Lipocine Announces Financial Results for the First Quarter Ended March 31, 2024

Rhea-AI Summary

Lipocine Inc. (NASDAQ: LPCN) announced financial results for Q1 2024, reporting $3.5M net income, $7.6M revenue, and positive clinical data for LPCN 1154, LPCN 1148, and LPCN 2401. The company also entered an exclusive license agreement for TLANDO with Verity Pharma, showing promising growth and development in its product pipeline.

Positive

• Lipocine reported net income of $3.5 million and revenue of $7.6 million for Q1 2024, a significant improvement compared to the same period in 2023.

• Positive clinical results were announced for LPCN 1154, LPCN 1148, and LPCN 2401, indicating potential treatments for postpartum depression, cirrhosis management, and obesity respectively.

• An exclusive license agreement for TLANDO with Verity Pharma was entered, with potential milestone payments and royalty fees, showcasing growth opportunities for Lipocine.

Negative

• Research and development expenses for Q1 2024 decreased compared to the same period in 2023, but costs related to LPCN 1154 clinical studies increased, impacting overall R&D expenses.

• General and administrative expenses increased in Q1 2024 due to higher business development expenses and other general expenses, offsetting reductions in various administrative costs.

Financial Analyst

The notable turnaround from a net loss of $3.9 million in Q1 2023 to a net income of $3.5 million in Q1 2024 for Lipocine is indicative of a significant operational shift. A substantial part of this change is attributable to the licensing revenue from the Verity License Agreement, which bolstered the revenue figures to $7.6 million, a dramatic increase from the previous year's $0.06 million. This strategic partnership may signal the company's successful pivot towards monetizing its developments more effectively. The reported increase in unrestricted cash reserves to $24.6 million provides additional financial stability and could support ongoing clinical trials and potential commercialization efforts.

Pharmaceuticals Market Analyst

The completion of subject dosing for the pivotal PK study of LPCN 1154 and the potential New Drug Application (NDA) filing at the end of Q4 2024 for postpartum depression treatment could become a significant catalyst for Lipocine's stock. The anticipation of topline results late in Q2 2024 may keep investor interest piqued in the short term. Additionally, the positive clinical results for LPCN 2401 in obesity management, with its potential as both monotherapy and in combination with other drugs, may present diversified market opportunities, addressing significant unmet needs within the obesity treatment landscape. Furthermore, LPCN 1148 showing efficacy in managing cirrhosis with improved patient outcomes over a 52-week period could position Lipocine favorably in the hepatology market, contingent on further successful trials and regulatory approvals.

Medical Research Analyst

The utilization of a 505(b)(2) NDA filing pathway for LPCN 1154 suggests an expedited regulatory strategy by leveraging the established safety and efficacy of an IV infusion of brexanolone. This strategy could reduce the time and investment required for Lipocine's drug development. Moreover, the use of LPCN 1148 for cirrhosis management appears promising, with the reported increase in Skeletal Muscle Index (SMI) and reduction in hepatic encephalopathy events offering potential therapeutic benefits over existing treatments. The drug's good tolerability profile aligns well with industry expectations for patient-centric care. The indication that LPCN 2401 has a favorable safety profile and efficacy in body composition improvement is noteworthy, especially given the current focus on treatments for obesity that extend beyond simple weight loss.

SALT LAKE CITY, May 9, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2024 and provided a corporate update.

LPCN 1154 for Postpartum Depression

• In May 2024, dosing of subjects was completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being developed as a treatment for postpartum depression
• The FDA has agreed with Lipocine's proposal for establishing the efficacy of LPCN 1154 through the pivotal PK bridge to an approved IV infusion of brexanolone via a 505(b)(2) NDA filing
• Topline results from the pivotal PK study are expected late in 2Q 2024. Positive results would support an NDA filing at the end of Q4 2024

LPCN 1148 for Management of Cirrhosis

• In March 2024, Lipocine announced positive Week 52 results from the LPCN 1148 Phase 2 study in patients with cirrhosis. The study met primary and hepatic encephalopathy endpoints
  • Increase in Skeletal Muscle Index (SMI) observed at Week 24 was maintained through 52 weeks
  • Participants on placebo increased SMI when switched to LPCN 1148
• Patients on LPCN 1148 therapy had fewer overt hepatic encephalopathy (OHE) events and longer time to first recurrent OHE event, with no OHE background therapy restrictions
• LPCN 1148 was well-tolerated, with adverse events (AE) rates and severities similar to placebo. Participants on LPCN 1148 were hospitalized for fewer days

LPCN 2401 for Obesity Management

• In April 2024, Lipocine announced positive clinical results from a multi-center prospective, blinded Phase 2 study evaluating LPCN 2401 in participants with obesity (BMI ≥30) and participants with BMI ≥27 with at least one weight-related comorbidity
• Results showed treatment with LPCN 2401 resulted in statistically significant body composition improvements
  • Increased lean mass (LM) by 4.4% and decreased fat mass (FM) by 6.7%
  • Reduced android fat (AF) by 4.1% and increased bone mineral content (BMC) by 2.8%
• LPCN 2401 was well-tolerated; AEs were similar to placebo. A replay of the webcast discussing the LPCN 2401 Phase 2 results can be accessed on Lipocine's website here
• Potential for LPCN 2401 to be used in combination with incretin mimetics (GLP-1 agonists and GLP/GIP dual agonists) for improved body composition (ameliorate muscle loss with android fat loss) or as a monotherapy post discontinuation

LPCN 2203 for Essential Tremor

• Oral GABA Positive Allosteric Modulator, targeting improved efficacy with fewer side effects e.g. somnolence, dizziness
• Daytime efficacy and improved tolerability remains an unmet need
• Achieved relevant target blood levels with good tolerability in multiple Phase 1 studies with no incidence of somnolence, sedation or dizziness

TRT Franchise - TLANDO™ and LPCN 1111 (TLANDO XR)

• In January 2024, Lipocine and Verity Pharma entered into an exclusive License Agreement under which Verity Pharma will market TLANDO in the United States and, if approved, in Canada. The terms of the license agreement call for a license fee of $11 million and development and sales milestones of up to $259 million in aggregate, dependent on achievement of certain milestones. In addition, the Company is eligible to receive tiered royalty payments ranging from 12% up to 18% on net sales in the U.S. and Canada.

First Quarter Ended March 31, 2024 Financial Results

Lipocine reported net income of $3.5 million, or $0.66 per diluted share, for the first quarter ended March 31, 2024, compared with a net loss of $3.9 million, or ($0.76) per diluted share, for the quarter ended March 31, 2023.

Revenue in the first quarter of 2024 was $7.6 million, primarily consisting of licensing revenue received from the Verity License Agreement.  This compares with revenue of $0.06 million in the comparable period in 2023.

Research and development expenses were $2.8 million and $3.1 million, respectively, for the quarters ended March 31, 2024 and 2023. The decrease in research and development expenses was a result of a decrease in contract research organization expense and outside consulting costs related to the completion of our LPCN 1148 study late in 2023, a decrease in personnel related costs, and a decrease in LPCN 1111 costs, offset by an increase in costs related to our LPCN 1154 clinical studies, and an increase in other R&D related costs.

General and administrative expenses were $1.6 million and $1.3 million, respectively for the quarters ended March 31, 2024 and 2023. The increase in general and administrative expenses was a result of an increase in business development expenses and in other various general and administrative expenses. These increases were offset by a decrease in various administrative consulting fees, a decrease in corporate insurance expense, a decrease in personnel salaries and benefits, and a decrease in legal fees.

As of March 31, 2024, Lipocine had $24.6 million of unrestricted cash, cash equivalents and marketable investment securities compared to $22.0 million at December 31, 2023. 

About Lipocine

Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products for CNS disorders. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs. 

Lipocine's clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant, as an adjunct therapy to incretin mimetics as an aid for improved body composition in chronic weight management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis including prevention of the recurrence of overt hepatic encephalopathy. Lipocine is exploring partnership opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 1148, for the management of decompensated cirrhosis, LPCN 2401 for obesity management and LPCN 1144, our candidate for treatment of non-cirrhotic NASH. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit www.lipocine.com.

Forward-Looking Statements

This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product development efforts, our strategic plans for developing products to treat CNS disorders, our ability to monetize product candidates, including through entering into partnering arrangements, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, the achievement of milestones within and completion of clinical trials, the timing and completion of regulatory reviews, outcomes of clinical trials of our product candidates, and the potential uses and benefits of our product candidates.  Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates to treat CNS disorders, we may not have sufficient capital to complete the development processes for our product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

 

LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
				March 31,		December 31,
				2024		2023
Assets
Current assets:
	Cash and cash equivalents			$         3,081,337		$      4,771,758
	Marketable investment securities			21,550,661		17,263,788
	Accrued interest income			100,134		52,254
	Prepaid and other current assets			583,087		773,424
		Total current assets		25,315,219		22,861,224
Property and equipment, net of accumulated depreciation of $1,190,703 and $1,182,191 respectively				107,583		116,095
Other assets				23,753		23,753
		Total assets		$       25,446,555		$    23,001,072
Liabilities and Stockholders' Equity
Current liabilities:
	Accounts payable			$           671,445		$      1,395,977
	Accrued expenses			761,465		1,218,486
	Warrant liability - current portion			57,238		17,166
		Total current liabilities		1,490,148		2,631,629
		Total liabilities		1,490,148		2,631,629
Stockholders' equity:
	Common stock, par value $0.0001 per share, 200,000,000 shares authorized; 5,316,166 issued and 5,315,830 outstanding			8,860		8,860
	Additional paid-in capital			220,262,456		220,171,250
	Treasury stock at cost, 336 shares			(40,712)		(40,712)
	Accumulated other comprehensive gain (loss)			(10,604)		7,259
	Accumulated deficit			(196,263,593)		(199,777,214)
		Total stockholders' equity		23,956,407		20,369,443
		Total liabilities and stockholders' equity		$       25,446,555		$    23,001,072

 

LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
				Three Months Ended March 31,
				2024		2023
Revenues:
	License revenue			$ 7,500,000		$      54,990
	Royalty revenue			117,174		-
		Total revenues		7,617,174		54,990
Operating expenses:
	Research and development			2,818,926		3,106,310
	General and administrative			1,575,719		1,287,313
		Total operating expenses		4,394,645		4,393,623
		Operating income (loss)		3,222,529		(4,338,633)
Other income (expense):
	Interest and investment income			331,364		370,469
	Unrealized gain (loss) on warrant liability			(40,072)		98,134
		Total other income, net		291,292		468,603
		Income (loss) before income tax expense		3,513,821		(3,870,030)
Income tax expense				(200)		(200)
		Net income (loss)		3,513,621		(3,870,230)
		Issuance of Series B preferred stock dividend		-		(89)
		Net income (loss) attributable to common shareholders		$ 3,513,621		$ (3,870,319)
Basic income (loss) per share attributable to common stock				$          0.66		$          (0.74)
Weighted average common shares outstanding, basic				5,315,830		5,234,830
Diluted income (loss) per share attributable to common stock				$          0.66		$          (0.76)
Weighted average common shares outstanding, diluted				5,357,530		5,234,830
Comprehensive loss:
		Net income (loss)		$ 3,513,621		$ (3,870,319)
		Net unrealized gain (loss) on available-for-sale securities		(17,863)		23,562
		Comprehensive income (loss)		$ 3,495,758		$ (3,846,757)

 

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SOURCE Lipocine Inc.

FAQ

<p>What were Lipocine's net income and revenue for Q1 2024?</p>

Lipocine reported a net income of $3.5 million and revenue of $7.6 million for the first quarter of 2024.

<p>What positive clinical results were announced by Lipocine?</p>

Lipocine announced positive results for LPCN 1154 in postpartum depression, LPCN 1148 in cirrhosis management, and LPCN 2401 in obesity treatment.

<p>With whom did Lipocine enter into an exclusive license agreement for TLANDO?</p>

Lipocine entered into an exclusive license agreement with Verity Pharma for TLANDO, including milestone payments and royalty fees.

<p>How did Lipocine's research and development expenses change in Q1 2024 compared to Q1 2023?</p>

Research and development expenses decreased in Q1 2024, but costs related to LPCN 1154 clinical studies increased.

<p>Why did Lipocine's general and administrative expenses increase in Q1 2024?</p>

General and administrative expenses increased due to higher business development expenses and various general expense increases.