Agile Therapeutics Reports First Quarter 2022 Financial Results and Provides Corporate Update
13 5월 2022 - 5:05AM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today reported financial results for the three months
ended March 31, 2022 and provided a corporate update.
“We produced another quarter of double-digit growth in key
prescription data for Twirla while also increasing revenue and
reducing cash burn,” said Agile Therapeutics Chairman and Chief
Executive Officer Al Altomari. “ Based on the prescription data
trends we are seeing so far in the second quarter and the
advancement of our Twirla business plan, we currently expect to
report a fourth consecutive quarter of strong demand growth for the
second quarter 2022 and provide further confidence that our
business plan is delivering.”
First Quarter and Recent Corporate Updates
- As previously reported in April 2022, Twirla experienced
another quarter of double-digit demand growth. From the end of the
fourth quarter 2021 to the end of the first quarter 2022, key
metrics for Twirla demand increased:
- Total cycles dispensed grew 29%
- Total prescriptions (TRx) grew 27%
- New prescriptions (NRx) grew 22%
- Refills (RRx) grew 31%
- Total prescribers grew 26%
- The Company’s three-part Twirla business plan for 2022 is
contributing to continued growth momentum for Twirla. Updates
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.
- During the first quarter of 2022, the Company focused on
initiating and mobilizing the Afaxys partnership and believes it is
beginning to contribute to Twirla revenue into April and May 2022.
The Company expects that the alliance with Afaxys can continue to
drive non-retail growth throughout 2022.
- Targeted Focus on California
- The Company is focused on growing the Twirla brand in
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.
- The Company is beginning to see an increase in Twirla market
share and Twirla prescribers in California, both of which it
believes are attributable to the existing sales team and
advertising via both general and targeted media.
- Launch of DTC Commercial on Connected TV (CTV)
- In late March 2022, the Company launched its first connected TV
(or CTV) advertisement, focusing on women in the targeted Twirla
age demographic of 18-24 years in states that have large markets
for contraceptives and potentially strong commercial coverage for
Twirla.
- The first month of data for the ad suggests that target
consumers are being effectively exposed to the ad at a frequency of
approximately twice per week and that a significant majority of the
viewers are not skipping through the ad.
- Updates on financing plan:
- Part 1: Work Down Debt Facility with Perceptive Advisors
(“Perceptive”)
- There are no plans to further leverage the Company and
additional funds will not be added under the debt facility.
- In January 2022, the Company paid back $5 million to
Perceptive, reducing its outstanding debt to $15 million.
- In the second quarter 2022, the Company plans to make another
payment of $5 million in principal to Perceptive in exchange for
relief on financial covenants.
- Part 2: Regain Compliance with Nasdaq
- As previously reported, the Company was notified by Nasdaq that
it was out of compliance with the Nasdaq Stock Market minimum bid
price requirement.
- The Company’s stock is now trading above the minimum bid price
requirement and, on May 11, 2022, the Company was notified by
Nasdaq that it had regained compliance.
- Part 3: Raise Additional Capital
- The Company plans to remain flexible and will continue to
evaluate all available financing options, including the recently
established at-the-market offering (ATM) program, and further
equity offerings. The Company also believes that an important part
of its plan moving forward is to explore all strategic options to
grow or transform its business.
- On April 26, 2022, the Company announced a 1-for-40 reverse
stock split of its common shares (the “Reverse Stock Split”). The
Reverse Stock Split became effective at 5:00 p.m. Eastern time on
April 26, 2022 and the Company’s common stock opened for trading on
The Nasdaq Capital Market on a post-split basis under the Company’s
existing trading symbol “AGRX” on April 27, 2022. At such time, the
Company’s common stock also commenced trading under a new CUSIP
number, 00847L209. All issued and outstanding shares of common
stock, warrants, common stock options, and unvested restricted
stock units and the related per share amounts contained in the
financial statements have been retroactively adjusted to reflect
the Reverse Stock Split for all periods presented.
First Quarter 2022 Financial Results
- Net revenue: In the first quarter 2022, the
Company realized net product sales revenue of $1.8 million, which
was within the guidance of $1.7 million to $1.9 million
communicated by the Company in April 2022.
- Cost of product revenues: Cost of product
revenues for the first quarter 2022 was $1.5 million, which
consisted of direct and indirect costs related to the manufacturing
of Twirla sold during the first quarter. The Company had no charges
for obsolescence during the first quarter of 2022 and remains
focused on managing its inventory levels to meet the needs of its
customers’ demand while avoiding oversupply.
- Total operating expenses: Total
operating expenses were $15.8 million for the quarter
ended March 31, 2022, compared to $15.2 million for
the comparable period in 2021. The $15.8 million amount was within
the guidance of $15.5 million to $16.5 million communicated by the
Company in April 2022. The Company plans to continue to optimize
its spending by engaging in targeted, focused spending in support
of growing Twirla, while seeking reductions in other areas of its
operations. Based on this plan, the Company anticipates future 2022
quarterly operating expenses to be lower than that experienced in
the first quarter 2022. The Company is examining other areas within
its operations that can be reduced in a way that will not
compromise its plan to grow Twirla. The Company’s officers and
senior management team have voluntarily forgone the annual bonuses
for 2021 performance that were awarded in January of 2022, which is
estimated to result in a savings of approximately $700,000 and will
be used for general corporate purposes.
- Cash and cash equivalents: As
of March 31, 2022, the Company had $3.7 million of
cash and cash equivalents, compared to $19.1 million of
cash and cash equivalents as of the end of the fourth quarter
2021. In April 2022, the Company added cash of $4.7 million from
the sale of its New Jersey Net Operating Losses, for which a
receivable was recorded in the first quarter. The decrease in cash
on hand reflects working capital burn during the quarter and a $5
million pay down of the debt with Perceptive in January, offset by
proceeds from a $4.85 million registered direct offering of
preferred stock with a single healthcare-focused institutional
investor.
- Net loss: Net loss was $11.8
million, or $3.78 per share, for the quarter
ended March 31, 2022, compared to a net loss of $17.1
million, or $8.00 per share, for the comparable period in
2021.
- Shares Outstanding: As of March 31, 2022,
Agile had 3,365,422 shares of common stock outstanding. This number
has been retroactively adjusted to reflect the Reverse Stock Split
effected in April 2022.
Conference Call and Webcast
Date |
Thursday, May 12, 2022 |
Time |
4:30 p.m. ET |
Webcast (live and
archived) |
Events &
Presentations |
Dial-in numbers |
(888) 330-2454 (U.S.
toll-free) or (240) 789-2714 |
Conference ID |
7871426 |
Investors interested in listening to the conference call may do
so by dialing (888) 330-2454 for domestic callers or (240) 789-2714
for international callers. The required Conference ID is 7871426. 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.
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. The prescription data results reported in this press release
are reported as of April 29, 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.
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, our partnership with Afaxys and its
ability to promote growth, our future plans with respect to our
existing debt financing from Perceptive Advisors, our prospects for
future financing arrangements, our ability to maintain compliance
with the listing requirements of Nasdaq, our operating expenses,
financial condition, 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 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 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 effects of
the ongoing 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 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.
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, |
|
|
|
2022 |
|
2021 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
3,743 |
|
|
$ |
19,143 |
|
|
Accounts receivable, net |
|
|
1,665 |
|
|
|
1,533 |
|
|
Income taxes receivable |
|
|
4,675 |
|
|
|
— |
|
|
Inventory, net |
|
|
2,693 |
|
|
|
966 |
|
|
Prepaid expenses and other current assets |
|
|
1,576 |
|
|
|
2,283 |
|
|
Total current assets |
|
|
14,352 |
|
|
|
23,925 |
|
|
Property and equipment, net |
|
|
12,047 |
|
|
|
12,447 |
|
|
Right of use asset |
|
|
888 |
|
|
|
949 |
|
|
Other non-current assets |
|
|
2,012 |
|
|
|
2,012 |
|
|
Total
assets |
|
$ |
29,299 |
|
|
$ |
39,333 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Long-term debt, current portion |
|
$ |
12,252 |
|
|
$ |
16,833 |
|
|
Accounts payable |
|
|
9,537 |
|
|
|
8,707 |
|
|
Accrued expenses |
|
|
3,828 |
|
|
|
3,563 |
|
|
Lease liability, current portion |
|
|
231 |
|
|
|
175 |
|
|
Total current liabilities |
|
|
25,848 |
|
|
|
29,278 |
|
|
|
|
|
|
|
|
|
|
Lease liabilities, long-term |
|
|
708 |
|
|
|
784 |
|
|
Long-term debt |
|
|
— |
|
|
|
— |
|
|
Total
liabilities |
|
|
26,556 |
|
|
|
30,062 |
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
|
Preferred stock, $.0001 par value, 10,000,000 shares authorized,
4,850 issued and 2,425 outstanding at March 31, 2022 and
no shares issued and outstanding at
December 31, 2021 |
|
|
887 |
|
|
|
— |
|
|
Common stock, $.0001 par value, 300,000,000 shares authorized,
3,365,422 and 3,034,901 issued and outstanding at
March 31, 2022 and December 31, 2021,
respectively |
|
|
— |
|
|
|
— |
|
|
Additional paid-in capital |
|
|
400,742 |
|
|
|
396,388 |
|
|
Accumulated deficit |
|
|
(398,886 |
) |
|
|
(387,117 |
) |
|
Total stockholders’
equity |
|
|
2,743 |
|
|
|
9,271 |
|
|
Total liabilities and
stockholders’ equity |
|
$ |
29,299 |
|
|
$ |
39,333 |
|
|
Agile Therapeutics,
Inc.Statements of
Operations(Unaudited)(in
thousands, except per share and share data)
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
Revenues, net |
$ |
1,761 |
|
|
$ |
116 |
|
|
Cost of product revenues |
|
1,527 |
|
|
|
1,161 |
|
|
Gross profit (loss) |
|
234 |
|
|
|
(1,045 |
) |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
$ |
1,257 |
|
|
$ |
2,123 |
|
|
Selling and marketing |
|
10,553 |
|
|
|
9,253 |
|
|
General and administrative |
|
3,997 |
|
|
|
3,801 |
|
|
Total operating expenses |
|
15,807 |
|
|
|
15,177 |
|
|
Loss from operations |
|
(15,573 |
) |
|
|
(16,222 |
) |
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
Interest income |
|
1 |
|
|
|
16 |
|
|
Interest expense |
|
(872 |
) |
|
|
(922 |
) |
|
Total other income (expense),
net |
|
(871 |
) |
|
|
(906 |
) |
|
Loss before benefit from
income taxes |
|
(16,444 |
) |
|
|
(17,128 |
) |
|
Benefit from income taxes |
|
4,675 |
|
|
|
— |
|
|
Net loss |
$ |
(11,769 |
) |
|
$ |
(17,128 |
) |
|
|
|
|
|
|
|
|
Net loss per share (basic and
diluted) |
$ |
(3.78 |
) |
|
$ |
(8.00 |
) |
|
|
|
|
|
|
|
|
Weighted-average common shares
(basic and diluted) |
|
3,115,211 |
|
|
|
2,190,650 |
|
|
Agile Therapeutics (NASDAQ:AGRX)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
Agile Therapeutics (NASDAQ:AGRX)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024