AGRX Agile Therapeutics Inc

Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today reported financial results for the three months ended June 30, 2023 and provided a corporate update.

“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 Al Altomari. “We are beyond pleased with the second quarter 2023 results, but the job is not done, and our focus is on accelerating future growth and achieving 2023 net revenue of $25-$30 million.”

“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 Amy Welsh. “The structure and strategy of our business plan is the foundation for our confidence in continued Twirla growth in the second half of 2023.”

Second Quarter Performance 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.
  • 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.

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.
  • 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.
  • 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 includes Planned 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.

Second Quarter 2023 Financial Results

• 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. On May 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 ended June 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 on April 10, 2023.

Conference Call and Webcast
Date	Wednesday, August 9, 2023
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 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 <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 DataThe Company receives prescription data for Twirla from Symphony Health Solutions, and the data are not created or owned by the Company. Prescription data are available through other subscription services as well, such as IQVIA. Unless otherwise noted, the prescription data results reported in this press release are reported as of June 30, 2023, by Symphony Health Solutions. The prescription data terms are defined as follows: Twirla cycles dispensed are the number of 3-patch packages dispensed.

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 Symphony Health Solutions and IQVIA. The factory sales reported from Twirla wholesalers do include sales to the non-retail channel and, therefore, the Company believes factory sales more closely represent the total demand for Twirla across all channels.

Use of Non-GAAP Financial MeasuresTo supplement our consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles (GAAP), we use non-GAAP operating expenses and non-GAAP net loss to measure our financial performance. We define the term non-GAAP operating expenses as GAAP operating expenses excluding one-time, non-cash charges incurred in connection with the loss on disposition of assets. We define the term non-GAAP net loss as GAAP net loss excluding recurring unrealized gains or losses pertaining to liability classified warrants and one-time non-cash charges incurred in connection with the loss on disposition of assets. We believe that the presentation of these non-GAAP financial metrics provides useful information about our operating results, enhances the overall understanding of past financial performance and future prospects, allows for greater transparency with respect to metrics used by our management in its financial and operational decision-making and produces a useful measure for period-to-period comparisons of our business.

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 StatementsCertain 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 Afaxys and Syneos and their ability to promote growth, our product supply agreement with Nurx and its ability to educate patients about Twirla, our prospects for future financing arrangements and ability to generate positive cashflow, our expected net revenue and operating expenses for the second half of 2023, and our financial condition, growth and strategies. Any or all of the forward- looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including risks related to our ability to maintain regulatory approval of Twirla and the labeling under any approval we obtain, the ability of Corium to produce commercial supply in quantities and quality sufficient to satisfy market demand for Twirla, our ability to successfully enhance the commercialization of and increase the uptake for Twirla, the size and growth of the markets for Twirla and our ability to serve those markets, regulatory and legislative developments in the United States and foreign countries, our ability to obtain and maintain intellectual property protection for Twirla and our product candidates, the lingering effects of the COVID-19 pandemic on our commercialization efforts, clinical trials, supply chain, operations and the operations of third parties we rely on for services such as manufacturing, marketing support and sales support, as well as on our potential customer base, our ability to regain compliance with the listing requirements of the Nasdaq Capital Market and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Contact:Matt RileyHead of Investor Relations & Corporate Communicationsmriley@agiletherapeutics.com

Agile Therapeutics, Inc.
Balance Sheets
(Unaudited)
(in thousands, except par value and share data)
	June 30,				December 31,
	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, $0.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at June 30, 2023 and no shares issued and outstanding at December 31, 2022		—				—
Common stock, $0.0001 par value, 300,000,000 shares authorized, 1,640,805 and 859,402 issued and outstanding at June 30, 2023 and December 31, 2022, respectively		—				—
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
	June 30,								June 30,
	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

Agile Therapeutics, Inc.
Reconciliation of Net Loss (GAAP) to adjusted Net Loss (non-GAAP)
(Unaudited)
(in thousands)
	Three Months Ended													Six Months Ended
		6/30/2023			3/31/2023			6/30/2022			3/31/2022				6/30/2023			6/30/2022
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