Agile Therapeutics Reports Fourth Quarter & Full Year 2020 Financial Results; Expands Loan Facility With Perceptive Advisors
March 01 2021 - 4:05PM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today reported financial results for the three and twelve
months ended December 31, 2020 and provided a corporate
update.
“We closed out 2020 on a high note with the commercial launch of
Twirla® in December, following the approval by the U.S. Food and
Drug Administration. Supported by the tireless efforts of the
entire Agile team, a dedicated sales force and broad wholesaler
relationships, we shipped commercial product to wholesalers in our
targeted time frame and we believe we are now well-positioned to
continue our early launch momentum with strong interest continuing
to support Twirla’s growth,” said Al Altomari, Chairman and Chief
Executive Officer of Agile. “We continue to be optimistic about
Twirla’s trajectory, which we expect to be further supported by our
new partnership with Sterling Specialty Pharmacy and bolstered by
the increased flexibility from the remaining $25 million
potentially available from Perceptive Advisors.”
Recent Corporate Developments, Financing Update and
Fourth Quarter & Full Year 2020 Results:
Twirla and Company Updates
- In 2020, The Company entered into distribution agreements with
three major U.S. wholesalers, as well as several regional
wholesalers.
- In the fourth quarter of 2020, Agile finalized the validation
of its commercial manufacturing process of Twirla and commenced
commercial shipments of product to wholesalers in December
2020.
- On February 24, 2021, the Company entered into an agreement
with Sterling Specialty Pharmacy – a company that shares our
patient-first philosophy – which we believe will play a critical
role in accelerating the uptake of Twirla by making it easy for
providers to prescribe and convenient for patients to receive their
filled prescription.
- The Company expects that Twirla will now become available to
the members of one of the country’s largest closed health care
systems, based on a recently negotiated group purchasing
organization agreement, which will provide another channel for
patients to access Twirla.
- Agile continued with its payor engagement strategy for
obtaining coverage and reimbursement for Twirla and estimates it
has achieved approximately 40-45% commercial formulary coverage so
far– inclusive of one of the three major pharmacy benefit managers
and other smaller plans. Efforts to increase formulary access are
ongoing.
- The Company continues to build awareness among prescribers, to
drive increased traction and support market access for Twirla.
Sampling efforts are ongoing and the compounded weekly prescription
(TRx) growth rate shows early momentum in the launch. Additionally,
the Company is beginning to see units dispersed at pharmacies as
refills.
- Agile hired Dr. Paul Korner, M.D., as the Chief Medical Officer
in August 2020. Dr. Korner is leading an evaluation of our existing
pipeline, including potential development costs and timelines. The
Company is also exploring potential expansion through business
development opportunities.
- In 2020, through Syneos Selling Solutions, the Company’s
contract sales force partner, Agile hired and deployed a sales
force of 8 regional virtual sales specialists and 65 sales
professionals; a total of 73 individuals calling on the healthcare
provider (“HCP”) audience. Since launch, the sales force has been
able to conduct roughly 70% of prescriber meetings face-to-face in
a COVID-19 compliant setting.
I’m So
Done – A National Unbranded
Awareness Campaign
- In September 2020, the Company launched I’m So
Done, an education and empowerment platform that encourages women
to think about their current contraceptive method and
decision-making journey. We are encouraged by our preliminary
results, which include:
- High levels of engagement with our website content via display
and paid social efforts, which has empowered women to join in the
birth control conversation.
- Agile is breaking the status quo of
the contraceptive category, introducing the first birth control
awareness campaign on TikTok, the most downloaded app of
2020.
Financing Update – Expanded Loan Facility with
Perceptive Advisors
- In February 2020, Agile entered into
a senior secured term loan credit facility with Perceptive Advisors
(Perceptive), which provided support for the commercialization of
Twirla. Of the initial $35 million in funding provided by
Perceptive, $20 million was drawn down by Agile in 2020 and $15
million is remaining through 2021, available upon the achievement
of certain revenue milestones.
- Perceptive Advisors is now providing
an additional $10 million through our loan facility, under a fourth
tranche. This amount will be available through June 2022 and is
also contingent on achieving a pre-determined revenue target.
- In total, our funding available from
Perceptive Advisors has increased to $45 million and reflects
continued support from a well-regarded leader in growth capital
financing.
- This strategic debt financing, along
with our cash balance, puts the Company in a position to not only
cover projected operating requirements in 2021, but also provides
Agile with increased financial flexibility going forward.
- Finally, with the pandemic impact
continuing into this year, should the impact of COVID-19 or other
factors impact the Company’s current business plans or its ability
to generate revenue from Twirla, the Company believes it has the
ability to revise its commercial plans, including curtailing sales
and marketing spending, to allow it to continue to fund its
operations.
Fourth Quarter and Full Year 2020 Financial
Results
- Gross revenue: As guided, the Company achieved
just over $1 million in gross revenue in the fourth quarter,
reflecting the initial stocking of Twirla into the channel.
- Cash, cash equivalents and marketable
securities: As of December 31, 2020, Agile
had $54.5 million of cash, cash equivalents and
marketable securities, compared to $34.5 million of cash
and cash equivalents as of December 31, 2019.
- Research and development (R&D)
expenses: R&D expenses were $3.0
million for the quarter ended December 31, 2020, compared
to $2.8 million for the comparable period in 2019. For
the full year, R&D expenses were $13.5 million in 2020, and
$9.9 million in 2019. The increase in year-over-year R&D
expenses was primarily due to costs to validate the commercial
manufacturing process for Twirla by Corium, the Company’s contract
manufacturer, as well as clinical development and personnel-related
expenses.
- Selling and marketing expenses: Selling and
marketing expenses were $10.7 million for the quarter ended
December 31, 2020, compared to $0.8 million for the comparable
period in 2019. For the full year, selling and marketing expenses
were $23.3 million in 2020, and $1.1 million in 2019. The increase
in year-over-year selling and marketing expenses was due to higher
costs associated with the Company’s pre-commercialization
activities for Twirla, such as brand building, advocacy, market
research and consulting, and the costs of establishing and
maintaining our contract sales force.
- General and administrative (G&A)
expenses: G&A expenses were $3.5
million for the quarter ended December 31, 2020, compared
to $2.5 million for the comparable period in
2019. For the full year, G&A expenses were $12.7 million
in 2020, and $7.9 million in 2019. The increase in year-over-year
G&A expenses reflected activities related to build out the
support infrastructure including higher personnel costs and
professional fees, as well as an increase in stock compensation
expense.
- Net loss: Net loss was $17.6
million, or $0.20 per share, for the quarter
ended December 31, 2020, compared to a net loss of $6.0
million, or $0.10 per share, for the comparable period in
2019. For the full year, net loss was $51.9 million, or $0.61 per
share in 2020, compared to a net loss of $18.6 million, or $0.38
per share in 2019.
- Shares Outstanding: Agile had 87,563,753
shares of common stock outstanding at year end 2020.
Conference Call and WebcastAgile
Therapeutics will host a conference call and webcast to
discuss financial results for the third quarter ended March 1,
2021, today at 4:30 pm ET. Investors and other interested
parties may participate by registering for a teleconference line or
live webcast link 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 forward-looking 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.
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®, the
development of our other potential product candidates, our results
of operations, financial condition, liquidity, prospects, growth
and strategies, 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 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 amount 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
Communicationsmriley@agiletherapeutics.com
Agile Therapeutics,
Inc.Balance
Sheets(Unaudited)(in thousands,
except par value and share data)
|
|
December 31, |
|
|
2020 |
|
|
2019 |
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
14,463 |
|
|
$ |
34,479 |
|
Marketable securities |
|
|
40,008 |
|
|
|
- |
|
Accounts receivable, net |
|
|
865 |
|
|
|
- |
|
Prepaid expenses |
|
|
1,449 |
|
|
|
840 |
|
Total
current assets |
|
|
56,785 |
|
|
|
35,319 |
|
Property and
equipment, net |
|
|
14,243 |
|
|
|
14,044 |
|
Right of use
asset |
|
|
138 |
|
|
|
158 |
|
Other
non-current assets |
|
|
1,896 |
|
|
|
19 |
|
Total assets |
|
$ |
73,062 |
|
|
$ |
49,540 |
|
|
|
|
|
|
|
|
Liabilities and stockholders equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,867 |
|
|
$ |
1,819 |
|
Accrued expenses |
|
|
3,348 |
|
|
|
1,804 |
|
Lease liability, current portion |
|
|
138 |
|
|
|
172 |
|
Total
current liabilities |
|
|
7,353 |
|
|
|
3,795 |
|
|
|
|
|
|
|
|
Long-term
debt |
|
|
16,381 |
|
|
|
- |
|
Total liabilities |
|
|
23,734 |
|
|
|
3,795 |
|
Commitments and contingencies |
|
|
|
|
|
|
Stockholders equity |
|
|
|
|
|
|
Common stock, $.0001 par value, 150,000,000 shares authorized,
87,563,753 and 69,810,305 issued and outstanding at December 31,
2020 and December 31, 2019, respectively |
|
|
9 |
|
|
|
7 |
|
Additional paid-in capital |
|
|
361,539 |
|
|
|
306,108 |
|
Accumulated other comprehensive income |
|
|
3 |
|
|
|
- |
|
Accumulated deficit |
|
|
(312,223 |
) |
|
|
(260,370 |
) |
Total stockholders equity |
|
|
49,328 |
|
|
|
45,745 |
|
Total liabilities and stockholders equity |
|
$ |
73,062 |
|
|
$ |
49,540 |
|
|
|
|
|
|
|
|
Agile Therapeutics,
Inc.Statements of
Operations(Unaudited)(in
thousands, except per share and share data)
|
|
Three Months
Ended |
|
Year
ended |
|
|
|
December 31, |
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues, net |
|
$ |
749 |
|
|
$ |
- |
|
|
$ |
749 |
|
|
$ |
- |
|
|
Cost of
product revenues |
|
|
282 |
|
|
|
- |
|
|
|
282 |
|
|
|
- |
|
|
Gross
profit |
|
|
467 |
|
|
|
- |
|
|
|
467 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
$ |
3,011 |
|
|
$ |
2,837 |
|
|
$ |
13,500 |
|
|
$ |
9,858 |
|
|
Selling and
marketing |
|
|
10,670 |
|
|
|
755 |
|
|
|
23,285 |
|
|
|
1,085 |
|
|
General and
administrative |
|
|
3,527 |
|
|
|
2,513 |
|
|
|
12,735 |
|
|
|
7,915 |
|
|
Total
operating expenses |
|
|
17,208 |
|
|
|
6,105 |
|
|
|
49,520 |
|
|
|
18,858 |
|
|
Loss from
operations |
|
|
(16,741 |
) |
|
|
(6,105 |
) |
|
|
(49,053 |
) |
|
|
(18,858 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
|
25 |
|
|
|
84 |
|
|
|
309 |
|
|
|
252 |
|
|
Interest
expense |
|
|
(904 |
) |
|
|
- |
|
|
|
(3,109 |
) |
|
|
- |
|
|
Total other
income (expense), net |
|
|
(879 |
) |
|
|
84 |
|
|
|
(2,800 |
) |
|
|
252 |
|
|
Loss before
benefit from income taxes |
|
|
(17,620 |
) |
|
|
(6,021 |
) |
|
|
(51,853 |
) |
|
|
(18,606 |
) |
|
Benefit from
income taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Net
loss |
|
$ |
(17,620 |
) |
|
$ |
(6,021 |
) |
|
$ |
(51,853 |
) |
|
$ |
(18,606 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share (basic and diluted) |
|
$ |
(0.20 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.61 |
) |
|
$ |
(0.38 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares (basic and diluted) |
|
|
87,448,501 |
|
|
|
62,559,514 |
|
|
|
84,683,084 |
|
|
|
49,432,487 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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