Agile Therapeutics Reports Third Quarter 2019 Financial Results
FDA Advisory Committee Meeting for Twirla® NDA Scheduled for
Cash Expected to
Third quarter 2019 and other recent corporate developments:
- Regulatory update: The
FDAcompleted its pre-approval inspection (PAI) at Corium International, Inc.(Corium), our third-party manufacturer, and the Company continues its preparations for the October 30, 2019meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee of the U.S. Foodand Drug Administration ( FDA) to review the Company’s new drug application (NDA) for Twirla. The FDAhas assigned the Twirla NDA a Prescription Drug User Fee Act (PDUFA) goal date of November 16, 2019. In advance of the Advisory Committee meeting, the FDAissued its briefing document in which it expresses a number of concerns regarding Twirla’s approvability, including, but not limited to, concerns related to Twirla’s efficacy when balanced against its safety. The FDAalso did not appear to agree with the Company’s proposal to include a limitation of use based on patient weight and BMI in the product label.
$12.7 Millionin Net Proceeds From Sale of Common Stock: The Company completed a public offering of 14,526,315 shares of common stock in August. Net proceeds from the public offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $12.7 million.
- If the Company receives approval of the Twirla NDA, it plans to acclerate its commercial activities. In
September 2019, the Company re-started manufacturing development at Corium. The Company is currently working with Corium to complete manufacturing development and process improvements and plans to commence pre-validation work when that work is complete. The Company’s goal is to manufacture three validation batches of Twirla and complete the validation of the commercial manufacturing process in the second half of 2020.
- In parallel, the Company plans to initiate work with managed care and patient payers to gain market access for Twirla in the first quarter of 2020. In the second quarter of 2020, the Company plans to hire and train an initial sales team, which it estimates will be in the range of 50 to 90 persons. The Company expects to ship product to wholesalers and commence its commercial launch in fourth quarter of 2020. The Company’s marketing efforts will initially focus on Obstetrician-gynecologists in
the United States, and it plans to use a significant number of samples in the early stage of commercial launch to gain patient trial and acceptance.
“The third quarter of 2019 was another productive quarter for the Company” said
Third Quarter Financial Results
- Cash and cash equivalents: As of
September 30, 2019, Agile had $18.4 millionof cash and cash equivalents compared to $7.8 millionof cash and cash equivalents as of December 31, 2018. During the quarter ended September 30, 2019, the Company raised net proceeds of approximately $12.7 millionfrom a sale of 14,526,315 shares of common stock through a public offering in August and $0.2 millionfrom the sale of 143,482 shares of common stock from its “at-the-market” equity offerings. The Company believes its cash and cash equivalents as of September 30, 2019will be sufficient to meet its projected operating requirements through the end of the first quarter 2020. The Company will require additional capital to fund operating needs for the rest of 2020 and beyond, which will primarily be used for the completion of its commercial plan for Twirla, if approved, including the completion of the validation of the commercial manufacturing process, the commercial launch, and advancing the development of its other potential product candidates.
- Research and development (R&D) expenses: R&D expenses were
$2.4 millionfor the quarter ended September 30, 2019, compared to $1.5 millionfor the comparable period in 2018. The increase in R&D expenses was primarily related to consulting fees incurred in the preparation of the upcoming FDA Advisory Committeemeeting. Partially offsetting this increase were decreases in manufacturing expense, commercialization expenses and stock compensation expense. The reduction in manufacturing and commercialization expenses reflects reduced activity associated with the scale-up of the commercial manufacturing process which was implemented as a result of the receipt of the 2017 CRL. The decrease in stock compensation expense was primarily the result of a lower stock price associated with the January 2019stock option grants as compared to the January 2018stock option grants.
- General and administrative (G&A) expenses: G&A expenses were
$2.1 millionfor the quarter ended September 30, 2019, compared to $1.8 millionfor the comparable period in 2018. The increase in G&A expenses was primarily due to legal and finance costs, including investment banking advisory fees. Partially offsetting the increase was a decrease in stock compensation expense primarily the result of a lower stock price associated with the January 2019stock option grants as compared to the January 2018stock option grants and the suspension of pre-commercialization activities as a result of the receipt of the 2017 CRL.
- Net loss: Net loss was
$4.4 million, or $0.08per share, for the quarter ended September 30, 2019, compared to a net loss of $3.8 million, or $0.11per share, for the quarter ended September 30, 2018.
- Shares Outstanding: At
September 30, 2019, Agile had 59,302,126 shares of common stock outstanding.
About Twirla® (AG200-15)
Twirla (ethinyl estradiol and levonorgestrel transdermal system) or AG200-15 is an investigational low-dose, once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients ethinyl estradiol (EE), a type of estrogen, and levonorgestrel (LNG), a type of progestin. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch. The Company has completed its Phase 3 clinical trials of Twirla and is pursuing regulatory approval in the U.S.
Xulane® is a registered trademark of
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, related to our regulatory submissions and projected cash position. 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 approvability and subsequent availability of Twirla, the interpretation of data that supports the approval of Twirla, the timing of our advisory committee meeting and of the FDA’s review of the Twirla NDA, and the fact that our existing cash and cash equivalents likely will not be sufficient to fund our current and planned operations after the end of 2019, which raises substantial doubt about our ability to continue as a going concern, and which, in turn, may create negative reactions to the price of our common stock making it more difficult to obtain financing in the future, our expectations about Twirla and its NDA. 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 available cash and our ability to obtain additional funding to fund our business plan without delay and to continue as a going concern, our ability to adequately respond to the deficiencies in the second Twirla CRL issued by the
Contact: Investor Relations -- 609-683-1880
|Agile Therapeutics, Inc.
Condensed Balance Sheets
|Cash and cash equivalents||$||18,370||$||7,851|
|Total current assets||19,686||8,458|
|Property and equipment, net||13,932||13,916|
|Right of use and other assets||214||18|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||1,717||$||2,218|
|Lease liability, current portion||178||-|
|Total current liabilities||1,895||2,218|
|Lease liability, long-term||34||-|
|Additional paid‑in capital||286,246||261,722|
|Total stockholders’ equity||31,903||20,174|
|Total liabilities and stockholders’ equity||$||33,832||$||22,392|
|Agile Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except share and per share amounts)
|Three Months Ended
|Nine Months Ended
|Research and development||$||2,361||$||1,549||$||7,021||$||7,921|
|General and administrative||2,138||1,767||5,732||7,173|
|Total operating expenses||4,499||3,615||12,753||15,809|
|Loss from operations||(4,499||)||(3,615||)||(12,753||)||(15,809||)|
|Other income (expense)|
|Change in fair value of warrants||—||—||—||29|
|Loss before benefit from income taxes||(4,432||)||(3,792||)||(12,585||)||(16,446||)|
|Benefit from income taxes||—||—||—||477|
Net loss per share - basic and diluted
|Weighted‑average shares outstanding –basic and diluted||53,609,511||34,377,329||40,957,809||34,295,240|
Source: Agile Therapeutics, Inc.