Search This Blog

Thursday, November 3, 2022

Genmab Improves Its 2022 Financial Guidance

  Genmab A/S (Nasdaq: GMAB) announced today that it is improving its 2022 financial guidance published on August 8, 2022The improved guidance is driven primarily by the positive foreign exchange rate impact on our royalty revenue, and the continued strong performance of DARZALEX® net sales.

Genmab expects its 2022 revenue to be in the range of DKK 13,500 – 14,500 million, an increase to the previous guidance of DKK 12,000 – 13,000 million, driven primarily by the positive foreign exchange rate impact on our royalty revenue, and the continued strong performance of DARZALEX net sales. The upper end of the revenue guidance range now assumes a significant milestone associated with the potential acceptance by the U.S. Food and Drug Administration to review the Biologics License Application submission for epcoritamab. Genmab’s projected revenue for 2022 primarily consists of DARZALEX royalties. Such royalties are based on Genmab’s revised estimate of DARZALEX 2022 net sales of USD 8.0 – 8.2 billion compared to Genmab’s previous estimate of USD 7.8 – 8.2 billion.

Genmab anticipates its 2022 operating expenses to be in the range of DKK 8,000 – 8,400 million, an increase to the previous guidance of DKK 7,600 – 8,200 million, primarily driven by the negative impact of the strong U.S. Dollar. Operating expenses continue to be driven by the advancement of Genmab’s clinical programs, continued investment in research and development, as well as building Genmab’s commercial organization and broader organizational infrastructure.

Genmab now expects its 2022 operating profit to be in the range of DKK 5,100 – 6,500 million, an increase to the previous guidance of DKK 3,800 – 5,400 million, driven primarily by the items described above.

  

 

 

 

 

 

 

 

Revised

 

Previous

 

(DKK million)

 

Guidance

 

Guidance

 

Revenue

 

13,500 - 14,500

 

12,000 - 13,000

 

Operating expenses

 

(8,000) - (8,400)

 

(7,600) - (8,200)

 

Operating profit

 

5,100 - 6,500

 

3,800 - 5,400

 

Genmab’s financial results for the first nine months of 2022 will be published on November 9, 2022.


Unintended consequences of using a ventilator

 Breakthrough research addresses a long-standing question in pulmonary medicine about whether modern ventilators overstretch lung tissue. They do.

These cutting-edge findings by UC Riverside researchers were recently published in the American Journal of Respiratory and Critical Care Medicine. They demonstrate major differences between how we naturally breathe versus how ventilators make us breathe. These results are critical, particularly in context of the COVID-19 pandemic and the rush to build ventilators.

"Using novel techniques, we observed that ventilators can overextend certain regions of the lungs," said Mona Eskandari, UCR assistant professor of mechanical engineering and the BREATHE Center in the School of Medicine, who led the research. These results provide an explanation for the decline in lung health experienced by patients the longer they spend on the machines, especially in the case of disease.

Eskandari's bMECH lab pioneered a technique to study lungs as they are made to breathe. On a custom-built ventilator designed in their lab, the researchers imitated both natural and artificial breathing. Then, they observed isolated lungs involved in both types of breathing using multiple cameras collecting fast, high-resolution images, a method called digital image correlation.

"Our setup allows us to imitate both physiological and artificial breathing on the same lung with the switch of a button," Eskandari said. "The unique combination of our ventilator with digital image correlation gives us unprecedented insights into the way specific regions of the lungs work in concert with the whole."

Using their innovative method to interface these two systems, UCR researchers collected evidence demonstrating that natural breathing stretches certain parts of the lung as little as 25% while those same regions stretch to as much as 60% when on a ventilator.

Scholars traditionally model the lungs like balloons, or what they refer to as thin-walled pressure vessels, where pushing air in and pulling air out are understood to be mechanically equivalent.

To explain what they observed in this study, the researchers propose moving away from thin-walled pressure vessel models and instead towards thick-walled models. Unlike thin-walled pressure vessels theory, a thick-walled model accounts for the differing levels of stress in airways resulting from ventilators pushing air in versus natural breathing, which pulls air in. This helps to explain how airways are more engaged and air is more evenly distributed in the lung during physiological breathing.

Iron lungs, the gigantic ventilators used during the late 1940s polio outbreak, acted more like a human chest cavity, expanding the lung as it naturally would. This creates a vacuum effect that pulls air into the lungs. Though this action is gentler for the lungs, these bulky systems prevented easy access to monitoring other organs in hospital care.

By contrast, modern ventilators are more portable and easier for caretakers to work with. However, they push air into the lungs that is not evenly distributed, overstretching some parts and causing a decline in lung health over time.

While it is unlikely that hospitals will return to the iron lung models, it is possible that modern machines can be altered to reduce injury.

"Now that we know about excessive strain when air is delivered to the lungs, the question for us becomes about how we can improve ventilation strategies by emulating natural breathing," Eskandari said.

Story Source:

Materials provided by University of California - Riverside. Original written by Jules Bernstein. Note: Content may be edited for style and length.


Journal Reference:

  1. Samaneh Sattari, Crystal A Mariano, Ware G Kuschner, Hossein Taheri, Jason H.T. Bates, Mona Eskandari. Positive- and Negative-Pressure Ventilation Characterized by Local and Global Pulmonary MechanicsAmerican Journal of Respiratory and Critical Care Medicine, 2022; DOI: 10.1164/rccm.202111-2480OC

Danica Patrick's Breast Implant Illness

 Former NASCAR driver Danica Patrick, 40, told People magazine that she had her breast implants removed after experiencing breast implant illness. Patrick previously decided to get breast implants in 2014 in a quest to attain "an ideal body."

Things went well for the first 3 years; however, she then began to experience unexplained symptoms. Her hair seemed to get very dry, grew more slowly, and began to fall out. She gained weight, and was unable to lose it, and her energy levels dropped dramatically. She also began to experience gastrointestinal issues, as well as hormone disruption, including low sex hormones.

A year later, one of her breast implants had become hard, and she thought perhaps it had ruptured. An MRI revealed that this wasn't the case. When the other breast became hard as well, she started to think that her breast implants may be playing a role in her symptoms. She watched over 100 videos on YouTube and social media by women with similar symptoms. Hearing their stories made her believe that she too was suffering from breast implant illness.

Patrick had her implants removed in April, and said she felt some relief within hours of the surgery. Six months later, Patrick is still on the mend. Her stomach problems and hormone levels have improved, and she said that she looks more like herself again.

Brief History of Breast Implants

Breast implants were introduced in 1962 by two surgeons, Thomas Cronin, MD, and Frank Gerow, MD. They have been used both to augment breast size and to replace breast tissue removed due to cancer, trauma, or failure to develop properly.

In 1976, the FDA was given jurisdiction over medical devices. However, breast implants were "grandfathered" in, meaning manufacturers were not required to provide scientific evidence of product efficacy and safety unless questions arose.

In the 1980s, consumer concerns over silicone breast implants emerged. The devices were subsequently classified as higher-risk and manufacturers had to start providing data on their safety. In 1992, the FDA concluded that silicone breast implant manufacturers had failed to properly address safety concerns and they were removed from the market.

In 1999, the Institute of Medicine (IOM) released a report entitled "Safety of Silicone Breast Implants," with three conclusions:

  • The primary safety concerns with silicone implants were related to preoperative, local, and perioperative complications
  • Risks seemed to accumulate over time, but quantitative data were lacking for the most recent devices
  • Women needed to be better informed about potential risks of breast implants
The IOM did not feel there was enough evidence at that time to say that breast implants were a cause of systemic disease, although they felt well-controlled, long-term, large studies were needed to determine this.

In 2006, silicone implants were put back on the market. However, since that time, the scientific community has conducted more research to address safety, and the FDA has required two manufacturers to conduct large post-approval studies to look for potential long-term risks.

Breast Implant Illness

As many as 3 million women are estimated to have breast implants worldwide, and there has been a recent resurgence in the concerns around the safety of silicone and silicone-coated saline breast implants.

Breast implant illness describes a variety of symptoms reported by women with breast implants, including fatigue, memory or concentration problems ("brain fog"), joint and muscle pain, hair loss, weight changes, anxiety/depression, rash, headache, and inflammation. These symptoms have been reported by women with all types of breast implants regardless of filling, shape, or surface characteristics, and onset occurs anywhere from immediately after implantation to years later.

Multiple studies have looked at whether breast implants have a causal relationship with systemic illness and/or autoimmune disease. The results have been mixed, and many of the studies were considered flawed.

2021 review concluded that "there have not been any concrete or evidence-based studies which support the formation of a new syndrome 'silicone implant disease.'" However, they pointed out that more recent data have suggested that breast implants may be associated with certain specific connective tissue diseases.

The review cited a cohort study that included nearly 100,000 women with breast implants followed for 7 years, which found significantly higher rates of Sjogren syndrome, scleroderma, and rheumatoid arthritis compared with the general population.

Some researchers consider breast implant illness a form of autoimmune/inflammatory syndrome induced by adjuvants (ASIA). Known adjuvants in humans include aluminum hydroxide, squalene, silica, or bacterially derived substances. Presumably, an adjuvant introduced into a susceptible patient can cause an enhanced specific immune reaction resulting in non-specific constitutional symptoms and autoantibody production.

One study concluded that there "appears to be a clear pathogenic relationship between silicone breast implants and breast implant illness/ASIA. Breast implants cause characteristic systemic reactions in certain women, leading to symptoms of sufficient severity to warrant device removal. [Implant] removal resolves the symptoms in most women, and removal is the most effective treatment."

Although the FDA maintains that silicone breast implants are safe for use, they have moved to strengthen labeling to improve communications on their risks between physicians and patients. In September, the agency issued a safety communication to highlight reports of squamous cell carcinoma and various lymphomas in the scar tissue that forms around breast implants. These lymphomas are not the same as those reported by the FDA in April.

That lymphoma, known as breast implant-associated anaplastic large cell lymphoma, is a type of non-Hodgkin's lymphoma usually found in the scar tissue and fluid near the implant. It is considered rare but is serious and can be fatal if not treated promptly. Symptoms include swelling, presence of a mass, or pain in the areas of the breast implant. In most cases, it can be successfully treated by surgical removal, but some patients may also require radiation and/or chemotherapy.

Michele R. Berman, MD, is a pediatrician-turned-medical journalist. She trained at Johns Hopkins, Washington University in St. Louis, and St. Louis Children's Hospital. Her mission is both journalistic and educational: to report on common diseases affecting uncommon people and summarize the evidence-based medicine behind the headlines.

https://www.medpagetoday.com/popmedicine/celebritydiagnosis/101566

Aptose Clinical Data to be Presented at the 2022 ASH Annual Meeting

 Aptose Biosciences Inc. (“Aptose”) (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, today announced that clinical data for tuspetinib (formerly HM43239), a myeloid kinome inhibitor, and luxeptinib, a dual lymphoid and myeloid inhibitor, have been accepted for poster presentations at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition, being held Saturday, December 10 – Monday, December 13, 2022 in New Orleans, LA and virtually.

The abstracts accepted for presentation are listed below and can be viewed online at the ASH conference website. Note that the actual presentations will include more recent updates and additional data not found in the abstracts. Aptose will hold a Clinical Update webcast during the ASH timeframe to provide up-to-date data. Details will be forthcoming.

Poster Presentation Details

Publication Number 2758A Phase 1/2 Dose Escalation Study of the Myeloid Kinase Inhibitor HM43239 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II
Session Date & Time: Sunday, December 11, 2022, 6:00 – 8:00 PM ET
Location: Ernest N. Morial Convention Center, Hall D

Publication Number 2767: A Phase 1a/b Dose Escalation Study of the FLT3/BTK Inhibitor Luxeptinib (CG-806) in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II
Session Date & Time: Sunday, December 11, 2022, 6:00 – 8:00 PM ET
Location: Ernest N. Morial Convention Center, Hall D

Publication Number 2893: A Phase 1a/b Dose Escalation Study of the BTK/FLT3 Inhibitor Luxeptinib in Patients with Relapsed or Refractory B-Cell Malignancies
Session Name: 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II
Session Date & Time: Sunday, December 11, 2022, 6:00 – 8:00 PM ET
Location: Ernest N. Morial Convention Center, Hall D

Apellis to Submit 24-Month Phase 3 Data for Pegcetacoplan NDA for Geographic Atrophy

 

  • Inclusion of the 24-month data has the potential to strengthen the product profile at launch, with minimal impact to launch timing

  • Submission will be a Major Amendment to the New Drug Application (NDA), extending the review period by three months with an expected PDUFA target action date in February 2023

Illumina Pummeled On Light Earnings Guidance Despite Quarterly Beat

 Illumina stock plummeted late Thursday after the biggest genomics company issued a lighter-than-expected earnings outlook for 2022.

For the year, the company now expects adjusted profit of $2.35 to $2.50 per share. That's well below expectations for $2.78 per share. On a year-over-year basis, earnings would tumble more than 58%. Illumina (ILMN) also posted a sales outlook that came up short.

The light outlook comes at a critical time for Illumina, which is trying to smooth over issues with its acquisition of Grail, a cancer-screening company. European regulators are scrutinizing the deal. Until the European Commission blesses the merger, Grail is being held as a separate company.

In after-hours trades on today's stock market, Illumina stock tumbled 5.9% near 199.50. During the regular session, shares rose a fraction to 211.93.

Illumina Stock Slumps On Light Outlook

During the September quarter, Illumina earned 34 cents per share, minus some items. Earnings fell almost 77%, but topped forecasts by four pennies. Sales inched 1% higher to $1.12 billion and were above calls for $1.11 billion, according to FactSet.

The lion's share of sales came from Illumina's core business. Grail, which initially spun off from Illumina several years ago, brought in $10 million in sales vs. $2 million in the year-ago period.

Illumina called for its core revenue to be flat this year, and for Grail to generate $55 million to $65 million in sales. All together, the guidance missed Illumina stock analysts' forecast for $4.71 billion in sales. Last year, Illumina reported $4.53 billion in sales.

https://www.investors.com/news/technology/illumina-stock-illumina-earnings-q3-2022/

Pulmonx cuts outlook

 2022 Financial Outlook

Pulmonx is updating its full year 2022 revenue guidance to be in the range of $51.5 million to $52.5 million, as compared to previously communicated guidance of $55 million to $60 million.

The Company now expects total operating expenses for the full year 2022 to fall in the range of $98 million to $100 million, as compared to previously communicated guidance of $100 million to $105 million, inclusive of stock-based compensation.

Webcast and Conference Call Details
Pulmonx will host a conference call today, November 3, 2022, at 1:30 p.m. PT / 4:30 p.m. ET to discuss its third quarter 2022 financial results. Investors interested in listening to the conference call should register online. Participants are required to register a day in advance or at minimum 15 minutes before the start of the call. A live webcast of the conference call will be available on the Investor Relations section of the Company's website at https://investors.pulmonx.com/. The webcast will be archived on the website following the completion of the call.

https://www.globenewswire.com/news-release/2022/11/03/2548321/0/en/Pulmonx-Reports-Third-Quarter-2022-Financial-Results.html