On November 12, 2020 Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, reported financial results for the three and nine months ended September 30, 2020 and provided a corporate update (Press release, Applied Therapeutics, NOV 12, 2020, View Source [SID1234570770]).
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"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 Webcast
Agile 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 View Source, 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.