Humoral immunodeficiency

Total Revenue of $231 million; Net Income of $93 million; Adjusted EBITDA of $137 million; GAAP Diluted EPS of $0.72 and Non-GAAP Diluted EPS of $0.911 Royalty Revenue Increased 12% YOY to $125 million Partner Approvals for Ocrevus® SC in Europe and the UK and VYVGART® Hytrulo for CIDP in the U.S. Maintain Recently Increased 2024 Financial Guidance: Total Revenue of $935 - $1,015 million, Representing YOY Growth of 13% - 22%, Adjusted EBITDA of $555 - $615 million, Representing YOY Growth of 30% - 44% and Non-GAAP Diluted EPS of $3.65 - $4.05, Representing YOY Growth of 32% - 46% SAN DIEGO, Aug. 6, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the second quarter ended June 30, 2024, and provided an update on its recent corporate activities and outlook. "Our strong financial results reflect another quarter of double-digit royalty revenue, EBITDA and earnings growth. We remain on track to deliver on our financial guidance for the full year that was recently raised following the issuance and validation of a new EU patent covering the ENHANZE rHuPH20 product. In the quarter, we also expanded ENHANZE into neurology treatment with Roche's EU and UK approval of Ocrevus SC, while also extending our reach into auto-immune diseases with argenx's FDA approval for VYVGART Hytrulo for the treatment of CIDP," said Dr. Helen Torley, president and chief executive officer of Halozyme. "Looking ahead, we have a robust pipeline with clear line of sight to 10 approved products with ENHANZE in 2025. This includes the potential U.S. approvals for Roche's Tecentriq SC and Ocrevus SC in September 2024. Building on this momentum, we project U.S. approval for BMS' nivolumab SC at the end of the year and Johnson & Johnson's amivantamab SC is on track for potential U.S. and EU launches in 2025. We are now 10 for 10 in terms of success in IV to SC Phase 3 studies, further cementing ENHANZE as the gold standard for rapid SC delivery." Recent Partner Highlights: In July, 2024, Janssen announced the U.S. Food and Drug Administration ("FDA") approved DARZALEX FASPRO® for an additional indication in newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplant in combination with bortezomib, lenalidomide, and dexamethasone. In July 2024, argenx announced the National Medical Products Administration ("NMPA") approved its Biologics License Application ("BLA") of efgartigimod subcutaneous ("SC") injection for generalized myasthenia gravis in China. In July 2024, Roche announced the approval of Ocrevus® (ocrelizumab) SC for the treatment of relapsing multiple sclerosis ("RMS") and primary progressive multiple sclerosis ("PPMS") by the Medicines and Healthcare products Regulatory Agency in Great Britain. In July 2024, Acumen initiated a Phase 1 study of sabirnetug (ACU193) co-formulated with ENHANZE® for the treatment of early Alzheimer's disease, resulting in a $3.0 million milestone payment recognized in June 2024. In June 2024, argenx announced the FDA approved VYVGART® Hytrulo with ENHANZE® for the treatment of chronic inflammatory demyelinating polyneuropathy ("CIDP"), and completed the regulatory submissions of VYVGART® SC for CIDP in Japan, Europe, and China during the second quarter of 2024. In June 2024, Roche announced the European Commission granted marketing authorization in the European Union of Ocrevus® (ocrelizumab) SC for the treatment of RMS and PPMS, marking our eighth approved partner product with ENHANZE®. In June 2024, Takeda announced that Health Canada approved HyQvia as a replacement therapy for primary humoral immunodeficiency and a secondary humoral immunodeficiency in pediatric patients two years of age and older. In June 2024, Bristol Myers Squibb ("BMS") announced the European Medicines Agency ("EMA") validated its Extension Application for the SC formulation of Opdivo (nivolumab) co-formulated with ENHANZE®, resulting in a $7.0 million milestone payment. In June 2024, Janssen announced the submission of a BLA to the FDA for amivantamab SC co-formulated with ENHANZE® for the treatment of patients with epidermal growth factor receptor ("EGFR") mutated non-small cell lung cancer ("NSCLC"). In May 2024, BMS announced the FDA accepted its BLA for the SC formulation of Opdivo® (nivolumab) co-formulated with ENHANZE®, resulting in a $15.0 million milestone payment. The FDA assigned an updated Prescription Drug User Fee Act ("PDUFA") goal date of December 29, 2024. In May 2024, Janssen announced the submission of a marketing authorization application to the EMA for the SC formulation of RYBREVANT® (amivantamab) with ENHANZE® for the treatment of patients with EGFR mutated NSCLC. In April 2024, Roche announced the FDA accepted its BLA submission of ocrelizumab SC with a PDUFA goal date of September 13, 2024. In April 2024, Roche's MabThera® SC was approved by China's NMPA to treat diffuse large B-cell lymphoma. Recent Corporate Highlights: In June 2024, we announced the issuance of a new European patent covering the ENHANZE® rHuPH20 product obtained from our ENHANZE® manufacturing methods that we provide to our licensees. The newly granted patent maintains the original royalty rate on sales of DARZALEX® SC in 37 European countries until expiration of the patent in March 2029. In June 2024, we completed the $250 million Accelerated Share Repurchase that was initiated in November of 2023, resulting in a total repurchase of 6.5 million shares at a price of $38.35 per share which concluded our December 2021 share repurchase program resulting in a total of 19.1 million shares repurchased over the three-year period at an average price per share of $39.31. Second Quarter 2024 Financial Highlights: Revenue was $231.4 million, compared to $221.0 million in the second quarter of 2023. The 5% year-over-year increase was primarily driven by royalty revenue growth and an increase in proprietary product sales, partially offset by lower milestone revenue. Revenue for the quarter included $124.9 million in royalties, an increase of 12% compared to $111.7 million in the second quarter of 2023, primarily attributable to increases in revenue of Phesgo®, the launch of VYVGART® Hytrulo and the U.S. launch of Teriparatide. DARZALEX® SC royalties were temporarily lowered in Europe between March and June prior to the issuance of the new European patent covering the ENHANZE® rHuPH20 product. Cost of sales was $39.6 million, compared to $50.1 million in the second quarter of 2023. The decrease was primarily due to lower device and bulk rHuPH20 sales, partially offset by higher proprietary product sales. Amortization of intangibles expense remained flat at $17.8 million, compared to the second quarter of 2023. Research and development expense was $21.0 million, compared to $19.7 million in the second quarter of 2023. The increase was primarily due to planned investments in ENHANZE® related to the development of our new high yield API manufacturing processes. Selling, general and administrative expense was $35.7 million, compared to $38.9 million in the second quarter of 2023. The decrease was primarily due to planned reductions in commercial marketing expense. Operating income was $117.2 million, compared to $94.5 million in the second quarter of 2023. Net Income was $93.2 million, compared to $74.8 million in the second quarter of 2023. EBITDA and Adjusted EBITDA was $137.0 million, compared to $115.1 million in the second quarter of 2023.1 GAAP diluted earnings per share was $0.72, compared to $0.56 in the second quarter of 2023. Non-GAAP diluted earnings per share was $0.91, compared to $0.74 in the second quarter of 2023.1 Cash, cash equivalents and marketable securities were $529.0 million on June 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 reiterating its financial guidance for 2024, which was increased on June 6, 2024 as a result of the new European patent for ENHANZE®. For the full year 2024, the Company expects: Total revenue of $935 million to $1,015 million, representing growth of 13% to 22% over 2023 total revenue primarily driven by increases in royalty revenue, collaboration revenue and growth in product sales from XYOSTED®. Revenue from royalties of $520 million to $555 million, representing growth of 16% to 24% over 2023. Adjusted EBITDA of $555 million to $615 million, representing growth of 30% to 44% over 2023. Non-GAAP diluted earnings per share of $3.65 to $4.05, representing growth of 32% to 46% 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 second quarter ended June 30, 2024 today, Tuesday, August 6, 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 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, EBITDA, Adjusted EBITDA, non-GAAP diluted earnings-per-share and potential share repurchases 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, 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 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: Reconciliations between GAAP reported and non-GAAP financial information for actual results are provided at the end. SOURCE Halozyme Therapeutics, Inc.

HyQvia®, which may be administered at home, will provide children and adolescents living with immunodeficiencies with a new treatment option TORONTO, June 21, 2024 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce that Health Canada has expanded the marketing authorization (NOC) for HyQvia® (normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution for subcutaneous infusion) as a replacement therapy for primary humoral immunodeficiency (PI) and secondary humoral immunodeficiency (SI) in pediatric patients 2 years of age and older. HyQvia is the only subcutaneous immune globulin (SCIG) infusion that can be administered every three or four weeks.1 "This approval is significant as it gives children and adolescents living with immunodeficiencies another treatment option," said Whitney Ayoub Goulstone, Executive Director, ImmUnity Canada. "Children living with immunodeficiencies can be severely impacted as it affects them physically, emotionally and socially. Our organization welcomes treatment options for patients in Canada as this is to the benefit of better health outcomes and patient preference." There are more than 300 genetic defects and disorders of the immune system that are recognized as PI. These forms range widely in severity and symptoms. On average, 1 in every 1,200 individuals are affected by this disease and early diagnosis and treatment are vital in saving lives. Approximately 29,000 Canadians suffer from PI and over 70% are undiagnosed.2 "The pediatric indication for HyQvia provides another treatment option for patients impacted by immunodeficiency disorders," said Jefferson Tea, Vice President, Medical & Scientific Affairs, Takeda. "We are committed to creating innovative solutions for Canadians living with immunodeficiency and are excited that parents and caregivers will have the option to support administration of this treatment to their children in their own home." Authorization for the treatment of pediatric patients was based on two pivotal studies in 66 patients ranging in age from 2 to 16 years. HyQvia was shown to be efficacious and no new safety signals were detected when compared to the adult population. Based on evidence from the pivotal, prospective, open-label, non-controlled Phase 3 clinical study in 44 pediatric patients with PI, there were no clinically meaningful differences in trough IgG levels across age groups. During the 12-month trial period, it was shown to be efficacious with respect to the occurrence of acute serious bacterial infections (ASBIs), a primary endpoint.1 The mean rate of ASBIs per subject-year was 0.04 and was statistically significantly lower (p<0.001) than the threshold rate of 1.0 ASBI per subject-year favoring efficacy of this treatment in pediatric subjects with PI. The efficacy of the treatment in this study was further demonstrated by the overall rate of infections per subject, which is consistent with results obtained in the pivotal clinical study. The mean rate of all infections per subject-year was 3.20, with an upper limit of the 95% CI of 4.05. The results of Study 161503 indicated similar safety profiles to adults.1 About HyQvia® HyQvia is indicated as replacement therapy for primary humoral immunodeficiency (PI) and secondary humoral immunodeficiency (SI) in adult and pediatric patients 2 years of age and older.1 This therapy is used in patients who do not have enough antibodies in their blood or have a weakened immune system and get frequent infections.1 Consult the product monograph for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The product monograph is also available through our medical information department. About Immunodeficiency Primary immunodeficiency disorder (PID) refers to a large heterogeneous group of disorders that result from defects in immune system development and/or function. PIDs are broadly classified as disorders of adaptive immunity (i.e., T cell, B-cell or combined immunodeficiencies) or of innate immunity (e.g., phagocyte and complement disorders). Although the clinical manifestations of PIDs are highly variable, many disorders involve an increased susceptibility to infection.2 Secondary immune deficiencies or acquired deficiencies, more frequent than primary immune deficiencies, are problems of the immune system that are not genetic and which are caused by external factors including viruses (such as HIV), severe malnutrition, certain chronic diseases such as diabetes, immunosuppressive medication or chemotherapy, certain cancers such as leukemia, and the absence of the spleen.3 About Takeda Canada Inc. Takeda Canada Inc. is the Canadian organization of Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK), a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit: References SOURCE Takeda Canada Inc. Company Codes: NYSE:TAK, Tokyo:4502

Signifies the Successful Fulfillment of BIVIGAM’s Post Marketing Commitments as Part of the Original BLA Approval Expanded Label in the U.S. Now Includes Pediatric PI Patients 2 Years of Age and Older RAMSEY, N.J. and BOCA RATON, Fla., Dec. 12, 2023 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics, today announced the U.S. Food and Drug Administration (“FDA”) has approved the Company’s supplemental Biologics License Application submitted under section 351(a) of the Public Health Service Act for BIVIGAM. The FDA approval represents the final study report for the Pediatric assessment as required in the post marketing commitment. Additionally, the approval provides for a revision of BIVIGAM’s prescribing information to expand the primary humoral immunodeficiency (“PI”) indication to pediatric patients 2 years of age and older. "We are pleased to announce that BIVIGAM has received FDA approval for treating PI in patients aged 2 years and older. Previously, the indication for BIVIGAM was restricted to PI patients aged 12 years and older,” said Adam Grossman, President and Chief Executive Officer of ADMA. “This expanded label for BIVIGAM allows ADMA to actively address the treatment needs of younger PI patients earlier in their treatment journey. In the periods ahead, we look forward to offering BIVIGAM as an FDA-approved treatment option for these pediatric PI patients,” concluded Mr. Grossman. “We extend our gratitude to the collaborative efforts of the PI disease community, physicians, and the invaluable contribution of the children and families who played a pivotal role in advancing this clinical program,” said Kaitlin Kestenberg, Senior Vice President, Compliance & Project Operations. “Enrolling and successfully completing these challenging trials is no small feat, and this approval is a testament to the commendable clinical execution and the dedication of the ADMA team.” About ADMA Biologics, Inc. (ADMA) ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 and European Patent No. 3375789, among others, related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com. About BIVIGAM® BIVIGAM (immune globulin intravenous, human – 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). BIVIGAM was approved by the FDA in May 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), including, but not limited to the following group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiency. BIVIGAM contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are directed against bacteria and viruses and help to protect PI patients against serious infections. BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin antibodies. Certain data and other information about BIVIGAM® or ADMA Biologics and its products can be found on the Company’s website at www.admabiologics.com. Additional Important Safety Information About BIVIGAM® WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE Thrombosis may occur with immune globulin intravenous (IGIV) products, including BIVIGAM. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors.Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients.Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. BIVIGAM does not contain sucrose.For patients at risk of thrombosis, renal dysfunction or renal failure, administer BIVIGAM at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. BIVIGAM® Contraindications: History of anaphylactic or severe systemic reactions to human immunoglobulin. IgA deficient patients with antibodies to IgA and a history of hypersensitivity. BIVIGAM® Warnings and Precautions: Thrombotic events have occurred in patients receiving IGIV therapy. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity. IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have medications such as epinephrine available immediately to treat any acute severe hypersensitivity reactions. Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output in patients at risk of developing acute renal failure. Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV therapy. Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion. Hemolytic anemia can develop subsequent to treatment with IGIV products. Monitor patients for hemolysis and hemolytic anemia. Monitor patients for pulmonary adverse reactions (Transfusion-related acute lung injury [TRALI]). If transfusion-related acute lung injury is suspected, test the product and patient for antineutrophil antibodies. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. BIVIGAM® Adverse Reactions: The most common adverse reactions to BIVIGAM (reported in ≥5% of clinical study subjects) were headache, fatigue, infusion site reaction, nausea, sinusitis, blood pressure increased, diarrhea, dizziness, and lethargy. To report SUSPECTED ADVERSE REACTIONS, contact ADMA Biologics at (800) 458-4244 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. COMPANY CONTACT:Skyler BloomSenior Director, Business Development and Corporate Strategy | 201-478-5552 | sbloom@admabio.com INVESTOR RELATIONS CONTACT:Michelle PappanastosSenior Managing Director, Argot Partners | 212-600-1902 | michelle@argotpartners.com