Amneal Pharmaceuticals
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Amneal Pharmaceuticals(AMRX) - 2024 Q1 - Earnings Call Transcript
2024-05-03 17:37
Financial Data and Key Metrics Changes - Q1 2024 total net revenue reached $659 million, an 18% increase year-over-year [6][22] - Adjusted EBITDA for Q1 was $152 million, reflecting a 31% growth [6][23] - Adjusted EPS for Q1 was $0.14, up 17% compared to the previous year [24] Business Line Data and Key Metrics Changes - Generics segment net revenue was $391 million, growing 14% driven by a diverse portfolio [22] - Specialty segment net revenues reached $105 million, a 15% increase, supported by the launch of ONGENTYS [22] - AvKARE segment net revenues grew by 33% to $163 million, reflecting strong growth across all customer channels [23] Market Data and Key Metrics Changes - The company fills approximately 175 million prescriptions annually in the U.S., with a focus on complex generics and injectables [7] - The biosimilars market is expected to see significant growth, with an estimated $192 billion in annual branded biologics losing exclusivity from 2024 to 2028 [11] Company Strategy and Development Direction - The strategic vision is to be a global, diversified pharmaceutical company providing access to high-quality, affordable medicines [6] - The company is expanding its portfolio in biosimilars and injectables, with plans to launch over 30 new products in 2024 [10][11] - International expansion is a focus, with expectations to add $5.2 billion in revenues by 2027 [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving financial commitments for 2024 and beyond, citing strong execution and growth momentum [6][24] - The recent approval of naloxone is seen as a significant step in addressing the opioid crisis, with plans to expand access through various channels [8][25] - The company is targeting the higher end of its full-year revenue outlook, expecting total net revenue of $2.55 billion to $2.65 billion [25] Other Important Information - The company has resolved legacy legal matters, including a nationwide opioid settlement, which is expected to alleviate financial overhangs [25] - The company has built capacity to supply up to 10 million units of naloxone starting next year [30] Q&A Session Summary Question: Can you talk about the California contract for naloxone? - The California contract starts now, with potential purchases of up to 3.2 million units per year, ramping up demand over time [28] Question: What is the earnings cadence for this year? - The company is focused on maximizing performance while also investing in R&D for long-term growth [33][34] Question: Can you provide an update on ONGENTYS and PEMRYDI? - Positive feedback has been received for ONGENTYS, and PEMRYDI is expected to drive growth as a ready-to-use oncology therapy [36][38] Question: What are the dynamics driving sales for ALYMSYS? - Strong sales are attributed to a well-established commercial team and a broader product portfolio that enhances negotiating power [49] Question: What is the potential for biosimilars Prolia and XGEVA? - Launches are expected in 2026, with good market penetration anticipated due to established relationships [62]
Amneal Pharmaceuticals(AMRX) - 2024 Q1 - Quarterly Results
2024-05-03 10:14
Exhibit 99.1 AMNEAL REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS ‒ Q1 2024 Net Revenue of $659 million; GAAP Net Loss of $92 million; Diluted Loss per Share of $0.30 ‒ ‒ Adjusted EBITDA of $152 million; Adjusted Diluted EPS of $0.14 ‒ ‒ Company has reached settlement in principle on a nationwide opioids settlement, payable over ten years ‒ ‒ Af irming 2024 Full Year Guidance ‒ BRIDGEWATER, NJ, May 3, 2024 - Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal" or the "Company") announced its results today f ...
Amneal Pharmaceuticals(AMRX) - 2023 Q4 - Annual Report
2024-03-14 21:04
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission file number 001-38485 Amneal Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware (State or oth ...
Amneal Pharmaceuticals(AMRX) - 2023 Q4 - Earnings Call Transcript
2024-03-01 17:26
Amneal Pharmaceuticals, Inc. AMRX) Q4 2023 Earnings Conference Call March 1, 2024 8:30 AM ET Company Participants Chirag Patel - Co-Founder & Co-CEO Chintu Patel - Co-Founder & Co-CEO Tasos Konidaris - CFO Andy Boyer - Generics Joe Renda - SVP & CCO, Specialty Harsher Singh - SVP, Biosciences Jason Daly - Chief Legal Officer Tony DiMeo - IR Conference Call Participants Nathan Rich - Goldman Sachs David Amsellem - Piper Sandler Balaji Prasad - Barclays Chris Schott - J.P. Morgan Leszek Sulewski - Truist Secu ...
Amneal Pharmaceuticals(AMRX) - 2023 Q4 - Earnings Call Presentation
2024-03-01 14:46
Q4 2023 Earnings Call March 1, 2024 Cautionary Statement on Forward Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; ex ...
Amneal Pharmaceuticals(AMRX) - 2023 Q4 - Annual Results
2024-03-01 11:13
[Financial Highlights and Business Overview](index=1&type=section&id=Financial%20Highlights%20and%20Business%20Overview) [Fourth Quarter 2023 Performance](index=1&type=section&id=Fourth%20Quarter%202023%20Performance) In Q4 2023, Amneal's net revenue saw a marginal 1% increase to $617 million, propelled by a 38% growth in AvKARE and a 2% rise in Specialty, which was partially offset by a 9% decline in the Generics segment, leading to increased GAAP Net Loss and declines in Adjusted EBITDA and Adjusted Diluted EPS Q4 2023 vs Q4 2022 Financial Metrics | Metric | Q4 2023 | Q4 2022 | Change | | :--- | :--- | :--- | :--- | | Net Revenue | $617 million | $610 million | +1% | | GAAP Net Loss | $99 million | $4 million | +$95M | | Diluted Loss per Share | $0.40 | $0.03 | +$0.37 | | Adjusted EBITDA | $142 million | $154 million | -8% | | Adjusted Diluted EPS | $0.14 | $0.23 | -39% | - Revenue growth was driven by a **38%** increase in AvKARE and a **2%** increase in Specialty, but was offset by a **9%** decline in Generics revenue due to the timing of orders[3](index=3&type=chunk) - The substantial increase in net loss was primarily attributed to non-cash intangible asset impairment charges and costs associated with the company's term loan refinancing[3](index=3&type=chunk) [Full Year 2023 Performance](index=1&type=section&id=Full%20Year%202023%20Performance) For the full year 2023, Amneal achieved an 8% increase in net revenue, reaching $2.39 billion, with growth recorded across all three business segments, while GAAP Net Loss significantly improved and Adjusted EBITDA grew, despite a slight decrease in Adjusted Diluted EPS due to higher interest expenses Full Year 2023 vs Full Year 2022 Financial Metrics | Metric | FY 2023 | FY 2022 | Change | | :--- | :--- | :--- | :--- | | Net Revenue | $2.39 billion | $2.21 billion | +8% | | GAAP Net Loss | $84 million | $130 million | -$46M | | Diluted Loss per Share | $0.48 | $0.86 | -$0.38 | | Adjusted EBITDA | $558 million | $514 million | +9% | | Adjusted Diluted EPS | $0.64 | $0.68 | -6% | - Full-year revenue growth was broad-based, with AvKARE growing **31%**, Generics **3%**, and Specialty **4%**[3](index=3&type=chunk) - The decrease in Adjusted Diluted EPS was a result of higher interest expense offsetting the growth in Adjusted EBITDA[3](index=3&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) The Co-CEOs described 2023 as a very successful year marked by strong execution and growth, expressing confidence for 2024 due to significant momentum and key catalysts such as complex high-value products, biosimilars, and specialty drugs, positioning Amneal for sustainable, profitable growth - The company is entering 2024 with substantial momentum driven by key catalysts, including complex high-value products, biosimilars, and specialty drugs[2](index=2&type=chunk) - Amneal's mission to provide high-quality, affordable, essential medicines is aligned with industry dynamics, positioning the business for sustainable growth[2](index=2&type=chunk) [2024 Financial Guidance](index=3&type=section&id=2024%20Financial%20Guidance) [2024 Financial Guidance](index=3&type=section&id=2024%20Financial%20Guidance) Amneal has issued its financial guidance for 2024, projecting net revenue to be between $2.55 billion and $2.65 billion, Adjusted EBITDA in the range of $580 million to $620 million, Adjusted Diluted EPS between $0.53 and $0.63, and operating cash flow between $260 million and $300 million 2024 Financial Guidance vs. 2023 Actuals | Metric | Full Year 2024 Guidance | Full Year 2023 Actuals | | :--- | :--- | :--- | | Net revenue | $2.55 billion - $2.65 billion | $2.39 billion | | Adjusted EBITDA | $580 million - $620 million | $558 million | | Adjusted diluted EPS | $0.53 - $0.63 | $0.64 | | Operating cash flow | $260 million - $300 million | $346 million | | Capital expenditures | $60 million - $70 million | $43 million | - The 2024 guidance is based on management's current expectations regarding prescription trends, pricing levels, the timing of future product launches, and restructuring activities[4](index=4&type=chunk) [Consolidated Financial Statements](index=6&type=section&id=Consolidated%20Financial%20Statements) [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) For the full year ended December 31, 2023, Amneal reported increased net revenue and gross profit, achieving an operating income compared to a prior-year loss, but still recorded a net loss primarily due to significant interest expense and a loss on refinancing Full Year Consolidated Statement of Operations Highlights (in thousands) | Line Item | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Net revenue | $2,393,607 | $2,212,304 | | Gross profit | $820,565 | $784,708 | | Operating income (loss) | $204,374 | $(94,928) | | Interest expense, net | $(210,629) | $(158,377) | | Net loss | $(48,722) | $(254,789) | | Net loss attributable to Amneal | $(83,993) | $(129,986) | [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of December 31, 2023, Amneal's total assets decreased to $3.47 billion, mainly due to lower intangible assets, while total liabilities also reduced to $3.41 billion driven by decreased long-term debt, and cash and cash equivalents significantly increased to $91.5 million Balance Sheet Highlights (in thousands) | Account | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $91,542 | $25,976 | | Total current assets | $1,377,863 | $1,411,818 | | Intangible assets, net | $890,423 | $1,096,093 | | Total assets | $3,472,569 | $3,799,341 | | Long-term debt, net | $2,386,004 | $2,591,981 | | Total liabilities | $3,411,265 | $3,590,413 | | Total stockholders' equity | $20,011 | $183,979 | [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In 2023, Amneal generated $345.6 million in net cash from operating activities, a significant improvement from the prior year, with cash used in investing and financing activities, resulting in a net increase in cash and equivalents to $99.1 million by year-end Full Year Cash Flow Summary (in thousands) | Cash Flow Activity | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Net cash provided by operating activities | $345,577 | $65,100 | | Net cash used in investing activities | $(69,189) | $(174,309) | | Net cash used in financing activities | $(212,573) | $(106,620) | | Net increase (decrease) in cash | $63,880 | $(221,512) | | Cash, cash equivalents, and restricted cash - end of period | $99,107 | $35,227 | [Reconciliation of GAAP to Non-GAAP Financial Measures](index=9&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Financial%20Measures) [Reconciliation of Net Loss to EBITDA and Adjusted EBITDA](index=9&type=section&id=Reconciliation%20of%20Net%20Loss%20to%20EBITDA%20and%20Adjusted%20EBITDA) For the full year 2023, Amneal reconciled its GAAP Net Loss of $48.7 million to a non-GAAP Adjusted EBITDA of $558.2 million, primarily by adding back non-cash and non-recurring items such as depreciation, amortization, interest expense, asset impairment charges, and refinancing losses FY 2023 Reconciliation of Net Loss to Adjusted EBITDA (in thousands) | Item | Amount | | :--- | :--- | | Net loss | $(48,722) | | Interest expense, net | $210,629 | | Provision for income taxes | $8,452 | | Depreciation and amortization | $229,400 | | **EBITDA (Non-GAAP)** | **$399,759** | | Key Adjustments (e.g., Stock comp, Legal, Impairments) | $158,455 | | **Adjusted EBITDA (Non-GAAP)** | **$558,214** | [Reconciliation of Net Loss to Adjusted Net Income and Adjusted Diluted EPS](index=10&type=section&id=Reconciliation%20of%20Net%20Loss%20to%20Adjusted%20Net%20Income%20and%20Adjusted%20Diluted%20EPS) For the full year 2023, the company's GAAP Net Loss of $48.7 million was adjusted to a non-GAAP Adjusted Net Income of $197.6 million, resulting in an Adjusted Diluted EPS of $0.64, driven by significant positive adjustments for amortization, asset impairment charges, and loss on refinancing, partially offset by a non-GAAP provision for income taxes FY 2023 Reconciliation of Net Loss to Adjusted Net Income (in thousands) | Item | Amount | | :--- | :--- | | Net loss | $(48,722) | | Amortization | $157,219 | | Asset impairment charges | $70,015 | | Loss on refinancing | $40,805 | | Provision for income taxes (Non-GAAP) | $(60,014) | | Net income attributable to non-controlling interests | $(29,873) | | Other Adjustments | $68,125 | | **Adjusted net income (Non-GAAP)** | **$197,555** | - The Adjusted Diluted EPS of **$0.64** was calculated using a non-GAAP weighted average of **310,234 thousand** diluted shares outstanding[23](index=23&type=chunk) [Segment Performance Analysis](index=12&type=section&id=Segment%20Performance%20Analysis) [Generics Segment](index=12&type=section&id=Generics%20Segment) The Generics segment's full-year 2023 net revenue increased modestly to $1.47 billion, with a slight decrease in non-GAAP gross margin but an improvement in non-GAAP operating income, though Q4 2023 revenue declined year-over-year Generics Segment Full Year Performance | Metric | FY 2023 | FY 2022 | | :--- | :--- | :--- | | Net Revenue | $1,471.4M | $1,432.1M | | Non-GAAP Gross Margin | 41.7% | 42.3% | | Non-GAAP Operating Income | $379.1M | $343.3M | - In Q4 2023, the Generics segment experienced a year-over-year revenue decline, reporting **$363.0 million** compared to **$399.2 million** in Q4 2022[30](index=30&type=chunk) [Specialty Segment](index=15&type=section&id=Specialty%20Segment) The Specialty segment reported increased full-year 2023 net revenue of $390.5 million, maintaining a high non-GAAP gross margin and improving non-GAAP operating income, despite a slight decrease in Q4 2023 operating income due to higher costs relative to revenue Specialty Segment Full Year Performance | Metric | FY 2023 | FY 2022 | | :--- | :--- | :--- | | Net Revenue | $390.5M | $374.1M | | Non-GAAP Gross Margin | 80.4% | 81.6% | | Non-GAAP Operating Income | $196.5M | $189.3M | - For Q4 2023, non-GAAP operating income was **$53.2 million**, down from **$59.6 million** in Q4 2022, primarily due to higher cost of goods sold and operating expenses relative to revenue[37](index=37&type=chunk) [AvKARE Segment](index=17&type=section&id=AvKARE%20Segment) The AvKARE segment demonstrated robust growth in 2023, with full-year net revenue surging to $531.7 million and gross margin expanding, leading to a more than doubling of non-GAAP operating income, a trend that continued into Q4 2023 AvKARE Segment Full Year Performance | Metric | FY 2023 | FY 2022 | | :--- | :--- | :--- | | Net Revenue | $531.7M | $406.1M | | Gross Margin | 16.3% | 14.0% | | Non-GAAP Operating Income | $46.9M | $22.6M | - The growth momentum continued in Q4 2023, with revenue increasing to **$149.5 million** from **$108.0 million** in Q4 2022[44](index=44&type=chunk)
Amneal Pharmaceuticals(AMRX) - 2023 Q3 - Quarterly Report
2023-11-08 23:51
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38485 Amneal Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 32-0546926 (State or other jurisdict ...
Amneal Pharmaceuticals(AMRX) - 2023 Q3 - Earnings Call Transcript
2023-11-07 20:19
Amneal Pharmaceuticals, Inc. (NYSE:AMRX) Q3 2023 Earnings Conference Call November 7, 2023 8:30 AM ET Company Participants Anthony DiMeo - Head-Investor Relations Chirag Patel - Co-Founder & Co-Chief Executive Officer Chintu Patel - Co-Founder & Co-Chief Executive Officer Tasos Konidaris - Chief Financial Officer Joe Renda - Senior Vice President & Chief Commercial Officer-Specialty Harsher Singh - Senior Vice President-Biosciences Conference Call Participants Leszek Sulewski - Truist Balaji Prasad - Barcla ...
Amneal Pharmaceuticals(AMRX) - 2023 Q3 - Earnings Call Presentation
2023-11-07 15:55
Q3 2023 Earnings Call November 7, 2023 Cautionary Statement on Forward Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including among other things: discussions of future operations, including internati ...
Amneal Pharmaceuticals(AMRX) - 2023 Q2 - Quarterly Report
2023-08-08 20:54
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38485 Amneal Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 32-0546926 (State or other jurisdiction o ...