Clovis: Revenue decline on Rubraca sales

 

• ATHENA study evaluating Rubraca® (rucaparib) monotherapy versus placebo (ATHENA-MONO) in first-line ovarian cancer maintenance treatment successfully achieved the primary endpoint of improved PFS in both populations in the primary efficacy analyses: HRD-positive and all patients randomized (ITT)

  • Median PFS of 20.2 months for Rubraca vs 9.2 months for placebo in ITT population

  • Late-breaker data to be presented in oral session at 2022 ASCO Annual Meeting on Monday, June 6

• Two additional top-line Phase 3 data read-outs for Rubraca expected in next 12 months with potential to address ovarian and prostate cancer patient populations

• Initial Phase 1 clinical data for targeted radiotherapy candidate FAP-2286 to be presented in oral presentation at SNMMI 2022 Annual Meeting on Tuesday, June 14

  • Initiation of Phase 2 expansion cohorts in multiple tumor types anticipated in Q4 2022

• $34.2M in Rubraca global net product revenues for Q1 2022, down 10% vs Q1 2021 and down 5% vs Q4 2021

  • Continued impact of COVID-19 on ovarian cancer diagnoses and treatments

• Reduction in R&D expense of $10.6M or 20% compared to Q1 2021

• $122.2M in cash and cash equivalents and $18.6M in available funding under the ATHENA financing at March 31, 2022

https://finance.yahoo.com/news/clovis-oncology-announces-first-quarter-120000026.html

eHealth conference call excerpt

 Our first quarter '22 revenue was in line with an adjusted EBITDA was ahead of our expectations. While the enrollment quality initiatives that we introduced in July of last year are still impacting telephonic conversion rates, we've also seen encouraging quality and retention metrics from the most recent Annual Enrollment Period cohort, members that we enroll during the fourth quarter with the policy effective date of January 1st, '22.

The initial traction we're seeing through the early part of 2022 combined with positive carrier feedback, reinforces our belief that eHealth can establish itself as a leader in Medicare distribution as this market moves away from volume at all costs and toward growth built on a foundation of enrollment quality, enhance consumer experience, and cash flow generation. One of the key priorities for me and the leadership team is to leverage this trend and to enhance member economics and return the company to profitable growth. As an increasing number of Americans age in the Medicare eligibility every day, we believe we are well-positioned to connect them efficiently and appropriately for the best plans to serve their needs based on our broad plan selection, consumer-centric approach, and data-driven recommendation algorithms. Our omnichannel shopping and enrollment capabilities give eHealth an advantage in attracting a broad range of customers, including younger Medicare eligible and new to M&A enrollees.

eHealth online platform is also a differentiator for our Individual family and small business segments, where more than 90% of it enrollments are completed online with no agent assistance. In line with our strategic plan, we're slowing down our conventional telephonic enrollment growth while continuing to invest in online business to expand and capture market share. The number of visitors to our online Medicare platform, top 3.2 million in Q1 representing 24% year-over-year growth. First quarter total Medicare Advantage online, unassisted applications grew to more than 11,000 submissions, up 50% compared to Q1 of 2021.

https://www.fool.com/earnings/call-transcripts/2022/05/04/ehealth-ehth-q1-2022-earnings-call-transcript/

Amarin FInancial, Business Update

 Initiated Next Phase of European Expansion Strategy with First National Reimbursement in Sweden

Market Access Negotiations and Launch Preparations for VAZKEPA Underway Across Multiple European Markets

Continued Progress on Go-To-Market Strategy in the US

Plans for Regulatory Filings for Approval of VASCEPA® (icosapent ethyl) in Several Additional Countries in 2022

Company to Host Conference Call Today at 8:00 a.m. ET

2022 Financial Outlook

Given the ongoing global impact of COVID-19, as well as the uncertainty resulting from the impact of generic IPE availability in the U.S. and challenges for most drugs seeking market access in Europe, Amarin will continue to suspend 2022 revenue guidance; however, the company will continue to evaluate its ability to provide greater financial outlook insight as the year progresses.

U.S. commercial operations are expected to continue to operate on a contribution margin positive basis. Amarin will continue to invest in building the appropriate infrastructure and foundation in Europe for successful commercial launches and to advance necessary actions to support regulatory activities in other international markets. Amarin will also progress lifecycle management (LCM) opportunities as described. The company will continue to evaluate its planned operational spend in 2022 and adjust if assumptions warrant it.

Amarin reiterates its belief that current cash and investments and other assets are adequate to support continued operations, including European launch activities for at least the next twelve months.

Conference Call and Webcast Information:

Amarin will host a conference call on May 4, 2022, at 8:00 a.m. ET to discuss this information. The conference call can be accessed on the investor relations section of the company's website at www.amarincorp.com, or via telephone by dialing 888-506-0062 within the United States, 973-528-0011 from outside the United States, and referencing conference ID 930259. A replay of the call will be made available for a period of two weeks following the conference call. To listen to a replay of the call, dial 877-481-4010 from within the United States and 919-882-2331 from outside of the United States, and reference conference ID 45008. A replay of the call will also be available through the company's website shortly after the call.

https://finance.yahoo.com/news/amarin-reports-first-quarter-2022-110000354.html

Connect Biopharma Top Line Trial Result Not Significant

 

• Primary endpoint of change from baseline on adapted Mayo Score for CBP-307 0.2 mg once-daily, orally administered dose showed a numerical improvement, but did not achieve statistical significance

• Clinical Remission on adapted Mayo Score and other secondary endpoints achieved statistical significance with strong evidence of pharmacodynamic activity as measured by reduction in lymphocyte counts, and CBP-307 was observed to be generally well tolerated

• Company intends to engage in partnership discussions for future development of CBP-307 to focus on lead program CBP-201 (IL4R antagonist)

https://finance.yahoo.com/news/connect-biopharma-announces-week-12-200500657.html

TransMedics Reports First Quarter 2022 Financial Results

 

• Net revenue of $15.9 million in the first quarter of 2022, a 125% increase compared to the first quarter of 2021

• Received FDA pre-market approval (PMA) of OCS™ DCD heart indication on April 28, 2022

• Results from the U.S. randomized OCS™ DCD Heart trial along with OCS™ Lung Trial 5-year data presented at the International Society of Heart and Lung Transplantation (ISHLT) annual meeting

https://finance.yahoo.com/news/transmedics-reports-first-quarter-2022-200500302.html

'Lost microbes of COVID-19'

 Sabine Hazan 1, Neil Stollman 2, Huseyin S Bozkurt 3, Sonya Dave 4 5, Andreas J Papoutsis 6, Jordan Daniels 6, Brad D Barrows 6, Eamonn Mm Quigley 7, Thomas J Borody 8

• DOI: 10.1136/bmjgast-2022-000871

• Abstract

  Objective: The study objective was to compare gut microbiome diversity and composition in SARS-CoV-2 PCR-positive patients whose symptoms ranged from asymptomatic to severe versus PCR-negative exposed controls.

  Design: Using a cross-sectional design, we performed shotgun next-generation sequencing on stool samples to evaluate gut microbiome composition and diversity in both patients with SARS-CoV-2 PCR-confirmed infections, which had presented to Ventura Clinical Trials for care from March 2020 through October 2021 and SARS-CoV-2 PCR-negative exposed controls. Patients were classified as being asymptomatic or having mild, moderate or severe symptoms based on National Institute of Health criteria. Exposed controls were individuals with prolonged or repeated close contact with patients with SARS-CoV-2 infection or their samples, for example, household members of patients or frontline healthcare workers. Microbiome diversity and composition were compared between patients and exposed controls at all taxonomic levels.

  Results: Compared with controls (n=20), severely symptomatic SARS-CoV-2-infected patients (n=28) had significantly less bacterial diversity (Shannon Index, p=0.0499; Simpson Index, p=0.0581), and positive patients overall had lower relative abundances of Bifidobacterium (p<0.0001), Faecalibacterium (p=0.0077) and Roseburium (p=0.0327), while having increased Bacteroides (p=0.0075). Interestingly, there was an inverse association between disease severity and abundance of the same bacteria.

  Conclusion: We hypothesise that low bacterial diversity and depletion of Bifidobacterium genera either before or after infection led to reduced proimmune function, thereby allowing SARS-CoV-2 infection to become symptomatic. This particular dysbiosis pattern may be a susceptibility marker for symptomatic severity from SARS-CoV-2 infection and may be amenable to preinfection, intrainfection or postinfection intervention.

• https://pubmed.ncbi.nlm.nih.gov/35483736/

Beijing to Postpone School Reopening at Least 1 Week After Labour Day Holiday

 Beijing will postpone school reopening for at least one week after the labour day holiday, an official said at a press briefing on Tuesday.

The date when schools can resume will be decided after studying the COVID situation in the city, Li Yi, spokesperson with Beijing municipal education commission, said.

https://www.usnews.com/news/world/articles/2022-05-03/beijing-to-postpone-school-reopening-for-at-least-one-week-after-labour-day-holiday