Twirla Delivers Third Quarter 2023 Net Revenue of
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
Management to Host Conference Call Today,
“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
ThirdQuarterPerformance 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 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.
- 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.
- Third quarter GAAP operating expenses (“OPEX”) were
- 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.
- In the third quarter 2023, the Company generated gross profit of approximately
- Continued Twirla Demand Growth
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.
- 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
- 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.
- 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
- 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.
- Advancing Twirla’s availability through telemedicine platforms such as Nurx,
- Furthering Promotional Efforts in Five
Third Quarter2023 FinancialResults
- 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 endedSeptember 30, 2023 , there were 2,950,136 weighted average shares of common stock outstanding.
Conference Call and Webcast
Date | |
Time | 8:30 a.m ET |
Webcast (live and archived) | Events & Presentations |
Registration Link | Register Here |
A live webcast of the conference call may be accessed via the Investor Relations portion of the
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.
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 and beyond, 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 | $ | 2,873 | $ | 5,246 | ||||||||||
Accounts receivable, net | 3,521 | 3,377 | ||||||||||||
Inventory, net | 2,411 | 1,332 | ||||||||||||
Prepaid expenses and other current assets | 1,259 | 1,403 | ||||||||||||
Total current assets | 10,064 | 11,358 | ||||||||||||
Property and equipment, net | 101 | 177 | ||||||||||||
Right of use asset | 486 | 695 | ||||||||||||
Other non-current assets | 238 | 2,012 | ||||||||||||
Total assets | $ | 10,889 | $ | 14,242 | ||||||||||
Liabilities and stockholders’ deficit | ||||||||||||||
Current liabilities: | ||||||||||||||
Long-term debt, current portion | $ | 1,589 | $ | 1,426 | ||||||||||
Notes payable, current portion | 379 | — | ||||||||||||
Accounts payable | 6,879 | 7,734 | ||||||||||||
Accrued expenses | 8,338 | 3,908 | ||||||||||||
Lease liability, current portion | 353 | 319 | ||||||||||||
Total current liabilities | 17,538 | 13,387 | ||||||||||||
Lease liabilities, long-term | 196 | 466 | ||||||||||||
Warrant liability | 5,566 | 5,934 | ||||||||||||
Total liabilities | 23,300 | 19,787 | ||||||||||||
Commitments and contingencies (Note 10) | ||||||||||||||
Stockholders’ deficit | ||||||||||||||
Preferred stock, | — | — | ||||||||||||
Common stock, | — | — | ||||||||||||
Additional paid-in capital | 406,288 | 403,157 | ||||||||||||
Accumulated deficit | (418,699 | ) | (408,702 | ) | ||||||||||
Total stockholders’ deficit | (12,411 | ) | (5,545 | ) | ||||||||||
Total liabilities and stockholders’ deficit | $ | 10,889 | $ | 14,242 | ||||||||||
Agile Therapeutics, Inc.
Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except per share and share data)
Three Months Ended | Nine Months Ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Revenues, net | $ | 6,662 | $ | 3,002 | $ | 15,979 | $ | 6,888 | ||||||||
Cost of product revenues | 2,477 | 1,425 | 6,787 | 5,183 | ||||||||||||
Gross profit | 4,185 | 1,577 | 9,192 | 1,705 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 705 | $ | 788 | $ | 2,171 | $ | 2,901 | ||||||||
Selling and marketing | 4,800 | 5,560 | 14,040 | 23,523 | ||||||||||||
General and administrative | 2,680 | 2,815 | 8,813 | 9,837 | ||||||||||||
Loss on disposition of assets | — | 11,122 | — | 11,122 | ||||||||||||
Total operating expenses | 8,185 | 20,285 | 25,024 | 47,383 | ||||||||||||
Loss from operations | (4,000 | ) | (18,708 | ) | (15,832 | ) | (45,678 | ) | ||||||||
Other income (expense) | ||||||||||||||||
Interest income | 13 | 46 | 61 | 50 | ||||||||||||
Interest expense | (341 | ) | (1,004 | ) | (1,114 | ) | (2,699 | ) | ||||||||
Unrealized gain on warrant liability | 3,529 | 13,736 | 6,890 | 22,171 | ||||||||||||
Total other income, net | 3,201 | 12,778 | 5,837 | 19,522 | ||||||||||||
Loss before benefit from income taxes | (799 | ) | (5,930 | ) | (9,995 | ) | (26,156 | ) | ||||||||
Benefit from income taxes | — | — | — | 4,675 | ||||||||||||
Net loss and comprehensive loss | $ | (799 | ) | $ | (5,930 | ) | $ | (9,995 | ) | $ | (21,481 | ) | ||||
Net loss per share (basic and diluted) | $ | (0.27 | ) | $ | (8.01 | ) | $ | (5.30 | ) | $ | (71.61 | ) | ||||
Weighted-average common shares (basic and diluted) | 2,950,136 | 739,957 | 1,884,793 | 299,970 |
See accompanying notes to unaudited financial statements.
Reconciliation of Net Loss (GAAP) to adjusted Net Loss (non-GAAP)
(Unaudited)
(in thousands)
Three Months Ended | Nine Months Ended | ||||||||||||||||||
GAAP Net Loss | $ | (799 | ) | (3,809 | ) | (5,930 | ) | (5,168 | ) | $ | (9,995 | ) | (21,481 | ) | |||||
Unrealized gain on warrant liability | 3,529 | 1,674 | 13,736 | 7,051 | 6,890 | 22,171 | |||||||||||||
Loss on disposition of assets | - | - | 11,122 | - | - | 11,122 | |||||||||||||
Non-GAAP Net Loss | $ | (4,328 | ) | (5,483 | ) | (8,544 | ) | (12,219 | ) | $ | (16,885 | ) | (32,530 | ) | |||||
Non-GAAP Net Loss Per Share | $ | (1.47 | ) | (3.10 | ) | (11.55 | ) | (135.46 | ) | $ | (8.96 | ) | (108.43 | ) | |||||
Weighted avg shares | 2,950,136 | 1,769,803 | 739,957 | 90,204 | 1,884,793 | 299,970 |
Source:
2023 GlobeNewswire, Inc., source