Human normal immunoglobulin(Takeda)

2Q 2024 Total Revenue of $107.2 Million, a 78% Increase Y-o-Y 2Q 2024 GAAP Net Income of $32.1 Million, a $38.4 Million Increase Y-o-Y 2Q 2024 Adjusted EBITDA(1) of $44.5 Million, a Nearly 600% Increase Y-o-Y Commercial Scale Production of ADMA’s Innovative Biologics Manufacturing Process Supports a Potential Yield Enhancement of Approximately 20% from Same Starting Plasma FY 2024 and 2025 Total Revenue Guidance Increased to More Than $400 Million and $445 Million, Respectively FY 2024 GAAP Net Income Guidance Increased to More Than $105 Million and Adjusted EBITDA Guidance Increased to More Than $150 Million FY 2025 GAAP Net Income Guidance Increased to More than $155 Million and Adjusted EBITDA Guidance Increased to More Than $200 Million Conference Call Scheduled for Today at 4:30 p.m. ET RAMSEY, N.J. and BOCA RATON, Fla., Aug. 08, 2024 (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 biologics, today announced its second quarter 2024 financial results and provided a business update. "ADMA’s excellent second quarter results showcased the strength of our operations, innovative business and product offerings, enabling the Company to significantly increase both 2024 and 2025 financial guidance,” said Adam Grossman, President and Chief Executive Officer of ADMA. “We believe the Company is well-positioned to further strengthen its balance sheet, reduce the cost of capital and sustain ADMA’s position as one of the fastest growing and profitable companies in the biotech and pharma sector.” Mr. Grossman continued, “ADMA’s commitment to serving immunodeficient patients, particularly those with complex comorbidities, remains the cornerstone of our mission. We see additional opportunities for ADMA to continue to grow substantially in the underserved, immune compromised and co-morbid patient population despite the availability of standard of care therapy. We are confident that incremental additional penetration with ASCENIV will accelerate near-term revenue growth and create a substantial peak revenue opportunity beyond our 2025 guided baseline. Looking to the remainder of 2024, we expect continued revenue and earnings growth, advancement of regulatory processes for manufacturing yield enhancement, favorable product mix shifts, and progress in our R&D programs.” Second Quarter 2024 Milestones and Objectives: Compounding Growth. Driven by 78% year-over-year revenue growth, ADMA grew Adjusted EBITDA and Net Income to $44.5 million and $32.1 million, respectively, during the second quarter. On a quarter-over-quarter basis, Adjusted EBITDA grew 69% and Net Income grew 80% compared to the first quarter of 2024. The Company anticipates building on this momentum throughout the remainder of 2024 and beyond.Favorably Evolving Mix Shift. ADMA’s higher margin product portfolio now accounts for over 50% of the Company’s total revenue. ADMA is actively implementing measures to increase ASCENIV supply. If successful, these initiatives could enable ASCENIV to contribute a significant majority of ADMA's total revenue over time, further advancing the Company's potential margin expansion and earnings growth.Strengthened Balance Sheet. Based on ADMA’s second quarter operating cash flow of $45.6 million and Adjusted EBITDA growth, the Company’s current net leverage ratio has organically improved to approximately 0.26x. The Company anticipates continued strengthening of the balance sheet driven by forecasted Adjusted EBITDA growth and ongoing cash generation in the second half of 2024 and beyond.Updated Marketing Materials. During the second quarter, ADMA revamped its corporate website, product websites and certain marketing materials, including those for Healthcare Providers (HCP). Additionally, the Company released a new video testimonial on the ASCENIV product website, highlighting the treatment journey of a co-morbid and refractive immunodeficient patient.Expanded ADMAlytics™ Implementation. ADMA successfully expanded implementation of ADMAlytics to the commercial arm of the organization during the second quarter. When fully implemented, ADMAlytics is expected to further optimize the Company’s commercial growth strategy. Initiated in February 2024, the staggered implementation of ADMAlytics continues to yield impressive results across multiple areas of ADMA’s operations. These benefits include increased production efficiency, enhanced visibility into the 7–12-month manufacturing process, optimized commercial planning, streamlined plasma pooling, and reduced variability and FTE hours. These efficiencies are expected to further solidify ADMA’s rapid earnings growth outlook. Upwardly Revised 2024-2025 Financial Guidance: FY 2024 and 2025 total revenue is now expected to be more than $400 million and $445 million, respectively, increased from prior guidance of more than $355 million and $410 million, respectively.FY 2024 and 2025 net income is now expected to exceed $105 million and $155 million, respectively, increased from prior guidance of $85 million and $135 million, respectively.FY 2024 and 2025 Adjusted EBITDA is now expected to exceed $150 million and $200 million, respectively, increased from prior guidance of $110 million and $160 million, respectively. Advancing Innovative Growth Opportunities: Below are the Company’s ongoing initiatives which, if successful, we believe represent the potential for upside to our current forecasted guidance: Biologic Production Yield Enhancement: During the second quarter and recent periods, commercial-scale production of ADMA's innovative biologics manufacturing process demonstrated a potential enhancement of yields by approximately 20% from the same starting plasma. If successful, we believe these yield improvements could significantly boost the Company’s future peak financial targets, potentially as early as the fourth quarter of 2025.R&D Program - S. pneumonia Hyperimmune Globulin: Streptococcus pneumoniae is the leading cause of community-acquired pneumonia in the U.S., with about one million adults developing pneumococcal pneumonia annually, resulting in 400,000 hospitalizations and a 5-7% mortality rate. Despite vaccines, vaccine-naive and immune-compromised individuals remain at risk. A hyperimmune globulin could provide immediate antibodies, potentially generating $300-500 million annually if approved. ADMA holds various U.S. and foreign patents which cover its proprietary pneumococcal hyperimmune technology, including hyperimmune anti-pneumococcal immune globulin, preparation methods, and its use in treating S. pneumonia infections.ASCENIV Label Expansion: The ongoing post-marketing pediatric clinical study for ASCENIV may provide label expansion opportunities, further strengthening ADMA’s product portfolio, if successful. Second Quarter 2024 Financial Results: Total revenues were $107.2 million for the quarter ended June 30, 2024, as compared to $60.1 million for the quarter ended June 30, 2023, an increase of $47.1 million, or approximately 78%. The increase is primarily related to increased sales of ASCENIV. During the second quarter, the Company recognized a non-recurring, $12.6 million increase to net revenues and a corresponding reduction of an accrual related to a change in estimate for U.S. Medicaid rebates. Gross profits were $57.5 million for the quarter ended June 30, 2024, as compared to $16.7 million for the quarter ended June 30, 2023, an increase of $40.8 million. As a result, ADMA achieved a corporate gross margin of 53.6% in the second quarter of 2024 as compared to 27.8% in the second quarter of 2023. Adjusted EBITDA was $44.5 million for the quarter ended June 30, 2024, as compared to Adjusted EBITDA of $6.4 million for the quarter ended June 30, 2023, an increase of $38.1 million, or approximately 592%. GAAP Net income was $32.1 million for the quarter ended June 30, 2024, compared to a GAAP Net Loss of $6.4 million for the quarter ended June 30, 2023. As of June 30, 2024, ADMA had working capital of approximately $259.5 million, primarily consisting of $179.8 million of inventory, $88.2 million of cash and cash equivalents and $30.1 million of net accounts receivable, partially offset by current liabilities of $44.2 million. Conference Call Information To access the conference call seamlessly, participants are required to register for the call here to receive the dial-in numbers and unique PIN. It is recommended that you join approximately 10 minutes prior to the event start (although you may dial in at any time during the call). Attendees who are not speaking during the call are encouraged to listen in to the live webcast here. An archived replay of the event will be available located under “Events & Webcasts” in the investor section of the Company’s website at https://ir.admabiologics.com/events-webcasts. About ASCENIV™ ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the United States Food and Drug Administration (FDA) in April 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age). ASCENIV is manufactured using ADMA’s unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and respiratory syncytial virus (RSV) plasma obtained from donors tested using the Company’s proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body’s immune system to neutralize microbes such as bacteria and viruses that safeguard against infection and disease. ASCENIV is protected by numerous issued patents in the United States and internationally and a wide range of patent applications worldwide. Certain data and other information about ASCENIV can be found by visiting www.asceniv.com. Information about ADMA and its products can be found on the Company’s website at www.admabiologics.com. Additional Important Safety Information About ASCENIV™ WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE Thrombosis may occur with immune globulin intravenous (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, 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 IGIV products in predisposed patients.Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose.For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV 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. ASCENIV™ Contraindications: History of anaphylactic or severe systemic reactions to human immunoglobulin. IgA deficient patients with antibodies to IgA and a history of hypersensitivity. ASCENIV™ Warnings and Precautions: IgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have medications such as epinephrine available to treat any acute severe hypersensitivity reactions. [4, 5.1] Thrombotic events have occurred in patients receiving IGIV treatments. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for patients at risk of hyperviscosity. [5.2, 5.4] In patients at risk of developing acute renal failure. monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output. [5.3, 5.9] Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV treatment. Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion. [5.5] Hemolytic anemia can develop subsequent to IGIV treatment. Monitor patients for hemolysis and hemolytic anemia. [5.6] 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. [5.7] 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. ASCENIV™ Adverse Reactions: The most common adverse reactions to ASCENIV (≥5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea To report SUSPECTED ADVERSE REACTIONS, contact ADMA Biologics at (800) 458-4244 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About ADMA Biologics, Inc. (ADMA) ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty 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 biologics and 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 holds numerous U.S. and foreign patents related to and encompassing various aspects of its products and product candidates. For more information, please visit www.admabiologics.com. Use of Non-GAAP Financial Measures This press release includes certain non-GAAP financial measures that are not prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The Company believes Adjusted EBITDA is useful to investors in evaluating the Company’s financial performance. The Company uses Adjusted EBITDA as a key performance measure because we believe that it facilitates operating performance comparisons from period to period that exclude potential differences driven by the impact of variations of non-cash items such as depreciation and amortization, as well as stock-based compensation or certain non-recurring items. The Company believes that investors should have access to the same set of tools used by our management and board of directors to assess our operating performance. Adjusted EBITDA should not be considered as a measure of financial performance under GAAP, and the items excluded from Adjusted EBITDA are significant components in understanding and assessing the Company’s financial performance. Accordingly, this key business metric has limitations as an analytical tool. It should not be considered as an alternative to net income/loss or any other performance measures derived in accordance with GAAP and may be different from similarly titled non-GAAP measures used by other companies. Please refer to the tables below for the reconciliation of GAAP measures to non-GAAP measures for applicable periods. Cautionary Note Regarding Forward-Looking Statements This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. (“we,” “our” or the “Company”). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain such words as “confident,” “estimate,” “project,” “intend,” “forecast,” “target,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “is likely,” “will likely,” “should,” “could,” “would,” “may,” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements include, but are not limited to, statements about the Company’s financial health, standing and future results of operations, including, but not limited to, revenue, net income and Adjusted EBITDA guidance in future periods, and certain assumptions in connection therewith; the market for ASCENIV, its potential impact on revenues and margin expansion; the utility of ADMAlytics and its impact on the Company’s earnings growth outlook; and additional growth opportunities, including but not limited to, targeting certain patient populations, the Company’s yield enhancement initiative and production processes and the timing related thereto, and the Company’s R&D program, including the newly announced hIG pipeline program targeting S. pneumonia (including the revenue potential) and ASCENIV label expansion. Actual events or results may differ materially from those described in this press release due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto. INVESTOR RELATIONS CONTACT:Michelle Pappanastos Senior Managing Director, Argot Partners | 212-600-1902 | michelle@argotpartners.com ADMA BIOLOGICS, INC. AND SUBSIDIARIESCONSOLIDATED BALANCE SHEETS (Unaudited) June 30, December 31, 2024 2023 (In thousands, except share data)ASSETS Current assets: Cash and cash equivalents$88,244 $51,352 Accounts receivable, net 30,113 27,421 Inventories 179,810 172,906 Prepaid expenses and other current assets 5,524 5,334 Total current assets 303,691 257,013 Property and equipment, net 54,326 53,835 Intangible assets, net 479 499 Goodwill 3,530 3,530 Right-to-use assets 9,152 9,635 Deposits and other assets 5,221 4,670 TOTAL ASSETS$376,399 $329,182 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable$14,179 $15,660 Accrued expenses and other current liabilities 27,726 32,919 Current portion of deferred revenue 1,130 182 Current portion of lease obligations 1,142 1,045 Total current liabilities 44,177 49,806 Senior notes payable, net of discount 131,074 130,594 Deferred revenue, net of current portion 1,619 1,690 End of term fee 1,688 1,688 Lease obligations, net of current portion 9,182 9,779 Other non-current liabilities 390 419 TOTAL LIABILITIES 188,130 193,976 COMMITMENTS AND CONTINGENCIES STOCKHOLDERS' EQUITY Preferred Stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding - - Common Stock - voting, $0.0001 par value, 300,000,000 shares authorized, 233,026,736 and 226,063,032 shares issued and outstanding at June 30, 2024 and December 31, 2023 23 23 Additional paid-in capital 644,634 641,439 Accumulated deficit (456,388) (506,256)TOTAL STOCKHOLDERS' EQUITY 188,269 135,206 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $376,399 $329,182 ADMA BIOLOGICS, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) Three Months ended June 30, Six Months ended June 30, 2024 2023 2024 2023 (In thousands, except share and per share data)REVENUES $107,191 $60,123 $189,066 $117,037 Cost of product revenue 49,738 43,433 92,505 83,834 Gross profit 57,453 16,690 96,561 33,203 OPERATING EXPENSES: Research and development 560 1,403 1,010 2,258 Plasma center operating expenses 942 1,333 1,947 3,114 Amortization of intangible assets 142 179 335 358 Selling, general and administrative 16,608 14,248 32,247 28,759 Total operating expenses 18,252 17,163 35,539 34,489 INCOME (LOSS) FROM OPERATIONS 39,201 (473) 61,022 (1,286) OTHER INCOME (EXPENSE): Interest income 449 414 833 581 Interest expense (3,783) (6,299) (7,552) (12,415)Other expense (16) (13) (51) (40)Other expense, net (3,350) (5,898) (6,770) (11,874) INCOME (LOSS) BEFORE INCOME TAXES 35,851 (6,371) 54,252 (13,160) Provision for income taxes 3,789 - 4,384 - NET INCOME (LOSS) $32,062 $(6,371) $49,868 $(13,160) BASIC EARNINGS (LOSS) PER COMMON SHARE $0.14 $(0.03) $0.22 $(0.06)DILUTED EARNINGS (LOSS) PER COMMON SHARE $0.13 $(0.03) $0.21 $(0.06) WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: Basic 232,417,645 222,683,393 230,646,246 222,304,676 Diluted 242,167,072 222,683,393 239,645,940 222,304,676 NON-GAAP RECONCILIATIONRECONCILIATION OF GAAP NET INCOME (LOSS) TO ADJUSTED EBITDA Three Months ended June 30, Six Months ended June 30, 2024 2023 2024 2023 (In thousands)Net income (loss)$32,062 $(6,371) $49,868 $(13,160)Depreciation 1,906 1,919 3,826 3,773 Amortization 142 179 335 358 Income taxes 3,789 - 4,384 - Interest expense 3,783 6,299 7,552 12,415 EBITDA 41,682 2,026 65,965 3,386 Stock-based compensation 2,863 1,637 5,004 2,747 IT systems disruption 2,770 - 2,770 Adjusted EBITDA$44,545 $6,433 $70,969 $8,903

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.