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Wednesday, May 5, 2021

Genmab Q1 results and update

 

  • Genmab and Seagen Inc. submitted tisotumab vedotin Biologics License Application (BLA) to the U.S. FDA for patients with recurrent or metastatic cervical cancer

  • First patient dosed in Phase 3 epcoritamab study triggers USD 40 million milestone in collaboration with AbbVie Inc.

  • DARZALEX® net sales increased 46% compared to the first quarter of 2020 to USD 1,365 million, resulting in royalty income of DKK 984 million

  • Janssen Biotech, Inc. granted U.S. FDA approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for patients with newly diagnosed light-chain (AL) amyloidosis

  • Novartis received positive CHMP opinion, followed by approval in Europe, for Kesimpta® (ofatumumab) in the treatment of relapsing forms of multiple sclerosis in adults with active disease defined by clinical or imaging features

Outlook
Genmab is maintaining its 2021 financial guidance published on February 23, 2021.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first quarter of 2021 today, Wednesday, May 5, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial
+1 631 913 1422 (U.S. participants) or +44 3333 000804 (international participants) and provide conference code 29164332.

A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.

https://finance.yahoo.com/news/genmab-announces-financial-results-first-150100576.html

FDA approval tracker: April

 Last month was loaded with US FDA knockbacks and delays. Reviews of four Jak inhibitors – abrocitinib, Xeljanz, Olumiant and Rinvoq – were pushed back until the third quarter, apparently on ongoing toxicity concerns with the class. Manufacturing inspection issues also rumbled on, resulting in a delay for Sol-Gel’s rosacea cream Epsolay and a CRL for Protalix’s Fabry candidate pegunigalsidase alfa. Meanwhile, the FDA’s adcom on accelerated approvals for anti-PD-(L)1 drugs gave positive votes for four of six indications discussed. The panel pushed back against Keytruda’s use in late-line gastric cancer and Opdivo’s in second-line liver cancer. Separately, Glaxosmithkline’s own anti-PD-L1 MAb Jemperli finally gained accelerated approved in second-line mismatch repair-deficient endometrial cancer, after a five-month delay caused by Covid-19 travel restrictions.

Notable first-time US approval decisions in April
ProjectCompany2026e sales by indication ($m)Outcome
Abrocitinib
(PF-04965842)
Pfizer1,127Decision extended to early Q3
Zynlonta (loncastuximab tesirine)ADC Therapeutics1,025Approved (accelerated) ~1 mth early
Jemperli
(dostarlimab)
Glaxosmithkline546Approved (accelerated)
Eohilia
(TAK-721)
Takeda350No decision yet
Oral sulopenem etzadroxilIterum329FDA needs more time to review filing, 2 Jun adcom postponed
IV TramadolAvenue273No decision yet
Qelbree
(SPN-812)
Supernus265Approved
TanezumabPfizer/Lilly155No decision yet
EpsolaySol-Gel-Delayed (manufacturing inspection)
Pegunigalsidase alfaProtalix-CRL (manufacturing inspection)
Adtralza (tralokinumab)Leo Pharma-CRL
Nextstellis
(Estelle)
Mithra/Mayne Pharma Group-Approved
TeplizumabProvention Bio-Deficiencies in filing, 27 May adcom
Source: Evaluate Pharma & company releases.

https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-april-0

Uber, Lyft Face Driver Shortages, Biden Unveils More Anti-Business, 'Gig Worker' Rule Threats

 Update (0915ET): The Biden administration has canceled a signature Trump-era rule that would’ve eased businesses’ ability to legally consider workers as independent contractors.

The U.S. Labor Department said the rollback was necessary to broadly extend wage protections while cracking down on employer abuses.

A final rule, issued Wednesday, rescinded the pro-business regulation without replacing it with a new interpretation of when workers can function as independent contractors and when they must be classified as employees under federal law, who are entitled to minimum wage and overtime pay.

In addition to dealing with potential looming regulation nationwide that could turn "contractors" into "employees" - essentially eviscerating their entire business models - Uber and Lyft are also in the midst of dealing with a nationwide shortage in drivers. 

"A lot of gig workers should be classified as employees,” U.S. Labor Secretary Marty Walsh said last week, according to Reuters. This added to President Joe Biden's campaign promises of making sure that gig workers received benefits. 

The comments cause shares of Uber and Lyft to temporarily plunge, with both names falling between 8% and 12%, before recovering. 

In addition to the looming threat to their business models, the companies are also having trouble serving the increased demand. Reuters notes that "many U.S. drivers still unwilling to return to the road over safety and financial concerns, meaning the companies risk disgruntled customers or higher costs to incentivize drivers to return."

Bernstein said in a recent note: "(It's) a better problem to have, but one that could put wrinkles in profitability timelines it if persists."

Lyft reported earnings on Tuesday after the bell, showing signs of a continued pandemic recovery and beating top and bottom line expectations, according to CNBC. Uber is expected to report earnings on Wednesday after the bell. The consensus EPS estimate for Uber heading into Wednesday is -$0.35 and revenue is expected to come in at $3.28 billion.

“We continue to believe there is still significant pent-up demand for mobility that will take time to play out,” Lyft CEO Logan Green said on the company's conference call.

If they can find the drivers...

https://www.zerohedge.com/markets/uber-and-lyft-now-face-driver-shortages-addition-gig-worker-regulatory-threats

Infected Indian Foreign Minister Disrupts G-7 Summit In London

 As India's brutal second COVID-19 wave spills over its borders and across the region, a team of forecasters at the Indian Institute of Science in Bangalore has warned - using a mathematical model - that deaths could double as soon as next week, India's foreign minister is now self-isolating after two delegates to recent G-7 meetings in London tested positive to the virus, Bloomberg reports.

India's External Affairs Minister Subrahmanyam Jaishankar was reportedly informed that he had been exposed to somebody infected with the virus on Wednesday, one day after Jaishankar held a socially distanced in-person meeting with UK home secretary Priti Patel on Tuesday, where the two agreed on a "migration and mobility deal' which will provide a "bespoke route" for young professionals from India looking to live and work in the UK. Jaishankar also met Antony Blinken, the US secretary of state, earlier this week.

As one twitter wit pointed out, the incident is like a metaphor for India's current situation, as more public-health experts warn that India's worsening outbreak risks reviving outbreaks in the US and Europe. Many countries have moved to cut off all non-essential travel between India for exactly this reason.

As Bloomberg points out, the blowback could turn into an embarrassment for the US and the Biden Administration. The announcement could swiftly shut down a high-profile event that is supposed to mark the G-7 debut of Secretary of State Antony Blinken. The two-day event is being hosted by the UK.

Fortunately, according to the FT, members of the Indian delegation hadn't yet attended G7 meetings in Lancaster House, London, where talks took place on Tuesday and continued on Wednesday.

The meetings, the first face-to-face gathering of the group’s foreign ministers in more than two years, were set to include representatives from Australia and India in some of the sessions alongside the G-7 advanced economies as the UK (and the US) seeks to strengthen its ties within the Indo-Pacific region.

British PM Boris Johnson defended the decision to hold the G7 meetings in person, arguing that it was important for the government “to try to continue as much business” as possible despite the pandemic. 

"We have a very important relationship with India and with our G7 partners”, he said while campaigning ahead of Thursday’s local elections. “As I understand it, what has happened is the individuals concerned are all isolating now,” he said.

BoJo added that he would have a meeting with Jaishankar on Wednesday afternoon via Zoom.

Officials believe that, based on discussions with Public Health England, those who attended meetings with Jaishankar have a low risk of contracting the virus. Still, fears about possible spread are already disrupting the summit, and could force delegates to attend meetings remotely from their hotel rooms.

Meanwhile, India reported a record 3,780 deaths on Wednesday for an overall toll of 226,188, along with 382,315 new cases, taking its outbreak past 20.6 million infections.

https://www.zerohedge.com/covid-19/infected-indian-foreign-minister-disrupts-g-7-summit-london

Peloton to recall treadmills after reports of injuries, one death

 Exercise equipment maker Peloton Interactive Inc is recalling its Tread+ and Tread treadmill machines after injuries and a death, according to a statement by the United States Consumer Product Safety Commission.

The recall comes more than a month after Peloton Chief Executive Officer John Foley asked owners of its treadmills to check safety warnings after a child died in an accident involving the company's exercise equipment.

"I want to be clear, Peloton made a mistake in our initial response to the Consumer Product Safety Commission's request that we recall the Tread+," Foley said in a statement.

"We should have engaged more productively with them from the outset. For that, I apologize".

The agency said Peloton has also stopped sale and distribution of the Tread+ and continues to work on additional hardware modifications.

https://finance.yahoo.com/news/1-peloton-recall-treadmills-reports-142434754.html

Nemaura Medical Announces Order for 200,000 sugarBEAT® Sensors

 Nemaura Medical, Inc. (NASDAQ: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing and commercializing non-invasive wearable diagnostic devices and supporting personalized lifestyle coaching programs, today announced receipt of a purchase order for 5,000 sugarBEAT® transmitters and 200,000 sugarBEAT® sensors from its U.K. licensee, DB Ethitronix Ltd, with an additional rolling monthly purchase order forecast for the next 24 months of 15,000 transmitters and 2.1 million sensors, with an option to increase volumes based on customer response.

This order follows positive feedback from DB Ethitronix’s soft launch of the sugarBEAT® non-invasive glucose monitoring (CGM) device in the U.K. DB Ethitronix has established a subscription service for diabetes management supported by the sugarBEAT® technology. User feedback has been extremely positive due to the fact that sugarBEAT® is the only daily-wear glucose monitoring device in the world that gives users the flexibility to monitor their glucose levels according to their own schedule, resulting in lowered costs to the end user. Based on the success of the soft launch in the U.K., the Company is advancing discussions for joint launches in Germany, Saudi Arabia and UAE.

“SugarBEAT® along with the adaptions provided by proBEAT® and the resulting BEAT® diabetes program, are a culmination of 10 years of research, development and human trials. We believe our technology is ground-breaking and represents a paradigm shift in the way persons with diabetes can manage their condition. We believe we have a critical first mover advantage with a product that is easier to use, more flexible and more cost-effective than existing technologies. We are not aware of any product of a similar nature in clinical studies or that has been submitted for regulatory approval,” said Nemaura CEO Dr. Faz Chowdhury. “As a result, we are very optimistic about our ability to drive sales and increase market share in Europe and ultimately the U.S. and elsewhere. We believe our device has the potential to significantly change the way people prevent, manage, and even possibly reverse Type 2 diabetes.

In preparation for the worldwide commercialization of SugarBEAT® the Company expects to:

  • Commence delivery of the sugarBEAT® transmitters and sensors to our U.K. licensee

  • Establish distribution channels in additional European territories, the U.S., and the Middle East

  • Enhance production capabilities through key partnerships

  • Focus on building a world-class sales and marketing team and strategy

AmerisourceBergen: Q2 Earnings Insights

 

Quarterly Results

Earnings per share rose 5.42% year over year to $2.53, which beat the estimate of $2.48.

Revenue of $49,154,000,000 higher by 3.66% from the same period last year, which missed the estimate of $49,850,000,000.

Guidance

AmerisourceBergen raised FY21 adjusted EPS guidance from $8.40-$8.60 to $8.45-$8.60.

Conference Call

Date: May 05, 2021

Time: 08:30 AM

ET Webcast URL: https://event.on24.com/eventRegistration/EventLobbyServlet?target=reg20.jsp&referrer=https%3A%2F%2Finvestor.amerisourcebergen.com%2F&eventid=2945

https://www.benzinga.com/news/earnings/21/05/20959483/amerisourcebergen-q2-earnings-insights