First Quarter Net Revenue Increased 58% and Factory Sales Increased 3% from Fourth Quarter 2023
Twirla First Quarter 2024 Demand Rebounded 18% from Fourth Quarter 2023
“We are excited about the start of 2024, which saw a rebound in demand, factory sales and net sales in the first quarter from our fourth quarter 2023 results. We plan to continue to focus on executing our business plan, which we believe can continue to grow Twirla and enable us to manage our operating expenses,” said Agile Therapeutics Chairperson and Chief Executive Officer
FirstQuarter 2024Performance Updates
- Net Revenue: Twirla delivered
$5.7 million in net revenue for the first quarter of 2024. This was an increase of 50% from the$3.8 million reported for the first quarter of 2023. The first quarter 2024 increase in net revenue was primarily due to increased demand. - First quarter 2024 net revenue reflects performance in the following key areas:
- Continued Twirla Demand Growth
- Twirla demand for the first quarter 2024 was 81,088 total cycles, a 18% increase from the fourth quarter 2023 and a 80% increase from the first quarter 2023.
- Retail demand was 43,748 total cycles in the first quarter of 2024, an increase of 8% from the fourth quarter 2023 and a 43% increase from the first quarter 2023.
- Non-retail demand for the first quarter 2024 was 37,340 total cycles, an increase of 32% from the fourth quarter 2023 and a 158% increase from the first quarter 2023.
- Twirla Factory Sales
- Twirla factory sales for the first quarter 2024 were 70,662 total cycles, a 3% increase from the fourth quarter 2023 and a 63% increase from the first quarter 2023.
- Company Operating Expenses
- First quarter 2024 operating expenses were
$6.8 million , a 24% increase from the fourth quarter 2023, and a decrease of 20% from the$8.5 million reported for the first quarter 2023.
- First quarter 2024 operating expenses were
- Continued Twirla Demand Growth
Additional Corporate Updates
- Trading on the “Over the Counter” Market
- As of
March 26, 2024 , the Company’s common stock is now trading on the “over the counter” market operated by the OTC Markets Group under its existing “AGRX” trading symbol. The Company has applied for trading on the OTC-QB market. - The Company does not expect the transition to OTC to impact its business operation and it remains focused on executing its business plan while continuing to explore strategic opportunities.
- As of
- Potential for Enhanced Access to Twirla
- The Company remains optimistic about the steps being taken by the
Biden-Harris Administration to enhance access to no-cost contraception products like Twirla. InJanuary 2024 , the Administration announced new guidance to enable expanded access to all FDA-approved contraceptives without cost. - Implementation of the new guidance could eliminate financial barriers for contraceptive products like Twirla for an estimated 49 million women.
- The Company remains optimistic about the steps being taken by the
First Quarter2024 FinancialResults
- Net Revenue: In the first quarter 2024, the Company realized net product sales revenue of
$5.7 million , a 58% increase from the fourth quarter 2023 and an increase of 50% as compared to the first quarter of 2023 net revenue of$3.8 million . - Cost of Goods Sold (COGS): Cost of goods sold, which consists of direct and indirect costs related to the manufacturing of Twirla, were
$1.7 million for the first quarter 2024 compared to the$2.2 million for the fourth quarter 2023 and compared to the$2.0 million for the first quarter 2023. - Total operating expenses: Total GAAP operating expenses were
$6.8 million for the quarter endedMarch 31, 2024 , compared to the$5.5 million for the fourth quarter 2023 and compared to$8.5 million for the comparable period in 2023 – a decrease of 20%. - GAAP Net income (loss): GAAP net income was
$1.3 million , or$0.28 per share, for the quarter endedMarch 31, 2024 , compared to a GAAP net loss of$4.5 million , or$1.51 per share, for the fourth quarter 2023 and compared to a GAAP net loss of$5.4 million , or$5.91 per share, for the comparable period in 2023. - Non-GAAP Net Loss: Non-GAAP net loss was
$2.9 million , or$0.63 per share, for the quarter endedMarch 31, 2024 , compared to a non-GAAP net loss of$4.3 million , or$1.46 per share, for the fourth quarter 2023 and compared to a non-GAAP net loss of$7.1 million , or$7.76 per share, for the comparable period in 2023. These results reflect the exclusion of the$4.2 million in other income for the first quarter of 2024,$0.1 million in other loss for the fourth quarter 2023, and$1.7 million in other income for the first quarter of 2023, all resulting from the change in value of the Company’s warrant liability. A reconciliation of non-GAAP to GAAP net loss is provided in the tables accompanying this press release. - Cash: As of
March 31, 2024 , the Company had$2.6 million of cash and cash equivalents, compared to$2.5 million of cash and cash equivalents as ofDecember 31, 2023 . 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. - Shares Outstanding: As of
March 31, 2024 , Agile had 6,856,229 shares outstanding and 4,631,902 weighted average shares of common stock outstanding for the three months endedMarch 31, 2024 .
Conference Call and Webcast
Agile Therapeutics will not host a conference call and webcast relating to its First Quarter 2024 financial results and does not plan to do so moving forward.
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 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 <30 kg/m2 before prescribing. Twirla is contraindicated in women with a BMI ≥ 30 kg/m2. Twirla is also contraindicated in women over 35 years old who smoke.
Cigarette smoking increases the risk of serious cardiovascular events from CHC use. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch.
About Prescription Data
The Company receives prescription data for Twirla from
Each 3-patch package represents one 28-day cycle of therapy. Total Cycles Dispensed represents every cycle dispensed from both retail and non-retail channels. Retail channels include retail pharmacies, mail order, and long-term care while non-retail channels include clinics and hospitals and other entities where prescriptions are dispensed directly to the patient. Total prescriptions (TRx) are the total number of prescriptions dispensed through the retail channels. This represents both new and refill prescriptions. New prescriptions (NRx) are new prescriptions dispensed through retail channels. Refill prescriptions (RRx) are refill prescriptions filled through retail channels. Total prescribers are the cumulative number of prescribers whose prescriptions were filled through retail channels since launch. Not all prescription demand in the non-retail channel is reported into third parties like
Use of Non-GAAP Financial Measures
To supplement our consolidated financial statements, which are prepared and presented in accordance with
The presentation of these non-GAAP financial measures are not intended to be a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP and may be different from non-GAAP financial measures used by other companies, and therefore, may not be comparable among companies. We believe the presentation of these non-GAAP financial measures provides meaningful supplemental information regarding our performance; however, we urge investors to review the reconciliation of this financial measures to the comparable GAAP financial measures included in the accompanying tables, and not to rely on any single financial measure to evaluate our business.
Forward-Looking Statements
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 our ongoing and planned manufacturing and commercialization of Twirla®, the potential market acceptance and uptake of Twirla, including the increasing demand for Twirla in 2024, our partnership with
Contact:
Agile Therapeutics Investor Relations
ir@agiletherapeutics.com
Agile Therapeutics, Inc. Balance Sheets (in thousands, except par value and share data) | ||||||||
2024 | 2023 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 2,615 | $ | 2,557 | ||||
Accounts receivable, net | 4,813 | 3,392 | ||||||
Inventory, net | 3,748 | 2,738 | ||||||
Prepaid expenses and other current assets | 811 | 843 | ||||||
Total current assets | 11,987 | 9,530 | ||||||
Property and equipment, net | 50 | 75 | ||||||
Right of use asset | 335 | 412 | ||||||
Other non-current assets | 238 | 238 | ||||||
Total assets | $ | 12,610 | $ | 10,255 | ||||
Liabilities and stockholders’ deficit | ||||||||
Current liabilities: | ||||||||
Long-term debt and notes payable | $ | - | $ | 1,706 | ||||
Accounts payable | 12,620 | 9,574 | ||||||
Accrued expenses | 8,443 | 9,131 | ||||||
Lease liability, current portion | 378 | 366 | ||||||
Total current liabilities | 21,441 | 20,777 | ||||||
Lease liabilities, long-term | - | 100 | ||||||
Warrant liability | 1,493 | 5,696 | ||||||
Total liabilities | 22,934 | 26,573 | ||||||
Stockholders’ deficit | ||||||||
Preferred stock, | - | - | ||||||
Common stock, | 5 | 4 | ||||||
Additional paid-in capital | 411,555 | 406,846 | ||||||
Accumulated deficit | (421,884 | ) | (423,168 | ) | ||||
Total stockholders’ deficit | (10,324 | ) | (16,318 | ) | ||||
Total liabilities and stockholders’ deficit | $ | 12,610 | $ | 10,255 |
Statement of Operations and Comprehensive Income (Loss) (in thousands, except share and per share data) | ||||||||
Three Months Ended | ||||||||
(Unaudited) | ||||||||
2024 | 2023 | |||||||
Revenues, net | $ | 5,716 | $ | 3,813 | ||||
Cost of product revenues | 1,680 | 2,003 | ||||||
Gross profit | 4,036 | 1,810 | ||||||
Operating expenses: | ||||||||
Research and development | $ | 495 | $ | 763 | ||||
Selling and marketing | 3,682 | 4,670 | ||||||
General and administrative | 2,616 | 3,085 | ||||||
Total operating expenses | 6,793 | 8,518 | ||||||
Loss from operations | (2,757 | ) | (6,708 | ) | ||||
Other income (expense) | ||||||||
Interest income | 23 | 33 | ||||||
Interest expense | (185 | ) | (402 | ) | ||||
Unrealized gain on warrant liability | 4,203 | 1,687 | ||||||
Total other income (expense), net | 4,041 | 1,318 | ||||||
Loss before benefit from income taxes | 1,284 | (5,390 | ) | |||||
Benefit from income taxes | - | - | ||||||
Net income (loss) and comprehensive income (loss) | $ | 1,284 | $ | (5,390 | ) | |||
Net income (loss) per share (basic and diluted) | $ | 0.28 | $ | (5.91 | ) | |||
Weighted-average common shares (basic and diluted) | 4,631,902 | 912,044 | ||||||
Comprehensive loss: | ||||||||
Net income (loss) | $ | 1,284 | $ | (5,390 | ) | |||
Other comprehensive income: | ||||||||
Unrealized (loss) gain on marketable securities | - | - | ||||||
Comprehensive income (loss) | $ | 1,284 | $ | (5,390 | ) | |||
Unaudited Reconciliation of Net Income (Loss) (GAAP) to adjusted Net (Loss) (non-GAAP) (in thousands) | ||||||||||||||||
Three Months Ended | ||||||||||||||||
GAAP net income (loss) | $ | 1,284 | $ | (4,467 | ) | (5,390 | ) | |||||||||
Unrealized gain (loss) on warrant liability | 4,203 | (130 | ) | 1,687 | ||||||||||||
Non-GAAP net loss | $ | (2,919 | ) | $ | (4,337 | ) | (7,077 | ) | ||||||||
Non-GAAP net loss per share | $ | (0.63 | ) | $ | (1.46 | ) | (7.76 | ) | ||||||||
Weighted-average common shares | 4,631,902 | 2,963,657 | 912,044 | |||||||||||||
Source:
2024 GlobeNewswire, Inc., source