ANI Pharmaceuticals Reports Record First Quarter 2025 Financial Results and Raises 2025 Guidance

 

• Generated record quarterly net revenues of $197.1 million, representing year-over-year growth of 43.4%
• Total Rare Disease quarterly net revenues of $69.0 million, which includes:
  • Purified Cortrophin® Gel net revenues of $52.9 million, an increase of 43.1% year-over-year, and
  • ILUVIEN® and YUTIQ® net revenues of $16.1 million
• Record Generics net revenues of $98.7 million, an increase of 40.5% year-over-year
• Delivered record quarterly adjusted non-GAAP EBITDA of $50.7 million, an increase of 34.9% year-over-year
• Diluted GAAP income per share of $0.69 and record adjusted non-GAAP diluted earnings per share of $1.70
• Increased 2025 guidance with expected net revenues of $768.0 million to $793.0 million, adjusted non-GAAP EBITDA of $195.0 million to $205.0 million, and adjusted non-GAAP diluted earnings per share of $6.27 to $6.62
• Rare Disease net revenues expected to represent 47% to 48% of total Company net revenues in 2025, including:
• Purified Cortrophin Gel net revenues of $265.0 million to $274.0 million, representing year-over-year growth of 33.8% to 38.3%, and
• ILUVIEN and YUTIQ net revenues of $97.0 million to $103.0 million

https://www.globenewswire.com/news-release/2025/05/09/3078088/0/en/ANI-Pharmaceuticals-Reports-Record-First-Quarter-2025-Financial-Results-and-Raises-2025-Guidance.html

Pharma still in waiting mode after UK-US trade agreement

 Hopes that the UK-US trade agreement would give some clarity on the situation for pharmaceuticals – one of the UK's biggest export categories – proved optimistic.

While the UK is the first country to announce a deal with the US since Donald Trump announced his tariffs in April, it has fallen short of the "full and comprehensive" agreement billed by the President ahead of its unveiling.

Pharma was not mentioned at all as Trump and UK Prime Minister Keir Starmer unveiled the 'agreement in principle', as it was described by the office of the US Trade Representative (USTR). It focused mainly on the car industry, which saw US tariffs fall from 27.5% to a blanket levy of 10%, while those on steel and aluminium fell to zero.

Trump has not announced any tariffs on medicines yet, so it was likely optimistic to think the pharma industry could be in the scope of a deal at this stage. In a statement, the UK government said that "work will continue on the remaining sectors – such as pharmaceuticals and remaining reciprocal tariffs."

Preferential treatment on pharma?

Moreover, Downing Street has indicated that the UK will receive "preferential treatment in any further tariffs imposed" as part of the US Department of Commerce's ongoing Section 232 investigation into pharma, which is viewed as the first stage before tariffs are imposed, potentially within the next couple of weeks.

"As the outcome of that investigation is widely expected to be a recommendation that President Trump impose significant tariffs on imports of pharmaceuticals into the US, the UK pharma industry has been left waiting to see exactly what this preferential treatment will mean for the £8.8 billion of medicinal and pharmaceutical products that the UK currently exports to the US, which are currently exempt for any tariffs at all," commented Ewan Townsend, partner at law firm Arnold Porter.

Pharma aside, there is little doubt that becoming the first company to reach a deal with the US in the new, more combative world trade arena is a fillip for the UK government as it faces a sharp decline in public satisfaction ratings.

"This historic deal delivers for British business and British workers, protecting thousands of British jobs in key sectors including car manufacturing and steel," said Starmer.

"My government has put Britain at the front of the queue because we want to work constructively with allies for mutual benefit rather than turning our back on the world," he added. "This is jobs saved, jobs won, but not job done, and our teams will continue to work to build on this agreement. "

The deal follows a trade deal with India that was also trumpeted by the UK government but has been held up as a missed opportunity by the Association of the British Pharmaceutical Industry (ABPI), which said it did not address "longstanding industry concerns about intellectual property protections for UK life science innovators within the Indian market."

https://pharmaphorum.com/news/pharma-still-waiting-mode-after-uk-us-trade-agreement

AZ plots wider Imfinzi use in bladder cancer after trial win

 AstraZeneca's run of positive trial results with its cancer therapies has continued with a win for its immunotherapy Imfinzi in non-muscle invasive bladder cancer (NMIBC).

Top-line results from the POTOMAC trial revealed this morning show that one year of treatment with PD-L1 inhibitor Imfinzi (durvalumab) plus standard BCG induction and maintenance therapy achieved a "statistically significant and clinically meaningful improvement in disease-free survival (DFS)" compared to standard treatment alone.

A second arm of the study comparing Imfinzi plus BCG induction-only therapy to BCG induction and maintenance therapy alone did not reach statistical significance for DFS.

The new data comes shortly after Imfinzi was approved as a peri-operative treatment for muscle-invasive bladder cancer (MIBC), based on the results of the NIAGARA trial, which marked a return to the bladder cancer area.

The drug claimed accelerated approval in previously treated adult patients with locally advanced or metastatic forms of the disease in 2017, although that was subsequently withdrawn after the failure of a confirmatory study.

The new NMIBC indication, which is being prepared for filing, represents a "meaningful new opportunity" for Imfinzi, which brought in around $4.7 billion in sales for AZ last year from its current labelling across lung, liver, endometrial, biliary tract, and bladder cancers, according to recent comments by AZ's head of oncology R&D, Susan Galbraith.

That said, there has been a string of recent approvals in NMIBC that have made the segment more competitive, including for MSD's rival PD-1 inhibitor Keytruda (pembrolizumab), ImmunityBio's Anktiva, and Ferring's Adstiladrin, while Johnson & Johnson is expecting a verdict from the US FDA later this year for its TAR-200 candidate.

More than 70% of bladder cancer patients are diagnosed with NMIBC, an early-stage cancer where the tumour is in the tissue that lines the inner surface of the bladder but has not invaded the muscle wall, according to AZ. Among these, around half will be at high risk of progression to more serious disease.

POTOMAC's lead investigator, Maria De Santis of Charité Universitätsmedizin Berlin in Germany, said that the DFS results are "exciting" because "while most patients with [NMIBC] are treated with curative intent, 80% see their disease return and almost half may require life-altering surgery to remove the bladder."

Imfinzi is being tested in a range of studies across early and late-stage bladder cancer in various treatment combinations, including the VOLGA study in patients with MIBC who are ineligible or refuse to take cisplatin and the NILE study as a first-line therapy versus chemotherapy in locally advanced or metastatic disease.

The new result follows hard on the heels of positive data with Daiichi Sankyo-partnered Enhertu (trastuzumab deruxtecan) in early-stage and advanced forms of breast cancer.

https://pharmaphorum.com/news/az-plots-wider-imfinzi-use-bladder-cancer-after-trial-win

Brussels Sues Five EU Countries For Failing To Enforce Digital Censorship

 by Thomas Brooke via Remix news,

The European Commission announced on Wednesday that it is referring five member states to the Court of Justice of the European Union (CJEU) for failing to properly implement the Digital Services Act (DSA), Brussels’ flagship legislation aimed at regulating online platforms.

The countries facing legal action are Czechia, Spain, Cyprus, Poland, and Portugal. According to the Commission, these member states either failed to appoint a national Digital Services Coordinator (DSC) or failed to empower those bodies with the authority required to enforce the DSA.

Additionally, none of the five countries has established penalties for violations of the regulation, as mandated by Brussels.

“The DSA required member states to designate one or more competent authorities for the supervision and enforcement of the DSA, and to designate one of them as their national DSC by Feb. 17, 2024,” the Commission said in its press release. 

“Member states are also required to empower their DSCs to enable them to carry out their tasks under the DSA.”

Poland is singled out for not appointing or authorizing a national coordinator at all, while Czechia, Spain, Cyprus, and Portugal appointed such bodies but did not grant them the legal powers necessary to fulfill their responsibilities.

The European Commission insists the DSA, which came into force in 2022, is designed to create a safer and more transparent online environment by requiring large platforms and search engines to combat illegal content, protect user privacy, and address public safety risks.

Critics, however, argue that it risks overreach by incentivizing platforms to over-remove content, potentially stifling free speech; imposes disproportionate burdens on smaller platforms, reinforcing the dominance of Big Tech; and compromises user privacy through mandated data access for regulators.

Disapproval of the regulation has been met by both libertarian politicians in Europe and by Republicans in Washington, DC.

In February, United States House Judiciary Chair Jim Jordan sent a letter to the European Commissioner for Technology Henna Virkkunen expressing his “serious concerns with how the DSA’s censorship provisions affect free speech in the United States.”

He argued that overregulation from Brussels would effectively create a “de facto global censorship standard” as social media platforms generally use one set of content moderation policies for consistent implementation worldwide.

X owner Elon Musk has also weighed in on the bureaucratic nature of the DSA and its overzealous approach to content moderation, while U.S. President Donald Trump himself also called fines imposed on U.S. tech companies by Brussels for failing to adhere to the DSA a “form of taxation.”

In Europe, Alternative for Germany (AfD) MP Maximilian Krah has argued that the DSA is designed to suppress dissenting viewpoints, claiming the legislation “is intended to prevent unorthodox and creative ideas from being shared on the internet,” while Sweden Democrats MEP Jessica Stegrud claimed an overfocus on combating disinformation and “harmful content” could undermine freedom of speech.

The Commission first launched infringement proceedings against the five countries in 2024. Letters of formal notice were sent to Czechia, Cyprus, Poland, and Portugal in April, and to Spain in July. After the member states failed to comply, the Commission escalated the matter to the EU’s highest court.

If the Court of Justice rules against them, the countries could face financial penalties and be required to act swiftly to meet their legal obligations.

https://www.zerohedge.com/political/brussels-sues-five-eu-countries-failing-enforce-digital-censorship

Massachusetts man charged with attempt to assassinate Bessent

 A Massachusetts man was charged Thursday with the attempted assassination of a Cabinet member nominee and carrying a dangerous weapon on the Capitol grounds after being arrested in late January. 

Ryan English, 24, brought two Molotov cocktails and a knife onto the property in an effort to kill Treasury Secretary Scott Bessent prior to his confirmation, according to the Department of Justice (DOJ).

He was found in possession of 50 milliliter bottles of vodka with a grey cloth affixed to the tops and a green lighter. A letter in his pocket was addressed to a family member that said, in part, “This is terrible but I can’t do nothing while nazis kill my sisters. … I’m so sorry for lying and plotting and lying.”

Authorities said English originally planned to target House Speaker Mike Johnson (R-La.) and Defense Secretary Pete Hegseth but shifted course when he realized Bessent’s confirmation hearing coincided with his visit to the Capitol.

He is charged with carrying a dangerous weapon or incendiary device on the grounds of the Capitol and unlawful possession of an incendiary device as a result of the incident.  

English admitted to traveling to the District of Columbia with the intention of killing a government official or burning down a think tank based in Washington, D.C., according to the DOJ.

He is in police custody and had an initial court appearance Thursday.

https://thehill.com/homenews/administration/5291393-massachusetts-man-charged-with-attempt-to-assassinate-cabinet-member/

FDA announces generative AI pilot and rapid rollout plans

 In a surprise post this afternoon, new FDA Commissioner Dr Martin Makary announced a completed pilot at the FDA of a generative AI-based system for speeding up drug review - and plans to roll out the system across the agency by the end of June.

“I was blown away by the success of our first AI-assisted scientific review pilot," Makary said in a statement. "We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.” 

The announcement contained very little information about the technology or the pilot. It said the rollout will be overseen by Jeremy Walsh, who just joined the agency days ago as its first chief AI officer. Walsh comes from government contractor Booz Allen Hamilton, where he was chief technologist for 14 years, including working with the FDA on contracts.

WIRED Magazine uncovered more information in a scoop published yesterday, citing unnamed sources to report that a small team from OpenAI met with the FDA and two individuals involved with the Department of Government Efficiency (DOGE) in recent weeks, with Walsh involved in the discussions. They have referred to the project as "cderGPT", likely a reference to the Center of Drug Evaluation at the FDA.

While the industry will no doubt welcome faster drug review times, the announcement raises questions about patient safety. Generative AI is notoriously error-prone and the rollout timeline is blisteringly fast - ironic for an agency that has been so hesitant to trust drug data that comes from AI tools. 

Makary justified the reduced timeline by appealing to the urgency of supporting innovation.

"There have been years of talk about AI capabilities in frameworks, conferences, and panels, but we cannot afford to keep talking," he said. "It is time to take action. The opportunity to reduce tasks that once took days to just minutes is too important to delay."

The urgency is also likely driven by the recently-announced layoffs at the FDA, which have sparked worries about delayed drug approval timelines. At AAPS National Biotech conference in Boston this week, Dr Alex Cadotte, a former FDA employee who now works for MCRA, discussed the effect of those layoffs on approval timelines.

"I'm aware of recent and planned RIFs, at least through channels that are basically available to the public, and basically the message there is that, in general, these are aimed at support personnel, rather than review staff," he explained. "So the immediate consequences of that may not be seen for a while, but it may be seen more long term. But for the most part, if you've got an application with FDA, the folks that are reviewing those are not likely to be affected."

Ironically, many of the staff who have already been laid off from the FDA were experts in AI modelling and machine learning, Cadotte said.

"With the February 14th layoffs, 75% of those [AI experts] were lost permanently," he said. "Many of them were invited back and declined. This is simply because they go out to industry and they find more lucrative positions and more stable positions. I think it's an obvious statement that that's a big loss for all of us in the sense that FDA's capacity to learn about these models is a little questionable at this point." 

https://pharmaphorum.com/news/fda-announces-generative-ai-pilot-and-rapid-rollout-plans

Qiagen Strong Q1 2025 Earnings

Qiagen’s recent earnings call painted a positive picture of the company’s performance, as they delivered a strong start to 2025. The sentiment expressed during the call was optimistic, with Qiagen exceeding expectations for net sales and earnings. Key product lines demonstrated robust growth, and the company significantly improved its profitability. Despite facing challenges in the Chinese market and encountering cautious customer spending, Qiagen reaffirmed its full-year outlook and expanded shareholder return options, showcasing confidence in its strategic direction and execution.

Exceeded Q1 2025 Outlook

Qiagen surpassed its Q1 2025 financial expectations, reporting net sales of $483 million, which marks a 7% increase at constant exchange rates compared to the previous year. The adjusted diluted earnings per share reached $0.50, meeting and exceeding the anticipated outlook.

Strong Performance of Key Products

The company’s key product lines showed impressive growth, with QIAstat achieving double-digit sales growth. The QuantiFERON tuberculosis test also delivered another strong quarter of double-digit sales growth, while the QIAcuity digital PCR platform continued to gain momentum in high-growth fields.

Increased Profitability

Qiagen’s profitability saw a notable improvement, with the adjusted operating income margin rising to 29.8% of sales. This increase, up more than four percentage points from Q1 2024, was driven by a favorable shift towards consumables and bioinformatics solutions.

Reaffirmed Full Year 2025 Outlook

The company reaffirmed its full-year 2025 outlook, projecting around 4% sales growth at constant exchange rates. Additionally, Qiagen upgraded its target for adjusted earnings per share to approximately $2.35, up $0.07 from the initial outlook for the year.

Expansion of Shareholder Returns

Qiagen announced an expansion of shareholder returns, introducing an annual cash dividend and proposing a synthetic share repurchase of up to $500 million over an 18-month period.

Challenges in China

The company continues to face challenges in the Chinese market, which accounts for about 3% to 4% of total sales. There was a high teens decline in constant exchange rates compared to Q1 2024, reflecting ongoing weak trends.

Qiagen’s forward-looking guidance remains optimistic, with the company exceeding its Q1 2025 outlook and projecting around 4% sales growth at constant exchange rates for the full year. The adjusted earnings per share target has been upgraded to approximately $2.35, reflecting confidence in the company’s growth drivers, including QIAstat, QuantiFERON, and QIAcuity. Strategic initiatives, such as the introduction of a cash dividend and a proposed $500 million synthetic share repurchase, underscore Qiagen’s commitment to returning value to shareholders.

https://www.tipranks.com/news/company-announcements/qiagens-strong-q1-2025-earnings-call-highlights-growth-and-confidence