Agile Therapeutics Reports Third Quarter 2020 Financial Results
Commercial Launch of Twirla® Expected by Year-End 2020
Management to Host Conference Call today at
“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
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
- The Company continued to build its distribution network by entering into an agreement with a third major
- 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
August 2020, the Company appointed Paul Korner, MD, MBA, as Chief Medical Officer. Dr. Korneris a board-certified obstetrician and gynecologist with more than 20 years of pharmaceutical and biotech industry experience, including significant experience within women’s healthcare.
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.
- The Company narrowed its operating expense guidance for the full year 2020 to be in the range of
$52 millionto $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 millionto $3 millionof 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, 2020will 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 millionof cash, cash equivalents and marketable securities compared to $34.5 millionof cash and cash equivalents as of December 31, 2019.
- Research and development (R&D) expenses: R&D expenses were
$3.7 millionfor the quarter ended September 30, 2020, compared to $2.4 millionfor 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 millionfor the quarter ended September 30, 2020, compared to $2.1 millionfor 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 $0.18per share, for the quarter ended September 30, 2020, compared to a net loss of $4.4 million, or $0.08per 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 Webcast
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.
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.
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.
Certain 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
Head of Investor Relations & Corporate Communications
Agile Therapeutics, Inc.
(in thousands, except par value and share data)
|Cash and cash equivalents||$||24,163||$||34,479|
|Total current assets||73,319||35,319|
|Property and equipment, net||14,271||14,044|
|Right of use asset||31||158|
|Other non-current assets||1,791||19|
|Liabilities and stockholders’ equity|
|Lease liability, current portion||34||172|
|Total current liabilities||7,204||3,795|
|Commitments and contingencies|
|Additional paid-in capital||360,713||306,108|
|Accumulated other comprehensive income||11||—|
|Total stockholders’ equity||66,130||45,745|
|Total liabilities and stockholders’ equity||$||89,412||$||49,540|
Agile Therapeutics, Inc.
Statements of Operations
(in thousands, except per share and share data)
|Three Months Ended||Nine Months Ended|
|Research and development||$||3,663||$||2,361||$||10,488||$||7,021|
|General and administrative||10,993||2,138||21,824||5,732|
|Total operating expenses||14,656||4,499||32,312||12,753|
|Loss from operations||(14,656||)||(4,499||)||(32,312||)||(12,753||)|
|Other income (expense)|
|Total other income (expense), net||(868||)||67||(1,921||)||168|
|Loss before benefit from income taxes||(15,524||)||(4,432||)||(34,233||)||(12,585||)|
|Benefit from income taxes||—||—||—||—|
|Net loss per share (basic and diluted)||$||(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|
|Other comprehensive income:|
|Unrealized gain on marketable securities||1||—||11||—|
Source: Agile Therapeutics, Inc.