Ultime notizie per Amphastar Pharma (NASDAQ:AMPH) Azioni

Amphastar Pharma

Amphastar Pharmaceuticals Inc is a biopharmaceutical company that focuses on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the company sells insulin API products. The company's finished products are used in hospital or urgent care clinical settings and are contracted and distributed through group purchasing organizations and drug wholesalers. The company has two reportable segments finished pharmaceutical products and API products. Geographically the business presence of the firm is seen in the United States, China and France of which the U.S. accounts for the majority of the revenue.

Amphastar Pharmaceuticals, Inc. - Common Stock

Amphastar Pharmaceuticals Inc

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AMPH

Amphastar Pharma shares are trading lower after the company reported worse-than-expected Q3 financial results.

News

Buybacks

Amphastar Pharmaceuticals Expands Share Buyback Program By $50M To Offset Equity Compensation Dilution, With No Set End Date

Amphastar Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMPH#NASDAQ">AMPH</a>) reported quarterly earnings of $0.96 per share which missed the analyst consensus estimate of $0.99 by 3.03 percent. The company reported quarterly sales of $191.20 million which missed the analyst consensus estimate of $194.69 million by 1.79 percent. This is a 5.90 percent increase over sales of $180.56 million the same period last year.

Earnings

Earnings Misses

Amphastar Pharma Q3 2024 Adj EPS $0.96 Misses $0.99 Estimate, Sales $191.20M Miss $194.69M Estimate

JP Morgan notes that while there&#8217;s a resurgence of interest and excitement in new product launches within the specialty group, including branded and complex generics/biosimilars, investors should be discerning about these opportunities.
The group&#8217;s core fundamentals have strengthened, buoyed by a more stable environment for generic and established brand pricing, which helps mitigate the usual erosion in base business prices.
However, growth in the overall sector remains modest, with most companies experiencing a top-line compound annual growth rate (CAGR) of 0-2%.
Additionally, valuations have recovered, with most stocks now trading near their historical averages.
JP Morgan writes that Teva Pharmaceutical Industries Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) continues to be the primary focus among investors in the group, with sentiment growing more bullish.
The analyst <a target="_blank" href="https://www.benzinga.com/quote/TEVA/analyst-ratings" rel="noreferrer noopener">maintains a Neutral rating</a>, as the market seems to have fully accounted for the company&#8217;s branded pipeline. Additionally, JP Morgan is cautious about Teva&#8217;s U.S. generic business compared to market expectations.
The analyst has given Viatris Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTRS#NASDAQ">VTRS</a>) <a target="_blank" href="https://www.benzinga.com/quote/VTRS/analyst-ratings" rel="noreferrer noopener">a Neutral rating</a>, citing its stable fundamentals and low valuation amidst uncertainties in business development.
Meanwhile, JP Morgan holds a <a target="_blank" href="https://www.benzinga.com/quote/PRGO/analyst-ratings" rel="noreferrer noopener">more optimistic view</a>, an Overweight rating on Perrigo Co plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PRGO#NYSE">PRGO</a>), noting the potential for earnings per share (EPS) to rebound to the low-mid $3 range soon due to currently low market sentiment. With shares currently trading at a significantly lower price than other consumer sector peers, the analyst believes there is substantial potential for an increase in valuation multiples as the recovery progresses.
Similarly, positive <a target="_blank" href="https://www.benzinga.com/quote/AMPH/analyst-ratings" rel="noreferrer noopener">prospects are seen</a> for Amphastar Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMPH#NASDAQ">AMPH</a>), where the analyst anticipates a promising series of catalysts leading into 2024/2025. Keeps Overweight rating.
JP Morgan is adjusting several ratings, which are relative to each other. The analyst has changed Amneal Pharmaceuticals, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMRX#NASDAQ">AMRX</a>) to <a target="_blank" href="https://www.benzinga.com/quote/AMRX/analyst-ratings" rel="noreferrer noopener">Neutral from Underweight</a> and Organon &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/OGN#NYSE">OGN</a>) to <a target="_blank" href="https://www.benzinga.com/quote/OGN/analyst-ratings" rel="noreferrer noopener">Underweight from Neutral</a>.
For Amneal, the company&#8217;s success in launching new products suggests the potential for improved financial forecasts, which could bolster the stock.
Conversely, Organon&#8217;s stock price has increased 60% year-to-date. Although its valuation still appears low, the recent price surge suggests more attractive opportunities within the sector may exist.
Price Action: OGN stock is down 2.95% at $20.73, and AMRX stock is down 1.42% at $8.33 at last check Friday.
Photo via Shutterstock
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Downgrades

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Price Target

Reiteration

Analyst Ratings

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General

AMRX

PRGO

TEVA

VTRS

JP Morgan Shows Most Interest In Teva, Organon As Specialty Pharma Sector Exhibits Signs Of Stability

Amphastar Pharmaceuticals shares are trading higher after the company reported better-than-expected Q2 financial results.

Needham analyst Serge Belanger reiterates Amphastar Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMPH#NASDAQ">AMPH</a>) with a Hold.

Needham Reiterates Hold on Amphastar Pharma

Piper Sandler analyst David Amsellem maintains Amphastar Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMPH#NASDAQ">AMPH</a>) with a Overweight and lowers the price target from $71 to $66.

Piper Sandler Maintains Overweight on Amphastar Pharma, Lowers Price Target to $66

Amphastar Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMPH#NASDAQ">AMPH</a>) reported quarterly earnings of $0.94 per share which beat the analyst consensus estimate of $0.77 by 22.08 percent. This is a 44.62 percent increase over earnings of $0.65 per share from the same period last year. The company reported quarterly sales of $182.39 million which beat the analyst consensus estimate of $170.94 million by 6.70 percent. This is a 25.17 percent increase over sales of $145.71 million the same period last year.

Earnings Beats

Amphastar Pharma Q2 Adj $0.94 Beats $0.77 Estimate, Sales $182.39M Beat $170.94M Estimate

Piper Sandler analyst David Amsellem reiterates Amphastar Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMPH#NASDAQ">AMPH</a>) with a Overweight and maintains $71 price target.

Piper Sandler Reiterates Overweight on Amphastar Pharma, Maintains $71 Price Target

Amphastar Pharmaceuticals Authorized A $50M Increase To The Company's Share Buyback Program

Amphastar Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMPH#NASDAQ">AMPH</a>) today announced that the U.S. Food and Drug Administration (&quot;FDA&quot;) has granted approval for the Company&#39;s Abbreviated New Drug Application (&quot;ANDA&quot;) for Albuterol Sulfate Inhalation Aerosol, previously known as AMP-008. This product is for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients four years of age and older. The FDA determined that Amphastar&#39;s albuterol is bioequivalent and therapeutically equivalent to Teva Respiratory LLC&#39;s ProAir&reg;&nbsp;HFA(albuterol sulfate) Inhalation Aerosol.

Government

Regulations

Amphastar Bags FDA Approval for Albuterol Sulfate Inhalation Aerosol

Amphastar Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMPH#NASDAQ">AMPH</a>) reported quarterly earnings of $1.04 per share which beat the analyst consensus estimate of $0.77 by 35.06 percent. The company reported quarterly sales of $171.800 million which missed the analyst consensus estimate of $174.713 million by 1.67 percent. This is a 22.70 percent increase over sales of $140.022 million the same period last year.

Amphastar Pharma Q1 2024 Adj EPS $1.04 Beats $0.77 Estimate, Sales $171.800M Miss $174.713M Estimate

The Federal Trade Commission (FTC) is intensifying its&nbsp;<a href="https://www.ftc.gov/news-events/news/press-releases/2024/04/ftc-expands-patent-listing-challenges-targeting-more-300-junk-listings-diabetes-weight-loss-asthma" target="_blank" rel="noreferrer noopener">efforts</a>&nbsp;to challenge numerous pharmaceutical patent listings, aiming to facilitate the availability of more affordable alternatives to brand-name drugs, including blockbusters like&nbsp;Novo Nordisk A/S&#8217;s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) Ozempic and Victoza.&nbsp;
What Happened: The FTC is disputing &#8220;junk patent listings&#8221; for diabetes, weight loss, asthma and COPD drugs.
This initiative represents the latest endeavor against what the agency perceives as patent tactics drugmakers employ to hinder generic competition.
At the center of the issue is the Orange Book, a Food and Drug Administration (FDA) publication containing patents relevant to brand-name pharmaceuticals.&nbsp;
According to a law designed to promote generics, successfully challenging listed patents can grant a period of exclusivity to generics makers before other generics are approved.&nbsp;
However, if a brand-name manufacturer decides to contest a challenge to an Orange Book patent in court, it can&nbsp;<a href="https://www.wsj.com/health/pharma/ftc-patents-ozempic-insulin-a2f5cee5" target="_blank" rel="noreferrer noopener">delay</a>&nbsp;the approval of generics for 30 months, the Wall Street Journal noted.
To promote competition, the FTC said it is disputing these patent listings as improper or inaccurate.&nbsp;
Why It Matters: Improper Orange Book patent listings can delay cheaper generic alternatives from entering the market, keeping brand-name drug prices artificially high.
In its latest move, the FTC&nbsp;<a target="_blank" href="https://www.ftc.gov/legal-library/browse/warning-letters/85231" rel="noreferrer noopener">issued</a>&nbsp;warning letters to 10 companies and notified the FDA that it disputes the accuracy or relevance of more than 300 Orange Book patent listings across 20 different brand name&nbsp;products.&nbsp;
The letters targeted what agency officials called &#8220;junk patent listings,&#8221; including Novo Nordisk&#8217;s diabetes medication Ozempic and various treatments from companies such as&nbsp;AstraZeneca Plc&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>),&nbsp;Boehringer Ingelheim and&nbsp;Novartis AG&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>).
&#8220;By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,&#8221; said FTC Chair Lina Khan. &#8220;By challenging junk patent filings, the FTC is fighting these illegal tactics and&nbsp;making sure&nbsp;that Americans can get timely access to innovative and affordable versions of the medicines they need.&#8221;
Other companies targeted include Amphastar Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMPH#NASDAQ">AMPH</a>) and Teva Pharmaceutical Industries Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>).
What Critics Say: The Wall Street Journal highlighted critics&#8217; concerns about the potential implications of the FTC&#8217;s actions, suggesting that delisted patents could increase the risk for generics entering the market, potentially leading to post-approval patent litigation. 
Additionally, some critics attribute part of the problem to the U.S. Patent and Trademark Office, accusing it of issuing flimsy or duplicative patents.
Looking ahead, the FDA has promised new guidance this year to provide companies with further instructions on which patents to list in the Orange Book.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo: i yunmai on Unsplash

Federal Trade Commission Targets 'Junk Patent Listings' For Diabetes, Weight Loss, Asthma Drugs From Companies Like Novo Nordisk, AstraZeneca

At the Needham Healthcare Conference,&nbsp;Amphastar Pharmaceuticals Inc&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMPH#NASDAQ">AMPH</a>) highlighted why they remain excited about Baqsimi, the inhaled glucagon&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/04/31954035/eli-lilly-divests-low-blood-sugar-drug-baqsimi-to-amphastar-for-500m-cash" rel="noreferrer noopener">product for severe hypoglycemia</a>.&nbsp;
Amphastar Pharmaceuticals develops, manufactures, markets, and sells generic and proprietary injectable, inhalation, and intranasal products.
Needham&nbsp;says the company still believes Baqsimi is the best glucagon product based on its expertise, which is difficult to genericize, and its IP that goes to 2036.
Needham notes that the market opportunity for Baqsimi is promising because only a small fraction of insulin users currently receive a prescription for glucagon to manage emergency hypoglycemia.&nbsp;
There&#8217;s a widespread recommendation among doctors and guidelines that all insulin users should have access to a glucagon product, akin to an Epipen, for diabetic emergencies.&nbsp;
Baqsimi is projected to reach peak sales of $250-270 million, a significant increase from $153 million in 2023.&nbsp;
These sales estimates might be conservative, especially if the market expands, as Baqsimi currently faces competition primarily from Gvoke, another injectable glucagon product.
In 2024, Amphastar Pharmaceuticals anticipates Baqsimi&#8217;s inaugural full-year performance to be fueled by a modest increase in product units sold, coupled with a slight decrease in prices due to elevated wholesaler fees compared to those paid by&nbsp;Eli Lilly And Co&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>).
In anticipation of competitors re-entering the market by the second half of 2024 and 2025, Amphastar Pharmaceuticals foresees new opportunities emerging despite potential shortages.&nbsp;
Amphastar Pharmaceuticals is keen on exploring business development prospects, particularly in the endocrinology sector, to expand its product portfolio by leveraging Baqsimi&#8217;s commercial infrastructure. With $300 million in cash reserves and strong cash flow, Amphastar Pharmaceuticals is inclined towards debt financing for potential asset acquisitions.
Needham&nbsp;<a target="_blank" href="https://www.benzinga.com/quote/AMPH/analyst-ratings" rel="noreferrer noopener">keeps the Hold rating</a>&nbsp;for Amphastar Pharmaceuticals.
Price Action:&nbsp;AMPH shares are down 2.33% at $39.95 on the last check Wednesday.

Amphastar Pharmaceuticals Interested In Potential Acquisitions In Endocrinology-Focused Companies

JP Morgan analyst Ekaterina Knyazkova initiates coverage on Amphastar Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMPH#NASDAQ">AMPH</a>) with a Overweight rating and announces Price Target of $60.

Initiation

JP Morgan Initiates Coverage On Amphastar Pharma with Overweight Rating, Announces Price Target of $60

Amphastar Pharmaceuticals shares are trading lower after the company reported mixed Q4 financial results.

Organon downgraded, Amneal upgraded as J.P. Morgan reviews specialty pharma

Amphastar: Perplexing Pipeline, Lumpy Revenues - I'm On Sidelines

Amphastar Pharmaceuticals Offers Interesting Growth And Income Prospects

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Analyst Tim Chiang of Capital One Financial assigned a Buy rating on Amphastar Pharmaceuticals (AMPH – Research Report), with a price target of $70...

Amphastar Pharmaceuticals: Strong Product Pipeline and Financial Position Justify Buy Rating

Amphastar: Objectively Undervalued But For Good Reason (Rating Downgrade)

Here are the major earnings after the close today

Amphastar Pharmaceuticals Non-GAAP EPS of $0.96 misses by $0.02, revenue of $191.2M misses by $3.49M

Amphastar Pharmaceuticals Inc. (AMPH) Q3 2024 Earnings Call Transcript

Amphastar Pharmaceuticals Inc ( ($AMPH) ) has released its Q3 earnings. Here is a breakdown of the information Amphastar Pharmaceuticals Inc presen...

Amphastar Pharmaceuticals Reports Strong Q3 2024 Results

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Legal

Press Releases

Amphastar Receives FDA Approval for Albuterol Sulfate Inhalation Aerosol

Events

Amphastar Pharmaceuticals to Present at the Jefferies Global Healthcare Conference

Amphastar Announces Additional $50 Million Increase to its Share Buyback Program

Opinion

BetterInvesting™ Magazine Update on Amphastar Pharmaceuticals Inc. and Medtronic PLC

Amphastar Pharmaceuticals to Release Second Quarter Earnings and Hold Conference Call on August 7, 2024

Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended June 30, 2024

Amphastar Pharmaceuticals to Present at the 2024 Wells Fargo Healthcare Conference

Amphastar Pharmaceuticals to Release Third Quarter Earnings and Hold Conference Call on November 6, 2024

Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended September 30, 2024

Amphastar Pharmaceuticals to Present at the Jefferies London Healthcare Conference

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