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Halozyme Announces FDA Approval of Bristol Myers Squibb's Opdivo Qvantig™ with ENHANZE® for Subcutaneous Use in Most Previously Approved Adult Solid Tumor Opdivo® (nivolumab) Indications
Prnewswire· 2024-12-30 11:30
Core Insights - Halozyme Therapeutics announced FDA approval for Opdivo Qvantig, the first subcutaneously administered PD-1 inhibitor, co-formulated with Halozyme's ENHANZE drug delivery technology [1][3][13] Group 1: Product Efficacy and Approval - Opdivo Qvantig demonstrated consistent efficacy and a comparable safety profile to IV Opdivo in the Phase 3 CheckMate-67T trial [1][3] - The trial showed noninferiority for co-primary endpoints: time-averaged concentration over 28 days (Cavgd28) with a geometric mean ratio (GMR) of 2.10 (90% CI: 2.00-2.20) and minimum concentration at steady state (Cminss) with a GMR of 1.77 (90% CI: 1.63-1.93) [3] - The overall response rate (ORR) for Opdivo Qvantig was 24% (95% CI: 19-30) compared to 18% (95% CI: 14-24) for IV Opdivo [3] Group 2: Administration and Patient Experience - Subcutaneous administration of Opdivo Qvantig is faster, taking three to five minutes compared to 30 minutes for IV Opdivo, potentially offering greater flexibility for patients [2][5] - The approval represents Halozyme's ninth co-formulated product, showcasing the effectiveness of the ENHANZE technology in improving patient experiences [3][6] Group 3: Safety Profile - Serious adverse reactions occurred in 28% of patients receiving Opdivo Qvantig, with the most frequent being pleural effusion and pneumonitis, each at 1.6% [4] - Common adverse reactions reported in ≥10% of patients included fatigue (20%), musculoskeletal pain (31%), and rash (15%) [4] - Fatal adverse reactions occurred in 1.2% of patients, including myocarditis and colitis complications, with 10% of patients discontinuing therapy due to adverse reactions [4]
3 Reasons Growth Investors Will Love Halozyme Therapeutics (HALO)
ZACKS· 2024-12-23 18:46
Growth stocks are attractive to many investors, as above-average financial growth helps these stocks easily grab the market's attention and produce exceptional returns. However, it isn't easy to find a great growth stock.In addition to volatility, these stocks carry above-average risk by their very nature. Also, one could end up losing from a stock whose growth story is actually over or nearing its end.However, it's pretty easy to find cutting-edge growth stocks with the help of the Zacks Growth Style Score ...
HALO or FOLD: Which Is the Better Value Stock Right Now?
ZACKS· 2024-12-23 17:46
Investors interested in stocks from the Medical - Biomedical and Genetics sector have probably already heard of Halozyme Therapeutics (HALO) and Amicus Therapeutics (FOLD) . But which of these two companies is the best option for those looking for undervalued stocks? Let's take a closer look.Everyone has their own methods for finding great value opportunities, but our model includes pairing an impressive grade in the Value category of our Style Scores system with a strong Zacks Rank. The Zacks Rank favors s ...
How Much Upside is Left in Halozyme Therapeutics (HALO)? Wall Street Analysts Think 27.08%
ZACKS· 2024-12-16 15:57
Core Viewpoint - Halozyme Therapeutics (HALO) shares have increased by 5.2% recently, with analysts suggesting a potential upside of 27.1% based on a mean price target of $61 [1][9]. Price Targets and Analyst Estimates - The mean estimate for HALO comprises 10 short-term price targets, with a standard deviation of $7.94, indicating variability among analysts [2]. - The lowest price target is $49, suggesting a 2.1% increase, while the highest target is $73, indicating a potential surge of 52.1% [2]. - A low standard deviation among price targets suggests strong agreement among analysts regarding the stock's price movement [7]. Earnings Estimates and Analyst Sentiment - Analysts have shown growing optimism regarding HALO's earnings prospects, as indicated by upward revisions in EPS estimates [9]. - The Zacks Consensus Estimate for the current year has increased by 1.2% over the past month, with one estimate rising and no negative revisions [10]. - HALO currently holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [11]. Reliability of Price Targets - While price targets are commonly referenced by investors, their reliability as indicators of stock price direction is often questioned [5][6]. - Analysts may set overly optimistic price targets due to business incentives, which can lead to inflated estimates [6]. - Despite skepticism towards price targets, the direction they imply can serve as a useful guide for further research [12].
Here is Why Growth Investors Should Buy Halozyme Therapeutics (HALO) Now
ZACKS· 2024-12-05 18:46
Core Viewpoint - Investors are increasingly seeking growth stocks that demonstrate above-average growth potential, with Halozyme Therapeutics (HALO) currently highlighted as a strong candidate due to its favorable growth metrics and Zacks Rank [1][2]. Earnings Growth - Halozyme Therapeutics has a historical EPS growth rate of 49.5%, with projected EPS growth of 46.3% for the current year, significantly outperforming the industry average of 23.4% [4]. Cash Flow Growth - The company exhibits a year-over-year cash flow growth of 19.7%, which is notably higher than the industry average of -2.5%. Additionally, its annualized cash flow growth rate over the past 3-5 years stands at 48.7%, compared to the industry average of 3.3% [5][6]. Earnings Estimate Revisions - There has been a positive trend in earnings estimate revisions for Halozyme Therapeutics, with the current-year earnings estimates increasing by 1.2% over the past month, indicating strong near-term stock price movement potential [7][9]. Overall Positioning - Halozyme Therapeutics holds a Zacks Rank of 2 (Buy) and a Growth Score of B, positioning it well for potential outperformance in the growth stock category [9][10].
HALO Withdraws Acquisition Bid for EVO, Reaffirms '24 View, Stock Up
ZACKS· 2024-11-25 16:40
Core Viewpoint - Halozyme Therapeutics, Inc. has withdrawn its non-binding proposal to acquire Evotec SE due to Evotec's management's unwillingness to discuss the offer, which was valued at €2.0 billion [1][5]. Group 1: Acquisition Proposal - Halozyme's acquisition offer was €11.00 per share in cash, representing a 109% premium over Evotec's undisturbed share price on October 15, 2024 [3]. - The acquisition was expected to create a global services company with complementary technologies and an innovative pipeline, potentially diversifying Halozyme's operations and extending revenues and EBITDA into the next decade [4]. Group 2: Financial Guidance - Halozyme reaffirmed its 2024 revenue guidance, expecting total revenues between $970 million and $1.02 billion, indicating a year-over-year growth of 13-22% [7]. - Royalty revenues are anticipated to be in the range of $550-$565 million, with adjusted EBITDA expected between $595 million and $625 million, reflecting a growth of 40% to 47% year over year [8]. - The company projects adjusted earnings per share between $4.00 and $4.20, indicating an improvement of 44-52% year over year [8]. Group 3: Stock Performance - Following the announcement of the acquisition withdrawal, shares of Halozyme increased by 7.2% on November 22, and the stock has rallied 32.6% year-to-date, contrasting with an industry decline of 8.5% [2].
Halozyme Therapeutics (HALO) Upgraded to Buy: Here's Why
ZACKS· 2024-11-22 18:05
Core Viewpoint - Halozyme Therapeutics (HALO) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in stock price movements [4]. Company Performance and Outlook - For the fiscal year ending December 2024, Halozyme Therapeutics is projected to earn $4 per share, reflecting a 44.4% increase from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for Halozyme has risen by 2.5%, indicating a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks based on earnings estimate revisions, with only the top 20% of stocks receiving a 'Strong Buy' or 'Buy' rating, suggesting superior potential for market-beating returns [9][10]. - Halozyme's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong likelihood of stock price appreciation in the near term [11].
Halozyme Withdraws Proposal to Acquire Evotec Following Evotec's Unwillingness to Engage in Discussions
Prnewswire· 2024-11-22 13:35
Core Viewpoint - Halozyme Therapeutics has withdrawn its non-binding proposal to acquire Evotec SE for €11.00 per share, which would have implied a fully diluted equity value of €2.0 billion, due to Evotec's unwillingness to engage in discussions about a potential combination [1][2]. Group 1: Acquisition Proposal - Halozyme's CEO stated that a combination with Evotec would create a leading global pharma services company, benefiting shareholders, patients, and employees [2]. - Despite extensive external diligence and attempts to engage with Evotec's management, Halozyme faced repeated refusals to discuss the potential transaction [3]. - The formal proposal was made to convey strong interest in exploring a transaction, but it became clear that Evotec's boards were not interested in constructive engagement [3]. Group 2: Company Outlook - Halozyme remains focused on improving patient treatment experiences and is confident in its future, with a strategy aimed at achieving 10 approved products with ENHANZE® by 2025 and $1 billion in royalty revenue by 2027 [4]. - The company has reiterated its 2024 revenue guidance of $970-$1,020 million and adjusted EBITDA of $595-$625 million, indicating significant double-digit growth [4]. Group 3: Company Profile - Halozyme is a biopharmaceutical company known for its ENHANZE® drug delivery technology, which facilitates subcutaneous delivery of drugs, improving patient experience [5]. - The company has impacted over 800,000 patients through its commercialized products and has partnered with major pharmaceutical companies like Roche, Takeda, and Pfizer [5]. - Halozyme also develops drug-device combination products aimed at enhancing patient comfort and adherence [6].
3 Reasons Why Growth Investors Shouldn't Overlook Halozyme Therapeutics (HALO)
ZACKS· 2024-11-19 18:46
Growth investors focus on stocks that are seeing above-average financial growth, as this feature helps these securities garner the market's attention and deliver solid returns. But finding a growth stock that can live up to its true potential can be a tough task.By their very nature, these stocks carry above-average risk and volatility. Moreover, if a company's growth story is over or nearing its end, betting on it could lead to significant loss.However, the Zacks Growth Style Score (part of the Zacks Style ...
HALO vs. FOLD: Which Stock Should Value Investors Buy Now?
ZACKS· 2024-11-19 17:40
Core Insights - Halozyme Therapeutics (HALO) is currently viewed as a stronger investment option compared to Amicus Therapeutics (FOLD) for those seeking undervalued stocks [1][3][7] Valuation Metrics - HALO has a forward P/E ratio of 10.63, significantly lower than FOLD's forward P/E of 42.62, indicating HALO may be undervalued [5] - The PEG ratio for HALO is 0.37, while FOLD's PEG ratio is 0.94, suggesting HALO has better expected earnings growth relative to its price [5] - HALO's P/B ratio stands at 11.96 compared to FOLD's 16.14, further supporting HALO's valuation advantage [6] Zacks Rank and Value Grades - HALO holds a Zacks Rank of 2 (Buy), indicating a stronger earnings outlook, while FOLD has a Zacks Rank of 3 (Hold) [3][7] - Based on valuation metrics, HALO has earned a Value grade of A, whereas FOLD has a Value grade of D, highlighting HALO's superior value proposition [6]