $5.91 per share, for the first quarter 2023, compared to a GAAP
net loss of $3.9 million, or $4.76 per share, for the fourth
quarter 2022 and a GAAP net loss of $10.4 million, or $166.68 per
share, for the comparable period in 2022, respectively. The fair
market value remeasurement of warrants resulted in $1.7 million,
$3.3 million and $1.4 million in other income for the first quarter
2023, fourth quarter 2022, and first quarter 2022, respectively.
The Company expects to continue to see fluctuations in GAAP net
income or loss depending on the non-cash accounting adjustments of
these warrants.
- Non-GAAP Net Loss: Non-GAAP net loss was $7.1
million, or $7.76 per share, for the first quarter 2023, compared
to a non-GAAP net loss of $7.3 million or $8.83 per share for the
fourth quarter 2022, and a non-GAAP net loss of $11.8 million, or
$188.91 per share, for the comparable period in 2022. These results
reflect the exclusion of the fair market value remeasurement of
warrants of $1.7 million for the first quarter 2023, $3.3 million
for the fourth quarter 2022 and $1.4 million for the first quarter
2022. A reconciliation of non-GAAP to GAAP net loss is provided in
the tables accompanying this press release.
- Shares Outstanding: As of March 31, 2023,
Agile had 932,101 shares outstanding and 912,044 weighted average
shares of common stock outstanding, as adjusted for the 1-for-50
reverse stock split implemented by Agile on April 10, 2023.
Conference Call
and Webcast
Date |
|
Thursday, May 11, 2023 |
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|
|
Time |
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4:30 p.m. ET |
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|
|
Webcast (live and archived) |
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Events & Presentations |
|
|
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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, Twitter account (@agilether), 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 March 31, 2022, 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 Statements
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 in 2023, 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 prospects for
future financing arrangements and ability to generate positive
cashflow, our expected net revenue and operating expenses for 2023,
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 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, the lingering effects of the
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 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
Communicationsmriley@agiletherapeutics.com
|
Agile Therapeutics, Inc.Balance
Sheets(Unaudited)(in thousands,
except par value and share data) |
|
|
|
March 31, |
|
December 31, |
|
|
2023 |
|
2022 |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
4,429 |
|
|
$ |
5,246 |
|
Accounts receivable, net |
|
|
3,123 |
|
|
|
3,377 |
|
Inventory, net |
|
|
2,211 |
|
|
|
1,332 |
|
Prepaid expenses and other current assets |
|
|
1,143 |
|
|
|
1,403 |
|
Total current assets |
|
|
10,906 |
|
|
|
11,358 |
|
Property and equipment,
net |
|
|
151 |
|
|
|
177 |
|
Right of use asset |
|
|
628 |
|
|
|
695 |
|
Other non-current assets |
|
|
2,012 |
|
|
|
2,012 |
|
Total
assets |
|
$ |
13,697 |
|
|
$ |
14,242 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ deficit |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Long-term debt, current portion |
|
$ |
1,508 |
|
|
$ |
1,426 |
|
Accounts payable |
|
|
10,358 |
|
|
|
7,734 |
|
Accrued expenses |
|
|
6,310 |
|
|
|
3,908 |
|
Lease liability, current portion |
|
|
330 |
|
|
|
319 |
|
Total current liabilities |
|
|
18,506 |
|
|
|
13,387 |
|
|
|
|
|
|
|
|
Lease liabilities,
long-term |
|
|
378 |
|
|
|
466 |
|
Warrant liability |
|
|
4,247 |
|
|
|
5,934 |
|
Total liabilities |
|
|
23,131 |
|
|
|
19,787 |
|
Stockholders’
deficit |
|
|
|
|
|
|
Preferred stock, $0.0001 par
value, 10,000,000 shares authorized, 4,850 issued and no shares
outstanding at March 31, 2023 and no shares issued and
outstanding at December 31, 2022 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par
value, 300,000,000 shares authorized, 932,101 and 859,402 issued
and outstanding at March 31, 2023 and December 31, 2022,
respectively |
|
|
— |
|
|
|
— |
|
Additional paid-in
capital |
|
|
404,658 |
|
|
|
403,157 |
|
Accumulated deficit |
|
|
(414,092 |
) |
|
|
(408,702 |
) |
Total stockholders’
deficit |
|
|
(9,434 |
) |
|
|
(5,545 |
) |
Total liabilities and
stockholders’ deficit |
|
$ |
13,697 |
|
|
|
14,242 |
|
|
Agile Therapeutics, Inc.Statement of
Operations(in thousands, except share and per
share data) |
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
(Unaudited) |
|
|
2023 |
|
2022 |
|
|
|
|
|
|
|
Revenues, net |
|
$ |
3,813 |
|
|
$ |
1,761 |
|
Cost of product revenues |
|
|
2,003 |
|
|
|
1,527 |
|
Gross profit |
|
|
1,810 |
|
|
|
234 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
763 |
|
|
$ |
1,257 |
|
Selling and marketing |
|
|
4,670 |
|
|
|
10,553 |
|
General and administrative |
|
|
3,085 |
|
|
|
3,997 |
|
Total operating expenses |
|
|
8,518 |
|
|
|
15,807 |
|
Loss from operations |
|
|
(6,708 |
) |
|
|
(15,573 |
) |
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
Interest income |
|
|
33 |
|
|
|
1 |
|
Interest expense |
|
|
(402 |
) |
|
|
(872 |
) |
Unrealized gain on warrant liability |
|
|
1,687 |
|
|
|
1,384 |
|
Total other income (expense), net |
|
|
1,318 |
|
|
|
513 |
|
Loss before benefit from
income taxes |
|
|
(5,390 |
) |
|
|
(15,060 |
) |
Benefit from income taxes |
|
|
— |
|
|
|
4,675 |
|
Net loss |
|
$ |
(5,390 |
) |
|
$ |
(10,385 |
) |
|
|
|
|
|
|
|
Net loss per share (basic and
diluted) |
|
$ |
(5.91 |
) |
|
$ |
(166.68 |
) |
|
|
|
|
|
|
|
Weighted-average common shares
(basic and diluted) |
|
|
912,044 |
|
|
|
62,304 |
|
|
Agile Therapeutics, Inc.Reconciliation of
GAAP Operating Expenses to Non-GAAP Operating
Expenses(Unaudited)(in
thousands) |
|
|
|
|
|
Three Months Ended |
|
|
|
|
3/31/2023 |
|
12/31/2022 |
|
9/30/2022 |
|
6/30/2022 |
|
3/31/2022 |
|
12/31/2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Operating expenses |
|
$ |
8,518 |
|
9,219 |
|
20,285 |
|
11,293 |
|
15,807 |
|
18,170 |
Non-GAAP adjustment: Loss on
disposition of assets |
|
|
- |
|
- |
|
11,122 |
|
- |
|
- |
|
- |
Non-GAAP operating
expenses |
$ |
8,518 |
|
9,219 |
|
9,163 |
|
11,293 |
|
15,807 |
|
18,170 |
|
Agile Therapeutics, Inc. Reconciliation of
Net Loss (GAAP) to adjusted Net Loss
(non-GAAP)(Unaudited)(in
thousands) |
|
|
Three Months Ended |
|
|
3/31/2023 |
|
3/31/2022 |
|
12/31/2022 |
GAAP Net Loss |
$ |
(5,390 |
) |
|
(10,385 |
) |
$ |
(3,929 |
) |
Unrealized gain on warrant liability |
|
1,687 |
|
|
1,384 |
|
|
3,349 |
|
Loss on disposition of assets |
|
- |
|
|
- |
|
|
- |
|
Non-GAAP Net Loss |
$ |
(7,077 |
) |
|
(11,769 |
) |
$ |
(7,278 |
) |
|
|
|
|
|
|
|
Non-GAAP Net Loss Per
Share |
$ |
(7.76 |
) |
|
(188.91 |
) |
$ |
(8.83 |
) |
|
|
|
|
|
|
|
Weighted avg shares |
|
912,044 |
|
|
62,304 |
|
|
824,651 |
|
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