Recent Insider Transactions • May 14
Independent Director recently sold US$451k worth of stock On the 11th of May, Deborah Autor sold around 35k shares on-market at roughly US$12.94 per share. This transaction amounted to 27% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$97m more than they bought in the last 12 months. Reported Earnings • May 11
First quarter 2026 earnings: EPS exceeds analyst expectations First quarter 2026 results: EPS: US$0.20 (up from US$0.039 in 1Q 2025). Revenue: US$722.5m (up 3.9% from 1Q 2025). Net income: US$62.3m (up 411% from 1Q 2025). Profit margin: 8.6% (up from 1.8% in 1Q 2025). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates. Revenue is forecast to grow 7.2% p.a. on average during the next 3 years, compared to a 8.7% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 74% per year but the company’s share price has increased by 87% per year, which means it is tracking significantly ahead of earnings growth. Aankondiging • May 10
Amneal Pharmaceuticals, Inc. Reaffirms Earnings Guidance for the Full Year Ending December 31, 2026 Amneal Pharmaceuticals, Inc. reaffirmed earnings guidance for the full year ending December 31, 2026. For the year, the company expects revenue to be $3.05 billion - $3.15 billion. Live nieuws • May 04
Amneal Pharmaceuticals Agrees to Acquire Kashiv BioSciences and Surpasses Q1 2026 Expectations Amneal agreed to acquire Kashiv BioSciences for up to US$1.10b, aiming to build a fully integrated global biosimilar platform.
The company reported preliminary Q1 2026 revenue of US$723m and earnings per share of US$0.27, above consensus estimates of US$0.17.
Amneal raised its full-year 2026 standalone guidance and plans multiple annual biosimilar launches, supported by UBS initiating coverage with a Buy rating and a US$19 price target.
For you as an investor, the Kashiv deal is about scale and capability in biosimilars. Kashiv brings development and manufacturing know-how, while Amneal contributes commercial reach. Management is targeting synergies and intends to fund the transaction with a mix of cash and debt, while also aiming to reduce net leverage over time. That balance between expansion and balance sheet discipline is something to watch as the deal progresses toward an expected close in the second half of 2026.
The Q1 2026 figures and raised standalone guidance indicate management confidence in the existing business, especially the Specialty segment, which recorded 23% growth driven by women’s health, ADHD and Parkinson’s disease products. At the same time, UBS coverage with a premium valuation case reflects external interest in Amneal’s biosimilar and specialty pipeline. Investors may want to track execution on the planned annual biosimilar launches and how the combined platform approaches the projected US$300b global biologics loss-of-exclusivity opportunity through 2030. Aankondiging • Apr 24
Amneal Pharmaceuticals, Inc. Updates Earnings Guidance for the Full Year 2026 Amneal Pharmaceuticals, Inc. updated earnings guidance for the full year 2026. For the year, the company expects revenue to be $3.05 billion - $3.15 billion compared to previous guidance of $3.05 billion - $3.15 billion. Aankondiging • Apr 23
Amneal Pharmaceuticals, Inc. (NasdaqGS:AMRX) has entered into a definitive agreement to acquire Kashiv BioSciences, LLC from Tarsadia Investments LLC and others for $1.1 billion. Amneal Pharmaceuticals, Inc. (NasdaqGS:AMRX) has entered into a definitive agreement to acquire Kashiv BioSciences, LLC from Tarsadia Investments LLC and others for $1.1 billion on April 21, 2026. A cash consideration of $375 million will be paid by Amneal Pharmaceuticals, Inc. The consideration consists of common equity of Amneal Pharmaceuticals, Inc. having a value of $375 million to be issued for common equity of Kashiv BioSciences, LLC. Amneal Pharmaceuticals, Inc. will pay an earnout/contingent payment of $350 million cash. Cash consideration of $375 million will be funded by cash on hand and debt. An independent Conflicts Committee was formed to negotiate the purchase agreement. The committee unanimously determined the transaction to be fair and recommended it for stockholder approval.
Transaction has been approved by the Amneal Board of Directors and Amneal's Committee of Independent Directors as Kashiv is a related party. The transaction is subject to approval by Amneal shareholders, receipt of regulatory approvals, antitrust approval, listing of new shares and satisfaction of customary closing conditions, and is expected to close in the second half of 2026.
Goldman Sachs & Co. LLC acted as financial advisor for Amneal Pharmaceuticals, Inc. Michael D. Allen, Robert B. Greco of Richards, Layton & Finger, P.A. acted as legal advisor for the committee of Independent directors of the board of directors of Amneal Pharmaceuticals, Inc. Richard Fenyes, Jakob Rendtorff, Benjamin Bodurian of Simpson Thacher & Bartlett LLP acted as legal advisor for Amneal Pharmaceuticals, Inc. J.P. Morgan Securities LLC acted as financial advisor for Kashiv BioSciences, LLC. Amy S. Leder, Charles A. Weiss and Emily J. Hantverk of Holland & Knight LLP acted as legal advisor for Kashiv BioSciences, LLC. Dhinal Shah Associates acted as India legal advisor. Aankondiging • Apr 20
Amneal Pharmaceuticals, Inc. Announces Additional Positive Interim Phase 4 ELEVATE-PD Results with CREXONT® for Parkinson’s Disease, Including Over 3 More Hours of Daily “Good On” Time When Switching from RYTARY Amneal Pharmaceuticals, Inc. announced new positive interim results from its ongoing Phase 4 ELEVATE-PD study, presented at the 2026 American Academy of Neurology (AAN). The first 111 patients evaluated after six weeks of treatment demonstrated substantial clinical benefit after switching to CREXONT (carbidopa and levodopa) extended-release capsules, regardless of whether patients switched from immediate-release carbidopa/levodopa (IR CD/LD), IR CD/LD plus a COMT inhibitor, or RYTARY (carbidopa and levodopa) extended-release capsules. These interim findings build on the established efficacy and safety profile of CREXONT demonstrated in the Phase 3 RISE-PD trial and reflected in the FDA-approved prescribing information. After patients switched from prior therapies, treatment with CREXONT delivered meaningful increases in “Good On” time, reductions in “Off” time, and improved motor symptom control. Patients switching from RYTARY achieved consistent gains in continuous “Good On” intervals – the length of uninterrupted time patients spend feeling their best. The most common adverse events (=3%) in the study were dizziness (9.0%), nausea (7.2%), falls (7.2%), dyskinesia (4.5%), hallucination (3.6%), and headache (3.6%). Safety: In the study, treatment-emergent adverse events (TEAEs) were generally mild to moderate and consistent with prior therapy. The most common (=3%) in the study were dizziness (9.0%), nausea (7.2%), falls (7.2%), dyskinesia (4.5%), hallucination (3.6%), and headache (3.6%). CREXONT should not be taken with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors. CREXONT may cause falling asleep during activities of daily living, somnolence, or dizziness. Treatment with carbidopa/levodopa, including CREXONT, may contribute to reduced vitamin B6 levels. Seizures associated with vitamin B6 deficiency have been reported. Evaluate vitamin B6 levels before and during treatment with carbidopa/levodopa therapies.CREXONT is Amneal’s next-generation extended-release carbidopa/levodopa (CD/LD) formulation that uses a novel mucoadhesive polymer designed to optimize levodopa delivery and absorption, providing the longest-lasting levodopa plasma levels of any oral CD/LD therapy available today. As ELEVATE-PD continues to enroll, Amneal will present longer-term outcomes and patient-reported results throughout 2026, building a comprehensive body of evidence for CREXONT’s impact on motor symptom control and functional independence for people living with Parkinson’s disease. Aankondiging • Apr 14
Amneal Pharmaceuticals, Inc. Launches First Two Respiratory Metered-Dose Inhalation Products in the U.S Amneal Pharmaceuticals, Inc. announced the U.S. launch of albuterol sulfate inhalation aerosol and beclomethasone dipropionate HFA inhalation aerosol, two widely prescribed respiratory products that were approved by the Food and Drug Administration (FDA) in 2025. These are the Company’s first two metered-dose inhalation (MDI) product launches in the U.S., marking Amneal’s entry into the complex inhalation category. Albuterol sulfate inhalation aerosol (90 mcg per actuation) is a generic equivalent of PROAIR HFA. Beclomethasone dipropionate HFA inhalation aerosol (40 mcg and 80 mcg per actuation) is a generic equivalent of the original QVAR Inhalation Aerosol, 40 mcg and 80 mcg. Both products utilize the hand-breath actuator device in which the cannister is depressed by the patient before inhaling. This option was previously discontinued for QVAR, creating a potential gap in patient choice. Manufactured at its dedicated inhalation facility in Ireland, these complex products reflect its ability to develop and scale difficult-to-make formulations that address meaningful gaps in patient access. With multiple additional inhalation products in active development, the company building a durable and differentiated presence in this attractive category. Albuterol Sulfate Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. The most common adverse reactions reported with the use of albuterol sulfate inhalation aerosol (=3.0% and greater than placebo) include headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis. Beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid indicated for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. It is not indicated for the relief of acute bronchospasm. The most common adverse reactions reported with the use of beclomethasone dipropionate HFA inhalation aerosol include headache, pharyngitis, upper respiratory tract infection, rhinitis, increased asthma symptoms, and sinusitis. Aankondiging • Apr 08
Amneal Pharmaceuticals, Inc. to Report Q1, 2026 Results on May 01, 2026 Amneal Pharmaceuticals, Inc. announced that they will report Q1, 2026 results Pre-Market on May 01, 2026 Aankondiging • Mar 27
Amneal Pharmaceuticals, Inc., Annual General Meeting, May 06, 2026 Amneal Pharmaceuticals, Inc., Annual General Meeting, May 06, 2026. Location: wwww.virtualshareholdermeeting.com/amrx2026, United States Recent Insider Transactions Derivative • Mar 08
Co-Founder exercised options and sold US$4.8m worth of stock On the 4th of March, Chirag Patel exercised options to acquire 362k shares at no cost and sold these for an average price of US$13.31 per share. This trade did not impact their existing holding. For the year to December 2019, Chirag's total compensation was 11% salary and 89% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2025, Chirag's direct individual holding has increased from 22.13m shares to 26.14m. Company insiders have collectively sold US$32m more than they bought, via options and on-market transactions in the last 12 months. New Risk • Mar 01
New major risk - Negative shareholders equity The company has negative equity. Total equity: -US$42m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Interest payments are not well covered by earnings (1.6x net interest cover). Negative equity (-US$42m). Minor Risk Large one-off items impacting financial results. Price Target Changed • Feb 28
Price target increased by 7.9% to US$16.40 Up from US$15.20, the current price target is an average from 5 analysts. New target price is 19% above last closing price of US$13.81. Stock is up 59% over the past year. The company is forecast to post earnings per share of US$0.25 for next year compared to US$0.23 last year. Reported Earnings • Feb 28
Full year 2025 earnings: EPS exceeds analyst expectations Full year 2025 results: EPS: US$0.23 (up from US$0.38 loss in FY 2024). Revenue: US$3.02b (up 8.0% from FY 2024). Net income: US$72.1m (up US$188.9m from FY 2024). Profit margin: 2.4% (up from net loss in FY 2024). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 22%. Revenue is forecast to grow 4.9% p.a. on average during the next 3 years, compared to a 8.4% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 63% per year but the company’s share price has increased by 93% per year, which means it is tracking significantly ahead of earnings growth. Aankondiging • Feb 27
Amneal Pharmaceuticals, Inc. Provides Earnings Guidance for 2026 Amneal Pharmaceuticals, Inc. provided earnings guidance for 2026. For the period, the company expects net revenue $3.05 billion - $3.15 billion. Price Target Changed • Feb 11
Price target increased by 8.6% to US$15.20 Up from US$14.00, the current price target is an average from 5 analysts. New target price is approximately in line with last closing price of US$14.70. Stock is up 88% over the past year. The company is forecast to post earnings per share of US$0.18 next year compared to a net loss per share of US$0.38 last year. Aankondiging • Jan 29
Amneal Pharmaceuticals, Inc. Announces Nationwide Opioids Settlement Agreement with Various States and Subdivisions On January 23, 2026, Amneal Pharmaceuticals, Inc. determined that it will make effective its nationwide agreement to settle a substantial majority of the opioids-related claims brought against the Company by various states and subdivisions (the “Nationwide Opioids Settlement Agreement”), having previously secured sufficient participation by those states and subdivisions, including all eligible state and territorial attorneys general and all subdivisions that previously sued the Company. The Nationwide Opioids Settlement Agreement will become effective on January 29, 2026. Under the terms of the Nationwide Opioids Settlement Agreement, the Company will pay the participating states and subdivisions $88.5 million and provide up to $177.4 million (valued at $125/twin pack) in naloxone nasal spray to help treat opioid overdoses. In lieu of receiving product, the settling parties can opt to receive 25% of the naloxone nasal spray's value (up to $44.4 million) in cash during the last four years of the ten year payment term, which could increase the total amount of cash the Company would agree to pay up to $132.9 million. Aankondiging • Jan 27
Amneal Pharmaceuticals, Inc. to Report Q4, 2025 Results on Feb 27, 2026 Amneal Pharmaceuticals, Inc. announced that they will report Q4, 2025 results Pre-Market on Feb 27, 2026 Aankondiging • Dec 24
mAbxience and Amneal Pharmaceuticals, Inc. Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA mAbxience and Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for Boncresa™ (denosumab-mobz), a biosimilar referencing Prolia®, and Oziltus™, a biosimilar referencing XGEVA®. Denosumab is a monoclonal antibody that inhibits bone resorption and is widely used across oncology andosteoporosis-related conditions. Under Amneal's partnership with mAbxience, mAbxience is responsible for development and manufacturing, while Amneal holds exclusive U.S. commercialization rights. Both drugs should be administered by a healthcare provider. Patients should be advised to maintain serum calcium levels and to seek medical attention for an allergic reaction. Prolia®: Prolia has a Boxed Warning for severe hypocalcemia in patients with advanced chronic kidney disease, which can be life-threatening. P pregnancy must be ruled out prior to administration. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. Aankondiging • Dec 10
Amneal Receives U.S. FDA Approval for Epinephrine Injection in Single- and Multi-Dose Vials for U.S. Hospitals Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company's epinephrine injection USP, 1 mg/mL (1 mL), in single-dose vials and 1 mg/mL (30 mL) multi-dose vials. This medicine is a critical therapy utilized by hospitals, emergency departments and other acute care facilities for patient care. Epinephrine is a non-selective alpha and beta adrenergic agonist. The 1 mg/mL formulation is indicated for the emergency treatment of allergic reactions (Type 1) including anaphylaxis, which may result from insect stings orbites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. The most common adverse reactions associated with systemically administered epinephrine include anxiety, accuracy, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism. According to IQVIA®?U.S. annual sales for epinephrine injection single- and multi-dose vials for the 12 monthsended October 2025 were approximately $118 million. Aankondiging • Dec 05
Amneal Pharmaceuticals, Inc. Announces Positive Interim Phase 4 Elevate-Pd Results with Crexont for Parkinson's Disease Amneal Pharmaceuticals, Inc. announced new positive interim results from its ongoing Phase 4 ELEVATE-PD study, presented at the Parkinson's Study Group (PSG) Annual Meeting. The first 55 patients evaluated after six weeks of treatment demonstrated substantial clinical benefit after switching to CREXONT®? (carbidopa and levodopa) extended-release capsules, including significant increases in daily "Good On" time, reductions in "Off" time, improved motor symptom control, and consistent gains in "Good On" time per dose--reg regardless of whether patients switched from immediate-release carbidopa/levodopa (IR CD/LD), IR CD/LD with a COMT inhibitor, or RYTARY®? (carbidopa & levodopa) extended- release capsules. CREXONT is Amneal's next-generation extended-release CD/LD formulation that uses a novel mucoadhesive polymer designed to optimize levodopa delivery and absorption, providing the longest-lasting levodopa plasma levels of any oral CD/LD therapy available today. Amneal will present longer-term outcomes and patient-reported results in 2026 as part of the ongoing, rolling ELEVATE-PD program, further strengthening the evidence for CREXONT's impact on motor symptom control and functional independence. Recent Insider Transactions • Nov 20
Independent Director recently sold US$586k worth of stock On the 17th of November, Ted Nark sold around 50k shares on-market at roughly US$11.72 per share. This transaction amounted to 15% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth US$1.2m. Insiders have been net sellers, collectively disposing of US$14m more than they bought in the last 12 months. Recent Insider Transactions Derivative • Nov 16
Insider exercised options and sold US$1.2m worth of stock On the 12th of November, Nikita Shah exercised 132k options at a strike price of around US$2.75 and sold these shares for an average price of US$11.92 per share. This trade did not impact their existing holding. Since March 2025, Nikita's direct individual holding has decreased from 483.07k shares to 146.40k. Company insiders have collectively sold US$27m more than they bought, via options and on-market transactions in the last 12 months. Aankondiging • Nov 14
Amneal Pharmaceuticals, Inc. Receives U.S. FDA Approval for Iohexol Injection Amneal Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has approved the Company's iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare's Omnipaque (iohexol) injection. Amneal expects to launch the product in the first quarter of 2026. Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intrarticular, and body cavity imaging procedures in adults and pediatric patients two weeks of age and older. According to IQVIA U.S. annual sales for iohexol injection for the 12 months ended September 2025 were approximately $652 million. Boxed Warning: Serious adverse reactions, including risk of death, convulsions, seizures, cerebral hemorrhage,a, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema, have been associated with Intrathecal administration of iohexol of a wrong iodine concentration. The most commonly reported adverse reactions based on route of administration are: Intrathecal: Headache, nausea, back/neck pain, dizziness; Intra-arterial /venous: Chest pain, arrhythmias, blurred vision, photomas, altered taste; Oral: Nausea, vomiting, diarrhea, abdominal discomfort; Body Cavity: Local pain, swelling, heat sensation. Price Target Changed • Oct 31
Price target increased by 8.0% to US$13.50 Up from US$12.50, the current price target is an average from 4 analysts. New target price is 25% above last closing price of US$10.81. Stock is up 27% over the past year. The company is forecast to post earnings per share of US$0.19 next year compared to a net loss per share of US$0.38 last year. Reported Earnings • Oct 31
Third quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Third quarter 2025 results: EPS: US$0.008 (up from US$0.001 loss in 3Q 2024). Revenue: US$784.5m (up 12% from 3Q 2024). Net income: US$2.37m (up US$2.53m from 3Q 2024). Profit margin: 0.3% (up from 0% in 3Q 2024). Revenue exceeded analyst estimates by 1.4%. Earnings per share (EPS) missed analyst estimates by 50%. Revenue is forecast to grow 7.7% p.a. on average during the next 3 years, compared to a 8.2% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 52% per year but the company’s share price has increased by 72% per year, which means it is tracking significantly ahead of earnings growth. Aankondiging • Oct 27
Amneal Pharmaceuticals, Inc. Launches Brekiya Amneal Pharmaceuticals, Inc. announced the U.S. commercial launch of Brekiya (dihydroergotamine mesylate) injection, the first and only ready-to-use dihydroergotamine (DHE) autoinjector approved for the acute treatment of cluster headaches in adults. The Brekiya autoinjector is now available by prescription exclusively through Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy. Migraine affects approximately 43 million Americans3, and about 300,000 live with cluster headache. Headache disorders are also the fourth most common reason for U.S. emergency department visits, accounting nearly for 3% of cases. There are limited treatment options available for cluster headache, and Brekiya autoinjectionor represents a new treatment option for this underserved population. Information for Physicians and Patients: Brekiya is available only through prescription. Eligible commercially insured patients may pay as little as $40 per carton (4 single-dose autoinjectors per carton), applied automatically through the specialty pharmacy. To support healthcare providers, field reimbursement specialists will be available to assist with patient access, coverage and reimbursement questions. do not take Brekiya with strong CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. See additional Important Safety Information below. Indication: Brekiya is a prescription medicine used for the acute treatment of migraine with or without aura and acute cluster headaches in adults. Brekiya is not used to prevent migraine or used to treat other types of headaches such as hemiplegic migraines (that make unable to move on one side of body) or basilar migraines (rare form of migraine with aura). It is not known if Brekiya is safe and effective in children. Serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine ("the active ingredient in Brekiya) with strong CYP3A 4 inhibitors (such as protease inhibitors and macrolides antibiotics) have been reported rarely. The most common but serious side effects of Brekiya are heart problems that happen but may lead to death. These heart problems include: temporary squeezing of arteries that supply the heart (coronary artery vasospasm) temporary decrease of blood flow to the heart (transient myocardial ischemia) and heart rhythm problems (ventricular tachycardia and ventricular fibrillation). Tell healthcare provider if one have any side effect that bothers or that does not go away. These are not all of the possible side effects of Brekiya. Call healthcare provider for medical advice about side effects. How should I store Brekiya? Store at room temperature between 68degF to 77degF (20degC to 25degC). Do not refrigerate or freeze. Protect Brekiya from light. Keep Brekiya in the original pack until ready to use. To report S-injector in Brekiya in the original packs until ready to use. Aankondiging • Oct 01
Amneal Pharmaceuticals, Inc. to Report Q3, 2025 Results on Oct 30, 2025 Amneal Pharmaceuticals, Inc. announced that they will report Q3, 2025 results at 9:30 AM, US Eastern Standard Time on Oct 30, 2025 Aankondiging • Sep 26
Amneal Pharmaceuticals, Inc. Announces BLA Submission of Biosimilar Candidate to XOLAIR®? (Omalizumab) Amneal Pharmaceuticals, Inc. announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a proposed biosimilar to XOLAIR®? (omalizumab), developed by Kashiv BioSciences, LLC. XOLAIR®? is a registered trademark of Novartis AG. Omalizumab, a humanized monoclonal antibody that targets free IgE, is indicated for the treatment of moderate to severe persistent asthma (6 years and older patients), chronic rhinosinusitis with nasal polyps (CRSwNP) (18 years and older patients), food allergies (>1 year and older patients), and chronic spontaneous urticaria (12 years and older patients). Omalizumab has a black boxed warning of anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of the first dose and beyond one year during regularly administered treatment. The drug should be initiated and administered in a healthcare setting (hospital or clinic setting) and patients should be closely observed for an appropriate period of time after administration, and if occurs, anaphylaxis should be managed. It is contraindicated in patients with severe hypersensitivity reaction to the drug or any ingredient contained in the product. According to IQVIA®?, U.S. annual sales for XOLAIR®? totaled approximately $4.1 billion for the 12 months ending July 2025. As a result of the earlier BLA filing, Amneal expects to incur a $22.5 million R&D milestone charge in the third quarter of 2025, rather than the fourth quarter as previously expected. This cost was included in the company's financial guidance. Amneal holds exclusive U.S. commercialization rights for the product, pending regulatory approval. Aankondiging • Sep 23
Amneal Pharmaceuticals, Inc. Receives U.S. FDA Approval for Bimatoprost Ophthalmic Solution, 0.01% Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution 0.01% (2.5 mL, 5 mL and 7.5 mL). The product is the generic equivalent of LUMIGAN®? (bimatoprost ophthal mic solution) 0.01%, whose design is a trademark of Allergan, Inc., an AbbVie company. Bimatoprost ophthal Micmic solution 0.01% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Price Target Changed • Sep 16
Price target increased by 7.8% to US$12.67 Up from US$11.75, the current price target is an average from 3 analysts. New target price is 30% above last closing price of US$9.74. Stock is up 10% over the past year. The company is forecast to post earnings per share of US$0.19 next year compared to a net loss per share of US$0.38 last year. Aankondiging • Sep 11
Amneal Receives U.S. FDA Approval of Sodium Oxybate Oral Solution Amneal Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approval of Amneal's sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA) which references Jazz Pharmaceuticals' Xyrem®?. Amneal had previously been distributing an authorized generic of sodium oxybate oral solution in limited quantities. Sodium oxybate oral solution is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. Narcolepsy is characterized by excessive daytime sleepiness, sudden sleep attacks, and cataplexy, a sudden loss of muscle control often triggered by emotions and sodium oxybate is considered a standard of care therapy in narcolepsy due to its ability to consolidate nighttime sleep and significantly reduce cataplexy episodes. The most common adverse reactions in adults taking sodium oxybate oral solution include nausea, dizziness, vomiting, headache, weight decrease, decreased appetite, dizziness, and sleep walking. Aankondiging • Sep 05
Amneal Pharmaceuticals, Inc. Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension Amneal Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50 mg/vial, which references Janssen's Risperdal Consta. The product is eligible for 180-day exclusivity under the FDA's Competitive Generic Therapy (CGT) designation. Product launch is planned for the fourth quarter of 2025. Risperidone extended-release injectionable suspension is an atypical antipsychotic indicated for the treatment of schizophrenia or may be used alone or as an adjunctive therapy with lithium or valproate for the maintenance treatment of Bipolar I disorder. The most commonly reported adverse reactions for risperidone extended- release injectable suspension in clinical studies were headache, parkinsonism, dizziness, movement disorder, fatigue, constipation, indigestion, sedation, weight increased, pain in extremity, and dry mouth. According to IQVIA®? U.S. annual sales for risperidone extended therelease injectable suspension for the 12 monthsended July 2025 were approximately $194 million. Recent Insider Transactions • Aug 14
Insider recently sold US$452k worth of stock On the 12th of August, Nikita Shah sold around 50k shares on-market at roughly US$9.04 per share. This transaction amounted to 13% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth US$453k. Insiders have been net sellers, collectively disposing of US$7.0m more than they bought in the last 12 months. Recent Insider Transactions Derivative • Aug 13
Insider notifies of intention to sell stock Nikita Shah intends to sell 50k shares in the next 90 days after lodging an Intent To Sell Form on the 12th of August. If the sale is conducted around the recent share price of US$9.06, it would amount to US$453k. Since September 2024, Nikita's direct individual holding has increased from 291.67k shares to 388.93k. Company insiders have collectively sold US$17m more than they bought, via options and on-market transactions in the last 12 months. Reported Earnings • Aug 05
Second quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2025 results: EPS: US$0.071 (up from US$0.019 in 2Q 2024). Revenue: US$724.5m (up 3.2% from 2Q 2024). Net income: US$22.4m (up 274% from 2Q 2024). Profit margin: 3.1% (up from 0.9% in 2Q 2024). Revenue missed analyst estimates by 2.7%. Earnings per share (EPS) exceeded analyst estimates by 17%. Revenue is forecast to grow 8.0% p.a. on average during the next 3 years, compared to a 8.7% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 44% per year but the company’s share price has only increased by 38% per year, which means it is significantly lagging earnings growth. Aankondiging • Aug 05
Amneal Pharmaceuticals, Inc. Revises Earnings Guidance for the Year Ending December 31, 2025 Amneal Pharmaceuticals, Inc. revised earnings guidance for the year ending December 31, 2025. For the year 2025, the company expects net revenue of $3.0 billion to $3.1 billion compared to previous guidance of $3.0 billion to $3.1 billion. Aankondiging • Jul 09
Amneal Pharmaceuticals, Inc. to Report Q2, 2025 Results on Aug 05, 2025 Amneal Pharmaceuticals, Inc. announced that they will report Q2, 2025 results Pre-Market on Aug 05, 2025 Recent Insider Transactions • Jun 13
Director recently sold US$453k worth of stock On the 10th of June, Gautam Patel sold around 56k shares on-market at roughly US$8.02 per share. This transaction amounted to 3.2% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$6.8m more than they bought in the last 12 months. Aankondiging • Jun 12
Amneal Receives U.S. FDA Approval for Prednisolone Acetate Ophthalmic Suspension Amneal Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approval of prednisolone acetate ophthalmic suspension, 1% sterile which references Pred Forte. Pred Forte and its design are trademarks of Allergan, Inc., an AbbVie company. Launch of this product is planned for the third quarter of 2025. Prednisolone acetate Ophthalmic suspension, USP 1% is a sterile, topical anti-inflammatory agent for ophthalmic use and is indicated for treating steroid-responsive ocular inflammation. Aankondiging • May 15
Amneal Receives U.S. FDA Approval for Brekiya®? (Dihydroergotamine Mesylate) Injection for the Acute Treatment of Migraine and Cluster Headaches in Adults Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Brekiya®? (dihydroergotamine mesylate) injection, the first and only dihydroergotamine (DHE) autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults. Brekiya autoinjector provides patients with the potential for sustained pain relief+ in a convenient, self-administered form. It contains the same medication (DHE) used in hospitals, now in a ready-to-use device. Brekiya autoinjectionor does not require refrigeration, assembly, or priming of the device. Patients can deliver one dose subcutaneously into the middle of the thigh. This may be beneficial for patients who respond inadequately to oral therapies due to lack of efficacy, experience nausea or vomiting during attacks, have gastroparesis, or delay dosing until too late into the attack. DHE is commonly administered in emergency rooms, urgent care facilities, and headache clinics intravenously. DHE can be used at any point during a migraine attack, and may protect patients from headache recurrence. Approximately 39 million Americans are living with migraine7, and up to one million with cluster headache. Also, headache is the fourth most common reason for emergency department visits, and accounts for 3% of all emergency room visits in the United States. There are limited treatment options available for cluster headache, and Brekiya autoinjectors represents a new treatment option for this underserved population.2 do not take Brekiya autoinjecter with strong CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. See additional Important Safety Information below. Brekiya autoin injector is a prescription medicine used for the acute treatment of migraine With or without aura and acute cluster headaches in adults. Breakiya autoinjector is not used to prevent migraine or used to treat other types of headaches such as migraine migraines (that make unable to move on one side of body) or basilar migraines (rare form of migraine with aura). These are not all of the possible side effects of Brekiya autoinject or freeze. Call healthcare provider for medical advice about side effects. How should I store Brekiya autoinjectOR? Store at room temperature between 68degF to 77degF (20degC to 25degC). Do not refrigerate or freeze. Protect Brekiya autoinjectore or freeze. Protect Brekiy autoinjector from light. Keep Brekiya autoinjecting in the original pack until ready to use. Recent Insider Transactions • May 14
Independent Director recently sold US$380k worth of stock On the 12th of May, John Kiely sold around 50k shares on-market at roughly US$7.59 per share. This transaction amounted to 16% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth US$1.1m. Insiders have been net sellers, collectively disposing of US$6.2m more than they bought in the last 12 months. Reported Earnings • May 04
First quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2025 results: EPS: US$0.039 (up from US$0.30 loss in 1Q 2024). Revenue: US$695.4m (up 5.5% from 1Q 2024). Net income: US$12.2m (up US$103.8m from 1Q 2024). Profit margin: 1.8% (up from net loss in 1Q 2024). The move to profitability was primarily driven by lower expenses. Revenue missed analyst estimates by 2.8%. Earnings per share (EPS) exceeded analyst estimates by 100%. Revenue is forecast to grow 7.2% p.a. on average during the next 3 years, compared to a 8.3% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 15% per year but the company’s share price has increased by 33% per year, which means it is tracking significantly ahead of earnings growth. New Risk • May 02
New major risk - Revenue and earnings growth Earnings have declined by 23% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$45m). Earnings have declined by 23% per year over the past 5 years. Minor Risk Significant insider selling over the past 3 months (US$45m sold). Aankondiging • May 02
Amneal Pharmaceuticals, Inc. Affirms Earnings Guidance for the Full Year 2025 Amneal Pharmaceuticals, Inc. affirmed earnings guidance for the full year 2025. Net revenue to be $3.0 billion - $3.1 billion. Aankondiging • Apr 09
Amneal Pharmaceuticals, Inc. to Report Q1, 2025 Results on May 02, 2025 Amneal Pharmaceuticals, Inc. announced that they will report Q1, 2025 results Pre-Market on May 02, 2025 Aankondiging • Apr 07
Amneal Pharmaceuticals, Inc. Announces New Data from Phase 3 Study Showing Significant Improvements in Sleep Quality with Crexont® (Carbidopa and Levodopa) Extended-Release Capsules in Parkinson's Disease Amneal Pharmaceuticals, Inc. announced a new analysis of the pivotal RISE-PD Phase 3 study showed that patients who successfully converted to CREXONT from immediate release (IR) carbidopa/levodopa (CD/LD) experienced statistically significant improvements in sleep quality. These improvements were measured by their Parkinson's Disease Sleep Scale-2 (PDSS-2) total scores, showing a mean difference of -2.35 (p about the RISE-PD Phase 3 Trial: The multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group RISE-PD trial evaluated the efficacy and safety of CREXONT compared with IR CD/LD in the treatment of patients with PD who have motor fluctuations. The primary endpoint of the trial assessed the change from baseline in "On" time in hours per day at the end of the double-blind treatment period (Week 20 or early termination). Secondary endpoint assessed the change from baseline in 'Off' time in hours per day, proportion of patients who were either " much improved" or "very much improved" in Patients' Global Impression of Change (PGI-C) scores, change from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score, and the change from baseline in sum of MDS-UPDRS Parts II and III scores. The study included 506 patients who had received a PD diagnosis at age 40 or older. CREXONT is an innovative formulation consisting of immediate-release granules with carbidopa and levodopa for rapid onset of action, and extended-release pellets with levodopa for long-lasting efficacy. CREXONT formulation and dosage strengths are different from RYTARY®? (carbidopa and levodopa) extended-release capsules approved by the U.S. FDA in 2015. CREXONT (carbidopa and levODopa) extended-release capsulesapproved by the U.S.FDA in 2015. CREXONT®? extended-release capsules is a prescription medication for the treatment of Parkinson's disease, Parkinson's disease caused by infection or inflammation of the brain, or Parkinson's disease-like symptoms that may result from carbon monoxide or manganese poisoning in adults. Do not take CREXONT with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors. Do not take CREXont with other carbidopa-levodopa-levodopa preparations without consulting healthcare provider. Become or intend to become pregnant. Based on animal data, CREXONT may cause fetal harm. Are breastfeeding during therapy. Have side effects; Have side effects; doctor can adjust dose. Aankondiging • Apr 04
Amneal Pharmaceuticals, Inc. Announces Expanded Coverage for CREXONT®? (Carbidopa and Levodopa) to Enhance Access for Parkinson's Disease Patients in the U.S Amneal Pharmaceuticals, Inc. announced that three large insurance coverage accounts, the Veterans Administration (VA), UnitedHealthcare and CVS Health, have added CREXONT®? (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson's disease (PD) to their national prescription drug formularies. CREXONT is a prescription medication for the treatment of PD approved by the U.S. FDA in August 2024. This expanded coverage increases CREXONT's total U.S. insurance coverage from about 30% of covered lives at the end of 2024 to over 50%. The Company had initially set a goal to surpass 50% coverage by the end of 2025, making this milestone--ach achieved nine months ahead of schedule--a testament to Amneal's commitment to broadening patient access. CREXONT's therapeutic benefits include: Novel formulation designed to provide long lasting efficacy: CREXONT is an innovative formulation of carbidopa/levodopa (CD/LD) that combines immediate-release (IR) granules for rapid onset of action and extended-release pellets with a novel technology, designed to target the area of absorption, making CREXONT the longest-lasting oral CD/LD formulation available today. The novel technology delivers more stable levodopa levels that do not wear off as quickly or as often as traditional IR formulation. Over time with IR CD/LD therapy, the duration of symptom control may become more unpredictable, and patients may experience more "Off" time. About half of patients taking a PD medication may experience "Off" episodes - time where their motor symptoms return or are not well-controlled - within 2 to 3 years of treatment initiation. More "Good On" time with less frequent dosing: A head-to-head clinical trial showed CREXONT provides more "Good On" time per day, and 1.55 more hours of "Good On" time per dose (where symptoms are well-controlled without troublesome involuntary movements) compared to IR CD/LD. This represents a 70% increase in the amount of time each dose helps people feel in control of their PD symptoms. Safety profile consistent with IR CD/LD: The most common adverse reactions with CREXONT (incidence 3% and greater than IR CD/LD) are nausea and anxiety. See Important Safety Information below. To further support patients, providers, and care partners as they navigate insurance coverage and their treatment on CREXONT, Amneal offers a full suite of services and support within the Amneal Patient Support Program. Aankondiging • Apr 01
Amneal Pharmaceuticals, Inc. and Shilpa Medicare Limited Launches BORUZU, First Ready-To-Use Bortezomib Injection for Multiple Myeloma and Mantle Cell Lymphoma Amneal Pharmaceuticals, Inc. and Shilpa Medicare Limited announced the U.S. launch of BORUZU, a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration. This new ready-to-use oncology product reduces the compounding preparation steps typically required with administration. BORUZU (bortezomib injection), a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma. This product references the branded product Velcade, a lyophilized powder requiring reconitution before use. Shilpa developed the molecule and Amneal will manufacture and commercialize the product. BORUZU has a unique J-code. The most commonly reported adverse reactions for BORUZU in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia. Aankondiging • Mar 26
Amneal Pharmaceuticals, Inc., Annual General Meeting, May 06, 2025 Amneal Pharmaceuticals, Inc., Annual General Meeting, May 06, 2025. Recent Insider Transactions • Mar 09
Insider recently sold US$1.1m worth of stock On the 5th of March, Andrew Boyer sold around 125k shares on-market at roughly US$8.89 per share. This transaction amounted to 30% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$5.9m more than they bought in the last 12 months. Recent Insider Transactions Derivative • Mar 06
Co-Founder exercised options and sold US$2.9m worth of stock On the 4th of March, Chirag Patel exercised options to acquire 327k shares at no cost and sold these for an average price of US$8.77 per share. This trade did not impact their existing holding. For the year to December 2018, Chirag's total compensation was 32% salary and 68% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2024, Chirag has owned 21.78m shares directly. Company insiders have collectively sold US$9.9m more than they bought, via options and on-market transactions in the last 12 months. Aankondiging • Mar 04
Amneal’S Bla Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. Fda Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has accepted for review its Biologics Licensing Application for two proposed denosumab biosimilars referencing Prolia and XGEVA. mAbxience is a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma. Fresenius Kabi is an operating company of Fresenius. The FDA has assigned a target action date in the fourth quarter of 2025. Currently, Amneal commercializes three biosimilars in the U.S., with the two denosumab biosimilar candidates representing its next potential biosimilar launches. Additionally, three more biosimilars are in development, positioning Amneal to have a portfolio of six biosimilars across eight product presentations by 2027. Denosumab is a monoclonal antibody drug that inhibits bone reabsorption. It is indicated for two major categories of therapy: bone metastasis from various forms of cancer and prevention of bone pain and fractures, including osteoporosis-related injuries. Under the terms of the agreement, mAbxience is responsible for the development and manufacturing of the biosimilars while Amneal will pursue regulatory approval and have exclusive commercialization rights in the United States. Amneal and mAbxience currently partner on ALYMSYS, a bevacizumab biosimilar, which was launched in 2022. Prolia®: In patients with postmenopausal osteoporosis, the most frequently reported adverse reactions included back musculoskeletal and extremity pain; hypercholesterolemia; and cystitis. Among male patients with osteoporosis, back pain, arthralgia, and nasopharyngitis were reported. Prolia also carries a Boxed Warning for patients with advanced chronic kidney disease. XGEVA: The most frequently reported serious adverse reaction was dyspnea. Other reported adverse reactions observed included fatigue, asthenia, hypophosphatemia, and nausea. Discontinuation was reported in patients with osteonecrosis and hypocalcemia. According to IQVIA, U.S. annual sales for Prolia and XGEVA for the 12 months ended December 2024 were approximately $5.0 billion. New Risk • Feb 28
New major risk - Revenue and earnings growth Earnings have declined by 3.4% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$45m). Earnings have declined by 3.4% per year over the past 5 years. Reported Earnings • Feb 28
Full year 2024 earnings: EPS misses analyst expectations Full year 2024 results: US$0.38 loss per share. Revenue: US$2.79b (up 17% from FY 2023). Net loss: US$116.9m (loss widened 39% from FY 2023). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 46%. Revenue is forecast to grow 5.1% p.a. on average during the next 3 years, compared to a 8.6% growth forecast for the Pharmaceuticals industry in the US. Aankondiging • Feb 28
Amneal Pharmaceuticals, Inc. Provides Earnings Guidance for the Full Year 2025 Amneal Pharmaceuticals, Inc. provided earnings guidance for the full year 2025. For the year, the company expects net revenue in the range of $3.0 billion - $3.1 billion. Price Target Changed • Feb 24
Price target increased by 13% to US$11.25 Up from US$10.00, the current price target is an average from 4 analysts. New target price is 36% above last closing price of US$8.30. Stock is up 43% over the past year. The company is forecast to post a net loss per share of US$0.26 next year compared to a net loss per share of US$0.48 last year. Aankondiging • Feb 19
Amneal Launches Mesalamine and Receives U.S. FDA Approval for Lenalidomide Amneal Pharmaceuticals, Inc. announced the launch of mesalamine 800 mg delayed-release tablets, an amosalicylate indicated for the treatment of moderately active ulcerative colitis in adults. Additionally, the Company has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for lenalidomide capsules in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg strengths. In settlement of all outstanding claims related to this product, Celgene agreed to provide Amneal with a license to Celgene's patents required to manufacture and sell generic lenalidomide in the U.S. beginning on January 31, 2026. Lenalidomide, a thalidomide analogue, is indicated for the treatment of several blood cancers. The most common side effects reported with ASACOL HD®? 800 mg include headache, stomach pain, burping, nausea,ore throat, dizziness, weakness, and diarrhea. Less commonly, patients have experienced chest pain, menstrual cramps, swelling in the limbs, skin rash, and worsening of colitis. REVLIMID®? is a thalidomide analogue indicated for the treatment of adult patients with multiple myeloma and transfusion-dependent anemia due to myelodysplastic syndromes (MDS). Some of the most common adverse reactions reported while lenalidomide was used include neutropenia, thrombocytopenia and leukopenia. According to IQVIA®?, U.S. annual sales for mesalamine800 mg for the 12 months ended December 2024 were approximately $147 million. Aankondiging • Jan 29
Amneal Pharmaceuticals, Inc. to Report Q4, 2024 Results on Feb 28, 2025 Amneal Pharmaceuticals, Inc. announced that they will report Q4, 2024 results Pre-Market on Feb 28, 2025 Aankondiging • Jan 23
Amneal Pharmaceuticals, Inc. Receives U.S. FDA Approval for Memantine/Donepezil Extended-Release Capsules and Everolimus Tablets for Oral Suspension, and Tentative U.S. FDA Approval for Rifaximin Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved memantine/donepezil 14-10 mg and 28-10 mg extended-release capsules, which references Abbvie’s NAMZARIC, and Everolimus 2 mg, 3 mg and 5 mg extended-release capsules, which references Novartis’ AFINITOR DISPERZ. In addition, the FDA has granted tentative approval to Amneal’s rifaximin 550 mg oral tablets, which references Bausch Health’s XIFAXAN. The FDA approval was tentative as this product is involved in litigation. Memantine/donepezil extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. The product has launched with 180-day exclusivity. Everolimus tablets for oral suspension are indicated for the treatment of Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) in adult and pediatric patients aged one year or older. This launch increases the supply of an oncology product that has limited suppliers. Rifaximin 550 mg oral tablets are indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. The most common adverse reactions with memantine hydrochloride were headache, diarrhea, and dizziness. The most common adverse reactions occurring in patients receiving donepezil include diarrhea, anorexia, vomiting, nausea, and bruising. The most common adverse reactions with everolimus tablets in patients treated for TSC-Associated SEGA: are stomatitis and respiratory tract infection. Recent Insider Transactions • Nov 26
Independent Director recently sold US$334k worth of stock On the 22nd of November, Deborah Autor sold around 40k shares on-market at roughly US$8.35 per share. This transaction amounted to 43% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth US$376k. Insiders have been net sellers, collectively disposing of US$2.3m more than they bought in the last 12 months. Aankondiging • Nov 22
Amneal Pharmaceuticals, Inc. Resubmits DHE Autoinjector New Drug Application and Receives U.S. FDA Approval of Exenatide, its First Generic Injectable GLP-1 Agonist Amneal Pharmaceuticals, Inc. announced the advancement of two key strategic initiatives. First, the Company has resubmitted to the U.S. Food and Drug Administration (FDA) its new drug application (NDA) for dihydroergotamine (DHE) prefilled syringe autoinjector for the acute treatment of migraine with or without aura and cluster headache in adults. Second, Amneal has received approval from the FDA for exenatide, which is the Company’s first generic injectable glucagon-like peptide-1 (GLP-1) agonist and reflects its innovation capabilities in peptide development and drug-device combinations. Resubmission of DHE Autoinjector New Drug Application: This first and only DHE autoinjector has the potential to provide patients with lasting pain relief from tough-to-treat headaches, particularly cluster headaches, with the same powerful medication used in hospitals. The single-dose, ready-to-use autoinjector will not require refrigeration, assembly, or priming, and allow patients to conveniently self-administer at home when experiencing painful attacks. The U.S. FDA previously issued a complete response letter to the original NDA, citing facility inspection issues at a third-party site. As a result, Amneal transferred production to in-house and leveraged its expertise in complex injectable manufacturing and engineering to complete development of this new product. The review of this NDA is expected to be completed in the second quarter of 2025. DHE is commonly administered in emergency rooms, urgent care facilities, and headache clinics intravenously. Currently, DHE is also available both as ampules for injection or as a nasal spray formulation for at-home use. Over 39 million Americans are living with migraines, and up to one million with cluster headaches. Also, headache is the fourth most common reason for emergency department visits, and accounts for 3% of all ER visits in the United States. U.S. FDA Approval of Exenatide, an Injectable GLP-1 Agonist: The approval of exenatide 1.2 mL and 2.4 mL prefilled pen injection, referencing BYETTA®, reflects the Company’s deep innovation and regulatory capabilities in complex pharmaceuticals and its ability to successfully develop this first synthetic generic peptide. Exenatide is a GLP-1 agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Patients have experienced changes in kidney function, low blood sugar, and inflammation of the pancreas while using exenatide. The most common side effects include nausea, low blood sugar, vomiting, diarrhea, feeling jittery, dizziness, headache, indigestion, constipation, and weakness. Major Estimate Revision • Nov 21
Consensus EPS estimates fall by 17% The consensus outlook for fiscal year 2024 has been updated. 2024 expected loss increased from -US$0.23 to -US$0.27 per share. Revenue forecast unchanged at US$2.76b. Pharmaceuticals industry in the US expected to see average net income decline 0.4% next year. Consensus price target of US$10.50 unchanged from last update. Share price fell 7.6% to US$8.32 over the past week. Recent Insider Transactions • Nov 20
Senior VP recently sold US$376k worth of stock On the 15th of November, Jason Daly sold around 44k shares on-market at roughly US$8.61 per share. This transaction amounted to 76% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$1.9m more than they bought in the last 12 months. Recent Insider Transactions Derivative • Nov 17
Senior VP notifies of intention to sell stock Jason Daly intends to sell 57k shares in the next 90 days after lodging an Intent To Sell Form on the 15th of November. If the sale is conducted around the recent share price of US$8.50, it would amount to US$487k. Since March 2024, Jason has owned 57.32k shares directly. Company insiders have collectively sold US$2.9m more than they bought, via options and on-market transactions in the last 12 months. Reported Earnings • Nov 10
Third quarter 2024 earnings released: US$0.001 loss per share (vs US$0.063 profit in 3Q 2023) Third quarter 2024 results: US$0.001 loss per share (down from US$0.063 profit in 3Q 2023). Revenue: US$702.5m (up 13% from 3Q 2023). Net loss: US$156.0k (down 102% from profit in 3Q 2023). Profit margin: 0% (down from 1.6% in 3Q 2023). Revenue is forecast to grow 5.6% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has fallen by 33% per year but the company’s share price has increased by 19% per year, which means it is well ahead of earnings. Aankondiging • Nov 08
Amneal Pharmaceuticals, Inc. Affirms Earnings Guidance for the Full Year 2024 Amneal Pharmaceuticals, Inc. affirmed earnings guidance for the full year 2024. The company expects net revenue to be $2.70 billion - $2.80 billion. New Risk • Nov 07
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 101% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$4.1m). Shareholders have been substantially diluted in the past year (101% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$25m net loss next year). Significant insider selling over the past 3 months (US$1.3m sold). Aankondiging • Oct 09
Amneal Pharmaceuticals, Inc. to Report Q3, 2024 Results on Nov 08, 2024 Amneal Pharmaceuticals, Inc. announced that they will report Q3, 2024 results Pre-Market on Nov 08, 2024 Aankondiging • Aug 20
Amneal Pharmaceuticals, Inc. Receives U.S. FDA Approval for Propofol Injectable Emulsion Single Dose Vials Amneal Pharmaceuticals, Inc. announced that it has received Abbreviated New Drug Application (‘ANDA’) approval from the U.S. Food and Drug Administration (FDA) for Propofol Injectable Emulsion USP, 200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), and 1,000 mg/100 mL (10 mg/mL), Single-Dose Vials. Propofol is an intravenous drug commonly used in hospitals for the induction and maintenance of anesthesia and sedation. It is currently on the American Society of Health System Pharmacists (ASHP) drug shortages list. Propofol has a history of shortage due to supply chain constraints. Amneal will manufacture the product in-house on a dedicated line to provide consistent supply. The Company expects to launch propofol in the fourth quarter of 2024. Recent Insider Transactions • Aug 18
Insider recently sold US$775k worth of stock On the 14th of August, Nikita Shah sold around 100k shares on-market at roughly US$7.75 per share. This transaction amounted to 26% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$1.5m more than they bought in the last 12 months. Recent Insider Transactions Derivative • Aug 16
Insider notifies of intention to sell stock Nikita Shah intends to sell 70k shares in the next 90 days after lodging an Intent To Sell Form on the 14th of August. If the sale is conducted around the recent share price of US$7.86, it would amount to US$550k. Since March 2024, Nikita has owned 391.67k shares directly. Company insiders have collectively sold US$1.6m more than they bought, via options and on-market transactions in the last 12 months. 
