Agile Therapeutics Reports Fourth Quarter & Full Year 2021 Financial Results and Provides Corporate Update
31 3월 2022 - 5:05AM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today reported financial results for the three and twelve
months ended December 31, 2021 and provided a corporate
update.
“2021 was our first full year of commercializing Twirla, and I
am proud of what our team was able to accomplish. We believe we
created a solid foundation for further Twirla growth in 2022
through targeted partnerships and allocation of our marketing spend
in key markets,” said Agile Therapeutics Chairman and Chief
Executive Officer Al Altomari. “We ended 2021 with double digit
growth in demand quarter over quarter and expect to see that
continue in the first quarter of 2022. We are also excited to
launch our first CTV commercial in April 2022. We believe we can
continue to build momentum through 2022, with this targeted
business plan.”
Fourth Quarter and Corporate Updates
- During the fourth quarter 2021, Twirla experienced double digit
demand growth. From the end of the third quarter to the end of the
fourth quarter 2021, key metrics for Twirla demand increased:
- Total cycles dispensed grew 32%
- Total prescriptions (TRx) grew 33%
- New prescriptions (NRx) grew 22%
- Refills grew 44%
- Total prescribers grew 24%
- The Company’s business plan for 2022 is focused on growing
demand for Twirla. Key elements include:
- Partnership with Afaxys
- In January 2022, the Company launched a co-promotion program
with Afaxys, through their group purchasing organization (GPO),
which primarily provides services to the non-retail channel, and
Afaxys Pharma, which has potential access to over 25,000 accounts,
including college and university student health centers and Planned
Parenthoods.
- The Company believes the alliance with Afaxys can drive
non-retail growth and expects to see the contribution from this
channel ramp throughout 2022.
- Targeted Focus on California
- The Company has placed a targeted focus on California, the
largest U.S. market for contraceptives, through preferred
positioning on Medi-Cal formulary.
- Medi-Cal provides healthcare to approximately 15 million
beneficiaries, and with Twirla now active on the Medi-Cal
formulary, increasing Twirla awareness and adoption in California
through direct-to-consumer (DTC) marketing is a priority.
- Launch of DTC Commercial on Connected TV (CTV)
- The Company is launching its first connected TV (or CTV)
advertisement, focusing on women in the targeted Twirla age
demographic of 18-24 years in the key states of California, Texas,
Florida, Illinois, and New York. All 5 of these states have large
markets for contraceptives and potentially strong commercial
coverage for Twirla.
- The Company believes the targeted markets mentioned above reach
approximately 41 – 45% of the current patient base, representing an
opportunity to effectively and efficiently grow our market
share.
- The Company’s CTV ad is expected to launch in early April
2022.
- In January 2022, the U.S. Departments of Labor, Health and
Human Services (HHS) and Treasury, updated guidelines reinforcing
the requirement for most commercial insurers and PBMs to cover all
FDA-approved contraceptives at no cost, if deemed medically
necessary by a provider. Additionally, The Health
Resources Service Administration (HRSA) updated their women’s
preventative service guidelines for plan years beginning in 2023 to
include that coverage of all FDA-approved, granted or cleared
contraceptives be made available as part of contraceptive care.
These updated guidelines are potentially significant for Twirla and
will be monitored throughout 2022.
- Updates on financing activities:
- The Company has no further plans to add additional funds under
the debt facility with Perceptive Advisors (“Perceptive”). In
January 2022, the Company repaid $5 million in debt from
Perceptive, reducing its debt to $15 million in exchange for relief
on certain financial covenants. The Company plans to make an
additional $5 million payment to Perceptive in the second quarter
2022.
- In March 2022, the Company closed a $4.85 million registered
direct offering of preferred stock with a single healthcare-focused
institutional investor.
- The Company expects to receive an estimated $4.7 million in
funds from the sale of New Jersey net operating losses through a
program run by the State of New Jersey in the second quarter
2022.
- The Company has called a Special Meeting of Stockholders to be
held on April 21, 2022, in order to seek approval for an amendment
to its certificate of incorporation to implement a reverse stock
split. The amendment is intended to allow the Company to regain
compliance with the Nasdaq listing requirements.
Fourth Quarter and Full Year 2021 Financial
Results
- Net revenue: In the fourth quarter 2021, the
Company realized net product sales revenue of $1.5 million, which
was at the high end of the range guided by the Company in January
2022. Revenue for the full year 2021 was $4.1 million.
- Cost of product revenues: Cost of product
revenues for the fourth quarter 2021 was $5.7 million, which
included a $4.5 million inventory obsolescence charge for product
not expected to be sold prior to its shelf-life date, which is 12
months prior to expiry. Full year cost of product revenue was $10.7
million, including $5.9 million of inventory obsolescence
reserves.
- Total operating expenses: Total
operating expenses were $18.2 million for the quarter
ended December 31, 2021, compared to $17.2
million for the comparable period in 2020. Full year operating
expenses were $64.4 million compared to $49.5 million in 2020. The
overall increase is primarily related to consumer-based marketing
efforts and the sales force, which was in place for the full year
of 2021.
- Cash and cash equivalents: As
of December 31, 2021, the Company had $19.1
million of cash and cash equivalents, compared to $14.7
million of cash and cash equivalents as of the end of the
third quarter 2021. The increase in cash on hand is related to a
public offering completed in the fourth quarter, netting $21.1
million, offset by working capital burn during the quarter.
- Net loss: Net loss was $23.4
million, or $0.20 per share, for the quarter
ended December 31, 2021, compared to a net loss of $17.6
million, or $0.20 per share, for the comparable period in
2020. For the full year, net loss was $74.9 million in 2021, or
$0.77 per share, compared to a net loss of $51.9 million, or $0.61
per share, in 2020.
- Shares Outstanding: Agile had 121,396,033
shares of common stock outstanding at year end 2021.
Conference Call and Webcast
Date |
Wednesday, March 30, 2022 |
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 |
7088441 |
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. The required Conference ID is 7088441. 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 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 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 partnership with Afaxys and its
ability to promote growth, regulatory and legislative developments
in the United States, our future plans with respect to our existing
debt financing from Perceptive Advisors, our receipt of funds from
the sale of net operating losses in New Jersey, our ability to come
into compliance with the listing requirements of Nasdaq, our
results of operations, revenues, financial condition, liquidity,
prospects, growth and strategies, and the expected benefits of our
marketing and sales distribution strategies generally. 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, 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 come into compliance with the listing requirements of Nasdaq 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.
|
|
Agile Therapeutics, Inc.Balance
Sheets(Unaudited)(in thousands,
except par value and share data) |
|
|
|
December 31, |
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
19,143 |
|
|
$ |
14,463 |
|
Marketable securities |
|
— |
|
|
|
40,008 |
|
Accounts receivable, net |
|
1,533 |
|
|
|
865 |
|
Inventory, net |
|
966 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
2,283 |
|
|
|
1,449 |
|
Total current assets |
|
23,925 |
|
|
|
56,785 |
|
Property and equipment, net |
|
12,447 |
|
|
|
14,243 |
|
Right of use asset |
|
949 |
|
|
|
138 |
|
Other non-current assets |
|
2,012 |
|
|
|
1,896 |
|
Total assets |
$ |
39,333 |
|
|
$ |
73,062 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Long-term debt, current portion |
$ |
16,833 |
|
|
$ |
— |
|
Accounts payable |
|
8,707 |
|
|
|
3,867 |
|
Accrued expenses |
|
3,563 |
|
|
|
3,348 |
|
Lease liability, current portion |
|
175 |
|
|
|
138 |
|
Total current liabilities |
|
29,278 |
|
|
|
7,353 |
|
|
|
|
|
|
|
Lease liabilities, long-term |
|
784 |
|
|
|
— |
|
Long-term debt |
|
— |
|
|
|
16,381 |
|
Total liabilities |
|
30,062 |
|
|
|
23,734 |
|
Commitments and contingencies |
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
Common stock, $.0001 par value, 150,000,000 shares authorized,
121,396,033 and 87,563,753 issued and outstanding at 12/31/21 and
12/31/20, respectively |
|
12 |
|
|
|
9 |
|
Additional paid-in capital |
|
396,376 |
|
|
|
361,539 |
|
Accumulated other comprehensive income |
|
— |
|
|
|
3 |
|
Accumulated deficit |
|
(387,117 |
) |
|
|
(312,223 |
) |
Total stockholders’ equity |
|
9,271 |
|
|
|
49,328 |
|
Total liabilities and stockholders’ equity |
$ |
39,333 |
|
|
$ |
73,062 |
|
|
|
|
|
|
Agile Therapeutics, Inc.Statements of
Operations(Unaudited)(in
thousands, except per share and share data) |
|
|
|
|
|
|
|
Three Months Ended |
|
Year ended |
|
|
December 31, |
|
December 31, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues, net |
|
$ |
1,514 |
|
|
$ |
749 |
|
|
$ |
4,101 |
|
|
$ |
749 |
|
Cost of product revenues |
|
|
5,702 |
|
|
|
282 |
|
|
|
10,718 |
|
|
|
282 |
|
Gross profit |
|
|
(4,188 |
) |
|
|
467 |
|
|
|
(6,617 |
) |
|
|
467 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,656 |
|
|
$ |
3,011 |
|
|
$ |
6,246 |
|
|
$ |
13,500 |
|
Selling and marketing |
|
|
12,670 |
|
|
|
10,670 |
|
|
|
43,444 |
|
|
|
23,285 |
|
General and administrative |
|
|
3,846 |
|
|
|
3,527 |
|
|
|
14,698 |
|
|
|
12,735 |
|
Total operating expenses |
|
|
18,172 |
|
|
|
17,208 |
|
|
|
64,388 |
|
|
|
49,520 |
|
Loss from operations |
|
|
(22,360 |
) |
|
|
(16,741 |
) |
|
|
(71,005 |
) |
|
|
(49,053 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1 |
|
|
|
25 |
|
|
|
25 |
|
|
|
309 |
|
Interest expense |
|
|
(999 |
) |
|
|
(904 |
) |
|
|
(3,914 |
) |
|
|
(3,109 |
) |
Total other income (expense), net |
|
|
(998 |
) |
|
|
(879 |
) |
|
|
(3,889 |
) |
|
|
(2,800 |
) |
Net loss |
|
$ |
(23,358 |
) |
|
$ |
(17,620 |
) |
|
$ |
(74,894 |
) |
|
$ |
(51,853 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share (basic and diluted) |
|
$ |
(0.20 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.77 |
) |
|
$ |
(0.61 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares (basic and diluted) |
|
117,917,775 |
|
|
|
87,448,501 |
|
|
|
97,072,847 |
|
|
|
84,683,084 |
|
Contact:
Matt Riley
Head of Investor Relations & Corporate Communications
mriley@agiletherapeutics.com
Agile Therapeutics (NASDAQ:AGRX)
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Agile Therapeutics (NASDAQ:AGRX)
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