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Wednesday, August 7, 2024

Intra-Cellular Ups 2024 CAPLYTA Sales Guidance

 CAPLYTA Q2 2024 net product sales were $161.3 million, compared to $110.1 million for the same period in 2023, representing a 46% increase

CAPLYTA’s strong prescription uptake continues: Q2 2024 CAPLYTA total prescriptions increased 36%, versus the same period in 2023

CAPLYTA 2024 net product sales guidance raised to $650 to $680 million

Announced positive Phase 3 results from Study 501 and Study 502 evaluating lumateperone as an adjunctive therapy to antidepressants in patients with major depressive disorder (MDD)

Supplemental NDA (sNDA) submission for lumateperone as an adjunctive therapy to antidepressants in patients with MDD anticipated in the second half of 2024

Commenced patient enrollment in ITI-1284 Phase 2 Studies in Generalized Anxiety Disorder and Psychosis associated with Alzheimer’s disease


https://www.biospace.com/intra-cellular-therapies-reports-second-quarter-2024-financial-results-provides-corporate-update-and-raises-2024-caplyta-sales-guidance

Medtronic FDA approval of Simplera™ CGM and global partnership with Abbott

 Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) approval for its Simplera™ continuous glucose monitor (CGM) — the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs. The discreet design simplifies the insertion and wear experience, eliminating the need for overtape.

The Simplera™ platform featuring the company's newest CGM form factor, includes the Simplera™ CGM, designed to be used as part of a Smart MDI system with the InPen™ smart insulin pen and the Simplera Sync™ sensor, which is designed to be integrated with the MiniMed™ 780G system.

The Simplera™ CGM and Simplera Sync™ sensor are CE Marked in Europe and launched earlier this year with positive feedback around ease of use and insertion, adding to the existing high satisfaction with the MiniMed™ 780G system.

The recent FDA approval for Simplera™ CGM lays the groundwork for future submission of the updated InPen™ smart insulin pen app, which would facilitate integration with Simplera™ CGM, as a Smart MDI system. Once FDA clearance is obtained, Medtronic will initiate a limited market release in the U.S. beginning with existing standalone CGM and InPen™ customers. The Simplera Sync™ sensor is under review by the FDA in a separate regulatory filing. It is investigational in the U.S. and not approved for commercial use.

Additional global regulatory submissions and approvals of the Simplera™ CGM and Simplera Sync™ sensor are pending.

https://www.prnewswire.com/news-releases/medtronic-announces-fda-approval-of-simplera-cgm-and-global-partnership-with-abbott-302216165.html

Oscar Health Raises Full Year Revenue and Adjusted EBITDA Outlook

 

  • For the quarter ended June 30, 2024:
    • Total Revenue of $2.2 billion, a 46% increase YoY
    • Medical Loss Ratio of 79.0%, a 90 bps improvement YoY
    • SG&A Expense Ratio of 19.6%, a 260 bps improvement YoY
    • Net income attributable to Oscar of $56.2 million, or $0.20 of diluted earnings per share, a $71.7 million improvement YoY
    • Adjusted EBITDA of $104.1 million, a $68.6 million improvement YoY
Oscar is updating its full year 2024 outlook to reflect first half outperformance. The Company projects Revenue to be in the $9.0 billion to $9.1 billion range, $700 million above the prior range of $8.3 billion to $8.4 billion, and Adjusted EBITDA to be in the $160 million to $210 million range, $35 million higher than the prior range of $125 million to $175 million. Additionally, the Company now projects a lower SG&A Expense Ratio in the range of 19.75% to 20.25%, and a modestly higher Medical Loss Ratio in the range of 80.5% to 81.5%.

Zimmer Biomet to Acquire OrthoGrid Systems

 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced that it signed a definitive agreement to acquire OrthoGrid Systems, Inc., (OrthoGrid) a privately-held medical technology company focused on artificial intelligence (AI)-driven surgical guidance systems for total hip replacement. The acquisition includes OrthoGrid's AI-powered, fluoroscopy-based surgical assistance platform Hip AI®, as well as two additional FDA-cleared orthopedic applications and over 40 patents.

Surgical guidance systems often rely on CT-based imaging which can result in a backlog of CT exams and, in turn, impact operating room (OR) workflow and efficiency. Fluoroscopy-based surgical guidance is a technique that uses real-time X-ray imaging to help guide procedures and improve surgical accuracy and safety. Unlike CT scans, fluoroscopy-based systems do not require preoperative preparation, allow real-time navigation with up-to-date images, and provide convenient bedside access to motion imaging.

OrthoGrid's Hip AI system provides real-time image analysis, automated measurements of leg length and offset, and guidance on optimal cup placement while maintaining a small OR footprint. In addition, surgeons can tailor Hip AI to align with their specific technique and workflow.

https://www.prnewswire.com/news-releases/zimmer-biomet-signs-definitive-agreement-to-acquire-orthogrid-systems-inc-302216131.html

Pharmacosmos Group to Acquire G1 Therapeutics

 Business Combination Expected to Provide Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC) Optimal Access to G1’s COSELA® (trilaciclib), the First and Only Proactive Multilineage Myeloprotection Agent -

- Pharmacosmos’ Significant Resources and Expertise in Hematology and Supportive Care to Maximize Availability of COSELA for Patients with ES-SCLC -

- Transaction Expands and Strengthens Pharmacosmos’ Global Commercial Portfolio -

- G1’s Shareholders to Receive U.S. $7.15 per Share in Cash for a Total Equity Value of Approximately $405 Million -

https://www.globenewswire.com/news-release/2024/08/07/2925767/0/en/Pharmacosmos-Group-to-Acquire-G1-Therapeutics.html

'WHO Director Considers Declaring Public Health Emergency Over Mpox Virus Outbreak'

 by Jack Phillips via The Epoch Times,

The World Health Organization’s director-general said the United Nations health body is considering declaring an emergency for mpox, also known as monkeypox, amid an outbreak in Africa.

“But more funding and support for a comprehensive response are needed,” WHO Director-General Tedros Adhanom Ghebreyesus wrote on the social media platform X on Sunday.

“I am considering convening an International Health Regulations emergency committee to advise me on whether the outbreak of mpox should be declared a public health emergency of international concern.”

By Tuesday, it was unclear when the WHO would declare the emergency or issue any warnings about the virus.

statement from Tedros published by the journal Science added that “this virus can and must be contained with intensified public health measures including surveillance, community engagement, treatment and targeted deployment of vaccines for those at higher risk of infection.”

“A further scaling up of the mpox response underway in affected countries is urgently needed amid the expanding outbreak,” his statement said, calling for “more funding for a comprehensive response” that factors in diagnostics, therapeutics, and vaccines.

A public health emergency of international concern is the strongest designation for an outbreak. Notably, such a declaration was made for COVID-19 during the early onset of the pandemic in 2020.

Later, WHO made the designation for an mpox outbreak that lasted from 2022 to 2023, while President Joe Biden’s administration declared an emergency over the virus. During that outbreak, which impacted Europe and the United States, officials say mpox primarily spread via sexual contact between men.

The latest announcement was made as the Africa Centers for Disease Control and Prevention (CDC) said in a report last week that mpox has now been detected in 10 African countries this year, including Congo, which has more than 96 percent of all cases and deaths.

Officials said nearly 70 percent of cases in Congo are affecting children younger than 15, who also accounted for 85 percent of deaths.

There have been an estimated 14,250 cases so far this year, nearly as many as all of last year, the Africa CDC said. Compared to the first seven months of 2023, the Africa CDC said cases are up 160 percent and deaths are up 19 percent, to 456.

Burundi and Rwanda both reported the virus for the first time this week, while new outbreaks were recently reported in the Central African Republic and Kenya.

“We are very concerned about the cases of monkeypox, which is ravaging (the capital region),” the Central African Republic’s public health minister, Pierre Somse, said on Monday.

Two cases were confirmed in Uganda, according to an Aug. 4 notice published by the International Society for Infectious Diseases, citing the country’s health ministry.

“Both individuals presented with symptoms such as skin rash, swollen lymph nodes, and general malaise, which are consistent with mpox,” the Ugandan Health Ministry stated.

Meanwhile, Kenya’s Health Ministry recently said it found mpox in a passenger traveling from Uganda to Rwanda at a border crossing in southern Kenya. In a statement, the ministry said that a single mpox case was enough to warrant an outbreak declaration.

Over the weekend, health officials in South Africa announced the country now has 22 cases of mpox, including three deaths.

“Contact tracing and monitoring activities are ongoing in the affected communities in both provinces, and the Department urges all the identified contacts to cooperate with health officials during contact tracing for screening and possible diagnosis to prevent further transmission of this preventable and treatable disease,” the South Africa Health Department said in a statement, published on Aug. 4.

Signs and symptoms of mpox, according to the U.S. CDC website, include a rash that might be located on the feet, hands, face, chest, and mouth, or near the genitals. The rash can form scabs and initially look like blisters or pimples, which may be itchy or painful.

Other symptoms include fever, swollen lymph nodes, chills, aches, exhaustion, and respiratory symptoms such as a cough, nasal congestion, or sore throat, according to the health agency.

https://www.zerohedge.com/geopolitical/who-director-considers-declaring-public-health-emergency-over-mpox-virus-outbreak

Novo Shares Drop Most In Two Years On "Disappointing Ozempic & Wegovy Misses"

 Novo Nordisk shares in Copenhagen fell 7.7%, marking the steepest intraday plunge in two years. The Danish pharmaceutical giant delivered underwhelming second-quarter sales for its Wegovy (semaglutide) blockbuster anti-obesity drug.

Shares are testing key support. 

Wegovy's second-quarter sales were 11.7 billion Danish kroner ($1.7 billion), while the Wall Street analyst estimate tracked by Bloomberg was about 13.66 billion kroner. 

During an earnings call, CFO Karsten Knudsen told investors that revenue from the anti-obesity drug was pressured by higher-than-expected price concessions to US pharmacy benefits managers, calling it a 'one-off factor.' 

Here's a breakdown of the second quarter results (courtesy of Goldman): 

Source: Goldman

Goldamn's James Quigley provided clients with a snapshot of the key beats and misses from the second quarter:

  • Wegovy 14% behind consensus (DKK -1.9bn, 468% of group sales miss). North America sales were driven by increased volumes, partially countered by lower realised prices. In the US, demand exceeds supply and to safeguard continuity of care the supply of the initiation dose strength remains capped. We note US Wegovy sales of DKK 9,907mn missed Visible Alpha Consensus Data of DKK 12,242mn by 19%, but ex. US sales of DKK 1,752mn beat VA consensus of DKK 1,360mn. We note the Wegovy US $ per script decreased 6% YoY and 25% QoQ, see below section. We note half of the Wegovy miss is due to rebate adjustments in prior period, so excluding this impact Wegovy would be a 7% miss and the YoY value would have declined by c.3%.
  • Ozempic 3% behind consensus (DKK -1bn, 240% of group sales miss).

Novo adjusted its full-year outlook, lowering its profit guidance while raising its sales outlook for the year. It now forecast full-year operating growth to range between 20% and 28%, with sales growth between 22% and 28% at constant exchange rates. Previously, it projected operating profit growth between 22% and 30% on sales growth ranging from 19% to 27% at constant exchange rates.

In Kroner terms, Wall Street analysts had projected operating profit growth of about 25% and sales growth of roughly 26%. The new guidance falls short of Wall Street's expectations on both the top and bottom lines

Quigley sheds more color on the new guidance: 

FY24 guidance was upgraded to operating profit growth of 19-27% on a reported basis, which is broadly in line with the mid-point of the current company-complied consensus implied growth of 24.8%, therefore we expect limited changes to forecasts for FY24. The Ozempic and Wegovy misses were disappointing, although we note that the guidance appear to reflect an acceleration in Wegovy in the 2H as obesity supply improves. Therefore, with half of the Wegovy miss relating to a prior period GTN adjustment, supply improving, demand still in excess of supply in the US and an implied beat for ex-US Wegovy, we continue to see a positive dynamic for the obesity portfolio into 2025 and beyond.

Quigley added:

Overall we see the underlying guidance upgrade as a positive indicator that Wegovy supply is improving. However, the miss on Ozempic and Wegovy in the quarter is likely to be disappointing in the short term and could weigh on the share price this morning. However, with Novo stock down c.14pp from the June highs, any weakness could be a buying opportunity into 2H'24 with the potential acceleration of the obesity franchise, in our view.

Wegovy deflation... 

Source: Goldman

Quigley maintained a 'Buy' rating on Novo with a 12-month price target of DKK 1,090 per share. 

Source: Goldman

Here's what other Wall Street analysts are telling clients after Novo reported (courtesy of Bloomberg):

Barclays (overweight)

  • Wegovy will be the focus, with 2Q sales missing estimates, analyst Emily Field writes in a note
  • The cut to the operating profit outlook was "widely understood" given the asset impairment
  • Although the 2Q results weren't necessarily the "picture perfect quarter" that Barclays had hoped for, the company's message is that volume is on track for obesity

BMO (outperform on ADRs)

  • The 2Q results were "mixed," with Wegovy still hurt by supply constraints amid strong demand, analyst Evan David Seigerman writes in a note
  • A negative gross-to-net-adjustment also contributed to Wegovy's sales miss
  • Even so, the commentary on continued strong demand for obesity medications is encouraging

Citi (buy)

  • Although the Wegovy "miss" will be in focus in the short term, volume trends are strengthening, analyst Peter Verdult writes in a note
  • Half of the consensus miss on 2Q Wegovy sales can be explained by gross-to-net adjustments

Jefferies (underperform)

  • 2Q sales for focus drugs Wegovy and Ozempic missed consensus expectations, analyst Peter Welford writes in a note
  • The FY sales outlook boost suggests there may be minor increases to consensus estimates "at most"
  • The "wide" Ebit guidance range for the year was decreased, with the "known" recent ocedurenone impairment charge hurting profit growth

Intron Health (buy)

  • The 2Q results were "soft," with both sales and EPS missing expectations, analyst Naresh Chouhan writes in a note
  • The downgraded Ebit guidance is because of the one-time ocedurenone impairment, "which every other Pharma company would exclude from their 'adjusted' earnings measure"
  • Wegovy's 2Q sales miss was partly because of gross-to-net price adjustments in the US, which suggests that consensus pricing assumptions were "too high"

The question becomes has the bubble in companies with exposure to GLP-1s finding a peak? 

For the bubble to continue, medications for obesity need to be covered by insurers. 

And now recession risks are elevated, some folks will have the difficult decision between affording car payments or GLP1 drugs.