Alnylam Pharmaceuticals (ALNY) came out with quarterly earnings of $0.56 per share, beating the Zacks Consensus Estimate of a loss of $0.74 per share. This compares to loss of $2.21 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 175.68%. A quarter ago, it was expected that this RNA interference drug developer would post a loss of $0.75 per share when it actually produced a loss of $0.16, delivering a surprise of 78.67%.Over t ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS%20%28Unaudited%29) Alnylam Pharmaceuticals' unaudited financial statements for Q2 2024 show increased assets and revenues, a narrowed net loss, and positive operating cash flow [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2024, reflects an increase in total assets and a significant improvement in stockholders' deficit Balance Sheet Items (In thousands) | Balance Sheet Items (In thousands) | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $968,492 | $812,688 | | Total current assets | $3,172,856 | $2,982,697 | | **Total assets** | **$4,009,634** | **$3,829,880** | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $1,055,251 | $967,786 | | **Total liabilities** | **$4,012,701** | **$4,050,524** | | **Total stockholders' deficit** | **$(3,067)** | **$(220,644)** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The statements of operations show a substantial increase in revenues and a significant reduction in net loss for both the quarter and six-month periods ended June 30, 2024 Statement of Operations (In thousands) | Statement of Operations (In thousands) | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | **Total revenues** | **$659,825** | **$318,754** | **$1,154,158** | **$638,044** | | Net product revenues | $410,088 | $305,705 | $775,251 | $582,033 | | Net revenues from collaborations | $227,338 | $5,844 | $345,886 | $42,306 | | Income (loss) from operations | $48,614 | $(229,831) | $5,179 | $(379,638) | | **Net loss** | **$(16,889)** | **$(276,024)** | **$(82,824)** | **$(450,125)** | | Net loss per common share | $(0.13) | $(2.21) | $(0.66) | $(3.62) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow statements for the first half of 2024 indicate a positive shift in operating cash flow and an overall net increase in cash and equivalents Cash Flow Activities (In thousands) | Cash Flow Activities (In thousands) | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $42,643 | $(225,461) | | Net cash used in investing activities | $(33,680) | $(84,930) | | Net cash provided by financing activities | $160,407 | $99,765 | | **Net increase (decrease) in cash** | **$156,309** | **$(208,580)** | | Cash, cash equivalents and restricted cash, end of period | $971,193 | $659,976 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes provide detailed insights into revenue drivers, significant liabilities, and ongoing patent infringement litigation - The company's strategy, **Alnylam Px25**, aims to transition it to a **top-tier biotech company** by the end of 2025 by delivering transformative medicines and achieving **strong financial performance**[29](index=29&type=chunk) Net Product Revenues (Six Months Ended June 30, In thousands) | Net Product Revenues (Six Months Ended June 30, In thousands) | 2024 | 2023 | | :--- | :--- | :--- | | ONPATTRO | $146,461 | $193,951 | | AMVUTTRA | $425,350 | $233,904 | | GIVLAARI | $120,183 | $105,805 | | OXLUMO | $83,257 | $48,373 | | **Total** | **$775,251** | **$582,033** | Net Revenues from Collaborations (Six Months Ended June 30, In thousands) | Net Revenues from Collaborations (Six Months Ended June 30, In thousands) | 2024 | 2023 | | :--- | :--- | :--- | | Roche | $91,186 | $— | | Regeneron Pharmaceuticals | $234,193 | $17,153 | | Novartis AG | $16,820 | $23,560 | | **Total** | **$345,886** | **$42,306** | - In June 2024, the company amended its agreement with Regeneron, granting a worldwide license for cemdisiran as a monotherapy, which resulted in the immediate recognition of **$191.5 million** in revenue[56](index=56&type=chunk)[61](index=61&type=chunk) - The company has filed **patent infringement lawsuits** against Pfizer/BioNTech and Moderna related to their mRNA COVID-19 vaccines, seeking damages, and these cases are ongoing[105](index=105&type=chunk)[106](index=106&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the significant revenue growth, controlled expense increases, narrowed net loss, and strong liquidity position for the first half of 2024 [Overview](index=28&type=section&id=Overview) This section provides an overview of Alnylam's focus on RNAi therapeutics, its strategic goals, commercialized products, and recent positive clinical trial results - The company's **Alnylam Px25 strategy**, launched in 2021, focuses on transitioning to a **top-tier biotech company** by the end of 2025 through sustainable innovation and strong financial performance[110](index=110&type=chunk) - **Positive topline results** from the **HELIOS-B trial** of **vutrisiran** in patients with **ATTR amyloidosis with cardiomyopathy** were reported in June 2024, with plans for global regulatory filings later in the year[110](index=110&type=chunk) [Our Product Pipeline](index=30&type=section&id=Our%20Product%20Pipeline) The company maintains a robust product pipeline spanning commercial products and numerous clinical programs, with recent positive data readouts and regulatory advancements - The pipeline features **five commercial products** and a **broad range of clinical programs** across rare, specialty, and prevalent diseases[115](index=115&type=chunk) - Recent **positive data readouts** include the **HELIOS-B Phase 3 study** for vutrisiran and the **KARDIA-2 Phase 2 study** for zilebesiran[122](index=122&type=chunk) - Collaboration partner **Sanofi** has submitted **regulatory filings** for **fitusiran** in China, Brazil, and the U.S., with a U.S. FDA target action date of March 28, 2025[122](index=122&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Operating results for the first half of 2024 show substantial revenue growth, particularly from collaborations, alongside increased operating expenses and a significantly reduced net loss Financial Performance (Six Months Ended June 30, in thousands) | Financial Performance (Six Months Ended June 30) | 2024 (in thousands) | 2023 (in thousands) | % Change | | :--- | :--- | :--- | :--- | | **Total revenues** | **$1,154,158** | **$638,044** | **81%** | | Net product revenues | $775,251 | $582,033 | 33% | | Net revenues from collaborations | $345,886 | $42,306 | >500% | | **Total operating costs and expenses** | **$1,148,979** | **$1,017,682** | **13%** | | Research and development | $555,137 | $479,095 | 16% | | Selling, general and administrative | $459,194 | $398,348 | 15% | | **Net loss** | **$(82,824)** | **$(450,125)** | **(82)%** | - The increase in collaboration revenue was primarily driven by the modification of the Regeneron agreement, which resulted in the immediate recognition of **$191.5 million** for the cemdisiran monotherapy license[134](index=134&type=chunk) - **R&D expenses increased** due to costs for preclinical activities, clinical trials for zilebesiran (KARDIA-3) and mivelsiran (cAPPRicorn-1), and expenses related to the HELIOS-B trial data readout[141](index=141&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity position is strong, with sufficient cash to fund operations and achieve self-sustainability without future equity financing, supported by positive operating cash flow - The company believes its current cash position will be sufficient to achieve a **self-sustainable profile** without the need for **future equity financing**[151](index=151&type=chunk) Cash Flow Summary (Six Months Ended June 30, In thousands) | Cash Flow Summary (Six Months Ended June 30, In thousands) | 2024 | 2023 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $42,643 | $(225,461) | | Net cash used in investing activities | $(33,680) | $(84,930) | | Net cash provided by financing activities | $160,407 | $99,765 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) There have been no significant changes to the company's financial market risk exposures, primarily related to interest rates, since the prior fiscal year-end - There have been **no significant changes** to the company's financial market risk exposures, which are mainly related to **interest rates**, since December 31, 2023[152](index=152&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls and procedures were effective as of June 30, 2024, with no material changes to internal control over financial reporting - As of June 30, 2024, the CEO and CFO concluded that the company's disclosure controls and procedures were **effective**[153](index=153&type=chunk) - **No material changes** were made to the internal control over financial reporting during the quarter ended June 30, 2024[154](index=154&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=41&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) This section refers to Note 13 for details on material pending legal proceedings, primarily patent infringement lawsuits against Pfizer and Moderna - For details on legal proceedings, the report refers to Note 13, which discusses ongoing **patent infringement lawsuits** against Pfizer and Moderna[156](index=156&type=chunk) [Item 1A. Risk Factors](index=41&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company faces diverse risks including financial performance, operational dependencies, clinical and regulatory challenges, intellectual property disputes, and market competition - Key business risks include the unsuccessful marketing of approved products, a history of financial losses (**$7.09 billion accumulated deficit** as of June 30, 2024), and the need for substantial future funding[158](index=158&type=chunk)[169](index=169&type=chunk) - The company is **highly dependent on third parties** for collaborations (e.g., Roche, Regeneron, Novartis), manufacturing, and conducting clinical trials, and failure by these parties could delay or terminate programs[158](index=158&type=chunk)[178](index=178&type=chunk) - Significant industry risks include potential **clinical trial failures**, inability to obtain **regulatory approval** (as exemplified by the FDA's CRL for patisiran for cardiomyopathy), ongoing regulatory oversight, and **unfavorable pricing regulations** or healthcare reforms like the Inflation Reduction Act[159](index=159&type=chunk)[190](index=190&type=chunk)[199](index=199&type=chunk) - **Intellectual property** is a major risk area, with potential for **patent challenges**, **litigation costs** (including ongoing lawsuits against Pfizer and Moderna), and the need to license third-party patents[163](index=163&type=chunk)[221](index=221&type=chunk) - The company faces **intense competition** from existing drugs and new technologies, including other RNAi and antisense therapies, which could render its products obsolete or noncompetitive[164](index=164&type=chunk)[226](index=226&type=chunk) [Item 5. Other Information](index=76&type=section&id=ITEM%205.%20OTHER%20INFORMATION) This section discloses executive Rule 10b5-1 trading plans and corrects the deadlines for stockholder proposals for the 2025 annual meeting - Executive Vice President Kevin Fitzgerald and Director Dennis A. Ausiello entered into **Rule 10b5-1 trading plans** in May 2024 for the potential sale of company stock[239](index=239&type=chunk)[240](index=240&type=chunk)[241](index=241&type=chunk) - The company **corrected the deadlines** for **stockholder proposals** for the 2025 annual meeting: proposals for inclusion in proxy materials are due by December 2, 2024, and other business must be noticed between January 16, 2025, and February 15, 2025[242](index=242&type=chunk)[243](index=243&type=chunk) [Item 6. Exhibits](index=77&type=section&id=ITEM%206.%20EXHIBITS) This section lists the exhibits filed with the Form 10-Q, including stock award agreements and required officer certifications - Exhibits filed include forms of **Performance Stock Unit**, **Restricted Stock Unit**, and **Nonstatutory Stock Option agreements**, as well as required **CEO and CFO certifications**[245](index=245&type=chunk)

Wall Street analysts forecast that Alnylam Pharmaceuticals (ALNY) will report quarterly loss of $0.71 per share in its upcoming release, pointing to a year-over-year increase of 67.9%. It is anticipated that revenues will amount to $452.73 million, exhibiting an increase of 42% compared to the year-ago quarter.The current level reflects an upward revision of 2.4% in the consensus EPS estimate for the quarter over the past 30 days. This demonstrates how the analysts covering the stock have collectively reapp ...

Alnylam Pharmaceuticals (ALNY) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2024. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on ...

Biopharmaceutical stock Alnylam Pharmaceuticals (NASDAQ:ALNY) is riding a tsunami of hope that a treatment for a rare heart condition receives Food & Drug Administration approval. Although it has several drugs already on the market, the biopharma is not yet profitable.But if Alnylam can gain expedited approval from the FDA for its RNA interference drug vutrisiran, that could change quickly. Alnylam stock soared 31% on positive Phase 3 trial news and continued rising afterward. Getting vutrisiran, which is m ...

Could Alnylam Pharmaceuticals (NASDAQ:ALNY) become a household name in 2024? At the very least, the company should be well known in the medical community. If you like to wager small amounts of money on biotechnology stocks, then you really ought to consider Alnylam Pharmaceuticals stock.As we’ll discuss in a moment, Alnylam Pharmaceuticals didn’t start off 2024 with perfect financials. However, a recent announcement indicates a breakthrough moment for Alnylam Pharmaceuticals and, potentially, for some heart ...

Intuitively, the case for biotechnology-related investments comes across rather obviously: the concept of healthcare should be a permanent one. And because of this permanence, the expected market value of the ecosystem should be massive. Grand View Research estimates that it would be worth $3.88 trillion by 2030. Still, the opportunistic investor may want to consider cheap biotech stocks.It comes down to adding more pieces on the table. You can always elect the high-flying names that command rich multiple p ...

UKRAINE - 2021/05/27: In this photo illustration, the Alnylam Pharmaceuticals logo seen on a ... [+] smartphone and a pc screen. (Photo Illustration by Pavlo Gonchar/SOPA Images/LightRocket via Getty Images)SOPA Images/LightRocket via Getty ImagesAlnylam Pharmaceuticals stock (NASDAQ: ALNY), a pharmaceutical company focused on RNA interference therapeutics for genetically defined diseases, has seen a significant rise of 60% in a week. This can be attributed to positive data from a late-stage clinical trial ...

Core Viewpoint - Alnylam Pharmaceuticals achieved a new 52-week high following positive results from the phase III HELIOS-B study of Amvuttra (vutrisiran), leading to a 34.5% increase in stock price [1]. Group 1: Study Results - The HELIOS-B study met its primary endpoint, showing a statistically significant reduction in all-cause mortality and recurrent cardiovascular events in both the overall and monotherapy populations [2]. - Statistically significant improvements were observed across all secondary endpoints, including key measures of disease progression at Month 30 [2]. - Vutrisiran reduced all-cause mortality in both populations up to Month 42, based on a pre-specified intent-to-treat analysis [2]. Group 2: Patient Population and Safety - The study enrolled 655 adult patients with ATTR amyloidosis and cardiomyopathy, who received either vutrisiran or placebo [3]. - Vutrisiran demonstrated a favorable safety and tolerability profile, with adverse event rates similar to the placebo group [4]. Group 3: Market Potential and Financial Performance - Alnylam plans to submit global regulatory applications starting in late 2024, aiming for vutrisiran to become the new standard of care for ATTR amyloidosis with cardiomyopathy [4]. - Amvuttra generated $195 million in sales in Q1, reflecting a 92% increase, driven by new patient uptake and switches from Onpattro [5].

Key TakeawaysAlnylam Pharmaceuticals announced a Phase-3 study of its treatment for a rare heart condition showed a significant reduction in deaths and recurrent cardiovascular events.The biopharmaceutical company said it would be seeking regulatory approval later this year, including asking the Food and Drug Administration for a priority review.The news sent shares of Alnylam soaring over 31% in early trading Monday. Shares of Alnylam Pharmaceuticals (ALNY) skyrocketed over 31% in early trading Monday afte ...