Agile Therapeutics Reports Second Quarter 2020 Financial Results
August 11 2020 - 4:01PM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today reported financial results for the three and six
months ended June 30, 2020 and provided a corporate update.
“Thanks to the dedication and commitment of the
Agile team, we made considerable progress on our objectives and we
believe we are on track to launch Twirla in the fourth quarter of
2020. During the second quarter, we transitioned into the final
validation phase of manufacturing commercial product. Through
Syneos Selling Solutions, our contract sales force partner, we also
hired several industry veterans to build out our sales force
highlighted by Terry Herring, a recognized leader with more than 30
years of pharmaceutical and healthcare experience, as our new
National Sales Leader. We believe our strong financial position and
cash balance, combined with our recent achievements, set us up well
to commercially launch Twirla and establish Agile in the
contraceptive prescription marketplace,” said Al Altomari,
Chairman and Chief Executive Officer of Agile.
Second Quarter 2020 and Other Recent
Corporate Developments:
COVID-19 Update
- As of today, despite the COVID-19 pandemic, the Company has
been able to continue to execute its plans according to planned
timelines, including its hiring a sales team, pre-validation and
validation of the commercial manufacturing process and its current
expectations to ship Twirla to wholesalers. This expectation is
subject to change depending on the length, uncertainty or change in
market conditions related to the pandemic.
Twirla Commercialization
Update
- In the second quarter 2020, the Company completed production of
the planned pre-validation batch of Twirla and transitioned to
manufacturing validation batches.
- Presently manufacturing three validation batches that the
Company expects will produce commercially-usable product.
- The Company continues to work with managed care and patient
payors to gain market access for Twirla.
- Through Syneos Selling Solutions, the Company’s contract sales
force partner, hired a national sales leader and seven experienced
regional sales managers, and is in the process of hiring a target
of 73 total territory and telemarketing sales reps.
- The Company intends to begin shipping product to wholesalers in
the fourth quarter of 2020.
Inclusion into the Russell 3000® and
2000® Indexes
- In June 2020, the Company was added to the Russell 3000 and
2000 Indexes, as part of the Russell Indexes annual
reconstitution.
Financial Guidance
- The Company reaffirmed its operating expense guidance for the
full year 2020 to be in the range of $52 million to $56 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
$2.5 million to $3 million of non-cash stock compensation
expense. The Company updated its net revenue guidance in the
fourth quarter of 2020, reflecting refined expectations of initial
stocking levels, to be in the range of $1 million to $2 million.
- Based on the Company’s current business plan and ability to
launch Twirla, the Company believes that its cash, cash equivalents
and marketable securities as of June 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.
Second Quarter Financial
Results
- Cash, cash equivalents and marketable
securities: As of June 30, 2020,
Agile had $87.2 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 June 30, 2020, compared to $1.8 million for the
comparable period in 2019. The increase in R&D expenses was
primarily due to costs to complete manufacturing development,
process improvements, and pre-validation work for commercial
manufacturing of Twirla by Corium, the Company’s contract
manufacturer.
- General and administrative (G&A)
expenses: G&A expenses were $6.4 million for the
quarter ended June 30, 2020, compared to $1.8 million for the
comparable period in 2019. The increase in G&A expenses
was primarily due to higher costs associated with our
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 $10.8 million, or
$0.12 per share, for the quarter ended June 30, 2020, compared to a
net loss of $3.5 million, or $0.08 per share, for the comparable
period in 2019.
- Shares Outstanding: At June 30, 2020,
Agile had 87,297,605 shares of common stock outstanding.
Conference Call and WebcastAgile Therapeutics
will host a conference call and webcast to discuss financial
results for the second quarter ended June 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 market availability of Twirla, our
projected cash position, our projected fiscal year 2020 operating
expenses 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 Relationsmriley@agiletherapeutics.com
|
|
Agile Therapeutics, Inc.Balance
Sheets(Unaudited)(in thousands,
except par value and share data) |
|
|
|
June 30, |
|
December 31, |
|
|
2020 |
|
2019 |
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
39,446 |
|
|
$ |
34,479 |
|
Marketable securities |
|
|
47,789 |
|
|
|
— |
|
Prepaid expenses |
|
|
1,527 |
|
|
|
840 |
|
Total
current assets |
|
|
88,762 |
|
|
|
35,319 |
|
Property
and equipment, net |
|
|
14,208 |
|
|
|
14,044 |
|
Right of
use and other assets |
|
|
94 |
|
|
|
177 |
|
Total assets |
|
$ |
103,064 |
|
|
$ |
49,540 |
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
5,121 |
|
|
$ |
1,819 |
|
Accrued expenses |
|
|
1,290 |
|
|
|
1,804 |
|
Lease liability, current portion |
|
|
82 |
|
|
|
172 |
|
Total
current liabilities |
|
|
6,493 |
|
|
|
3,795 |
|
|
|
|
|
|
|
|
Long-term debt |
|
|
15,775 |
|
|
|
— |
|
Total liabilities |
|
|
22,268 |
|
|
|
3,795 |
|
Commitments and contingencies |
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
Common stock, $.0001 par value, 150,000,000 shares authorized,
87,297,605 and 69,810,305 issued and outstanding at
June 30, 2020 and December 31, 2019,
respectively |
|
|
9 |
|
|
|
7 |
|
Additional paid-in capital |
|
|
359,856 |
|
|
|
306,108 |
|
Accumulated other comprehensive income |
|
|
10 |
|
|
|
— |
|
Accumulated deficit |
|
|
(279,079 |
) |
|
|
(260,370 |
) |
Total stockholders’ equity |
|
|
80,796 |
|
|
|
45,745 |
|
Total liabilities and stockholders’ equity |
|
$ |
103,064 |
|
|
$ |
49,540 |
|
|
|
|
|
|
|
|
|
|
Agile Therapeutics, Inc.Statements of
Operations(Unaudited)(in
thousands, except per share and share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
3,661 |
|
|
$ |
1,779 |
|
|
$ |
6,825 |
|
|
$ |
4,660 |
|
General and administrative |
|
|
6,378 |
|
|
|
1,768 |
|
|
|
10,831 |
|
|
|
3,594 |
|
Total
operating expenses |
|
|
10,039 |
|
|
|
3,547 |
|
|
|
17,656 |
|
|
|
8,254 |
|
Loss
from operations |
|
|
(10,039 |
) |
|
|
(3,547 |
) |
|
|
(17,656 |
) |
|
|
(8,254 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
115 |
|
|
|
63 |
|
|
|
247 |
|
|
|
101 |
|
Interest expense |
|
|
(902 |
) |
|
|
— |
|
|
|
(1,300 |
) |
|
|
— |
|
Total
other income (expense), net |
|
|
(787 |
) |
|
|
63 |
|
|
|
(1,053 |
) |
|
|
101 |
|
Loss
before benefit from income taxes |
|
|
(10,826 |
) |
|
|
(3,484 |
) |
|
|
(18,709 |
) |
|
|
(8,153 |
) |
Benefit
from income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net
loss |
|
$ |
(10,826 |
) |
|
$ |
(3,484 |
) |
|
$ |
(18,709 |
) |
|
$ |
(8,153 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share (basic and diluted) |
|
$ |
(0.12 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.20 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares (basic and diluted) |
|
|
87,221,441 |
|
|
|
43,776,549 |
|
|
|
81,936,815 |
|
|
|
40,560,259 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(10,826 |
) |
|
$ |
(3,484 |
) |
|
$ |
(18,709 |
) |
|
$ |
(8,153 |
) |
Other
comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on marketable securities |
|
|
10 |
|
|
|
— |
|
|
|
10 |
|
|
|
— |
|
Comprehensive loss |
|
$ |
(10,816 |
) |
|
$ |
(3,484 |
) |
|
$ |
(18,699 |
) |
|
$ |
(8,153 |
) |
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