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Tuesday, August 1, 2023

Biomarin's Q2 Beat Street View, Raises Voxzogo Annual Guidance

Biomarin Pharmaceutical Inc 

 reported a Q2 adjusted EPS of $0.54, higher than $0.41 a year ago and beating the consensus of $0.47.

The company's revenue rose 12% to $595.3 million, beating the consensus of $518.91 million.

Voxzogo drug sales increased 229% to $113.3 million due to continued global expansion and rapid patient uptake across all regions.

Over 2,000 were being treated with commercial Voxzogo globally. Pivotal Program with Voxzogo in a new, potential second indication, hypochondroplasia, to start in Q4 of 2023.

Palynziq product revenues increased 22% to $74.9 million, primarily due to new patients initiating therapy.

Naglazyme product revenues declined 22% To $90.1 million, primarily driven by the timing of orders in countries that place large government orders, particularly in Latin America.

"For the remainder of 2023, we plan to build on the foundation of growth and profitability achieved in the first half of the year, expand VOXZOGO globally and treat the first ROCTAVIAN patients in the U.S. and Europe," said Jean-Jacques Bienaimé, Chairman and CEO of BioMarin.

Guidance: BioMarin has upped its FY23 Voxzogo sales forecast to $400 million-$440 million from $380 million-$430 million.

The company reaffirms FY23 revenue guidance of $2.375 billion - $2.5 billion versus the consensus of $2.46 billion.

It updated the adjusted EPS outlook to $1.85 - $2.10 from $1.80 - $2.05 versus the consensus of $1.02.

https://www.benzinga.com/general/biotech/23/08/33485934/biomarins-q2-beat-street-view-raises-voxzogo-annual-guidance-driven-by-global-demand

Neurocrine Ups 2023 INGREZZA Sales Guidance


INGREZZA® (valbenazine) Second Quarter Net Product Sales of $440 Million Representing 26% Year-Over-Year Growth

INGREZZA® (valbenazine) 2023 Net Product Sales Guidance Raised to $1.77 - $1.82 Billion

https://www.biospace.com/article/releases/neurocrine-biosciences-reports-second-quarter-2023-financial-results-and-raises-2023-ingrezza-sales-guidance/

Immutep Receives Positive Scientific Advice from European Medicines Agency

Immutep (Formerly known as Prima Biomed) Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received positive scientific advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the continued development of eftilagimod alpha (efti), the Company's soluble LAG-3 protein and first-in-class MHC Class II agonist.

In May 2023, Immutep requested scientific advice from the EMA regarding future development of efti, and in particular whether further toxicity studies would be required before the Company could seek marketing authorisation for efti in Europe. Based on the available clinical data and acknowledgement that additional studies in animal models are unlikely to provide relevant information, the CHMP advised that further toxicology studies are not needed for a future Marketing Authorisation Application (MAA). Similar advice was received from the US Food and Drug Administration (FDA) as it relates to a potential future Biologics License Application (BLA).

Immutep continues to be encouraged with its constructive interaction with regulatory agencies regarding its expanding late-stage clinical pipeline with efti. As recently reported, Immutep has also received positive feedback from the FDA regarding the upcoming TACTI-004 Phase III trial in 1st line non-small cell lung cancer as well as for the AIPAC-003 Phase II/III trial in metastatic breast cancer, which began dosing patients during the second quarter of CY2023.

https://www.biospace.com/article/releases/immutep-receives-positive-scientific-advice-from-european-medicines-agency/

scPharma: Positive Type C Meeting Feedback on Potential Heart Failure Class IV Indication Expansion

  scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that the Company has received positive Type C meeting feedback from the US Food and Drug Administration (FDA) regarding the potential expansion of the FUROSCIX® indication to allow for use in New York Heart Association (NYHA) Class IV heart failure patients. FUROSCIX is currently indicated for the treatment of congestion due to fluid overload in adult patients with NYHA Class II and Class III chronic heart failure.

“We are very pleased with the outcome of our recent Type C meeting with the FDA, and believe this paves the way for potential expansion of the FUROSCIX indication to allow for use in NYHA Class IV patients,” stated John Tucker, Chief Executive Officer of scPharmaceuticals. “We estimate that as many as 10% of all heart failure patients are Class IV, and a meaningful percentage of these – as many as 40% - may benefit from FUROSCIX. To that end, we plan to file for Class IV indication expansion by the end of this year.”

https://www.biospace.com/article/releases/scpharmaceuticals-announces-positive-type-c-meeting-feedback-from-fda-on-potential-heart-failure-class-iv-indication-expansion-/

Ukraine Escalating War Into Moscow With 2nd Drone Strike On Skyscraper Housing Government Ministries

 Moscow's mayor has said that overnight a high-rise building in the capital which houses Russian government ministries has suffered a direct impact from a drone strike for a second time in three days.

Mayor Sergei Sobyanin confirmed that it was the same tower that had been previously struck on Sunday, and separately the defense ministry said it intercepted two more drones over the nearby districts of Odintsovo and Narofominsk. The ministry identified Ukraine as the culprit for the "attempted terrorist attack."

Ukraine's President Volodymyr Zelensky had just previewed and threatened two nights ago that he's ready to take to war to Russian soil, saying: "Gradually, the war is returning to the territory of Russia — to its symbolic centers and military bases." He added, "And this is an inevitable, natural and absolutely fair process."

There were also overnight statements by the Russian military describing a wave of drone attacks against Russian naval ships in the Black Sea.

And in a fresh August 1st tweet, Ukrainian presidential adviser, Mykhailo Podolyak, also vowed more is coming, saying the following:

Moscow is rapidly getting used to a full-fledged war, which, in turn, will soon finally move to the territory of the "authors of the war" to collect all their debts …

Everything that will happen in Russia is an objective historical process. More unidentified drones, more collapse, more civil conflicts, more war...

The New York Times has meanwhile confirmed that Kiev has stepped up targeting to include intelligence, military, and financial centers of the Russian capital, after the intensified border region activity (particularly strikes and cross-border action against Belgorod) of the past many months of war.

"Drones have exploded over the gilded domes of the Kremlin. They have hit strategic Russian air bases hundreds of miles from Ukraine," NY Times observes. "They have struck a Moscow tower that houses several government ministry offices, including the one responsible for the military-industrial complex."

"And they have landed a stone’s throw from one of the main Russian military headquarters, where officers sitting in large situation rooms with vast screens on its walls directly oversee and manage the war in Ukraine," the report adds.

One thing is becoming very evident, Ukraine is escalating the war into Moscow, as the West remains silent in face of the greatly heightened increased potential for a full Russia-NATO clash, while also still seeking to conceal its own role.

This is also evidenced in the fact that for the first time Zelensky and his top officials have begun owning up to the attacks on Russian territory, openly admitting the cross-border operations after months of denial and cover-up, chiefly for the sake of Western audiences:

  • Zelensky, May 14: We don’t attack Russian territory
  • Zelensky, July 30: We're bringing the war to Russian territory

White House National Security Council spokesman John Kirby is still sticking by the Washington official line that the US is not encouraging such attacks. He recently reiterated in an interview with CNN that the US administration is "not encouraging attacks inside Russia, decision is for Ukraine to make." 

But this is very clearly obfuscation and outright dishonesty, attempting to escape blame despite it long being known that the US assisting Ukrainian forces with intelligence and targeting information, as has been revealed time and time again.

* * *

Max Abrahms, a professor of international security and author/expert on counterterrorism at Northeastern University, had this to say of the latest Moscow drone strikes [emphasis ZH]...

"The attacks inside Russia against civilian targets do not have the intended communicative effect. The standard Western view is the attacks will signal to Putin the costs of occupying Ukraine so he withdraws."

"But I believe the attacks only reinforce his priors that NATO is waging a proxy war against Russians whose security depends on weakening Ukraine and securing territories close to Russia. The attacks in Russia validate his worldview."

https://www.zerohedge.com/geopolitical/ukraine-escalating-war-moscow-2nd-drone-strike-skyscraper-housing-government

Definitive Healthcare to Restate Previously Issued Financials

 On July 31, 2023, the Audit Committee of the Board of Directors of the Company (the “Audit Committee”), based on the recommendation of, and after consultation with, the Company’s management, concluded that the Company’s previously issued audited consolidated financial statements as of December 31, 2022 and 2021 and for the years ended December 31, 2022, 2021 and 2020, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 (the “2022 Annual Report”), and the Company’s unaudited condensed consolidated financial statements included in the Quarterly Reports on Form 10-Q for the quarterly periods within those years (the “Historical Quarterly Reports”), as well as the unaudited condensed consolidated financial statements included in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 (the “Q1 2023 Quarterly Report” and, together with the 2022 Annual Report and the Historical Quarterly Reports, the “Reports” and all financial statements included in the Reports, collectively the “Affected Financials”), should no longer be relied upon. Similarly, related press releases, shareholder communications, investor presentations or other communications describing relevant portions of the Affected Financials should no longer be relied upon.


Zimmer Biomet lifts profit forecast as surgeries rebound

 Zimmer Biomet Holdings Inc on Tuesday raised its full-year profit forecast, anticipating demand to hold up for its medical devices following a rebound in knee and hip replacement procedures.

The company also beat estimates for profit to extend a strong second quarter for the industry that is benefiting from patients resuming non-urgent procedures and surgeries postponed during the pandemic and staffing shortages easing at hospitals.

Abbott Laboratories attributed its strong quarter to hospitals addressing bottlenecks from the pandemic while Johnson & Johnson said it expected to top profit estimates with surgeries bouncing back.

Combined sales at Zimmer's hips and knees units rose 7% to $1.28 billion from a year earlier, compared to the average $1.21 billion by four analysts, according to Refinitiv data.

The company now expects full-year profit of $7.47 to $7.57 per share, compared with its previous forecast of $7.40 to $7.50.

Analysts were expecting an annual profit of $7.45 per share.

While expectations were high, the results support the brokerage's positive view regarding both Zimmer's improved competitiveness and persisting growth in orthopedic markets, Baird Equity Research analyst Jeff Johnson said in a note.

The Indiana-based company's second-quarter revenue rose nearly 5% to $1.87 billion, beating analysts' estimates of $1.83 billion.

Zimmer also expects reported revenue to grow between 6.5% and 7% this year, compared to its prior forecast of between 5% and 6%.

Excluding items, the company earned $1.82 per share, compared with estimates of $1.81.

https://finance.yahoo.com/news/medical-device-maker-zimmer-biomet-122133634.html