Agile Therapeutics Inc. (NASDAQ: AGRX) is on a journey to fulfill the unmet health needs of women with products designed to provide them with contraceptive options.
The company’s product and 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.
Agile’s initial product Twirla® (levonorgestrel and ethinyl estradiol) transdermal system, is a nondaily prescription contraceptive based on the company’s proprietary transdermal patch technology called Skinfusion®, which is designed to allow drug delivery through the skin.
The Twirla 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.
The patch is used as a contraceptive by women with a body mass index (BMI) less than 30 kilograms per meter (kg/m2) for whom a combined hormonal contraceptive is appropriate. It is less effective in women with a BMI of 25 or more.
Q3 Financial Results And Corporate Update
On Nov. 7, Agile released financial results for the three months that ended Sept. 30 and provided a corporate update.
Financial Results Highlights:
Net revenue: Twirla delivered $3.0 million in net revenue for the third quarter of 2022. This was an increase of 43% from the second quarter of 2022 – the largest quarter-over-quarter increase the Company has achieved.
Cost of product revenue: Cost of product revenue totaled $1.4 million and consisted of direct and indirect costs related to the manufacturing of Twirla® sold, compared to $2.7 million for the third quarter of 2021 – a decrease of 47%. The decrease reflects the elimination of an inventory obsolescence reserve, which the company established in the third quarter of 2021.
Total generally accepted accounting principles (GAAP) operating expenses: Total GAAP operating expenses were $20.3 million for the quarter that ended Sept. 30, compared to $14.4 million for the comparable period in 2021 — an increase of 41%. The GAAP operating expenses for the third quarter of 2022 represent an increase of 80% from the $11.3 million of GAAP operating expenses reported for the second quarter of 2022.
Total non-GAAP operating expenses: Total non-GAAP operational expenditures were $9.2 million for the quarter that ended Sept. 30, compared to $14.4 million for the comparable period in 2021 — a decrease of 36%. The non-GAAP operating expenses for the third quarter decreased 19% from the $11.3 million non-GAAP operating expenses reported for the second quarter of 2022. The company had a one-time, non-cash charge associated with the transfer of equipment to Corium in the third quarter and believes the non-GAAP operating expense, which excludes this charge from GAAP operating expenses, presents a more useful comparison of the results from its operations because prior periods did not include a similar charge. The company provided a reconciliation of its GAAP operating expenses versus non-GAAP operating expenses in its press release.
Cash: As of Sept. 30, the company had $6.1 million of cash, compared to $13 million of cash and cash equivalents as of the end of the second quarter of 2022.
Net loss: Net loss was $19.7 million, or 53 cents per share for the quarter that ended Sept. 30, compared to a net loss of $16.8 million, or $7.20 per share, for the comparable period in 2021. The company incurred a one-time, noncash operating expense charge of $11.1 million in the third quarter of 2022 related to the transfer of equipment ownership to Corium Inc., which is reflected in the net loss for the third quarter of 2022.
Shares outstanding: As of Sept. 30, Agile had 39,026,823 shares issued and 36,997,836 weighted average shares of common stock outstanding.
Key Contributors To Future Growth
Although the company reported a net loss for the quarter due to reasons that included extraordinary ones, it says it has an effective business plan in place and is tracking towards its goal of generating positive cash flow.
An important contributor to the company’s third-quarter growth was its partnership with Afaxys Inc., which drove volume in the nonretail channel. In the second quarter of 2022, 1,404 nonretail cycles of Twirla®were purchased, and that number surged 361% in the third quarter to 6,479 nonretail cycles.
“This growth is the product of the efforts being made by Afaxys to penetrate the Planned Parenthood network. In the third quarter, we began to see the conversion of Planned Parenthood accounts in California, which drove significant sales and growth for the quarter. We believe this represents a sustainable customer base for future periods,” Agile Therapeutics Chief Commercial Officer Amy Welsh said.
She added that by focusing on five key states — California, Texas, Florida, Illinois, and New York — “It is estimated that we can reach 45% of U.S. women between the ages of 18 and 24. In the future, we expect the retail channel to continue to grow.”
Additionally, Agile plans to launch its collaboration with female telehealth leader Nurx in the fourth quarter of 2022 and expects the collaboration to begin to contribute to retail channel growth in 2023. Nurx is a leader in female-focused digital healthcare amongst the Twirla target audience and offers patients access to its telehealth platform and expert medical providers that have prescribed contraception to more than 1 million patients
Generating Positive Cash Flow
In an industry with players like Dare Bioscience Inc. (NASDAQ: DARE) and Hologic Inc. (NASDAQ: HOLX), Agile is exploring business development opportunities that could potentially accelerate the timeline for generating positive cash flow.
“Our stated plan has been to effectively manage expenses while continuing to grow Twirla® sales and demand. This is the third consecutive quarter we have increased Twirla® sales and demand while simultaneously decreasing company operating expenses, excluding the noncash, one-time charge incurred this quarter,” Chairman and CEO and Director of Agile Therapeutics Chairman and CEO Alfred Altomari said.
“We are working — and have been working — to identify and implement strategies and exploit opportunities that will contribute to further growth,” he added.
If Agile maintains its quarterly revenue growth rate and operating expenses consistent with the past two quarters, the company could potentially begin to generate positive cash flow at the end of 2023. The addition of a business development opportunity or partnership could potentially accelerate that timeline.
Agile Therapeutics is a women's healthcare company dedicated to fulfilling the unmet health needs of today’s women. Our product and 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), a 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.
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Matt Riley - Head of Investor Relations & Corporate Communications