Agile Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Published

Twirla Delivers Third Quarter 2023 Net Revenue of $6.7 Million, a 21% Increase from Second Quarter 2023

Company Announces It Expects to Generate Positive Cash Flow from Operations in First Quarter 2024

Gross Margin Grows to 63% in Third Quarter 2023 from 58% in Second Quarter 2023

Company Reaffirms Expected Full Year 2023 Net Revenue of At Least $25 Million

Management to Host Conference Call Today, Thursday, November 9, 2023 at 8:30 a.m. ET

PRINCETON, N.J., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today reported financial results for the three and nine months ended September 30, 2023, and provided a corporate update.

“In the third quarter 2023, we once again achieved all-time highs across several leading indicators, including net revenue, Twirla demand, factory sales, and gross margin,” said Agile Therapeutics’ Chair and Chief Executive Officer Al Altomari. “We believe our continued focus on revenue growth and fiscal discipline can help us achieve our 2023 net revenue goal of at least $25 million, lead to continued improvement in our gross margin, and, in turn, help us begin to generate positive cash flow from operations in the first quarter 2024. We believe this plan will put us in the position of having options about how to invest our future cash.”

Third Quarter Performance Updates

  • Twirla delivered $6.7 million in net revenue for the third quarter 2023. This was an increase of 122% from the $3.0 million reported for the third quarter 2022 and an increase of 21% from the $5.5 million reported for the second quarter 2023. Net revenue results for the third quarter of 2023 reflect factory sales growth across all channels and an improved mix of sales which led to lower gross-to-net deductions.
    • Continued Twirla Demand Growth
      • Twirla demand for the third quarter 2023 was 74,325 total cycles, a 33% increase from the second quarter 2023 and a 147% increase from the third quarter 2022.
        • Retail demand, which is the Company’s most profitable channel, was 40,196 total cycles in the third quarter 2023, a 13% increase from the second quarter 2023.
        • Non-retail demand for the third quarter 2023 was 34,129 total cycles and an increase of 71% from the second quarter 2023.
    • Twirla Factory Sales
      • Twirla factory sales for the third quarter 2023 were 74,424 total cycles, an increase of 20% compared to the second quarter 2023 and a 125% increase from the third quarter 2022.
      • The Company believes wholesaler inventory levels have now stabilized in 2023.
    • Company Operating Expenses
      • Third quarter GAAP operating expenses (“OPEX”) were $8.2 million for 2023, a decrease of 2% from the $8.3 million reported for the second quarter 2023 and an 11% decrease from the third quarter 2022.
      • The Company plans to continue to actively manage its operating expenses and expects operating expenses for the full year 2023 to be lower than the full year 2022.
    • Gross Margin
      • In the third quarter 2023, the Company generated gross profit of approximately $4.2 million, or gross margin of 63%, compared to $3.2 million, or gross margin of 58%, in the second quarter 2023.

Plan for Continued Growth

  • It has been approximately one year since the Company recalibrated its business plan to put an emphasis on partnerships that maximize Twirla growth while simultaneously managing Company OPEX levels.
  • Compared to the first nine months of 2022, the recalibrated business plan has delivered consistent improvement during the first nine months of 2023:
    • Net revenue growth of 132%
    • Twirla demand growth of 156%
    • OPEX reduction of 31%
  • Additional growth and upside potential are expected from the following areas:
    • Furthering Promotional Efforts in Five Key States
      • The Company continues to focus its Twirla promotional efforts on five states that have high levels of reimbursement potential for Twirla and are estimated to reach over 45% of U.S. women between the ages of 18 and 24.
      • The Company believes there is more room for growth in these states through increased penetration into the current prescriber base, as well as focusing on current non-writers of Twirla.
    • Additional Volume from the Afaxys Customer Network
      • While the Company grew non-retail demand 71% in the third quarter 2023 compared to second quarter 2023, it estimates that it currently reaches less than 20% of the total Afaxys customer network and plans to tap into additional volume moving forward.
    • Advancing Twirla’s Availability Through Telemedicine Platforms
      • Advancing Twirla’s availability through telemedicine platforms such as Nurx, TwentyEight Health, and Pandia are all part of the Company’s strategy to sustain growth in the retail channel.

Third Quarter 2023 Financial Results

  • Net Revenue: In the third quarter 2023, the Company realized net product sales revenue of $6.7 million, an increase of 21% as compared to the second quarter 2023 revenue of $5.5 million. Third quarter 2023 net revenue of $6.7 million represents a 122% increase from the $3.0 million reported for the comparable period in 2022.
  • Cost of Goods Sold (COGS): Cost of goods sold, which consists of direct and indirect costs related to the manufacturing of Twirla sold, was $2.5 million for the third quarter 2023, compared to the $2.3 million reported for the second quarter 2023 and $1.4 million for the comparable period in 2022.
  • Total operating expenses: Total operating expenses were $8.2 million for the third quarter 2023, compared to $8.3 million for the second quarter 2023 and $9.2 million for the comparable period in 2022.
  • Cash: As of September 30, 2023, the Company had $2.9 million of cash, compared to $2.8 million of cash and cash equivalents as of the end of the second quarter 2023. In addition to the Company’s existing at-the-market (ATM) arrangement, the Company will continue to evaluate all available options to finance the Company and continue to explore all opportunities that can potentially accelerate the timeline to generating positive cash flow.
  • GAAP Net Loss: GAAP net loss was $0.8 million or $0.27 per share for the third quarter 2023, compared to a GAAP net loss of $3.8 million, or $2.15 per share, for the second quarter 2023 and a GAAP net loss of $5.9 million, or $8.01 per share, for the comparable period in 2022, respectively. The Company expects to continue to see fluctuations in GAAP net income or loss depending on the non-cash accounting adjustments of its warrants.
  • Non-GAAP Net Loss: Non-GAAP net loss was $4.3 million, or $1.47 per share, for the third quarter 2023, compared to a non-GAAP net loss of $5.5 million, or $3.10 per share for the second quarter 2023, and $19.7 million, or $26.58 per share, for the comparable period in 2022. The Company incurred a one-time, non-cash operating expense charge of $11.1 million in the third quarter 2022 related to the transfer of equipment ownership to Corium, which is reflected in the net loss for the third quarter 2022. The non-GAAP results reflect the exclusion of this charge and of the fair market value remeasurement of warrant liabilities, which resulted in other income of $3.5 million in the third quarter 2023, $1.7 million in the second quarter 2023, and $13.7 million in the third quarter 2022. A reconciliation of GAAP to non-GAAP net loss is provided in the tables accompanying this press release.
  • Shares Outstanding: As of September 30, 2023, Agile had 2,277,657 shares outstanding. For the three months ended September 30, 2023, there were 2,950,136 weighted average shares of common stock outstanding.

Conference Call and Webcast

DateThursday, November 9, 2023
Time8:30 a.m ET
Webcast (live and archived) Events & Presentations
Registration LinkRegister Here
  

A live webcast of the conference call may be accessed via the Investor Relations portion of the Agile Therapeutics website at https://ir.agiletherapeutics.com/events-and-presentations.

To participate in the live conference call via telephone, please register here. Upon registering, a dial-in number and unique PIN will be provided to join the conference call.

About Agile Therapeutics, Inc.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. 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, Twitter account (@agilether), and LinkedIn account.

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. Healthcare providers (HCPs) are encouraged to consider Twirla’s reduced efficacy in women with a BMI ≥ 25 to

In This Story

AGRX