Agile Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results
Current Cash and Cash Equivalents Expected to Meet Projected Operating Requirements through End of 2020
Twirla®, Company’s Lead Product Candidate, Receives FDA Approval
Company Plans to Commence Distributing Product to Wholesalers in the Fourth Quarter of 2020
Fourth Quarter 2019 and Other Recent Corporate Developments:
- FDA Advisory Committee Meeting Completed: As previously announced, in
October 2019, The Bone, Reproductive, and Urologic Drugs Advisory Committee(BRUDAC) of the U.S. Food and Drug Administration( FDA) met to discuss the Company’s New Drug Application for Twirla. The BRUDAC voted 14-1, with 1 abstention, that the benefits of Twirla in the prevention of pregnancy outweigh the risks to support approval.
- Twirla (levonorgestrel and ethynyl estradiol) transdermal system Approved by
FDA: On February 14, 2020, the Company announced that it had received FDAapproval for its lead product candidate, Twirla. Twirla is approved for the prevention of pregnancy in women with a 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 Commercialization Plans: The Company plans to begin the pre-validation and validation of the commercial manufacturing process in the first half of 2020, manufacture three validation batches of Twirla and complete the validation process in the second half of 2020. At the same time, the Company will prepare for the availability of commercial product supply. In the first quarter of 2020, the Company intends to initiate work with managed care and patient payors to gain market access for Twirla. In the second quarter of 2020, the Company plans to begin hiring and training an initial sales team, which it estimates to be in the range of 70 to 100 persons. The Company intends to ship product to wholesalers in the fourth quarter of 2020.
- In November 2019, the Company entered into an at-the market (ATM) agreement, under which the Company was authorized to issue and sell shares of common stock having aggregate sales proceeds of up to
$20.0 millionfrom time to time. In the year ended December 31, 2019, the Company issued and sold 10,440,908 shares of common stock under the ATM, resulting in net proceeds of approximately $19.3 millionand representing the entire capacity of the ATM.
February 2020, the Company entered into a senior secured term loan credit facility with Perceptive Advisorsfor a senior secured term loan facility of up to $35 million. A first tranche of $5 millionwas funded on execution of the credit agreement. A second tranche of $15 millionwas funded as a result of the approval of Twirla by the FDA. Another $15 milliontranche will be available upon the achievement of certain revenue milestones. The Company is permitted to make interest-only payments on the loan until February 2023. In addition, the Company issued Perceptive warrants to purchase 1,400,000 shares of Agile common stock.
Fourth Quarter Financial Results
- Cash and cash equivalents: As of
December 31, 2019, Agile had $34.5 millionof cash and cash equivalents compared to $7.9 millionof cash and cash equivalents as of December 31, 2018. The Company believes its cash and cash equivalents as of December 31, 2019, along with the proceeds of the Perceptive credit agreement received to date, will be sufficient to meet its projected operating requirements through the end of 2020. The Company will require additional capital to fund operating needs beyond 2020, which it expects primarily will consist of commercializing Twirla, and exploring the advancement of our existing pipeline and its possible expansion through business development activities.
- Research and development (R&D) expenses: R&D expenses were
$2.7 millionfor the quarter ended December 31, 2019and $9.9 millionfor the year ended December 31, 2019, compared to $1.9 millionand $9.8 millionfor the comparable periods in 2018. The increase in R&D expenses was primarily due to consulting fees and costs associated with the preparation for and attendance at the FDAadvisory committee meeting as well as costs associated with the on-going qualification process of the commercial manufacturing equipment at Corium.
- General and administrative (G&A) expenses: G&A expenses were
$3.3 millionfor the quarter ended December 31, 2019and $9.0 millionfor the year ended December 31, 2019, compared to $1.6 millionand $8.7 millionfor the comparable periods in 2018. The increase in G&A expenses was primarily due to the use of financial consultants, recruiting and search fees and an increase in promotional activities as the Company prepares for the commercialization of Twirla.
- Net loss: Net loss was
$6.0 million, or $0.10per share, for the quarter ended December 31, 2019, compared to a net loss of $3.8 million, or $0.11per share, for the quarter ended December 31, 2018. Net loss for the year ended December 31, 2019was $18.6 million, or $0.38per share, compared to a net loss of $19.8 million, or $0.58per share, for the year ended December 31, 2018.
- Shares Outstanding: At
February 18, 2020, Agile had 69,810,305 shares of common stock outstanding.
Twirla (levonorgestrel and ethinyl estradiol) transdermal system is 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.
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 market availability of Twirla, our projected cash position 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, including the qualification and validation of equipment related to the expansion of Corium's manufacturing facility, the performance and financial condition of Corium or any of the suppliers to our third-party manufacturer, 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
Contact: Investor Relations -- 609-683-1880
Condensed Balance Sheets
|Cash and cash equivalents||$34,479||$7,851|
|Total current assets||35,319||8,458|
|Property and equipment, net||14,044||13,916|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$3,623||$2,218|
|Lease liability, current portion||172||-|
|Additional paid‑in capital||306,108||261,722|
|Total stockholders’ equity||45,745||20,174|
|Total liabilities and stockholders’ equity||$49,540||$22,392|
Agile Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except share and per share amounts)
|Three Months Ended
|Research and development||$2,728||$1,856||$9,858||$9,777|
|General and administrative||3,337||1,567||9,000||8,739|
|Total operating expenses||6,105||3,727||18,858||19,535|
|Loss from operations||(6,105)||(3,727)||(18,858)||(19,535)|
|Other income (expense)|
|Change in fair value of warrants||—||—||—||29|
|Loss before benefit from income taxes||(6,021)||(3,810)||(18,606)||(20,256)|
|Benefit from income taxes||—||—||—||477|
|Net loss per share - basic and diluted||$(0.10)||$(0.11)||$(0.38)||$(0.58)|
|Weighted‑average shares outstanding –basic and diluted||62,559,514||34,377,329||49,432,487||34,315,931|
Source: Agile Therapeutics, Inc.