ViiV Healthcare UK Ltd.

Servier and its fellow front-runners lead an industry that has fallen in the estimation of patient groups. A French drugmaker has hopped across the pond and stolen the hearts of U.S. patient groups. Asked by PatientView which pharma company has the best reputation, 314 organizations coalesced (PDF) around a new name: Servier.  The survey caps off Servier’s rapid rise up the ranks. In 2020, the French drugmaker came in (PDF) tenth. Servier was one of the biggest climbers in 2021 (PDF) but still failed to crack the top three. That changed in 2022, when Servier rose (PDF) a spot to take third place on the podium behind Horizon Therapeutics and Roche. With Amgen buying Horizon, 2023 presented Servier with an opportunity to climb again.  In the end, Servier was the only member of the top trio of 2022 to retain a place on the leaderboard. Roche fell out of the top three, allowing ViiV Healthcare, a frequent sight toward the top of the rankings, to take second place. Amgen came in third. Limiting the analysis to groups that work with the company shook things up a little, with ViiV taking the top spot ahead of Servier and Gilead Sciences. Servier and its fellow front-runners lead an industry that has fallen in the estimation of patient groups. PatientView’s global survey results showed the proportion of U.S. groups with an excellent or good view of the pharma industry fell again in 2023, sliding eight percentage points to 57%. A closer look at the U.S. data shows the decline is about more than just perennial pain points such as pricing.  The proportion of patient groups with a good or excellent view of pharma fell on all bar one of the 14 metrics tracked by PatientView. The only metric that held steady was fair pricing policies, an area where the industry’s reputation is already almost rock bottom.  Pharma’s reputation fell by 1% to 12% on all other metrics. Some of the biggest drops affect areas where the industry has traditionally enjoyed a good standing with U.S. patient groups. There were double-digit drops in the scores for patient-centricity, information, integrity, patient-group relations, services “beyond the pill” and access to medicines. Innovation and ensuring patient safety fell 6% and 9%, respectively.

Approved for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV infection in at-risk adults and adolescents aged 12 years and older, weighing at least 35 kg, including men who have sex with men, transgender women, and cisgender women. APRETUDE (cabotegravir extended release injectable suspension) is the first and only long-acting injectable PrEP treatment approved in Canada. Given as few as six times per year after initiation and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition in 2 clinical trials.1 The latest Canadian surveillance data shows that there were 1,833 new HIV diagnoses in 2022, a 24.9 per cent increase from 2021.2 MONTRÉAL, May 13, 2024 /CNW/ - ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi as shareholders, announced that Health Canada has granted approval for APRETUDE (cabotegravir tablets and extended release injectable suspension) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at risk individuals who are HIV-1 negative.1 APRETUDE is indicated for at-risk adults and adolescents aged 12 years and older and weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV-1 infection.1 APRETUDE is the only long-acting injectable HIV PrEP option approved in Canada that reduces the number of doses needed for effective HIV prevention from daily pills to as few as six injections per year. Cabotegravir tablets and extended release injectable suspension for PrEP has demonstrated superior efficacy to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF tablets) in reducing the risk of HIV acquisition in 2 clinical trials, giving Canadians more options for PrEP.1 Jean-Francois Fortin, Country Medical Director, Canada at ViiV Healthcare, said: "With the approval of APRETUDE in Canada, we are proud to be able to offer a new prevention option for Canadians at risk of acquiring HIV. We are confident that by providing another highly effective preventative option for Canadians, we are one step closer to our collective goal of ending the HIV epidemic. We look forward to working with provincial, territorial, and national health authorities to bring APRETUDE to Canadians across the country." HIV remains a critical public health issue in Canada, with cases of HIV increasing by 24.9 per cent in 2022 from 2021.2 PrEP has been identified as an effective tool in reducing new cases of HIV, key to ending the HIV epidemic. Despite the wide availability of daily oral PrEP, inconsistent adherence as well as structural and cultural barriers lead to underutilization in key populations. Health Canada approval was based on the results of two key phase IIb/III studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in men who have sex with men, transgender women, and cisgender women who were at increased risk of HIV.3,4 The studies demonstrated that cabotegravir long-acting injectables for PrEP was superior to daily oral emtricitabine/tenofovir disproxil fumarate (FTC/TDF), with clinical trial participants experiencing 69 per cent lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 083, and a 90 per cent lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 084.5,6 About Cabotegravir extended release injectable suspension Cabotegravir extended release injectable suspension is the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option proven superior to daily oral FTC/TDF in reducing HIV acquisition. It is indicated for at-risk adults and adolescents aged 12 years and older, weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV-1 infection. Cabotegravir extended release injectable suspension is administered as a single 600 mg (3-ml) intramuscular (IM) injection of cabotegravir in the buttocks by a health care professional every two months after two initiation injections administered one month apart. Cabotegravir tablets can be used as an optional oral lead-in to assess tolerability or as short-term oral PrEP in individuals who will miss planned dosing with cabotegravir extended release injectable suspension. Cabotegravir is an integrase strand transfer inhibitor (INSTI). INSTIs, like cabotegravir extended release injectable suspension, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease.1 About HPTN 083 (NCT02720094)7 The HPTN 083 trial is a phase IIb/III double blind non-inferiority trial designed to evaluate the safety and efficacy of long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg). The trial included the prespecified ability to test for superiority of long-acting cabotegravir over FTC/TDF. The trial design included an oral lead-in phase to assess tolerability to cabotegravir before administering the intramuscular injection. HPTN 083 was conducted in 4,566 men who have sex with men and transgender women who have sex with men. The study opened to enrollment in November 2016 at research centres in Argentina, Brazil, Peru, United States, South Africa, and Vietnam.5 At a pre-planned interim review of trial data, a multinational Data and Safety Monitoring Board (MDSMB) recommended that the blinded phase of HPTN 083 be stopped due to the demonstration of superior efficacy of cabotegravir when compared to daily, oral FTC/TDF and that subjects randomized to the active FTC/TDF group be offered cabotegravir. The most common adverse reactions (all grades) observed in at least 1 per cent of subjects receiving long acting cabotegravir were injection sites reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, and abdominal pain.5 For further information on HPTN 083 please see . About HPTN 084 (NCT03164564)6 The HPTN 084 trial is a phase III double blind superiority trial designed to evaluate the safety and efficacy of the long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg) in 3,224 cisgender women who are at increased risk of HIV acquisition. The trial design included an oral lead-in phase to assess tolerability to cabotegravir before administering the intramuscular injection. HPTN 084 opened to enrolment in November 2017 and is being conducted at research centres in Botswana, Kenya, Malawi, South Africa, Eswatini, Uganda, and Zimbabwe.6 The MDSMB recommended early termination of the blinded, randomized portion of HPTN 084 after an interim analysis indicated that pre-specified stopping criteria had been met (superiority of cabotegravir compared with FTC/TDF). The most common adverse reactions (all grades) observed in at least 1% of subjects receiving long acting cabotegravir were injection site reactions, diarrhea, headache, fatigue, sleep disorders, nausea, dizziness, abdominal pain, vomiting, myalgia, and rash.6 For further information please see . About HIV HIV (human immunodeficiency virus) is a virus that attacks the body's immune system.8 HIV is spread by contact with certain bodily fluids of a person with HIV, most commonly during unprotected sex (sex without a condom or HIV medicine to prevent or treat HIV), or through sharing injected drug equipment.9 If HIV is not treated, it can lead to AIDS (acquired immunodeficiency virus). AIDS is the most severe stage of HIV (Stage 3).10 There is currently no cure for HIV, but with proper treatment and care, people with HIV can maintain a high quality of life and avoid passing HIV to others. At the end of 2022, 39 million people lived with HIV around the world, with 1.3 million new diagnoses that year and 630,000 deaths from AIDS-related illnesses.11 Important Safety Information for APRETUDE for PrEP1 The APRETUDE Product Monograph includes a Serious Warning and Precautions Box: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE IN UNDIAGNOSED HIV-1 INFECTION.1 Individuals must be tested for HIV-1 infection prior to initiating APRETUDE and should be tested for HIV-1 infection with each subsequent injection of APRETUDE. APRETUDE must not be prescribed until confirmation of negative HIV-1 infection status. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.1 Individuals who become infected with HIV-1 while receiving APRETUDE must transition to a complete HIV-1 treatment regimen. The Product Monograph also includes warnings and precautions regarding hypersensitivity reactions, hepatotoxicity (liver damage) and depressive disorders.1 The Product Monograph, posted at , should be consulted for complete administration and safety information, including contraindications, additional warnings and precautions, adverse reactions and drug interactions.1 Prior to being posted online, the Product Monograph is also available by calling 1-877-393-8448. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company's aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. SOURCE ViiV Healthcare

Revenue Increased 21% YOY to $196 million; Net Income of $77 million; Adjusted EBITDA of $116 million; GAAP Diluted EPS of $0.60 and Non-GAAP Diluted EPS of $0.791 Royalty Revenue Increased 21% YOY to $121 million Reiterating 2024 Financial Guidance: Total Revenue of $915 - $985 million, Representing YOY Growth of 10% - 19%, Adjusted EBITDA of $535 - $585 million, Representing YOY Growth of 26% - 37% and Non-GAAP Diluted EPS of $3.55 - $3.90, Representing YOY Growth of 28% - 41% Announced New $750 million Share Repurchase Program SAN DIEGO, May 7, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the first quarter ended March 31, 2024, and provided an update on its recent corporate activities and outlook. "We are pleased to report another quarter of double-digit revenue and earnings growth, which keeps us on track to meet our financial guidance for the full year. We entered the new year with continued strong advancement of our ENHANZE partner products and pipeline. Our partnership with argenx represents a significant growth opportunity following the approval for VYVDURA, efgartigimod co-formulated with ENHANZE, for generalized myasthenia gravis in Japan and with the potential U.S. approval for VYVGART Hytrulo for CIDP in June 2024. Following European approval of Roche's Tecentriq SC, we look forward to potential U.S. approval for Tecentriq SC in September 2024. Roche has also received a recommendation for approval of ocrelizumab SC by the European Medicines Agency's Committee for Medicinal Products for Human Use, with final approval expected mid-year and a potential U.S. approval in September 2024. Continuing our strong Wave 3 progress, BMS recently announced a U.S. Prescription Drug User Fee Act goal date of February 28, 2025 for nivolumab SC," said Dr. Helen Torley, president and chief executive officer of Halozyme. "Our leading innovations are the driver of our robust portfolio and patent estate that is resulting in new revenue opportunities and durable revenue and EBITDA growth." Recent Partner Highlights: In May 2024, Bristol Myers Squibb announced that the U.S. Food and Drug Administration ("FDA") accepted its Biologics License Application for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with ENHANZE®, resulting in a $15.0 million milestone payment. The FDA assigned a Prescription Drug User Fee Act ("PDUFA") goal date of February 28, 2025. In April 2024, Roche announced that European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of Ocrevus® (ocrelizumab) subcutaneous ("SC") for its multiple sclerosis indications. A final decision on its approval from the European Commission ("EC") is expected mid-2024. In April 2024, Roche announced that the FDA has accepted the submission of ocrelizumab SC with potential approval in September 2024. In March 2024, ViiV initiated a Phase 1 study of VH4524184 with ENHANZE® to evaluate the safety, tolerability, and pharmacokinetics in healthy adults. In the first quarter of 2024, argenx initiated two registrational studies evaluating efgartigimod with ENHANZE® administered by pre-filled syringe in subjects with thyroid eye disease. In February 2024, argenx announced that the FDA has accepted for priority review a supplemental Biologics License Application ("sBLA") for VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy ("CIDP"). The application has been granted a PDUFA action date of June 21, 2024. In February 2024, Takeda submitted a New Drug Application in Japan seeking approval for TAK-771, subcutaneous 10% human immunoglobulin with ENHANZE®, for treatment of primary immunodeficiency. In January 2024, Janssen announced submission of a sBLA to the FDA seeking approval of a new indication for DARZALEX FASPRO® in combination with bortezomib, lenalidomide and dexamethasone for induction and consolidation treatment and with lenalidomide for maintenance treatment of adult patients who are newly diagnosed with multiple myeloma and are eligible for autologous stem cell transplant. In January 2024, Roche received European Commission marketing authorization for Tecentriq® subcutaneous for all approved indications of Tecentriq® IV for multiple cancer types. In January 2024, Takeda received FDA approval for HYQVIA® for the treatment of CIDP as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults. In January 2024, Takeda received EC approval for HYQVIA® for the treatment of CIDP as maintenance therapy in patients of all ages after stabilization with intravenous immunoglobulin therapy. In January 2024, argenx received regulatory approval in Japan for VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) co-formulated with ENHANZE® for the treatment of adult patients with generalized myasthenia gravis including options for self-administration, and in April 2024, VYVDURA® was made available to patients resulting in $14.0 million total milestone payments. Recent Corporate Highlights: In February 2024, the Company announced its third share repurchase program to repurchase up to $750 million of its outstanding common stock. First Quarter 2024 Financial Highlights: Revenue was $195.9 million compared to $162.1 million in the first quarter of 2023. The 21% year-over-year increase was primarily driven by royalty revenue growth and an increase in milestone revenue. Revenue for the quarter included $120.6 million in royalties, an increase of 21% compared to $99.6 million in the prior year period, primarily attributable to increases in revenue of subcutaneous DARZALEX® (daratumumab) and Phesgo®. Cost of sales was $28.3 million, compared to $35.2 million in the first quarter of 2023. The decrease was primarily driven by lower bulk rHuPH20 sales, partially offset by higher proprietary product sales. Amortization of intangibles expense remained flat at $17.8 million compared to the first quarter of 2023. Research and development expense was $19.1 million, compared to $18.0 million in the first quarter of 2023. The increase was primarily due to planned investments in ENHANZE®. Selling, general and administrative expense was $35.1 million, compared to $37.4 million in the first quarter of 2023. The decrease was primarily due to reductions in commercial marketing expense, partially offset by increased compensation expense. Operating income was $95.5 million, compared to $53.8 million in the first quarter of 2023. Net Income was $76.8 million, compared to $39.6 million in the first quarter of 2023. EBITDA and Adjusted EBITDA were $115.7 million, compared to $74.3 million in the first quarter of 2023.1 GAAP diluted earnings per share was $0.60, compared to $0.29 in the first quarter of 2023. Non-GAAP diluted earnings per share was $0.79, compared to $0.47 in the first quarter of 2023.1 Cash, cash equivalents and marketable securities were $463.5 million on March 31, 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 reiterating its financial guidance for 2024, which was initially provided on January 17, 2024. For the full year 2024, the Company expects: Total revenue of $915 million to $985 million, representing growth of 10% to 19% over 2023 total revenue primarily driven by increases in royalty revenue, collaboration revenue and growth in product sales from XYOSTED®. Revenue from royalties of $500 million to $525 million, representing growth of 12% to 17% over 2023. Adjusted EBITDA of $535 million to $585 million, representing growth of 26% to 37% over 2023. Non-GAAP diluted earnings per share of $3.55 to $3.90, representing growth of 28% to 41% over 2023.1 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 first quarter ended March 31, 2024 today, Tuesday, May 7, 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 reducing treatment burden for patients. Having touched more than 800,000 patient lives in post-marketing use in seven 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 several pharmaceutical companies including 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, inventory adjustments and certain adjustments to income tax expense. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding one-time items. 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, revenue durability, EBITDA, Adjusted EBITDA, non-GAAP diluted earnings-per-share and potential share repurchase under its share repurchase program. 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, PDUFA action dates and potential approvals of new partnered or proprietary products. 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 delays in the execution of the Company's share repurchase program, 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 and adjusted guidance measures are provided at the end. SOURCE Halozyme Therapeutics, Inc.