Twirla Delivers Second Quarter 2023 Net Revenue of
Twirla Demand and Factory Sales Up 24% and 42% Respectively in Second Quarter 2023 Compared to First Quarter 2023
Gross Margin Grows to 58% in Second Quarter 2023 from 47% in First Quarter 2023
Company Reaffirms Expected Full Year 2023 Net Revenue in Range of
Management to Host Conference Call Today,
“We set single-quarter record highs in demand, net revenue and factory sales, all while reporting another quarterly decrease in operating expenses,” said Agile Therapeutics’ Chairperson and Chief Executive Officer
“Strong, focused external relationships are an integral part of our business plan, and we expect to continue to explore collaborations that can positively impact our business, allow us to expand without incurring significant costs and promote a growing, sustainable, fiscally-responsible business,” added Chief Commercial Officer
SecondQuarterPerformance Updates
- Twirla delivered
$5.5 million in net revenue for the second quarter 2023. This was an increase of 159% from the$2.1 million reported for the second quarter 2022 and an increase of 44% from the$3.8 million reported for the first quarter 2023. Net revenue results for the second 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 second quarter 2023 was 55,687 total cycles, a 24% increase from the first quarter 2023 and a 158% increase from the second quarter 2022.
- Retail demand, which is the Company’s most profitable channel, was 35,682 total cycles in the second quarter 2023, a 17% increase from the first quarter 2023. The retail channel is the Company’s most profitable channel and retail demand accounted for 64% of total second quarter 2023 demand.
- Non-retail demand for the second quarter 2023 was 20,005 total cycles and an increase of 38% from the first quarter 2023.
- Twirla Factory Sales
- Twirla factory sales for the second quarter 2023 were 61,770 total cycles, an increase of 42% compared to the first quarter 2023 and a 188% increase from the second quarter 2022.
- The Company believes wholesaler inventory levels have now stabilized in the second quarter 2023.
- Company Operating Expenses
- Second quarter GAAP operating expenses were
$8.3 million for 2023, a decrease of 2% from the$8.5 million reported for the first quarter 2023 and a 27% decrease from the second 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 full year 2022.
- Second quarter GAAP operating expenses were
- Gross Margin
- In the second quarter 2023, The Company generated gross profit of approximately
$3.2 million , or gross margin of 58%, compared to$1.8 million , or gross margin of 47%, in the first quarter 2023.
- In the second quarter 2023, The Company generated gross profit of approximately
- Continued Twirla Demand Growth
Plan for Second Half 2023 Growth
- The Company remains focused on achieving its key goals of growing Twirla, attaining 2023 net revenue in the range of
$25-$30 million and, ultimately, generating positive cash flow. The Company remains confident it can accomplish these key goals by:- Targeting Promotional Efforts on 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 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
- Increasing Footprint in Telemedicine
- In the second quarter 2023, the Company continued to focus on expanding access to Twirla in the retail channel through its collaborations with female telehealth providers including Nurx,
Twentyeight Health and Pandia.
- In the second quarter 2023, the Company continued to focus on expanding access to Twirla in the retail channel through its collaborations with female telehealth providers including Nurx,
- Expanding Access to Twirla
- In
June 2023 , the Company announced that Twirla would become available through relationships with FPA Women’s Health and MMCAP, which are planned to augment Afaxys’ efforts and contribute to further second half 2023 non-retail growth. - The Company believes there is additional potential for Twirla volume growth in this channel based on the reach of the
Afaxys customer network, which includesPlanned Parenthood and student health centers. - The Company also believes it will continue to experience increased growth in the retail channel from physicians who gain more clinical experience with Twirla in the
Planned Parenthood setting and become more comfortable prescribing Twirla in their other practices.
- In
- Targeting Promotional Efforts on Five
Second Quarter2023 FinancialResults
- Net Revenue: In the second quarter 2023, the Company realized net product sales revenue of
$5.5 million , an increase of 44% as compared to the first quarter 2023 revenue of$3.8 million . Second quarter 2023 net revenue of$5.5 million represents a 159% increase from the$2.1 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
$2.3 million for the second quarter 2023, compared to the$2.0 million reported for the first quarter 2023 and$2.2 million for the comparable period in 2022.
- Total operating expenses: Total operating expenses were
$8.3 million for the second quarter 2023, compared to$8.5 million for the first quarter 2023 and$11.3 million for the comparable period in 2022.
- Cash: As of
June 30, 2023 , the Company had$2.8 million of cash, compared to$4.4 million of cash and cash equivalents as of the end of the first quarter 2023. OnMay 25, 2023 , the Company completed a public offering which raised net proceeds of$6.5 million through the sale of 1,896,286 shares of common stock (or pre-funded warrants in lieu thereof). 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
$3.8 million , or$2.15 per share, for the second quarter 2023, compared to a GAAP net loss of$5.4 million , or$5.91 per share, for the first quarter 2023 and a GAAP net loss of$5.2 million , or$57.29 per share, for the comparable period in 2022, respectively. The fair market value remeasurement of warrants resulted in$1.7 million ,$1.7 million and$7.1 million in other income for the second quarter 2023, first quarter 2023, and second quarter 2022, respectively. The Company expects to continue to see fluctuations in GAAP net income or loss depending on the non-cash accounting adjustments of these warrants.
- Non-GAAP Net Loss: Non-GAAP net loss was
$5.5 million , or$3.10 per share, for the second quarter 2023, compared to a non-GAAP net loss of$7.1 million or$7.76 per share for the first quarter 2023, and a non-GAAP net loss of$12.2 million , or$135.46 per share, for the comparable period in 2022. These results reflect the exclusion of the fair market value remeasurement of warrants noted above. A reconciliation of GAAP to non-GAAP net loss is provided in the tables accompanying this press release.
- Shares Outstanding: As of
June 30, 2023 , Agile had 1,640,805 shares outstanding. For the three months endedJune 30, 2023 , there were 1,769,803 weighted average shares of common stock outstanding, as adjusted for the 1-for-50 reverse stock split implemented by Agile onApril 10, 2023 .
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About Agile Therapeutics, Inc.
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 2023, our partnerships with
Contact:
Head of Investor Relations & Corporate Communications
mriley@agiletherapeutics.com
Agile Therapeutics, Inc. | |||||||
Balance Sheets | |||||||
(Unaudited) | |||||||
(in thousands, except par value and share data) | |||||||
2023 | 2022 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 2,785 | $ | 5,246 | |||
Accounts receivable, net | 4,461 | 3,377 | |||||
Inventory, net | 2,537 | 1,332 | |||||
Prepaid expenses and other current assets | 1,866 | 1,403 | |||||
Total current assets | 11,649 | 11,358 | |||||
Property and equipment, net | 126 | 177 | |||||
Right of use asset | 558 | 695 | |||||
Other non-current assets | 238 | 2,012 | |||||
Total assets | $ | 12,571 | $ | 14,242 | |||
Liabilities and stockholders’ deficit | |||||||
Current liabilities: | |||||||
Long-term debt, current portion | $ | 1,562 | $ | 1,426 | |||
Notes payable, current portion | 502 | — | |||||
Accounts payable | 6,156 | 7,734 | |||||
Accrued expenses | 6,747 | 3,908 | |||||
Lease liability, current portion | 342 | 319 | |||||
Total current liabilities | 15,309 | 13,387 | |||||
Lease liabilities, long-term | 288 | 466 | |||||
Warrant liability | 9,095 | 5,934 | |||||
Total liabilities | 24,692 | 19,787 | |||||
Commitments and contingencies (Note 10) | |||||||
Stockholders’ deficit | |||||||
Preferred stock, | — | — | |||||
Common stock, | — | — | |||||
Additional paid-in capital | 405,779 | 403,157 | |||||
Accumulated deficit | (417,900 | ) | (408,702 | ) | |||
Total stockholders’ deficit | (12,121 | ) | (5,545 | ) | |||
Total liabilities and stockholders’ deficit | $ | 12,571 | $ | 14,242 | |||
Agile Therapeutics, Inc. | |||||||||||||||
Statements of Operations and Comprehensive Loss | |||||||||||||||
(Unaudited) | |||||||||||||||
(in thousands, except per share and share data) | |||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Revenues, net | $ | 5,503 | $ | 2,126 | $ | 9,316 | $ | 3,887 | |||||||
Cost of product revenues | 2,307 | 2,231 | 4,310 | 3,758 | |||||||||||
Gross profit | 3,196 | (105 | ) | 5,006 | 129 | ||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 703 | $ | 856 | $ | 1,466 | $ | 2,113 | |||||||
Selling and marketing | 4,570 | 7,411 | 9,240 | 17,964 | |||||||||||
General and administrative | 3,049 | 3,026 | 6,133 | 7,023 | |||||||||||
Total operating expenses | 8,322 | 11,293 | 16,839 | 27,100 | |||||||||||
Loss from operations | (5,126 | ) | (11,398 | ) | (11,833 | ) | (26,971 | ) | |||||||
Other income (expense) | |||||||||||||||
Interest income | 15 | 2 | 48 | 3 | |||||||||||
Interest expense | (372 | ) | (823 | ) | (773 | ) | (1,695 | ) | |||||||
Unrealized gain on warrant liability | 1,674 | 7,051 | 3,361 | 8,435 | |||||||||||
Total other income, net | 1,317 | 6,230 | 2,636 | 6,743 | |||||||||||
Loss before benefit from income taxes | (3,809 | ) | (5,168 | ) | (9,197 | ) | (20,228 | ) | |||||||
Benefit from income taxes | — | — | — | 4,675 | |||||||||||
Net loss and comprehensive loss | $ | (3,809 | ) | $ | (5,168 | ) | $ | (9,197 | ) | $ | (15,553 | ) | |||
Net loss per share (basic and diluted) | $ | (2.15 | ) | $ | (57.29 | ) | $ | (6.85 | ) | $ | (203.76 | ) | |||
Weighted-average common shares (basic and diluted) | 1,769,803 | 90,204 | 1,343,293 | 76,331 | |||||||||||
Reconciliation of Net Loss (GAAP) to adjusted Net Loss (non-GAAP) | |||||||||||||||||||
(Unaudited) | |||||||||||||||||||
(in thousands) | |||||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||||
GAAP Net Loss | $ | (3,809 | ) | (5,390 | ) | (5,168 | ) | (10,385 | ) | $ | (9,197 | ) | (15,553 | ) | |||||
Unrealized gain on warrant liability | 1,674 | 1,687 | 7,051 | 1,384 | 3,361 | 8,435 | |||||||||||||
Loss on disposition of assets | - | - | - | - | - | - | |||||||||||||
Non-GAAP Net Loss | $ | (5,483 | ) | (7,077 | ) | (12,219 | ) | (11,769 | ) | $ | (12,558 | ) | (23,988 | ) | |||||
Non-GAAP NetLoss Per Share | $ | (3.10 | ) | (7.76 | ) | (135.46 | ) | (188.90 | ) | $ | (9.35 | ) | (314.26 | ) | |||||
Weighted avg shares | 1,769,803 | 912,044 | 90,204 | 62,304 | 1,343,293 | 76,331 |
Source:
2023 GlobeNewswire, Inc., source