Testosterone

SALT LAKE CITY, Nov. 7, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the third quarter and nine months ended September 30, 2024 and provided a corporate update. Neuroactive Steroids LPCN 1154, oral brexanolone, is being developed as a treatment for postpartum depression (PPD). It is targeted to be a highly effective, oral, fast-acting and short duration treatment option. The Company has completed labeling studies such as a food effect study and PK profiling in women with PPD, and is targeting NDA submission for LPCN 1154 by the end of 2024. In October, Lipocine announced positive results from a quantitative electroencephalogram (qEEG) study conducted in healthy subjects administered single doses of LPCN 1154. The results indicated robust central nervous system (CNS) activity of LPCN 1154, with concentration- and time-dependent post-dose changes in qEEG. The study confirmed GABAA positive allosteric modulation and supports future development of LPCN 1154 in neuropsychiatric indications. LPCN 2401 for obesity management LPCN 2401 is an oral formulation comprised of a proprietary anabolic androgen receptor agonist targeted for once daily regimen. In October, Lipocine hosted a virtual key opinion leader (KOL) event on LPCN 2401. The event highlighted positive data from the Phase 2 study of LPCN 2401 and the data support the potential for the product to be used as an adjunct with incretin mimetics (GLP-1/GIP agonists) or as a monotherapy, including post incretin mimetic discontinuation. Frank Greenway, MD (Professor and Chief Medical Officer at Pennington Biomedical Research Center) discussed the unmet needs and current treatment landscape in obesity management with a focus on fat loss and lean muscle mass preservation for patients on incretin therapies. A poster "Oral LPCN 2401 Reduces Fat Mass and Increases Lean Mass in Men With Obesity" featuring the Phase 2 data was presented by Dr. Greenway at the Obesity Society's Annual ObesityWeek® conference on November 5, 2024 in San Antonio, TX. Lipocine plans to meet with the FDA to discuss the study design for a proof-of-concept Phase 2 study for LPCN 2401 and expansion to the female population. LPCN 1148 Management of Cirrhosis Lipocine is evaluating LPCN 1148 for the management of decompensated cirrhosis and has conducted a successful Phase 2 study that met its primary endpoint. The Company plans to request a Type C meeting with the FDA to discuss the clinical development plan for LPCN 1148. TLANDO® In October, Lipocine signed an exclusive supply and distribution agreement with Pharmalink to commercialize TLANDO, its oral testosterone replacement therapy, in the Gulf Cooperation Council (GCC) countries consisting of Saudi Arabia, Kuwait, the United Arab Emirates (UAE), Qatar, Bahrain, and Oman. In September, Lipocine signed an exclusive distribution and license agreement with SPC Korea to commercialize TLANDO in South Korea. The company continues to pursue opportunities for partnering and/or development arrangements for the continued development and/or marketing of our remaining pipeline candidates. Third Quarter Ended September 30, 2024 Financial Results Lipocine reported a net loss of $2.2 million, or ($0.44) per diluted share, for the third quarter ended September 30, 2024, compared with a net loss of $6.7 million, or ($1.27) per diluted share, for the quarter ended September 30, 2023. There were no revenues recorded during the third quarter ended September 30, 2024. In the third quarter of 2023, the company recorded a non-cash revenue reversal of variable consideration for minimum guaranteed royalties of $3.1 million related to the termination of the Antares License Agreement. Research and development expenses were $1.6 million and $2.9 million, respectively, for the quarters ended September 30, 2024 and 2023. The decrease was a result of a decrease in TLANDO related costs, a decrease in contract research organization expense and outside consulting costs related to the wind down of the LPCN 1148 study in 2024, and a decrease in costs related to LPCN 1154 clinical studies, offset by increases in personnel related costs and other research and development related costs and supplies. General and administrative expenses were $1.0 million in each of the quarters ended September 30, 2024 and 2023. As of September 30, 2024, Lipocine had $19.8 million of unrestricted cash, cash equivalents and marketable investment securities compared to $22.0 million at December 31, 2023. Nine Months Ended, September 30 2024, Financial Results Lipocine reported a net loss of $1.8 million, or ($0.33) per diluted share, for the nine months ended September 30, 2024, compared with a net loss of $14.1 million, or ($2.72) per diluted share, for the nine months ended September 30, 2023. Revenues for the nine-month period ended September 30, 2024 were $7.7 million, primarily consisting of licensing revenue received from our Verity License Agreement, in addition to TLANDO royalty revenue of $206,000. During the nine months ended September 30, 2023, the company recognized a non-cash revenue reversal of variable consideration for minimum guaranteed royalties of $3.1 million relating to the termination of the Antares License Agreement offset by licensing revenue of approximately $55,000 for payments received related to the Spriaso license agreement. Research and development expenses were $6.3 million and $8.5 million, respectively, for the nine months ended September 30, 2024 and 2023. The decrease was a result of a decrease in contract research organization expense and outside consulting costs related to the wind down of the LPCN 1148 study in 2024, a decrease in TLANDO related costs, a decrease in personnel related costs, and a decrease in other research and development related costs. These decreases were offset an increase in costs related to the LPCN 1154 clinical studies. General administrative expenses were $4.1 million and $3.8 million respectively, for the nine months ended September 30, 2024 and 2023. The increase in general and administrative expenses was a result of increases in business development expenses, corporate legal fees and director fees, offset by decreases in corporate insurance expense, professional fees, other administrative consulting fees, personnel related costs, and travel related costs. For more information on Lipocine's financial results, refer to Form 10-Q filed by the Company with the SEC. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products. 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 anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in obesity management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for obesity management, LPCN 1148, for the management of decompensated cirrhosis, 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 . 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 development and commercialization of TLANDO and TLANDO XR by our licensees, the amount of the license fee, milestone payments, and royalty payments we will ultimately receive, the ability of our licensees to grow the TLANDO franchise, our product development efforts, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1148 and LPCN 2401, the timing of our submission of a NDA with the FDA for LPCN 1154, 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 . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Total Revenue Increased 34% YOY to $290 million and Royalty Revenue Increased 36% YOY to $155 million Net Income Increased 67% YOY to $137 million and Adjusted EBITDA Increased 60% YOY to $184 million GAAP Diluted EPS Increased 72% YOY to $1.05 and Non-GAAP Diluted EPS Increased 69% YOY to $1.271 Raised 2024 Financial Guidance Ranges for Total Revenue of $970-$1,020 million, Representing YOY Growth of 17%-23%, Adjusted EBITDA of $595-$625 million, Representing YOY Growth of 40%-47%, and Non-GAAP Diluted EPS of $4.00-$4.20, Representing YOY Growth of 44%-52% SAN DIEGO, Oct. 31, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the third quarter ended September 30, 2024, and provided an update on its recent corporate activities and outlook. "Our robust third quarter financial results highlight the strong execution and accelerating momentum we have across our business and exceeded expectations with total revenue growth of 34% and adjusted EBITDA growth of 60%. Based on the strong performance year-to-date, we have raised our 2024 guidance ranges and expect the advancement of our ENHANZE pipeline and new nominations from two global licensing agreements to support our future growth trajectory," said Dr. Helen Torley, president and chief executive officer of Halozyme. "In the quarter, the announcement of two highly anticipated partner approvals in the U.S. for Roche's TECENTRIQ HYBREZA and OCREVUS ZUNOVO reinforces ENHANZE's track record of 100% phase 3 study and subsequent regulatory success. The new nominations for ENHANZE from argenx, for a total of six targets, and ViiV Healthcare, for an additional undisclosed target, further demonstrate the value of our leading technology for rapid, large volume subcutaneous delivery." Recent Partner Highlights: In October 2024, argenx initiated two studies evaluating VYVGART® Hytrulo with ENHANZE®, a Phase 3 study for adult patients with ocular myasthenia gravis ("oMG") and a Phase 2 study for kidney transplant recipients with antibody mediated rejection ("AMR"). In October 2024, Janssen announced the European Commission approved DARZALEX® SC for the treatment of patients newly diagnosed with multiple myeloma ("NDMM") who are eligible for autologous stem cell transplant ("ASCT") in combination with bortezomib, lenalidomide, and dexamethasone ("D-VRd"). In September 2024, argenx expanded its global collaboration and license agreement nominating four additional targets that provides them exclusive access to our ENHANZE® drug delivery technology for a total of six targets. Under the terms of the expanded exclusive agreement, we received upfront payments of $7.5 million per target nomination for a total of $30.0 million. argenx is obligated to make future milestone payments of up to $85.0 million per new nominated target, subject to achievements of specified development, regulatory and sales-based milestones. We are also entitled to receive royalties on net sales of commercialized products with our ENHANZE® technology. In September 2024, ViiV expanded its global collaboration and license agreement providing ViiV the ability to exclusively access our ENHANZE® drug delivery technology for one additional undisclosed target. In September 2024, Roche announced the U.S. Food and Drug Administration ("FDA") approved OCREVUS ZUNOVO™ with ENHANZE® as a twice a year ten-minute subcutaneous ("SC") injection for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis. In September 2024, Roche announced the FDA approved TECENTRIQ HYBREZA™ with ENHANZE® for all approved adult indications of intravenous ("IV") TECENTRIQ® and was made available to patients, resulting in a $12.0 million milestone payment. In September 2024, Janssen announced the submission of a supplemental Biologic License Application to the FDA for approval of a new indication of DARZALEX FASPRO® in combination with D-VRd for the treatment of adult patients with NDMM for whom ASCT is deferred or who are ineligible for ASCT. In August 2024, the FDA designated Janssen's Biologics License Application ("BLA") priority review status for amivantamab SC in combination with LAZCLUZE™ for currently approved or submitted indication of IV in certain patients with non-small cell lung cancer. In August 2024, Takeda submitted a New Drug Application in Japan seeking approval for TAK-771 with ENHANZE® for treatment of chronic inflammatory demyelinating polyneuropathy/Multifocal Motor Neuropathy. In July 2024, Janssen announced the FDA approved DARZALEX FASPRO® for an additional indication in NDMM patients who are eligible for ASCT in combination with D-VRd. In July 2024, argenx announced the National Medical Products Administration approved the BLA of efgartigimod SC for generalized myasthenia gravis in China. In July 2024, Acumen initiated a Phase 1 study of sabirnetug ("ACU193") co-formulated with ENHANZE® for the treatment of early Alzheimer's disease. Third Quarter 2024 Financial Highlights: Revenue was $290.1 million, compared to $216.0 million in the third quarter of 2023. The 34% year-over-year increase was primarily driven by royalty revenue growth and an increase in milestone revenue. Revenue for the quarter included $155.1 million in royalties, an increase of 36% compared to $114.4 million in the third quarter of 2023, primarily attributable to increases in revenue of DARZALEX® SC and Phesgo®, and the prior year launch of VYVGART® Hytrulo. Cost of sales was $49.4 million, compared to $54.8 million in the third quarter of 2023. The decrease was primarily due to lower device and bulk rHuPH20 sales. Amortization of intangibles expense was $17.8 million, compared to $20.3 million in the third quarter of 2023. The decrease was primarily due to an impairment charge of $2.5 million recognized in the prior year to fully impair the TLANDO® product rights intangible asset. Research and development expense was $18.5 million, compared to $17.3 million in the third quarter of 2023. The increase was primarily due to increased compensation expense. Selling, general and administrative expense was $41.2 million, compared to $35.3 million in the third quarter of 2023. The increase was primarily due to increased compensation expense and consulting and professional service fees. Operating income was $163.2 million, compared to $88.3 million in the third quarter of 2023. Net Income was $137.0 million, compared to $81.8 million in the third quarter of 2023. EBITDA was $183.6 million, compared to $124.6 million in the third quarter of 2023. Adjusted EBITDA was $183.6 million, compared to $114.9 million in the third quarter of 2023.1 GAAP diluted earnings per share was $1.05, compared to $0.61 in the third quarter of 2023. Non-GAAP diluted earnings per share was $1.27, compared to $0.75 in the third quarter of 2023.1 Cash, cash equivalents and marketable securities were $666.3 million on September 30, 2024, compared to $336.0 million on December 31, 2023. The increase was primarily a result of cash generated from operations. Financial Outlook for 2024 The Company is raising its financial guidance for 2024. For the full year 2024, the Company expects: Total revenue of $970 million to $1,020 million, representing growth of 17% to 23% over 2023 total revenue primarily driven by increases in royalty revenue, collaboration revenue and growth in product sales from XYOSTED®. Revenue from royalties of $550 million to $565 million, representing growth of 23% to 26% over 2023. Adjusted EBITDA of $595 million to $625 million, representing growth of 40% to 47% over 2023. Non-GAAP diluted earnings per share of $4.00 to $4.20, representing growth of 44% to 52% over 2023. The Company's earnings per share guidance does not consider the impact of potential future share repurchases. Table 1. 2024 Financial Guidance Webcast and Conference Call Halozyme will host its Quarterly Update Conference Call for the third quarter ended September 30, 2024 today, Thursday, October 31, 2024 at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: . The call will also be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched more than 800,000 patient lives in post-marketing use in eight commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and Idorsia Pharmaceuticals. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Note Regarding Use of Non-GAAP Financial Measures In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release and the accompanying tables contain certain non-GAAP financial measures. The Company reports earnings before interest, taxes, depreciation, and amortization ("EBITDA"), adjusted EBITDA and Non-GAAP diluted earnings per share, and guidance with respect to those measures, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discounts, intangible asset amortization, one-time changes in contingent liabilities, inventory adjustments, impairment charges, and certain adjustments to income tax expense. The Company calculates non-GAAP diluted shares excluding the dilutive impact of convertible notes which is used in calculating non-GAAP diluted earnings. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding one-time items such as changes in contingent liabilities and inventory adjustments. Reconciliations between GAAP and Non-GAAP financial measures are included at the end of this press release. The Company does not provide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in share-based compensation expense and the effects of any discrete income tax items. The Company evaluates other items of income and expense on an individual basis for potential inclusion in the calculation of Non-GAAP financial measures and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of the Company's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP, and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures, and the Company may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. The Company considers these non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations. The Company uses non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs. Safe Harbor Statement In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's financial performance (including the Company's financial outlook for 2024) and expectations for future growth, profitability, total revenue, royalty revenue, EBITDA, Adjusted EBITDA, and non-GAAP diluted earnings-per-share. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's business may include potential growth and receipt of royalty and milestone payments driven by our partners' development and commercialization efforts, potential new clinical trial study starts and clinical data, regulatory submissions and product launches, the size and growth prospects of our partners' drug franchises, potential new or expanded collaborations and collaborative targets and regulatory review, and potential approvals of new partnered or proprietary products, and the potential timing of these events. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-359-3016 [email protected] Samantha Gaspar Teneo 212-886-9356 [email protected] Footnotes: 1. Reconciliations between GAAP reported and non-GAAP financial information for actual results are provided at the end. SOURCE Halozyme Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED