Regadenoson

Five new launches reinforce Baxter’s focus on differentiated products and enhance the company’s Pharmaceuticals portfolio in critical therapeutic areas Products feature ready-to-use formulations to help support patient safety and offer added convenience for healthcare professionals DEERFIELD, Ill.--(BUSINESS WIRE)-- Baxter International Inc. (NYSE:BAX), a global leader in injectables, anesthesia and drug compounding, announced the continued expansion of its Pharmaceuticals portfolio with five injectable product launches in the U.S. “These launches demonstrate Baxter’s focus on differentiated products that address unmet patient needs in key therapeutic areas, including anti-infective and anti-hypotensive medications,” said Alok Sonig, executive vice president and group president, Pharmaceuticals, at Baxter. “We are proud to offer important new options for our customers and look forward to continuing to bring new innovations to the market.” Product launches within Baxter’s Pharmaceuticals portfolio in the U.S. include the following. For all products, please see full Indications, Important Risk Information and links to full Prescribing Information below. Norepinephrine Bitartrate in 5% Dextrose Injection in a new 16 mg/250 mL strength, which is indicated to raise blood pressure in adult patients with severe, acute hypotension. Baxter offers the first and only FDA-approved ready-to-use Norepinephrine in Dextrose, and now provides Norepinephrine in 4 mg/250 mL, 8 mg/250 mL and 16 mg/250 mL strengths. Vasopressin in 0.9% Sodium Chloride Injection, the first and only FDA-approved ready-to-use Vasopressin in a flexible container. Vasopressin uses Baxter’s proprietary sterile, closed system container, which is collapsible and does not require a vented intravenous set.1 Manufactured closed drug-delivery systems decrease the need for manual admixture and reduce the possibility of contamination.2 Vasopressin is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Baxter offers Vasopressin in 20 units/100 mL and 40 units/100 mL strengths. Vancomycin Injection, USP in 5% Dextrose in new 1.25 g/250 mL and 1.5 g/300 mL strengths. These launches are Baxter’s first frozen ready-to-use offerings in 250 mL and 300 mL volumes. Vancomycin is indicated for serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. Baxter now offers Vancomycin in 500 mg/100 mL, 750 mg/150 mL, 1 g/200 mL, 1.25 g/250 mL and 1.5 g/300 mL strengths. Ropivacaine Hydrochloride Injection, USP in a ready-to-use, single-dose infusion bag. Ropivacaine is indicated in adults to produce local or regional anesthesia for surgery and for acute pain management. Baxter offers Ropivacaine in 200 mg/100 mL and 400 mg/200 mL strengths. Regadenoson Injection pre-filled syringe, a coronary vasodilator that is commonly used in pharmacologic stress testing. Baxter offers Regadenoson in a 0.4 mg/5 mL strength. Ready-to-use formats of standard concentrations of commonly prescribed drugs may offer operational efficiencies for healthcare providers. Compounding a drug for patient use is a multi-step, manual process that requires oversight by pharmacy staff. A ready-to-use product can simplify the preparation process and support patient safety by reducing the chance of contamination2 and avoiding potential errors that may occur when medications are compounded.3 These newly launched products are now available for use in the U.S. About Baxter Every day, millions of patients, caregivers and healthcare providers rely on Baxter’s leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit and follow us on X/Twitter, LinkedIn and Facebook. Norepinephrine Bitartrate in 5% Dextrose Injection Indications Norepinephrine Bitartrate in Dextrose Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Important Risk Information Contraindications: None. Tissue Ischemia: Administration of Norepinephrine Bitartrate in Dextrose Injection to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and reduced urine output, tissue hypoxia, lactic acidosis, and reduced systemic blood flow despite “normal” blood pressure. Address hypovolemia prior to initiating Norepinephrine Bitartrate in Dextrose Injection. Avoid use in patients with mesenteric or peripheral vascular thrombosis, as this may increase ischemia and extend the area of infarction. Gangrene of the extremities has occurred in patients with occlusive or thrombotic vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients. Extravasation of Norepinephrine Bitartrate in Dextrose Injection may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein, check the infusion site frequently for free flow, and monitor for signs of extravasation. Avoid administration into the veins in the leg in elderly patients. Emergency Treatment of Extravasation: Infiltrate the ischemic area as soon as possible, using a syringe with a fine hypodermic needle with 5 to 10 mg of phentolamine mesylate in 10 to 15 mL of 0.9% Sodium Chloride Injection in adults. Hypotension after Abrupt Discontinuation: Sudden cessation of the infusion rate may result in marked hypotension. When discontinuing the infusion, gradually reduce the infusion rate while expanding blood volume with intravenous fluids. Cardiac Arrhythmias: Norepinephrine Bitartrate in Dextrose Injection elevates intracellular calcium concentrations and may cause arrhythmias, particularly in the setting of hypoxia or hypercarbia. Perform continuous cardiac monitoring of patients with arrhythmias. Elderly Patients: May be at a greater risk of developing adverse reactions. Adverse Reactions: Most common adverse reactions are hypertension and bradycardia. Drug Interactions: Co-administration of Norepinephrine Bitartrate in Dextrose Injection with monoamine oxidase (MAO) inhibitors or other drugs with MAO-inhibiting properties (e.g., linezolid) or with tricyclic antidepressants can cause severe, prolonged hypertension. Anti-diabetics: Norepinephrine Bitartrate in Dextrose Injection can decrease insulin sensitivity and raise blood glucose. Concomitant use of Norepinephrine Bitartrate in Dextrose Injection with halogenated anesthetics may lead to ventricular tachycardia or ventricular fibrillation. Monitor cardiac rhythm in patients receiving concomitant halogenated anesthetics. Please see accompanying full Prescribing Information for Norepinephrine Bitartrate in 5% Dextrose Injection. Vasopressin in 0.9% Sodium Chloride Injection Indications Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Important Risk Information Contraindications: Vasopressin in Sodium Chloride Injection is contraindicated in patients with a known allergy or hypersensitivity to 8-L-arginine vasopressin. Worsening Cardiac Function: A decrease in cardiac index may be observed with the use of vasopressin. Reversible Diabetes Insipidus: Patients may experience reversible diabetes insipidus, manifested by the development of polyuria, a dilute urine, and hypernatremia, after cessation of treatment with vasopressin. Monitor serum electrolytes, fluid status and urine output after vasopressin discontinuation. Some patients may require readministration of vasopressin or administration of desmopressin to correct fluid and electrolyte shifts. Adverse Reactions: The most common adverse reactions include decreased cardiac output, bradycardia, tachyarrhythmias, hyponatremia and ischemia (coronary, mesenteric, skin, digital). Drug Interactions: Pressor effects of catecholamines and Vasopressin in Sodium Chloride Injection are expected to be additive. Indomethacin may prolong effects of Vasopressin in Sodium Chloride Injection. Co-administration of ganglionic blockers or drugs causing SIADH (syndrome of inappropriate antidiuretic hormone secretion) may increase the pressor response. Co-administration of drugs causing diabetes insipidus may decrease the pressor response. Pregnancy: May induce tonic uterine contractions that could threaten the continuation of pregnancy. Please see accompanying full Prescribing Information for Vasopressin in 0.9% Sodium Chloride Injection. Vancomycin Injection, USP in 5% Dextrose Indications Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin is effective in the treatment of: Infective Endocarditis (staphylococcal endocarditis; endocarditis caused by Streptococcus viridans or S. bovis, alone or in combination with an aminoglycoside; endocarditis caused by enterococci (e.g., E. faecalis), only in combination with an aminoglycoside; diphtheroid endocarditis; early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids in combination with either rifampin, an aminoglycoside, or both) Septicemia Skin and Skin Structure Infections Bone Infections Lower Respiratory Tract Infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Important Risk Information Contraindications: Vancomycin is contraindicated in patients with known hypersensitivity to this antibiotic. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products. Infusion Reactions: Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock, and, rarely, cardiac arrest. During or soon after rapid infusion of vancomycin, patients may develop anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, or pruritus. Rapid infusion may also cause flushing of the upper body (“vancomycin infusion reaction”) or pain and muscle spasm of the chest and back. Vancomycin should be administered over a period of not less than 60 minutes. Stopping the infusion usually results in prompt cessation of these reactions. Nephrotoxicity: Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase. Monitor renal function in all patients; especially with underlying renal impairment, with co-morbidities, and receiving concomitant therapy with a known nephrotoxic drug. Ototoxicity: It may be transient or permanent. It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Vancomycin should be used with caution in patients with renal insufficiency. Severe Dermatologic Reactions: Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) have been reported. Cutaneous signs or symptoms reported include skin rashes, mucosal lesions, and blisters. Discontinue vancomycin Injection at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD. Dosage of vancomycin must be adjusted for patients with renal dysfunction. Clostridioides difficile associated diarrhea (CDAD): May range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. Hemorrhagic Occlusive Retinal Vasculitis: Including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or the intravitreal route have not been established. Adverse Reactions: Not already mentioned above, patients have been reported to have neutropenia, phlebitis, drug fever, nausea, chills, and vasculitis in association with administration of vancomycin. Drug Interactions: Anesthetic Agents: Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing and anaphylactoid reactions. Monitor renal function in patients receiving vancomycin and concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, or cisplatin. Please see accompanying full Prescribing Information for Vancomycin Injection, USP. Ropivacaine Hydrochloride Injection, USP Indications Ropivacaine Hydrochloride Injection is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration. Important Risk Information Contraindications: Ropivacaine Hydrochloride Injection is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. General Warning: Delay in proper management of dose-related toxicity, underventilation, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. The safe and effective use of local anesthetics depends on proper dosage, correct technique, adequate precautions, and readiness for emergencies. It is essential that aspiration for blood, or cerebrospinal fluid (where applicable), be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. Unintended Intravenous Injection: In performing Ropivacaine Hydrochloride Injection blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest. Ropivacaine hydrochloride injection should be administered in incremental doses. It is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary. Intra-Articular Infusions and Risk of Chondrolysis: Intra-articular infusions of local anesthetics may cause chondrolysis. Ropivacaine Hydrochloride Injection is not approved for this use. Risk of Methemoglobinemia: Patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure. Immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue ropivacaine hydrochloride injection and any other oxidizing agents. Central Nervous System Toxicity: Careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness should be performed after each local anesthetic injection. Hepatic Disease: Because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease are at a greater risk of developing toxic plasma concentrations. Adverse Reactions: Most common adverse reactions (incidence ≥ 5%) are hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain. Drug Interactions: Agents structurally related to amide-type local anesthetics: Concurrent use may cause additive effects. Please see accompanying full Prescribing Information for Ropivacaine Hydrochloride Injection, USP. Regadenoson Injection Indications Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. Important Risk Information Contraindications: Do not administer regadenoson injection to patients with: Second- or third-degree AV block, or Sinus node dysfunction, unless these patients have a functioning artificial pacemaker. Myocardial Ischemia: Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example unstable angina or cardiovascular instability, who may be at greater risk. Cardiac resuscitation equipment and trained staff should be available before administration. Sinoatrial (SA) and Atrioventricular (AV) Nodal Block: Adenosine receptor agonists, including regadenoson injection, can depress the SA and AV nodes and may cause first-, second- or third-degree AV block, or sinus bradycardia. Atrial Fibrillation/Atrial Flutter: New-onset or recurrent atrial fibrillation with rapid ventricular response and atrial flutter have been reported. Hypersensitivity, Including Anaphylaxis: Anaphylaxis, angioedema, cardiac or respiratory arrest, respiratory distress, decreased oxygen saturation, hypotension, throat tightness, urticaria and rashes have occurred. Have personnel and resuscitative equipment immediately available. Hypotension: Adenosine receptor agonists, including regadenoson injection, induce vasodilation and hypotension. The risk of serious hypotension may be higher in patients with autonomic dysfunction, stenotic valvular heart disease, pericarditis or pericardial effusions, stenotic carotid artery disease with cerebrovascular insufficiency, or hypovolemia. Hypertension: Adenosine receptor agonists, including regadenoson injection, may induce clinically significant increases in blood pressure particularly in patients with a history of hypertension and when the MPI includes low level exercise. Bronchoconstriction: Adenosine receptor agonists, including regadenoson injection, may induce dyspnea, bronchoconstriction and respiratory compromise, especially in patients with chronic obstructive pulmonary disease (COPD) or asthma. Resuscitative measures should be available. Seizure: Regadenoson injection may lower the seizure threshold. New onset or recurrence of convulsive seizures has occurred. Some seizures are prolonged and require urgent anticonvulsive management. Methylxanthine use is not recommended in patients who experience a seizure in association with regadenoson injection. Cerebrovascular Accident (Stroke): Hemorrhagic and ischemic cerebrovascular accidents have occurred. Adverse Reactions: The most common (incidence ≥ 5%) adverse reactions to regadenoson injection are dyspnea, headache, flushing, chest discomfort, dizziness, angina pectoris, chest pain, and nausea. Drug Interactions: Methylxanthines, e.g., caffeine, aminophylline and theophylline, interfere with the activity of regadenoson injection. Aminophylline may be used to attenuate severe and/or persistent adverse reactions to regadenoson injection. Dipyridamole may increase the activity of regadenoson injection. When possible, withhold dipyridamole for at least two days prior to regadenoson injection administration. Please see accompanying full Prescribing Information for Regadenoson Injection. This release includes forward-looking statements concerning Norepinephrine Bitartrate in 5% Dextrose Injection, Vasopressin in 0.9% Sodium Chloride Injection, Vancomycin Injection, USP in 5% Dextrose, Ropivacaine Hydrochloride Injection, USP and Regadenoson Injection pre-filled syringe, including potential benefits associated with the use of these products. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: demand for and market acceptance for new and existing products; product development risks; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and Form 10-Q and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements. Baxter is a registered trademark of Baxter International Inc. 1 Baxter data on > 2 Mercaldi CJ, Lanes S, Bradt J. Comparative risk of bloodstream infection in hospitalized patients receiving intravenous medication by open, point-of-care, or closed delivery systems. Am J Health-Syst Pharm. 2013;70:957-965. 3 Billstein-Leber M, Carrillo CJD, Cassano AT, Moline K, Robertson JJ. ASHP Guidelines on Preventing Medication Errors in Hospitals. Am J Health Syst Pharm. 2018;75(19):1493-1517. US-PH57-240005 (v1.0) 04/2024 View source version on businesswire.com: Contacts Media Contact Andrea Johnson, (224) 948-5353 media@baxter.com Investor Contact Clare Trachtman, (224) 948-3020 Source: Baxter International Inc. View this news release online at:

Reports Net Revenues of $178.1 Million for the Three Months Ended December 31, 2023 RANCHO CUCAMONGA, CA / ACCESSWIRE / February 28, 2024 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company") today reported results for the three months and full-year ended December 31, 2023. Fourth Quarter Highlights Net revenues of $178.1 million for the fourth quarter GAAP net income of $36.2 million, or $0.68 per share, for the fourth quarter Adjusted non-GAAP net income of $46.9 million, or $0.88 per share, for the fourth quarter Full-Year Highlights Net revenues of $644.4 million for the fiscal year GAAP net income of $137.5 million, or $2.60 per share, for the fiscal year Adjusted non-GAAP net income of $175.7 million, or $3.32 per share, for the fiscal year Dr. Jack Zhang, Amphastar's President and Chief Executive Officer, commented: "We enter 2024 with strong momentum. 2023 was an important year for the Company driven by the strong performance of glucagon and Primatene MIST ® alongside the acquisition of BAQSIMI ® , which strengthened our diabetes portfolio. The recent submission of our first BLA for Insulin Aspart, known as AMP-004, underscores our continued pipeline development in diabetes management, and marks another milestone for Amphastar." Three Months Ended Year Ended December 31, December 31, 2023 2022 2023 2022 (in thousands, except per share data) Net revenues $ 178,105 $ 135,023 $ 644,395 $ 498,987 GAAP net income $ 36,167 $ 33,913 $ 137,545 $ 91,386 Adjusted non-GAAP net income* $ 46,875 $ 37,638 $ 175,699 $ 103,186 GAAP diluted EPS $ 0.68 $ 0.66 $ 2.60 $ 1.74 Adjusted non-GAAP diluted EPS* $ 0.88 $ 0.73 $ 3.32 $ 1.97 ____________________________________ * Adjusted non-GAAP net income and adjusted non-GAAP diluted EPS are non-GAAP financial measures. Please see the discussion in the section entitled "Non-GAAP Financial Measures" and the reconciliation of GAAP to non-GAAP financial measures in Table III of this press release. Fourth Quarter Results Three Months Ended December 31, Change 2023 2022 Dollars % (in thousands) Product revenues: Glucagon $ 31,198 $ 18,319 $ 12,879 70 % Epinephrine 24,646 21,427 3,219 15 % Primatene MIST® 24,484 22,279 2,205 10 % Lidocaine 14,988 13,286 1,702 13 % Phytonadione 11,922 11,666 256 2 % Enoxaparin 6,092 7,812 (1,720 ) (22 )% Naloxone 4,230 4,845 (615 ) (13 )% Other finished pharmaceutical products 35,015 33,082 1,933 6 % Total finished pharmaceutical products net revenues $ 152,575 $ 132,716 $ 19,859 15 % API 3,074 2,307 767 33 % Other revenues 22,456 - 22,456 N/A Total product revenues, net $ 178,105 $ 135,023 $ 43,082 32 % Changes in product revenues as compared to the fourth quarter of the prior year were primarily driven by: Glucagon sales increased primarily due to an increase in unit volumes, as a result of two competitors discontinuing their glucagon injection products at the end of 2022 Epinephrine sales increased primarily due to an increase in unit volumes, as a result of supplier shortages Lidocaine sales increased primarily due to higher unit volumes as supply chain issues eased allowing us to fulfill backorders Primatene MIST® sales increased $1.3 million due to an increase in unit volumes, with the remainder of the increase due to an increase in average selling price Enoxaparin and naloxone sales decreased primarily due to a decrease in unit volumes Other finished pharmaceutical product sales increased primarily due to: Higher unit volumes of atropine, calcium chloride, and sodium bicarbonate, due to increased demand caused by supplier shortages during the fourth quarter Launch of regadenoson in April 2023 Active Pharmaceutical Ingredient ("API") sales increased primarily due to the timing of customer purchases Other revenues are comprised of net revenues from the sales of BAQSIMI® of $22.5 million during the three months ended December 31, 2023, which was recognized on a net basis similar to a royalty arrangement and based on Eli Lilly & Company's ("Lilly") reported BAQSIMI® net sales of $37.6 million. Currently, BAQSIMI® is being sold by Lilly on our behalf under the Transition Services Agreement ("TSA") with Lilly, whereby Lilly provides certain services to support the transition of the BAQSIMI® operations to us. Once Amphastar takes over the distribution of BAQSIMI®, Amphastar will recognize the entire revenue amount. This revenue recognition change is expected to be phased in by country during 2024. Three Months Ended December 31, Change 2023 2022 Dollars % (in thousands) Net revenues $ 178,105 $ 135,023 $ 43,082 32 % Cost of revenues 81,965 63,855 18,110 28 % Gross profit $ 96,140 $ 71,168 $ 24,972 35 % as % of net revenues 54 % 53 % Changes in the cost of revenues and gross margin were primarily driven by: Increased sales of higher-margin products such as glucagon and Primatene MIST®, as well as the sales of regadenoson, which we launched in April 2023. As a result of the TSA, the revenue relating to BAQSIMI® is recognized on a net basis within net revenues. These factors were partially offset by charges included in cost of revenues to adjust our inventory and related purchase commitments to their net realizable value, which includes a $3.6 million inventory reserve as a result of amending the Supply Agreement with MannKind Corporation in December 2023. Three Months Ended December 31, Change 2023 2022 Dollars % (in thousands) Selling, distribution, and marketing $ 8,619 $ 5,472 $ 3,147 58 % General and administrative 13,122 10,628 2,494 23 % Research and development 20,419 17,236 3,183 18 % Non-operating (expenses) income, net (12,635 ) 3,428 (16,063 ) NM Selling, distribution, and marketing expenses increased primarily due to expenses related to the expansion of our sales and marketing efforts related to BAQSIMI®. General and administrative expenses increased primarily due to an increase in salary and personnel-related expenses, as well as costs related to the acquisition of BAQSIMI®, which was partially offset by a decrease in legal fees. Research and development expenses increased due to an increase in materials and supply expenses, primarily related to our inhalation pipeline products. The change in non-operating (expenses) income, net is primarily a result of: Interest expense in the fourth quarter of 2023, which was primarily related to our Wells Fargo Bank syndicated loan, as well as our convertible debt Foreign currency fluctuations Mark-to-market adjustments relating to our interest rate swap contracts. Year-End Results Year Ended December 31, Change 2023 2022 Dollars % (in thousands) Product revenues: Glucagon $ 113,684 $ 55,322 $ 58,362 105 % Primatene MIST® 89,321 84,309 5,012 6 % Epinephrine 81,650 74,204 7,446 10 % Lidocaine 58,162 52,539 5,623 11 % Phytonadione 44,939 49,500 (4,561 ) (9 )% Enoxaparin 31,533 34,950 (3,417 ) (10 )% Naloxone 19,004 26,269 (7,265 ) (28 )% Other finished pharmaceutical products 140,823 109,412 31,411 29 % Total finished pharmaceutical products net revenues $ 579,116 $ 486,505 $ 92,611 19 % API 14,122 12,482 1,640 13 % Other revenues 51,157 - 51,157 N/A Total product revenues, net $ 644,395 $ 498,987 $ 145,408 29 % Changes in product revenues were primarily driven by: Glucagon sales increased primarily due to an increase in unit volumes as a result of two competitors discontinuing their glucagon injection products at the end of 2022 Primatene MIST® sales increased due to an increase in the average selling price Epinephrine and lidocaine sales increased primarily due to an increase in unit volumes as a result of supplier shortages Phytonadione sales decreased due to lower unit volumes as a result of increased competition Enoxaparin sales decreased primarily due to a decrease in unit volumes Sales of naloxone decreased due to lower unit volumes, reducing sales by $4.6 million, as well as a lower average selling price, reducing sales by $2.7 million as a result of increased competition Other finished pharmaceutical product sales increased primarily due to: Higher unit volumes of dextrose, atropine, calcium chloride, and sodium bicarbonate due to increased demand caused by supplier shortages during the year A full year of sales for ganirelix and vasopressin, which was launched in June 2022 and August 2022, respectively Launch of regadenoson in April 2023 API sales increased primarily due to the timing of customer purchases Other revenues are comprised of net revenues from the sales of BAQSIMI® of $51.2 million during the year ended December 31, 2023, which was recognized on a net basis similar to a royalty and based on Lilly's reported BAQSIMI® net sales of $86.3 million. Year Ended December 31, Change 2023 2022 Dollars % (in thousands) Net revenues $ 644,395 $ 498,987 $ 145,408 29 % Cost of revenues 293,274 250,127 43,147 17 % Gross profit $ 351,121 $ 248,860 $ 102,261 41 % as % of net revenues 54 % 50 % Changes in the cost of revenues and gross margin were primarily driven by: Increased sales of higher-margin products such as glucagon and Primatene MIST®, the sales of ganirelix and vasopressin that were launched in 2022, as well as the sales of regadenoson, which we launched in April 2023 As a result of the TSA, the revenue relating to BAQSIMI® is recognized on a net basis within net revenues. These factors were partially offset by an impairment charge of $2.7 million related to the impairment of the IMS (UK) international product rights, as well as charges included in cost of revenues to adjust our inventory and related purchase commitments to their net realizable value, which includes a $3.6 million inventory reserve as a result of amending the Supply Agreement with MannKind Corporation in December 2023 Year Ended December 31, Change 2023 2022 Dollars % (in thousands) Selling, distribution, and marketing $ 28,853 $ 21,531 $ 7,322 34 % General and administrative 51,540 45,061 6,479 14 % Research and development 73,741 74,771 (1,030 ) (1 )% Non-operating (expenses) income, net (25,628 ) 8,543 (34,171 ) NM Selling, distribution, and marketing expenses increased primarily due to expenses related to the expansion of our sales and marketing efforts related to BAQSIMI®, as well as an increase in advertising spending for Primatene MIST® General and administrative expenses increased primarily due to an increase in salary and personnel-related expenses, as well as costs related to the acquisition of BAQSIMI®, which was partially offset by a decrease in legal fees Research and development expenses decreased due to: Decreases in materials and supply expenses as a result of a ramp-up of expenses in 2022 for AMP-018 and our insulin pipeline products This decrease was partially offset by an increase in salary and personnel-related expenses The change in non-operating (expenses) income, net is primarily a result of: Foreign currency fluctuations Costs incurred in connection with the syndicated credit agreement we entered into with Wells Fargo Bank, as syndication agent, to finance the acquisition of BAQSIMI® Mark-to-market adjustments relating to our interest rate swap contracts Cash flow provided by operating activities for the year ended December 31, 2023 was $183.5 million. Pipeline Information The Company currently has four abbreviated new drug applications ("ANDAs") and one biosimilar insulin candidate on the U.S. Food and Drug Administration (the "FDA") targeting products with a market size of over $3 billion and $4 billion, respectively, three biosimilar products in development targeting products with a market size of over $10 billion, and six generic products in development targeting products with a market size of over $8 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2023. The Company is developing multiple proprietary products with injectable and intranasal dosage forms. Amphastar's Chinese subsidiary, Amphastar Nanjing Pharmaceuticals, Co., Ltd. ("ANP"), currently has multiple Drug Master Files ("DMFs"), on the FDA and is developing several additional DMFs. Company Information Amphastar is a bio-pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products. Most of the Company's finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information and resources are available at . Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar®, BAQSIMI®, Primatene MIST®, REXTOVYTM, Amphadase®, and Cortrosyn®, are the property of Amphastar. Non-GAAP Financial Measures To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles ("GAAP"), the Company is disclosing non-GAAP financial measures when providing financial results. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results, including (i) Adjusted non-GAAP net income (loss) and (ii) Adjusted non-GAAP diluted EPS, which exclude amortization expense, share-based compensation, impairment charges, expenses related to our acquisition of BAQSIMI®, debt issuance costs, legal settlements, and other one-time events in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance because the Company's management uses these measures internally for forecasting, budgeting, and measuring its operating performance. Whenever the Company uses such non-GAAP measures, it will provide a reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measures. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. Conference Call Information The Company will hold a conference call to discuss its financial results today, February 28, 2024, at 2:00 p.m. Pacific Time. To access the conference call, dial toll-free (877) 407-0989 or (201) 389-0921 for international callers, ten minutes before the conference. The call can also be accessed on the Investors page on the Company's website at . Forward-Looking Statements All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding future financial performance and business trends, our future growth, sales and marketing of our products, market size and expansion, product portfolio, product development, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to our pipeline of product candidates, the timing and results of clinical trials, the prospective benefits of the acquisition of BAQSIMI®, and other future events. These statements are not facts but rather are based on Amphastar's historical performance and our current expectations, estimates, and projections regarding our business, operations, and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 1, 2023, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 9, 2023, in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, filed with the SEC on August 8, 2023, and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, filed with the SEC on November 8, 2023. In particular, there can be no guarantee that the acquisition of BAQSIMI® will be beneficial to our business, that any event, change or other circumstance could cause the results of the acquisition and integration of BAQSIMI® into our product portfolio to differ from Amphastar's expectation, that all or any of the contingent consideration will be payable on the terms described herein or at all, or that Amphastar can reliably predict the impact of BAQSIMI® on its financial results or financial guidance. You can locate these reports through our website at and on the SEC's website at . The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change. Contact Information: Amphastar Pharmaceuticals, Inc. Bill Peters Chief Financial Officer (909) 476-3416 Table I Amphastar Pharmaceuticals, Inc. Condensed Consolidated Statement of Operations (Unaudited; in thousands, except per share data) Three Months Ended Year Ended December 31, December 31, 2023 2022 2023 2022 Net revenues: Product revenues, net $ 155,649 $ 135,023 $ 593,238 $ 498,987 Other revenues 22,456 - 51,157 - Total net revenues 178,105 135,023 644,395 498,987 Cost of revenues 81,965 63,855 293,274 250,127 Gross profit 96,140 71,168 351,121 248,860 Operating expenses: Selling, distribution, and marketing 8,619 5,472 28,853 21,531 General and administrative 13,122 10,628 51,540 45,061 Research and development 20,419 17,236 73,741 74,771 Total operating expenses 42,160 33,336 154,134 141,363 Income from operations 53,980 37,832 196,987 107,497 Non-operating (expenses) income, net (12,635 ) 3,428 (25,628 ) 8,543 Income before income taxes 41,345 41,260 171,359 116,040 Income tax provision 4,673 7,290 31,833 23,477 Net income before equity in losses of unconsolidated affiliate 36,672 33,970 139,526 92,563 Equity in losses of unconsolidated affiliate (505 ) (57 ) (1,981 ) (1,177 ) Net income $ 36,167 $ 33,913 $ 137,545 $ 91,386 Net income per share: Basic $ 0.75 $ 0.70 $ 2.85 $ 1.88 Diluted $ 0.68 $ 0.66 $ 2.60 $ 1.74 Weighted-average shares used to compute net income per share: Basic 47,957 48,298 48,265 48,551 Diluted 53,014 51,716 53,001 52,427 Table II Amphastar Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (Unaudited; in thousands, except share data) December 31, December 31, 2023 2022 ASSETS Current assets: Cash and cash equivalents $ 144,296 $ 156,098 Restricted cash 235 235 Short-term investments 112,510 19,664 Restricted short-term investments 2,200 2,200 Accounts receivable, net 114,943 88,804 Inventories 105,833 103,584 Income tax refunds and deposits 526 171 Prepaid expenses and other assets 9,057 7,563 Total current assets 489,600 378,319 Property, plant, and equipment, net 282,746 238,266 Finance lease right-of-use assets 564 753 Operating lease right-of-use assets 32,333 25,554 Investment in unconsolidated affiliate 527 2,414 Goodwill and intangible assets, net 613,295 37,298 Long-term investments 14,685 - Other assets 25,910 20,856 Deferred tax assets 53,252 38,527 Total assets $ 1,512,912 $ 741,987 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities $ 93,366 $ 84,242 Accrued payments for BAQSIMI® 126,090 - Income taxes payable 1,609 4,571 Current portion of long-term debt 436 3,046 Current portion of operating lease liabilities 3,906 3,003 Total current liabilities 225,407 94,862 Long-term reserve for income tax liabilities 6,066 7,225 Long-term debt, net of current portion and unamortized debt issuance costs 589,579 72,839 Long-term operating lease liabilities, net of current portion 29,721 23,694 Deferred tax liabilities - 144 Other long-term liabilities 22,718 14,565 Total liabilities 873,491 213,329 Commitments and contingencies Stockholders' equity: Preferred stock: par value $0.0001; 20,000,000 shares authorized; no shares issued and outstanding - - Common stock: par value $0.0001; 300,000,000 shares authorized; 59,390,194 and 48,068,881 shares issued and outstanding as of December 31, 2023 and 58,110,231 and 48,112,069 shares issued and outstanding as of December 31, 2022, respectively 6 6 Additional paid-in capital 486,056 455,077 Retained earnings 409,268 271,723 Accumulated other comprehensive loss (8,478 ) (8,624 ) Treasury stock (247,431 ) (189,524 ) Total equity 639,421 528,658 Total liabilities and stockholders' equity $ 1,512,912 $ 741,987 Table III Amphastar Pharmaceuticals, Inc. Reconciliation of Non-GAAP Measures (Unaudited; in thousands, except per share data) Three Months Ended Year Ended December 31, December 31, 2023 2022 2023 2022 GAAP net income $ 36,167 $ 33,913 $ 137,545 $ 91,386 Adjusted for: Intangible amortization 6,178 331 12,830 1,419 Share-based compensation 4,622 4,304 20,242 17,860 Impairment of long-lived assets 1 - 3,175 - Expenses related to BAQSIMI® acquisition 2,148 - 5,830 - Debt issuance costs 742 - 6,785 - Litigation settlements - - - (4,929 ) Income tax provision on pre-tax adjustments (2,983 ) (910 ) (10,708 ) (2,550 ) Non-GAAP net income $ 46,875 $ 37,638 $ 175,699 $ 103,186 Non-GAAP net income per share: Basic $ 0.98 $ 0.78 $ 3.64 $ 2.13 Diluted $ 0.88 $ 0.73 $ 3.32 $ 1.97 Weighted-average shares used to compute non-GAAP net income per share: Basic 47,957 48,298 48,265 48,551 Diluted 53,014 51,716 53,001 52,427 Three Months Ended December 31, 2023 Cost of revenue Selling, distribution and marketing General and administrative Research and development Non-operating (expenses) income, net Income tax provision GAAP $ 81,965 $ 8,619 $ 13,122 $ 20,419 $ (12,635 ) $ 4,673 Intangible amortization (6,158 ) - (3 ) (17 ) - - Share-based compensation (1,023 ) (221 ) (2,946 ) (432 ) - - Impairment of long-lived assets - - (1 ) - - - Expenses related to BAQSIMI® acquisition - - (322 ) - 1,826 - Debt issuance costs - - - - 742 - Income tax provision on pre-tax adjustments - - - - - 2,983 Non-GAAP $ 74,784 $ 8,398 $ 9,850 $ 19,970 $ (10,067 ) $ 7,656 Three Months Ended December 31, 2022 Cost of revenue Selling, distribution and marketing General and administrative Research and development Non-operating (expenses) income, net Income tax provision GAAP $ 63,855 $ 5,472 $ 10,628 $ 17,236 $ 3,428 $ 7,290 Intangible amortization (205 ) - (126 ) - - - Share-based compensation (941 ) (186 ) (2,791 ) (386 ) - - Income tax provision on pre-tax adjustments - - - - - 910 Non-GAAP $ 62,709 $ 5,286 $ 7,711 $ 16,850 $ 3,428 $ 8,200 Year Ended December 31, 2023 Cost of revenue Selling, distribution and marketing General and administrative Research and development Non-operating (expenses) income, net Income tax provision GAAP $ 293,274 $ 28,853 $ 51,540 $ 73,741 $ (25,628 ) $ 31,833 Intangible amortization (12,741 ) - (19 ) (70 ) - - Share-based compensation (4,891 ) (870 ) (12,269 ) (2,212 ) - - Impairment of long-lived assets (3,170 ) - (5 ) - - - Expenses related to BAQSIMI® acquisition - - (2,179 ) - 3,651 - Debt issuance costs - - - - 6,785 - Income tax provision on pre-tax adjustments - - - - - 10,708 Non-GAAP $ 272,472 $ 27,983 $ 37,068 $ 71,459 $ (15,192 ) $ 42,541 Year Ended December 31, 2022 Cost of revenue Selling, distribution and marketing General and administrative Research and development Non-operating (expenses) income, net Income tax provision GAAP $ 250,127 $ 21,531 $ 45,061 $ 74,771 $ 8,543 $ 23,477 Intangible amortization (865 ) - (554 ) - - - Share-based compensation (4,179 ) (726 ) (11,180 ) (1,775 ) - - Litigation settlements - - (800 ) - (5,729 ) - Income tax provision on pre-tax adjustments - - - - - 2,550 Non-GAAP $ 245,083 $ 20,805 $ 32,527 $ 72,996 $ 2,814 $ 26,027 SOURCE: Amphastar Pharmaceuticals, Inc. 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