Agile Therapeutics Reports Third Quarter 2020 Financial Results
November 12 2020 - 4:05PM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today reported financial results for the three and nine
months ended September 30, 2020 and provided a corporate update.
“With our commercial launch of Twirla expected
by the end of the year, we remain on track to deliver on our plan.
The final validation of our commercial manufacturing process
continues to progress as all three of our batches are expected to
be released for commercial use in December 2020. By taking steps to
build out an experienced sales force, secure major wholesaler
agreements and increase market access for Twirla, we believe we are
well-prepared to hit the ground running. Having our first
FDA-approved product nearing launch marks an exciting time for
Agile and we look forward to bringing to the market another choice
for women to help fulfill their contraceptive needs,” said Al
Altomari, Chairman and Chief Executive Officer of Agile.
Third Quarter 2020 and Other Recent
Corporate Developments:
Twirla Commercialization
Update
- The Company intends to begin shipping product to wholesalers by
year-end 2020.
- Agile remains on track to finalize the validation of its
commercial manufacturing process of Twirla.• All three
validation batches are expected to be released for commercial use
in December 2020.
- The Company continued to build its distribution network by
entering into an agreement with a third major U.S.
wholesaler.
- The Company continues to build awareness among prescribers and
health care providers to gain market access for Twirla.•
Product sampling expected to begin at launch.
- Through Syneos Selling Solutions, the Company’s contract sales
force partner, Agile completed the hiring of an initial sales team
of 73 persons.• The sales force initiated discussions with
healthcare providers after it was fully deployed in
mid-October.
Strengthened Executive Leadership
Team
- In August 2020, the Company appointed Paul Korner, MD, MBA, as
Chief Medical Officer. Dr. Korner is a board-certified obstetrician
and gynecologist with more than 20 years of pharmaceutical and
biotech industry experience, including significant experience
within women’s healthcare.
Launched I’m So Done – A National
Unbranded 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.
Financial Guidance
- The Company narrowed its operating
expense guidance for the full year 2020 to be in the range of $52
million to $54 million, with general and administrative expenses
accounting for approximately 70% of the spending as it builds out
its commercial infrastructure. The Company’s operating expenses
guidance includes $2.7 million to $3 million of non-cash stock
compensation expense. The Company expects its gross revenue
in the fourth quarter of 2020, reflecting expectations of initial
stocking of Twirla by wholesalers, to be approximately $1
million.
- Based on the Company’s current
business plan and pending launch of Twirla, the Company believes
that its cash, cash equivalents and marketable securities as of
September 30, 2020 will be sufficient to meet its projected
operating requirements through the end of 2021. If the
COVID-19 pandemic or other factors impact the Company’s current
business plans or its ability to generate revenue from the launch
of 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.
Third Quarter Financial
Results
- Cash, cash equivalents and
marketable securities: As of
September 30, 2020, Agile had $71.9 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 $3.7
million for the quarter ended September 30, 2020, compared to $2.4
million for the comparable period in 2019. The increase in R&D
expenses was primarily due to costs to conduct validation work for
commercial manufacturing of Twirla by Corium, the Company’s
contract manufacturer.
- General and administrative
(G&A) expenses: G&A expenses were $11.0
million for the quarter ended September 30, 2020, compared to $2.1
million for the comparable period in 2019. The increase in
G&A expenses was primarily due to higher costs associated with
the Company’s pre-commercialization activities for Twirla, such as
brand building, advocacy, market research and consulting. The
increase in G&A expenses was also attributable to activities
related to building out the commercial organization and included
higher salaries and higher professional fees related to recruiting
fees and consultants, and an increase in stock compensation
expense.
- Net loss:
Net loss was $15.5 million, or $0.18 per share, for the quarter
ended September 30, 2020, compared to a net loss of $4.4 million,
or $0.08 per share, for the comparable period in 2019.
- Shares
Outstanding: As of September 30, 2020, Agile had
87,434,604 shares of common stock outstanding.
Conference Call and
WebcastAgile Therapeutics will host a conference call and
webcast to discuss financial results for the third quarter ended
September 30, 2020 today at 4:30pm ET. Investors interested in
listening to the conference call may do so by dialing (877)
407-2991 for domestic callers or (201) 389-0925 for international
callers. 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 to
prevent pregnancy. 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 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 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 the status and timing of the validation of our
commercial manufacturing process, market availability of Twirla,
our projected cash position, our projected fiscal year 2020
operating expenses and gross and net revenue and the expected
timing and structure of our commercialization plan for
Twirla. 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, our ability along with our third-party
manufacturer, Corium, to complete successfully the scale-up of the
commercial manufacturing process for Twirla, the performance and
financial condition of Corium or any of its suppliers, 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 successful development of
our sales and marketing capabilities, 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, 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 Communications
mriley@agiletherapeutics.com
Agile
Therapeutics, Inc.Balance
Sheets(Unaudited)(in thousands,
except par value and share data)
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
2020 |
|
2019 |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
24,163 |
|
|
$ |
34,479 |
|
Marketable securities |
|
47,742 |
|
|
|
— |
|
Prepaid expenses |
|
1,414 |
|
|
|
840 |
|
Total current assets |
|
73,319 |
|
|
|
35,319 |
|
Property and equipment, net |
|
14,271 |
|
|
|
14,044 |
|
Right of use asset |
|
31 |
|
|
|
158 |
|
Other non-current assets |
|
1,791 |
|
|
|
19 |
|
Total
assets |
$ |
89,412 |
|
|
$ |
49,540 |
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
5,016 |
|
|
$ |
1,819 |
|
Accrued expenses |
|
2,154 |
|
|
|
1,804 |
|
Lease liability, current portion |
|
34 |
|
|
|
172 |
|
Total current liabilities |
|
7,204 |
|
|
|
3,795 |
|
|
|
|
|
|
|
Long-term debt |
|
16,078 |
|
|
|
— |
|
Total
liabilities |
|
23,282 |
|
|
|
3,795 |
|
Commitments and
contingencies |
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
Common stock, $.0001 par value, 150,000,000 shares authorized,
87,434,604 and 69,810,305 issued and outstanding at
September 30, 2020 and December 31, 2019,
respectively |
|
9 |
|
|
|
7 |
|
Additional paid-in capital |
|
360,713 |
|
|
|
306,108 |
|
Accumulated other comprehensive income |
|
11 |
|
|
|
— |
|
Accumulated deficit |
|
(294,603 |
) |
|
|
(260,370 |
) |
Total stockholders’
equity |
|
66,130 |
|
|
|
45,745 |
|
Total liabilities and
stockholders’ equity |
$ |
89,412 |
|
|
$ |
49,540 |
|
Agile
Therapeutics, Inc.Statements of
Operations(Unaudited)(in
thousands, except per share and share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
3,663 |
|
|
$ |
2,361 |
|
|
$ |
10,488 |
|
|
$ |
7,021 |
|
General and administrative |
|
10,993 |
|
|
|
2,138 |
|
|
|
21,824 |
|
|
|
5,732 |
|
Total operating expenses |
|
14,656 |
|
|
|
4,499 |
|
|
|
32,312 |
|
|
|
12,753 |
|
Loss from operations |
|
(14,656 |
) |
|
|
(4,499 |
) |
|
|
(32,312 |
) |
|
|
(12,753 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
37 |
|
|
|
67 |
|
|
|
284 |
|
|
|
168 |
|
Interest expense |
|
(905 |
) |
|
|
— |
|
|
|
(2,205 |
) |
|
|
— |
|
Total other income (expense),
net |
|
(868 |
) |
|
|
67 |
|
|
|
(1,921 |
) |
|
|
168 |
|
Loss before benefit from income
taxes |
|
(15,524 |
) |
|
|
(4,432 |
) |
|
|
(34,233 |
) |
|
|
(12,585 |
) |
Benefit from income taxes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
$ |
(15,524 |
) |
|
$ |
(4,432 |
) |
|
$ |
(34,233 |
) |
|
$ |
(12,585 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share (basic and
diluted) |
$ |
(0.18 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.41 |
) |
|
$ |
(0.28 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares
(basic and diluted) |
|
87,350,505 |
|
|
|
53,609,511 |
|
|
|
83,754,550 |
|
|
|
44,957,809 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(15,524 |
) |
|
$ |
(4,432 |
) |
|
$ |
(34,233 |
) |
|
$ |
(12,585 |
) |
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on
marketable securities |
|
1 |
|
|
|
— |
|
|
|
11 |
|
|
|
— |
|
Comprehensive loss |
$ |
(15,523 |
) |
|
$ |
(4,432 |
) |
|
$ |
(34,222 |
) |
|
$ |
(12,585 |
) |
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